Use of bilateral internal mammary arteries in CABG stagnates

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HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.

“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”

The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.

Dr. Alexander Iribarne of Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
Dr. Alexander Iribarne
The researchers found that the absolute national rate of BIMA use fell from 0.216 claims per 1,000 beneficiaries in 2009 to 0.143 in 2014 (P less than .001). However, when indexed with CABG use, the use of BIMA remained constant over time (P = .02). When Dr. Iribarne and his associates aggregated single internal mammary artery (SIMA) use by hospital referral region, which is a validated unit for quantifying regional variation in health care, it ranged from 1.3 to 8.5 claims per 1,000 beneficiaries, while BIMA use ranged from 0 to 1.5 (P less than .001). They also observed a significant correlation between volume of SIMA use and likelihood of BIMA use as reflected in a correlation coefficient of 0.673 (P less than .001).

“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”

A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.

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HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.

“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”

The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.

Dr. Alexander Iribarne of Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
Dr. Alexander Iribarne
The researchers found that the absolute national rate of BIMA use fell from 0.216 claims per 1,000 beneficiaries in 2009 to 0.143 in 2014 (P less than .001). However, when indexed with CABG use, the use of BIMA remained constant over time (P = .02). When Dr. Iribarne and his associates aggregated single internal mammary artery (SIMA) use by hospital referral region, which is a validated unit for quantifying regional variation in health care, it ranged from 1.3 to 8.5 claims per 1,000 beneficiaries, while BIMA use ranged from 0 to 1.5 (P less than .001). They also observed a significant correlation between volume of SIMA use and likelihood of BIMA use as reflected in a correlation coefficient of 0.673 (P less than .001).

“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”

A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.

 

HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.

“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”

The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.

Dr. Alexander Iribarne of Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
Dr. Alexander Iribarne
The researchers found that the absolute national rate of BIMA use fell from 0.216 claims per 1,000 beneficiaries in 2009 to 0.143 in 2014 (P less than .001). However, when indexed with CABG use, the use of BIMA remained constant over time (P = .02). When Dr. Iribarne and his associates aggregated single internal mammary artery (SIMA) use by hospital referral region, which is a validated unit for quantifying regional variation in health care, it ranged from 1.3 to 8.5 claims per 1,000 beneficiaries, while BIMA use ranged from 0 to 1.5 (P less than .001). They also observed a significant correlation between volume of SIMA use and likelihood of BIMA use as reflected in a correlation coefficient of 0.673 (P less than .001).

“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”

A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.

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Key clinical point: Over the past 5 years, there was no growth in BIMA use among Medicare beneficiaries.

Major finding: The absolute national rate of BIMA use fell from 0.216 claims per 1,000 beneficiaries in 2009 to 0.143 in 2014 (P less than .001).

Data source: An analysis of medical records from nearly 150 million Medicare beneficiaries during 2009-2014.

Disclosures: Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.

Moderate stenosis in coronary arteries grows severe over time

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Wed, 01/02/2019 - 09:47

 

HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

Dr. Joseph F. Sabik III, of the department of surgery and the Harrington Heart and Vascular Institute at University Hospitals Cleveland Medical Center
Dr. Joseph F. Sabik


The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.

“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”

Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.

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HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

Dr. Joseph F. Sabik III, of the department of surgery and the Harrington Heart and Vascular Institute at University Hospitals Cleveland Medical Center
Dr. Joseph F. Sabik


The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.

“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”

Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.

 

HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

Dr. Joseph F. Sabik III, of the department of surgery and the Harrington Heart and Vascular Institute at University Hospitals Cleveland Medical Center
Dr. Joseph F. Sabik


The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.

“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”

Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.

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Key clinical point: Internal thoracic artery grafting of moderately stenosed coronary arteries should be considered.

Major finding: At 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 72% of nongrafted coronary arteries, in 87% of internal thoracic artery–grafted arteries, and in 92% of saphenous vein–grafted moderately stenosed coronary arteries.

Data source: An analysis of medical records from 55,567 patients who underwent primary isolated CABG at the Cleveland Clinic from 1972 to 2011.

Disclosures: Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.

Nicardipine okay to use after pediatric cardiac surgery

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Tue, 02/14/2023 - 13:06

 

HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Dr. Matthew L. Stone stands by his poster at the meeting.
Doug Brunk/Frontline Medical News
Dr. Matthew L. Stone


In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.

Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.

No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.

“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.

“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”

Dr. Stone reported having no financial disclosures.

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HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Dr. Matthew L. Stone stands by his poster at the meeting.
Doug Brunk/Frontline Medical News
Dr. Matthew L. Stone


In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.

Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.

No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.

“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.

“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”

Dr. Stone reported having no financial disclosures.

 

HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Dr. Matthew L. Stone stands by his poster at the meeting.
Doug Brunk/Frontline Medical News
Dr. Matthew L. Stone


In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.

Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.

No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.

“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.

“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”

Dr. Stone reported having no financial disclosures.

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Key clinical point: Hesitation to use nicardipine after cardiac surgery in infants should be reevaluated.

Major finding: The incidence of adverse postoperative events was similar between children who were younger than 6 months and those who were older than 6 months (17% vs. 9%, respectively), but no significant adverse events, including stroke and cardiogenic shock, occurred in either group.

Data source: A retrospective review of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery during 2010-2015.

Disclosures: Dr. Stone reported having no financial disclosures.

Study finds community-hospital lung cancer screening feasible

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HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

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HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

 

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

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Key clinical point: Challenges with lung cancer screening include concerns about precertification delays.

Major finding: Of patients who participated in a community screening program over the course of 1 year, 88% were diagnosed with Lung-RADS 1 or 2, 7% were Lung-RADS 3, and 5% were Lung-RADS 4.

Data source: A 12-month prospective study of 278 patients at risk for lung cancer.

Disclosures: One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.

VIDEO: Public reporting of congenital heart disease outcomes should be easily understood

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Tue, 02/14/2023 - 13:06

 

HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.

Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.

“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”

Dr. Irons reported having no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.

Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.

“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”

Dr. Irons reported having no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.

Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.

“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”

Dr. Irons reported having no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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FROM THE STS ANNUAL MEETING HOUSTON

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After TAVR, 1 in 10 Medicare patients need permanent pacemaker

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Fri, 01/18/2019 - 16:30

 

HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.

“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).

To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.

Dr. Fenton McCarthy


The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.

The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).

Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).

In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).

“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”

A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.

Dr. McCarthy reported having no financial disclosures.

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Dr. Hossein Almassi
Dr. Hossein Almassi
G. Hossein Almassi, MD, FCCP, comments: The need for new permanent pacemaker implantation in TAVR patients has been higher as compared with surgical AVR. The current analysis on the administrative database of Medicare patients undergoing TAVR has the advantage of a large sample size but lacks details at the patient level. The PARTNER 2A trial in medium-risk patients (N Engl J Med. 2016;374:1609-20) found no statistical difference between TAVR and surgical AVR for the need for permanent pacemaker implantation at 30 days (8.5% and 6.9%, respectively; P = 0.17).

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Dr. Hossein Almassi
Dr. Hossein Almassi
G. Hossein Almassi, MD, FCCP, comments: The need for new permanent pacemaker implantation in TAVR patients has been higher as compared with surgical AVR. The current analysis on the administrative database of Medicare patients undergoing TAVR has the advantage of a large sample size but lacks details at the patient level. The PARTNER 2A trial in medium-risk patients (N Engl J Med. 2016;374:1609-20) found no statistical difference between TAVR and surgical AVR for the need for permanent pacemaker implantation at 30 days (8.5% and 6.9%, respectively; P = 0.17).

Body

Dr. Hossein Almassi
Dr. Hossein Almassi
G. Hossein Almassi, MD, FCCP, comments: The need for new permanent pacemaker implantation in TAVR patients has been higher as compared with surgical AVR. The current analysis on the administrative database of Medicare patients undergoing TAVR has the advantage of a large sample size but lacks details at the patient level. The PARTNER 2A trial in medium-risk patients (N Engl J Med. 2016;374:1609-20) found no statistical difference between TAVR and surgical AVR for the need for permanent pacemaker implantation at 30 days (8.5% and 6.9%, respectively; P = 0.17).

 

HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.

“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).

To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.

Dr. Fenton McCarthy


The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.

The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).

Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).

In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).

“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”

A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.

Dr. McCarthy reported having no financial disclosures.

 

HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.

“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).

To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.

Dr. Fenton McCarthy


The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.

The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).

Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).

In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).

“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”

A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.

Dr. McCarthy reported having no financial disclosures.

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Key clinical point: Permanent pacemaker placement in Medicare TAVR patients is not uncommon during index hospitalization, though rare thereafter.

Major finding: Pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).

Data source: A study of 14,305 Medicare beneficiaries who underwent TAVR between January 2011 and December 2013.

Disclosures: Dr. McCarthy reported having no financial disclosures.

SAVR an option for elderly with aortic stenosis

G. Hossein Almassi, MD, FCCP, comments on SAVR an option for elderly with aortic stenosis
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HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.

“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.

Dr. Vinod H. Thourani speaks during the Society of Thoracic Surgery annual meeting.
Doug Brunk/Frontline Medical News
Dr. Vinod H. Thourani

The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).

Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.

The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.

Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.

The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.

The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)

Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.

“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”

Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.

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This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediate­risk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.

Dr. Hossein Almassi
2016;374:1609-20). The trial proved the noninferiority of the catheter-based aortic valve implantation as compared with surgical AVR. With further refinement and advances in technology and design of these valves, and, more importantly, patients’ demand, the TAVR is destined to become the main stay of the AVR for patients with severe aortic stenosis.

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This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediate­risk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.

Dr. Hossein Almassi
2016;374:1609-20). The trial proved the noninferiority of the catheter-based aortic valve implantation as compared with surgical AVR. With further refinement and advances in technology and design of these valves, and, more importantly, patients’ demand, the TAVR is destined to become the main stay of the AVR for patients with severe aortic stenosis.

Body

This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediate­risk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.

Dr. Hossein Almassi
2016;374:1609-20). The trial proved the noninferiority of the catheter-based aortic valve implantation as compared with surgical AVR. With further refinement and advances in technology and design of these valves, and, more importantly, patients’ demand, the TAVR is destined to become the main stay of the AVR for patients with severe aortic stenosis.

Title
G. Hossein Almassi, MD, FCCP, comments on SAVR an option for elderly with aortic stenosis
G. Hossein Almassi, MD, FCCP, comments on SAVR an option for elderly with aortic stenosis

 

HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.

“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.

Dr. Vinod H. Thourani speaks during the Society of Thoracic Surgery annual meeting.
Doug Brunk/Frontline Medical News
Dr. Vinod H. Thourani

The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).

Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.

The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.

Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.

The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.

The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)

Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.

“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”

Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.

 

HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.

“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.

Dr. Vinod H. Thourani speaks during the Society of Thoracic Surgery annual meeting.
Doug Brunk/Frontline Medical News
Dr. Vinod H. Thourani

The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).

Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.

The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.

Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.

The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.

The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)

Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.

“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”

Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.

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Key clinical point: Mortality in medium-risk elderly patients who receive SAVR is similar to that of those treated with TAVR.

Major finding: All-cause operative mortality was 4.1%, which is lower than STS predicted risk models.

Data source: A study of 937 medium-risk patients with aortic stenosis who were randomized to SAVR in the PARTNER 2A trial.

Disclosures: Dr. Thourani is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.

Parents seek easily understood public reporting of cardiac outcome measures

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HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.

“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”

Dr. Mallory Irons of the University of Pennsylvania, Philadelphia
Dr. Mallory Irons
Dr. Irons, who is an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia, noted that the star rating system used by the STS assigns one, two, or three stars to hospitals performing pediatric heart surgery, with two stars representing expected performance, three stars representing better than expected performance, and one star representing worse performance than expected. In contrast to the STS star rating system, she continued, the Pennsylvania Health Care Cost Containment Council has adopted a different approach, reporting tabular hospital-specific discharge mortality data for each STS benchmark operation separately.

“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.

“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”

She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.

Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.

When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.

Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.

Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”

In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.

“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”

Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”

Dr. Irons reported having no financial disclosures.

 

 

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HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.

“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”

Dr. Mallory Irons of the University of Pennsylvania, Philadelphia
Dr. Mallory Irons
Dr. Irons, who is an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia, noted that the star rating system used by the STS assigns one, two, or three stars to hospitals performing pediatric heart surgery, with two stars representing expected performance, three stars representing better than expected performance, and one star representing worse performance than expected. In contrast to the STS star rating system, she continued, the Pennsylvania Health Care Cost Containment Council has adopted a different approach, reporting tabular hospital-specific discharge mortality data for each STS benchmark operation separately.

“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.

“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”

She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.

Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.

When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.

Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.

Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”

In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.

“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”

Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”

Dr. Irons reported having no financial disclosures.

 

 

 

HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.

“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”

Dr. Mallory Irons of the University of Pennsylvania, Philadelphia
Dr. Mallory Irons
Dr. Irons, who is an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia, noted that the star rating system used by the STS assigns one, two, or three stars to hospitals performing pediatric heart surgery, with two stars representing expected performance, three stars representing better than expected performance, and one star representing worse performance than expected. In contrast to the STS star rating system, she continued, the Pennsylvania Health Care Cost Containment Council has adopted a different approach, reporting tabular hospital-specific discharge mortality data for each STS benchmark operation separately.

“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.

“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”

She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.

Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.

When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.

Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.

Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”

In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.

“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”

Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”

Dr. Irons reported having no financial disclosures.

 

 

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Key clinical point: A numerical, procedure-based format is the parent-preferred display method for outcomes data.

Major finding: When parents of children with congenital heart disease were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme, they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important

Data source: A retrospective survey of 1,862 parents of children born with heart defects.

Disclosures: Dr. Irons reported having no financial disclosures.

Mortality may be reduced when surgical ablation for AF is done with mitral operations

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HOUSTON – At the time of mitral valve repair or replacement operations, the addition of surgical ablation to treat atrial fibrillation (AF) can be performed without increased risk of mortality, results from a large cohort study has demonstrated.

“Surgical ablation for atrial fibrillation performed concomitant to mitral valve repair or replacement is accepted to reduce long-term AF rates and improve quality of life, and has recently attained a class I, level of evidence A recommendation in the recent Society of Thoracic Surgeons Guidelines,” Vinay Badhwar, MD, said in an interview. Dr. Badhwar is the lead author of the STS Guidelines and senior author of the current study on mortality following surgical ablation of AF. “Nevertheless, the direct impact of surgical ablation on operative mortality has not been studied on a large scale using robust registry data.”

Dr. Vinay Badhwar
Dr. Vinay Badhwar


In an effort to examine the impact of performing or not performing surgical ablation (SA) on mortality of contemporary mitral valve repair or replacement (MVRR) operations, Dr. Badhwar, Gordon F. Murray Professor and Chair, department of cardiovascular and thoracic surgery at West Virginia University, Morgantown, W.Va., and his associates at eight other leading centers nationwide evaluated the medical records of 88,765 MVRR patients in the STS Adult Cardiac Surgery Database between July 2011 and June 2014.

The research, presented as the Richard E. Clark award winning paper in adult cardiac surgery by study leader J. Scott Rankin, MD, professor of surgery in the department of cardiovascular and thoracic surgery at West Virginia University, included cases of tricuspid repair and coronary artery bypass grafting and assessed all STS comorbid risk variables and mitral etiology for predictors of mortality. After performing multivariable logistic regression, the researchers compared risk-adjusted odds ratios for mortality by AF type at operation and SA performance: group 1 (no AF plus no SA), group 2 (no AF plus SA), group 3 (AF plus no SA), group 4 (AF plus SA), group 5 (persistent AF plus no SA), and group 6 (persistent AF plus SA).

The median age of patients ranged from 63 to 72 years. Compared with their counterparts in other groups, patients in groups 3 and 5 were older (median age of 71 and 72 years, respectively), had worse symptoms (50% in each group had NYHA class III or IV disease), had more reoperations (30% vs. 32%), and had higher unadjusted mortalities (6.7% vs. 6.6%).

Following multivariable risk adjustment, groups 2-6 with AF history plus or minus SA were referenced to group 1 patients without AF or SA. Groups 2-4 represented the overall population, and groups 5 and 6 were patients with persistent AF. Patients with AF at the time of operation not receiving SA (groups 3 and 5) had odds ratios of 1.16 and 1.17, respectively, or an increase of 16% and 17% in relative risk of mortality (P = .004 and P = .01, respectively). In groups 4 and 6, concomitant SA reduced the AF-related mortality to a level that was statistically comparable to reference baseline group 1 without a history of AF (P = .13 and P = .21, respectively).

“The present study appears to clearly illustrate the adverse effects of AF on operative mortality following MVRR,” Dr. Badhwar said. “After thorough risk adjustment, we were impressed to learn that the relative mortality risk of mitral procedures increased by nearly 15% for either paroxysmal or persistent AF, and results were similar for the two AF types. A remote history of AF with preoperative sinus rhythm immediately prior to surgery had little effect on prognosis, and these patients appeared to have outcomes more like those without AF. In patients with active AF at the time of mitral operation, SA reduced the AF-related mortality and decreased operative mortality to levels not statistically different from patients without AF.” He added that the findings of this study support the recent STS Guidelines on Surgical Ablation published in the January 2017 edition of Annals of Thoracic Surgery (Ann Thorac Surg. 2017 Jan;103[1]:329-41). “However, the ultimate decision on whether or not to add surgical ablation must always remain between the surgeon and the patient,” he said.

Dr. Badhwar acknowledged that the study is limited by the information available in version 2.73 of the STS Adult Cardiac Surgery Database. “This does highlight the ongoing need for participants in the database to provide as much complete information as possible for all patients undergoing cardiac operations, especially those involving surgical ablation,” he said.

Dr. Badhwar reported having no financial disclosures. Dr. Rankin disclosed ties with Admedus, AtriCure, and BioStable Science and Engineering.

 

 

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HOUSTON – At the time of mitral valve repair or replacement operations, the addition of surgical ablation to treat atrial fibrillation (AF) can be performed without increased risk of mortality, results from a large cohort study has demonstrated.

“Surgical ablation for atrial fibrillation performed concomitant to mitral valve repair or replacement is accepted to reduce long-term AF rates and improve quality of life, and has recently attained a class I, level of evidence A recommendation in the recent Society of Thoracic Surgeons Guidelines,” Vinay Badhwar, MD, said in an interview. Dr. Badhwar is the lead author of the STS Guidelines and senior author of the current study on mortality following surgical ablation of AF. “Nevertheless, the direct impact of surgical ablation on operative mortality has not been studied on a large scale using robust registry data.”

Dr. Vinay Badhwar
Dr. Vinay Badhwar


In an effort to examine the impact of performing or not performing surgical ablation (SA) on mortality of contemporary mitral valve repair or replacement (MVRR) operations, Dr. Badhwar, Gordon F. Murray Professor and Chair, department of cardiovascular and thoracic surgery at West Virginia University, Morgantown, W.Va., and his associates at eight other leading centers nationwide evaluated the medical records of 88,765 MVRR patients in the STS Adult Cardiac Surgery Database between July 2011 and June 2014.

The research, presented as the Richard E. Clark award winning paper in adult cardiac surgery by study leader J. Scott Rankin, MD, professor of surgery in the department of cardiovascular and thoracic surgery at West Virginia University, included cases of tricuspid repair and coronary artery bypass grafting and assessed all STS comorbid risk variables and mitral etiology for predictors of mortality. After performing multivariable logistic regression, the researchers compared risk-adjusted odds ratios for mortality by AF type at operation and SA performance: group 1 (no AF plus no SA), group 2 (no AF plus SA), group 3 (AF plus no SA), group 4 (AF plus SA), group 5 (persistent AF plus no SA), and group 6 (persistent AF plus SA).

The median age of patients ranged from 63 to 72 years. Compared with their counterparts in other groups, patients in groups 3 and 5 were older (median age of 71 and 72 years, respectively), had worse symptoms (50% in each group had NYHA class III or IV disease), had more reoperations (30% vs. 32%), and had higher unadjusted mortalities (6.7% vs. 6.6%).

Following multivariable risk adjustment, groups 2-6 with AF history plus or minus SA were referenced to group 1 patients without AF or SA. Groups 2-4 represented the overall population, and groups 5 and 6 were patients with persistent AF. Patients with AF at the time of operation not receiving SA (groups 3 and 5) had odds ratios of 1.16 and 1.17, respectively, or an increase of 16% and 17% in relative risk of mortality (P = .004 and P = .01, respectively). In groups 4 and 6, concomitant SA reduced the AF-related mortality to a level that was statistically comparable to reference baseline group 1 without a history of AF (P = .13 and P = .21, respectively).

“The present study appears to clearly illustrate the adverse effects of AF on operative mortality following MVRR,” Dr. Badhwar said. “After thorough risk adjustment, we were impressed to learn that the relative mortality risk of mitral procedures increased by nearly 15% for either paroxysmal or persistent AF, and results were similar for the two AF types. A remote history of AF with preoperative sinus rhythm immediately prior to surgery had little effect on prognosis, and these patients appeared to have outcomes more like those without AF. In patients with active AF at the time of mitral operation, SA reduced the AF-related mortality and decreased operative mortality to levels not statistically different from patients without AF.” He added that the findings of this study support the recent STS Guidelines on Surgical Ablation published in the January 2017 edition of Annals of Thoracic Surgery (Ann Thorac Surg. 2017 Jan;103[1]:329-41). “However, the ultimate decision on whether or not to add surgical ablation must always remain between the surgeon and the patient,” he said.

Dr. Badhwar acknowledged that the study is limited by the information available in version 2.73 of the STS Adult Cardiac Surgery Database. “This does highlight the ongoing need for participants in the database to provide as much complete information as possible for all patients undergoing cardiac operations, especially those involving surgical ablation,” he said.

Dr. Badhwar reported having no financial disclosures. Dr. Rankin disclosed ties with Admedus, AtriCure, and BioStable Science and Engineering.

 

 

HOUSTON – At the time of mitral valve repair or replacement operations, the addition of surgical ablation to treat atrial fibrillation (AF) can be performed without increased risk of mortality, results from a large cohort study has demonstrated.

“Surgical ablation for atrial fibrillation performed concomitant to mitral valve repair or replacement is accepted to reduce long-term AF rates and improve quality of life, and has recently attained a class I, level of evidence A recommendation in the recent Society of Thoracic Surgeons Guidelines,” Vinay Badhwar, MD, said in an interview. Dr. Badhwar is the lead author of the STS Guidelines and senior author of the current study on mortality following surgical ablation of AF. “Nevertheless, the direct impact of surgical ablation on operative mortality has not been studied on a large scale using robust registry data.”

Dr. Vinay Badhwar
Dr. Vinay Badhwar


In an effort to examine the impact of performing or not performing surgical ablation (SA) on mortality of contemporary mitral valve repair or replacement (MVRR) operations, Dr. Badhwar, Gordon F. Murray Professor and Chair, department of cardiovascular and thoracic surgery at West Virginia University, Morgantown, W.Va., and his associates at eight other leading centers nationwide evaluated the medical records of 88,765 MVRR patients in the STS Adult Cardiac Surgery Database between July 2011 and June 2014.

The research, presented as the Richard E. Clark award winning paper in adult cardiac surgery by study leader J. Scott Rankin, MD, professor of surgery in the department of cardiovascular and thoracic surgery at West Virginia University, included cases of tricuspid repair and coronary artery bypass grafting and assessed all STS comorbid risk variables and mitral etiology for predictors of mortality. After performing multivariable logistic regression, the researchers compared risk-adjusted odds ratios for mortality by AF type at operation and SA performance: group 1 (no AF plus no SA), group 2 (no AF plus SA), group 3 (AF plus no SA), group 4 (AF plus SA), group 5 (persistent AF plus no SA), and group 6 (persistent AF plus SA).

The median age of patients ranged from 63 to 72 years. Compared with their counterparts in other groups, patients in groups 3 and 5 were older (median age of 71 and 72 years, respectively), had worse symptoms (50% in each group had NYHA class III or IV disease), had more reoperations (30% vs. 32%), and had higher unadjusted mortalities (6.7% vs. 6.6%).

Following multivariable risk adjustment, groups 2-6 with AF history plus or minus SA were referenced to group 1 patients without AF or SA. Groups 2-4 represented the overall population, and groups 5 and 6 were patients with persistent AF. Patients with AF at the time of operation not receiving SA (groups 3 and 5) had odds ratios of 1.16 and 1.17, respectively, or an increase of 16% and 17% in relative risk of mortality (P = .004 and P = .01, respectively). In groups 4 and 6, concomitant SA reduced the AF-related mortality to a level that was statistically comparable to reference baseline group 1 without a history of AF (P = .13 and P = .21, respectively).

“The present study appears to clearly illustrate the adverse effects of AF on operative mortality following MVRR,” Dr. Badhwar said. “After thorough risk adjustment, we were impressed to learn that the relative mortality risk of mitral procedures increased by nearly 15% for either paroxysmal or persistent AF, and results were similar for the two AF types. A remote history of AF with preoperative sinus rhythm immediately prior to surgery had little effect on prognosis, and these patients appeared to have outcomes more like those without AF. In patients with active AF at the time of mitral operation, SA reduced the AF-related mortality and decreased operative mortality to levels not statistically different from patients without AF.” He added that the findings of this study support the recent STS Guidelines on Surgical Ablation published in the January 2017 edition of Annals of Thoracic Surgery (Ann Thorac Surg. 2017 Jan;103[1]:329-41). “However, the ultimate decision on whether or not to add surgical ablation must always remain between the surgeon and the patient,” he said.

Dr. Badhwar acknowledged that the study is limited by the information available in version 2.73 of the STS Adult Cardiac Surgery Database. “This does highlight the ongoing need for participants in the database to provide as much complete information as possible for all patients undergoing cardiac operations, especially those involving surgical ablation,” he said.

Dr. Badhwar reported having no financial disclosures. Dr. Rankin disclosed ties with Admedus, AtriCure, and BioStable Science and Engineering.

 

 

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Key clinical point: At the time of mitral valve repair or replacement (MVRR), surgical ablation for atrial fibrillation (AF) can be done without increasing mortality.

Major finding: Adding surgical ablation to treat AF at the time of MVRR reduced the AF-related mortality to a rate that was comparable to a reference baseline group that had no history of AF.

Data source: An analysis of medical records from 88,765 MVRR patients in the STS Adult Cardiac Surgery Database between July 2011 and June 2014.

Disclosures: Dr. Badhwar reported having no financial disclosures. Dr. Rankin disclosed ties with Admedus, AtriCure, and BioStable Science and Engineering.

Early, in-hospital shunt failure common among infants

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HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.

“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.

“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”

Dr. Nhue Do
Dr. Nhue Do
The current investigation, which began when Nhue Do, MD, was a cardiac surgery chief resident at Johns Hopkins Hospital, Baltimore, is the largest reported analysis of factors associated with postoperative in-hospital shunt failure in neonates and infants with congenital heart disease. It is the first multicenter study to define preoperative risk factors and patient characteristics associated with early shunt failure.

Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.

Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.

In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).

“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.

“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”

He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.

The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.

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HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.

“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.

“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”

Dr. Nhue Do
Dr. Nhue Do
The current investigation, which began when Nhue Do, MD, was a cardiac surgery chief resident at Johns Hopkins Hospital, Baltimore, is the largest reported analysis of factors associated with postoperative in-hospital shunt failure in neonates and infants with congenital heart disease. It is the first multicenter study to define preoperative risk factors and patient characteristics associated with early shunt failure.

Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.

Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.

In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).

“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.

“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”

He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.

The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.

 

HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.

“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.

“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”

Dr. Nhue Do
Dr. Nhue Do
The current investigation, which began when Nhue Do, MD, was a cardiac surgery chief resident at Johns Hopkins Hospital, Baltimore, is the largest reported analysis of factors associated with postoperative in-hospital shunt failure in neonates and infants with congenital heart disease. It is the first multicenter study to define preoperative risk factors and patient characteristics associated with early shunt failure.

Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.

Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.

In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).

“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.

“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”

He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.

The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.

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Key clinical point: In-hospital shunt failure is common among neonates and infants.

Major finding: Among neonates and infants who underwent shunt operations, 7.3% experienced early, in-hospital shunt failure.

Data source: A retrospective analysis of 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015.

Disclosures: The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.