More tricuspid valve regurgitation should be fixed

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CHICAGO– Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

Dr. Allen C. Bolling
Dr. Allen C. Bolling
“When functional tricuspid regurgitation is fixed, the right ventricle gets better,” said Dr. Bolling, citing a study that showed favorable right ventricular remodeling after concomitant MV-TV repair.

A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).

Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.

The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).

“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.

And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.

Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.

Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).

However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).

According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.

The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.

For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.

In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.

Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.

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CHICAGO– Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

Dr. Allen C. Bolling
Dr. Allen C. Bolling
“When functional tricuspid regurgitation is fixed, the right ventricle gets better,” said Dr. Bolling, citing a study that showed favorable right ventricular remodeling after concomitant MV-TV repair.

A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).

Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.

The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).

“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.

And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.

Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.

Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).

However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).

According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.

The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.

For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.

In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.

Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.

 

CHICAGO– Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

Dr. Allen C. Bolling
Dr. Allen C. Bolling
“When functional tricuspid regurgitation is fixed, the right ventricle gets better,” said Dr. Bolling, citing a study that showed favorable right ventricular remodeling after concomitant MV-TV repair.

A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).

Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.

The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).

“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.

And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.

Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.

Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).

However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).

According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.

The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.

For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.

In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.

Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.

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EXPERT ANALYSIS FROM HEART VALVE SUMMIT 2016

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Sutureless aortic valve replacement: Is ease worth the cost?

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– Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.

“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani


Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”

Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.

Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.

Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).

Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.

Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).

Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.

Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.

“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.

Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.

Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.

Dr. Thourani reported multiple financial relationships with medical device companies.

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– Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.

“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani


Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”

Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.

Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.

Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).

Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.

Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).

Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.

Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.

“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.

Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.

Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.

Dr. Thourani reported multiple financial relationships with medical device companies.

 

– Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.

“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani


Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”

Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.

Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.

Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).

Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.

Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).

Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.

Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.

“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.

Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.

Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.

Dr. Thourani reported multiple financial relationships with medical device companies.

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EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT 2016

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Most infective endocarditis calls for early surgery

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CHICAGO- Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.

“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.

Dr. Joseph S. Coselli
The bottom line? “Operate sooner rather than later,” said Dr. Coselli. “Once there’s an indication for surgery, operate. Leaky valves won’t become competent; disintegrated tissue will not regrow.” This requires something of a shift in mindset, he said. “Infective endocarditis is not a reason to postpone an operation otherwise indicated, but the opposite.”

“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.

Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.

Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.

The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.

According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.

The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.

Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.

Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.

Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.

Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.

The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.

Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).

Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.

For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
 

 

 

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CHICAGO- Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.

“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.

Dr. Joseph S. Coselli
The bottom line? “Operate sooner rather than later,” said Dr. Coselli. “Once there’s an indication for surgery, operate. Leaky valves won’t become competent; disintegrated tissue will not regrow.” This requires something of a shift in mindset, he said. “Infective endocarditis is not a reason to postpone an operation otherwise indicated, but the opposite.”

“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.

Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.

Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.

The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.

According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.

The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.

Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.

Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.

Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.

Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.

The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.

Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).

Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.

For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
 

 

 

 

CHICAGO- Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.

“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.

Dr. Joseph S. Coselli
The bottom line? “Operate sooner rather than later,” said Dr. Coselli. “Once there’s an indication for surgery, operate. Leaky valves won’t become competent; disintegrated tissue will not regrow.” This requires something of a shift in mindset, he said. “Infective endocarditis is not a reason to postpone an operation otherwise indicated, but the opposite.”

“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.

Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.

Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.

The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.

According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.

The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.

Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.

Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.

Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.

Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.

The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.

Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).

Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.

For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
 

 

 

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EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT 2016

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