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Southern Association for Vascular Surgery (SAVS): Annual Meeting
Acute renal failure biggest short-term risk in I-EVAR explantation
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
AT THE SAVS ANNUAL MEETING
Key clinical point: Minimizing cross-clamp time may reduce the rate of acute renal failure 30 days post op in infected EVAR explantation patients.
Major finding: One-third of I-EVAR patients had postoperative acute renal failure; perioperative mortality in I-EVAR was 8%, and overall mortality was 25%.
Data source: Retrospective analysis of 36 patients with infected EVAR explants performed between 1997 and 2014 across four surgical centers.
Disclosures: Dr. Davila reported he had no relevant disclosures.
Clinical follow-up data promising for EVAR in AAA with angulated aortic neck
SCOTTSDALE, ARIZ. – Endovascular abdominal aortic aneurysm repair using a flexible endovascular stent graft in patients with infrarenal aortic neck angles of sixty degrees or greater had more favorable survival and major adverse event rates when compared with open repair, although the difference was not statistically significant, according to clinical, 2-year, postmarketing data.
At this year’s annual Southern Association for Vascular Surgery meeting, Dr. Mahmoud B. Malas presented 2-year safety and efficacy follow-up data from the PYTHAGORAS trial to evaluate the Aorfix (Lombard Medical, U.K.). The device, approved in 2013 by the Food and Drug Administration, is an endovascular stent graft for use in patients whose aortic neck angulation of between 60 and 90 degrees typically has disqualified them from having endovascular aneurysm repair (EVAR) for AAA.
The device is placed within the aneurysm, where it conforms to the individual patient’s anatomy, creating an internal bypass of the aneurysm to reduce the risk of rupture.
“The freedom from major adverse events, despite this hostile neck anatomy, was excellent,” Dr. Malas said of the data.
The PYTHAGORAS study enrolled and treated 151 patients with aortic neck angles of 60 degrees or greater, and 67 patients with necks less than 60 degrees using EVAR. The primary control group consisted of 67 patients undergoing actual open surgical repair (OSR). A secondary control group was a meta-analysis of 323 patients taken from other U.S. EVAR studies (SVS Lifeline).
There were no statistically significant differences between major adverse event rates, nor 30-day and 1-year mortality rates between low- or high-angle EVAR groups when compared with controls. There also was no difference between low- and high-angle EVAR patients sac shrinkage, type I/III endoleaks, and endograft migration, according to Dr. Malas.
The median neck angle in the EVAR group was 71 degrees (standard deviation of ±23 degrees; P < .05), compared with 48 degrees (SD, ± 23 degrees; P < .05) in the OSR control group. There were twice as many women in the EVAR group (35% vs.17%; P < .0001). Patient demographics and comorbidities were similar between the entire EVAR cohort and control group, with the exception of age (76 years vs. 70 years, respectively; P < .05) and heart failure (13% vs. 7%, P = .015). Operative data favored EVAR for procedure duration, blood loss, and hospital length of stay (P < .05 for all).
Dr. Malas said that in the combined EVAR cohort, there was a tendency for the infrarenal area to dilate more rapidly than the suprarenal aorta. “If the neck dilated more than 10%, there was a significant increase in risk of migration and sac expansion, especially close to the renal, but it was not true as you went beyond 7 mm distal to the renal.”
He also noted that the suprarenal aorta does change in association with migration and that there is a “clear association between the degree of oversizing and neck dilation.”
The presentation’s discussant, Dr. Jean M. Panneton, a vascular surgeon at Sentara Heart Hospital in Norfolk, Va., challenged the findings.
“Unfortunately, this trial did suffer from a slow accrual. As a result, only a small proportion of patients have reached the 5-year follow-up, and any subanalysis of such a small study population divided into three groups reduces the n value to the point that a type II error can easily be introduced into your analysis.”
Among the issues he raised was that the mortality data at 30 days, 1 year, and 2 years for the patients with the highest neck angulations could be misleading. “The patients in this group had a threefold increase [in mortality] compared with the standard group. Could this difference have been significant with a larger number?”
To overcome the lack of follow-up time, Dr. Malas said he and his colleagues used statistical modeling that gave them 500 data points on which they based their analysis.
Dr. Panneton also wondered if in the realm of EVAR AAA outside of the study, patients whose aortic neck lengths he said would average between 10 and 15 mm, would enjoy the same success rates as those EVAR patients in the study whose median aortic neck size was 20 mm-25 mm. “Do you think that this long seal zone accounted partially for the performance of the Aorfix? And will this performance hold up in real life?”
Dr. Malas responded that the investigators mandated at least a 15-mm neck for patients in the EVAR arms “because the way the seal zone is in a severely angulated neck means the effective seal zone will be on the inner curve of the neck, which might end up being only 4 or 5 mm, even if you have a 15-mm neck. So, it is very important to get the message out that if you’re going to use the Aorfix in a standard neck – less than 60 degrees – that you have zero migration. If you’re going to place this at a 90-degree angle, it’s very important you do not put it in a patient who doesn’t have a 15-mm neck.”
Dr. Mahmoud was one of the lead site investigators for the PYTHAGORAS trial, sponsored by Lombard Medical.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Endovascular abdominal aortic aneurysm repair using a flexible endovascular stent graft in patients with infrarenal aortic neck angles of sixty degrees or greater had more favorable survival and major adverse event rates when compared with open repair, although the difference was not statistically significant, according to clinical, 2-year, postmarketing data.
At this year’s annual Southern Association for Vascular Surgery meeting, Dr. Mahmoud B. Malas presented 2-year safety and efficacy follow-up data from the PYTHAGORAS trial to evaluate the Aorfix (Lombard Medical, U.K.). The device, approved in 2013 by the Food and Drug Administration, is an endovascular stent graft for use in patients whose aortic neck angulation of between 60 and 90 degrees typically has disqualified them from having endovascular aneurysm repair (EVAR) for AAA.
The device is placed within the aneurysm, where it conforms to the individual patient’s anatomy, creating an internal bypass of the aneurysm to reduce the risk of rupture.
“The freedom from major adverse events, despite this hostile neck anatomy, was excellent,” Dr. Malas said of the data.
The PYTHAGORAS study enrolled and treated 151 patients with aortic neck angles of 60 degrees or greater, and 67 patients with necks less than 60 degrees using EVAR. The primary control group consisted of 67 patients undergoing actual open surgical repair (OSR). A secondary control group was a meta-analysis of 323 patients taken from other U.S. EVAR studies (SVS Lifeline).
There were no statistically significant differences between major adverse event rates, nor 30-day and 1-year mortality rates between low- or high-angle EVAR groups when compared with controls. There also was no difference between low- and high-angle EVAR patients sac shrinkage, type I/III endoleaks, and endograft migration, according to Dr. Malas.
The median neck angle in the EVAR group was 71 degrees (standard deviation of ±23 degrees; P < .05), compared with 48 degrees (SD, ± 23 degrees; P < .05) in the OSR control group. There were twice as many women in the EVAR group (35% vs.17%; P < .0001). Patient demographics and comorbidities were similar between the entire EVAR cohort and control group, with the exception of age (76 years vs. 70 years, respectively; P < .05) and heart failure (13% vs. 7%, P = .015). Operative data favored EVAR for procedure duration, blood loss, and hospital length of stay (P < .05 for all).
Dr. Malas said that in the combined EVAR cohort, there was a tendency for the infrarenal area to dilate more rapidly than the suprarenal aorta. “If the neck dilated more than 10%, there was a significant increase in risk of migration and sac expansion, especially close to the renal, but it was not true as you went beyond 7 mm distal to the renal.”
He also noted that the suprarenal aorta does change in association with migration and that there is a “clear association between the degree of oversizing and neck dilation.”
The presentation’s discussant, Dr. Jean M. Panneton, a vascular surgeon at Sentara Heart Hospital in Norfolk, Va., challenged the findings.
“Unfortunately, this trial did suffer from a slow accrual. As a result, only a small proportion of patients have reached the 5-year follow-up, and any subanalysis of such a small study population divided into three groups reduces the n value to the point that a type II error can easily be introduced into your analysis.”
Among the issues he raised was that the mortality data at 30 days, 1 year, and 2 years for the patients with the highest neck angulations could be misleading. “The patients in this group had a threefold increase [in mortality] compared with the standard group. Could this difference have been significant with a larger number?”
To overcome the lack of follow-up time, Dr. Malas said he and his colleagues used statistical modeling that gave them 500 data points on which they based their analysis.
Dr. Panneton also wondered if in the realm of EVAR AAA outside of the study, patients whose aortic neck lengths he said would average between 10 and 15 mm, would enjoy the same success rates as those EVAR patients in the study whose median aortic neck size was 20 mm-25 mm. “Do you think that this long seal zone accounted partially for the performance of the Aorfix? And will this performance hold up in real life?”
Dr. Malas responded that the investigators mandated at least a 15-mm neck for patients in the EVAR arms “because the way the seal zone is in a severely angulated neck means the effective seal zone will be on the inner curve of the neck, which might end up being only 4 or 5 mm, even if you have a 15-mm neck. So, it is very important to get the message out that if you’re going to use the Aorfix in a standard neck – less than 60 degrees – that you have zero migration. If you’re going to place this at a 90-degree angle, it’s very important you do not put it in a patient who doesn’t have a 15-mm neck.”
Dr. Mahmoud was one of the lead site investigators for the PYTHAGORAS trial, sponsored by Lombard Medical.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Endovascular abdominal aortic aneurysm repair using a flexible endovascular stent graft in patients with infrarenal aortic neck angles of sixty degrees or greater had more favorable survival and major adverse event rates when compared with open repair, although the difference was not statistically significant, according to clinical, 2-year, postmarketing data.
At this year’s annual Southern Association for Vascular Surgery meeting, Dr. Mahmoud B. Malas presented 2-year safety and efficacy follow-up data from the PYTHAGORAS trial to evaluate the Aorfix (Lombard Medical, U.K.). The device, approved in 2013 by the Food and Drug Administration, is an endovascular stent graft for use in patients whose aortic neck angulation of between 60 and 90 degrees typically has disqualified them from having endovascular aneurysm repair (EVAR) for AAA.
The device is placed within the aneurysm, where it conforms to the individual patient’s anatomy, creating an internal bypass of the aneurysm to reduce the risk of rupture.
“The freedom from major adverse events, despite this hostile neck anatomy, was excellent,” Dr. Malas said of the data.
The PYTHAGORAS study enrolled and treated 151 patients with aortic neck angles of 60 degrees or greater, and 67 patients with necks less than 60 degrees using EVAR. The primary control group consisted of 67 patients undergoing actual open surgical repair (OSR). A secondary control group was a meta-analysis of 323 patients taken from other U.S. EVAR studies (SVS Lifeline).
There were no statistically significant differences between major adverse event rates, nor 30-day and 1-year mortality rates between low- or high-angle EVAR groups when compared with controls. There also was no difference between low- and high-angle EVAR patients sac shrinkage, type I/III endoleaks, and endograft migration, according to Dr. Malas.
The median neck angle in the EVAR group was 71 degrees (standard deviation of ±23 degrees; P < .05), compared with 48 degrees (SD, ± 23 degrees; P < .05) in the OSR control group. There were twice as many women in the EVAR group (35% vs.17%; P < .0001). Patient demographics and comorbidities were similar between the entire EVAR cohort and control group, with the exception of age (76 years vs. 70 years, respectively; P < .05) and heart failure (13% vs. 7%, P = .015). Operative data favored EVAR for procedure duration, blood loss, and hospital length of stay (P < .05 for all).
Dr. Malas said that in the combined EVAR cohort, there was a tendency for the infrarenal area to dilate more rapidly than the suprarenal aorta. “If the neck dilated more than 10%, there was a significant increase in risk of migration and sac expansion, especially close to the renal, but it was not true as you went beyond 7 mm distal to the renal.”
He also noted that the suprarenal aorta does change in association with migration and that there is a “clear association between the degree of oversizing and neck dilation.”
The presentation’s discussant, Dr. Jean M. Panneton, a vascular surgeon at Sentara Heart Hospital in Norfolk, Va., challenged the findings.
“Unfortunately, this trial did suffer from a slow accrual. As a result, only a small proportion of patients have reached the 5-year follow-up, and any subanalysis of such a small study population divided into three groups reduces the n value to the point that a type II error can easily be introduced into your analysis.”
Among the issues he raised was that the mortality data at 30 days, 1 year, and 2 years for the patients with the highest neck angulations could be misleading. “The patients in this group had a threefold increase [in mortality] compared with the standard group. Could this difference have been significant with a larger number?”
To overcome the lack of follow-up time, Dr. Malas said he and his colleagues used statistical modeling that gave them 500 data points on which they based their analysis.
Dr. Panneton also wondered if in the realm of EVAR AAA outside of the study, patients whose aortic neck lengths he said would average between 10 and 15 mm, would enjoy the same success rates as those EVAR patients in the study whose median aortic neck size was 20 mm-25 mm. “Do you think that this long seal zone accounted partially for the performance of the Aorfix? And will this performance hold up in real life?”
Dr. Malas responded that the investigators mandated at least a 15-mm neck for patients in the EVAR arms “because the way the seal zone is in a severely angulated neck means the effective seal zone will be on the inner curve of the neck, which might end up being only 4 or 5 mm, even if you have a 15-mm neck. So, it is very important to get the message out that if you’re going to use the Aorfix in a standard neck – less than 60 degrees – that you have zero migration. If you’re going to place this at a 90-degree angle, it’s very important you do not put it in a patient who doesn’t have a 15-mm neck.”
Dr. Mahmoud was one of the lead site investigators for the PYTHAGORAS trial, sponsored by Lombard Medical.
On Twitter @whitneymcknight
AT THE SAVS ANNUAL MEETING 2015
Key clinical point: AAA patients with 60 degree or greater aortic neck angles may benefit from EVAR with flexible stent graft instead of open surgical repair.
Major finding: There was no statistical difference in rates of major adverse events between open repair and EVAR in AAA patients with a 60-90 degree aortic neck angulation .
Data source: Postmarketing safety and efficacy data from the controlled, prospective, nonrandomized, multicenter PYTHAGORAS study of 218 patients.
Disclosures: Dr. Mahmoud was one of the lead site investigators for the PYTHAGORAS trial, sponsored by Lombard Medical.
Nonclinical interventions enhance care and outcomes for vascular patients
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE SAVS 2015 ANNUAL MEETING
