User login
Robotic PCI succeeds in patients with acute MI
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: A proof-of-principle study suggests that procedural success with robotic angioplasty is at least as good in patients with acute myocardial infarction as previously shown in elective percutaneous coronary intervention.
Major finding: In a series of 17 consecutive patients with acute MI, procedural success was 100%.
Data source: A cohort study.
Disclosures: Dr. Madder disclosed a financial relationship with InfraRedx.
CABG with ITA for moderate stenosis improved long-term survival
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Grafting moderately stenosed coronary arteries using with internal thoracic arteries improved long-term survival.
Major finding: ITA grafting, compared with no grafting or use of a saphenous vein graft, yielded a 22% lower long-term mortality.
Data source: Researchers performed a prospective study of 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry who had a single coronary artery with moderate stenosis.
Disclosures: The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
MRI assessment of pulmonary vein stenosis predicts outcomes
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
 |
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Survival after pulmonary vein stenosis repair was adversely affected by smaller upstream cross-sectional area indexed to body surface area.
Major finding: Smaller upstream total cross-sectional area indexed for body surface area (P = .30) and greater number of stenotic pulmonary veins (P = .007) were associated with increased early risk of death.
Data source: Researchers reviewed the outcomes of 31/145 patients who underwent surgical repair of pulmonary stenosis who had preoperative computed tomography and magnetic resonance imaging between 1990 and 2012.
Disclosures: The authors reported that they had no conflicts of interest.
STS: Lactate dehydrogenase of 1,150 IU/L flags LVAD thrombosis
PHOENIX – A blood lactate dehydrogenase level of at least 1,150 IU/L may be the best cutoff for identifying pump thrombosis in patients who have received a left ventricular assist device based on findings from a combined series of 502 pump recipients.
Using this cutoff correlated with a positive predictive value of 74% and a negative predictive value of 92%, Dr. Vikram Sood said at the annual meeting of the Society of Thoracic Surgeons.
Results from several prior studies had established an elevated blood level of lactate dehydrogenase (LDH) as perhaps the best early flag of significant thrombus inside of a left ventricular assist device (LVAD), a condition called pump thrombosis. But prior studies had not identified a specific cutoff value to use that could confidently diagnose pump thrombosis. A level of 1,150 IU/L is about five times the upper limit of normal, noted Dr. Francis D. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
Dr. Sood and his associates reviewed records for 502 patients who received a HeartMate II LVAD at either the University of Michigan or at the Mayo Clinic in Rochester, Minn., during 2004-2014. During that time, 58 of the patients required a total of 70 LVAD explants. Fifty-two of the explants were for suspected pump thrombosis, 12 for infection, and 6 for lead fracture. The average time from LVAD placement to explant was 12 months.
Among the 52 LVADs explanted for suspected pump thrombosis, 47 actually had thrombosis. In addition, six of the LVADs that were explanted for other reasons also had a significant amount of thrombus, resulting in 53 total explanted LVAD with confirmed pump thrombosis.
The researchers analyzed blood levels of LDH during the 6 months prior to explant. Among the patients with the 53 LVADs explanted with confirmed pump thrombosis, the median of all LDH levels during the period was 1,061 IU/L and the median maximum LDH level for each patient was 1,940 IU/L, reported Dr. Sood, a cardiac surgeon at the University of Michigan. In contrast, among the patients who had a total of 17 LVADs explanted without pump thrombosis, the median value for all LDH measures during the 6 months prior to explant was 533 IU/L, and their medium maximum level was 504 IU/L.
Analysis of LDH levels prior to explant and subsequent confirmation of pump thrombosis identified a cut off of 1,150 IU/L as able to identify pump thrombosis with a sensitivity of 78% and a specificity of 90%, Dr. Sood reported.
On Twitter @mitchelzoler
PHOENIX – A blood lactate dehydrogenase level of at least 1,150 IU/L may be the best cutoff for identifying pump thrombosis in patients who have received a left ventricular assist device based on findings from a combined series of 502 pump recipients.
Using this cutoff correlated with a positive predictive value of 74% and a negative predictive value of 92%, Dr. Vikram Sood said at the annual meeting of the Society of Thoracic Surgeons.
Results from several prior studies had established an elevated blood level of lactate dehydrogenase (LDH) as perhaps the best early flag of significant thrombus inside of a left ventricular assist device (LVAD), a condition called pump thrombosis. But prior studies had not identified a specific cutoff value to use that could confidently diagnose pump thrombosis. A level of 1,150 IU/L is about five times the upper limit of normal, noted Dr. Francis D. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
Dr. Sood and his associates reviewed records for 502 patients who received a HeartMate II LVAD at either the University of Michigan or at the Mayo Clinic in Rochester, Minn., during 2004-2014. During that time, 58 of the patients required a total of 70 LVAD explants. Fifty-two of the explants were for suspected pump thrombosis, 12 for infection, and 6 for lead fracture. The average time from LVAD placement to explant was 12 months.
Among the 52 LVADs explanted for suspected pump thrombosis, 47 actually had thrombosis. In addition, six of the LVADs that were explanted for other reasons also had a significant amount of thrombus, resulting in 53 total explanted LVAD with confirmed pump thrombosis.
The researchers analyzed blood levels of LDH during the 6 months prior to explant. Among the patients with the 53 LVADs explanted with confirmed pump thrombosis, the median of all LDH levels during the period was 1,061 IU/L and the median maximum LDH level for each patient was 1,940 IU/L, reported Dr. Sood, a cardiac surgeon at the University of Michigan. In contrast, among the patients who had a total of 17 LVADs explanted without pump thrombosis, the median value for all LDH measures during the 6 months prior to explant was 533 IU/L, and their medium maximum level was 504 IU/L.
Analysis of LDH levels prior to explant and subsequent confirmation of pump thrombosis identified a cut off of 1,150 IU/L as able to identify pump thrombosis with a sensitivity of 78% and a specificity of 90%, Dr. Sood reported.
On Twitter @mitchelzoler
PHOENIX – A blood lactate dehydrogenase level of at least 1,150 IU/L may be the best cutoff for identifying pump thrombosis in patients who have received a left ventricular assist device based on findings from a combined series of 502 pump recipients.
Using this cutoff correlated with a positive predictive value of 74% and a negative predictive value of 92%, Dr. Vikram Sood said at the annual meeting of the Society of Thoracic Surgeons.
Results from several prior studies had established an elevated blood level of lactate dehydrogenase (LDH) as perhaps the best early flag of significant thrombus inside of a left ventricular assist device (LVAD), a condition called pump thrombosis. But prior studies had not identified a specific cutoff value to use that could confidently diagnose pump thrombosis. A level of 1,150 IU/L is about five times the upper limit of normal, noted Dr. Francis D. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
Dr. Sood and his associates reviewed records for 502 patients who received a HeartMate II LVAD at either the University of Michigan or at the Mayo Clinic in Rochester, Minn., during 2004-2014. During that time, 58 of the patients required a total of 70 LVAD explants. Fifty-two of the explants were for suspected pump thrombosis, 12 for infection, and 6 for lead fracture. The average time from LVAD placement to explant was 12 months.
Among the 52 LVADs explanted for suspected pump thrombosis, 47 actually had thrombosis. In addition, six of the LVADs that were explanted for other reasons also had a significant amount of thrombus, resulting in 53 total explanted LVAD with confirmed pump thrombosis.
The researchers analyzed blood levels of LDH during the 6 months prior to explant. Among the patients with the 53 LVADs explanted with confirmed pump thrombosis, the median of all LDH levels during the period was 1,061 IU/L and the median maximum LDH level for each patient was 1,940 IU/L, reported Dr. Sood, a cardiac surgeon at the University of Michigan. In contrast, among the patients who had a total of 17 LVADs explanted without pump thrombosis, the median value for all LDH measures during the 6 months prior to explant was 533 IU/L, and their medium maximum level was 504 IU/L.
Analysis of LDH levels prior to explant and subsequent confirmation of pump thrombosis identified a cut off of 1,150 IU/L as able to identify pump thrombosis with a sensitivity of 78% and a specificity of 90%, Dr. Sood reported.
On Twitter @mitchelzoler
AT THE STS ANNUAL MEETING
Key clinical point: In patients who have received a left ventricular assist device, a blood level of lactate dehydrogenase of at least 1,150 IU/L had a good positive and negative predictive value for pump thrombosis.
Major finding: A 1,150 IU/L cutoff for LDH had a positive predictive value of 74% and a negative predictive value of 92%.
Data source: Retrospective review of 502 patients who received a HeartMate II LVAD at either of two U.S. centers during 2004-2014.
Disclosures: Dr. Sood and Dr. Pagani had no disclosures.
STS: Minimizing LVAD pump thrombosis poses new challenges
PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.
Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.
Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.
Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.
“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.
Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.
“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.
“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.
“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”
The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).
“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.
More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.
“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.
Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).
Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.
Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.
On Twitter @mitchelzoler
Dr. Hossein Almassi, FCCP, comments: With improvements in technology and development of rotary pumps, there has been a significant growth in the use of mechanical circulatory support (MCS) for treatment of end stage heart failure with a parallel improvement in patients’ survival and the quality of life.
 |
| Dr. Hossein Almassi |
The authors of this report presented at the 2016 annual meeting of the STS, are authorities in the field of MCS outlining the observed increase in pump thrombosis noted in 2012. The sharp increase in the thrombosis rate is different from the lower incidence seen in the preapproval stage of the pump trial.
It should be noted that the report is related mainly to the HeatMate II left ventricular assist device (LVAD) and not the more recently implanted HeartWare device.
The diagnostic algorithm outlined in the accompanying reference (J Heart Lung Transplant. 2013 July;32[7]:667-70) regarding the diagnosis and management of suspected pump thrombosis is worth reading with the main criteria heralding a potential pump thrombosis being 1)sustained pump power elevation, 2) elevation of cardiac LDH or plasma-free hemoglobin, 3) hemolysis, and 4) symptoms of heart failure.
With further refinements in technology, the field of MCS is awaiting the development of newer LVAD devices that would mitigate the serious problem of pump thrombosis.
Dr. Hossein Almassi, FCCP, comments: With improvements in technology and development of rotary pumps, there has been a significant growth in the use of mechanical circulatory support (MCS) for treatment of end stage heart failure with a parallel improvement in patients’ survival and the quality of life.
|
| Dr. Hossein Almassi |
The authors of this report presented at the 2016 annual meeting of the STS, are authorities in the field of MCS outlining the observed increase in pump thrombosis noted in 2012. The sharp increase in the thrombosis rate is different from the lower incidence seen in the preapproval stage of the pump trial.
It should be noted that the report is related mainly to the HeatMate II left ventricular assist device (LVAD) and not the more recently implanted HeartWare device.
The diagnostic algorithm outlined in the accompanying reference (J Heart Lung Transplant. 2013 July;32[7]:667-70) regarding the diagnosis and management of suspected pump thrombosis is worth reading with the main criteria heralding a potential pump thrombosis being 1)sustained pump power elevation, 2) elevation of cardiac LDH or plasma-free hemoglobin, 3) hemolysis, and 4) symptoms of heart failure.
With further refinements in technology, the field of MCS is awaiting the development of newer LVAD devices that would mitigate the serious problem of pump thrombosis.
Dr. Hossein Almassi, FCCP, comments: With improvements in technology and development of rotary pumps, there has been a significant growth in the use of mechanical circulatory support (MCS) for treatment of end stage heart failure with a parallel improvement in patients’ survival and the quality of life.
|
| Dr. Hossein Almassi |
The authors of this report presented at the 2016 annual meeting of the STS, are authorities in the field of MCS outlining the observed increase in pump thrombosis noted in 2012. The sharp increase in the thrombosis rate is different from the lower incidence seen in the preapproval stage of the pump trial.
It should be noted that the report is related mainly to the HeatMate II left ventricular assist device (LVAD) and not the more recently implanted HeartWare device.
The diagnostic algorithm outlined in the accompanying reference (J Heart Lung Transplant. 2013 July;32[7]:667-70) regarding the diagnosis and management of suspected pump thrombosis is worth reading with the main criteria heralding a potential pump thrombosis being 1)sustained pump power elevation, 2) elevation of cardiac LDH or plasma-free hemoglobin, 3) hemolysis, and 4) symptoms of heart failure.
With further refinements in technology, the field of MCS is awaiting the development of newer LVAD devices that would mitigate the serious problem of pump thrombosis.
PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.
Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.
Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.
Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.
“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.
Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.
“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.
“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.
“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”
The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).
“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.
More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.
“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.
Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).
Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.
Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.
On Twitter @mitchelzoler
PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.
Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.
Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.
Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.
“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.
Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.
But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.
“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.
“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.
“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”
The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).
“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.
More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.
“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.
Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).
Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.
Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE STS ANNUAL MEETING
TAVR forges ahead in PARTNER III for low-risk patients
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
What’s next for Watchman stroke prevention device
SNOWMASS, COLO. – The goal is finally in sight following an odyssey to develop the Watchman left atrial appendage closure device as a safe and effective alternative to oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.
It’s all coming together: The Watchman, a small percutaneously delivered parachute-like device, has received FDA marketing approval as the sole authorized left atrial appendage closure device in this country on the strength of two compellingly positive randomized controlled trials. A recent meta-analysis of those trials showed significantly fewer hemorrhagic strokes, fewer cardiovascular or unexplained deaths, and fewer nonprocedural bleeding events in Watchman recipients than in patients randomized to warfarin. And a cost-effectiveness analysis has concluded that after 8 years, the Watchman becomes “the dominant strategy” – meaning more effective and less costly for stroke prevention in patients with atrial fibrillation (AF) having a contraindication to warfarin – compared with the novel oral anticoagulant apixaban (J Am Coll Cardiol. 2015 Dec 22;66[24]:2728-39).
Moreover, the final pieces required for the Watchman to become a mainstream reimbursable therapy are falling into place. The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology, and the Heart Rhythm Society (HRS) have jointly issued institutional and operator requirements for left atrial appendage occlusion programs (J Am Coll Cardiol. 2015 Dec 8. pii: S0735-1097[15]07550-6). The ACC’s National Cardiovascular Data Registry has set up a new left atrial occlusion registry. And most important of all from a reimbursement standpoint, the Centers for Medicare and Medicaid Services has released a preliminary National Coverage Determination for left atrial appendage occlusion.
“This will affect your patients and your lives,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn. He and the Mayo Clinic share a financial interest in the Watchman technology, which has been licensed to Boston Scientific.
The CMS will cover the Watchman only when the catheter procedure is performed by an experienced interventional cardiologist or electrophysiologist in an experienced center as defined by the SCAI/ACC/HRS standards, and only in patients enrolled in the national prospective registry. The registry will monitor operator and device-related complications, stroke and systemic embolism rates, deaths, and major bleeding rates for 5 years post-procedure.
“If you want to be in this field, you will be in that registry because reimbursement will depend on that,” Dr. Holmes explained. “This registry will be incredibly important. It will tell us how we’re doing, what we should be doing, and what we could potentially be doing in the future.”
One hitch is that the preliminary National Coverage Determination states that coverage will be limited to AF patients with high stroke-risk and HAS-BLED scores as well as a contraindication to warfarin, whereas the FDA-approved indication says patients must be deemed by their physician to be suitable for warfarin.
“In this particular case, CMS was not talking with FDA. We don’t know how that will get sorted out,” according to the cardiologist. “But as soon as CMS comes through with their final regulatory coverage determination, I think we will finally be there. We’ll then be able to offer this as a treatment strategy for stroke prevention in selected patients with atrial fibrillation, realizing that with this device there’s a 40% reduction in the composite endpoint of cardiovascular or unexplained death, stroke, and systemic embolism compared to warfarin.”
That figure of a 40% relative risk reduction comes from the 46-month follow-up data in the randomized PROTECT AF trial (JAMA. 2014 Nov 19;312[19]:1988-98).
More recently, Dr. Holmes and his coinvestigators published a patient-level meta-analysis of data from PROTECT AF and PREVAIL, the other randomized trial of the Watchman versus warfarin. They reported that Watchman recipients had a 78% reduction in hemorrhagic strokes, a 52% reduction in cardiovascular or unexplained deaths, and a 49% lower rate of nonprocedural bleeding, compared with patients assigned to warfarin (J Am Coll Cardiol. 2015 Jun 23;65[24]:2614-23).
There have been no randomized trials comparing the Watchman to novel oral anticoagulants.
Dr. Holmes said the worldwide experience to date has been that roughly 95% of AF patients are able to safely go off warfarin or a novel oral anticoagulant 12 months after Watchman placement.
“So instead of taking eight drugs when you’re 75 years old, you can take seven. Most patients think that’s a pretty good deal,” the cardiologist observed.
Session moderator Dr. Samuel J. Asirvatham posed a question: Since recurrence of AF following catheter ablation is common and it’s now thought that up to 20% of AF arises from foci located in the left atrial appendage, what about combining standard catheter ablation of AF via pulmonary vein isolation with placement of the Watchman in a single procedure?
If such a combined procedure can be done efficiently, it should enable recipients of AF catheter ablation to safely go off oral anticoagulation, noted Dr. Asirvatham, an electrophysiologist who is professor of medicine and pediatrics at the Mayo Clinic, Rochester, Minn.
Dr. Holmes said several small studies of patients who have received combined AF ablation and Watchman implantation have been published.
“It’s uncertain whether left atrial appendage closure will affect AF recurrence rates post ablation, but it should reduce stroke risk. It’s a terribly important field of exploration that will be pursued in registries both in Europe and the United States,” he said.
SNOWMASS, COLO. – The goal is finally in sight following an odyssey to develop the Watchman left atrial appendage closure device as a safe and effective alternative to oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.
It’s all coming together: The Watchman, a small percutaneously delivered parachute-like device, has received FDA marketing approval as the sole authorized left atrial appendage closure device in this country on the strength of two compellingly positive randomized controlled trials. A recent meta-analysis of those trials showed significantly fewer hemorrhagic strokes, fewer cardiovascular or unexplained deaths, and fewer nonprocedural bleeding events in Watchman recipients than in patients randomized to warfarin. And a cost-effectiveness analysis has concluded that after 8 years, the Watchman becomes “the dominant strategy” – meaning more effective and less costly for stroke prevention in patients with atrial fibrillation (AF) having a contraindication to warfarin – compared with the novel oral anticoagulant apixaban (J Am Coll Cardiol. 2015 Dec 22;66[24]:2728-39).
Moreover, the final pieces required for the Watchman to become a mainstream reimbursable therapy are falling into place. The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology, and the Heart Rhythm Society (HRS) have jointly issued institutional and operator requirements for left atrial appendage occlusion programs (J Am Coll Cardiol. 2015 Dec 8. pii: S0735-1097[15]07550-6). The ACC’s National Cardiovascular Data Registry has set up a new left atrial occlusion registry. And most important of all from a reimbursement standpoint, the Centers for Medicare and Medicaid Services has released a preliminary National Coverage Determination for left atrial appendage occlusion.
“This will affect your patients and your lives,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn. He and the Mayo Clinic share a financial interest in the Watchman technology, which has been licensed to Boston Scientific.
The CMS will cover the Watchman only when the catheter procedure is performed by an experienced interventional cardiologist or electrophysiologist in an experienced center as defined by the SCAI/ACC/HRS standards, and only in patients enrolled in the national prospective registry. The registry will monitor operator and device-related complications, stroke and systemic embolism rates, deaths, and major bleeding rates for 5 years post-procedure.
“If you want to be in this field, you will be in that registry because reimbursement will depend on that,” Dr. Holmes explained. “This registry will be incredibly important. It will tell us how we’re doing, what we should be doing, and what we could potentially be doing in the future.”
One hitch is that the preliminary National Coverage Determination states that coverage will be limited to AF patients with high stroke-risk and HAS-BLED scores as well as a contraindication to warfarin, whereas the FDA-approved indication says patients must be deemed by their physician to be suitable for warfarin.
“In this particular case, CMS was not talking with FDA. We don’t know how that will get sorted out,” according to the cardiologist. “But as soon as CMS comes through with their final regulatory coverage determination, I think we will finally be there. We’ll then be able to offer this as a treatment strategy for stroke prevention in selected patients with atrial fibrillation, realizing that with this device there’s a 40% reduction in the composite endpoint of cardiovascular or unexplained death, stroke, and systemic embolism compared to warfarin.”
That figure of a 40% relative risk reduction comes from the 46-month follow-up data in the randomized PROTECT AF trial (JAMA. 2014 Nov 19;312[19]:1988-98).
More recently, Dr. Holmes and his coinvestigators published a patient-level meta-analysis of data from PROTECT AF and PREVAIL, the other randomized trial of the Watchman versus warfarin. They reported that Watchman recipients had a 78% reduction in hemorrhagic strokes, a 52% reduction in cardiovascular or unexplained deaths, and a 49% lower rate of nonprocedural bleeding, compared with patients assigned to warfarin (J Am Coll Cardiol. 2015 Jun 23;65[24]:2614-23).
There have been no randomized trials comparing the Watchman to novel oral anticoagulants.
Dr. Holmes said the worldwide experience to date has been that roughly 95% of AF patients are able to safely go off warfarin or a novel oral anticoagulant 12 months after Watchman placement.
“So instead of taking eight drugs when you’re 75 years old, you can take seven. Most patients think that’s a pretty good deal,” the cardiologist observed.
Session moderator Dr. Samuel J. Asirvatham posed a question: Since recurrence of AF following catheter ablation is common and it’s now thought that up to 20% of AF arises from foci located in the left atrial appendage, what about combining standard catheter ablation of AF via pulmonary vein isolation with placement of the Watchman in a single procedure?
If such a combined procedure can be done efficiently, it should enable recipients of AF catheter ablation to safely go off oral anticoagulation, noted Dr. Asirvatham, an electrophysiologist who is professor of medicine and pediatrics at the Mayo Clinic, Rochester, Minn.
Dr. Holmes said several small studies of patients who have received combined AF ablation and Watchman implantation have been published.
“It’s uncertain whether left atrial appendage closure will affect AF recurrence rates post ablation, but it should reduce stroke risk. It’s a terribly important field of exploration that will be pursued in registries both in Europe and the United States,” he said.
SNOWMASS, COLO. – The goal is finally in sight following an odyssey to develop the Watchman left atrial appendage closure device as a safe and effective alternative to oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.
It’s all coming together: The Watchman, a small percutaneously delivered parachute-like device, has received FDA marketing approval as the sole authorized left atrial appendage closure device in this country on the strength of two compellingly positive randomized controlled trials. A recent meta-analysis of those trials showed significantly fewer hemorrhagic strokes, fewer cardiovascular or unexplained deaths, and fewer nonprocedural bleeding events in Watchman recipients than in patients randomized to warfarin. And a cost-effectiveness analysis has concluded that after 8 years, the Watchman becomes “the dominant strategy” – meaning more effective and less costly for stroke prevention in patients with atrial fibrillation (AF) having a contraindication to warfarin – compared with the novel oral anticoagulant apixaban (J Am Coll Cardiol. 2015 Dec 22;66[24]:2728-39).
Moreover, the final pieces required for the Watchman to become a mainstream reimbursable therapy are falling into place. The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology, and the Heart Rhythm Society (HRS) have jointly issued institutional and operator requirements for left atrial appendage occlusion programs (J Am Coll Cardiol. 2015 Dec 8. pii: S0735-1097[15]07550-6). The ACC’s National Cardiovascular Data Registry has set up a new left atrial occlusion registry. And most important of all from a reimbursement standpoint, the Centers for Medicare and Medicaid Services has released a preliminary National Coverage Determination for left atrial appendage occlusion.
“This will affect your patients and your lives,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn. He and the Mayo Clinic share a financial interest in the Watchman technology, which has been licensed to Boston Scientific.
The CMS will cover the Watchman only when the catheter procedure is performed by an experienced interventional cardiologist or electrophysiologist in an experienced center as defined by the SCAI/ACC/HRS standards, and only in patients enrolled in the national prospective registry. The registry will monitor operator and device-related complications, stroke and systemic embolism rates, deaths, and major bleeding rates for 5 years post-procedure.
“If you want to be in this field, you will be in that registry because reimbursement will depend on that,” Dr. Holmes explained. “This registry will be incredibly important. It will tell us how we’re doing, what we should be doing, and what we could potentially be doing in the future.”
One hitch is that the preliminary National Coverage Determination states that coverage will be limited to AF patients with high stroke-risk and HAS-BLED scores as well as a contraindication to warfarin, whereas the FDA-approved indication says patients must be deemed by their physician to be suitable for warfarin.
“In this particular case, CMS was not talking with FDA. We don’t know how that will get sorted out,” according to the cardiologist. “But as soon as CMS comes through with their final regulatory coverage determination, I think we will finally be there. We’ll then be able to offer this as a treatment strategy for stroke prevention in selected patients with atrial fibrillation, realizing that with this device there’s a 40% reduction in the composite endpoint of cardiovascular or unexplained death, stroke, and systemic embolism compared to warfarin.”
That figure of a 40% relative risk reduction comes from the 46-month follow-up data in the randomized PROTECT AF trial (JAMA. 2014 Nov 19;312[19]:1988-98).
More recently, Dr. Holmes and his coinvestigators published a patient-level meta-analysis of data from PROTECT AF and PREVAIL, the other randomized trial of the Watchman versus warfarin. They reported that Watchman recipients had a 78% reduction in hemorrhagic strokes, a 52% reduction in cardiovascular or unexplained deaths, and a 49% lower rate of nonprocedural bleeding, compared with patients assigned to warfarin (J Am Coll Cardiol. 2015 Jun 23;65[24]:2614-23).
There have been no randomized trials comparing the Watchman to novel oral anticoagulants.
Dr. Holmes said the worldwide experience to date has been that roughly 95% of AF patients are able to safely go off warfarin or a novel oral anticoagulant 12 months after Watchman placement.
“So instead of taking eight drugs when you’re 75 years old, you can take seven. Most patients think that’s a pretty good deal,” the cardiologist observed.
Session moderator Dr. Samuel J. Asirvatham posed a question: Since recurrence of AF following catheter ablation is common and it’s now thought that up to 20% of AF arises from foci located in the left atrial appendage, what about combining standard catheter ablation of AF via pulmonary vein isolation with placement of the Watchman in a single procedure?
If such a combined procedure can be done efficiently, it should enable recipients of AF catheter ablation to safely go off oral anticoagulation, noted Dr. Asirvatham, an electrophysiologist who is professor of medicine and pediatrics at the Mayo Clinic, Rochester, Minn.
Dr. Holmes said several small studies of patients who have received combined AF ablation and Watchman implantation have been published.
“It’s uncertain whether left atrial appendage closure will affect AF recurrence rates post ablation, but it should reduce stroke risk. It’s a terribly important field of exploration that will be pursued in registries both in Europe and the United States,” he said.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Hemodynamic principles key to managing right ventricular heart failure
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
EXPERT ANALYSIS AT THE STS ANNUAL MEETING
Cadaveric allograft system used to reconstruct anterior chest wall
PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.
“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”
Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.
Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.
Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).
All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.
To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.
Dr. Marulli reported having no financial disclosures.
PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.
“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”
Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.
Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.
Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).
All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.
To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.
Dr. Marulli reported having no financial disclosures.
PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.
“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”
Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.
Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.
Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).
All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.
To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.
Dr. Marulli reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point: Cadaveric allograft sternal replacement appears to be an effective option for reconstructing the anterior chest wall.
Major finding: To date, no infections or rejections of the grafts have occurred in patients who underwent cadaveric allograft sternal replacement.
Data source: An analysis of 18 patients who underwent the procedure between January 2009 and January 2015.
Disclosures: Dr. Marulli reported having no financial disclosures.
Fewer general surgery residents doing thoracic surgery cases
PHOENIX – Over the past 11 years, fewer general surgery residents have participated in important types of general thoracic surgery cases, a retrospective review found.
“These findings may be the result of the work-hours reduction causing less exposure to general thoracic surgery and/or a reluctance to allow general surgery residents to perform the increasingly common minimally invasive procedures,” researchers led by Dr. William S. Ragalie wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons.
Dr. Ragalie of the Medical College of Wisconsin, Milwaukee, and his associates retrospectively reviewed the Accreditation Council for Graduate Medical Education resident case log database for the most recent 11 years in an effort to quantify and trend the operative experience among general surgery residents. They categorized cases by year, level of resident participation, and level of complexity. Major general thoracic cases were defined as esophagectomy, pneumonectomy, and lobectomy, while cases that did not involve hilar dissection were classified as “other thoracic.”
The researchers found that the 90th percentile of first assist thoracic surgery cases decreased significantly over the study period by an average of 1.46 cases per year (P = .0012). Decreased case volumes in pneumonectomy were also noted at the junior level (–0.012 cases per year; P less than .0001) and at the chief resident level (–0.31 cases per year; P less than .001). This was also true of open lobectomy cases (–0.14 cases per year at the junior level; P less than .001, and –3.41 cases per year at the chief resident level; P less than .0001).
As for video-assisted thoracoscopic surgery (VATS) lobectomy, the researchers observed an increase in average case volume at the junior surgeon level of .13 cases per year, but a decrease at the chief resident level of one case per year (P less than .001 for both).
Dr. Ragalie and his associates also observed a decrease in the following procedures performed by chief residents: open exploratory thoracoscopy (–3.17 cases per year; P less than .001), VATS exploratory thoracoscopy (–2.95 cases per year; P less than .0001), open wedge resection (–1.52 cases per year; P less than .0227), VATS wedge resection (–2.72 cases per year; P less than .0002), “other thoracic” (–6.3 cases per year; P = .0001), and thoracoscopic pleurodesis (–2.09 cases per year; P less than .0001).
At the same time, a significant trend of decreased case volume at the junior surgeon level was noted for open exploratory thoracoscopy (–0.10 cases per year; P less than .0001) and open wedge resection (–0.22 cases per year; P = . 0115).
The researchers reported having no financial disclosures.
PHOENIX – Over the past 11 years, fewer general surgery residents have participated in important types of general thoracic surgery cases, a retrospective review found.
“These findings may be the result of the work-hours reduction causing less exposure to general thoracic surgery and/or a reluctance to allow general surgery residents to perform the increasingly common minimally invasive procedures,” researchers led by Dr. William S. Ragalie wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons.
Dr. Ragalie of the Medical College of Wisconsin, Milwaukee, and his associates retrospectively reviewed the Accreditation Council for Graduate Medical Education resident case log database for the most recent 11 years in an effort to quantify and trend the operative experience among general surgery residents. They categorized cases by year, level of resident participation, and level of complexity. Major general thoracic cases were defined as esophagectomy, pneumonectomy, and lobectomy, while cases that did not involve hilar dissection were classified as “other thoracic.”
The researchers found that the 90th percentile of first assist thoracic surgery cases decreased significantly over the study period by an average of 1.46 cases per year (P = .0012). Decreased case volumes in pneumonectomy were also noted at the junior level (–0.012 cases per year; P less than .0001) and at the chief resident level (–0.31 cases per year; P less than .001). This was also true of open lobectomy cases (–0.14 cases per year at the junior level; P less than .001, and –3.41 cases per year at the chief resident level; P less than .0001).
As for video-assisted thoracoscopic surgery (VATS) lobectomy, the researchers observed an increase in average case volume at the junior surgeon level of .13 cases per year, but a decrease at the chief resident level of one case per year (P less than .001 for both).
Dr. Ragalie and his associates also observed a decrease in the following procedures performed by chief residents: open exploratory thoracoscopy (–3.17 cases per year; P less than .001), VATS exploratory thoracoscopy (–2.95 cases per year; P less than .0001), open wedge resection (–1.52 cases per year; P less than .0227), VATS wedge resection (–2.72 cases per year; P less than .0002), “other thoracic” (–6.3 cases per year; P = .0001), and thoracoscopic pleurodesis (–2.09 cases per year; P less than .0001).
At the same time, a significant trend of decreased case volume at the junior surgeon level was noted for open exploratory thoracoscopy (–0.10 cases per year; P less than .0001) and open wedge resection (–0.22 cases per year; P = . 0115).
The researchers reported having no financial disclosures.
PHOENIX – Over the past 11 years, fewer general surgery residents have participated in important types of general thoracic surgery cases, a retrospective review found.
“These findings may be the result of the work-hours reduction causing less exposure to general thoracic surgery and/or a reluctance to allow general surgery residents to perform the increasingly common minimally invasive procedures,” researchers led by Dr. William S. Ragalie wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons.
Dr. Ragalie of the Medical College of Wisconsin, Milwaukee, and his associates retrospectively reviewed the Accreditation Council for Graduate Medical Education resident case log database for the most recent 11 years in an effort to quantify and trend the operative experience among general surgery residents. They categorized cases by year, level of resident participation, and level of complexity. Major general thoracic cases were defined as esophagectomy, pneumonectomy, and lobectomy, while cases that did not involve hilar dissection were classified as “other thoracic.”
The researchers found that the 90th percentile of first assist thoracic surgery cases decreased significantly over the study period by an average of 1.46 cases per year (P = .0012). Decreased case volumes in pneumonectomy were also noted at the junior level (–0.012 cases per year; P less than .0001) and at the chief resident level (–0.31 cases per year; P less than .001). This was also true of open lobectomy cases (–0.14 cases per year at the junior level; P less than .001, and –3.41 cases per year at the chief resident level; P less than .0001).
As for video-assisted thoracoscopic surgery (VATS) lobectomy, the researchers observed an increase in average case volume at the junior surgeon level of .13 cases per year, but a decrease at the chief resident level of one case per year (P less than .001 for both).
Dr. Ragalie and his associates also observed a decrease in the following procedures performed by chief residents: open exploratory thoracoscopy (–3.17 cases per year; P less than .001), VATS exploratory thoracoscopy (–2.95 cases per year; P less than .0001), open wedge resection (–1.52 cases per year; P less than .0227), VATS wedge resection (–2.72 cases per year; P less than .0002), “other thoracic” (–6.3 cases per year; P = .0001), and thoracoscopic pleurodesis (–2.09 cases per year; P less than .0001).
At the same time, a significant trend of decreased case volume at the junior surgeon level was noted for open exploratory thoracoscopy (–0.10 cases per year; P less than .0001) and open wedge resection (–0.22 cases per year; P = . 0115).
The researchers reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point: Fewer general surgery residents are participating in important types of general thoracic surgery cases during their residency.
Major finding: The 90th percentile of first-assist thoracic surgery cases decreased significantly over the study period by an average of 1.46 cases per year (P = .0012).
Data source: A retrospective analysis of the Accreditation Council for Graduate Medical Education resident case log database for the most recent 11 years.
Disclosures: The researchers reported having no financial disclosures.
