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As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.
Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.
This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).
The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).
The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.
Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.
The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).
The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.
A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.
Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.
They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.
Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.
Calling this report an “early milestone in the relentless simplification” of transcatheter aortic valve replacement (TAVR), Dr. Craig Smith of Columbia University Medical Center/New York Presbyterian Hospital, wrote in his invited commentary that it nonetheless leaves a few questions unanswered – and may leave surgeons seeing their role in TAVR marginalized as the procedure moves from the operating room to the catheterization lab (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.082). .
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Dr. Craig Smith |
One unanswered question revolves around the use of conscious sedation and transthoracic echocardiography (TTE) for the minimalist approach (MA), rather than general anesthesia and transesophageal echocardiography (TEE) of the traditional transfemoral approach. “MA requires reliance on [TTE] for assessment of paravalvular leak, and since TTE can’t be compared to TEE in the same patients and still be MA, the merits of this trade-off cannot be assessed in this population,” he said.
Further, he said that the study data do not conclusively link MA to early discharge because the early discharge patients had lower Society of Thoracic Surgery scores.
Another important unanswered question is whether endocarditis is more frequent in TAVR when it’s performed outside the operating room.
“While I suspect the answer will be ‘yes,’ this question will be left dangling until large numbers have been done in hybrid cath labs, because the frequency will be low, and because the forces propelling a ‘cath lab’ alternative to surgical or transcatheter valve replacement done in an operating room will be too powerful to retard on a hunch,” Dr. Smith wrote. “What will the departure of TAVR from operating rooms mean for the role of the surgeon? That is for surgeons to determine. Stay involved, or say goodbye!”
Calling this report an “early milestone in the relentless simplification” of transcatheter aortic valve replacement (TAVR), Dr. Craig Smith of Columbia University Medical Center/New York Presbyterian Hospital, wrote in his invited commentary that it nonetheless leaves a few questions unanswered – and may leave surgeons seeing their role in TAVR marginalized as the procedure moves from the operating room to the catheterization lab (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.082). .
|
Dr. Craig Smith |
One unanswered question revolves around the use of conscious sedation and transthoracic echocardiography (TTE) for the minimalist approach (MA), rather than general anesthesia and transesophageal echocardiography (TEE) of the traditional transfemoral approach. “MA requires reliance on [TTE] for assessment of paravalvular leak, and since TTE can’t be compared to TEE in the same patients and still be MA, the merits of this trade-off cannot be assessed in this population,” he said.
Further, he said that the study data do not conclusively link MA to early discharge because the early discharge patients had lower Society of Thoracic Surgery scores.
Another important unanswered question is whether endocarditis is more frequent in TAVR when it’s performed outside the operating room.
“While I suspect the answer will be ‘yes,’ this question will be left dangling until large numbers have been done in hybrid cath labs, because the frequency will be low, and because the forces propelling a ‘cath lab’ alternative to surgical or transcatheter valve replacement done in an operating room will be too powerful to retard on a hunch,” Dr. Smith wrote. “What will the departure of TAVR from operating rooms mean for the role of the surgeon? That is for surgeons to determine. Stay involved, or say goodbye!”
Calling this report an “early milestone in the relentless simplification” of transcatheter aortic valve replacement (TAVR), Dr. Craig Smith of Columbia University Medical Center/New York Presbyterian Hospital, wrote in his invited commentary that it nonetheless leaves a few questions unanswered – and may leave surgeons seeing their role in TAVR marginalized as the procedure moves from the operating room to the catheterization lab (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.082). .
|
Dr. Craig Smith |
One unanswered question revolves around the use of conscious sedation and transthoracic echocardiography (TTE) for the minimalist approach (MA), rather than general anesthesia and transesophageal echocardiography (TEE) of the traditional transfemoral approach. “MA requires reliance on [TTE] for assessment of paravalvular leak, and since TTE can’t be compared to TEE in the same patients and still be MA, the merits of this trade-off cannot be assessed in this population,” he said.
Further, he said that the study data do not conclusively link MA to early discharge because the early discharge patients had lower Society of Thoracic Surgery scores.
Another important unanswered question is whether endocarditis is more frequent in TAVR when it’s performed outside the operating room.
“While I suspect the answer will be ‘yes,’ this question will be left dangling until large numbers have been done in hybrid cath labs, because the frequency will be low, and because the forces propelling a ‘cath lab’ alternative to surgical or transcatheter valve replacement done in an operating room will be too powerful to retard on a hunch,” Dr. Smith wrote. “What will the departure of TAVR from operating rooms mean for the role of the surgeon? That is for surgeons to determine. Stay involved, or say goodbye!”
As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.
Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.
This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).
The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).
The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.
Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.
The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).
The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.
A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.
Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.
They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.
Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.
As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.
Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.
This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).
The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).
The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.
Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.
The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).
The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.
A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.
Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.
They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.
Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A minimalist approach to transcatheter aortic valve replacement (MA-TAVR) is feasible with acceptable outcomes.
Major finding: Transition to MA-TAVR in a high-volume center had a relatively small learning curve.
Data source: A review of 151 consecutive patients who had MA-TAVR at Emory University between May 2012 and July 2014.
Disclosures: Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.
