Open Surgery Holds Its Own in TEVAR Era

INDIANAPOLIS – The introduction of thoracic endovascular aortic repair increased the total number of aneurysm repairs, but did not replace conventional surgery, according to a population-based analysis.

The study, using the Nationwide Inpatient Sample (NIS) database, is the first to evaluate national trends in utilization of thoracic endovascular aortic repair (TEVAR) and to provide outcomes in the “real world,” according to principal investigator Dr. Jeffrey Jim. The NIS database is the largest all-payer inpatient care database in the United States and is designed to approximate a 20% sample of all U.S. hospitals.

Researchers at Washington University in St. Louis identified 18,267 hospitalizations for treatment of intact thoracic aortic aneurysms from October 2005, when the first ICD-9 procedural code for TEVAR became available, through December 2008, the latest data available.

A total of 4,649 patients (25%) underwent TEVAR and 13,618 (75%) underwent open aneurysm repair (OAR).

In terms of utilization, TEVAR was immediately adopted on a national basis, Dr. Jim said at the annual meeting of the Midwestern Vascular Surgical Society. The overall use of TEVAR in the study period was 25.6%.

The use of OAR, however, did not significantly decrease with the introduction of TEVAR. The number of OAR cases rose from 704 in the fourth quarter of 2005 to 1,264 cases in the fourth quarter of 2008. At the same time, the total number of thoracic aneurysm repairs jumped from 3,946 for all of 2005 to 6,628 for 2008.

“One thing that’s very surprising is that it [TEVAR] was rapidly adopted in the beginning, but really hasn’t changed over time,” said Dr. Jim, a vascular surgeon at Washington University.

Although sex did not significantly influence the use of TEVAR, age was a big factor, he said. Almost half (49%) of patients aged 80 years and older were treated with TEVAR, compared with 29.5% of those aged 65-79 years, and just 14% for those aged 50-64 years.

Overall mortality rates were similar: 3.2% for TEVAR and 2.6% for OAR. While TEVAR conferred no mortality benefit, it was associated with a significantly shorter length of stay (mean, 7.4 days vs. 9.1 days for OAR patients) and significantly fewer patients with any complication (38% vs. 51%), Dr. Jim said.

The use of TEVAR vs. OAR was associated with significantly lower rates of cardiac (5.4% vs. 17%), pulmonary (3% vs. 5%) and respiratory (5.5% vs. 7.5%) complications, but a significantly higher rate of neurologic complications (0.7% vs. 0.1%). This was true even though TEVAR patients had a significantly higher prevalence of comorbid conditions than did OAR patients, including cerebral (10% vs. 4.4%), peripheral vascular disease (18% vs. 6%), chronic obstructive pulmonary disease (35.5% vs. 18%), and renal insufficiency (14% vs. 6.5%).

Dr. Jim acknowledged the study was limited by the inherent variability in the accuracy of coding, the lack of anatomical information and operative details, and the inability to perform a longitudinal analysis or to accurately evaluate the rate of spinal cord ischemic injuries/paraplegia.

Still, the analysis is more inclusive than are institution reports, state databases, and even Medicare databases, which cover only about two-thirds of this population, he said.

While one attendee questioned the accuracy of the NIS database, the most pointed comment came from Dr. Alexander Shepard, codirector of the Edith and Benson Ford Heart & Vascular Institute in Detroit: “I rise to challenge all of us to look at these results and ask ourselves what we are really accomplishing with some of these patients.”

He noted that clinical trials show a 1-year mortality rate approaching 25% for patients who undergo thoracic repairs, whether open or endovascular. In addition, there is the issue of quality of life in relation to the outlay of reimbursement and financing.

“Just because it can be done, should it be done?” he asked. “I would challenge all of us, as we look at these older patients that we’re subjecting to these procedures – are we really getting the bang for our buck?”

Dr. Jim reported no conflicts or study support. Coinvestigator Dr. Luis Sanchez stated that he has consulting agreements with Aptus Endosystems Inc., Cook Medical Inc., Endologix Inc., W.L. Gore & Associates Inc., Medtronic Inc., and Trivascular Inc.

INDIANAPOLIS – The introduction of thoracic endovascular aortic repair increased the total number of aneurysm repairs, but did not replace conventional surgery, according to a population-based analysis.

The study, using the Nationwide Inpatient Sample (NIS) database, is the first to evaluate national trends in utilization of thoracic endovascular aortic repair (TEVAR) and to provide outcomes in the “real world,” according to principal investigator Dr. Jeffrey Jim. The NIS database is the largest all-payer inpatient care database in the United States and is designed to approximate a 20% sample of all U.S. hospitals.

Researchers at Washington University in St. Louis identified 18,267 hospitalizations for treatment of intact thoracic aortic aneurysms from October 2005, when the first ICD-9 procedural code for TEVAR became available, through December 2008, the latest data available.

A total of 4,649 patients (25%) underwent TEVAR and 13,618 (75%) underwent open aneurysm repair (OAR).

In terms of utilization, TEVAR was immediately adopted on a national basis, Dr. Jim said at the annual meeting of the Midwestern Vascular Surgical Society. The overall use of TEVAR in the study period was 25.6%.

The use of OAR, however, did not significantly decrease with the introduction of TEVAR. The number of OAR cases rose from 704 in the fourth quarter of 2005 to 1,264 cases in the fourth quarter of 2008. At the same time, the total number of thoracic aneurysm repairs jumped from 3,946 for all of 2005 to 6,628 for 2008.

“One thing that’s very surprising is that it [TEVAR] was rapidly adopted in the beginning, but really hasn’t changed over time,” said Dr. Jim, a vascular surgeon at Washington University.

Although sex did not significantly influence the use of TEVAR, age was a big factor, he said. Almost half (49%) of patients aged 80 years and older were treated with TEVAR, compared with 29.5% of those aged 65-79 years, and just 14% for those aged 50-64 years.

Overall mortality rates were similar: 3.2% for TEVAR and 2.6% for OAR. While TEVAR conferred no mortality benefit, it was associated with a significantly shorter length of stay (mean, 7.4 days vs. 9.1 days for OAR patients) and significantly fewer patients with any complication (38% vs. 51%), Dr. Jim said.

The use of TEVAR vs. OAR was associated with significantly lower rates of cardiac (5.4% vs. 17%), pulmonary (3% vs. 5%) and respiratory (5.5% vs. 7.5%) complications, but a significantly higher rate of neurologic complications (0.7% vs. 0.1%). This was true even though TEVAR patients had a significantly higher prevalence of comorbid conditions than did OAR patients, including cerebral (10% vs. 4.4%), peripheral vascular disease (18% vs. 6%), chronic obstructive pulmonary disease (35.5% vs. 18%), and renal insufficiency (14% vs. 6.5%).

Dr. Jim acknowledged the study was limited by the inherent variability in the accuracy of coding, the lack of anatomical information and operative details, and the inability to perform a longitudinal analysis or to accurately evaluate the rate of spinal cord ischemic injuries/paraplegia.

Still, the analysis is more inclusive than are institution reports, state databases, and even Medicare databases, which cover only about two-thirds of this population, he said.

While one attendee questioned the accuracy of the NIS database, the most pointed comment came from Dr. Alexander Shepard, codirector of the Edith and Benson Ford Heart & Vascular Institute in Detroit: “I rise to challenge all of us to look at these results and ask ourselves what we are really accomplishing with some of these patients.”

He noted that clinical trials show a 1-year mortality rate approaching 25% for patients who undergo thoracic repairs, whether open or endovascular. In addition, there is the issue of quality of life in relation to the outlay of reimbursement and financing.

“Just because it can be done, should it be done?” he asked. “I would challenge all of us, as we look at these older patients that we’re subjecting to these procedures – are we really getting the bang for our buck?”

Dr. Jim reported no conflicts or study support. Coinvestigator Dr. Luis Sanchez stated that he has consulting agreements with Aptus Endosystems Inc., Cook Medical Inc., Endologix Inc., W.L. Gore & Associates Inc., Medtronic Inc., and Trivascular Inc.

INDIANAPOLIS – The introduction of thoracic endovascular aortic repair increased the total number of aneurysm repairs, but did not replace conventional surgery, according to a population-based analysis.

The study, using the Nationwide Inpatient Sample (NIS) database, is the first to evaluate national trends in utilization of thoracic endovascular aortic repair (TEVAR) and to provide outcomes in the “real world,” according to principal investigator Dr. Jeffrey Jim. The NIS database is the largest all-payer inpatient care database in the United States and is designed to approximate a 20% sample of all U.S. hospitals.

Researchers at Washington University in St. Louis identified 18,267 hospitalizations for treatment of intact thoracic aortic aneurysms from October 2005, when the first ICD-9 procedural code for TEVAR became available, through December 2008, the latest data available.

A total of 4,649 patients (25%) underwent TEVAR and 13,618 (75%) underwent open aneurysm repair (OAR).

In terms of utilization, TEVAR was immediately adopted on a national basis, Dr. Jim said at the annual meeting of the Midwestern Vascular Surgical Society. The overall use of TEVAR in the study period was 25.6%.

The use of OAR, however, did not significantly decrease with the introduction of TEVAR. The number of OAR cases rose from 704 in the fourth quarter of 2005 to 1,264 cases in the fourth quarter of 2008. At the same time, the total number of thoracic aneurysm repairs jumped from 3,946 for all of 2005 to 6,628 for 2008.

“One thing that’s very surprising is that it [TEVAR] was rapidly adopted in the beginning, but really hasn’t changed over time,” said Dr. Jim, a vascular surgeon at Washington University.

Although sex did not significantly influence the use of TEVAR, age was a big factor, he said. Almost half (49%) of patients aged 80 years and older were treated with TEVAR, compared with 29.5% of those aged 65-79 years, and just 14% for those aged 50-64 years.

Overall mortality rates were similar: 3.2% for TEVAR and 2.6% for OAR. While TEVAR conferred no mortality benefit, it was associated with a significantly shorter length of stay (mean, 7.4 days vs. 9.1 days for OAR patients) and significantly fewer patients with any complication (38% vs. 51%), Dr. Jim said.

The use of TEVAR vs. OAR was associated with significantly lower rates of cardiac (5.4% vs. 17%), pulmonary (3% vs. 5%) and respiratory (5.5% vs. 7.5%) complications, but a significantly higher rate of neurologic complications (0.7% vs. 0.1%). This was true even though TEVAR patients had a significantly higher prevalence of comorbid conditions than did OAR patients, including cerebral (10% vs. 4.4%), peripheral vascular disease (18% vs. 6%), chronic obstructive pulmonary disease (35.5% vs. 18%), and renal insufficiency (14% vs. 6.5%).

Dr. Jim acknowledged the study was limited by the inherent variability in the accuracy of coding, the lack of anatomical information and operative details, and the inability to perform a longitudinal analysis or to accurately evaluate the rate of spinal cord ischemic injuries/paraplegia.

Still, the analysis is more inclusive than are institution reports, state databases, and even Medicare databases, which cover only about two-thirds of this population, he said.

While one attendee questioned the accuracy of the NIS database, the most pointed comment came from Dr. Alexander Shepard, codirector of the Edith and Benson Ford Heart & Vascular Institute in Detroit: “I rise to challenge all of us to look at these results and ask ourselves what we are really accomplishing with some of these patients.”

He noted that clinical trials show a 1-year mortality rate approaching 25% for patients who undergo thoracic repairs, whether open or endovascular. In addition, there is the issue of quality of life in relation to the outlay of reimbursement and financing.

“Just because it can be done, should it be done?” he asked. “I would challenge all of us, as we look at these older patients that we’re subjecting to these procedures – are we really getting the bang for our buck?”

Dr. Jim reported no conflicts or study support. Coinvestigator Dr. Luis Sanchez stated that he has consulting agreements with Aptus Endosystems Inc., Cook Medical Inc., Endologix Inc., W.L. Gore & Associates Inc., Medtronic Inc., and Trivascular Inc.