PARIS, France—The first full year of experience with a transcatheter aortic valve implantation (TAVI) in over 1,000 patients, many of them not eligible for surgery, shows survival rates over 80% in patients treated via the transfemoral route, and over 70% in patients treated via the transapical route. The registry results were presented May 25 at EuroPCR 2010.
Martyn Thomas, MD, of Guys and St. Thomas’ NHS Foundation Trust (London, United Kingdom), reported the results of the SOURCE registry's first cohort, which includes 1,038 patients from 32 European centers treated with the Sapien aortic valve (Edwards, Irvine, CA) from November 2007 to January 2009. One-year follow-up was available for 98% of patients.
In terms of baseline characteristics, the transapical patients (n = 575) were much higher risk than the transfemoral patients (n = 463; table 1).
Table 1. Baseline Risk Factors
|
Transfemoral
(n = 463)
|
Transapical
(n = 575)
|
P Value
|
Logistic EuroSCORE
|
25.8
|
29.0
|
0.007
|
Renal Dysfunction
|
25.5%
|
32.5%
|
0.016
|
Peripheral Disease
|
10.6%
|
28.0%
|
< 0.001
|
Carotid Stenosis > 50%
|
7.1%
|
17.2%
|
< 0.001
|
CAD
|
47.5%
|
55.1%
|
0.02
|
Porcelain Aorta
|
4.5%
|
11.3%
|
0.001
|
Prior CABG
|
17.5%
|
27.0%
|
0.003
|
Mitral Valve Disease
|
15.8%
|
32.0%
|
< 0.001
|
Most Deaths Noncardiac in Nature
At 1 year, survival was 76.1% overall, 72.1% in transapical patients, and 81.1% in transfemoral patients. There were no definitive structural valve failures and no need for reinterventions.
As previously published, 91 deaths occurred within the first 31 days after TAVI. Of the 179 deaths that occurred between 30 days and 1 year, one-fourth (25.1%) were cardiac-related, almost half (49.2%) were noncardiac, and another fourth (25.7%) were of unknown cause. Most of the cardiac deaths were related to heart failure (62.2%) and MI (13.3%), while noncardiac deaths were related to respiratory failure (23.9%), renal failure (12.5%), cancer (11.4%), and other complications.
A significant relationship existed between vascular access complications and mortality. Transfemoral patients without such complications experienced an 83.9% survival rate at 1 year, compared with 72.2% in patients with access complications (P = 0.0121). And transapical patients without access complications experienced a 73.2% survival rate, compared with 47.4% in those with access complications (P = 0.0188).
Improving Over Time
To gauge improvement and compare the SOURCE mortality rates with a valid historical control population, Dr. Thomas and colleagues compiled data from 4 previous monitored, adjudicated TAVI studies performed from January 2006 to January 2008 (REVIVE, REVIVAL, TRAVERCE, and PARTNER EU) totaling 296 transapical and 207 transfemoral patients.
Compared with a 1-year transapical mortality rate of 27.9% in SOURCE, the rate in the transapical historical control population was 41.9%. The corresponding rates for transfemoral patients were 18.9% in SOURCE and 25.1% in historical controls. Dr. Thomas noted how the 1-year survival in SOURCE transapical patients (72.1%) was approaching that of the transfemoral historical controls (74.9%).
In addition, lower-risk patients from SOURCE according to EuroSCORE (< 20) were associated with similar Kaplan-Meier estimates of 1-year survival for transapical (78.4%) and transfemoral (80.9%) patients.
“Outcomes at 1 year for cohort 1 of the SOURCE registry show an improvement compared to historical controls, with survival for the transfemoral approach now greater than 80%,” Dr. Thomas said. “There has been a marked improvement in the transapical outcomes with survival now similar to historical transfemoral controls. In addition, lower-risk transapical patients have the same 1-year risk as transfemoral patients. Cohort 1 outcomes provide a benchmark against which future TAVI cohorts may be measured.”
Caution Called For
William Wijns, MD, PhD, of Cardiovascular Center Aalst (Aalst, Belgium), and chairman of EuroPCR 2010, agreed that the results represent an important step forward for the TAVI technology, but he stressed that clinicians should remain cautious regarding its use.
“There is improved survival with the use of the device,” Dr. Wijns told TCTMD in an interview. “But whether that improves patient outcome compared with a patient who would still be denied any form of treatment beside drugs? I don’t think we’ve proven that yet.”
He agreed with the view that good surgical candidates for aortic valve repair or replacement should still be operated on without exception, and that “uncontrolled release, so to speak” of the TAVI technology would be extremely damaging to the field.
“If we disseminate it prematurely, before proper evaluation, we will devalue it,” Dr. Wijns said. “It will be worth nothing, because doctors will use it without reimbursement, which is a big mistake. We should take the lessons from the coronary work.”
Source:
Thomas M. The SOURCE family of registries: One-year results from cohort 1 of the SOURCE registry. The European registry of transcatheter aortic valve implantation using the Edwards Sapien valve. Presented at: EuroPCR; May 25, 2010; Paris, France.
Disclosures:
- Dr. Thomas reports serving as a consultant for Edwards.
- Dr. Wijns reports no relevant conflicts of interest.
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