European Registry: TAVR Devices Show Similar Short-, Long-term Outcomes
Patients undergoing transcatheter aortic valve replacement (TAVR) obtain largely similar short- and long-term outcomes regardless of whether they receive CoreValve or Sapien devices. The one exception, according to European registry findings published online January 16, 2013, ahead of print in the Journal of the American College of Cardiology, is a greater need for permanent pacemaker implantation with CoreValve.
Antonio Colombo, MD, of San Raffaele Scientific Institute (Milan, Italy), and colleagues analyzed 793 patients who underwent transfemoral TAVR at 4 experienced centers in Italy, France, and The Netherlands between November 2005 and August 2011. The choice of device was CoreValve (Medtronic, Minneapolis, MN) in 57.1% of cases and Sapien (Edwards Lifesciences, Irvine, CA) in 42.9%. Using propensity-score matching, the researchers identified 204 patient pairs for comparison. Endpoints were defined according to Valve Academic Research Consortium criteria.
At 30 days, nearly all outcome measures were similar between the CoreValve and Sapien groups. The only exception was pacemaker requirement, which was greater in patients receiving CoreValve (table 1).
Table 1. Clinical Outcomes at 30 Days
|
CoreValve |
Sapien |
P Value |
All-Cause Mortality |
8.8% |
6.4% |
0.352 |
Cardiac Mortality |
6.9% |
6.4% |
0.842 |
Spontaneous MI |
0.5% |
1.5% |
0.339 |
Major Stroke |
2.9% |
1.0% |
0.174 |
Major Vascular Complications |
9.3% |
12.3% |
0.340 |
Life-Threatening Bleeding |
13.7% |
8.8% |
0.120 |
Major Bleeding |
18.1% |
22.1% |
0.324 |
Acute Kidney Injury |
3.9% |
3.4% |
0.785 |
Device Success |
95.6% |
96.6% |
0.611 |
Permanent Pacemaker |
22.5% |
5.9% |
< 0.001 |
Both devices continued to demonstrate similar results at 1 year, with an all-cause mortality rate of 16.2% for CoreValve and 12.3% for Sapien (P = 0.266). Moderate/severe aortic regurgitation, meanwhile, was seen in 5.2% of CoreValve patients and 2.8% of Sapien patients (P = 0.302).
In an unadjusted analysis, moderate/severe aortic regurgitation was associated with increased all-cause (P = 0.001) and cardiac mortality (P = 0.002) at 1 year compared with mild aortic regurgitation.
Moving Beyond the Limitations
The greater need for pacemaker implantation seen with CoreValve is “likely related to valve structure and design,” Dr. Colombo and colleagues note.
Although the rate of aortic regurgitation importantly did not differ by device, the researchers stress that its effect on mortality confirms a growing body of literature. “The presence of residual [aortic regurgitation] is one of the limitations of the currently available TAVI devices, and paravalvular leaks need to be decreased to improve outcomes further,” they write. “In addition, facilitation of accurate positioning, device retrieval, and reduction of the delivery catheter diameter will continue to improve outcomes.”
The current results, though “encouraging,” do not replace the need for “longer term follow-up in the setting of an adequately powered randomized clinical trial,” the investigators conclude.
Similarity No Surprise
In a telephone interview, Peter C. Block, MD, of Emory University School of Medicine (Atlanta, GA), told TCTMD that it should come as no surprise that CoreValve and Sapien are similar, asking, “Why should there be that much difference between the two?”
The good news, Dr. Block commented, is how well both devices performed. “The fact that they had such good results is (1) comforting and (2) not surprising, since they’re very experienced [centers].”
However, the findings also confirm that pacemaker requirement is “a real problem,” he said. “If you want a candid opinion, I think [the added cost of needing a pacemaker] is a big deal.”
Going forward, device manufacturers will have to address that issue as well as paravalvular leak and retrievability, Dr. Block added. He reported that at least 3 other TAVR devices are expected to begin trials in the United States within the next 6 months to 1 year: DirectFlow (DirectFlow, Santa Rosa, CA), Lotus (Boston Scientific, Natick, MA), and Portico (St. Jude Medical, St. Paul, MN).
Informing Device Choice
In a telephone interview with TCTMD, Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), agreed that more research is needed on valve hemodynamics, which may differ slightly among devices.
Although propensity matching is useful, “the next step to show whether or not these devices are similar . . . is probably a randomized trial,” he said. “In the next few months there will be many valves available. At some point, it will be like [the head-to-head trials of] stents.”
Dr. Rodés-Cabau explained that, for now, device choice depends not only on operator but also institutional preference. In addition, he advised against using CoreValve to treat patients in whom a loss of rhythm and subsequent need for pacemaker would be particularly “deleterious,” or in those with conduction abnormalities at baseline, where “probably your chances of ending up with a pacemaker are extremely high.”
Source:
Chieffo A, Buchanan GL, Van Mieghem NM, et al. Transcatheter aortic valve implantation with the Edwards Sapien versus the Medtronic CoreValve Revalving System devices: A multicenter collaborative study: The PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol. 2013;Epub ahead of print.
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Caitlin E. Cox is News Editor of TCTMD and Associate Director, Editorial Content at the Cardiovascular Research Foundation. She produces the…
Read Full BioDisclosures
- Dr. Colombo reports no relevant conflicts of interest.
- Dr. Block reports serving as an investigator for the PARTNER trial and as a consultant to Medtronic.
- Dr. Rodés-Cabau reports serving as a consultant to Edwards Lifesciences and St. Jude Medical.
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