No Deaths With Mild/Moderate Paravalvular Leaks: CoreValve Extreme Risk at Two Years

Shelley Wood

September 14, 2014

WASHINGTON, DC — Two-year results from the Medtronic CoreValve US "extreme-risk" study confirm the improved survival benefit seen at one year, Dr Steven Yakubov (Riverside Methodist Hospital, Columbus, OH) reported yesterday at TCT 2014 .

As reported by heartwire at TCT 2013 in San Francisco, CoreValve Extreme Risk was originally designed to randomize patients 2:1 to transfemoral transcatheter aortic-valve implantation (TAVI) or best medical care (including valvuloplasty). Those plans were sidelined following the 2010 release of the PARTNER B results using the Edwards Sapien device, which rendered medical care alone ethically unacceptable.

Dr Steven Yakubov

In the updated results, Yakubov showed that, at 24 months, the rate of all-cause mortality or major stroke among 489 patients was 38% at two years.

In a landmark analysis looking only at mortality events between year 1 and 2, 10% of patients died of cardiovascular causes, while the rate of all-cause mortality was 16.1%.

Importantly, the improvement in NYHA class appeared stable out to two years. There was also a nonsignificant trend toward lower rates of paravalvular regurgitation between one month and one year that was sustained out to two years, a finding that supports a theory that the self-expanding design of the CoreValve might help reduce the risk of paravalvular leaks.

Also of note, there was no association between mild or moderate paravalvular regurgitation and mortality—that's different from what was seen in earlier registry studies and in the pivotal PARTNER A trial, where even mild paravalvular leaks were linked to mortality at two years.

Asked about this during a morning press conference, Yakubov told heartwire he "really had no answer for that," noting that there is a clear signal that mortality is related to severe paravalvular leaks, but no such association appeared in these two-year data relating to less severe degrees of regurgitation.

Also commenting, Dr Ajay Kirtane pointed out that the PARTNER and CoreValve trials enrolled different patients, at different risk levels, and used different core labs, so "it's really tough to know" if this difference is worth considering.

"The reality is that if we're not getting surgical-like results with our therapies, then that's not going to be optimal," Kirtane said. "So there should be every effort to reduce paravalvular leak" at the time of the procedure.

Cost-Efficacy Data From Surgery-Eligible Patients

Dr Matthew Reynolds

In a separate presentation at TCT, Dr Matthew Reynolds presented a cost-efficacy analysis based on the CoreValve High-Risk 12-month results, projecting life expectancy, quality-adjusted life expectancy, and costs among patients eligible for surgery but treated with the less invasive therapy.

The analysis assumed an estimated commercial price of the CoreValve of $32 000 and no survival benefit from TAVR beyond 12 months—an assumption that may in fact be inaccurate, given yesterday's PARTNER five-year results.

According to Reynolds, TAVR was associated with:

  • A reduction in hospital stay of 4.4 days compared with surgical aortic-valve repair (SAVR).

  • A reduced need for rehab services at discharge (23% vs 44%, p<0.001).

  • Higher costs: $69 000 vs $58 000.

  • A projected higher lifetime cost of $13 700.

  • Better cost efficacy for patients treated via a transfemoral route than a nontransfemoral route, although numbers of the latter were small.

  • Better quality of life at one month, but not at six or 12 months.

  • An improvement of 0.24 life-years and 0.20 quality-adjusted life-years compared with SAVR.

The increased cost of TAVR compared with SAVR are within the range of what is deemed acceptable in the US, Reynolds noted—coming in at slightly more expensive than atrial-fibrillation ablation, but cheaper than dialysis.

Reynolds disclosed grant/research support from Medtronic and Edwards Lifesciences and consulting fees/honoraria from Medtronic. Kirtane reported grant/research support from Abbott Vascular, Vascular Dynamics, Daiichi-Sankyo/Eli Lilly, St Jude Medical, Medtronic, and Boston Scientific. Yakubov disclosed receiving consulting fees from Medtronic and being a member of the CoreValve US Pivotal Trial screening, steering, and publication committees.

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