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Structural valve deterioration of the Sapien valve requiring intervention was rare more than 3 years after transcatheter aortic valve replacement (TAVR), but early paravalvular regurgitation predicted later outcomes, according to two PARTNER trial analyses.

In the extreme-risk PARTNER 1A, 1B, and continued access cohorts, population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of from 12.1 to 9.2 mm Hg in aortic valve mean gradient, an increase from 0.509 to 0.537 in Doppler velocity index, and a widening in effective orifice area from 1.63 to 1.72 cm², the investigators reported.

Over a median 3.1-year follow-up, the aortic valve mean gradient had crept back up to 10.1 mm Hg and Doppler velocity index almost fully rebounded to 0.510. The effective orifice area was squarely back to 1.63 cm².

The overall rate of moderate-to-severe transvalvular regurgitation observed after TAVR was 3.7%, which increased from 0.8% at 30 days to 4.1% at 5 years among those with paired echocardiographic data at both points, reported Pamela Douglas, MD, of Duke University Medical Center in Durham, N.C., and colleagues online in JAMA Cardiology. Top-line results were presented last year at the Transcatheter Cardiovascular Therapeutics conference.

In the 2,795-patient analysis, 20 TAVR patients required reintervention (0.8% of those with 5-year echocardiograms), with structural deterioration of the valve responsible for five cases: stenosis in one, valve thrombosis in one, and transvalvular regurgitation in three.

Those who got surgery in PARTNER 1 had no valve deterioration over follow-up and a similar mean gradient achieved over long-term follow-up.

Implications

The data highlight the "excellent durability" of both transcatheter and surgical heart valves, Douglas' group suggested. "Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation."

"In short, Douglas et al report a very favorable hemodynamic profile with no significant valve deterioration during study follow-up, a clear demonstration of the excellent longitudinal durability of both TAVR and surgical aortic valve replacement prostheses over this time. Importantly, there were no echocardiographic warning signs that it would be inappropriate to perform a long-term TAVR study in the lower-risk (younger age) population," commented Stephen Little, MD, and Michael Reardon, MD, both of Houston Methodist Hospital.

Their accompanying editorial, however, called the present analysis "only a starting point" on the durability issue for TAVR. "In this elderly group of patients, it is unlikely that we will see structural valve deterioration in TAVR valves if they behave similarly to surgical valves because death will compete with structural valve deterioration in this high-risk population," Little and Reardon said. They suggested it will take the 10-year data from Sapien's intermediate- and low-risk trials to really answer the question.

Paravalvular Regurgitation

In a separate analysis of PARTNER data, this time the PARTNER II SAPIEN 3 observational study in intermediate-risk patients, moderate-or-worse paravalvular regurgitation 30 days after TAVR was associated with poorer outcomes.

The 3.5% who had moderate-or-worse paravalvular regurgitation had more-than-doubled odds of mortality (HR 2.40, 95% CI 1.30-4.43) and combined mortality and rehospitalization (HR 2.35, 95% CI 1.52-3.62).

But a lesser severity was not tied to more such events, Philippe Pibarot, DVM, PhD, of the Institut Universitaire de Cardiologie et de Pneumologie de Québec, and colleagues reported in JAMA Cardiology.

These main findings stayed the same after multivariable adjustment. Moreover, 73% of patients with at least moderate paravalvular regurgitation at 30 days showed a reduced severity by year's end.

TAVR with the third-generation balloon-expandable Sapien 3 valve resulted in a 44.3% rate of any regurgitation at 30 days, the study showed. By 1 year, mortality and heart failure rehospitalization reached 9.3% and 14.2%, respectively.

It is "essential" to prevent moderate paravalvular regurgitation at the time of TAVR, Pibarot's group urged. "This effort includes comprehensive periprocedural imaging to assess the presence and severity of paravalvular regurgitation as well as the use of corrective procedures (i.e., balloon postdilation) if at least moderate paravalvular regurgitation is present."

For this prespecified analysis of the PARTNER II data, core laboratories evaluated paravalvular regurgitation according to transthoracic echocardiograms. Included were Sapien 3 recipients in the registry who had paravalvular regurgitation assessed (n=1,592).