Transcatheter Heart Valves Show Outstanding Durability in PARTNER 1 Trial

Data from the PARTNER 1 trial demonstrate the excellent durability of transcatheter heart valves, comparable with surgical prostheses and consistent with reports in smaller cohorts or those with shorter follow-up, according to a study published Sept. 27 in JAMA Cardiology.

Using the core laboratory-based data from echocardiograms obtained in PARTNER 1, Pamela S. Douglas, MD, MACC, et al., compared outcomes in patients with successful transcatheter aortic valve replacement (TAVR) or surgical AVR (SAVR) at pre-implantation and post-implantation at seven days, one and six months, and one, two, three, four and six years.

Outcomes were measured according to peak and mean aortic valve gradients, effective orifice area (EOA) and Doppler velocity index (DVI) to evaluate valve systolic hemodynamics and transvalvular aortic regurgitation. The clinical endpoints were all-cause death and aortic valve reintervention due to structural deterioration.

Results showed the mean age was 84.5 years and 47 percent of the 2,795 patients were women. Population hemodynamic trends showed early favorable hemodynamic changes in the first few months post-TAVR, with a decrease of −2.9mm Hg in aortic valve mean gradient, an increase of 0.028 in DVI and an increase of 0.09cm2 in EOA.

There was midterm stability at a median follow-up of 3.1 years and moderate to severe transvalvular regurgitation was noted in 89 patients (3.7 percent) after TAVR and increased over time. Patients with SAVR showed no significant changes.

In TAVR patients, death and reintervention was associated with lower ejection fraction, stroke volume index and aortic valve mean gradient up to three years, with no association with DVI or valve area.

Reintervention and severely abnormal hemodynamics on echocardiograms were infrequent and not associated with excess death in patients after either TAVR or SAVR.

The study authors write, "The PARTNER 1 Trial represents a unique and carefully curated large data set, which, despite low event-free survival (34 percent at five years), yielded a robust patient cohort at five years, representing the entire trial rather than a substudy population."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Aortic Valve, Aortic Valve Insufficiency, Stroke Volume, Transcatheter Aortic Valve Replacement, Disease-Free Survival, Follow-Up Studies, Echocardiography, Echocardiography, Doppler, Prostheses and Implants

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