Favorable Outcomes Three Years After Valve-in-Valve TAVR

By Will Boggs MD

July 02, 2019

NEW YORK (Reuters Health) - Favorable outcomes persist three years after valve-in-valve (VIV) transcatheter aortic-valve replacement (TAVR) for degenerated bioprostheses, according to findings from the PARTNER 2 registry.

"The results with VIV TAVR are very encouraging," Dr. John G. Webb from St. Paul's Hospital, in Vancouver, Canada, told Reuters Health by email. "It seems likely that, in future, the majority of patients with failed surgical valves will favor VIV rather than repeat surgery."

Data from the PARTNER 2 registry earlier showed that VIV TAVR was associated with relatively low rates of mortality and major complications, improved hemodynamic status and excellent improvement in functional and quality-of-life outcomes at 30 days and one year.

In the current study, Dr. Webb and colleagues report three-year outcomes of 365 patients who underwent VIV procedures at 34 sites. Complete follow-up was available for 337 patients (92.3%), with the remainder either withdrawn from the study or lost to follow-up at three years.

The estimated all-cause mortality was 32.7% (the primary endpoint). Cardiac mortality was 20.5%, 6.2% had strokes, and 1.9% had repeat aortic-valve replacement, the researchers report in the June 4 issue of the Journal of the American College of Cardiology.

Among the 158 patients with evaluable echocardiograms at three years, the mean gradient was 16.6 mmHg, the mean effective orifice area (EOA) was 1.15 cm2, and the mean indexed EOA was 0.60 cm2/m2, values that were not significantly different from those at 30 days.

Total aortic regurgitation was less than mild in 97.5% and moderate in 2.5% of patients; none had severe aortic regurgitation.

Only two of 160 (1.3%) patients had moderate hemodynamic valve deterioration and two of 160 had severe hemodynamic valve deterioration at three years.

From baseline to three years, there were significant decreases in mean left ventricular mass index, moderate or severe mitral regurgitation, and moderate or severe tricuspid regurgitation.

The proportion of patients in New York Park Association functional class III or IV decreased significantly from 90.4% at baseline to 10.4% at 30 days and remained low at three years (14.1%), and patients experienced significant and sustained improvements in Kansas City Cardiomyopathy Questionnaire scores.

"The early improvements associated with VIV TAVR are maintained through 3 years, supporting the value of VIV TAVR as an important alternative therapy in appropriate patients with aortic bioprosthetic valve failure," the researchers conclude.

"Longer-term follow-up beyond 3 years is still required to assess durability following VIV TAVR, which perhaps will not be obtained in the current cohort," write Dr. Stephen Windecker from Inselspital, University of Bern, in Switzerland, and colleagues in a linked editorial. "It is unlikely we will have a randomized trial that compares redo surgery with VIV TAVR; rather, the procedure will gradually become standard of care by default unless new adverse data become available."

"Perhaps we should already be thinking about which transcatheter heart valves are most amenable to repeat intervention and how to optimize current designs to facilitate this," they conclude.

Dr. Gregory Trachiotis from DC Veterans Affairs Medical Center and The George Washington University, in Washington, D.C., who has reported successful double VIV transcatheter aortic- and tricuspid-valve replacement, said that with recent technical advances, VIV TAVR has become "an alternative and perhaps preferred strategy in selected patients with failed bioprosthesis. These candidates are best determined by a Heart Valve Team skilled at these procedures."

"Newer surgical bioprosthetic aortic valves are constructed for a longer durability, as well as, allowing for enhanced fitting if a VIV procedure is needed for failure in a lifetime," he told Reuters Health by email. "Thus, an effective strategy for managing primary therapy for aortic stenosis, and perhaps eventual redo procedure (either surgical or with a transcatheter VIV), needs to be discussed among the Heart Valve team going forward."

"Patients that will continue to derive benefit from a VIV procedure will be those patients at too-high risk to undergo a redo surgical valve replacement due to advanced age, frailty, or contraindications to a surgical approach," said Dr. Trachiotis, who was not involved in the new work. "Caution should be advised in a lower-risk or younger population, as the long-term durability of a transcatheter VIV procedure is not defined."

Dr. Webb is a consultant for Edwards Lifesciences, which sponsored PARTNER 2 and also has ties to several other authors, including the editorialists.

SOURCE: https://bit.ly/2wDeDAb and https://bit.ly/2MBEq6y

J Am Coll Cardiol 2019.

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