Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses (CoreValve US Expanded Use Study)

Selected in Circulation Cardiovascular Interventions by D. Milasinovic , M. Pighi

Valve-in-valve transcatheter aortic valve implantation (VIV TAVI) over the last few years has been regarded as a reasonable treatment option for patients with failed surgical bioprostheses who are at increased risk for surgical reoperation and suitable anatomical features. While VIV TAVI showed good short-term hemodynamic and clinical outcomes, longer-term data are still lacking. The present study aimed to assess 3-year outcomes of VIV TAVI, using a self-expanding, supra-annular prosthesis.

Reviewers

Dejan Milasinovic

@MilasinD18

Interventional cardiologist / Cardiologist

Clinical Centre of Serbia - Belgrade, Serbia

Michele Pighi

@PighiMichele

Interventional cardiologist / cardiologist

University of Verona - Verona, Italy

Our Comment

This joint review is part of the PCRonline GLOBAL Journal Club Initiative by selected members of the EAPCI/PCR Journal Club and EAPCI young ambassadors, and is based on the underlying idea of “Bringing peers together, exchanging ideas, towards a common standard of care”.

How was it executed – the methodology?

• This observational study (CoreValve US Expanded Use Study) included 226 patients with symptomatic failed surgical biologic aortic valves, which were at extreme risk for surgical reintervention (mean STS-PROM score 9.0%).
• Subjects were stratified by presence of surgical valve prosthesis-patient mismatch (PPM).
• Study endpoints included all-cause mortality, need for reintervention, hemodynamic changes over time, and quality of life.

What is the main result?

• Valve-in-valve CoreValve TAVI was associated with stable or improving hemodynamics over 3-year follow-up.
• Moderate or severe structural valve deterioration (SVD) occurred in approximately 1 in 10 VIV TAVI patients at three years, with a 4.4% rate of repeat aortic valve intervention over 3 years of follow-up.
• Pre-existing surgical valve PPM, predicted by the patient’s body surface area and surgical valve’s estimated effective orifice area (EOA), was present in 47.2% of patients. Severe PPM was associated with significantly less improvement in quality of life and increased incidence of major stroke post VIV TAVI, as compared with patients with none, mild, or moderate PPM.

Critical reading and the relevance for clinical practice

This report represents the largest analysis focused on the intermediate outcomes of self-expandable valves in the context of VIV TAVI. The results showed reassuring data in terms of durability of the hemodynamic performance and clinical outcomes, with particular regard to a stable and persisting improvement of the quality of life up to 3 years after the procedure. PARTNER 2 registry results, published earlier this year on the performance of balloon-expandable valves for the treatment of failing surgical bioprostheses, showed a 3-year mortality rate of 32.7%, as compared with 27.7% in the here presented study. Of note, a durable improvement of EOA and Doppler velocity index was noted with the CoreValve, which was not previously seen at the intermediate-term evaluation after balloon-expandable VIV TAVI. Both studies did not detect any significant association between preexisting surgical valve PPM and mortality (p=0.71 and p=0.27). A key finding was the dramatic improvement in the quality of life among all patients (evaluated by the Kansas City Cardiomyopathy Questionnaire) after VIV TAVI and sustained up to three years; a data also supported by the PARTNER 2 analysis. However, while the latter study did not show any reduction in quality of life at intermediate-term when patients were stratified according to the presence of moderate/severe PPM, the CoreValve US showed that quality of life improvement was not maintained over the 3-year follow-up in patients presenting pre-existing severe PPM.

The positive results on the durability of VIV TAVI procedures will require further investigations to appreciate the long-term durability. Of note, the present report underlines the need to address the issue of surgical valve PPM, which seems to represent a key determining for the long-term hemodynamic and clinical outcomes.