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Is valve choice a significant determinant of paravalular leak post-transcatheter aortic valve implantation? A systematic review and meta-analysis

Selected in European Journal of Cardio-thoracic Surgery by Rylski

References

Authors

Katie E. O'Sullivan, Aideen Gough, Ricardo Segurado, Mitchel Barry, Declan Sugrue, John Hurley

Reference

Eur J Cardiothorac Surg 2014;45:826-833

Published

May 2014

Link

Access the article here

My Comment

Background

Paravalvular regurgitation (PVR) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with poor survival. The authors aimed to analyse the incidence and risk factors predisposing to PVR after implantation of Medtronic CoreValve (MCV) vs Edward Sapien (ES) prostheses.

Results

  • Meta-analysis on 5910 patients from 9 studies
  • MCV was associated with a higher PVR rate compared with ES (16% vs. 4%, P=0.0002)
  • Valve position, size and commissural calcification influenced PVR incidence¬†

My comments

The authors clearly showed that valve choice is a significant determinant of PVR after TAVI. This is a very important finding, since according to PARTNER trial (3-year follow-up), PVR significantly increases mortality from 35% for mild to 61% for moderate-to-severe PVR. It is still unresolved complication of TAVI without any established endovascular treatment option. New generation of TAVI devices and better imaging might decrease the incidence of this serious complication. 

1 comment

  • Michael Reardon 17 May 2014

    This article reviews registries which have self reported PVL data without external monitoring of the data or independent core labs. We have several studies of the Sapien and the Corevalve that have PVL collected in trials with required data entry, external data monitoring and external, independent echo for labs. These are the PARTNER and PARTNER II trials and the Corevalve US pivotal trial. In these trial we see 30 days PVL rates PARTNER IA 12.2% PARTNER IB 13% PARTNER IIB Sapien 16.9% PARTNER IIB Sapien XT 24.2% Corevalve Extrene risk trail 11.5% High risk trial 9.0% Extreme risk Non femoral 11.8% At 1 year we see PARTNER IA 7% PARTNER IB 12% PARTNER IIB Sapien 20.9% PARTNER IIB Sapien XT 29.2% Corevalve Extreme trial 4.3% High risk trial 6.1% Extreme non femoral 2.4% These are much more robust data than a metaanalysis of non adjudicated trials. In these independent for lab adjudicated trials Corevalve has less PVL than Sapien, Imprves with time with over 80% improving with continued self expansion and moderate PVL has not been associated with increased mortality likely due to lessening PVL with time due to continued expansion Conclusions from met analysis of non adjudicated trials should be taken with caution Michael Readon, MD Professor of Cardiothoracic Surgery Houston Methodist DeBakey Heart