Clinical Research
Excellent Outcomes for Transcatheter Aortic Valve Replacement Within 1 Year of Opening a Low-Volume Centre and Consideration of Requirements

https://doi.org/10.1016/j.cjca.2014.08.010Get rights and content

Abstract

Background

After the approval of transcatheter aortic valve replacement (TAVR) for high-risk or inoperable patients with severe aortic stenosis (AS), many low- and moderate-volume TAVR programs were initiated. Contemporary outcomes from these newly initiated centres remain unknown.

Methods

In March 2013, our institution was authorized by the Québec Ministry of Health to perform 30 TAVR procedures. After thorough clinical screening and imaging evaluation, suitable patients underwent transfemoral TAVR with the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (THV). In-hospital and 30-day outcomes were prospectively collected and reported according to Valve Academic Research Consortium 2 guidelines.

Results

From April 2013 to January 2014, 30 consecutive high-risk (n = 16 [53.3%]) or inoperable (n = 14 [46.7%]) patients (mean age, 84.6 years; mean Society of Thoracic Surgery score, 7) with symptomatic severe AS underwent transfemoral TAVR. No catastrophic intraprocedural complications such as annulus rupture, valve embolization, aortic dissection, or coronary occlusion occurred, and there were no deaths at 30 days. Disabling stroke occurred in 1 (3.3%) patient 48 hours after THV implantation. Major vascular complications and major bleeding occurred in 1 (3.3%) patient. No moderate or severe paravalvular leak was observed. The median length of stay was 2 (1-3) days, with 8 (26.7%) patients discharged within 24 hours after the procedure.

Conclusions

Excellent outcomes can be achieved in newly initiated relatively low-volume centres, which compares favorably to previously published large series. Important considerations include appropriate team training, rigorous patient screening, use of multimodality imaging techniques, a heart team approach, constant integration of lessons learned from larger published experiences, and maintaining a recommended minimum volume of 25 cases per year.

Résumé

Introduction

Après l’approbation du remplacement valvulaire aortique par cathétérisme (TAVR) chez les patients inopérables ayant une sténose aortique (SA) sévère, plusieurs programmes de TAVR de volume faible ou modéré ont été inaugurés. On en connaît peu sur les résultats contemporains de ces nouveaux centres.

Méthodes

En mars 2013, le ministère de la Santé et des Services sociaux du Québec a autorisé notre établissement à réaliser 30 TAVR. Après un dépistage clinique rigoureux et une évaluation en imagerie, les patients admissibles ont subi l’implantation d’une valve cardiaque transcathéter SAPIEN XT (Edwards Lifesciences, Irvine, CA) expansible par ballonnet lors d’un TAVR transfémoral. Les résultats intrahospitaliers et à 30 jours ont été prospectivement recueillis et présentés selon les lignes directrices du VARC-2 (Valve Academic Research Consortium 2).

Résultats

D’avril 2013 à janvier 2014, 30 patients consécutifs à risque élevé (n = 16 [53,3 %]) ou inopérables (n = 14 [46,7 %]; âge moyen, 84,6 ans; score moyen de la Society of Thoracic Surgery, 7) ayant une SA symptomatique sevère ont subi un TAVR transfémoral. Aucune complication per-procédure catastrophique telle que la rupture annulaire, l’embolisation valvulaire, la dissection aortique ou l’occlusion coronarienne n’est survenue, et aucun décès n'a été observé dans les 30 jours. Un accident vasculaire cérébral invalidant est survenu chez 1 (3,3 %) patient 48 heures après l’implantation de la prothèse. Une complication vasculaire majeure et une hémorragie majeure sont survenues chez 1 (3,3 %) patient. Aucune fuite paravalvulaire modérée ou sévère n'a été observée. La durée médiane du séjour a été de 2 (1 à 3) jours, et 8 patients (26,7 %) ont obtenu leur congé 24 heures après l’intervention.

Conclusions

Les centres de faible volume ayant récemment été initiés peuvent atteindre d’excellents résultats, qui se comparent favorablement aux grandes séries publiées antérieures. Il est notamment important de prendre en considération la formation en équipe appropriée, le dépistage rigoureux des patients, l’utilisation des techniques d’imagerie multimodale, l’approche d’équipe multidisciplinaire, l’intégration constante des leçons tirées des plus grandes expériences publiées et le maintien du volume minimal recommandé de 25 cas par année.

Section snippets

Patient population

In March 2013, the Ministry of Health authorized our institution to perform TAVR procedures in patients with severe AS who were unsuitable for surgical aortic valve replacement (SAVR). All patients underwent extensive screening, including simultaneous clinical evaluation by a cardiologist, cardiothoracic surgeon, and dedicated nurse in a specialized TAVR clinic. Multimodality imaging assessment was performed in all patients, including transthoracic echocardiography, transesophageal

Definitions

All outcomes were adjudicated according to the standardized Valve Academic Research Consortium 2 (VARC-2) guidelines20 by 2 cardiologists. Clinical data were collected prospectively from systematic follow-up of all patients. Echocardiographic evaluation was performed by 2 experienced cardiologists in accordance with published guidelines from the American Society of Echocardiography.21, 22

Paravalvular leak (PVL) was defined according to VARC-2 recommendations.20 When available, the density of

Patient population

Between April 2013 and January 2014, 30 consecutive patients underwent TF-TAVR. Baseline characteristics are shown in Table 1. The mean age was 84.6 ± 4.0 years, with a mean Society of Thoracic Surgery score of 7.0% ± 3.5%. Fourteen (46.7%) patients were deemed inoperable (ie, porcelain aorta) and 16 (53.3%) were at high risk. One patient had a previous degenerated (severe aortic regurgitation) surgical bioprosthesis and underwent a transcatheter valve-in-valve procedure.25

Procedural and 30-day outcomes

Device and procedure

Discussion

The current report represents the first-year experience of a newly initiated contemporary TAVR program. The 30-day results from our TAVR program demonstrated excellent results compared with current published data. Several reasons may explain these findings. First, “shortening” of the learning curve and improvement in outcomes is to be expected in light of all the knowledge accumulated since 2002. Indeed, multiple lessons learned from the first large randomized trials and registries were central

Disclosures

PG has received speaker fees from Edwards Lifesciences. The other authors have no conflicts of interest to disclose.

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