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Eur Heart J. 2017 Dec 1;38(45):3359-3366. doi: 10.1093/eurheartj/ehx297.

Safety and efficacy of a repositionable and fully retrievable aortic valve used in routine clinical practice: the RESPOND Study.

Author information

1
Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin (DZHB), Augustenburger Platz 1, 13353 Berlin, Germany.
2
Department for Cardiovascular Surgery, Charité Berlin, Chariteplatz 1, 10117 Berlin, Germany.
3
Deutsches Zentrum für Herz-Kreislaufforschung (DZHK), Hessische Strasse 3-4, 10115 Berlin, Germany.
4
Internal Medicine II, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
5
Sussex Cardiac Centre, Royal Sussex County Hospital, Eastern Road, BN2 1ES, Brighton, UK.
6
Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Lazarettstr 36, 80636 Munich, Germany.
7
Department of Cardiology, Spire Leeds Hospital, Leeds General Infirmary, Great George Street, LS1 3EX, Leeds, UK.
8
Herzzentrum, Klinik für Kardiologie und Angiologie, Segeberger Kliniken GmbH, Kurpark 1, 23795 Bad Segeberg, Germany.
9
Gemeinschaftskrankenhaus Bonn gGmbH, Bonner Talweg 4-6, 53113 Bonn, Germany.
10
Department of Internal Medicine - Cardiology, Herzzentrum, Universität Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.
11
Department for Cardiology, University Hospital Rostock, Ernst-Heydemann-Straße 6, DE - 18057, Rostock, Germany.
12
Swiss Cardiovascular Center Bern, University Hospital Bern, Freiburgstrasse 8, 3010 Bern, Switzerland.
13
Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752, USA.
14
Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.

Abstract

Aims:

RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis.

Methods and results:

RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6.0 ± 6.9). Repositioning was attempted in 29.2% of patients, with 99% success. The rate of all-cause mortality in the intent-to-treat population at 30 days (primary endpoint) was 2.6% (P < 0.001 vs. pre-specified performance goal). Thirty-day clinical follow-up was completed for 97.3% of patients. Among patients who received a Lotus Valve, the 30-day overall and disabling stroke rates were 3.0% and 2.2%, respectively. The 30-day permanent pacemaker implantation rate was 30.0% in all patients, and 34.6% in pacemaker-naïve patients. Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory. Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge (P < 0.001). Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge (P < 0.001). At hospital discharge, paravalvular leak (PVL) was absent or trace in 92% of patients; no patients had severe PVL, 0.3% of patients exhibited moderate PVL, and 7.7% of patients had mild PVL. Clinical follow-up in RESPOND will extend to 5 years.

Conclusion:

The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice.

Trial registration:

ClinicalTrials.gov #NCT 02031302.

KEYWORDS:

Aortic regurgitation; Aortic valve stenosis; Transcatheter aortic valve replacement; Transfemoral

PMID:
28651336
DOI:
10.1093/eurheartj/ehx297
[Indexed for MEDLINE]

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