Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement

BMC Cardiovascular Disorders
Karolina BerntorpMatthias Götberg

Abstract

The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry. Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm2. There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular co...Continue Reading

References

Oct 22, 2010·The New England Journal of Medicine·Martin B LeonUNKNOWN PARTNER Trial Investigators
Mar 15, 2011·Heart·Mohamed Abdel-WahabUNKNOWN German transcatheter aortic valve interventions registry investigators
Jun 7, 2011·The New England Journal of Medicine·Craig R SmithUNKNOWN PARTNER Trial Investigators
Nov 5, 2011·Journal of Cardiovascular Electrophysiology·Damir ErkapicStefan H Hohnloser
Jun 26, 2012·Journal of the American College of Cardiology·Lutz BuellesfeldStephan Windecker
Oct 23, 2012·The Journal of Thoracic and Cardiovascular Surgery·A Pieter KappeteinUNKNOWN Valve Academic Research Consortium-2
Oct 31, 2013·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Ian T MeredithKeith D Dawkins
Mar 25, 2014·Journal of the American College of Cardiology·Jeffrey J PopmaUNKNOWN CoreValve United States Clinical Investigators
Jul 12, 2014·Journal of the American College of Cardiology·George C M SiontisStephan Windecker
Sep 4, 2014·The New England Journal of Medicine·Sanjay Kaul
Jun 20, 2015·JACC. Cardiovascular Interventions·Robert P GooleyIan T Meredith
Apr 5, 2016·The New England Journal of Medicine·Martin B LeonUNKNOWN PARTNER 2 Investigators
Aug 21, 2016·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Jochen WöhrleWolfgang Rottbauer
Mar 18, 2017·The New England Journal of Medicine·Michael J ReardonUNKNOWN SURTAVI Investigators

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Methods Mentioned

BETA
sedation

Clinical Trials Mentioned

ISRCTN14952278

Software Mentioned

Lotus
RESPOND

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