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Outcome of patients treated with engager transapical aortic valve implantation: one-year results of the feasibility study


Sündermann, Simon H; Grünenfelder, Jürg; Corti, Roberto; Rastan, Ardawan J; Linke, Axel; Lange, Rüdiger; Falk, Volkmar; Bleiziffer, Sabine (2013). Outcome of patients treated with engager transapical aortic valve implantation: one-year results of the feasibility study. Innovations : Technology And Techniques In Cardiothoracic And Vascular Surgery, 8(5):332-336.

Abstract

OBJECTIVE: The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation.
METHODS: Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year.
RESULTS: All patients underwent the implantation procedure successfully. No device-related or delivery system-related complications were observed. One patient died of non-device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up.
CONCLUSIONS: Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system-related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation.

Abstract

OBJECTIVE: The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation.
METHODS: Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year.
RESULTS: All patients underwent the implantation procedure successfully. No device-related or delivery system-related complications were observed. One patient died of non-device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up.
CONCLUSIONS: Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system-related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2013
Deposited On:04 Feb 2014 07:43
Last Modified:05 Apr 2016 17:30
Publisher:Lippincott, Williams & Wilkins
ISSN:1556-9845
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/IMI.0000000000000018
PubMed ID:24346580

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