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Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48 consecutive patients: initial experience.
MedLine Citation:
PMID:  22932071     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France.
METHODS: The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial.
RESULTS: Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%).
CONCLUSION: The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.
Authors:
Quan-Ming Zhao; Therese Lognone; Calin Ivascau; Remi Sabatier; Vincent Roule; Ziad Dahdouh; Massimo Massetti; Gilles Grollier
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Chinese medical journal     Volume:  125     ISSN:  0366-6999     ISO Abbreviation:  Chin. Med. J.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-30     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513795     Medline TA:  Chin Med J (Engl)     Country:  China    
Other Details:
Languages:  eng     Pagination:  2807-10     Citation Subset:  IM    
Affiliation:
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
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