Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.
OBJECTIVE
Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry.


RESULTS
Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%.


CONCLUSIONS
In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.
Zahn
Ralf
R
Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Bremserstrasse 79, Ludwigshafen, Germany. erzahn@aol.com
Gerckens
Ulrich
U
Grube
Eberhard
E
Linke
Axel
A
Sievert
Horst
H
Eggebrecht
Holger
H
Hambrecht
Rainer
R
Sack
Stefan
S
Hauptmann
Karl Eugen
KE
Richardt
Gert
G
Figulla
Hans-Reiner
HR
Senges
Jochen
J
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000401:mortality; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods* / Q000401:mortality; D002404:Catheterization / Q000379:methods; D003422:Critical Care / Q000706:statistics & numerical data; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D013318:Stroke Volume / Q000502:physiology; D016896:Treatment Outcome