Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry.
The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).



TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.



ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.



A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.



TAo access for TAVR seems to be a safe alternative to the transapical procedure.
St. Thomas' Hospital, London, United Kingdom. Electronic address: vnbapat@yahoo.com.
Vinayak
V
Bapat
Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, Germany.
Derk
D
Frank
Heart Center, Academic Medical Center, University of Amsterdam, Netherlands.
Ricardo
R
Cocchieri
Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Poland.
Dariusz
D
Jagielak
University Hospital for Cardiac Surgery, Medical University Innsbruck, Austria.
Nikolaos
N
Bonaros
Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S. Matteo, Pavia University School of Medicine, Pavia, Italy.
Marco
M
Aiello
Department of Cardiovascular Surgery, Hospital Louis Pradel, Lyon, France.
Joel
J
Lapeze
Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland.
Mika
M
Laine
Cardiothoracic Surgery, Hospital Jean Minjoz, University Hospital of Besancon, France.
Sidney
S
Chocron
Cardiothoracic Division, James Cook Hospital, Middlesbrough, United Kingdom.
Douglas
D
Muir
Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany.
Walter
W
Eichinger
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Hospital Essen, Germany.
Matthias
M
Thielmann
Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, France.
Louis
L
Labrousse
Department of Cardiothoracic Surgery, Rikshospital Oslo, Norway.
Kjell Arne
KA
Rein
Department of Cardiovascular Surgery, CHU Rennes, France.
Jean-Philippe
JP
Verhoye
Department of Cardiac Surgery, University of Padova, Italy.
Gino
G
Gerosa
Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Germany.
Hardy
H
Baumbach
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Peter
P
Bramlage
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Cornelia
C
Deutsch
Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland.
Martin
M
Thoenes
Institut Hospitalier Jacques Cartier, Massy, France.
Mauro
M
Romano
D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta / Q000000981:diagnostic imaging; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology / Q000628:therapy; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
TAVR; access; transaortic; transapical; transcatheter heart valve; transfemoral