Author + information
- Received February 19, 2015
- Accepted March 1, 2015
- Published online July 1, 2015.
- Marco Barbanti, MD∗,†∗ (, )
- Anna Sonia Petronio, MD‡,
- Federica Ettori, MD§,
- Azeem Latib, MD‖,
- Francesco Bedogni, MD¶,
- Federico De Marco, MD#,
- Arnaldo Poli, MD∗∗,
- Carla Boschetti, MD††,
- Marco De Carlo, MD‡,
- Claudia Fiorina, MD§,
- Antonio Colombo, MD‖,
- Nedy Brambilla, MD¶,
- Giuseppe Bruschi, MD#,
- Paola Martina, MD∗∗,
- Claudia Pandolfi, MD††,
- Cristina Giannini, MD‡,
- Salvatore Curello, MD§,
- Carmelo Sgroi, MD∗,†,
- Simona Gulino, MD∗,
- Martina Patanè, MD∗,
- Yohei Ohno, MD∗,
- Claudia Tamburino, MD∗,
- Guilherme F. Attizzani, MD∗,
- Sebastiano Immè, MD∗,
- Alessandra Gentili, MS‡‡ and
- Corrado Tamburino, MD, PhD∗,†
- ∗Ferrarotto Hospital, University of Catania, Catania, Italy
- †ETNA Foundation, Catania, Italy
- ‡AOU Pisana, Pisa, Italy
- §Spedali Civili, Brescia, Italy
- ‖Scientific Institute S. Raffaele, Milan, Italy
- ¶Clinical Institute S. Ambrogio, Milan, Italy
- #Niguarda Ca’Granda Hospital, Milan, Italy
- ∗∗Ospedale Civile, Legnano, Italy
- ††Azienda ASL S. Camillo Forlanini, Rome
- ‡‡Quinario SA, Biostatistics Consultancy, Lugano, Switzerland
- ↵∗Reprint requests and correspondence:
Dr. Marco Barbanti, Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Citelli 1, Catania, Italy 95100.
Objectives The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
Background There is a paucity of evidence on long-term durability of currently available transcatheter heart valves.
Methods Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.
Results All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.
Conclusions TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.
Dr. Petronio has served as a clinical proctor for Medtronic and Boston Scientific. Dr. Ettori has served as a medical proctor for Medtronic. Dr. Latib has served on the advisory board of Medtronic; and has served as a consultant for Direct Flow Medical. Dr. Colombo is a minor shareholder in Direct Flow. Dr. Bruschi has served as a consultant for Medtronic and Direct Flow. Dr. Attizzani has served as a consultant for St. Jude Medical, Medtronic, and Edwards Lifesciences; and has served as a proctor for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships with industry to disclose.
- Received February 19, 2015.
- Accepted March 1, 2015.
- 2015 American College of Cardiology Foundation