Author + information
- Received January 10, 2014
- Revision received March 19, 2014
- Accepted March 27, 2014
- Published online September 1, 2014.
- Marco Barbanti, MD∗,†∗ (, )
- Anna Sonia Petronio, MD‡,
- Davide Capodanno, MD, PhD∗,†,
- Federica Ettori, MD§,
- Antonio Colombo, MD‖,
- Francesco Bedogni, MD¶,
- Federico De Marco, MD#,
- Marco De Carlo, MD‡,
- Claudia Fiorina, MD§,
- Azeem Latib, MD‖,
- Luca Testa, MD¶,
- Giuseppe Bruschi, MD#,
- Arnaldo Poli, MD∗∗,
- Cristina Giannini, MD‡,
- Salvatore Curello, MD§,
- Diego Maffeo, MD§,
- Carmelo Sgroi, MD∗,†,
- Paola Martina, MD∗∗,
- Simona Gulino, MD∗,
- Martina Patanè, MD∗,
- Yohei Ohno, MD∗,
- Guilherme F. Attizzani, MD∗,
- Sebastiano Immè, MD∗,
- Stefano Cannata, MD∗,
- Alessandra Gentili, MS††,
- Agnese Rossi, 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
- ††EMEA Regional Clinical Center, Medtronic Clinical Research Institute, Rome, Italy
- ‡‡Medtronic Italy, Milan, Italy
- ↵∗Reprint requests and correspondence:
Dr. Marco Barbanti, Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Citelli 1, 95100 Catania, Italy.
Objectives The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
Background BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety.
Methods The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure.
Results Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815).
Conclusions This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.
Medtronic Italy is the sponsor of the ClinicalService Project. Dr. Latib is on the Advisory Board of Medtronic and a consultant for Direct Flow Medical. Drs. Bedogni, Ettori, Bruschi, and Petronio are consultants for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 10, 2014.
- Revision received March 19, 2014.
- Accepted March 27, 2014.
- American College of Cardiology Foundation