Author + information
- Received November 26, 2018
- Revision received February 25, 2019
- Accepted March 5, 2019
- Published online August 19, 2019.
- Stanimir Georgiev, MDa,∗ (, )
- Peter Ewert, PhDa,
- Daniel Tanase, MDa,
- John Hess, PhDa,
- Alfred Hager, PhDa,
- Julie Cleuziou, PhDb,
- Christian Meierhofer, MDa and
- Andreas Eicken, PhDa
- aDepartment of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Technische Universität München, Munich, Germany
- bDepartment of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
- ↵∗Address for correspondence:
Dr. Stanimir Georgiev, Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Lazarettstrasse 36, 80636 Munich, Germany.
Objectives The aim of this study was to report long-term outcomes after percutaneous pulmonary valve implantation (PPVI).
Background Excellent short- and mid-term results after PPVI for right ventricular outflow tract (RVOT) dysfunction have been reported. Data on long-term results after PPVI are scarce.
Methods All 226 patients treated with PPVI at a single institution were prospectively enrolled in a database and included in the study. Follow-up information regarding outcomes was collected. Risk-factor analysis for death and reinterventions was performed.
Results Follow-up data (up to 11 years) were available in 96% of the patients. At the end of the study period, 219 patients (92.8%) still lived with the initially implanted valve. Seven patients died, 2 of them from procedure-related complications. Seventeen patients (7.2%) needed valve replacement surgically (n = 11) or percutaneously (n = 6) for infectious endocarditis (n = 10) or valve degeneration (n = 7). In the remaining patients, the valves retained excellent function, and right ventricular dimensions and exercise capacity improved. A post-interventional RVOT gradient >15 mm Hg was a risk factor for death (hazard ratio: 7.57; 95% confidence interval: 1.26 to 45.38; p = 0.027) and for valve failure (hazard ratio: 3.76; 95% confidence interval: 1.43 to 9.93; p = 0.007). The best outcome was achieved with RVOT pre-stenting and a post-interventional gradient <15 mm Hg, resulting in an estimated event-free survival rate of 88% at 10 years.
Conclusions Patients after PPVI have excellent long-term outcomes. Right ventricular volumes, function, and exercise capacity improve significantly. A residual RVOT gradient <15 mm Hg was associated with the best outcome.
Dr. Ewert is a proctor for the Medtronic Melody valve and for the Edwards pulmonic transcatheter valve. Dr. Eicken is a proctor for the Medtronic Melody valve. Dr. Hager has received lecture fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 26, 2018.
- Revision received February 25, 2019.
- Accepted March 5, 2019.
- 2019 American College of Cardiology Foundation
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