CLINICAL RESEARCH
INTERVENTIONS FOR VALVULAR DISEASE AND HEART FAILURE
EuroIntervention 2017;12: 1715-1723 DOI: 10.4244/EIJ-D-16-00443
1715
© Europa Digital & Publishing 2017. All rights reserved.
*Corresponding author: Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München,
Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany. E-mail: hager@dhm.mhn.de
Five-year results from a prospective multicentre study of
percutaneous pulmonary valve implantation demonstrate
sustained removal of significant pulmonary regurgitation,
improved right ventricular outflow tract obstruction and
improved quality of life
Alfred Hager
1
*, MD; Stephan Schubert
2
, MD; Peter Ewert
1,2
, MD; Lars Søndergaard
3
, MD;
Maarten Witsenburg
4
, MD, PhD; Paolo Guccione
5
, MD; Lee N. Benson
6
, MD;
José Suárez de Lezo
7
, MD; Te-Hsin Lung
8
, PhD; John Hess
1
, MD; Andreas Eicken
1
, MD;
Felix Berger
2
, MD
1. Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Technische Universität
München, Munich, Germany; 2. Department of Pediatric Cardiology – Congenital Heart Defects, Deutsches Herzzentrum Berlin,
Germany; 3. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen, Denmark; 4. Department of Cardiology/
Congenital Heart Disease, Erasmus Medical Center, Rotterdam, The Netherlands; 5. Department of Pediatric Cardiology and
Cardiac Surgery, Ospedale Bambino Gesú, Rome, Italy; 6. Department of Paediatrics, Cardiac Diagnostic and Interventional
Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; 7. Department of Cardiology, Hospital
Reina Sofía, University of Córdoba, Córdoba, Spain; 8. Department of Coronary & Structural Heart Clinical Affairs, Medtronic,
Minneapolis, MN, USA
A. Hager and S. Schubert contributed equally as primary authors. A. Eicken and F. Berger contributed equally as senior authors.
This paper also includes supplementary data published online at: http://www.pcronline.com/eurointervention/111th_issue/281
Abstract
Aims: Percutaneous pulmonary valve implantation (PPVI) is used to treat patients with dysfunctional pul-
monary valve conduits. Short- and longer-term results from multiple trials have outlined haemodynamic
improvements. Our aim was to report the long-term results, including quality of life, from a multicentre
trial in Europe and Canada.
Methods and results: From October 2007 to April 2009, 71 patients (24 female; median age 19.0 [IQR:
14.0 to 25.0] years) were enrolled in a prospective cohort study. PPVI was performed successfully in
63 patients. At five-year follow-up four patients had died. Moderate and severe pulmonary regurgita-
tion were completely resolved in all except one patient, who needed re-PPVI. Outflow tract obstruction
improved significantly from a mean pressure gradient of 37.7±12.1 mmHg before PPVI to 17.3±9.7 mmHg
at five-year follow-up; however, 11 patients needed treatment for restenosis. The EQ-5D quality of life
utility index and visual analogue scale scores were both significantly improved six months post PPVI and
remained so at five years.
Conclusions: Five-year results following PPVI demonstrate resolved moderate or severe pulmonary regur-
gitation, improved right ventricular outflow tract obstruction, and improved quality of life.
KEYWORDS
• clinical research
• pulmonary stenosis
• quality of life
SUBMITTED ON 31/05/2016 - REVISION RECEIVED ON N/A - ACCEPTED ON 09/06/2016