Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system.
- Haas NA Department of Pediatric Cardiology, Pediatric Intensive Care, LMU, München, Germany; Centre for Congenital Heart Defects, Heart and Diabetes Centre Bad Oeynhausen, Ruhr University Bochum, Bad Oeynhausen, Germany. Electronic address: nikolaus.haas@med.uni-muenchen.de.
- Carere RG St. Paul's Hospital, Vancouver, Canada. Electronic address: rcarere@providencehealth.bc.ca.
- Kretschmar O University Children's Hospital Zurich, University Hospital Zurich, Switzerland. Electronic address: oliver.kretschmar@kispi.uzh.ch.
- Horlick E Toronto General Hospital, Toronto, Canada. Electronic address: eric.horlick@uhn.ca.
- Rodés-Cabau J Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
- de Wolf D Gent University Hospital, Belgium. Electronic address: daniel.dewolf@uzgent.be.
- Gewillig M ZU Gasthuisberg, Belgium. Electronic address: marc.gewillig@uzleuven.be.
- Mullen M The Heart Hospital, London, UK. Electronic address: michael.mullen@uclh.nhs.uk.
- Lehner A Department of Pediatric Cardiology, Pediatric Intensive Care, LMU, München, Germany. Electronic address: anja.lehner@med.uni-muenchen.de.
- Deutsch C Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: cornelia.deutsch@ippmed.de.
- Bramlage P Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.
- Ewert P Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Centre Munich, Technical University Munich, Germany. Electronic address: ewert@dhm.mhn.de.
- 2017-10-12
Published in:
- International journal of cardiology. - 2018
Congenital heart disease
Percutaneous pulmonary valve implantation
Pulmonary valve
SAPIEN XT
Adolescent
Adult
Cardiac Catheterization
Child
Female
Follow-Up Studies
Heart Valve Prosthesis Implantation
Humans
Male
Middle Aged
Prospective Studies
Pulmonary Valve
Pulmonary Valve Insufficiency
Registries
Retrospective Studies
Treatment Outcome
Young Adult
English
BACKGROUND
Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking.
METHODS AND RESULTS
We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years.
CONCLUSIONS
The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS.
GOV IDENTIFIER
NCT02302131.
Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking.
METHODS AND RESULTS
We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years.
CONCLUSIONS
The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS.
GOV IDENTIFIER
NCT02302131.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.ijcard.2017.10.015
- PMID 29017776
- Persistent URL
- https://sonar.ch/global/documents/47367
Statistics
Document views: 66
File downloads:
- Full-text: 0