European Heart Journal Advance Access originally published online on August 7, 2007
European Heart Journal 2007 28(19):2361-2368; doi:10.1093/eurheartj/ehm314
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Transcatheter closure of congenital ventricular septal defects: results of the European Registry
1 Departements of Pediatric Cardiology, IRCCS Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy
2 Birmingham Children's Hospital, Birmingham, UK
3 Departement of Pediatric Cardiology, Kiel, Germany
4 UZ Leuven, Leuven, Belgium
5 Heart-Center Bad Oeynhausen, Bad Oeynhausen, Germany
6 Institut Jacques Cartier, Massy, France
7 Ospedale Monaldi, Napoli, Italy
8 CardioVascular Center Frankfurt, Frankfurt, Germany
9 CNR Ospedale G. Pasquinucci, Massa, Italy
10 Our Lady's Hospital for Sick Children, Dublin, Ireland
Received 6 November 2006; revised 7 June 2007; accepted 21 June 2007; online publish-ahead-of-print 7 August 2007.
* Corresponding author. Tel: +39 (0) 2 52774531; fax: +39 (0) 2 52774459. E-mail address: carminati.mario{at}lycos.com
Aim: To report the experience of 23 tertiary referral European Centres on transcatheter closure of congenital ventricular septal defects (VSD).
Methods and results: Implantation of transcatheter devices was attempted in 430 patients (pts) with congenital VSDs until July 2005. The following anatomic types were present: 119 muscular, 250 perimembranous, 16 multiple, 45 residual post-surgery. Median VSD size was 7 mm (range 3–22), fluoroscopy time 33 min (range 3–146). Devices implanted were Amplatzer muscular or membranous devices in 364, PDA devices in 12, ASD devices in seven, Starflex in seven, and coils in nine patients. Procedure was successful in 410 cases (95%). Complications: device embolization in five cases (surgery in two, catheter retrieval in three), aortic regurgitation in 14 cases (two of which requiring surgery), tricuspid regurgitation in 27 cases (no surgery was necessary), minor rhythm disturbances in 10 pts, death in one patient, complete heart block (cAVB) in 16 pts [perimembranous 12 of 250 (5%), muscular one of 119 (0.8%), residual post-surgery VSD three of 45 (6.7%)]. CAVB was transient in six patients, requiring permanent pace-makers in 10 cases (3.8%) (six early, four late). In the multivariate analysis, the only variable associated with a risk of the occurrence of complication was age (P = 0.012) and weight (P = 0.0035). In the univariate analysis, risk factors for the development of cAVB were, device type (P = 0.03) and VSD location (P = 0.05). After the multivariable Cox proportional hazards analysis, no risk factor was found.
Conclusion: Transcatheter closure of congenital VSDs offers encouraging results. Complications are limited; the most relevant one seems to be the device related to cAVB in perimembranous VSD. More experience and long-term follow-up are mandatory to assess safety and effectiveness of this procedure as an alternative to conventional surgery.
Key Words: Ventricular septal defect • Treatment • Transcatheter
This paper was guest edited by Prof. Michael A. Gatzoulis, Royal Brompton Hospital, Cardiac Dept., Sydney Street, London, UK