Transcatheter closure of congenital ventricular septal defects: Results of the European Registry

Mario Carminati, Gianfranco Butera, Massimo Chessa, Joseph De Giovanni, Gunter Fisher, Marc Gewillig, Mathias Peuster, Jean Francois Piechaud, Giuseppe Santoro, Horst Sievert, Isabella Spadoni, Kevin Walsh

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)2361-2368
Number of pages8
JournalEuropean Heart Journal
Volume28
Issue number19
DOIs
Publication statusPublished - Oct 2007

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Ventricular Heart Septal Defects
Registries
Equipment and Supplies
Tricuspid Valve Insufficiency
Heart Block
Aortic Valve Insufficiency
Fluoroscopy
Tertiary Care Centers
Multivariate Analysis
Catheters
Safety
Weights and Measures

Keywords

  • Transcatheter
  • Treatment
  • Ventricular septal defect

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Transcatheter closure of congenital ventricular septal defects : Results of the European Registry. / Carminati, Mario; Butera, Gianfranco; Chessa, Massimo; De Giovanni, Joseph; Fisher, Gunter; Gewillig, Marc; Peuster, Mathias; Piechaud, Jean Francois; Santoro, Giuseppe; Sievert, Horst; Spadoni, Isabella; Walsh, Kevin.

In: European Heart Journal, Vol. 28, No. 19, 10.2007, p. 2361-2368.

Research output: Contribution to journalArticle

Carminati, M, Butera, G, Chessa, M, De Giovanni, J, Fisher, G, Gewillig, M, Peuster, M, Piechaud, JF, Santoro, G, Sievert, H, Spadoni, I & Walsh, K 2007, 'Transcatheter closure of congenital ventricular septal defects: Results of the European Registry', European Heart Journal, vol. 28, no. 19, pp. 2361-2368. https://doi.org/10.1093/eurheartj/ehm314
Carminati, Mario ; Butera, Gianfranco ; Chessa, Massimo ; De Giovanni, Joseph ; Fisher, Gunter ; Gewillig, Marc ; Peuster, Mathias ; Piechaud, Jean Francois ; Santoro, Giuseppe ; Sievert, Horst ; Spadoni, Isabella ; Walsh, Kevin. / Transcatheter closure of congenital ventricular septal defects : Results of the European Registry. In: European Heart Journal. 2007 ; Vol. 28, No. 19. pp. 2361-2368.
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abstract = "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.",
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T2 - Results of the European Registry

AU - Carminati, Mario

AU - Butera, Gianfranco

AU - Chessa, Massimo

AU - De Giovanni, Joseph

AU - Fisher, Gunter

AU - Gewillig, Marc

AU - Peuster, Mathias

AU - Piechaud, Jean Francois

AU - Santoro, Giuseppe

AU - Sievert, Horst

AU - Spadoni, Isabella

AU - Walsh, Kevin

PY - 2007/10

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N2 - 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.

AB - 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.

KW - Transcatheter

KW - Treatment

KW - Ventricular septal defect

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