Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation

Philippe Genereux, Susheel Kodali, Martin B. Leon, Craig R. Smith, Yanai Ben-Gal, Ajay J. Kirtane, Benoit Daneault, George R. Reiss, Jeffrey W. Moses, Mathew R. Williams

Research output: Contribution to journalArticle

88 Citations (Scopus)

Abstract

Objectives: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). Background: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. Methods: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. Results: Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. Conclusions: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.

Original languageEnglish (US)
Pages (from-to)861-867
Number of pages7
JournalJACC: Cardiovascular Interventions
Volume4
Issue number8
DOIs
StatePublished - Aug 1 2011
Externally publishedYes

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Balloon Occlusion
Aortic Valve
Blood Vessels
Hemorrhage
Length of Stay
Equipment and Supplies
Mortality
Aortic Valve Stenosis
Femoral Artery
Hospitalization
Incidence
Research
Transcatheter Aortic Valve Replacement

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Kodali, Susheel ; Leon, Martin B. ; Smith, Craig R. ; Ben-Gal, Yanai ; Kirtane, Ajay J. ; Daneault, Benoit ; Reiss, George R. ; Moses, Jeffrey W. ; Williams, Mathew R. / Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. In: JACC: Cardiovascular Interventions. 2011 ; Vol. 4, No. 8. pp. 861-867.
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abstract = "Objectives: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). Background: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. Methods: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the {"}pre-close{"} technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. Results: Successful closure was obtained in all but 3 patients (94.6{\%}). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1{\%}, 14.3{\%}, and 5.4{\%} respectively. No deaths were directly related to access site complications. Fourteen patients (25{\%}) received at least 1 transfusion during the index hospitalization, of which 8 (57.1{\%}) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. Conclusions: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.",
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Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. / Genereux, Philippe; Kodali, Susheel; Leon, Martin B.; Smith, Craig R.; Ben-Gal, Yanai; Kirtane, Ajay J.; Daneault, Benoit; Reiss, George R.; Moses, Jeffrey W.; Williams, Mathew R.

In: JACC: Cardiovascular Interventions, Vol. 4, No. 8, 01.08.2011, p. 861-867.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation

AU - Genereux, Philippe

AU - Kodali, Susheel

AU - Leon, Martin B.

AU - Smith, Craig R.

AU - Ben-Gal, Yanai

AU - Kirtane, Ajay J.

AU - Daneault, Benoit

AU - Reiss, George R.

AU - Moses, Jeffrey W.

AU - Williams, Mathew R.

PY - 2011/8/1

Y1 - 2011/8/1

N2 - Objectives: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). Background: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. Methods: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. Results: Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. Conclusions: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.

AB - Objectives: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). Background: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. Methods: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. Results: Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. Conclusions: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.

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