Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis

Azeem Latib, Wesley Pedersen, Francesco Maisano, John Lesser, Neil Ruparelia, Filippo Figini, Antonio Colombo, Anil Poulose, James Kolbeck, Michael Mooney, Robert Schwartz, Alicia Youssef, David Ungs, Irv Goldenberg, Paul Sorajja

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. Background: An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. Methods: We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Results: Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. Conclusions: BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses.

Original languageEnglish
Pages (from-to)1306-1313
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume87
Issue number7
DOIs
Publication statusPublished - Jun 1 2016

Fingerprint

Balloon Valvuloplasty
Aortic Valve
Prostheses and Implants
Heart Block
Aortic Valve Stenosis
Surgical Instruments
Echocardiography
Transcatheter Aortic Valve Replacement
Incidence
Wounds and Injuries

Keywords

  • aortic valve stenosis
  • heart valve
  • heart valve prosthesis implantation
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis. / Latib, Azeem; Pedersen, Wesley; Maisano, Francesco; Lesser, John; Ruparelia, Neil; Figini, Filippo; Colombo, Antonio; Poulose, Anil; Kolbeck, James; Mooney, Michael; Schwartz, Robert; Youssef, Alicia; Ungs, David; Goldenberg, Irv; Sorajja, Paul.

In: Catheterization and Cardiovascular Interventions, Vol. 87, No. 7, 01.06.2016, p. 1306-1313.

Research output: Contribution to journalArticle

Latib, A, Pedersen, W, Maisano, F, Lesser, J, Ruparelia, N, Figini, F, Colombo, A, Poulose, A, Kolbeck, J, Mooney, M, Schwartz, R, Youssef, A, Ungs, D, Goldenberg, I & Sorajja, P 2016, 'Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis', Catheterization and Cardiovascular Interventions, vol. 87, no. 7, pp. 1306-1313. https://doi.org/10.1002/ccd.26462
Latib, Azeem ; Pedersen, Wesley ; Maisano, Francesco ; Lesser, John ; Ruparelia, Neil ; Figini, Filippo ; Colombo, Antonio ; Poulose, Anil ; Kolbeck, James ; Mooney, Michael ; Schwartz, Robert ; Youssef, Alicia ; Ungs, David ; Goldenberg, Irv ; Sorajja, Paul. / Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis. In: Catheterization and Cardiovascular Interventions. 2016 ; Vol. 87, No. 7. pp. 1306-1313.
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abstract = "Objectives: The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. Background: An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. Methods: We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Results: Eleven patients were studied (median age, 82 years; 64{\%} female). Ten patients (91{\%}) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. Conclusions: BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses.",
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AU - Latib, Azeem

AU - Pedersen, Wesley

AU - Maisano, Francesco

AU - Lesser, John

AU - Ruparelia, Neil

AU - Figini, Filippo

AU - Colombo, Antonio

AU - Poulose, Anil

AU - Kolbeck, James

AU - Mooney, Michael

AU - Schwartz, Robert

AU - Youssef, Alicia

AU - Ungs, David

AU - Goldenberg, Irv

AU - Sorajja, Paul

PY - 2016/6/1

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N2 - Objectives: The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. Background: An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. Methods: We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Results: Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. Conclusions: BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses.

AB - Objectives: The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. Background: An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. Methods: We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Results: Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. Conclusions: BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses.

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