Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation

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Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation. / Schneeberger, Yvonne; Schaefer, Andreas; Schofer, Niklas; Silaschi, Miriam; Deuschl, Florian; Blankenberg, Stefan; Reichenspurner, Hermann; Treede, Hendrik; Schäfer, Ulrich; Charitos, Efstratios I; Conradi, Lenard.

In: INT J CARDIOL, Vol. 275, 15.01.2019, p. 65-69.

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@article{d38075f95cbf4779b6a45d1f8f71540b,
title = "Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation",
abstract = "BACKGROUND: Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow{\texttrademark}, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP.METHODS: Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ± 6.6 years, logEuroSCORE I 15.8 ± 10.3%, STS Prom Score 2.5 ± 0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions.RESULTS: Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ± 17.4 min, 16.7 ± 6.9 min and 156.9 ± 92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ± 3.5 mm Hg. In one patient a moderate paravalvular leakage was seen.CONCLUSIONS: In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.",
keywords = "Aged, 80 and over, Aortic Valve/pathology, Aortic Valve Stenosis/diagnosis, Balloon Valvuloplasty/instrumentation, Calcinosis/diagnosis, Echocardiography, Transesophageal, Female, Fluoroscopy, Humans, Male, Multidetector Computed Tomography, Prosthesis Design, Retrospective Studies, Severity of Illness Index, Surgery, Computer-Assisted, Transcatheter Aortic Valve Replacement/methods, Treatment Outcome",
author = "Yvonne Schneeberger and Andreas Schaefer and Niklas Schofer and Miriam Silaschi and Florian Deuschl and Stefan Blankenberg and Hermann Reichenspurner and Hendrik Treede and Ulrich Sch{\"a}fer and Charitos, {Efstratios I} and Lenard Conradi",
note = "Copyright {\textcopyright} 2018 Elsevier B.V. All rights reserved.",
year = "2019",
month = jan,
day = "15",
doi = "10.1016/j.ijcard.2018.10.059",
language = "English",
volume = "275",
pages = "65--69",
journal = "INT J CARDIOL",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

RIS

TY - JOUR

T1 - Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation

AU - Schneeberger, Yvonne

AU - Schaefer, Andreas

AU - Schofer, Niklas

AU - Silaschi, Miriam

AU - Deuschl, Florian

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Treede, Hendrik

AU - Schäfer, Ulrich

AU - Charitos, Efstratios I

AU - Conradi, Lenard

N1 - Copyright © 2018 Elsevier B.V. All rights reserved.

PY - 2019/1/15

Y1 - 2019/1/15

N2 - BACKGROUND: Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow™, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP.METHODS: Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ± 6.6 years, logEuroSCORE I 15.8 ± 10.3%, STS Prom Score 2.5 ± 0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions.RESULTS: Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ± 17.4 min, 16.7 ± 6.9 min and 156.9 ± 92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ± 3.5 mm Hg. In one patient a moderate paravalvular leakage was seen.CONCLUSIONS: In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.

AB - BACKGROUND: Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow™, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP.METHODS: Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ± 6.6 years, logEuroSCORE I 15.8 ± 10.3%, STS Prom Score 2.5 ± 0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions.RESULTS: Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ± 17.4 min, 16.7 ± 6.9 min and 156.9 ± 92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ± 3.5 mm Hg. In one patient a moderate paravalvular leakage was seen.CONCLUSIONS: In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.

KW - Aged, 80 and over

KW - Aortic Valve/pathology

KW - Aortic Valve Stenosis/diagnosis

KW - Balloon Valvuloplasty/instrumentation

KW - Calcinosis/diagnosis

KW - Echocardiography, Transesophageal

KW - Female

KW - Fluoroscopy

KW - Humans

KW - Male

KW - Multidetector Computed Tomography

KW - Prosthesis Design

KW - Retrospective Studies

KW - Severity of Illness Index

KW - Surgery, Computer-Assisted

KW - Transcatheter Aortic Valve Replacement/methods

KW - Treatment Outcome

U2 - 10.1016/j.ijcard.2018.10.059

DO - 10.1016/j.ijcard.2018.10.059

M3 - SCORING: Journal article

C2 - 30366854

VL - 275

SP - 65

EP - 69

JO - INT J CARDIOL

JF - INT J CARDIOL

SN - 0167-5273

ER -