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Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry

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Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry. / Demir, Ozan M; Conradi, Lenard; Prendergast, Bernard; Ho, Edwin; Montorfano, Matteo; Duncan, Alison; Denti, Paolo; Modine, Thomas; Rodés-Cabau, Josep; Taramasso, Maurizio; Fam, Neil; Grayburn, Paul A; De Bruijin, Sabine; Tzalamouras, Vasileios; Wilkins, Ben; Ben-Ali, Walid; Ladanyi, Annamaria; Ludwig, Sebastian; Adams, Heath; Rajani, Ronak; Ferreira-Neto, Alfredo N; Maisano, Francesco; Sievert, Horst; MacCarthy, Philip; Redwood, Simon; Sondegaard, Lars; Colombo, Antonio; Leon, Martin; Latib, Azeem.

In: CAN J CARDIOL, Vol. 39, No. 5, 05.2023, p. 581-589.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Demir, OM, Conradi, L, Prendergast, B, Ho, E, Montorfano, M, Duncan, A, Denti, P, Modine, T, Rodés-Cabau, J, Taramasso, M, Fam, N, Grayburn, PA, De Bruijin, S, Tzalamouras, V, Wilkins, B, Ben-Ali, W, Ladanyi, A, Ludwig, S, Adams, H, Rajani, R, Ferreira-Neto, AN, Maisano, F, Sievert, H, MacCarthy, P, Redwood, S, Sondegaard, L, Colombo, A, Leon, M & Latib, A 2023, 'Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry', CAN J CARDIOL, vol. 39, no. 5, pp. 581-589. https://doi.org/10.1016/j.cjca.2023.01.017

APA

Demir, O. M., Conradi, L., Prendergast, B., Ho, E., Montorfano, M., Duncan, A., Denti, P., Modine, T., Rodés-Cabau, J., Taramasso, M., Fam, N., Grayburn, P. A., De Bruijin, S., Tzalamouras, V., Wilkins, B., Ben-Ali, W., Ladanyi, A., Ludwig, S., Adams, H., ... Latib, A. (2023). Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry. CAN J CARDIOL, 39(5), 581-589. https://doi.org/10.1016/j.cjca.2023.01.017

Vancouver

Demir OM, Conradi L, Prendergast B, Ho E, Montorfano M, Duncan A et al. Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry. CAN J CARDIOL. 2023 May;39(5):581-589. https://doi.org/10.1016/j.cjca.2023.01.017

Bibtex

@article{8fb196563f1b47b19e0d7eae97aef326,
title = "Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry",
abstract = "BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes.METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened.RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively.CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.",
keywords = "Humans, Mitral Valve/diagnostic imaging, Heart Valve Prosthesis Implantation/methods, Heart Valve Prosthesis, Retrospective Studies, Risk Factors, Cardiac Catheterization/methods, Treatment Outcome, Ventricular Outflow Obstruction/surgery, Registries, Mitral Valve Insufficiency/diagnosis",
author = "Demir, {Ozan M} and Lenard Conradi and Bernard Prendergast and Edwin Ho and Matteo Montorfano and Alison Duncan and Paolo Denti and Thomas Modine and Josep Rod{\'e}s-Cabau and Maurizio Taramasso and Neil Fam and Grayburn, {Paul A} and {De Bruijin}, Sabine and Vasileios Tzalamouras and Ben Wilkins and Walid Ben-Ali and Annamaria Ladanyi and Sebastian Ludwig and Heath Adams and Ronak Rajani and Ferreira-Neto, {Alfredo N} and Francesco Maisano and Horst Sievert and Philip MacCarthy and Simon Redwood and Lars Sondegaard and Antonio Colombo and Martin Leon and Azeem Latib",
note = "Copyright {\textcopyright} 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.",
year = "2023",
month = may,
doi = "10.1016/j.cjca.2023.01.017",
language = "English",
volume = "39",
pages = "581--589",
journal = "CAN J CARDIOL",
issn = "0828-282X",
publisher = "Pulsus Group Inc.",
number = "5",

}

RIS

TY - JOUR

T1 - Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry

AU - Demir, Ozan M

AU - Conradi, Lenard

AU - Prendergast, Bernard

AU - Ho, Edwin

AU - Montorfano, Matteo

AU - Duncan, Alison

AU - Denti, Paolo

AU - Modine, Thomas

AU - Rodés-Cabau, Josep

AU - Taramasso, Maurizio

AU - Fam, Neil

AU - Grayburn, Paul A

AU - De Bruijin, Sabine

AU - Tzalamouras, Vasileios

AU - Wilkins, Ben

AU - Ben-Ali, Walid

AU - Ladanyi, Annamaria

AU - Ludwig, Sebastian

AU - Adams, Heath

AU - Rajani, Ronak

AU - Ferreira-Neto, Alfredo N

AU - Maisano, Francesco

AU - Sievert, Horst

AU - MacCarthy, Philip

AU - Redwood, Simon

AU - Sondegaard, Lars

AU - Colombo, Antonio

AU - Leon, Martin

AU - Latib, Azeem

N1 - Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

PY - 2023/5

Y1 - 2023/5

N2 - BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes.METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened.RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively.CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.

AB - BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes.METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened.RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively.CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.

KW - Humans

KW - Mitral Valve/diagnostic imaging

KW - Heart Valve Prosthesis Implantation/methods

KW - Heart Valve Prosthesis

KW - Retrospective Studies

KW - Risk Factors

KW - Cardiac Catheterization/methods

KW - Treatment Outcome

KW - Ventricular Outflow Obstruction/surgery

KW - Registries

KW - Mitral Valve Insufficiency/diagnosis

U2 - 10.1016/j.cjca.2023.01.017

DO - 10.1016/j.cjca.2023.01.017

M3 - SCORING: Journal article

C2 - 36690327

VL - 39

SP - 581

EP - 589

JO - CAN J CARDIOL

JF - CAN J CARDIOL

SN - 0828-282X

IS - 5

ER -