Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study

Enrico Poletti; Matti Adam; Hendrik Wienemann; Antonio Sisinni; Kush P Patel; Ignacio J Amat-Santos; Mateusz Orzalkiewicz; Francesco Saia; Damiano Regazzoli; Claudia Fiorina; Vasileios Panoulas; Christina Brinkmann; Arturo Giordano; Maurizio Taramasso; Francesco Maisano; Marco Barbanti; Ole De Backer; Nicolas M Van Mieghem; Azeem Latib; Mattia Squillace; Stephan Baldus; Martin Geyer; Andreas Baumbach; Francesco Bedogni; Tanja K Rudolph; Luca Testa

doi:10.1016/j.jcin.2024.05.019

Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study

Enrico Poletti, Matti Adam, Hendrik Wienemann, Antonio Sisinni, Kush P Patel, Ignacio J Amat-Santos, Mateusz Orzalkiewicz, Francesco Saia, Damiano Regazzoli, Claudia Fiorina, Vasileios Panoulas, Christina Brinkmann, Arturo Giordano, Maurizio Taramasso, Francesco Maisano, Marco Barbanti, Ole De Backer, Nicolas M Van Mieghem, Azeem Latib, Mattia SquillaceStephan Baldus, Martin Geyer, Andreas Baumbach, Francesco Bedogni, Tanja K Rudolph, Luca Testa

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Abstract

BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs.

OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR.

METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate.

RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355).

CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

Originalsprog	Engelsk
Tidsskrift	JACC. Cardiovascular interventions
Vol/bind	17
Udgave nummer	13
Sider (fra-til)	1597-1606
Antal sider	10
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2024.05.019
Status	Udgivet - 8 jul. 2024

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10.1016/j.jcin.2024.05.019

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Poletti, E., Adam, M., Wienemann, H., Sisinni, A., Patel, K. P., Amat-Santos, I. J., Orzalkiewicz, M., Saia, F., Regazzoli, D., Fiorina, C., Panoulas, V., Brinkmann, C., Giordano, A., Taramasso, M., Maisano, F., Barbanti, M., De Backer, O., Van Mieghem, N. M., Latib, A., ... Testa, L. (2024). Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study. JACC. Cardiovascular interventions, 17(13), 1597-1606. https://doi.org/10.1016/j.jcin.2024.05.019

Poletti, E, Adam, M, Wienemann, H, Sisinni, A, Patel, KP, Amat-Santos, IJ, Orzalkiewicz, M, Saia, F, Regazzoli, D, Fiorina, C, Panoulas, V, Brinkmann, C, Giordano, A, Taramasso, M, Maisano, F, Barbanti, M, De Backer, O, Van Mieghem, NM, Latib, A, Squillace, M, Baldus, S, Geyer, M, Baumbach, A, Bedogni, F, Rudolph, TK & Testa, L 2024, 'Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study', JACC. Cardiovascular interventions, bind 17, nr. 13, s. 1597-1606. https://doi.org/10.1016/j.jcin.2024.05.019

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title = "Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study",

abstract = "BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated {"}purpose-built{"} Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs.OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR.METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate.RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355).CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.",

keywords = "Humans, Aortic Valve Insufficiency/physiopathology, Female, Male, Retrospective Studies, Aged, Registries, Treatment Outcome, Heart Valve Prosthesis, Aged, 80 and over, Risk Factors, Aortic Valve/surgery, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Prosthesis Design, Severity of Illness Index, Patient Readmission, Recovery of Function, Europe, Heart Failure/mortality, Hemodynamics",

author = "Enrico Poletti and Matti Adam and Hendrik Wienemann and Antonio Sisinni and Patel, {Kush P} and Amat-Santos, {Ignacio J} and Mateusz Orzalkiewicz and Francesco Saia and Damiano Regazzoli and Claudia Fiorina and Vasileios Panoulas and Christina Brinkmann and Arturo Giordano and Maurizio Taramasso and Francesco Maisano and Marco Barbanti and {De Backer}, Ole and {Van Mieghem}, {Nicolas M} and Azeem Latib and Mattia Squillace and Stephan Baldus and Martin Geyer and Andreas Baumbach and Francesco Bedogni and Rudolph, {Tanja K} and Luca Testa",

year = "2024",

month = jul,

day = "8",

doi = "10.1016/j.jcin.2024.05.019",

language = "English",

volume = "17",

pages = "1597--1606",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "13",

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TY - JOUR

T1 - Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation

T2 - The PURPOSE Study

AU - Poletti, Enrico

AU - Adam, Matti

AU - Wienemann, Hendrik

AU - Sisinni, Antonio

AU - Patel, Kush P

AU - Amat-Santos, Ignacio J

AU - Orzalkiewicz, Mateusz

AU - Saia, Francesco

AU - Regazzoli, Damiano

AU - Fiorina, Claudia

AU - Panoulas, Vasileios

AU - Brinkmann, Christina

AU - Giordano, Arturo

AU - Taramasso, Maurizio

AU - Maisano, Francesco

AU - Barbanti, Marco

AU - De Backer, Ole

AU - Van Mieghem, Nicolas M

AU - Latib, Azeem

AU - Squillace, Mattia

AU - Baldus, Stephan

AU - Geyer, Martin

AU - Baumbach, Andreas

AU - Bedogni, Francesco

AU - Rudolph, Tanja K

AU - Testa, Luca

PY - 2024/7/8

Y1 - 2024/7/8

N2 - BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs.OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR.METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate.RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355).CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

AB - BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs.OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR.METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate.RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355).CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

KW - Humans

KW - Aortic Valve Insufficiency/physiopathology

KW - Female

KW - Male

KW - Retrospective Studies

KW - Aged

KW - Registries

KW - Treatment Outcome

KW - Heart Valve Prosthesis

KW - Aged, 80 and over

KW - Risk Factors

KW - Aortic Valve/surgery

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Prosthesis Design

KW - Severity of Illness Index

KW - Patient Readmission

KW - Recovery of Function

KW - Europe

KW - Heart Failure/mortality

KW - Hemodynamics

UR - http://www.scopus.com/inward/record.url?scp=85196938830&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2024.05.019

DO - 10.1016/j.jcin.2024.05.019

M3 - Journal article

C2 - 38986659

SN - 1936-8798

VL - 17

SP - 1597

EP - 1606

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

IS - 13

ER -

Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study

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