Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry

Tullio Palmerini; Francesco Saia; Won Keun Kim; Matthias Renker; Alessandro Iadanza; Massimo Fineschi; Antonio Giulio Bruno; Gabriele Ghetti; Maarten Vanhaverbeke; Lars Søndergaard; Ole De Backer; Enrico Romagnoli; Francesco Burzotta; Carlo Trani; Rik Adrichem; Nicolas M. Van Mieghem; Elena Nardi; Francesco Chietera; Mateusz Orzalkiewicz; Daijiro Tomii; Thomas Pilgrim; Tiziana Claudia Aranzulla; Giuseppe Musumeci; Matti Adam; Max M. Meertens; Nevio Taglieri; Cinzia Marrozzini; Hector Alfonso Alvarez Covarrubias; Michael Joner; Giulia Nardi; Francesca Maria Di Muro; Carlo Di Mario; Lucca Loretz; Stefan Toggweiler; Enrico Gallitto; Mauro Gargiulo; Luca Testa; Francesco Bedogni; Sergio Berti; Marco B. Ancona; Matteo Montorfano; Alessandro Leone; Carlo Savini; Davide Pacini; Jonas Gmeiner; Daniel Braun; Roberto Nerla; Fausto Castriota; Marco De Carlo; Anna Sonia Petronio; Marco Barbanti; Giuliano Costa; Corrado Tamburino; Pier Pasquale Leone; Bernhard Reimers; Giulio Stefanini; Mitsumasa Sudo; Georg Nickenig; Tommaso Piva; Andrea Scotti; Azeem Latib; Matteo Vercellino; Italo Porto; Pablo Codner; Ran Kornowski; Antonio L. Bartorelli; Giuseppe Tarantini; Chiara Fraccaro; Mohamed Abdel-Wahab; Eberhard Grube; Nazzareno Galié; Gregg W. Stone

doi:10.1016/j.jcin.2022.12.009

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry

Tullio Palmerini
, Francesco Saia
, Won Keun Kim
, Matthias Renker
, Alessandro Iadanza
, Massimo Fineschi
, Antonio Giulio Bruno
, Gabriele Ghetti
, Maarten Vanhaverbeke
, Lars Søndergaard
, Ole De Backer
, Enrico Romagnoli
, Francesco Burzotta
, Carlo Trani
, Rik Adrichem
, Nicolas M. Van Mieghem
, Elena Nardi
, Francesco Chietera
, Mateusz Orzalkiewicz
, Daijiro Tomii

Thomas Pilgrim, Tiziana Claudia Aranzulla, Giuseppe Musumeci, Matti Adam, Max M. Meertens, Nevio Taglieri, Cinzia Marrozzini, Hector Alfonso Alvarez Covarrubias, Michael Joner, Giulia Nardi, Francesca Maria Di Muro, Carlo Di Mario, Lucca Loretz, Stefan Toggweiler, Enrico Gallitto, Mauro Gargiulo, Luca Testa, Francesco Bedogni, Sergio Berti, Marco B. Ancona, Matteo Montorfano, Alessandro Leone, Carlo Savini, Davide Pacini, Jonas Gmeiner, Daniel Braun, Roberto Nerla, Fausto Castriota, Marco De Carlo, Anna Sonia Petronio, Marco Barbanti, Giuliano Costa, Corrado Tamburino, Pier Pasquale Leone, Bernhard Reimers, Giulio Stefanini, Mitsumasa Sudo, Georg Nickenig, Tommaso Piva, Andrea Scotti, Azeem Latib, Matteo Vercellino, Italo Porto, Pablo Codner, Ran Kornowski, Antonio L. Bartorelli, Giuseppe Tarantini, Chiara Fraccaro, Mohamed Abdel-Wahab, Eberhard Grube, Nazzareno Galié, Gregg W. Stone

Clinic for Heart and Vascular Diseases

University of Bologna
DIBINEM, Alma Mater Studiorum, University of Bologna
Kerckhoff Clinic Bad Nauheim
Azienda Ospedaliero-Universitaria Senese
Rigshospitalet
Università Cattolica del Sacro Cuore
Erasmus University Medical Center
Inselspital Universitatsspital
Ospedale Mauriziano Umberto I
University Hospital of Cologne
Technical University of Munich
IMSS
Unit of Gastroenterology SOD2
Heart Center Lucerne
San Donato Hospital Arezzo
Ospedale del Cuore
IRCCS San Raffaele Scientific Institute
Ludwig-Maximilians-Universität München
Cardioangiology Cath Lab
University Hospital
Università di Catania
Humanitas Clinical and Research Center
University of Bonn and University Hospital Bonn
Azienda Ospedaliero-Universitaria
Albert Einstein College of Medicine of Yeshiva University
Cardiovascular Research Foundation
IRCCS for Cancer Research
Rabin Medical Center Israel
Istituto di Ricovero e Cura A Carattere Scientifico (IRCCS)
University of Milan
University of Padova
University of Leipzig
Mount Sinai School of Medicine

Research output: Contribution to journal › Article › peer-review

66 Scopus citations

Abstract

Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (P_interaction = 0.049). Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Original language	English
Pages (from-to)	396-411
Number of pages	16
Journal	JACC: Cardiovascular Interventions
Volume	16
Issue number	4
DOIs	https://doi.org/10.1016/j.jcin.2022.12.009
State	Published - 27 Feb 2023

Keywords

alternative access
critical patient
femoral access
transcatheter aortic valve replacement

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10.1016/j.jcin.2022.12.009

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Palmerini, T., Saia, F., Kim, W. K., Renker, M., Iadanza, A., Fineschi, M., Bruno, A. G., Ghetti, G., Vanhaverbeke, M., Søndergaard, L., De Backer, O., Romagnoli, E., Burzotta, F., Trani, C., Adrichem, R., Van Mieghem, N. M., Nardi, E., Chietera, F., Orzalkiewicz, M., ... Stone, G. W. (2023). Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry. JACC: Cardiovascular Interventions, 16(4), 396-411. https://doi.org/10.1016/j.jcin.2022.12.009

@article{72888fb5c01747969e0e4f9fbf0f642f,

title = "Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry",

abstract = "Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). Results: Among the 1,707 patients included in the registry, 518 (30.3\%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6\%) with TTA, and 547 (32.0\%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95\% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95\% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95\% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.",

keywords = "alternative access, critical patient, femoral access, transcatheter aortic valve replacement",

author = "Tullio Palmerini and Francesco Saia and Kim, \{Won Keun\} and Matthias Renker and Alessandro Iadanza and Massimo Fineschi and Bruno, \{Antonio Giulio\} and Gabriele Ghetti and Maarten Vanhaverbeke and Lars S{\o}ndergaard and \{De Backer\}, Ole and Enrico Romagnoli and Francesco Burzotta and Carlo Trani and Rik Adrichem and \{Van Mieghem\}, \{Nicolas M.\} and Elena Nardi and Francesco Chietera and Mateusz Orzalkiewicz and Daijiro Tomii and Thomas Pilgrim and Aranzulla, \{Tiziana Claudia\} and Giuseppe Musumeci and Matti Adam and Meertens, \{Max M.\} and Nevio Taglieri and Cinzia Marrozzini and \{Alvarez Covarrubias\}, \{Hector Alfonso\} and Michael Joner and Giulia Nardi and \{Di Muro\}, \{Francesca Maria\} and \{Di Mario\}, Carlo and Lucca Loretz and Stefan Toggweiler and Enrico Gallitto and Mauro Gargiulo and Luca Testa and Francesco Bedogni and Sergio Berti and Ancona, \{Marco B.\} and Matteo Montorfano and Alessandro Leone and Carlo Savini and Davide Pacini and Jonas Gmeiner and Daniel Braun and Roberto Nerla and Fausto Castriota and \{De Carlo\}, Marco and Petronio, \{Anna Sonia\} and Marco Barbanti and Giuliano Costa and Corrado Tamburino and Leone, \{Pier Pasquale\} and Bernhard Reimers and Giulio Stefanini and Mitsumasa Sudo and Georg Nickenig and Tommaso Piva and Andrea Scotti and Azeem Latib and Matteo Vercellino and Italo Porto and Pablo Codner and Ran Kornowski and Bartorelli, \{Antonio L.\} and Giuseppe Tarantini and Chiara Fraccaro and Mohamed Abdel-Wahab and Eberhard Grube and Nazzareno Gali{\'e} and Stone, \{Gregg W.\}",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = feb,

day = "27",

doi = "10.1016/j.jcin.2022.12.009",

language = "English",

volume = "16",

pages = "396--411",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "4",

}

Palmerini, T, Saia, F, Kim, WK, Renker, M, Iadanza, A, Fineschi, M, Bruno, AG, Ghetti, G, Vanhaverbeke, M, Søndergaard, L, De Backer, O, Romagnoli, E, Burzotta, F, Trani, C, Adrichem, R, Van Mieghem, NM, Nardi, E, Chietera, F, Orzalkiewicz, M, Tomii, D, Pilgrim, T, Aranzulla, TC, Musumeci, G, Adam, M, Meertens, MM, Taglieri, N, Marrozzini, C, Alvarez Covarrubias, HA, Joner, M, Nardi, G, Di Muro, FM, Di Mario, C, Loretz, L, Toggweiler, S, Gallitto, E, Gargiulo, M, Testa, L, Bedogni, F, Berti, S, Ancona, MB, Montorfano, M, Leone, A, Savini, C, Pacini, D, Gmeiner, J, Braun, D, Nerla, R, Castriota, F, De Carlo, M, Petronio, AS, Barbanti, M, Costa, G, Tamburino, C, Leone, PP, Reimers, B, Stefanini, G, Sudo, M, Nickenig, G, Piva, T, Scotti, A, Latib, A, Vercellino, M, Porto, I, Codner, P, Kornowski, R, Bartorelli, AL, Tarantini, G, Fraccaro, C, Abdel-Wahab, M, Grube, E, Galié, N & Stone, GW 2023, 'Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry', JACC: Cardiovascular Interventions, vol. 16, no. 4, pp. 396-411. https://doi.org/10.1016/j.jcin.2022.12.009

TY - JOUR

T1 - Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR

T2 - The Hostile Registry

AU - Palmerini, Tullio

AU - Saia, Francesco

AU - Kim, Won Keun

AU - Renker, Matthias

AU - Iadanza, Alessandro

AU - Fineschi, Massimo

AU - Bruno, Antonio Giulio

AU - Ghetti, Gabriele

AU - Vanhaverbeke, Maarten

AU - Søndergaard, Lars

AU - De Backer, Ole

AU - Romagnoli, Enrico

AU - Burzotta, Francesco

AU - Trani, Carlo

AU - Adrichem, Rik

AU - Van Mieghem, Nicolas M.

AU - Nardi, Elena

AU - Chietera, Francesco

AU - Orzalkiewicz, Mateusz

AU - Tomii, Daijiro

AU - Pilgrim, Thomas

AU - Aranzulla, Tiziana Claudia

AU - Musumeci, Giuseppe

AU - Adam, Matti

AU - Meertens, Max M.

AU - Taglieri, Nevio

AU - Marrozzini, Cinzia

AU - Alvarez Covarrubias, Hector Alfonso

AU - Joner, Michael

AU - Nardi, Giulia

AU - Di Muro, Francesca Maria

AU - Di Mario, Carlo

AU - Loretz, Lucca

AU - Toggweiler, Stefan

AU - Gallitto, Enrico

AU - Gargiulo, Mauro

AU - Testa, Luca

AU - Bedogni, Francesco

AU - Berti, Sergio

AU - Ancona, Marco B.

AU - Montorfano, Matteo

AU - Leone, Alessandro

AU - Savini, Carlo

AU - Pacini, Davide

AU - Gmeiner, Jonas

AU - Braun, Daniel

AU - Nerla, Roberto

AU - Castriota, Fausto

AU - De Carlo, Marco

AU - Petronio, Anna Sonia

AU - Barbanti, Marco

AU - Costa, Giuliano

AU - Tamburino, Corrado

AU - Leone, Pier Pasquale

AU - Reimers, Bernhard

AU - Stefanini, Giulio

AU - Sudo, Mitsumasa

AU - Nickenig, Georg

AU - Piva, Tommaso

AU - Scotti, Andrea

AU - Latib, Azeem

AU - Vercellino, Matteo

AU - Porto, Italo

AU - Codner, Pablo

AU - Kornowski, Ran

AU - Bartorelli, Antonio L.

AU - Tarantini, Giuseppe

AU - Fraccaro, Chiara

AU - Abdel-Wahab, Mohamed

AU - Grube, Eberhard

AU - Galié, Nazzareno

AU - Stone, Gregg W.

PY - 2023/2/27

Y1 - 2023/2/27

N2 - Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

AB - Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

KW - alternative access

KW - critical patient

KW - femoral access

KW - transcatheter aortic valve replacement

UR - https://www.scopus.com/pages/publications/85148365693

U2 - 10.1016/j.jcin.2022.12.009

DO - 10.1016/j.jcin.2022.12.009

M3 - Article

AN - SCOPUS:85148365693

SN - 1936-8798

VL - 16

SP - 396

EP - 411

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 4

ER -

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry

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