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

^*Corresponding author for this work

Cardiology

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

56 Citations (Scopus)

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
Publication status	Published - 27 Feb 2023

Bibliographical note

Funding information:
Dr Palmerini has received speaker fees from Edwards Lifesciences
and Medtronic. Dr Saia has received consulting and lecture fees from
Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received
personal fees from Abbott, Boston Scientific, Edwards Lifesciences,
Medtronic, Merill Life Sciences, and Shockwave Medical. Dr
Søndergaard has received consulting fees and/or institutional
research grants from Abbott, Boston Scientific, Medtronic, and
Sahajanand Medical Technologies. Dr Burzotta has received speaker
fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli
has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from
Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards
Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim
has received research grants to his institution from Boston Scientific Biotronik, and Edwards Lifesciences; and honoraria from Biotronik,
Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has
received personal and proctoring fees from Abbott, Boston Scientific,
Edwards Lifesciences, JenaValve, and Medtronic (during the conduct
of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo,
Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served
as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant
for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and
Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D
Imaging. Dr Testa has received consulting fees from and served as a
proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has
served as a proctor for Edwards Lifesciences, Abbott, and Boston
Scientific. Dr Ancona has received consultant fees from Abbott. Dr
Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring
fees from Abbott and Medtronic. Dr Petronio has received consultant
and research funds from Medtronic, Boston Scientific, and Abbott.
Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker
honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca,
Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb,
Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options
with Beren, Cardiovalve; has served in clinical trials with Abbott,
AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol
Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo,
Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and
has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium für Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb,
Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis,
and Pfizer. Dr Stefanini has received speaker fees from Abbott
Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research
grants to his institution from Boston Scientific. Dr Latib has served as
a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston
Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received
consulting or speaker fees from Biotronik, Abiomed, Medtronic,
Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and
Bayer, not related to this work. Dr Grube has served on the Speakers
Bureau/Scientific Advisory Board for Medtronic, Boston Scientific,
JenaValve, and High Life; and owns equity interest in Millipede, PiCardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone
has received speaker honoraria from Medtronic, Pulnovo, and
Infraredx; has served as a consultant for Valfix, TherOx, Robocath,
HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc,
Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics,
the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria,
Cardiac Success, Valfix, and Xenter; has a daughter who is an
employee at Medtronic; and his employer (Mount Sinai Hospital) has
received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular
Dynamics, and V-wave. All other authors have reported that they
have no relationships relevant to the contents of this paper to
disclose.

Publisher Copyright:
© 2023 American College of Cardiology Foundation

Access to Document

10.1016/j.jcin.2022.12.009

Cite this

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{5b27c9cbd04c42f2b7475fdcf7e8f187,

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.",

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 = "Funding information: Dr Palmerini has received speaker fees from Edwards Lifesciences and Medtronic. Dr Saia has received consulting and lecture fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Merill Life Sciences, and Shockwave Medical. Dr S{\o}ndergaard has received consulting fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies. Dr Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim has received research grants to his institution from Boston Scientific Biotronik, and Edwards Lifesciences; and honoraria from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has received personal and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic (during the conduct of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo, Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D Imaging. Dr Testa has received consulting fees from and served as a proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has served as a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Ancona has received consultant fees from Abbott. Dr Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring fees from Abbott and Medtronic. Dr Petronio has received consultant and research funds from Medtronic, Boston Scientific, and Abbott. Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options with Beren, Cardiovalve; has served in clinical trials with Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium f{\"u}r Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis, and Pfizer. Dr Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research grants to his institution from Boston Scientific. Dr Latib has served as a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received consulting or speaker fees from Biotronik, Abiomed, Medtronic, Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and Bayer, not related to this work. Dr Grube has served on the Speakers Bureau/Scientific Advisory Board for Medtronic, Boston Scientific, JenaValve, and High Life; and owns equity interest in Millipede, PiCardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at Medtronic; and his employer (Mount Sinai Hospital) has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular Dynamics, and V-wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. 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.

N1 - Funding information: Dr Palmerini has received speaker fees from Edwards Lifesciences and Medtronic. Dr Saia has received consulting and lecture fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Merill Life Sciences, and Shockwave Medical. Dr Søndergaard has received consulting fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies. Dr Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim has received research grants to his institution from Boston Scientific Biotronik, and Edwards Lifesciences; and honoraria from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has received personal and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic (during the conduct of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo, Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D Imaging. Dr Testa has received consulting fees from and served as a proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has served as a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Ancona has received consultant fees from Abbott. Dr Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring fees from Abbott and Medtronic. Dr Petronio has received consultant and research funds from Medtronic, Boston Scientific, and Abbott. Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options with Beren, Cardiovalve; has served in clinical trials with Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium für Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis, and Pfizer. Dr Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research grants to his institution from Boston Scientific. Dr Latib has served as a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received consulting or speaker fees from Biotronik, Abiomed, Medtronic, Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and Bayer, not related to this work. Dr Grube has served on the Speakers Bureau/Scientific Advisory Board for Medtronic, Boston Scientific, JenaValve, and High Life; and owns equity interest in Millipede, PiCardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at Medtronic; and his employer (Mount Sinai Hospital) has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular Dynamics, and V-wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2023 American College of Cardiology Foundation

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.

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

C2 - 36858659

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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