Clinical trial NCT04589962: SUrgical Versus PERcutaneous AXillary Artery International Registry
Official title: SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical and the Percutaneous Approach to the Upper Extremity Access
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated between January 2010 and May 2020 for a condition involving the aortic valve or the aorta and/or its side branches with procedures requiring an upper extremity access at the level of the axillary or brachial artery

Brief summary: The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.


Eligibility criteria: Inclusion Criteria:

* Patients who received a surgical or percutaneous access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting, between January 2010 and May 2020
* Adult patients ≥18 years

Exclusion Criteria:

* Introducer sheath internal diameter (ID) used \< 5F or \> 22F
* Patient with previous surgical axillary access on the puncture side (Pacemaker excluded)
* Patient with subclavian / axillary / brachial occlusive disease with stenosis greater than 50%
* Patient with previous bypass surgery or stent placement in the vicinity of access site (ie. Axillary extracorporeal cannulation with, axillo-femoral bypass, patch (venous or synthetic repair of previous axillary access, etc)
* Bleeding diathesis or coagulopathy
* Patients with active systemic or cutaneous infection or inflammation
* Patients who are pregnant or lactating
* Patient younger than 18 years of age
* Patients who are morbidity obese (BMI \> 40 Kg/m2)

Primary outcomes:
measure: optimal hemostasis
timeFrame: 30 days
measure: vascular complications
timeFrame: 30 days
measure: Incidence of permanent peripheral nerve injury
timeFrame: 30 days
measure: stroke Incidence
timeFrame: periprocedural
measure: Durability of vessel closure
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Ascension St John Hospital and Medical Center
state: Michigan
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Rennes
country: France
facility: Service de Chirurgie Thoracique et Cardiovasculaire
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: University hospital Leipzig
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Perugia
country: Italy
facility: S. Maria della Misericordia Hospital
city: Roma
country: Italy
facility: San Filippo Neri Hospital
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Oxford
country: United Kingdom
facility: Nuffield Dept. of Clinical Neurosciences, University of Oxford
Study officials:
affiliation: IRCCS San Raffaele Hospital
name: Luca Bertoglio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mirza AK, Oderich GS, Sandri GA, Tenorio ER, Davila VJ, Karkkainen JM, Hofer J, Cha S. Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair. J Vasc Surg. 2019 Mar;69(3):635-643. doi: 10.1016/j.jvs.2018.05.214. Epub 2018 Oct 24.
citation: Branzan D, Steiner S, Haensig M, Scheinert D, Schmidt A. Percutaneous Axillary Artery Access for Endovascular Treatment of Complex Thoraco-abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2019 Sep;58(3):344-349. doi: 10.1016/j.ejvs.2019.01.011. Epub 2019 Jul 30.
citation: Malgor RD, Marques de Marino P, Verhoeven E, Katsargyris A. A systematic review of outcomes of upper extremity access for fenestrated and branched endovascular aortic repair. J Vasc Surg. 2020 May;71(5):1763-1770.e2. doi: 10.1016/j.jvs.2019.09.028. Epub 2019 Nov 15.
citation: Deuschl F, Schofer N, Seiffert M, Hakmi S, Mizote I, Schaefer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schafer U. Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis. Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1167-1174. doi: 10.1002/ccd.26986. Epub 2017 Mar 15.
citation: Schafer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol. 2017 Apr 1;232:247-254. doi: 10.1016/j.ijcard.2017.01.010. Epub 2017 Jan 7.
citation: Frohlich GM, Baxter PD, Malkin CJ, Scott DJ, Moat NE, Hildick-Smith D, Cunningham D, MacCarthy PA, Trivedi U, de Belder MA, Ludman PF, Blackman DJ; National Institute for Cardiovascular Outcomes Research. Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry). Am J Cardiol. 2015 Nov 15;116(10):1555-9. doi: 10.1016/j.amjcard.2015.08.035. Epub 2015 Sep 3.
citation: Arnett DM, Lee JC, Harms MA, Kearney KE, Ramos M, Smith BM, Anderson EC, Tayal R, McCabe JM. Caliber and fitness of the axillary artery as a conduit for large-bore cardiovascular procedures. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):150-156. doi: 10.1002/ccd.27416. Epub 2017 Nov 11.
citation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.
citation: Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20.
citation: Schaefer A, Schirmer J, Schofer N, Schneeberger Y, Deuschl F, Blankenberg S, Reichenspurner H, Conradi L, Schafer U. Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study. Clin Res Cardiol. 2019 Jul;108(7):779-786. doi: 10.1007/s00392-018-1407-z. Epub 2018 Dec 17.
citation: De Palma R, Ruck A, Settergren M, Saleh N. Percutaneous axillary arteriotomy closure during transcatheter aortic valve replacement using the MANTA device. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):998-1001. doi: 10.1002/ccd.27383. Epub 2017 Oct 25.
citation: Puippe GD, Kobe A, Rancic Z, Pfiffner R, Lachat M, Pfammatter T. Safety of percutaneous axillary artery access with a suture-mediated closing device for parallel endograft aortic procedures - a retrospective pilot study. Vasa. 2018 Jun;47(4):311-317. doi: 10.1024/0301-1526/a000702. Epub 2018 Mar 27.