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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Group |
| ||
| Surgical Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| access axillary or brachial artery | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| optimal hemostasis | Closure success rate of the procedure without any adjunctive procedures | 30 days |
| vascular complications | freedom from major access vascular complications requiring adjunctive endovascular or open procedures | 30 days |
| Incidence of permanent peripheral nerve injury | freedom from permanent peripheral nerve injury with functional compromise | 30 days |
| stroke Incidence | freedom from periprocedural stroke | periprocedural |
| Durability of vessel closure | freedom from secondary intervention at access site | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Luca Bertoglio, MD | IRCCS San Raffaele Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension St John Hospital and Medical Center | Detroit | Michigan | 48201 | United States | ||
| Medical University of Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30714569 | Background | 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. | |
| 31375342 | Background | 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. |
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| Vienna |
| Austria |
| Imelda Hospital | Bonheiden | Belgium |
| Service de Chirurgie Thoracique et Cardiovasculaire | Rennes | France |
| University Hospital of Cologne | Cologne | Germany |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| University Heart and Vascular Center Hamburg | Hamburg | Germany |
| University Hospital Hamburg-Eppendorf | Hamburg | Germany |
| University hospital Leipzig | Leipzig | Germany |
| IRCCS San Raffaele Hospital | Milan | 20132 | Italy |
| IRCCS San Raffaele | Milan | 20132 | Italy |
| S. Maria della Misericordia Hospital | Perugia | Italy |
| San Filippo Neri Hospital | Roma | Italy |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Spain |
| Skåne University Hospital | Malmö | Sweden |
| UniversitätsSpital Zürich | Zurich | Switzerland |
| Nuffield Dept. of Clinical Neurosciences, University of Oxford | Oxford | United Kingdom |
| 31740188 | Background | 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. |
| 28296065 | Background | 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. |
| 28118931 | Background | 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. |
| 26409640 | Background | 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. |
| 29130612 | Background | 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. |
| 23026738 | Background | 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. |
| 32089506 | Background | 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. |
| 30560381 | Background | 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. |
| 29068128 | Background | 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. |
| 29583101 | Result | 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. |