Surgical and the Percutaneous Approach to the Upper Extremity Access
Conditions
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.
Interventions
OTHERaccess axillary or brachial artery
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
Sponsors
IRCCS San Raffaele
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| optimal hemostasis | 30 days | Closure success rate of the procedure without any adjunctive procedures |
| vascular complications | 30 days | freedom from major access vascular complications requiring adjunctive endovascular or open procedures |
| Incidence of permanent peripheral nerve injury | 30 days | freedom from permanent peripheral nerve injury with functional compromise |
| stroke Incidence | periprocedural | freedom from periprocedural stroke |
| Durability of vessel closure | 30 days | freedom from secondary intervention at access site |
Countries
Austria, Belgium, France, Germany, Italy, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed