title: Use of a balloon-expandable transfemoral sheath in a TAVI cohort with complex access site - a propensity score matched analysis.
abstract: OBJECTIVE
  In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications.
  
  
  RESULTS
  Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy. Propensity score matching (2:1) was performed except for the sheath to femoral artery ratio (SFAR). Compared to standard sheath patients, we found no significant difference in 30-day and one-year mortality (SoloPath vs. standard sheath, 9.3% vs. 3.5%; p=0.2, and 18.6% vs. 23.3%; p=0.7), major vascular complications (9.3% vs. 4.7%; p=0.3), and major bleeding (9.3% vs. 10.5%; p=0.5) in the cohort with the balloon-expandable sheath.
  
  
  CONCLUSIONS
  The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.
authors: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors: Alexander
authors: A
authors: Sedaghat
authors: Conrad
authors: C
authors: von Dobbeler
authors: Bruno
authors: B
authors: Sontag
authors: Jan-Malte
authors: JM
authors: Sinning
authors: Rolf
authors: R
authors: Fimmers
authors: Fritz
authors: F
authors: Mellert
authors: Wolfgang
authors: W
authors: Schiller
authors: Armin
authors: A
authors: Welz
authors: Eberhard
authors: E
authors: Grube
authors: Georg
authors: G
authors: Nickenig
authors: Karl Eugen
authors: KE
authors: Hauptmann
authors: Nikos
authors: N
authors: Werner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005858:Germany; D006349:Heart Valve Diseases / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D058729:Peripheral Arterial Disease / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D057216:Propensity Score; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D061205:Vascular Calcification / Q000150:complications* / Q000175:diagnosis / Q000401:mortality