title: Transfemoral transcatheter aortic valve insertion-related intraoperative morbidity: Implications of the minimalist approach.
abstract: OBJECTIVE
  Transfemoral transcatheter aortic valve insertion may be performed in a catheterization laboratory (ie, the minimalist approach). It seems reasonable when considering this approach to avoid it in patients at risk for intraoperative morbidity that would require surgical intervention. We hypothesized that it would be possible to associate baseline characteristics with such morbidity, which would help heart teams select patients for the minimalist approach.
  
  
  METHODS
  We reviewed the records of 215 consecutive patients who underwent transfemoral transcatheter aortic valve insertion with a current commercially available device from November 2008 through July 2015. Demographic characteristics of the patients included a mean age of 78.9 ± 10.6 years, female sex in 73 patients (34.0%), and a mean Society of Thoracic Surgeons predicted risk of mortality of 8.7% ± 5.4%. Valve prostheses were balloon-expandable in 126 patients (58.6%) and self-expanding in 89 patients (41.4%).
  
  
  RESULTS
  Significant intraoperative morbidity occurred in 22 patients (10.2%) and included major vascular injury in 12 patients (5.6%), hemodynamic compromise requiring cardiopulmonary bypass support in 4 patients (1.9%), cardiac tamponade requiring intervention in 3 patients (1.4%), ventricular valve embolization in 2 patients (0.9%), and inability to obtain percutaneous access requiring open vascular access in 1 patient (0.5%). Intraoperative morbidity was similarly distributed across all valve types (P = .556) and sheath sizes (P = .369). There were no baseline patient characteristics predictive of intraoperative morbidity.
  
  
  CONCLUSIONS
  Patient and valve characteristics are not predictive of significant intraoperative morbidity during transfemoral transcatheter aortic valve insertion. The finding has implications for patient selection for the minimalist approach.
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: greason.kevin@mayo.edu.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pochettino
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn.
authors.forename: Gurpreet S
authors.initials: GS
authors.lastname: Sandhu
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minn.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: King
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005263:Femoral Artery; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D006801:Humans; D007431:Intraoperative Complications / Q000175:diagnosis / Q000209:etiology*; D008297:Male; D018579:Patient Selection; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
keywords: catheterization; complications; hybrid operating room; laboratory; minimalist; transapical; transcatheter aortic valve insertion; transcatheter aortic valve replacement; transfemoral