title: Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.
abstract: OBJECTIVE
  The aim of this study was to compare transfemoral transcatheter aortic valve replacement (TF TAVR) performed in a catheterization laboratory (minimalist approach [MA]) with TF TAVR performed in a hybrid operating room (standard approach [SA]).
  
  
  BACKGROUND
  A MA-TF TAVR can be performed without general anesthesia, transesophageal echocardiography, or a surgical hybrid room. The outcomes and cost of MA-TF TAVR compared with those of the SA have not been described.
  
  
  METHODS
  Patients who underwent elective, percutaneous TF TAVR using the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) were studied. Baseline characteristics, outcomes, and hospital costs of MA-TF TAVR and SA-TF TAVR were compared.
  
  
  RESULTS
  A total of 142 patients were studied (MA-TF TAVR, n = 70 and SA-TF TAVR, n = 72). There were no differences in baseline comorbidities (Society of Thoracic Surgeons score, 10.6 ± 4.3 vs. 11.4 ± 5.8; p = 0.35). All procedures in the MA-TF TAVR group were successful; 1 patient was intubated. Three patients in the SA-TF TAVR group had procedure-related death. Procedure room time (150 ± 48 min vs. 218 ± 56 min, p < 0.001), total intensive care unit time (22 h vs. 28 h, p < 0.001), length of stay from procedure to discharge (3 days vs. 5 days, p < 0.001), and cost ($45,485 ± 14,397 vs. $55,377 ± 22,587, p < 0.001) were significantly less in the MA-TF TAVR group. Mortality at 30 days was not significantly different in the MA-TF TAVR group (0 vs. 6%, p = 0.12) and 30-day stroke/transient ischemic attack was similar (4.3% vs. 1.4%, p = 0.35). Moderate or severe paravalvular leak and device success were similar in the MA-TF TAVR and SA-TF TAVR groups (3% vs. 5.8%, p = 0.4 and 90% vs. 88%, p = 0.79, respectively) at 30 days. At a median follow-up of 435 days, there was no significant difference in survival (MA-TF TAVR, 83% vs. SA-TF TAVR, 82%; p = 0.639).
  
  
  CONCLUSIONS
  MA-TF TAVR can be performed with minimal morbidity and mortality and equivalent effectiveness compared with SA-TF TAVR. The shorter length of stay and lower resource use with MA-TF TAVR significantly lowers hospital costs.
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia. Electronic address: vbabali@emory.edu.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Chandan
authors.initials: C
authors.lastname: Devireddy
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Stamatios
authors.initials: S
authors.lastname: Lerakis
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Robert
authors.initials: R
authors.lastname: Leonardi
authors.affiliation: Structural Heart and Valve Center, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Sebastian A
authors.initials: SA
authors.lastname: Iturra
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Kreton
authors.initials: K
authors.lastname: Mavromatis
authors.affiliation: Structural Heart and Valve Center, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Bradley G
authors.initials: BG
authors.lastname: Leshnower
authors.affiliation: Structural Heart and Valve Center, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Guyton
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Mihir
authors.initials: M
authors.lastname: Kanitkar
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Patricia
authors.initials: P
authors.lastname: Keegan
authors.affiliation: Structural Heart and Valve Center, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Amy
authors.initials: A
authors.lastname: Simone
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: James P
authors.initials: JP
authors.lastname: Stewart
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Nima
authors.initials: N
authors.lastname: Ghasemzadeh
authors.affiliation: Structural Heart and Valve Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Peter
authors.initials: P
authors.lastname: Block
authors.affiliation: Structural Heart and Valve Center, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General / Q000191:economics; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000191:economics* / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000191:economics* / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D017548:Echocardiography, Transesophageal / Q000191:economics; D005260:Female; D005263:Femoral Artery; D005845:Georgia; D006350:Heart Valve Prosthesis / Q000191:economics; D019918:Heart Valve Prosthesis Implantation / Q000191:economics* / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D017721:Hospital Costs; D006801:Humans; D007362:Intensive Care Units / Q000191:economics; D007902:Length of Stay / Q000191:economics; D008297:Male; D009873:Operating Rooms / Q000191:economics*; D017064:Process Assessment, Health Care / Q000191:economics*; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVI; TAVR; aortic stenosis; cost; minimalist; transcatheter aortic valve replacement