title: Balloon dilatation and outcome among patients undergoing trans-femoral aortic valve replacement.
abstract: BACKGROUND
  Balloon pre-dilatation before transcatheter aortic valve replacement (TAVR) is performed at the discretion of the treating physician. Clinical data assessing the implications of this step on procedural outcomes are limited.
  
  
  METHODS
  We conducted a retrospective analysis of 1164 consecutive TAVR patients in the Israeli multicenter TAVR registry (Sheba, Rabin, and Tel Aviv Medical Centers) between the years 2008 and 2014. Patients were divided to those who underwent balloon pre-dilation (n=1026) versus those who did not (n=138).
  
  
  RESULTS
  Rates of balloon pre-dilation decreased from 95% in 2008-2011 to 59% in 2014 (p for trend=0.002). Baseline characteristics between groups were similar except for more smoking (22% vs. 8%, p=0.008), less past CABG (18% vs. 26%, p=0.016), less diabetes mellitus (35% vs. 45%, p=0.01), and lower STS mortality scores (5.2±3.7 vs. 6.1±3.5, p=0.006) in the pre-dilatation group. The pre-dilation group included less patients with moderate to severely depressed LVEF (7% vs. 16%, p<0.001) and higher aortic peak gradients (76.9±22.7mmHg vs. 71.4±24.3mmHg, p=0.01). Stroke rates were comparable in both groups (2.5% vs. 3%, p=0.8), but pre-dilation was associated with lower rates of balloon post-dilatation (9% vs. 26%, p<0.001). On multivariate analysis, balloon pre-dilatation was not a predictor of device success or any post-procedural complications (p=0.07).
  
  
  CONCLUSIONS
  Balloon pre-dilatation was not associated with procedural adverse events and may decrease the need for balloon post-dilatation. The results of the present study support the current practice to perform liberally balloon pre-dilatation prior to valve implantation.
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Noam
authors.initials: N
authors.lastname: Fink
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Amit
authors.initials: A
authors.lastname: Segev
authors.affiliation: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.affiliation: Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Finkelstein
authors.affiliation: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Abid
authors.initials: A
authors.lastname: Assali
authors.affiliation: Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Zach
authors.initials: Z
authors.lastname: Rozenbaum
authors.affiliation: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Hana
authors.initials: H
authors.lastname: Vaknin-Assa
authors.affiliation: Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Halkin
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Paul
authors.initials: P
authors.lastname: Fefer
authors.affiliation: Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Ben-Shoshan
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Ehud
authors.initials: E
authors.lastname: Regev
authors.affiliation: Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Maayan
authors.initials: M
authors.lastname: Konigstein
authors.affiliation: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Katia
authors.initials: K
authors.lastname: Orvin
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Victor
authors.initials: V
authors.lastname: Guetta
authors.affiliation: Leviev Heart Center, Interventional Cardiology, Sheba Medical Center, Ramat Gan, Israel. Electronic address: ibarbash@gmail.com.
authors.forename: Israel M
authors.initials: IM
authors.lastname: Barbash
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000379:methods*; D005260:Female; D006801:Humans; D015994:Incidence; D007557:Israel / Q000453:epidemiology; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: Balloon dilatation; Complications; Transcatheter aortic valve replacement