PMID- 31257214
OWN - NLM
STAT- MEDLINE
DCOM- 20200122
LR  - 20200122
IS  - 1557-2501 (Electronic)
IS  - 1042-3931 (Linking)
VI  - 31
IP  - 7
DP  - 2019 Jul
TI  - A Direct Comparison of Self-Expandable Portico Versus Balloon-Expandable Sapien 3 
      Devices for Transcatheter Aortic Valve Replacement: A Case-Matched Cohort Study.
PG  - E199-E204
AB  - OBJECTIVES: Pairwise comparisons of clinical and hemodynamic outcomes with new 
      transcatheter aortic valve replacement (TAVR) prostheses are needed to help 
      interventionists select the most appropriate device. The self-expandable Portico 
      valve (Abbott Vascular) was compared with the balloon-expandable Sapien 3 valve 
      (Edwards Lifesciences) at a high-volume center in a real-world setting. METHODS: 
      All patients undergoing TAVR with a new-generation device from March 2015 to 
      September 2017 at a single center were included. Baseline, peri-interventional, 
      and prospective 30-day follow-up data were obtained. A nearest-neighbor 
      propensity-score matching procedure (2:1) was used, based on age, STS score, 
      EuroScore II, New York Heart Association (NYHA) status, and sex. Primary endpoint 
      was 30-day all-cause mortality. Secondary endpoints included procedural results, 
      complications according to Valve Academic Research Consortium (VARC)-2 criteria, 
      and echocardiographic findings. RESULTS: A total of 177 out of 273 patients were 
      matched (104 Portico valves and 73 Sapien 3 valves). Procedural success rates 
      were 99.0% vs 98.6%, respectively; P=NS). Contrast dye use (160 mL for Portico vs 
      120 mL for Sapien 3; P<.001) and fluoroscopy time (19.0 min for Portico vs 15.5 
      min for Sapien 3; P=.048) were significantly lower with the Sapien 3 device. 
      Thirty-day mortality rate was 5.8% for the Portico group vs 4.1% for the Sapien 3 
      group (P=.74). Complication rates were similar between Portico and Sapien 3 
      groups: stroke (2.9% vs 4.1%, respectively; P=.31), major bleeding (3.8% vs 5.5%, 
      respectively; P=.51), major vascular complications (5.8% vs 5.5%, respectively; 
      P=.99), and pacemaker implantation (21.9% vs 17.5%, respectively; P=.55). A 
      more-than-mild paravalvular leak was observed in 8.2% vs 4.5%, respectively 
      (P=NS). CONCLUSIONS: Short-term clinical and hemodynamic outcomes were similar 
      with Portico and Sapien 3 prostheses; no statistically significant differences 
      were observed in mortality and major complication rates. An individually tailored 
      prosthesis choice is suggested.
FAU - Mas-Peiro, Silvia
AU  - Mas-Peiro S
AD  - Department of Cardiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 
      60590 Frankfurt am Main, Germany. silvia.mas@kgu.de.
FAU - Seppelt, Philipp Christian
AU  - Seppelt PC
FAU - Weiler, Helge
AU  - Weiler H
FAU - Mohr, Gina-Lisa
AU  - Mohr GL
FAU - Papadopoulos, Nestoras
AU  - Papadopoulos N
FAU - Walther, Thomas
AU  - Walther T
FAU - Zeiher, Andreas M
AU  - Zeiher AM
FAU - Fichtlscherer, Stephan
AU  - Fichtlscherer S
FAU - Vasa-Nicotera, Mariuca
AU  - Vasa-Nicotera M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - J Invasive Cardiol
JT  - The Journal of invasive cardiology
JID - 8917477
SB  - IM
MH  - Aged, 80 and over
MH  - Aortic Valve/diagnostic imaging/*surgery
MH  - Aortic Valve Stenosis/diagnosis/physiopathology/*surgery
MH  - Echocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis
MH  - Hemodynamics/physiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Postoperative Complications/epidemiology
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Survival Rate/trends
MH  - Time Factors
MH  - Transcatheter Aortic Valve Replacement/*methods
MH  - Treatment Outcome
MH  - United States/epidemiology
OTO - NOTNLM
OT  - Portico
OT  - Sapien 3
OT  - Valve Academic Research Consortium (VARC)-2 criteria
OT  - aortic stenosis
OT  - new-generation device
OT  - transcatheter aortic valve replacement
EDAT- 2019/07/02 06:00
MHDA- 2020/01/23 06:00
CRDT- 2019/07/02 06:00
PHST- 2019/07/02 06:00 [entrez]
PHST- 2019/07/02 06:00 [pubmed]
PHST- 2020/01/23 06:00 [medline]
PST - ppublish
SO  - J Invasive Cardiol. 2019 Jul;31(7):E199-E204.