Self-Expanding TAVR Is Best…. Subhash Banerjee, MD, FACC, FSCAI Professor of Medicine, UT Southwestern Med. Ctr. Chief of Cardiology, VA North Texas H...
Self-Expanding TAVR Is Best…. Subhash Banerjee, MD, FACC, FSCAI Professor of Medicine, UT Southwestern Med. Ctr. Chief of Cardiology, VA North Texas Health Care System Dallas, TX
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Disclosures ▪ ▪ ▪
Honoraria: Medtronic, CSI Research grants: Boston Scientific, InfraRedx, Merck Intellectual property: Mdcareglobal, HygeiaTel
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Dallas Cardiovascular Innovation 2016
Endurance swimming
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Objective ▪
Swimming against a current, it exhausts you. So after a while whoever you are you just have to let go, and the current will bring you home… Mark Twain Dallas CVI
Dallas Cardiovascular Innovation 2016
Transcatheter aortic valve replacement (TAVR)
Balloon expandable TAVR
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Self-expanding TAVR
Transcatheter aortic valve replacement (TAVR) ▪
Incontrovertible evidence that TAVR saves lives: ▪ ▪
Balloon-expandable Edward Sapien valve (first approved) 5-year mortality in PARTNER 1 trial: ▪ ▪ ▪ ▪ ▪
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TAVR group= 71.8%; standard treatment= 93.6% Impressive reduction in readmission & heart failure symptoms Most of the deaths accrued in the first 2 years 358 included from 3015 screened patients Oxygen-dep. COPD and PAD major predictors of mortality
Greater access to treatment & improve safety Dallas CVI
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Kapadia et al. Lancet. 2015 Jun 20;385(9986):2485-91
What are we debating? Self-expanding TAVR (Evolute R)
Balloon Expanding TAVR (S3)
Sheath size
True 18F outer diameter
Pre-dilation with balloon Rapid ventricular pacing Deployment Positioning
Not necessary Not necessary Controlled release Easy, micro adjustments possible Yes
Expandable sheath diameter > indicated vessel diameter Necessary Necessary Balloon inflation More difficult, one-time inflation (foreshortening) No
Features
Ability to recapture
TCT 2015: Large Multicenter Assessment of S3 Transcatheter Aortic Valve Implantation: Optimization of Clinical Outcomes with Precise Device Positioning Dallas CVI
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Achilles heel of TAVR: Vascular complications (PAD in ~50%)
18F
18F
6 mm
Cook sheath: OD=22F
Evolute R: OD= True 18F (In-line sheathTM)
Sapien balloon-expanding valve e-sheath OD Max. external diameter at pusher Indicated vessel diameter Dallas CVI
Self-expandable valve
Dallas Cardiovascular Innovation 2016
14F-23 mm 5.80±0.12 7.65±0.34 5.5 mm
14F-26 mm 14F-29 mm 5.80±0.12 6.5±0.11 7.64±0.42 8.18±0.27 36% oversizing 5.5 mm 6.0 mm
Koehler T, et. Al. “Changes of the eSheath Outer Dimensions Used for Transfemoral Transcatheter Aortic Valve Replacement.” Biomed Research International. 2015
What are we debating? Features Risk of valve embolization Risk of annular rupture Paravalvular leak (PVL) New perm. pacemaker Alternate access Valve in valve indication AFIB with LAA clot
Self-expanding TAVR (Evolute R)
Balloon Expanding TAVR (S3)
No
Yes
No Evolute R: Mod=6.8%; severe=0% 13% Subclavian, aortic Yes Yes
Yes S3: Mod=3.7%; severe=0.1% 13.3% Aortic, apical No No
2Catheterization
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and Cardiovascular Interventions 86:508–515 (2015) 3Circulation. 2015;131:1989-2000
Present & the future of TAVR Manufacturer’s choice
JAMA 2014;311:1503–14 J Am Coll Cardiol 2015;66:791–800
Self-expanding vs balloon-expanding valve platforms for TAVR
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Take home message for you’ll: ▪ ▪
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Self-expanding valve allows us to treat more patients Enhanced safety features of the self-expanding platform has made it the go to design for current & next gen. TAVR
