1. Early Outcomes with the Evolut R Repositionable Self-Expanding Transcatheter Aortic Valve in the United States
Mathew Williams, MD, For the Evolut R US Clinical Study Investigators

2. Background
Self-expanding transcatheter aortic valve replacement (TAVR) has shown a survival advantage in both extreme- and high-risk surgical patients.
The Evolut R is a 2nd generation, repositionable self- expanding TAV with a smaller diameter delivery system
We assessed early safety and efficacy outcomes following initial study of the device in the CoreValve US Evolut R Clinical Study.
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3. Methods and Study Procedures
The primary safety endpoints were:
The rate of all-cause mortality at 30 days
The rate of disabling stroke at 30 days
Safety and efficacy endpoints were assessed at 30 days based on the use of the resheathing/recapturing features of the CoreValve Evolut R transcatheter aortic valve (Medtronic).
CT imaging for valve sizing and vascular access assessment
Evaluated 23 mm, 26 mm, 29 mm valves sizes in aortic annuli from 18 – 26 mm
Independent Echocardiographic Core Laboratory (Mayo Clinic, Rochester, MN)
Local Heart Team required comprising a cardiothoracic surgeon, an interventional cardiologist and an echocardiographer
National Screening Committee to confirm eligibility
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4. Inclusion and Exclusion Criteria
Severe aortic stenosis defined as an aortic valve area ≤ 1.0 cm2 or aortic valve index ≤ 0.6 cm2/m2 and either a mean aortic valve gradient > 40 mm Hg or a peak aortic valve velocity > 4.0 meters per second, at rest or with dobutamine
NYHA II or greater
Deemed at high to extreme surgical risk
Gastrointestinal hemorrhage precluding anticoagulation
End state renal disease
Left ventricular ejection fraction <20%
Recent percutaneous coronary or peripheral intervention
Life expectancy < 1 year due to comorbidities
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5. Catheter Delivery System
CoreValve Evolut R System
Catheter Delivery System
14Fr-equivalent profile
Inline Sheath
Capsule
Loading System
Transcatheter Valve
Supra-annular design, optimized sealing

6. Baseline Characteristics
Characteristic, mean ± SD or %
N = 241
Age (years)
83.3 ± 7.2
Female
68.5
BSA (m2)
1.8 ± 0.2
STS – PROM (%)
7.4 ± 3.4
NYHA Class III or IV
83.0
Previous CABG
23.2
Atrial fibrillation / atrial flutter
30.7
Diabetes mellitus
32.4
Any chronic lung disease
54.0
Any peripheral vascular disease
34.9
Severely atherosclerotic aorta
5.8
Frailty
69.7
Pre-existing permanent pacemaker
16.2
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7. Procedural Outcomes Characteristic, % (no./total no.) N = 241
General anesthesia
80.7 (188/233)
Iliofemoral access approach
89.5 (214/239)
Pre-TAVR balloon dilation performed
36.8 (88/239)
Valve Size Implanted
23 mm
1.3 (3/237)
26 mm
35.0 (83/237)
29 mm
63.7 (151/237)
Post implant dilation performed
32.2 (77/239)
Correct positioning of one valve in proper location
98.7 (234/237)
Mean gradient < 20 mm Hg or peak velocity < 3m/sec
99.1 (220/222)
Absence of moderate or severe regurgitation
96.5 (222/230)
EOAi > 0.85 cm2/m2
73.2 (145/198)
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8. Resheathing/ Recapture
Resheathing - a portion of the Evolut R TAV is retracted into the capsule of the delivery catheter with the intent to reposition
Recapture - the entire Evolut R TAV is retracted into the capsule of the delivery catheter until there is no gap between capsule and the tip
Successfully used 63 times among 54 patients (22.6%)
Partial resheathing used 31 times in 24 patients
Fully retrieved in 4 patients to exchange or remove the valve
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9. Effective Orifice Area, cm2
Valve Performance
Effective Orifice Area, cm2
Mean Gradient, mm Hg
Gradient
237
222
223
EOA
211
198
205
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10. New York Heart Association
Percentage of Patients
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11. Percent of Evaluable Echocardiograms
Paravalvular Leak*
Percent of Evaluable Echocardiograms
*Core Lab adjudicated per Zoghbi WA, et al. J Am Soc Echocardiogr 2009; 22: 975.
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12. Safety Outcomes Outcome, no. (KM rates) N = 241 All-cause mortality
6 (2.5)
Disabling stroke
8 (3.3)
Major vascular complications
18 (7.5)
Life-threatening or disabling bleeding
17 (7.1)
Pacemaker
39 (16.4)
There were no instances of embolization or migration, annular rupture, endocarditis or valve thrombosis
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13. Outcomes at 30 Days by Resheath/Recapture
KM Event Rates (%)
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14. Summary In this early experience with the Evolut R in the US:
The Evolut R self-expanding TAV was shown to be safe and effective in this patient population.
The mean AV gradient and EOA were significantly improved compared to baseline with a low 7.8 mm Hg mean AV gradient at 30 days.
No patients had severe PVL, and moderate PVL was present in 5.3% of patients overall; less in patients in whom the repositioning features were used.
Use of the resheath feature was not associated with an increase in stroke.
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