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Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From.

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Presentation on theme: "Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From."— Presentation transcript:

1 Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From the CoreValve US Pivotal Trial Steven J. Yakubov, MD FACC For the CoreValve US Clinical Investigators

2 Disclosures TCT 2014 Steven J. Yakubov, MD FACC Consultant to Medtronic: member of the CoreValve US Pivotal Trial screening, steering, and publications committees 2 Medtronic personnel performed all statistical analyses and assisted in the graphical display of the data

3 Background Popma JJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014; 63: 1972-81. TCT 2014 3

4 Pivotal Trial Design TCT 2014 4

5 Primary Endpoint 1-Year All-Cause Mortality or Major Stroke TCT 2014 5

6 18F Delivery System Study Device TCT 2014 6 4 Valve Sizes (18–29 mm annular diameter)

7 Study Disposition TCT 2014 7

8 Primary Analysis was performed using the “Attempted Implant” population: all enrolled subjects with a documented attempt for an iliofemoral implant procedure defined when subject was brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed or any monitoring line placed Analysis Cohort TCT 2014 8

9 Participating Sites TCT 2014 9

10 99.2% Follow-up (n=364/367) 100% Follow-up (n=489/489) 98.2% Follow-up (n=441/449) 93.8% Follow-up (n=286/305) Study Compliance 100% Echo Performed (n=489/489) 96.4% Echo Performed (n=433/449) 91.6% Echo Performed (n=336/367) Clinical Assessments Echocardiographic Assessments Baseline N=489 1 Month N=449 84.9% Echo Performed (n=259/305) 2 Years N=305 1 Year N=367 TCT 2014 10

11 Chairman: Michael J. Reardon, MD Two clinical site cardiac surgeons and one interventional cardiologist determined patient eligibility All patients were reviewed on web-based conference calls with site investigators to confirm eligibility and access route Detailed portfolio included: STS PROM and all other risk factors Independent review of transthoracic echocardiogram Independent review of chest/abdominal CTA findings Two senior surgeons and one cardiologist on the screening committee had to concur with the local heart team assessment to qualify the patient for trial enrollment National Screening Committee TCT 2014 11

12 Baseline Demographics Characteristic, % N=489 Age, years83.2 ± 8.7 Male47.9 STS Predicted Risk of Mortality10.3 ± 5.5 Logistic EuroSCORE22.6 ± 17.1 New York Heart Association class III/IV91.8 Diabetes mellitus 41.5 Insulin requiring diabetes 18.4 Prior stroke 13.7 Coronary artery disease 81.8 Prior coronary artery bypass grafting 39.5 Prior percutaneous coronary intervention 37.0 Prior balloon aortic valvuloplasty 20.4 TCT 2014 12

13 Comorbidities, Frailty, Disabilities Characteristic, %N=489 Prohibitive Anatomy Severe aortic calcification*17.2 Hostile mediastinum11.9 Comorbidities Severe chronic lung disease23.5 Home oxygen29.9 Frailty Anemia with prior transfusion22.8 Albumin < 3.3 g/dL18.2 5-Meter gait speed > 6 secs84.2 Disabilities Assisted living27.6 ≥ 2 Katz ADL deficits20.9 Wheelchair bound16.6 *Aorta calcification measured on screening CTA TCT 2014 13

14 CoreValve US Pivotal Trial Extreme Risk Iliofemoral 2-Year Results

15 All-Cause Mortality or Major Stroke TCT 2014 15 * Calculated rate for 117 events in 179 patients (65.4%, lower confidence bound of 57.9% by Exact method) (Makkar RR, et al, New Engl J Med, 2012)

16 2-Year Mortality TCT 2014 16

17 17 TCT 2014 2-Year Mortality Landmark Analysis

18 2-Year Major Stroke TCT 2014 18

19 19 TCT 2014 2-Year Major Stroke Landmark Analysis

20 Secondary Endpoints Events*, % 1 Year2 Years Any stroke 7.08.7 Major4.35.1 Minor3.24.1 Myocardial infarction2.02.8 Reintervention1.8 VARC bleeding42.845.3 Life threatening or disabling18.020.8 Major28.329.1 Major vascular complications8.4 Permanent pacemaker implant26.428.9 Per ACC guidelines19.522.0 * Percentages obtained from Kaplan Meier estimates TCT 2014 20

21 NYHA Class in 2-Year Survivors Paired Analysis TCT 2014 21

22 Echocardiographic Findings TCT 2014 22

23 Paravalvular Regurgitation TCT 2014 23

24 PVL and All-Cause Mortality TCT 2014 24

25 TCT 2014 25 Pacemaker and All-Cause Mortality

26 Subgroup Analysis 2-Year All-Cause Mortality or Major Stroke TCT 2014 26

27 TCT 2014 27 Subgroup Analysis 2-Year All-Cause Mortality or Major Stroke

28 At 2 years the CoreValve US Pivotal Extreme Risk Study showed: –Low rates of all-cause mortality –Low rates of major stroke –Improvement in NYHA classifications –Durable improvement in hemodynamic valve performance (EOA and mean gradients) –Low rates of moderate or severe aortic insufficiency –No association of mild or moderate paravalvular regurgitation on mortality Conclusions TCT 2014 28

29 The 1-year results from the CoreValve US Pivotal Extreme Risk Study support the safety and efficacy of this therapy in patients unsuitable for surgical AVR The 2-year results confirm the improved survival benefit in these patients Summary TCT 2014 29

30 Thank You On Behalf of the CoreValve US Investigators

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