Outcomes in the Commercial Use of Self-expanding Prostheses in Transcatheter Aortic Valve Replacement: A Comparison of the Medtronic CoreValve and

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1 Outcomes in the Commercial Use of Self-expanding Prostheses in Transcatheter Aortic Valve Replacement: A Comparison of the Medtronic CoreValve and Evolut R platforms in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry TM Paul Sorajja, MD, Susheel Kodali, MD, Michael Reardon, MD, Wilson Szeto, MD, Stanley Chetcuti, MD, James Hermiller, Jr, MD, David Adams, MD, Jeffrey J Popma, MD

2 Abstract Background. Transcatheter aortic valve replacement (TAVR) continues to evolve, with rapid adoption of iterative changes for commercial practice. This analysis compared the outcomes of commercial TAVR with the new repositionable Evolut TM R platform to those observed with the CoreValve TM platform in the STS/ACC Transcatheter Valve Therapy (TVT) Registry TM. Methods. Patients in the STS/ACC TVT Registry TM who had TAVR for native aortic stenosis using a 23, 26, or 29 mm Medtronic self-expanding prosthesis (CoreValve TAV or Evolut R TAV) were included in this analysis. Site-reported events for acute, in-hospital, and 30-day outcomes were examined. Results. Between Jan 2014 and April 2016, 9,616 patients underwent TAVR with a Medtronic self-expanding prosthesis in the U.S and were reported in the STS/ACC TVT Registry TM. Compared to patients treated with CoreValve TAV, those who received Evolut R TAV were slightly younger (81.2±8.0 yrs vs. 81.6±8.1 yrs; p=0.02), had lower STS-PROM (8.0±5.4% vs. 8.7±5.3%; p<0.001) and a greater use of ilio-femoral access (91.6% vs. 89.0%; p<0.001). With Evolut R TAV, there was a lower acute need for a second prosthesis [2.2% vs. 4.5%; p<0.001], less device migration (0.2% vs. 0.6%; p=0.01), a lower incidence of moderate or severe paravalvular regurgitation (4.4% vs. 6.2%; p<0.001), and shorter length of hospital stay (median, 4.0 vs. 5.0 days; p<0.001). Overall, patients treated with Evolut R TAV had a greater frequency of acute device success (96.3% vs. 94.9%; p=0.001). At 30-day follow-up, major vascular complications and residual aortic gradients after TAVR were low in both groups [7.7 mmhg vs. 7.3 mmhg; p<0.001], while all-cause mortality and the need for permanent pacemaker was lower for those who received Evolut R. Conclusions. The commercial adoption of TAVR with the Evolut R platform is associated with significant clinical improvements in the acute procedural outcomes for patients undergoing TAVR for aortic stenosis. 2

3 Background Transcatheter aortic valve replacement (TAVR) remains a rapidly evolving therapy. Continued examination of adoption of iterative changes into commercial practice is needed. 3

4 Study Aim To compare the outcomes of commercial TAVR with the new repositionable Evolut R platform to those observed with the CoreValve platform in the STS/ACC Transcatheter Valve Therapy (TVT) Registry TM. 4

5 Methods Between Jan 2014 and April 2016, 9,616 patients underwent commercial TAVR for treatment of native aortic valve stenosis using a 23, 26, or 29 mm Medtronic self-expanding prosthesis. Site-reported events for acute, in-hospital, and 30-day outcomes as reported in the STS/ACC TVT Registry TM were examined. Comparisons of outcome were performed for valve platform (CoreValve TAV or Evolut R TAV) and valve size (23 mm vs. 26 mm vs. 29 mm). Statistical significance was set a priori at p<0.05. Due to the large sample sizes, a statistical difference may be detected even though the difference is not clinically significant. 5

6 Baseline Demographics Demographics CoreValve (N=5806) Evolut R (N=3810) p value Age 1 (years) 81.6 ± ± Body Surface Area (m 2 ) 1.8 ± ± Male 35.1% 37.5% 0.01 STS Score (Risk of Mortality, %) 8.7 ± ± 5.4 < Diabetes Mellitus 36.2% 36.8% 0.53 Creatinine Level >2 mg/dl 7.1% 8.9% History of Hypertension 90.3% 90.7% 0.50 Peripheral Vascular Disease 29.8% 29.4% 0.73 Prior Stroke 12.5% 12.1% 0.52 Prior TIA 10.1% 9.6% 0.45 Cardiac Surgery (Open Heart) 25.7% 23.2% 0.01 Coronary Artery Disease 66.0% 64.3% 0.08 Pre-Existing IPG/ICD 19.1% 19.2% Subjects with age >90 are reported as 90 plus in the database and for calculation are set to 90. Values are presented as mean ± standard deviation or % of patients. 6

7 Procedural Data Assessment CoreValve (N=5806) Evolut R (N=3810) p value Valve Size Implanted 23 mm 5.4% 3.9% mm 34.3% 35.2% mm 60.3% 60.9% 0.59 Type of Anesthesia < Conscious/Moderate Sedation 12.7% 27.4% General 86.4% 72.1% Combination 0.8% 0.4% Access Site Ilio-femoral 89.2% 91.6% < Subclavian 4.6% 5.4% 0.07 Axillary 1.0% 0.7% 0.09 Direct Aortic 4.6% 1.8% < Other 0.5% 0.4% 0.63 Need for a second prosthesis 1 4.5% 2.2% <0.001 Device 1 Implanted Successfully 98.0% 99.0% <0.001 More than 1 valve used during the same procedure. Device Values are Success presented as mean ± standard deviation or % of patients. 94.9% 96.3%

8 In-Hospital and 30-Day Outcomes CoreValve (N=5806) Evolut R (N=3810) CoreValve (N=5806) Evolut R (N=3810) In-Hospital 30 Day All-cause mortality 3.7% 2.7% Ŧ 5.3% 3.7% Ŧ Any stroke 2.7% 2.6% 3.1% 3.1% Ischemic stroke 2.3% 2.2% 2.6% 2.6% Major vascular complication 1.4% 1.4% 1.5% 1.5% New permanent pacemaker 19.2% 16.6% Ŧ 20.1% 18.3% * Aortic valve reintervention 0.3% 0.2% 0.5% 0.3% Myocardial infarction 0.4% 0.1% Ŧ 0.5% 0.2% * PCI 0.4% 0.1% Ŧ 0.6% 0.2% Ŧ KCCQ N/A N/A 68.7 ± 23.7 (3885) 71.2 ± 23.0 Ŧ (2562) In-hospital: % = Proportion of subjects with events. 30 Days: % = Kaplan-Meier rate. KCCQ: mean ± standard deviation (n). CoreValve vs. Evolut R: *P<0.05; Ŧ P<0.01 8

9 Hospital Stay 9

10 Discharge Status Discharge Location: P<0.001 CoreValve vs. Evolut R 10

11 Hemodynamics Effective Orifice Area (cm 2 ) Baseline Post-procedure CoreValve 0.67 ± 0.25 (5688) 1.90 ± 0.64 (3829) Evolut R 0.68 ± 0.25* (3720) 1.88 ± 0.59 (2685) Data presented as mean ± standard deviation (n). *P<0.05 CoreValve vs. Evolut R. (effective orifice area not collected at 1 month) 11

12 Conclusions The use of Evolut R is associated with significant clinical improvements in acute procedural outcomes for patients undergoing TAVR for aortic stenosis. These improvements include lower procedural mortality, greater use of transfemoral access, shorter hospital stay, and less paravalvular regurgitation. These findings demonstrate that adoption of Evolut R, in the context of continued improvements in TAVR practice, has been of significant clinical benefit for patients with severe, native aortic valve stenosis. 12

13 Acknowledgments This research used data provided by the American College of Cardiology Foundation s National Cardiovascular Data Registry and The Society of Thoracic Surgeons National Database. The views expressed in this presentation represent those of the author(s), and do not necessarily represent the official views of either organization. Learn more about the STS/ACC TVT Registry at Statistical analysis was performed by Sharla Chenoweth, MS, and editorial support with tables and figures provided by Jessica Dries- Devlin, PhD, both of Medtronic 13

14 Disclosures Dr. Sorajja has received consulting and speaking fees from Abbott Vascular; consulting fees from Medtronic, speaking fees from Boston Scientific, and consulting fees from Lake Region; Dr. Kodali discloses financial relationships with Edwards Lifesciences, Thubrikar Aortic Valve Inc, Claret Medical, Meril Lifesciences, and VS Med Tech; Dr. Reardon has received fees from Medtronic for providing educational services; Dr.Szeto reports a financial relationship with MicroInterventional Devices ; Dr Chetcuti reports receiving grant support from Edwards Lifesciences, Boston Scientific, and Medtronic, and proctoring fees from Medtronic; Dr. Hermiller has received fees for educational services from Medtronic; Dr. Adams has received grant support from Medtronic and has royalty agreements through Mount Sinai School of Medicine with Medtronic and with Edwards Lifesciences. Dr. Popma has received grants from Medtronic, Boston Scientific, and Direct Flow Medical, and receives compensation from Boston Scientific for participation in a Medical Advisory Board and serves as a Consultant for Direct Flow Medical receiving consulting fees and equity. 14

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