Outcomes in the Commercial Use of Self-expanding Prostheses in - - PowerPoint PPT Presentation

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 RegistryTM

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

Abstract

2

TCT 2016

• 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 EvolutTM R platform to those observed with the CoreValveTM platform in the STS/ACC Transcatheter Valve Therapy (TVT) RegistryTM.

• Methods. Patients in the STS/ACC TVT RegistryTM who had TAVR for native aortic stenosis using a 23, 26,
• r 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 RegistryTM. 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.

Background

3

TCT 2016

• Transcatheter aortic valve replacement (TAVR) remains a rapidly

evolving therapy.

• Continued examination of adoption of iterative changes into

commercial practice is needed.

Study Aim

4

TCT 2016

• 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) RegistryTM.

Methods

5

TCT 2016

• 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 RegistryTM 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.

Baseline Demographics

6

TCT 2016

Demographics CoreValve (N=5806) Evolut R (N=3810) p value Age1 (years) 81.6 ± 8.1 81.2 ± 8.0 0.02 Body Surface Area (m2) 1.8 ± 0.2 1.8 ± 0.3 0.01 Male 35.1% 37.5% 0.01 STS Score (Risk of Mortality, %) 8.7 ± 5.3 8.0 ± 5.4 < 0.001 Diabetes Mellitus 36.2% 36.8% 0.53 Creatinine Level >2 mg/dl 7.1% 8.9% 0.002 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% 0.86

1Subjects 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.

Procedural Data

7

TCT 2016

Assessment CoreValve (N=5806) Evolut R (N=3810) p value Valve Size Implanted 23 mm 5.4% 3.9% 0.001 26 mm 34.3% 35.2% 0.36 29 mm 60.3% 60.9% 0.59 Type of Anesthesia < 0.001 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% < 0.001 Subclavian 4.6% 5.4% 0.07 Axillary 1.0% 0.7% 0.09 Direct Aortic 4.6% 1.8% < 0.001 Other 0.5% 0.4% 0.63 Need for a second prosthesis1 4.5% 2.2% <0.001 Device Implanted Successfully 98.0% 99.0% <0.001 Device Success 94.9% 96.3% 0.001

1More than 1 valve used during the same procedure.

Values are presented as mean ± standard deviation or % of patients.

In-Hospital and 30-Day Outcomes

8

TCT 2016

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 ± 23.0Ŧ (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; ŦP<0.01

Hospital Stay

9

TCT 2016

Discharge Status

10

TCT 2016

Discharge Location: P<0.001 CoreValve vs. Evolut R

Hemodynamics

11

TCT 2016

CoreValve Evolut R Baseline 0.67 ± 0.25 (5688) 0.68 ± 0.25* (3720) Post-procedure 1.90 ± 0.64 (3829) 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)

Effective Orifice Area (cm2)

Conclusions

12

TCT 2016

• 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.

Acknowledgments

13

TCT 2016

• 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 www.tvtregistry.org.
• Statistical analysis was performed by Sharla Chenoweth, MS, and

editorial support with tables and figures provided by Jessica Dries- Devlin, PhD, both of Medtronic

Disclosures

14

TCT 2016

• 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.