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Incidence and Outcomes of Valve Hemodynamic Deterioration in Transcatheter Aortic Valve Replacement in U.S. Clinical Practice: A Report from the Society.

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Presentation on theme: "Incidence and Outcomes of Valve Hemodynamic Deterioration in Transcatheter Aortic Valve Replacement in U.S. Clinical Practice: A Report from the Society."— Presentation transcript:

1 Incidence and Outcomes of Valve Hemodynamic Deterioration in Transcatheter Aortic Valve Replacement in U.S. Clinical Practice: A Report from the Society of Thoracic Surgery / American College of Cardiology Transcatheter Valve Therapy Registry Sreekanth Vemulapalli MD, David Dai MS, Michael Mack MD, David Holmes MD, Fred Grover MD, Raj Makkar MD, Vinod H. Thourani MD, Pamela S. Douglas MD On behalf of the STS/ACC TVT Registry

2 Disclosures, Funding and Disclaimer Sreekanth Vemulapalli, MD Abbott Vascular, American College of Cardiology This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR). The views expressed in this presentation represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com.www.ncdr.com

3 Background TAVR effectively treats patients with severe aortic stenosis There are recent reports of TAVR leaflet abnormalities and valve thrombosis (4DCT / TEE) or Valve Hemodynamic Deterioration (VHD) (increase in aortic valve mean gradient) Planned prospective studies to investigate this using advanced imaging will take years to complete STS / ACC TVT Registry: Collaboration of STS, ACC, CMS, FDA, hospitals, industry, SCAI, AATS, NIH, and consumer advocates – Unique opportunity to track current TAVR performance in the community – All commercial valve implantations in US – Linked to CMS database for long term follow up – Prespecified post-procedure, 30-day, 1-year transthoracic echo (TTE) – TTEs are site read

4 Objectives and Methods Aim 1: Incidence of VHD (≥ 10 mm Hg ↑ g radient) Post-procedure Echo 30-day Echo Short Term Cohort TAVR

5 Objectives and Methods Aim 1: Incidence of VHD (≥ 10 mm Hg ↑ g radient) Post-procedure Echo 30-day Echo 1-year Echo Short Term Cohort TAVR 30-day Echo Long Term Cohort

6 Objectives and Methods Mortality Stroke Heart failure Re-intervention Aim 2: 18-month cardiovascular outcomes Aim 1: Incidence of VHD (≥ 10 mm Hg ↑ g radient) Post-procedure Echo 30-day Echo 1-year Echo Short Term Cohort CMS linkage TAVR 30-day Echo Long Term Cohort

7 Objectives and Methods Mortality Stroke Heart failure Re-intervention Aim 2: 18-month cardiovascular outcomes Aim 3: Predictors of VHD Aim 1: Incidence of VHD (≥ 10 mm Hg ↑ g radient) Post-procedure Echo 30-day Echo 1-year Echo Backwards selection regression model Short Term Cohort CMS linkage TAVR 30-day Echo Long Term Cohort

8 22,271 TAVRs 22,231 patients (360 sites) 661 cases aborted 124 died in lab 12,212 without CMS linkage Study Design 35,268 TAVRs 34,977 patients (365 sites) November 2011 – March 2015

9 10,099 TAVRs 10,095 patients (334 sites) 22,271 TAVRs 22,231 patients (360 sites) 661 cases aborted 124 died in lab 12,212 without CMS linkage 4340 missing post gradient 6794 missing 30-day gradient Short Term Cohort ( ↑ 0–30 days) 769 deaths before next gradient 269 deaths before post gradient Study Design 35,268 TAVRs 34,977 patients (365 sites) November 2011 – March 2015

10 10,099 TAVRs 10,095 patients (334 sites) 3175 TAVRs 3175 patients (254 sites) Long Term Cohort ( ↑ 30 days–1 yr) 22,271 TAVRs 22,231 patients (360 sites) 661 cases aborted 124 died in lab 12,212 without CMS linkage 1111 deaths before 30-day gradient 8716 missing 30-day gradient 864 deaths before next gradient 8405 missing 1-year gradient 4340 missing post gradient 6794 missing 30-day gradient Short Term Cohort ( ↑ 0–30 days) 769 deaths before next gradient 269 deaths before post gradient Study Design 35,268 TAVRs 34,977 patients (365 sites) November 2011 – March 2015

11 Baseline Patient Characteristics Short Term Cohort (N=10,099) Long Term Cohort (N=3175) Age (years), median (IQR)84.0 (78.0,88.0) Male sex5182 (51.3)1487 (46.8) Hypertension9003 (89.1)2801 (88.2) Diabetes Mellitus3593 (35.6)1109 (34.9) Prior MI2405 (23.8)774 (24.4) Prior stroke or TIA1891 (18.7)582 (18.3) Atrial fibrillation/flutter4146 (41.1)1222 (38.5) Dialysis dependent379 (3.8)84 (2.6) STS PROM Score, median (IQR)6.7 (4.5,10.0)6.4 (4.5,9.6) Aspirin (Discharge)8798 (87.1)2816 (88.7) Warfarin (Discharge)2510 (24.9)780 (24.6) Dabigatran (Discharge)2602 (25.8)832 (26.2) P2Y12 inhibitor (Discharge)6586 (65.2)2106 (66.3) Factor Xa inhibitor (Discharge)373 (3.7)59 (1.9)

12 Procedure and Echo Variables Short Term Cohort (N=10,099) Long Term Cohort (N=3175) Baseline echo variables LVEF median (IQR)58.0 (45.0,64.0)58.0 (48.0,63.5) Procedure variables Balloon expanding valve8029 (79.5)2981 (93.9) Self-expanding valve2068 (20.5)194 (6.1) Valve size = 23 mm3273 (32.4)1376 (43.3) Valve size = 26 mm4502 (44.6)1647 (51.9) Valve size = 29 mm1612 (16.0)91 (2.9) Valve size = 31 mm710 (7.0)61 (1.9) Valve in valve486 (4.8)137 (4.3) Postprocedure echo variables Valve oversizing1.2 (1.1,1.4)1.3 (1.1,1.4) Mean AV gradient mm Hg, median (IQR)9.0 (6.0,12.0)10.0 (7.0,13.0) EOA index cm 2, median (IQR)1.0 (0.8,1.2)0.9 (0.7,1.2) PPM present (moderate/severe)2957 (29.3%) 847 (26.7%)

13 Short Term Cohort (↑ gradient 0–30 days) Long Term Cohort (↑ gradient 30 day–1 yr) Incidence of VHD VHD defined as ↑ AS mean gradient ≥ 10 mm Hg VHD 2.1% VHD + Death (0–30 d) 7.1% VHD 2.5% VHD + Death (30 d–1 yr) 23.5%

14 Composite % (Mortality/Stroke/AVRI) 30 20 10 0 0 Months from Index Procedure 10099 211 No. at Risk <10 mm Hg ≥ 10 mm Hg Landmark Cumulative Incidence of Mortality/Stroke /Aortic Valve Reintervention Short Term Cohort (↑ gradient 0–30 days)

15 Composite % (Mortality/Stroke/AVRI) 30 20 10 0 03 6 91215 18 Months from Index Procedure 10099 7734 5925 4423 3359 2609 2024 211 173 140 105 87 70 50 No. at Risk <10 mm Hg ≥ 10 mm Hg Landmark Cumulative Incidence of Mortality/Stroke /Aortic Valve Reintervention Short Term Cohort (↑ gradient 0–30 days)

16 Composite % (Mortality/Stroke/AVRI) 0 10 20 30 20 10 0 03 6 91215 18 0 Months from Index Procedure 10099 7734 5925 4423 3359 2609 2024 10099 211 173 140 105 87 70 50 211 No. at Risk <10 mm Hg ≥ 10 mm Hg <10 mm Hg ≥ 10 mm Hg Months from Index Procedure Landmark Cumulative Incidence of Mortality/Stroke /Aortic Valve Reintervention Short Term Cohort (↑ gradient 0–30 days) Long Term Cohort (↑ gradient 30 day–1 yr)

17 Composite % (Mortality/Stroke/AVRI) 0 10 20 30 20 10 0 03 6 91215 18 30 69 12 Months from Index Procedure 10099 7734 5925 4423 3359 2609 2024 10099 3031 3004 2943 2548 211 173 140 105 87 70 50 211 77 75 75 63 No. at Risk <10 mm Hg ≥ 10 mm Hg <10 mm Hg ≥ 10 mm Hg Months from Index Procedure Landmark Cumulative Incidence of Mortality/Stroke /Aortic Valve Reintervention Short Term Cohort (↑ gradient 0–30 days) Long Term Cohort (↑ gradient 30 day–1 yr)

18 Composite % (Mortality/Stroke/AVRI) 0 10 20 30 20 10 0 03 6 91215 18 30 69 12 1518 Months from Index Procedure 10099 7734 5925 4423 3359 2609 2024 10099 3031 3004 2943 2548 2036 1588 211 173 140 105 87 70 50 211 77 75 75 63 56 45 No. at Risk <10 mm Hg ≥ 10 mm Hg <10 mm Hg ≥ 10 mm Hg Months from Index Procedure Landmark Cumulative Incidence of Mortality/Stroke /Aortic Valve Reintervention Short Term Cohort (↑ gradient 0–30 days) Long Term Cohort (↑ gradient 30 day–1 yr)

19 Short Term Cohort (↑ gradient 0–30 days) Long Term Cohort (↑ gradient 30 day–1 yr) 18-Month Outcomes Event p=ns <10 mm Hg ≥ 10 mm Hg <10 mm Hg ≥ 10 mm Hg Rate

20 Discharge P2Y12 Discharge Factor Xa inhibitor 26 mm TAVR (vs 23 mm) 29 mm TAVR (vs 23 mm) 31 mm TAVR (vs 23 mm) ↑ Pre discharge gradient Factors Associated with VHD Odds Ratio for VHD 1 5 0.1 ↑ Age (per 5 years) Male ↑ BMI (per 5 kg / m 2 ) Severe Chronic Lung Disease Afib/flutter ↑ Baseline AoV Gradient (per 5 mm Hg) Valve in Valve 26 mm TAVR (vs 23 mm) 29 mm TAVR (vs 23 mm) 31 mm TAVR (vs 23 mm) ↑ Pre discharge gradient (per 1 mm Hg) Severe PPM Long Term Cohort Short Term Cohort

21 Summary There is a small but present incidence of Valvular Hemodynamic Deterioration after TAVR (defined by ↑ AV gradient ≥ 10 mmHg) – 2.1% in the post-procedure to 30 day timeframe – 2.5% in the 30 day to 1-year timeframe VHD does not appear to be not associated with excess events – Cumulative incidence of a composite of death, stroke, and aortic valve re- intervention and of its components are similar between those with and without VHD Predictors of VHD include both patient and procedural factors – Patient: Male, ↑BMI severe lung disease, – Procedural: 23 mm TAVR valve, valve-in-valve, ↑Baseline AoV gradient, severe PPM

22 Limitations Retrospective analysis using site reported, surveillance echo data obtained at pre-specified time points – Uncertain relationship to clinical events, if any – May also detect asymptomatic or clinically unapparent VHD Definition of VHD (↑ 10 mm Hg mean gradient) is not validated Incidence of VHD may be underestimated due to death/reoperation before follow-up gradient measurement – The incidence of VHD when including death is 2–4x the rate of VHD Significant echo data missingness; Clinical follow-up only in CMS pts Absence of 4DCT/TEE to determine etiology of VHD or leaflet abnormalities

23 Conclusions Incidence of VHD as reported in clinical practice is low; ~2% VHD is not clearly associated with adverse CV events These findings, especially patient and procedural predictors, may help to inform TAVR care including patient selection, surveillance and preventive strategies Large, prospective studies using advanced imaging (4DCT/TEE) are necessary to fully elucidate the incidence, mechanisms and consequences of VHD

24

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