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Transcatheter Mitral Valve-in-Valve and Valve-in-Ring

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Presentation on theme: "Transcatheter Mitral Valve-in-Valve and Valve-in-Ring"— Presentation transcript:

1 Transcatheter Mitral Valve-in-Valve and Valve-in-Ring
Sung-Han Yoon, MD Raj Makkar, MD On behalf of the TMVR Registry Investigators Cedars-Sinai Heart Institute, Los Angeles, California

2 Disclosure Statement of
Financial Interest Sung-Han Yoon, MD Within the past 12 months, I or my spouse/partner have had no financial interest/arrangement or affiliation with any organization(s).

3 Background Valvular heart disease will increase with aging population
High risk for repeat cardiac surgery for degenerated mitral bioprostheses and failed annuloplasty rings Transcatheter treatment has become standard for AS Transcatheter mitral valve replacement (TMVR) as less invasive alternative

4 Methods The TMVR multicenter registry was used to evaluate the outcomes of mitral valve-in-valve (ViV) and valve-in-ring (ViR) Procedural and clinical outcomes were assessed according to MVARC criteria Outcomes of mitral ViV and ViR were compared

5 Participating Institutions (N = 25)
Country Institution (cases) Investigator U.S. Cedars-Sinai Heart Institute (33) Raj Makkar Germany German Heart Center (33) Sabine Bleiziffer Intermountain Heart Institute (30) Brian Whisenant Hamburg University Heart Center (22) Niklas Schofer, Ulrich Schaefer Italy San Raffaele Scientific Institute (21) Azeem Latib, Antonio Columbo Hamburg University Cardiovascular Center (15) Joachim Schofer Netherland Leiden University Medical Center (14) Victoria Delgado, Jeroen J. Bax U.K. St. Thomas Hospital (11) Bernard Prendergast, Simon Redwood Rahr-University Bochum (10) Buntaro Fujita, Stephan M. Ensminger Switzerland University Hospital Zurich (8) Francesco Maisano, Fabian Nietlispach Bern University Hospital (8) Thomas Pilgrim, Stephan Windecker New York-Presbyterian Hospital (8) S. Chiu Wong Houston Methodist DeBakey Heart and Vascular Center (7) Colin Barker, Michael Reardon University of Alabama-Birmingham (7) James Davies German Heart Center (6) Markus Kasel Spain Hospital Clinicio San Carlos (6) Luis Nombela-Franco University of Texas Health Science Center (6) Abhijeet Dhoble Sussex Cardiac Center (4) David Hildick-Smith Canada Center Hospitalier de l’universite de Montreal (4) Jean-Bernard Masson Cardiovascular Center (3) Horst Sievert Leed Teaching Hospital (2) Daniel J. Blackman Hospital General Universitario Gregorio Maranon (2) Enrique Gutierrez-Ibanes

6 Baseline Characteristics Demographics
Overall (n = 248) ViV (n = 176) ViR (n = 72) P value Age, years 73 ± 12 73 ± 13 71 ± 10 0.36 Female 57% 63% 42% 0.002 NYHA class III / IV 89% 88% 92% 0.41 STS score, % 8.9 ± 6.8 9.3 ± 7.0 8.1 ±6.2 0.24 Logistic EuroSCORE, % 26.9 ± 15.8 26.2 ±15.6 28.2 ±16.2 0.44

7 Baseline Characteristics Comorbidities
Overall (n = 248) ViV (n = 176) ViR (n = 72) P value Diabetes mellitus 23% 26% 17% 0.11 Creatinine, mg/dl 1.5 ± 1.2 1.4 ± 1.1 1.7 ± 1.4 0.08 Peripheral vascular disease 7% 6% 10% 0.34 Prior CVA 21% 0.003 Chronic lung disease 25% 24% 28% 0.58 Prior CABG 27% 22% 38% 0.01

8 Baseline Characteristics Ecocardiogram
Overall (n = 248) ViV (n = 176) ViR (n = 72) P value LVEF, % 53 ± 14 55 ± 11 46 ± 17 < 0.001 Mean gradient, mm Hg 11 ± 6 12 ± 6 7 ± 5 MR ≥ moderate at baseline 77% 71% 90% 0.001 Mechanism of failure MR 48% 36% 78% MS 27% 4% Combined 25% 28% 18% 0.11

9 Baseline Characteristics Procedure
Overall (n = 248) ViV (n = 176) ViR (n = 72) P value Transseptal access 33% 65% 28% 0.26 Transapical access 67% 64% 72% 0.23 Device type Balloon-expandable valves 90% 94% 79% < 0.001 Sapien XT 38% 39% 35% 0.56 Sapien 3 41% 43% 0.46 Lotus 6% 5% 8% 0.24 Direct Flow 9% 10% 13%

10 Procedural Outcomes Overall (n = 248) ViV (n = 176) ViR (n = 72)
P value Procedure-related death 1.2% 1.1% 1% > 0.99 Conversion to surgery 2.0% 4.2% 0.15 LVOT obstruction 3.2% 2.3% 0.18 Valve embolization 1.6% 2.8% 0.58 Need for second valve 5.1% 11.1% 0.008 LV perforation 0.4% 0.6% 0.0% Technical success * 92.3% 96% 83% 0.001 * Absence of procedural mortality; successful access, delivery; and retrieval of the device delivery system; successful deployment and correct positioning of the first intended device; freedom from emergent surgery or reintervention

11 Mitral Valve Regurgitation
Overall ViV ViR

12 Procedural Outcomes Overall (n = 248) ViV (n = 176) ViR (n = 72)
P value Re-intervention 10.1% 7.4% 16.7% 0.03 PVL closure 3.6% 2.3% 6.9% 0.07 ASD closure 4.0% 4.2% 0.95 Surgical MVR 1.6% 1.1% 2.8% 0.58 Echocardiographic findings LVEF, % 50 ± 14 53 ± 12 44 ± 15 < 0.001 MR ≥ moderate 10.3% 6.8% 19.4% 0.003 Device success * 85.5% 89.2% 76.4% 0.001 * Absence of procedural mortality and stroke; proper placement and positioning of device; freedom from unplanned surgical or interventional procedures; no significant MS or MR (> moderate)

13 Clinical Outcomes Overall (n = 248) ViV (n = 176) ViR (n = 72) P value
All-cause mortality at 30 days 6.5% 5.7% 8.3% 0.44 Stroke 1.6% 2.3% 0.0% 0.33 Life-threatening bleeding 4.0% 0.03 Major vascular complication 1.7% 1.4% > 0.99 AKI (stage 2 or 3) 6.0% 11.1% Procedural success* 73.4% 79.5% 58.3% 0.001 * Device success without death, stroke, life-threatening bleeding, major vascular complications, stage 2 or 3 AKI, congestive heart failure, valve-related dysfunction, or other complications requiring surgery or repeat intervention.

14 Mid-term Mortality

15 1-year All-cause Mortality Overall All-cause Mortality (%)
16.9% Days No. at Risk 248 129 120

16 1-year All-cause Mortality ViV vs ViR All-cause Mortality (%)
Log-rank p value = 0.01 ViV 28.7% All-cause Mortality (%) 12.6% No. at Risk Days ViV 176 100 96 ViR 72 29 25

17 1-year All-cause Mortality Transseptal vs Transapical
Log-rank p value = 0.74 All-cause Mortality (%) 17.4% 16.2% No. at Risk Days Transapical 165 97 90 Transseptal 82 33 30

18 Anticoagulation and Thrombosis

19 Antithrombotic Treatment The first 3 months
(30%) (47%) (6%) (17%) (n = 185)

20 Clinical Thrombosis Anticoagulant vs Antiplatelet only
Incidence (%) Anticoagulant Treatment Antiplatelet Treatment Only

21 Conclusions TMVR for degenerated mitral bioprostheses or failed annuloplasty rings showed acceptable outcomes Compared to mitral ViV, mitral ViR was associated with lower technical, device and procedural success The 1-year all-cause mortality was higher in mitral ViR compared with mitral ViV Absence of anticoagulant for the first 3 months after TMVR was associated with increased rate of clinical thrombosis

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