Treatment of Bio-Prosthetic Valve Deterioration Using Transcatheter Techniques

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1 Treatment of Bio-Prosthetic Valve Deterioration Using Transcatheter Techniques Pablo Codner, Abid Assali, Hanna Vaknin-Assa, Katia Orvin, Ram Sharony, Leor Perl, Gabriel Greenberg, Marina Kupershmidt, Soraya Taic, Tamir Bental, Yaron Shapira, Alon Barsheshet, Alexander Sagie, Ran Kornowski. Cardiology Department - Rabin Medical Center & Sackler Faculty of Medicine Tel Aviv University - ISRAEL

2 Authors Disclosure Information The authors have no conflicts of interests regarding the content of this presentation.

3 Background Valve-in-Valve Experience Rabin Medical Center IHS Conference 2015 Structural bio-prosthetic valve deterioration may be secondary to leaflet: - Calcification Retraction Endocarditis - Tear / Disruption Entrapment by pannus tissue Thrombus Producing clinically significant regurgitation or stenosis Calcification Tear and disruption Pannus and Retraction Endocarditis Thrombosis 1. Piazza N, Bleiziffer S, Brockmann G, et al. J Am Coll Cardiol Intv. 2011;4(7):

4 Background The standard of care for patients presenting with structural valve deterioration is redo-surgical valve replacement, however many of these patients are high risk surgical candidates. Percutaneous implantation of valves devices has risen as an alternative for the treatment of valve deterioration. 2 The mean survival of patients treated with surgical valve replacement is frequently longer than the durability of their implanted valves; therefore valve deterioration is frequently seen in clinical practice. 2. Dvir D, John Webb, Stephen Brecker, et al. Circulation 2012;126:

5 Aim We aim to report our experience in treating patients with structural bioprosthetic valve deterioration, using the percutaneous implantation of both: the self-expandable and the balloon expandable valve devices.

6 Methods From 2008 to 2015, >400 patients were treated with the percutaneous implantation of a valve device in our institution. This report is focused on our Valve-in Valve experience. All Valve-in-Valve patients (N=39) were rejected from re-do surgery due to high surgical risk, high fragility index, porcelain aorta, chest deformation, etc.

7 Methods Pre-procedure assessment included: Trans-esophageal echocardiography % of cases. Coronary and peripheral angiography % of cases. Gated cardiac CT % of cases. We performed detailed analysis of: 1) The bioprosthetic valve manufacturer characteristics 2) Patient`s operative report.

8 Methods Devices and access routes Aortic valve-in-valve (N=3) Mitral valve-in-valve (N=10) Tricuspid valve-in-valve (N=1) Aortic valve-in-valve (N=2) Aortic valve-in-valve (N=23) * 39 patients treated, 40 valves implanted; one patient was treated with both a mitral and an aortic valve in valve procedure in the same session. 8

9 Aortic Valve in Valve Procedures

10 Results - Aortic Procedures Baseline Characteristics Value N=28 Age (yrs) 80.1 ±4.6 Female 17 (60.7%) Diabetes mellitus type 2 13 (46.4%) Chronic obstructive lung disease 7 (25%) Previous coronary bypass surgery 15 (54%) Mean glomerular filtration rate (ml/min/1.73m 2 ) * 66.2 ± 19.8 New York Heart Association Functional Class III - IV 92.8% Society of Thoracic Surgeons score 8.9 ± 4.4 Mode of failure - Pure aortic stenosis 10 (36%) - Pure aortic regurgitation 8 (28%) - Combined aortic stenosis and regurgitation 10 (36%) Maximal and mean aortic valve gradient (mmhg) Ɨ 68 / 41

11 Results - Aortic Procedures Nr. Age (yrs) Gender Surgical valve brand name Percutaneous device Years from surgery 1 81 Male Toronto SPV 29mm CoreValve 29mm 14.5 Transfemoral 2 87 Female Mitroflow 21mm CoreValve 26mm 14.7 Transaxilary 3 86 Male Carpentier Edwards porcine 23mm CoreValve 26mm 13.9 Transaxilary 4 88 Female Mitroflow 21mm CoreValve 26mm 17.3 Transfemoral 5 88 Female Mitroflow 21mm CoreValve 26mm 8.8 Transfemoral 6 82 Male Mitroflow 23mm CoreValve 26mm 8.0 Transfemoral 7 86 Male Toronto SPV 23mm CoreValve 26mm 16.4 Transfemoral 8 83 Male Hancock II 27mm Edwards Sapien 29mm 10.6 Transapical 9 78 Male Toronto SPV 25mm CoreValve 26mm 16.7 Transaxilary Female Mitoflow 19mm CoreValve 23mm 10.0 Transfemoral Female Mitoflow 19mm CoreValve 23mm 10.1 Transfemoral Male Mosaic 23mm CoreValve 26mm 11.2 Transfemoral Female Mitroflow 19mm CoreValve 23mm 6.3 Transfemoral Female Mitroflow 21mm CoreValve 23mm 5.3 Transfemoral Female Mitroflow 19mm CoreValve 23mm 15.5 Transfemoral Male Mosaic 23mm CoreValve 26mm 16.7 Transfemoral Female Mitroflow 19mm CoreValve 23mm 11.7 Transfemoral Female Mitroflow 19mm CoreValve 23mm 4.9 Transfemoral Male Magna 23mm CoreValve 26mm 7.0 Transfemoral Male Mosaic 25mm CoreValve 26mm 11.1 Transfemoral Female Carpentier Edwards SPV 23mm CoreValve 26mm 2.0 Transfemoral 22* 82 Male Carpentier Edwards porcine 25mm (aortic) Edwards Sapien (aortic) 26mm 16.3 Transapical Female Perimount 21mm CoreValve Evolut 23mm 11 Transfemoral Female Carpentier Edwards SPV 26mm CoreValve Evolut 26mm 10 Transfemoral Male Perimount 21mm CoreValve 26mm 11 Transfemoral Female Mitroflow 19mm CoreValve 23mm 9 Transfemoral Female Mitroflow 19mm CoreValve 23mm 9 Transfemoral Female Mitroflow 19mm CoreValve 23mm 10 Transfemoral % 19 29mm 13 Access

12 Results - Aortic Procedures Procedural characteristics and outcomes valve-in-valve aortic position N=28 General anesthesia 18 (64%) Balloon pre-dilatation 1 (3.5%) Tamponade 0% Coronary obstruction 0% Valve snaring 1 (3.5%) Two valves 1 (3.5%) Valve success 27 (96.4%) In hospital mortality 0% In hospital CVA 0% Need for pacemaker implantation 0% Mean length of hospitalization 4.2 ± month max / mean trans-aortic valve gradient (mmhg) 24.4 ± 16.4 / 15.7 ± 11.1 NYHA I/II (1year follow up) 100% 1 month death / 1 year death 0 (%) / 1 (3.5%) Mean follow up (years) 1.6 ± 1.1

13 Aortic Procedures CoreValve Evolut 23mm in Perimount 21mm

14 Mitral Valve in Valve Procedures

15 Results - Mitral Procedures Baseline Characteristics Value N=10 Age (yrs) 73.6 ± 15 Female 6 (60%) Diabetes mellitus type 2 2 (20%) Previous coronary bypass surgery 5 (50%) Mean glomerular filtration rate (ml/min/1.73m 2 ) * 67.2 ± 26.1 New York Heart Association Functional Class III 7 (70%) Society of Thoracic Surgeons score 7.7 ± 4.1 Mean time from valve surgery (yrs) 12.6 ± 3.4 Mode of failure - Pure mitral regurgitation 10 (100%) Mean vena contracta (cm) 0.62 ± 0.9 Proximal isovelocity surface area radius (cm) 0.8 ± 0.3 Effective regurgitant orifice area (cm 2 ) 0.34 ± 0.6

16 Results - Mitral Procedures Nr. Age (yrs) Gende r Surgical valve brand name Percutaneous device Years from surgery Access 1 51 Female Carpentier Edwards porcine 27mm Edwards Sapien 26mm 13.0 Transapical 2 80 Female Carpentier Edwards SAV 25mm Edwards Sapien 26mm 9.3 Transapical 3 81 Female Carpentier Edwards SAV 27mm Edwards Sapien 26mm 10.8 Transapical 4 63 Female Magna 25mm Edwards Sapien 26mm 3.9 Transapical 5 87 Male Carpentier Edwards SAV 31mm Edwards Sapien 29mm 10.2 Transapical 6 80 Female Hancock II 27mm Edwards Sapien 26mm 10.5 Transapical 7 77 Male Carpentier Edwards SAV 27mm Edwards Sapien 26mm 11.4 Transapical 8 46 Female Hancock II 29mm Edwards Sapien 29mm 8.6 Transapical 9 89 Male Carpentier Edwards SAV 31mm Edwards Sapien 29mm 16.3 Transapical 10* 82 Male Carpentier Edwards Porcine 27mm Edwards Sapien 29mm 16.3 Transapical %

17 Results - Mitral Procedures Procedural characteristics and outcomes valve-in-valve mitral position Value General anesthesia 10 (100%) Tamponade 0 (0%) Two valves 0 (%) Valve success 10 (100%) In hospital mortality 1 (10%) Mean length of hospitalization (days) 6.6 ± month mitral regurgitation grade > 1 0% (0%) 1 month / 1 year NYHA I or II 100% 1 month death / 1 year death 1 (10%) / 2(20%) 1 month cerebrovascular accident 0 (0%) Mean follow up (years) 1.7 ± 1.2

18 Combined Aortic and Mitral Trans-apical Valve-in-Valve procedure Aortic Valve-in-Valve Edwards Sapien XT 26mm in CE Porcine 25mm Mitral Valve-in-Valve Edwards Sapien XT 29mm in CE Porcine 27mm Optimal Final Positioning of Both Valves

19 The Tricuspid Valve in Valve Procedures

20 Results The Tricuspid Procedure The case of a 78-year-old female patient with overwhelming right sided heart failure, 35 years after combined mitral and tricuspid valve replacement, was discussed in our heart team meeting. At TEE the tricuspid bioprosthesis - Hancock 31mm, Medtronic, MN, USAshowed elevated valve gradients 26/16 mmhg, thickened prosthetic valve leaflets and mild regurgitation.

21 Conclusion In our experience, the Valve-in-Valve procedure for the treatment of failed mitral, aortic and tricuspid bio-prosthetic valves, using multiple access techniques and available devices, was correlated with: Significant symptomatic improvement. Very low peri procedural morbidity. Very low mortality rates. This therapeutic modality should be considered as an alternative to redo-surgery in patients with structural bio-prosthetic valve deterioration. Whether valve-in-valve offers a prognostic advantage over redo-valve surgery should be assessed in a prospective randomized trial. 21

22 Thank You

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