University Heart Center Hamburg

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Presentation transcript:

University Heart Center Hamburg Transcatheter valve-in-valve therapy using six different devices in four anatomic positions – clinical outcomes and technical considerations Conradi L, Silaschi M, Seiffert M, Lubos E, Blankenberg S, Reichenspurner H, Schäfer U, Treede H University Heart Center Hamburg 1 1

Disclosures Proctorship: - JenaValve Technology GmbH, Munich, Germany - Medtronic, Inc., MA, USA - Symetis SA, Ecublens, Switzerland Consultancy: - Edwards Lifesciences, Inc., CA, USA

Background 88% biological valves in 2014!

Development of aortic valve procedures University Heart Center Hamburg Background Development of aortic valve procedures University Heart Center Hamburg Primary procedures Redo procedures 48.4% 52.4% 51.6% 47.6%

TAVI procedures at UHC Hamburg Edwards Sapien (XT) 598 TF 295 TA 301 TS/Ax 1 TAo 1 V-i-V 31 Edwards Sapien 3 243 TF 183 TS/Ax 5 TA 54 V-i-V 7 Medtronic CoreValve 178 TF 168 TS/Ax 6 TAo 4 V-i-V 28 JenaValve 160 TF 6 TA 154 V-i-V 2 Symetis Acurate 161 TF 47 TA 114 Medtronic Engager 86 TA 81 TAo 5 Directflow Medical 18 TF 18 Boston Scientific Lotus 23 TF 23 V-i-V 3 SJM Portico 5 TF 5 Biotronik Biovalve 12 TF 12 n = 1484 31/03/2015

Baseline demographics I Results Baseline demographics I Baseline demographics All ViV (n=75) Aortic (n=54) Mitral (n=17) Pulmonary (n=2) Tricuspid Age (years) 74.1±12.9 77.9±8.0 69.6±14.5 37-60 28-44 Male gender, n (%) 38 (50.7) 31 (57.4) 4 (23.5) 1 (50) 2 (100) BMI 26.2±4.8 26.6±4.3 24.9±6.8 24-26 25-26 Logistic EuroSCORE I (%) 26.2±17.8 28.4±18.3 23.0±15.2 8-11 1-5 STS Score (%) 8.8±7.4 8.7±7.7 10.7±8.2 1-2 Diabetes mellitus, n (%) 10 (13.3) 7 (13.0) 3 (17.6) Peripheral vascular disease, n (%) 22 (29.3) 20 (37.0) 2 (11.8) Creatinine (mg/dl) 1.4±1.2 1.5±1.3 1.2±0.4 0.9-1.0 1.0-1.1 Atrial fibrillation, n (%) 12 (16.0) 7 (12.9) 5 (29.4) Previous stroke / TIA, n (%) 15 (20.0) 8 (47.1) Left ventricular ejection fraction - normal (>50%), n (%) - moderate reduction (30-50%), n (%) - severe reduction (<30%), n (%) 68 (90.7) 4 (5.3) 3 (4.0) 47 (87.0) 4 (7.4) 3 (5.6) 17 (100) NYHA functional class, n (%) - I/II - III/IV 8 (10.7) 67 (89.3) 5 (9.3) 49 (90.7) 1 (5.9) 16 (94.1)

Baseline demographics II Results Baseline demographics II Baseline demographics All ViV (n=75) Aortic (n=54) Mitral (n=17) Pulmonary (n=2) Tricuspid > 1 previous valve replacement, n (%) 7 (9.3) 4 (7.4) 3 (17.6) Interval to index procedure (years) 9.3±4.9 9.8±4.9 8.8±5.1 1-3 6-8 Type of previous valve, n (%) - stented - stentless - unknown 64 (85.3) 10 (13.3) 1 (1.3) 45 (83.3) 8 (14.8) 1 (1.9) 17 (100) 2 (100) 1 (50) Size of previous valve, n (%) - ≤21mm - 23mm - ≥25mm - Unknown 12 (16.0) 27 (36.0) 35 (46.7) 12 (22.2) 27 (50.0) 15 (27.8) 2 (100.0) Mode of deterioration, n (%) - stenosis - regurgitation - mixed 29 (38.7) 28 (37.3) 18 (24.0) 24 (44.4) 19 (35.2) 11 (20.4) 4 (23.5) 8 (47.1) 5 (29.4) Valve gradient (mmHg) - 35.9±16.9 14.0±6.5 34-47 8-9 Valve regurgitation ≥ moderate, n (%) 43 (57.3) 26 (48.2) 14 (82.4) 1 (50.0)

Results Procedural data I Periprocedural results All ViV (n=75) Aortic Mitral (n=17) Pulmonary (n=2) Tricuspid Procedure time (minutes) 104.3± 47.2 101.7±50.8 110.4±33.2 140-170 55-100 Flouroscopy time (minutes) 15.5±12.4 13.3±12.7 15.5±10.2 35-38 14-33 Contrast agent (ml) 119.6±89.6 114.1± 81.6 93.9±80.5 195-378 134-150 Access route - transapical, n (%) - transvascular, n (%) - direct aortic, n (%) 40 (53.3) 33 (44.0) 2 (2.7) 23 (42.6) 29 (53.7) 2 (3.7) 17 (100) 2 (100) THV type, n (%) - all Sapien - Sapien (XT) - Sapien 3 - all CoreValve - CoreValve - CoreValveEvolut - St. Jude Portico - Boston Lotus - Medtronic Engager - JenaValve 39 (52.0) 31 (41.3) 8 (10.7) 26 (34.7) 12 (16.0) 14 (18.7) 3 (4.0) 21 (38.9) 16 (29.6) 3 (5.6) 26 (48.1) 12 (22.2) 14 (25.9) - 14 (82.4) 12 (70.6) 2 (11.8) 3 (17.6) 1 (50)

Case examples Tricuspid V-i-V RV Angiography

Case examples Mitral V-i-V Lotus 25 mm in Hancock 27 mm

VARC-2 acute clinical outcome Results VARC-2 acute clinical outcome 30-day clinical outcomes All ViV (n=75) Aortic (n=54) Mitral (n=17) Pulmonary (n=2) Tricuspid Length of stay ICU (days) 2.2±1.7 2.2±1.8 2.3±1.6 1-3 1 Duration of hospital stay (days) 7.4±13.7 6.5±15.6 10.7±6.2 6 4-7 Immediate procedural mortality (<72h), n (%) 2 (2.7) 1 (1.9) 1 (5.9) All-cause death, n (%) 6 (8.0) 3 (5.6) 3 (17.6) Cardiovascular death, n (%) Any stroke, n (%) Myocardial infarction, n (%) 1 (1.3) Major vascular complication, n (%) 4 (5.3) Major/life-threatening bleeding, n (%) Acute kidney injury type II/III, n (%) 3 (4.0) Permanent pacemaker implantation, n (%) 8 (10.7) 6 (11.1) 2 (11.8) Early Safety, n (%) 12 (16.0) 7 (13.0) 5 (29.4) Clinical efficacy, n (%) 49 (65.3) 31 (57.4) 14 (82.4) 2 (100)

Results Valve regurgitation

Acute hemodynamic outcomes Results Acute hemodynamic outcomes Acute hemodynamic outcomes All ViV (n=75) Aortic (n=54) Mitral (n=17) Pulmonary (n=2) Tricuspid Valve area (cm²) - 1.5±1.4 2.4±0.9 n.a. Peak gradient (mmHg) 34.1±14.2 14.2±8.2 22-29 8-12 Mean gradient (mmHg) 20.1±7.1 4.7±3.1 12-15 4-9 Paravalvular regurgitation no/trace, n (%) 51 (68.0) 33 (61.1) 14 (82.4) 2 (100) Paravalvular regurgitation mild, n (%) 24 (33.8) 21 (38.9) 3 (17.6) Paravalvular regurgitation moderate/severe, n (%)

Residual transvalvular gradients Aortic V-i-V

Resultant indexed EOA Aortic V-i-V

Kaplan-Meier Survival Results Kaplan-Meier Survival

Valve-in-valve therapy Conclusions ViV therapy well established for treatment of SVD in aortic and mitral positions Technical feasibility demonstrated in tricuspid and pulmonary positions Multiple types of THV available for aortic and mitral ViV Excellent hemodynamic outcome regarding PVL Concern: elevated transvalvular gradients after aortic ViV, especially in valves ≤ 23 mm Open questions: - Suitability of respective THV types? - Balloon-expandable or self-expanding? - Patient selection: ViV vs. redo surgery Increasing importance of ViV can be anticipated (more bioprostheses in younger patients)

Thank you for your attention!

THV deployment (Sapien3 26 mm in Shelhigh 31 mm) Case examples Tricuspid V-i-V THV deployment (Sapien3 26 mm in Shelhigh 31 mm)

Case examples Mitral V-i-V Lotus 25 mm in Hancock 27 mm

Case examples Mitral V-i-V Lotus 25 mm in Hancock 27 mm