Transcatheter/Hybrid Aortic Valves in the Young Prof. Dr. Mirko Doss Kerckhoff Klinik, Bad Nauheim

AVR vs TAVR Implants

Indications for AVR in the Young Congenital AV disease Rheumatic fever Intervention Endocarditis Repair Trauma Degenerative disorders AVR Significant valve destruction Failed repair Failed intervention Risk

Optimal substitute for AVR Readily available in different sizes Excellent hemodynamic performance Growth potential Non-immunogenic Minimal thrombo-embolism Low structural valve degeneration incidence

Transcatheter procedures in the young Melody Pulmonary Valve Bovine jugular vein Platinum Iridium frame

Available Sutureless Prostheses Enable (Medtronic) Perceval (St Jude) Intuity (Edwards Lifesciences)

Available transcatheter prostheses Device Status Features JENAVALVE (Jenavalve) CE - TA Devel. –TF - anatomical orientation - partial repositioning ENGAGER (Medtronic) MC trial -TA no TF ACURATE (Symetis) Clin.trial –TF partial repositioning intuitive positioning PORTICO (SJM) Clin.trial - TF Devel. - TA SAPIEN 3 (Edwards) Clin. Trial -TF+TA - PV leak prevention

Transcatheter vs Sutureless AVR

Access routes for the young Transapical Transfemoral Transaortic  2 cm  5 – 5.5 cm

TA: get as minimally invasive as TF Percutaneous TA access & closure: (1) small incisions + non rib spreading approach (2) Validated access & closure devices (3) Truly percutaneous? => Imaging! CardiApex

Edwards Sapien example: SAPIEN 3

TA- ACURATE (2011) Symetis

TA- Engager Medtronic

TAVR Complications Paravalvuar leakage AV Block Migration Leaflet dysfunction Annulus ruptur Dissection/ perforation Coronary obstruction Mitral valve dysfunction

TAVI Results

Cohorte B Mortality

Cohorte A Mortality

Echocardiographic Findings (AT) TAVR AVR Valve Area (cm2) p = 0.001 p = 0.002 p = 0.003 p = 0.16 Core lab echocardiographic analysis reveals that mean valve area improves to ~1.5cm2 and there is no evidence of deterioration in either arm over two year follow-up. Numbers at Risk TAVR 301 269 223 210 139 AVR 290 224 162 151 110

Echocardiographic Findings Mean and Peak Gradients (AT) Peak Gradient - TAVR Mean Gradient - TAVR Peak Gradient - AVR Mean Gradient - AVR Gradient (mmHg) Mean gradients are reduced to ~10 mmHg and they remain stable over the course of two year follow-up. Numbers at Risk TAVR 307 275 233 218 144 AVR 295 228 168 155 112

Paravalvular AR and Mortality TAVR Patients (AT) None - Trace Mild - Moderate - Severe HR [95% CI] = 2.01 [1.38, 2.92] p (log rank) = 0.0002 39.5% Mortality 29.5% 24.8% 14.5% We sought to look at the impact of paravalvular AR on mortality. This KM curve reveals mortality is significantly higher in patients with mild-moderate-severe AR with a hazard ratio of 2.01. The KM estimates for mortality at one year were doubled and at two years the mortality with mild-mod-severe Paravalvular AR was 39.5% vs. 24.8% in those with none-trace paravalvular AR. Months Post Procedure Numbers at Risk None-Tr 167 149 140 126 87 41 16 Mild-Mod-Sev 160 134 112 101 64 26 12

Total AR and Mortality TAVR Patients (AT) None - Trace Mild Moderate - Severe p (log rank) < 0.001 50.7% 35.3% 33.4% Mortality 26.2% 26.3% Separating these curves in three categories (none-tr vs. mild vs. mod-severe) shows an interesting stepwise increase in mortality with worsening AR. 12.7% Months Post Procedure Numbers at Risk None-Tr 135 125 115 101 68 31 11 Mild 165 139 121 111 71 33 16 Mod-Sev 34 25 22 19 15 6 2

German Aortic Valve RegistrY One-year outcomes of transcatheter aortic valve implantation in 9.111 consecutive patients C. W. Hamm, H. Möllmann, F.W. Mohr, A. Beckmann, F. Beyersdorf, J. Cremer, H.-R. Figulla, G. Heusch, D. Holzhey, K.-H. Kuck, R. Lange, T. Meinertz, T. Neumann, R. Zahn, K. Papoutsis, S. Sack, S. Schneider, G. Schuler, A. Welz, T. Walther for the GARY-Executive Board Christian W. Hamm Kerckhoff Heart and Thorax Center Bad Nauheim and Medical Clinic I, University of Giessen, Germany

TAVI Valve Type transvascular transapical n = 2.632 n =6.479 ™ Engager™ ™ ACURATE™ SAPIEN™ CoreValve™ SAPIEN™ n = 2.632 n =6.479

1-year follow-up: Stroke

GER 2011 Mandatory AQUA Quality assessment AKL Score (Risikogruppen) Conv. AV Surgery expected observed T-AVI 0 - <3% 1,62 % 1,54 % 2,31 % 3,32 % 3 - <6% 4,03 % 3,18 % 4,35 % 5,44 % 6 - <10% 7,54 % 9,91 % 7,65 % 7,09 % ≥ 10% 20,22 % 18,7 % 17,99 % 13,94 % lower than expected mortality higher than expected mortality Courtesy of Prof. Welz

Large scale registry on surgical & TAVI procedures, all comers Conclusions from GARY Large scale registry on surgical & TAVI procedures, all comers Excellent 1-year follow-up (98%) Continuous increase in mortality after hospital discharge, predominately in high risk groups. Surgical AVR better in low / intermediate risk TAVI and surgical AVR equal in highest risk groups

Conclusion In low risk consider suture less AVR Less invasive procedures are the future In low risk consider suture less AVR In high risk consider TAVR TA: The FRONT DOOR approach

Thank you for your attention! m.doss@kerckhoff-klinik.de

no personal financial disclosures

no personal financial disclosures

no personal financial disclosures

no personal financial disclosures