Triển vọng can thiệp bệnh van tim qua đường ống thông cho người châu á bước tiếp theo là gì và đâu là giới hạn

Perspectives of Transcatheter Aortic Valve Implantation in Asia: What are the next steps and what are the limitations? Paul Chiam Cardiologist Adjunct Associate Professor National University of Singapore Mount Elizabeth Hospital Singapore Patient with severe AS Rejected for surgery (extreme risk) No other options Circulation 2002 Medtronic CoreValve Edwards Sapien XT valve (Self-expandable) (Balloon-expandable) Both achieved European CE mark 2007 PARTNER (Placement of Aortic Transcatheter Valves) Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients N = 699 High Risk Inoperable Parallel Trials: Individually Powered ASSESSMENT: Yes Transfemoral Access Transfemoral (TF) 1:1 Randomization ASSESSMENT: No Transfemoral Access Transapical (TA) 1:1 Randomization Yes No 1:1 Randomization N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS N = 358 VS Primary Endpoint: All-Cause Mortality at yr (Non-inferiority) Not In Study VS Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Cohort B (inoperable) All cause mortality Standard Rx All-cause mortality (%) TAVI ∆ at yr = 20.0% NNT = 5.0 pts 50.7% 30.7% HR [95% CI] = 0.54 [0.38, 0.78] P (log rank) < 0.0001 Months Numbers at Risk TAVI Standard Rx 179 179 138 121 122 83 67 41 26 12 All-Cause Mortality (ITT) Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 93.6% All-Cause Mortality (%) 80.9% 87.5% 68.0% 71.8% 50.8% 64.1% 53.9% 43.0% 30.7% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 Months * In an age and gender matched US population without comorbidities, the mortality at years is 40.5% Median Survival 11.1 Months p (log rank) < 0.0001 29.7 Months Months PARTNER (Placement of Aortic Transcatheter Valves) Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients N = 699 High Risk Inoperable Parallel Trials: Individually Powered ASSESSMENT: Yes Transfemoral Access Transfemoral (TF) 1:1 Randomization ASSESSMENT: No Transfemoral Access Transapical (TA) 1:1 Randomization Yes No 1:1 Randomization N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS N = 358 VS Primary Endpoint: All-Cause Mortality at yr (Non-inferiority) Not In Study VS Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Cohort A – High risk 0.5 Primary Endpoint: All-Cause Mortality at Year HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 0.62 TAVR AVR 0.4 26.8 0.3 0.2 24.2 0.1 0 No at Risk 12 18 24 Months TAVR 348 298 260 147 67 AVR 351 252 236 139 65 All-Cause Mortality (ITT) HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 44.8% 44.2% 34.6% 26.8% 33.7% 24.3% No at Risk TAVR 348 298 261 239 222 187 149 AVR 351 252 236 223 202 174 142 30-Day Outcomes Event, % * KM Rate (%) All-cause mortality 0.0 All stroke 0.0 Moderate or severe PVL 3.4 Permanent pacemaker implantation 11.7 * Percentages obtained from Kaplan Meier estimates Source: Meredith IT, et al Early Results from the CoreValve Evolut R CE Study [2101-295] Presented at the Annual Meeting of the American College of Cardiology March 14, 2015 36 N = 229, BAV = 21 (9.2%) 60.00% 52.40% BAV 47.60% Non-BAV 40.00% 19% 20.00% 14.90% 8.20% 4.80% 0% 0.00% Edwards CoreValve 30-Day Mortality Hayashida K et al Circ Cardiovasc Interv 2013;6:284-91 AR ≥ 1.00% AR > 30-Day Outcomes 20% JACC 2013;61:1577-84 16.30% 15% 10% 9.30% 4.70% 5% 4.70% 0% Mortality Major Stroke AR 2+ AR 3+ • TAVR for pure AR feasible in selected patients • Higher risk of valve embolization • Increased need for use of CoreValves CoreValve implantation Pure severe AR due to a flail leaflet (previous endocarditis) Survived years post TAVI 57 year female Collapsed in Japan Tracheostomy SLE – platelet 20K On steroids Sapien XT valve Patient well at years NYHA 29mm Sapien XT valve via TA approach in a 33mm mitral bioprosthesis NYHA at 24 months with trivial MR Which patients should we consider for TAVR • Inoperable patients with severe AS and life expectancy > year • High surgical risk patients • INTERMEDIATE surgical risk patients • Degenerated surgical bioprosthesis What are the next steps for Asia • Educate non-interventional cardiologists / internists on the results of TAVI • Changing mind set of cardiologists/ internists to move away from surgery first option  consider TAVI and surgery as equal options (except in LOW risk patients) • Training of centres of excellence to perform TAVI • Establish a “multidisciplinary heart team” in such centres What are the next steps for Asia • Increased research to determine if there are any particular groups of Asians at increased risk for TAVI or have poorer outcomes • Which valves produce good / better outcomes in Asians What are the limitations • Vast geography of Asia • A significant proportion of the Asian population live in rural villages with poor access to health care • TAVI centres only in major cities • Many centres have low volumes  cases infrequent and thus have limited experience What are the limitations • No universal health coverage in most Asian countries • Private health insurance lacking in many Asian countries • Cost of the device • Currently approx USD 30,000 ! •  biggest single limiting factor inhibiting the growth of TAVI in Asia Conclusion • TAVR is the standard of care for inoperable patients with severe AS and may be SUPERIOR to AVR in highrisk and intermediate risk patients • Durable clinical and hemodynamic results in Asians (7.5 years) • Off label use in bicuspid valves, non-calcific AS and selected pure severe AR feasible • Newer (better) devices will improve safety of the procedure Thank you paulchiam@heartvascularcentre.com www.heartvascularcentre.com ... Transcatheter 391 378 354 334 219 Surgical 359 343 304 282 191 15 All Stroke 16 Echocardiographic Findings TAVR had significantly better valve performance over SAVR at all follow-up visits (P