Επεμβατική Καρδιολογία πέραν της Στεφανιαίας Νόσου Το παρόν και το μέλλον. Εμμανουήλ Βαβουρανάκης Καθηγητής Καρδιολογίας ΕΚΠΑ Δ/της Γ ΠΚΚ
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1 Επεμβατική Καρδιολογία πέραν της Στεφανιαίας Νόσου Το παρόν και το μέλλον Εμμανουήλ Βαβουρανάκης Καθηγητής Καρδιολογίας ΕΚΠΑ Δ/της Γ ΠΚΚ
2 CONFLICT OF INTEREST PROCTOR MEDTRONIC CORE VALVE
3 ΔΙΑΚΑΘΕΤΗΡΙΑΚΗ ΑΝΤΙΚΑΤΑΣΤΑΣΗ ΑΟΡΤΙΚΗΣ ΒΑΛΒΙΔΟΣ ΑΝΕΠΑΡΚΕΙΑ ΜΙΤΡΟΕΙΔΟΥΣ
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5 TAVI as an alternative therapy for AS in elderly patients (Mean Age 83.1 years, Logistic EuroSCORE: 26.4% TAVI vs. 30.4% standard therapy)
6 TAVI should be determined NOT by Age per se Clinical Characteristics Very high STS score
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8 mean age of 83.2 years
9 TAVI in Intermediate Risk Trials Sapien XT Sapiεn 3 Corevalve
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11 ESC/EACTS Guidelines for VHD
12 Διαδερμική Αντιμετώπιση της Στενωσης της Αορτικής Βαλβιδας Τα τελευταια χρόνια η Διαδερμική Αντιμετώπιση της Στενωσης της Αορτικής Βαλβιδας απο μία πρωτοεμφανιζόμενη τεχνική με σοβαρές επιπλοκές έχει γίνει μια επέμβαση ρουτίνας
13 Estimated Global TAVR Growth This year > 100,000 and by 2025 almost 300,000
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15 Transfemoral TAVR Devices Iterative Device Design Iterative devices have been designed to mitigate complications, simplify the procedure, and improve upon current anatomic exclusions to enable the treatment of more patients Evolut R Lotus SAPIEN 3 Portico ACURATE neo Frame Nitinol Nitinol Cobalt Chromium Nitinol Nitinol PVL Managment Extended Skirt Adaptive Seal PET Fabric Skirt Pericardial cuff Pericardial skirt Annular Range mm mm mm mm mm Positioning Recapturable Recapturable -- Recapturable -- Caliber 14 Fr/ 16 Fr equiv. 18 Fr 14 Fr / 16 Fr 18 Fr / 19 Fr 18 Fr
16 Διακαθετηριακή αντικατάσταση αορτικής βαλβίδας στην κλινική πράξη. Έφτασε στην κορυφή ή είμαστε έτοιμοι για το επόμενο βήμα? Σε Χαμηλού κινδύνου ασθενείς
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18 LOW-RISK TRIAL
19 In hospital procedure-related Outcome* TAVR (n=200) SAVR (n=719) p-value Difference (95% CI) Length of stay post-procedure, days 2.0± ±3.9 < (-4.95 : -3.85) VARC 2 life-threatening or major bleeding 5/200 (2.5) 74/719 (10.3) < (-0.13 : ) VARC 2 major vascular complications 5/200 (2.5) Acute kidney injury 0/200 (0) All-cause death 0/200 (0) 5/719 (0.7) (-0.02 : 0.01) Stroke 0/200 (0) 4/719 (0.6) (-0.02 : 0.01) MI 0/200 (0) Endocarditis 0/200 (0) New-onset atrial fibrillation 6/200 (3.0) 293/719 (40.8) < (-0.46 :-0.30) New PPM implantation 10/200 (5.0) 32/719 (4.5) * Unadjusted 0.5 (-0.04: 0.05) Coronary artery obstruction 1/200 (0.5)
20 30 days Outcome TAVR (n=200) SAVR (n=686) p- value All-cause death 0/200 (0) 12/686 (1.7) p= VARC 2 life-threatening or major bleeding 6/200 (3.0) Disabling Stroke 0/200 (0) Non Disabling stroke 1/200(0.5) Composite of death and stroke 0/200 (0) All Cause Death: Zero at 30 days Endocarditis 0/200 (0) New-onset atrial fibrillation 9/200 (4.5) Disabling stroke: Zero at 30 days New PPM implantation 13/200 (6.5) Acute kidney injury 0/200 (0) Difference (95% CI) -0.7 (-0.02 : 0.01) at 30 days 6 SAVR patients were still in the hospital of these, 1 died on post-operative day 51 and the remaining 5 were eventually discharged alive * Unadjusted
21 MODERATE AS AND CLINICAL HEART FAILURE THE TRANSCATHETER AORTIC VALVE REPLACEMENT TO UNLOAD THE LEFT VENTRICLE IN PATIENTS WITH ADVANCED HEART FAILURE STUDY (TAVR- UNLOAD; NCT ) WILL COMPARE CLINICAL OUTCOMES AMONG SYMPTOMATIC PATIENTS (NEW YORK HEART ASSOCIATION CLASS 2) IN HEART FAILURE (LEFT VENTRICULAR EJECTION FRACTION %) AND MODERATE AS UNDERGOING TAVI WITH THE SAPIEN 3 VALVE VERSUS OPTIMISED HEART FAILURE THERAPY.
22 IT HAS BEEN SUGGESTED THAT AN OPTIMAL TAVI CENTRE SHOULD BE ABLE TO ACHIEVE THE FOLLOWING OUTCOMES IN HIGH-RISK PATIENTS WITH SEVERE AS IN THE FUTURE: 1) ALL-CAUSE MORTALITY OF APPROXIMATELY 2 3 % AT 30 DAYS AND <10 % AT 1 YEAR; 2) SIGNIFICANT STROKES AT 30 DAYS IN <2 %; 3) MAJOR VASCULAR COMPLICATIONS IN <5 %; 4) NEW PERMANENT PACEMAKERS IN <10 % 5) MODERATE OR SEVERE PARAVALVULAR AORTIC REGURGITATION IN <5 %
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26 Popma, et. Al. EVOLUT R BICUSPID TVT REGISTRY Outcome, No. (%)* Bicuspid (N=191) Tricusp id P (N=65 26) All-cause mortality 4 (2.2) 199 (3.2) 0.49 Stroke 5 (2.6) 220 (3.4) 0.59 Myocardial infarction 0 (0) 22 (0.4) 0.43 Life threatening/major 16 (8.6) 461 (7.2) 0.45 bleeding Major vascular complication 1 (0.5) 102 (1.6) 0.25 Permanent pacemaker 23 (12.6) 1136 (17.8) 0.06 New requirement for dialysis 0 (0) 54 (0.9) 0.21 Aortic valve re-intervention 3 (1.8) 15 (0.2) <0.01
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28 SIMPLIFICATION OF PROCEDURE REDUCES TAVI COSTS R EYNOLDS MR ET AL. J A M C OLL C ARDIOL 2012;60: B ABALIAROS V ET AL. J A M C OLL C ARDIOL I NTV 2014;7: Total index hospitalization cost (TF TAVR) $74,721 $61,297 $45,485 PARTNER 1A TA cohort PARTNER 1A TF cohort Emory optimized approach Length of stay (TF TAVR) 10 days 7 days 3.0 days
29 FUTURE TAVI WILL NOT BE CURTAILED BY RISK STRATIFICATION BUT RATHER WILL BE INFLUENCED MORE BY ANATOMIC CLINICAL FACTORS AND PROBABLY PATIENT PREFERENCE FINANCIAL ISSUES
30 ΑΝΕΠΑΡΚΕΙΑ ΜΙΤΡΟΕΙΔΟΥΣ MITRA CLIP
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36 THE COAPT TRIAL Cardiovascular Outcomes Assessment of the MitraClip PercutaneousTherapy for Heart Failure Patients with Functional Mitral Regurgitation A parallel-controlled, open-label, multicenter trial in ~610 patients with heart failure and moderate-to-severe (3+) or severe (4+) secondary MR who remained symptomatic despite maximally-tolerated GDMT Randomize 1:1* MitraClip + GDMT N=305 GDMT alone N=305 *Stratified by cardiomyopathy etiology (ischemic vs. non-ischemic) and site
37 PRIMARY ENDPOINTS Primary effectiveness endpoint: All HF hospitalizations through 24 months* Powered for superiority of the Device group compared with the Control group Primary safety endpoint: Freedom at 12 mos from device-related complications: - Single leaflet device attachment - Device embolization - Endocarditis requiring surgery - Echo core laboratory-confirmed mitral stenosis requiring surgery - Left ventricular assist device implant - Heart transplant -Any device-related complication requiring non-elective cardiovascular surgery Powered for superiority of the Device group vs. a pre-specified OPG** *Analyzed when the last subject completes 12 months of follow-up; **Objective performancegoal
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39 HF parameters MitraClip + GDMT (N=302) GDMT alone (N=312) Echo core lab MitraClip + GDMT (N=302) GDMT alone (N=312) Etiology of HF MR severity - Ischemic 60.9% 60.6% - Mod-to-sev (3+) 49.0% 55.3% - Non-ischemic 39.1% 39.4% - Severe (4+) 51.0% 44.7% NYHA class EROA, cm ± ± I 0.3% 0% LVESD, cm 5.3 ± ± II 42.7% 35.4% LVEDD, cm 6.2 ± ± III 51.0% 54.0% LVESV, ml ± ± IV 6.0% 10.6% LVEDV, ml ± ± 72.9 HF hosp w/i 1 year 58.3% 56.1% LVEF, % 31.3 ± ± 9.6 Prior CRT 38.1% 34.9% - 40% 82.2% 82.0% Prior defibrillator 30.1% 32.4% RVSP, mmhg 44.0 ± ± 14.0
40 Cumulative HF Hospitalizations (n) All Hospitalizations for HF within 24 months MitraClip + GDMT GDMT alone 283 in 151 pts in 92 pts HR (95% CI] = 0.53 [ ] P<0.001 No. at Risk: Time After Randomization (Months) Median [25%, 75%]FU = 19.1 [11.9, 24.0] mos MitraCl ip GDMT
41 Freedom from Device-related Complications within 12 months 100% 96.6%* MitraClip procedure attempted N=293 90% 80% 70% 60% 50% 94.8% [95% LCL] 88% OPC P<0.001 Device-related complications 9 (3.4%) - Single leaflet device attachment 2 (0.7%) - Device embolization 1 (0.3%) - Endocarditis requiring surgery 0 (0.0%) - Mitral stenosis requiring surgery 0 (0.0%) - Left ventricular assist device 3 (1.2%) implant - Heart transplant 2 (0.8%) - Any device-related complication requiring non-elective CV surgery 1 (0.3%) *KM estimate; **Calculated from Z test with Greenwood s method of estimated variance against a pre-specified objective performance goal of 88%
42 All-cause Mortality (%) ALL-CAUSE MORTALITY 100% 80% 60% 40% MitraClip + GDMT GDMT alone NNT (24 mo) = 5.9 [95% CI 3.9, 11.7] HR [95% CI] = 0.62 [ ] P< % 20% 29.1% 0% No. at Risk: Time After Randomization (Months) MitraClip GDMT GDMT alone
43 All-cause Mortality or HF Hospitalization (%) DEATH OR HF HOSPITALIZATION 100% 80% MitraClip + GDMT GDMT alone HR [95% CI] = 0.57 [ ] P< % 60% 45.7% 40% 20% NNT (24 mo) = 4.5 [95% CI 3.3, 7.2] No. at Risk: 0% Time After Randomization (Months) MitraClip GDMT GDMT alone
44 24-MONTH EVENT RATES (II) MitraClip + GDMT (n=302) GDMT alone (n=312) HR [95% CI] P-value MV intervention or surgery* 4.0% 9.0% 0.61 [0.27, 1.36] MitraClip 3.7% 6.6% 0.99 [0.38, 2.58] Mitral valve surgery 0.4% 2.5% 0.14 [0.02, 1.17] 0.07 PCI or CABG 2.8% 4.3% 0.62 [0.24, 1.60] 0.32 Stroke 4.4% 5.1% 0.96 [0.42, 2.22] 0.93 Myocardial infarction 4.7% 6.5% 0.82 [0.38, 1.78] 0.62 New CRT implant 2.9% 3.3% 0.85 [0.31, 2.34] 0.75 LVAD or heart transplant 4.4% 9.5% 0.37 [0.17, 0.81] LVAD 3.0% 7.1% 0.34 [0.13, 0.87] Heart transplant 1.4% 3.6% 0.35 [0.09, 1.32] 0.12 *Unplanned. Kaplan-Meier time-to-first event rates
45 LVEDV (ml) LVEDV change from BL to 12 mo ( LSM SE) CHANGE IN LVEDV FROM BASELINE TO 12 MONTHS 215 GDMT alone MitraClip + GDMT Adjusted change* ± ± P< ± ± ± ± n= n=174 n=174 n=175 Baseline 12 Months -10 *Ancova
![Death or HF Hospitalization (%) Death or HF Hospitalization (%) MITRA-FR COAPT 100% 90% MitraClip + MT MT alone 100% 90% MitraClip + GDMT GDMT alone 80% 70% 60% 50% 40% 30% 20% 10% 0% OR [95% CI]= 1.](/docs-images/88/115478206/images/46-2.jpg "16 [0.73 1.84] P=0.53 54.6% 51.3% 80% 70% 60% 50% 40% 30% 20% 10% HR [95% CI]= 0.63 [0.49 0.82] P<0.001 46.5% 33.9% 0% No.")
46 Death or HF Hospitalization (%) Death or HF Hospitalization (%) MITRA-FR COAPT 100% 90% MitraClip + MT MT alone 100% 90% MitraClip + GDMT GDMT alone 80% 70% 60% 50% 40% 30% 20% 10% 0% OR [95% CI]= 1.16 [ ] P= % 51.3% 80% 70% 60% 50% 40% 30% 20% 10% HR [95% CI]= 0.63 [ ] P< % 33.9% 0% No. at Risk: Control Group Device Group Months No. at Risk: Control Group Device Group Months Obadia JF et al. NEJM Aug 27. doi: /NEJMoa Stone GW et al. NEJM Sept 23.
47 COAPT VS. MITRA-FR: MR, LV VOLUMES AND FUNCTION COAPT (n=614) MITRA-FR (n=304) EROA, mm 2 (mean ± SD) 41 ± ± 10 - <30 mm 2 14% (80/591) 52% (157/301) mm 2 46% (270/591) 32% (95/301) - >40 mm 2 41% (241/591) 16% (49/301) LVEF, % (mean ± SD) 31 ± 9 33 ± 7 LVEDV, ml/m 2 (mean ± SD) 101 ± ± 35 Obadia JF et al. NEJM Aug 27. doi: /NEJMoa ; Stone GW et al. NEJM Sept 23.
48 COAPT VS. MITRA-FR: MITRACLIP OUTCOMES COAPT (n=302) MITRA-FR (n=152) MitraClip attempted 293 (97.0%) 144 (94.7%) 1 Clip implanted 287 (95.0%) 138 (90.8%) Procedural complications 25/293 (8.5%) 21/144 (14.6%) - Device implant failure 6 (2.0%) 6 (4.2%) - Transfusion or vasc compl requiring surgery 16 (5.5%) 5 (3.5%) - ASD 2 (0.7%) 4 (2.8%) - Cardiogenic shock 1 (0.3%) 4 (2.8%) - Cardiac embolism/stroke 1 (0.3%) 2 (1.4%) - Tamponade 1 (0.3%) 2 (1.5%) - Urgent cardiac surgery 1 (0.3%) 0 (0%) Acute result: MR 3+ 5% 9% 12-month result: MR 3+ 5% 17% Stone GW et al. NEJM Sept 23; Obadia JF et al. NEJM Aug 27. doi: /NEJMoa
49 Transapical off-pump mitral valve repair with neochordae implantation (TOP-MINI), also know as NeoChord procedure, is a novel transcatheter procedure to treat patient suffering severe symptomatic degenerative MR
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53 TRANSCATHETER MITRAL VALVE REPLACEMENT
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