State of the Art and Future perspective
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1 State of the Art and Future perspective Giuseppe Tarantini, MD, PhD, FESC Associate professor University of Padua Director Interventional Cardiology Dpt of Cardiac Thoracic and Vascular Sciences, Padua
2 Clinical case # 1 83 years old male Severe aortic stenosis No comorbidity STS score 1.6%!!! How to treat!!
3 Clinical case # 2 68 years old male Severe aortic stenosis comorbidity STS score 9 How to treat!!
4 TAVI - EVOLUTIONs Commitment to Evidence - Based Med. The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications Tarantini G, Nai Fovino L, Gersh B, European Heart Journal 2017
5 TAVI - EVOLUTIONs Commitment to Evidence - Based Med. The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications Tarantini G, Nai Fovino L, Gersh B, European Heart Journal 2017
6 2014 AHA/ACC Valvular Heart disease Guidelines Nishimura et al JACC 2014 I I
7 New market I I I I I I I I I Pre-existing market (SAVR) I I I I I I 2017 AHA/ACC Focused Update Nishimura et al JACC (2 days before SURTAVI)
8 The TAVR Path through Risk Categories Isolated AVR STS Database (n=141,905) 6.2% STS > 8 Pre-existing h market New market Thourani, Ann Thor Surg 2015
9 The PARTNER 2A Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team Operable (STS 4%) 5.8 Randomized Patients n = 2032 Yes ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical (TA) / TransAortic (Tao) 1:1 Randomization (n = 1550) 1:1 Randomization (n = 482) TF TAVR (n = 775) VS. Surgical AVR (n = 775) TA/TAo TAVR (n = 236) VS. Surgical AVR (n = 246) Leon M, et al. NEJM 2016 I EP: All-Cause Mortality or Disabling Stroke at 2 Years
10 All-Cause Mortality or Disabling Stroke (%) I EP (ITT): All-Cause Mortality or Disabling Stroke Surgery TAVR HR [95% CI] = 0.89 [0.73, 1.09] p (log rank) = % 16.4% 14.5% 21.1% 19.3% 0 6.1% Number at risk: Months from Procedure Surgery TAVR Leon M, et al. NEJM 2016
![All-Cause Mortality or Disabling Stroke (%) I EP (ITT) - TF All-Cause Mortality or Disabling Stroke 1 50 1 40 TF Surgery TF TAVR HR: 0.79 [95% CI: 0.62, 1.00] p (log rank) = 0.05 30 20 15.9% 20.](/docs-images/93/114027097/images/11-1.jpg "4% 10 7.7% 12.3% 16.8% 0 4.9% Number at risk: 0 3 6 9 12 15 18 21 24 Months from Procedure TF Surgery 775 643 628 604 595 577 569 557 538 TF TAVR 775 718 709 685 663 652 644 634 612 Leon M, et al.")
11 All-Cause Mortality or Disabling Stroke (%) I EP (ITT) - TF All-Cause Mortality or Disabling Stroke TF Surgery TF TAVR HR: 0.79 [95% CI: 0.62, 1.00] p (log rank) = % 20.4% % 12.3% 16.8% 0 4.9% Number at risk: Months from Procedure TF Surgery TF TAVR Leon M, et al. NEJM 2016
12 Large registry # 1 -P2S3i (1078 pts) Mortality and Stroke: S3i At 30 Days (As Treated Patients) All-Cause Mortality Cardiovascular All Stroke Stroke Disabling Age 82 STS (STS 5.3%) 1,1 0,9 S3i % % ,6 1.0 S3i
13 Propensity SCORE 1-year results Sapien 3 Intermediate Risk Registry AGE 82, STS 5.2 N=1077 Surgical AVR arm Partner 2A trial AGE 82, STS 5.4 N=944 SAPIEN 3 TAVR SAVR Cardiac death 4.5% 8.1% Any stroke 4.6% 8.2%
14 FUNCTIONAL STATUS - TF COHORT 100% P<0.001 P = 0.04 P = % 60% 40% Dead Worse No change Slightly improved Moderately improved Substantially improved 20% 0% TAVR SAVR 1 month TAVR SAVR 1 year TAVR SAVR 2 years *P-values from ordinal logistic regression
15 FUNCTIONAL STATUS - TT COHORT 100% P = NS P = NS P = NS 80% 60% 40% Dead Worse No change Slightly improved Moderately improved Substantially improved 20% 0% TAVR SAVR 1 month TAVR SAVR 1 year TAVR SAVR 2 years *P-values from ordinal logistic regression
16 Large registry # 2 European SOURCE XT PLUS SOURCE 3 Propensity Adjusted 30-day Outcomes 1947 pts S3 vs 2688 pts XT Age 82 STS 7 G Tarantini TCT 2016
17 Background before MARCH 2017 I I I 2017 (2 days before SURTAVI) 2017 AHA/ACC Focused Update Nishimura et al JACC 2017
18 SURTAVI Trial Study Design Symptomatic Severe Aortic Stenosis Intermediate Surgical Risk STS PROM 3% and <15% Heart Team Evaluation Assess inclusion/exclusion Risk classification Randomization n=1,746 Stratified by need for revascularization Screening Committee Confirmed eligibility Baseline neurological assessments TAVR N=864 age 79.9 mean STS 4.4% TAVR only TAVR + PCI SAVR N=796 age 79.6 mean STS 4.5% SAVR only SAVR + CABG I EP: All-Cause Death or Disabling Stroke at 2 Years (non-inferiority) Reardon M, ACC 2017
19 All-Cause Mortality or Disabling Stroke All-Cause Mortality or Disabling Stroke 30% 25% 20% 24 Months TAVR SAVR 12.6% 14.0% Difference (95% CI) 1.4% ( 5.2%, 2.3%) 15% 10% 5% No. at Risk SAVR TAVR 0% Months Post-Procedure Reardon M, ACC 2017
20 30-Day Safety and Procedure-related Complications SAVR TAVR Stroke Shock Acute renal failure (stg 2-3) > 2 U blood transfusions Major vascular complications PM implantation 5.6 % 3.4% 3.8% 1.1% 4.4% 1.7% 29.8% 9.2% 1.1% 6.0% 6.6% 25.9% Reardon M, ACC 2017
21 Total Aortic Regurgitation (core lab adjudication) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 3% 36% 1% 7% 5% 34% 61% 93% 61% 90% 60% 90% TAVR (N=832) SAVR (N=707) TAVR (N=599) 1% 9% SAVR (N=506) 5% 35% TAVR (N=299) Discharge 12 Months 24 Months 1% 9% SAVR (N=244) Severe Moderate Mild None/trace Reardon M, ACC 2017
22 LOWER RISK SAVR vs. TAVR Meta-analysis of 5 studies pts - STS 4.7 Outcome of interest: All-cause mortality+disabling stroke TARANTINI G ET AL. EHJ 2017 REGISTRIES OR (95% CI) OBSERVANT 1.10 ( ) SAPIEN 3iR 0.69 ( ) RCT NOTION PARTNER 2 SURTAVI TARANTINI 0.61 ( ) 0.90 ( ) 0.91 ( ) COMBINED 0.87 ( ) P= Favors TAVR Favors SAVR
23 2014 I I 2017 I I I (2 days before SURTAVI) 20XX I SURTAVI - PARTNER 3 NOTION 2 EVOLUT PRO Nishimura et al JACC
24 PLATO
25 Insights
26
27 30-day mortality 30-day mortality Discrimination vs. Calibration The best predictive score should have both good discrimination and calibration 13,9 14,4 13,6 11,9 SAVR TARANTINI G ET AL. EHJ ,5 5,4 5,5 6,4 1,7 1,7 1,6 1,7 STS >8 ( ) STS >8 ( ) STS 4-8 ( ) STS 4-8 ( ) STS <4 ( ) STS <4 ( ) TAVR 11,2 10,3 8,4 11,8 5 5,2 5,8 5,2 3,9 1,1 4,4 2,2 2,9 2,1 3,1 2,8 PARTNER 1B CoreValve ER EXTREME-HIGH (>8%) PARTNER 1A PARTNER 2 S3IR SURTAVI INTERMEDIATE (4-8%) NOTION LOW (<4%) STACCATO
28 30-day mortality 30-day mortality INTERACTION BETWEEN RISK AND AGE SAVR ,9 14,4 13,6 11,9 5,5 5,4 5,5 6,4 65 AGE (years) 1,7 1,7 1,6 1,7 STS >8 ( ) STS >8 ( ) STS 4-8 ( ) STS 4-8 ( ) STS <4 ( ) STS <4 ( ) ,2 11,8 10,3 8,4 TAVR AGE (years) 5 5,2 5,8 5,2 3,9 1,1 4,4 2,2 2,9 2,1 3,1 2,8 PARTNER 1B CoreValve ER EXTREME-HIGH (>8%) PARTNER 1A PARTNER 2 S3IR SURTAVI INTERMEDIATE (4-8%) NOTION LOW (<4%) STACCATO
29 SOURCE 3 Registry Risk analysis
30 STS score % PURE VALVE Registry TAVR pts Mean Age 0
31 From US-TVT registry TAVR pts Holmes JACC to % of TAVR pts were 80 years, In 2014 median STS was 6.7% and 95% deemed at extreme or high risk Benjamin E et al, Circulation 2017
32 Observed 30-day MORTALITY after TAVI 10 % 5 80 y 0 5,1 3,9 3,4 3,3 2,1 2,2 2,2 1,1 NOTION SURTAVI P2A S3IR P1A (All) S3HR CoreValve HR P2B P1B Below 80 years At large NOT EXPLORED LOW (<4%) INTERMEDIATE (4-10%) HIGH (10-15%) EXTREME (>15%)
33 ON-GOING LOW-RISK TRIALS PARTNER 3 Evolut R Low Risk NOTION 2 Trial ID NCT NCT NCT N of patients Design Non-inferiority Non-inferiority Non-inferiority Low Risk def STS <4% STS <3% STS <4% THV in TAVR arm SAPIEN 3 Evolut R or Corevalve Any THV Follow-up Up to 10 years Up to 5 years Up to 5 years
34 Severe aortic stenosis: age distribution Severe aortic stenosis in patients undergoing AVR n=932 pts BICUSPID VALVES TRICUSPID VALVES 7% 39% 93% 54% <70 years years >80 years 24% 31% 76% 45% <70 years years >80 years Roberts W, Circulation 2005
35 DURABILITY (PARTNER 1-5 years) AV mean gradient 5 years Hemodynamic Outliers Late change: 9.2 to 10.3mmHg 2404 TAVR patients AV mean gradient 20 mmhg N=10 (0.45%) Any mean gradient 40 mmhg N=11 (0.46%) Any DVI 0.25 N=44 (1.8%) Douglas et al, TCT 2016
36 PUREVALVE registry Single-center, prospective, Padua registry consecutive TAVR pts (N=171) Follow-up 5 yrs Edwards Sapien N=84 CoveValve N=87 Mean age 81 yrs STS 7.5% - Logistic EuroScore 18% TF approach 68%
37 Clinical outcomes Mortality CV mortality Hemodynamic performance LATE PROSTHESIS FAILURE 2.4% Tarantini G e t al. Ann Cardiothor Surg 2017
38 Heart Team CLASS I LoE C
39 The HEART TEAM A DEAL WITH THE DEVIL? Cardiac Surgeon Interventional cardiologist
40 MULTI-DISCIPLINARY HEART TEAM Collaboration across specialties is critical Hospital Administrator Heart Failure Specialist Cardiac Surgery Interventional Cardiology Echo Cardiology Anesthesiology Nursing / Cath-Lab Staff Collaboration Required for: Patient Referral Optimal Patient Selection Plan Therapy & Resources Echo Guidance & Communication Post Procedure Care Optimal Patient Care
41 Clinical characteristics favoring TAVI: STS/EuroSCORE II 4% (logistic EuroSCORE I 10%) Presence of severe co-morbidity (not adequately reflected by scores) Age 75 years Previous cardiac surgery Frailty Restricted mobility and conditions that may affect the rehabilitation process after the procedure Anatomical and technical aspects favoring TAVI: Favourable access for TF TAVI Sequelae of chest radiation Porcelain aorta Presence of intact CABG at risk when sternotomy is performed Expected patient-prosthesis mismatch Severe chest deformation or scoliosis
42 Clinical case # 1 83 years old male Severe aortic stenosis No comorbidity STS score 1.6%!!! THIS PATIENT WILL GO FOR TAVI IN MOST INSTITUTIONS!!
43 Clinical case # 2 68 years old male Severe aortic stenosis comorbidity STS score 9 THIS PATIENT WILL GO FOR AVR IN MOST INSTITUTIONS in 2017!!
44 TAVI - EVOLUTIONs Commitment to Evidence - Based Med. The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications Tarantini G, Nai Fovino L, Gersh B, European Heart Journal 2017
45 TAVI - EVOLUTIONs Commitment to Evidence - Based Med. The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications Tarantini G, Nai Fovino L, Gersh B, European Heart Journal 2017
46 TAVI Systems Global Inventory (#25) Sapien 3 Evolute R Lotus Symetis Portico Jena Valve Centera STANDARD Shangai Valve Trinity Colibri Inovare Thubrikar Valve Medical Syntheon Verso Triskele BioValve MyVal HLT NVT J Valve Xeltis Zurich TEHV OF CARE
47 EVOLUTION of Balloon-Expandable THVs VALVE SHEATH SIZE
48 TAVI ACCESSORY DEVICES LARGE BORE VASCULAR SHEATHS LARGE HOLE VASCULAR CLOSURE REDUCTION OF VASCULAR COMPLICATIONS FROM 15% TO <5%
49 TAVI ACCESSORY DEVICES NOVEL VALVULOPLASTY DEVICES NEW MATERIALS INCREASED STABILITY NO NEED FOR PM
50 TAVI ACCESSORY DEVICES NEUROEMBOLIC PROTECTION Claret sentinel Triguard
51 My thoughts on EVOLUTION: Commitment to Evidence-Based Medicine The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications
52 TAVI PROCEDURE ROOM YESTERDAY TODAY
53 My thoughts on EVOLUTION: Commitment to Evidence - Based Medicine The multi-disciplinary Heart Team Rapid Technology Enhancement Simplification of the Procedure Striking Reduction in Complications
54 TAVI VS SAVR: META-ANALYSIS OF 4 RANDOMIZED TRIALS SIONTIS ET AL. EUR HEART J 2016 Death from any cause Access Route HR (95% CI) p Transfemoral 0.87 ( ) Transthoracic 0.61 ( ) Favours TAVI Favours SAVR
55 WHICH THERAPY DO YOU THINK IS BETTER? SAVR BETTER VASCULAR COMPLICATIONS PARAVALVULAR LEAKAGE PACEMAKER TAVI BETTER MORTALITY STROKES AKI BLEEDING NEW AFIB VALVE AREA 30-DAY QOL 30-DAY 6MWT HOSPITAL STAY
56 EXPECTATIONS
57 EXPECTATIONS IMPROVED DISEASE AWARENESS AND ACCESS TO TAVR EXPLOSIVE GROWTH IN TAVI WORLDWIDE ACCELERATED INNOVATION OF TAVR PLATFORMS RE-DEFINING DISEASE STATE AND TIMING/TRIGGER POINTS FOR THERAPY REALIZATION OF NEW CLINICAL INDICATIONS Tarantini G, Nai Fovino L, Gersh B, European Heart Journal 2017
58 IMPROVED AWARNESS 2015 SEVERE SYMPTOMATIC AS PATIENTS IN THE U.S. O SAVR o TAVR o UNTREATED Nkomo 2006, Ilvanainen 1996, Pellikka 2005, Thourani 2015
59 TAVI GROWTH Global TAVI Units X4 growth in 10 years
60 NEW TRIGGER POINTS AORTIC STENOSIS REDEFINED: FUNCTIONAL CLASSIFICATION Mild AS Moderate AS Symptoms - Moderate AS Symptoms + Severe AS Symptoms - Severe AS Symptoms + TAVI UNLOAD EARLY TAVI PARTNERS LOW / INT / HIGH RISK ACTIVE SURVEILLANCE TAVI TAVR
61 Final thoughts on TAVI Survival of the Fittest
62 COMING SOON!!! 68 years old male Severe aortic stenosis comorbidity STS score 9 THIS PATIENT WILL GO FOR TAVI IN MOST INSTITUTIONS!!
63 Thank You Merci Danke Bedankt Grazie Shukran Děkuji Ευχαριστώ תודה Dziękuję Ci Obrigado Gracias Tack Köszönöm
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