L evoluzione nel management della valvulopatia aortica

Transcription

1 L evoluzione nel management della valvulopatia aortica Giuseppe Tarantini, MD, PhD, FESC Director of Interventional Cardiology University of Padua GISE president

2 TAVI: BIG BANG 2002

3 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, et al al EHJ 2017 Aug 24.

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, et al al EHJ 2017 Aug 24.

5 2014 I IIa IIb III I IIa IIb III 2017 I IIa IIb III I IIa IIb III I IIa IIb III (2 days before SURTAVI) Nishimura et al JACC

6 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

7 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

8 2014 I IIa IIb III I IIa IIb III 2017 I IIa IIb III I IIa IIb III I IIa IIb III (2 days before SURTAVI) I IIa IIb III 20XX SURTAVI - PARTNER 3 NOTION 2 EVOLUT PRO Nishimura et al JACC

9 The TAVR Path through Risk Categories Isolated AVR STS Database (n=141,905) 6.2% STS > 8 Pre-existing market h New market Thourani, Ann Thor Surg 2015

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11 30-day mortality 30-day mortality INTERACTION BETWEEN RISK AND AGE SAVR AGE (years) STS >8 ( ) STS >8 ( ) STS 4-8 ( )STS 4-8 ( ) STS <4 ( ) STS <4 ( ) TAVR AGE (years) PARTNER 1B CoreValve ER EXTREME-HIGH (>8%) PARTNER 1A PARTNER 2 S3IR SURTAVI INTERMEDIATE (4-8%) NOTION LOW (<4%) STACCATO

12 SOURCE 3 Registry Risk analysis Tarantini G et al. PCR 2017

13 STS score % PURE VALVE Registry TAVR pts Mean Age 0

14 Heart Team CLASS I LoE C

15 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

16 Euro S3 registry 1785 pts Tarantini G et al. submitted

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18 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

19 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

20 TAVI ACCESSORY DEVICES LARGE BORE VASCULAR SHEATHS LARGE HOLE VASCULAR CLOSURE REDUCTION OF VASCULAR COMPLICATIONS FROM 15% TO <5%

21 TAVI ACCESSORY DEVICES NOVEL VALVULOPLASTY DEVICES NEW MATERIALS INCREASED STABILITY NO NEED FOR PM

22 TAVI ACCESSORY DEVICES NEUROEMBOLIC PROTECTION Claret sentinel Triguard

23 TAVI PROCEDURE ROOM YESTERDAY TODAY

24 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

25 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

26 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%

27 Clinical outcomes Mortality CV mortality Hemodynamic performance LATE PROSTHESIS FAILURE 2.4% Tarantini G e t al. Ann Cardiothor Surg 2017

28 Editorial the next TAVI challenge Taking two birds (durability and lower risk) with one stone (younger patients): G. Tarantini Ann Cardiothorac Surg. 2017

29 EXPECTATIONS

30 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

31 TAVI GROWTH Global TAVI Units X4 growth in 10 years

32 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

33 Final thoughts on TAVI Survival of the Fittest

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35 Thank You Merci Danke Bedankt Grazie Shukran Děkuji Ευχαριστώ תודה Dziękuję Ci Obrigado Gracias Tack Köszönöm