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NOTION TRIAL

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TAVR VS SAVR IN LOW-RISK AORTIC STENOSIS PATIENTS
MEDTRONIC CORE VALVE
EUROPEAN STUDY
5 YEAR FOLLOW UP RESULTS

Publié dans : Formation
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NOTION TRIAL

  1. 1. Thyregod HGH.
  2. 2. Dr.Alain Cribier April 16th 2002 A 57-year-old patient with severe AS presented in cardiogenic shock with major left ventricular dysfunction (the ejection fraction was 12%!)
  3. 3. TAVR = SAVR TAVR = SAVR TAVR = SAVR  Futile
  4. 4. STS PROM SCORE Logistic EURO SCORE Very high risk >15% High Risk >8% -15% >20% Intermediate Risk 4-8% 10-20% Low risk <4% <10% Logistic EuroSCORE II • Better than EuroSCORE I, (overestimates risk) • well compared with the STS risk score. • more flexibility than the STS score for complex procedures and to be considered for the same.
  5. 5. TAVI2-SCORe Parameter HR Value Old Age 1.68 1 Male sex 1.81 1 Recent MI 3.78 2 Anemia 2.03 1 LV dysfunction 1.98 1 Critical aortic stenosis 2.46 1 Renal dysfunction 1.76 1 Porcelain Thoracic aorta 2.56 1 0,1 2.6 Survival rate is 88% at 1 year 2 3.6 3 10.5 54% >4 17.6 Am J Cardiol 2015 Jan 15;115(2):234-42. Epub 2014 Oct 29. Cannot be generalised Cannot be applicable to low risk patients with low comorbidities
  6. 6. TRIALEVIDENCE
  7. 7. PARTNER 1A PARTNER 1B Results: TAVR was superior to Medical management in inoperable patients, TAVR was non inferior to SAVR in High risk patients.Consistent at 5 years also.
  8. 8. PARTNER 2A Conclusion: TAVR using SAPIEN XT and SAVR were similar (non inferior) for primary end point at 2 years.Decreased reduction of stroke and all cause mortality in TF TAVR compared to surgery. PARTNER II S3 : Propensity score matching showed SAPIEN 3 TAVR is noninferior to SAVR at 1 year .
  9. 9. “This was a very early trial. It started 2 years after CoreValve was approved in Europe, without any resheathable system, and also at that time we really didn’t know which patients needed a pacemaker and which didn’t, so we put more pacemakers in them than we would for the same conduction abnormalities today,” Sondergaard commented. Yet despite the high pacemaker rates and PVL rates, the TAVR and SAVR patients have the same outcomes, he pointed out. “You can just imagine how that might be today, with lower pacemaker [implantation] rates, lower paravalvular leaks, and better procedural outcomes. Ten years down the line, it’s going to be very interesting to see the current low-risk studies come out.”
  10. 10. Although prognosis remains impaired compared with an age-, sex-, and origin-matched standardized population, periprocedural PPM implantation does not seem to affect clinical outcomes adversely among patients undergoing transfemoral TAVI. PARTNER 2A trial investIgators
  11. 11. CONCLUSIONS: The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up. J Am Coll Cardiol Intv 2018;11:301–10
  12. 12. G. Tarantini et al. Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? European Heart Journal (2017) 0, 1–12
  13. 13. Conclusions  NOTION (82% with STS<4%).  no differences  Prosthetic valve opening was larger and mean gradient lower for TAVR  more mild/moderate prosthetic regurgitation  New Pacemaker implantation increased 
  14. 14. Thank you ‘It was another world’….. ‘suddenly I was travelling all over the world on a weekly basis to deliver huge training sessions and supervise on-site proctoring. I was in demand for conferences and workshops as well as for writing academic papers and articles. It was a very intense and demanding period. My goal had only been to treat a small number of patients. I never envisaged that TAVI would take off in the way it has done, and move towards replacing conventional cardiac surgery so soon’ – Dr.Alain Cribier after the First TAVR. French, “ta vie” means “your life”

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