Downloaded 119 times
![ Safety and Efficacy Study of the Medtronic CoreValve®
System in the Treatment of Severe, Symptomatic Aortic
Stenosis in Intermediate Risk Subjects Who Need Aortic
Valve Replacement (SURTAVI).
intermediate risk [ STS score of 3-8% ]](https://image.slidesharecdn.com/trialevidence-151009160334-lva1-app6892/75/TRIAL-EVIDENCE-OF-TAVI-37-2048.jpg)
Uploaded byPraveen Nagula
TRIAL EVIDENCE OF TAVI
The document discusses various studies and registries related to the use of transcatheter aortic valve implantation (TAVI) for treating severe aortic stenosis, showcasing procedural success rates, mortality rates, and improvements in patient outcomes. Over time, different approaches, such as transfemoral and transapical techniques, have been evaluated for their safety, efficacy, and complications, with findings indicating significant benefits and ongoing clinical studies to assess long-term impacts. The evolving technology and techniques aim to optimize valve sizing and reduce complications, contributing to improved patient survival and quality of life.
More Related Content
Similar to TRIAL EVIDENCE OF TAVI
More from Praveen Nagula
TRIAL EVIDENCE OF TAVI
- 1. TRIAL EVIDENCEOF TAVI Dr.Praveen Nagula
- 4. April 16,2002first case report. From 2003 -2004, single center registeries - for feasibility. I REVIVE – Initial Registry of Endovascular Implantation of Valves in Europe RECAST – Registry of Endovascular Critical Aortic Stenosis Treatment. o 23 mm bioprosthesis o Equine pericardium mounted on a stainless steel balloon expandable stent o Antegrade (trans septal ) approach. o Procedural success – 75%. o Aortic valve area increased consistently from 0.6 cm2 to 1.6 cm2. o Fall in mean trans valvular gradient (37 mm Hg to 9 mm Hg). o Increase in LVEF (45% +18% to 53% +14%) o 30 day mortality rate was 23%. o MACCEs – 26%. o Patient survival was 63% by 6 months. o Moderate to severe perivalvular AR (63%), valve embolization were limitations of the procedure.
- 5. To reducethe degree of the perivalvular aortic insufficiency – valves were oversized in relation to the aortic annulus – 26 mm size prosthesis became available. Appropriate valve sizing – transverse diameter of the aortic annulus at the level of the aortic leaflet insertion. Retroflex catheter – atraumatic passage across the aortic arch, facilitated passage through retrograde approach. Sheath length was increased to deliver the catheter-valve ensembly directly into the descending aorta. Minimal arterial diameter, vessel tortuoisity and vessel calcification were still the major limiting factors.
- 6. REVIVAL II REVIVE Canada (Canadian Special Access) Valve area < 0.8 cm2 High predictive operative mortality >20%. New valve modifications were included. o Use of bovine pericardium o Increase of the skirt to decrease the perivalvular insufficiency. o Addition of the anticalcification treatment Webb et al – retrograde approach – 78% success – 96% after 25 cases. 30 day mortality was 12%(expected was 28%). Moderate perivalvular leaks in 3 patients at 1 month. Led to valve approval and commercialization in Europe in 2007
- 7. Most recentlydeveloped form of transcatheter AVR. First reported by Lichtenstein 7 patients with severe AS. Valve implantation was successful in all of them. No Procedural deaths. Results were consistent with that of the retrograde approach. Observed 30 day mortality was 14%(expected 35%). Walther et al – 93.2% successful implantation. Conversion rate to conventional AVR -6.8%. Trace to mild AR - 23 patients. 30 day mortality was 13.6%(26.8%) Use of extracorporeal life support was frequent(47%)
- 8. Rate of90% successful valve placements. Persistent improvement in symptoms,valve area,mean gradient,aortic insufficiency and quality of life(Qol). Survival MACCEs were seen in 65% 1 month 81.8% 3 months 71.7% 6 months 58.7% Stroke 5% Emergent cardiac surgery 2.5% Myocardial infarction 17.5% Svensson LG,Kapadia S,et al. Ann Thorac Surg 86;46-55,2008.
- 9. No. of Patients1123 Centers in Europe 32 centers Procedural success 93.8% 30 day mortality was 6.3% Mean survival was 74% NYHA class improvement was 86% at 30 days (p<0.001) Mean gradient decreased from 46.1 mm hg to 11.2 mm Hg No valve deterioration structurally. Vascular complications 8.3% transfemoral approach , hemodynamic support in 0.9%, tamponade in 4%, PPI in 4.4%, infection in 2.4%, stroke in 5.3%. AF 12%
- 10. Trans apicalapproach is associated with high mortality not because of procedure but because of increased comorbidities and age of the patient. To date, transfemoral approach is the default one and transapical is offered only to those who donot qualify for transfemoral approach. Comparison of SAVR and trans apical TAVR – similar operative mortality,similar 1 yr survival,shorter ICU stay and shorter duration of mechanical ventilation. Trans apical is complementary to trans femoral approach.
- 11. 2005-2009. 339patients(high risk) 49.6% trans femoral ,50.4% - trans apical Procedural success was 93.3%. 30day mortality was 10.4%. Mortality increased to 22% at mean follow up of 8 months – COPD,CKD, Periprocedural sepsis – independent predictors. Patients with porcelain aorta had better survival at 1 yr follow up.
- 12. 19 sitesin France. Valve area <0.6cm2. Edwards SAPIEN Core Valve Trans femoral 39% 27% Trans apical 29% Sub clavian 5% Results Death at 30 days 13% stroke 4% Vascular complications 7% Transfusions > 1 unit 21% Need for PPI High in Core Valve group Mean survival was 76.5% Mean valvular gradients were 10 mmHg NYHA Ior II 86%
- 13. Primary Safety endpoint Freedom from death from the index procedure to 30 days and 6 months. Primary efficacy end point Hemodynamic status of the valve,QoL,NYHA class improvement at 12 months after implantation. Inclusion criteria Logistic Euro SCORE >20% STS score >10% if the earlier was less than 20% Porcelain aorta or chest deformities All patients had Senile degenerative aortic stenosis (<0.8cm2,PG >40mm Hg,AJV>4m/sec) Mean patient age was 82 yrs Clinical status 84% of transfemoral ,85% of trans apical – NYHA III,IV Post procedure Mean gradient fell to 10 mm Hg,valve are increased to 1.6cm2. NYHA class improvement 60% had improved to NYHA I/II at 6 months,1yr. Survival at 18 months Transfemoral 71%,transapical 44% (not comparable )
- 14. Severe symptomaticAS patients. Cohort A – powered for noninferiority analysis o traditional AVR vs TAVI o 700 patients Cohort B – powered for superiority analysis o 358 patients o Optimal medical treatment(including BAV ) vs TAVI Cohort C – frail patients o Who die with aortic stenosis but not because of aortic stenosis.
- 19. Results of CohortA AVR TAVI P value All cause mortality 50.7% 30.7% <0.001 CV mortality 41.9% 19.6% <0.001 Repeat hospitalization 44.1% 22.3% <0.001 Death or repeat hospitalization (composite end point) 72.6% 42.5% <0.001 Follow up No degeneration No re stenosis Less HF symptoms Vascular complications 1.1% 16.2% <0.001 Major bleeding 11.2% 22.3% <0.001 Major strokes 1.1% 5.5% 0.06
- 22. N = 358Inoperable Standard Therapy n= 179 ASSESSMENT: Transfemoral Access TF TAVR n = 179 Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) 1:1 Randomization VS Symptomatic Severe Aortic Stenosis • Primary endpoint evaluated when all patients reached one year follow-up. • After primary endpoint analysis reached, patients were allowed to cross-over to TAVR. Severe Symptomatic AS with AVA< 0.8 cm2 (EOA index < 0.5 cm2/m2), and mean gradient > 40 mmHg or jet velocity > 4.0 m/s Inoperable defined as risk of death or serious irreversible morbidity of AVR as assessed by cardiologist and two surgeons exceeding 50%.
- 23. • All-Cause Mortality •Cardiac Mortality • Re-hospitalization • Stroke • NYHA functional class • Echo-derived valve areas, transvalvular gradients, and paravalvular leak. • Mortality outcomes stratified by STS score, paravalvular leak and age.
- 24. N = 358 RandomizedInoperable N = 179 TAVR N = 179 Standard Therapy 124 / 124 patients 100% followed at 1 Yr 85 / 85 patients 100% followed at 1 Yr 81 / 83 patients 97.6% followed at 3 Yrs 19 / 19 patients 100% followed at 3 Yrs 50 / 51 patients 98.0% followed at 5 Yrs* 6 / 6 patients 100% followed at 5 Yrs* Cross Over 11 pts Cross Over 9 pts 10 Patients Withdrew * ± 2 months follow-up window
- 25. Characteristic TAVR N =179 Standard Rx N = 179 p-value Age – yr 83.1 ± 8.6 83.2 ± 8.3 0.95 Male sex (%) 45.8 46.9 0.92 STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14 NYHA I or II (%) III or IV (%) 7.8 92.2 6.1 93.9 0.68 0.68 CAD (%) 67.6 74.3 0.20 COPD Any (%) O2 dependent (%) 41.3 21.2 52.5 25.7 0.04 0.38 Creatinine > 2 mg/dL (%) 5.6 9.6 0.23 Frailty (%) 18.1 28.0 0.09 Porcelain aorta (%) 19.0 11.2 0.05 Chest wall radiation (%) 8.9 8.4 1.00
- 29. • Mortality benefitwas similar in elderly (>85 yr) patients compared to those ≤85 years. • Cardiovascular mortality and all-cause mortality benefit was seen even in patients with high STS score. • Patients with O2 dependent COPD may have less mortality benefit. • Beyond early procedural risk of stroke there was no persistent risk over 5-year follow up. • Moderate and severe paravalvular leak is associated with higher cardiovascular mortality particularly in patients with less comorbidities.
- 30. • At 5years follow-up benefits of TAVR were sustained as measured by: – All-Cause Mortality – Cardiovascular Mortality – Repeat Hospitalization – Functional Status • Valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area.
- 34.
- 36. Safety andefficacy of the CoreValve Revalving System in two cohorts of patients. 1 end point - 12 month all cause mortality or major stroke. 30 day risk of mortality No. of patients First Cohort Extreme risk for surgery (sAVR) or Inoperable for sAVR >50% 487 pts Subclavian –axillary Trans aortic access 100 pts Second cohort High risk for surgery (sAVR) >15% 790 pts
- 37. Safety andEfficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). intermediate risk [ STS score of 3-8% ]
- 38. Surgical Replacementand Transcatheter Aortic Valve Implantation Multicenter randomized clinical study. Europe. Broader group of patients( intermediate risk for SAVR ) Safety and efficacy of TAVI vs SAVR Heart team approach is used.
- 40. Long termand real world impact of TAVI therapy. Prospective,observational international post market study to evaluate clinical outcomes of patients with severe AS. 1000 patients 90 sites. Followed up for atleast 5 years after the implantation. 1 end point - MACCEs at 30 days after the procedure.
- 41. Enrollment of100 patients in 7 to10 experienced CoreValve European sites Characterize implantation procedures at best european sites. Intermediate term outcomes in high risk patients. Best practice event rates. 30 day and 1 yr mortality Stroke Vascular complications AR Development of conduction disturbance requiring PPP.