Percutaneous aortic valve replacement should NOT be preferred therapy for aortic stenosis

Transcription

1 Percutaneous aortic valve replacement should NOT be preferred therapy for aortic stenosis James Bartholomew McClurken, MD FACC, FCCP, FACS, FESC Professor & Vice-Chair of Surgery, Temple University Hosp., Philadelphia, PA, USA

2 DECLARATION OF CONFLICT OF INTEREST none

3

4 - from a thought in 1989 Edwards TAVItalk, January 2011

5

6

7 December 17, 1903

8 Pg 31 of 36

9

10 Outcomes TAVI v BAV

11

12

13 Press Conference Transcatheter Aortic Valve Implantation in Inoperable Patients with Severe Aortic Stenosis Martin B. Leon, MD on behalf of the PARTNER Investigators TCT 2010; Washington, DC; September 23, 2010

14 Paravalvular Regurgitation: TAVI No changes over time 30 Day 6 Month 1 Year None/Trace Mild Moderate Severe

15

16 Noninferiority for death from any cause at 1 year

17 Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis: Results From The PARTNER Trial Craig R. Smith, MD on behalf of The PARTNER Trial Investigators ACC 2011 New Orleans April 3, 2011

18 Patients, % Paravalvular Aortic Regurgitation P < P < P < Days 6 Months None Trace Mild Moderate Severe 1 Year

19 Conclusions (1) The primary endpoint of the trial was met: In patients with aortic stenosis at high risk for operation, TAVR was non-inferior to AVR for all-cause mortality at 1 year (24.2% vs. 26.8%, p=0.001 for non inferiority) Transfemoral TAVR subgroup was also non-inferior to AVR (p=0.002 for non-inferiority) Death at 30 days was lower than expected in both arms of the trial: TAVR mortality (3.4%) was the lowest reported in any series, despite an early generation device and limited previous operator experience AVR mortality (6.5%) was lower than the expected operative mortality (11.8%)

20 Conclusions (3) Symptom improvement (NYHA class and 6-min walk distance) favored TAVR at 30 days and was similar to AVR at one year Echo findings indicate: Small hemodynamic benefit with TAVR vs. AVR at 1 year (mean gradient p=0.008, AVA p=0.002) Increased para-valvular regurgitation associated with TAVR (p<0.001) Preliminary subgroup analyses should be interpreted cautiously: Possible TAVR benefit in women and patients without prior CABG

21

22

23

24

25 . All a matter of perspective Hans Holbein The Ambassadors De Artificiali Perspectiva, or Anamorphosis. Brothers Quay ombresblanches@wordpress.com

26 Things are not always what they seem contrailscience.com

27 FDA Review of Sapien system

28 FDA concerns about Cohort B standard therapy arm Pg 13 of 36

29 adjunctive adjudication?? Pg 14 of 36

30

31 FDA reported MACCE Pg 19 of 36

32 Success rate; no MACCE < 30d Pg 28 of 36

33 Access issues longer term? pg 24 of 36

34 Total AR central and paravalvular Pg 25 of 36

35 Flip side of question: in whom should this NOT be considered? Pg 29 of 36

36 the bottom line: Pg 32 of 36

37 What about good old fashioned surgery? Samuel D. Gross ( ), age 70 T. Eakins 1875

38

39 Minimally invasive AVR Mini upper partial sternotomy Right parasternal or intercostal CTSNet.org BL Frazier, et al, Eur J Cardiothorac Surg 1998;14:S122-S125

40 or some newer surgical options Courtesy of Dr. Hargrove

41 Peter Bent Brigham, L. Cohn series min AVR pts > : 249 consecutive mini AVR pts > 80 96% followup, extended up to 12 yrs. Median modified EuroSCORE 11% Median STS PROM 10.5% Operative mortality - 3% CVA 4% 1, 5, 10 yr survival: 93%, 77%, 56%

42 Age 80-95; 84 Mod EuroScore /STS PROM; 11%/10.5% N = 249 Op Mortal: 3%

43

44 Difficulty in accurate predictive op mortality scoring

45

46 What patients were excluded? Serious malignancy Significant mental issues End stage renal disease Personal communication with Lawrence H. Cohn, M.D. 2 August 2011

47 Problems with current surgical/tavi risk assessment EuroScore overestimates risk in higher risk pts STS underestimates risk in higher risk pts Liver dysfunction not accounted for Frailty and dementia not assessed in either Morbid obesity? Predictor for discharge to home rather than Nursing Home/ECF Aortopathy?

48

49

50

51 Primary isolated aortic valve surgery in octogenarians E Ferrari*, P Tozzi, M Hurni, P Ruchat, F Stumpe, L K. von Segesser 124 consecutive isolated AVR s Mean age 82 (80-90) EuroScore predicted: 12.6% +/- 5.7% Observed hospital mortality: 5.6% Mean LOS 15d Complications: Neurologic events (all transient): 2% Hemodialysis (all short term): 2% Reop for bleeding: 5% AF: 48% Eur J Cardiothorac Surg 2010;38: doi: /j.ejcts

52 the dreaded porcelain aorta in a reoperative patient

53 Transformational therapy for AS patients with high surgical risks Parallel, substantial improvement in survival for surgical AVR, including complex older patients Both for traditional and minimally invasive Declining LOS for surgical patients Improving TAVI technology, global experience: Lessons learned about evaluation, access, sizing Stroke reduction strategies, technologies

54 Position Paper on TAVI ACC/STS: Simultaneous JACC, ATS publications

55

56

57 TAVI obstacles Paravalvular leaks Neurologic events Access Durability Applicability for BAV, AR, multivalve, CAD? Non-dialysis renal insufficiency Just because we can do this, should we?

58 Appropriate Use: not yet to AUC. Data accumulating In a vote of 9-0-1, the committee said the "benefits of the Edwards SAPIEN Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication outweigh the risks of the Edwards SAPIEN Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication." The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee 27 July 2011

59 from David Holmes, ACC President: Perhaps all the TAVR debates should be framed such that the surgeon takes the viewpoint that TAVR should always be the default position, and the interventional cardiologist takes the viewpoint that traditional surgery is always the default position. David With permission, 15 August 2011