Melody Transcatheter Pulmonary Valve. Device and Patient Selection

Transcription

1 Melody Transcatheter Pulmonary Valve. Device and Patient Selection Carlos AC Pedra, MD, PhD Director, Catheterization Laboratory for CHD Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil MDT Symposium. July 25, 2013 SOLACI/SBHCI São Paulo, Brazil

2 Introduction Percutaneous Valvar Implantation Feasible in patients status-post RV-PA conduit with severe stenosis and/or pulmonary insufficiency T4F, PA + VSD, DORV, DTGA, Truncus, Ross Not new technology!!!! Bonhoeffer (9/00): First percutaneous implantation of Pulmonary Valve (before first TAVR!!!!!)

3 Functional Conduit Lifespan Conduit becomes dysfunctional Conduit replacement surgery New conduit placement

4 Actuarial Survival Curve of Free of Conduit Replacement Tweddell et al. Factors affecting longevity of homograft valves used in RVOT reconstruction for CHD Circ 2000;102:(Suppl):III-130-III-135.

5 Causes of Conduit Dysfunction HSC, n=945 operations, 726 patients HSC/TTH > 8 years of follow up Up to 31 years of age Caldarone et al, JTCVS 2000; 120(6):

6 Stenosis in the RV-PA Conduit Mechanisms of obstruction Extrinsic compression (sternon, ascending aorta) Calcification Kinking Neointimal fibrotic proliferation Stenosis in the proximal/distal anastomosis Somatic growth Balloon dilation: limited results Stent implantation: prolongs conduit life span at the expense of free pulmonary insufficiency Melody TM TPV

7 Management of Conduit Dysfunction Surgical conduit replacement Valved conduits Homografts Current Options Xenografts Transcatheter Balloon angioplasty Bare metal stent Bioprostheses

8 Consequences of Free PI Increase in RV preload with ventricular dilatation Inhomogeneous electric activation with slow conduction: pro arrhythmic RV dilatation with IVS bowing to the LV: reduction in the LV diastolic volume Exercise Intolerance Sudden death

9 Medtronic Melody TPV & Ensemble BDS Balloon-in-balloon catheter 22 Fr crossing profile Retractable sheath 3 outer balloon diameters 18 mm 20 mm 22 mm

10 Historical Perspectives 1 st Implant Paris, France (2000) Bonhoeffer Cohort ( ) CE Mark, Health Canada Approval (2006) 1 st US Implant (2007) US Cohort ( ) HDE Approval 2000 Sept Revised TPV (2003) ANVISA: February 2013 World Wide: >4000 patients, >180 centers, 35 countries

11 Patient selection: Clinical criteria Objective evidence of conduit dysfunction Clinical indication for surgical replacement

12 Echocardiography Significant RA/ RV dilation No intracardiac shunt

13 Echocardiography RV enlargement Abnormal septal curvature

14 Echocardiography Free PI in the homograft PSG 41mmHg Pulmonary annulus diameter: 20.3mm

15 MRI/MRA

16 MRA. Indications for PPVI RV ESVi > 80 ml/m2 LV ESVi < 80 ml/m2 RF > 25% RV EDVi > 150 ml/m2 RV EF < 45%

17 Patient selection: technical criteria Weight 20 kgs System profile RV-PA conduit Not appropriate for transannular patch Conduit or bioprosthetic valve > 16 mm < 22 mm Avoids malfunction/restenosis or embolization Sizing balloon 14 mm and 20 mm Compliance test: test for coronary coronary compression

18 Deployment

19 Balloon interrogation of the conduit

20 Balloon interrogation of the conduit

21 PA Angiogram Pre Implant

22 PA Angiogram Post Implant

23 3D-RTA under rapid VP. CT reconstruction

24 ICE Confirms TPV Function

25 44 y/o TOF with 22mm Hancock LAD from RCA

26 44 y/o TOF with 22mm Hancock LAD from RCA

27 Could we have predicted this?

28 Age 5 years Weight 30 kg US IDE Trial in 5 centers Conduit 16 mm Conduit dysfunction Inclusion Criteria NYHA II,III,IV - RVOT mean Doppler gradient 35 mmhg, or - Moderate or Severe PR NYHA I - RVOT mean Doppler gradient 40 mmhg, or - Severe PR with RV dilation or dysfunction McEhnney D. Circulation 2010

29 Results: Study Population 166 subject enrolled from 1/2007 1/2010 Median Age: 22 yrs [7-53 yrs] Diagnoses n=166 TOF 48% Ross 21% TGA Truncus Other 11% 10% 10% # of Subjects

30 Results: Study Population n=166 Prior surgical conduits: median 1 (1-5) More than 1 surgical conduit: n=73 (44%) NYHA I 16% II 66% III 18% IV 1% # of Subjects

31 Results: Study Population n=166 Primary implant indication: Regurgitation 53% Stenosis Mixed 20% 27% # of Subjects

32 Results: Conduits Conduit size: median 21 mm (16-28 mm) Previously stented conduits: n=37 (22%) Conduit type: n=166 Homograft 76% Bioprosthetic valve/conduit 19% Synthetic 5% # of Subjects

33 Results: Acute Procedural Catheterization n=166 Implant Attempted n=150 Implant > 24 hrs n=149 Not Attempted n=16 Explant < 24 hrs n=1 Risk of coronary compression (6) RVOT not suitable for Melody TPV implant (7) Patient parents declined after balloon dilation (1) Bilateral branch stenosis (1) Need for PA Stenting (1) Homograft rupture In Follow-up n=143 Expired n=2 Explant n=2 Lost n=2 Coronary dissection and ECMO Subjects enrolled in study from January, 2007 through January, 2010

34 100 Results: Acute hemodynamics * Mean ± SD n=150 * * Pre TPV Post TPV RV systolic pressure (mmhg) RV-PA gradient (mmhg) * P< RV:AO ratio (%)

35 mmhg F/U Results: Mean RVOT Gradient * 60 * * * D/C (n=139) 6 mo (n=129) 1 yr (n=106) 2 yrs (n=53) 3 yrs (n=17) Core lab results paired to pre-tpv Pre implant Interval F/U *p<0.001 p<0.01

36 % of Subjects Results: Pulmonary Regurgitation None Trivial Mild Moderate Severe Pre- D/C 6 1 year 2 years 3 years TPV month (n=139) (n=140) (n=134) (n=107) (n=51) (n=17)

37 Results: Improvement in NYHA 100% 15% 77% 77% 71% 89% I II % of Subjects 75% 50% 25% III IV 0% Pre-TPV 6 mo 12 mo 24 mo 36 mo (n=150) (n=141) (n=133) (n=77) (n=26)

38 Freedom from TPV Dysfunction Freedom from Events mo (n=142) 97±2% 1 yr (n=111) 94±2% 2 yrs (n=54) 86±4% Time (years)

39 F/U Results: Stent Fractures Stent fractures observed in 37 of 150 (25%) 14 of 37 (38%) of pts with stent fractures required re-implantation of a 2 nd TPV Time from observation of stent fracture to reimplantation: median 13.5 mo (range 3-30 mo)

40 Pre stenting reduces the incidence of fractures, conduit dysfunction and replacement

41 Freedom from reintervention. Learning curve Lurz P. JACC 2009

42 Limitations of the Melody TPV The Melody TPV only can treat 15% of the patients that need it (only 15% have RV PA Conduit) What about the 85% of patients with native RVOT reconstruction??? 1 st in Man Native RV Outflow Tract TPV Clinical Research Centers currently being evaluated

43 First in Man: Philip Bonhoeffer

44

45 Conclusions Melody Valve Incidence of successful implants - high (98%) Procedural adverse events - low (6%) Pulmonary valve competence is maintained Functional capacity improves (NYHA status) Device related adverse events low Stent fracture, recurrent RVOTO and re-intervention Need for surgical re-intervention rare (<1%)

46 Acknowledgements Dr John P Cheatham and Sharon H Cheatham

47 Thank you for your attention!