TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE (PPVI)

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1 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE (PPVI) BASIL D. THANOPOULOS MD, PhD Director Interventional Cardiology of CHD Euroclinic ATHENS - GREECE

2 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Surgical implantation of valved aortic homografts or heterografts is the initial procedure of choice for patients with tetralogy of Fallot and severe pulmonary stenosis or atresia. This surgical procedure can be performed with low mortality and rate of complications in experienced centers, but valved conduits have limited lifespan, less than 10 years. As a result, the majority of patients with right ventricular outflow tract conduits will undergo multiple re-operations with increased complexity and surgical risk as a result of conduit stenosis and/or insufficiency, particularly, if the initial surgery was performed early in life. Conduit failure worldwide

3 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE RATIONALE Help to reduce the total number of surgeries over the patient s lifetime by postponing time to surgery while restoring pulmonic function Option to intervene earlier, providing better outcomes for patients while avoiding surgical complications

4 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Available pulmonary valves Melody valve Edwards Sapien THV

5 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Melody transcatheter pulmonary valve

6 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE The percutaneous implantation of pulmonary valve in patients with dysfunctioning RV to pulmonary artery conduits is considered to be the most exciting advancement in interventional pediatric cardiology the last 5 years. BONHOEFER ET AL Year-old boy with stenosis and insufficiency of a RV-PA conduit

7 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE CONDUIT FAILURE (Stenosis + insufficiency) Progressive RV dilation can lead to eventual heart failure Enlarged RV can be arrhythmogenic-af RV dysfunction can ultimately lead to LV dysfunction RV failure can lead to early mortality Timely intervention can save RV function and regress dilatation

8 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE INDICATIONS A. Patients with stenotic and/or regurgitant prosthetic right ventricular outflow tract (RVOT) conduits with a clinical indication for invasive or surgical intervention. 1. Doppler gr 40 mm Hg 2. Moderate to Severe PR 3. RVEDV ml/m² 4.RV Fractional area 40% B. Existence of a full RVOT conduit 16 mm/ 22 mm when originally implanted.

9 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE RESULTS (Melody valve implanters: MS Vienna 2015) * 1000 pts-fu (694:1Y FU) RVOT obstruction: 40% PR: 20% Mixed: 30% *= 8000 Pts

10 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE RESULTS (Melody valve implanters: MSR Vienna 2015) * No significant residual gradient PR: p 0.01 (+-++/ 72 months) RVEDV + RVESV Exercise capacity

11 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE COMPLICATIONS (Melody valve implanters: MSR Vienna 2015) Early: 1 pt Mortality Late: 6 pts Homograft rupture: 3 pts Dislodgment of the stented valve: 2 pts Stent fracture: 8-20%-<5% Bacterial endocarditis: 5% (2.4% AR) Coronary compression: 2 pts (4.7-6%) Rare P.Edema PA injury

12 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Stent fracture: 8-20%

13 Early: 1 pt Mortality Late: 4 pts

14 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE PPVI Versus SI/R AEPC 2011

15 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE 25 patients Dysfunctioning aortic homograph: 19 pts (Stenotic regurgitant) Native RVOT: 2 pt Gore-tex conduit: 1pt RVOT patch: 1 pt Magna Ease valve : 1 pt Hancock conduit: 1 pt Age 8-31 years

16 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Surgical history TOF + PA: 16 pts TOF + APV: 2 pts TGA + PS: 3 pts Ross procedure: 4 pts Previous surgical conduit replacements 2-3 : 8 pts

17 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE RVOT obstruction: 14 pts Mixed (PR): 9 pts PR : 2 pts Hemodynamic data PGr: mm Hg PR: Dysfunctioning RV 12 pts: (EF<50%)

18 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

19 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

20 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Greek experience

21 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Native RVOT-TGA

22 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

23 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

24 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

25 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

26 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

27 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

28 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

29 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE EDWARDS SAPIEN VALVE

30 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE HANCOCK VALVE CONDUIT

31 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Results PGr: 0 25 mm Hg PR: 0 (23 pts) Trivial (2pts) Complications Prestent embolization: 2 pts

32 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Complications

33 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE FOLLOW-UP Clinical examination Chest x-ray ECG Holter monitoring 2-D + Doppler echocardiography Cardiac MRI (MSCT)

34 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

35 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE STENT EXPANSION

36 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE 22-24F DS 26 mm 23 mm

37 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE EDWARDS SAPIEN VALVE Success: 31/36 (86%) Dgr=15-20 mmhg No significant PR GLOBAL EXPERIENCE:36 PTS Kenny et al (JACC 2011) Results Follow-up: 6 m No valve failure (1 pt) No stent fractures Complications: Embolization: 3 pts VF: 2 pts

38 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE EDWARDS SAPIEN VALVE Comparative outcome of the Edwards-Sapien and Melody valve Faza et al (CCI 2013) Melody valve (13 pts) Men RSG =11.2 mm Hg Stent migration - ES valve 20 pts) Men RSG =11.2 mm Hg Stent migration 1 pt No deaths

39 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Medronic native outflow tract device

40 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE

41 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Venous-P Valve

42 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Melody transcatheter pulmonary valve CONCLUSIONS I Transcatheter replacement of pulmonary valve using the Medronic pulmonary valve implant is a safe and effective alternative to open heart surgery for the treatment of selected patients with dysfunctioning valve conduits. Close collaboration between Congenital Cardiac Surgery and Cardiology teams are key to longterm success!!

43 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE CONCLUSIONS II RV to PA conduits are currently a great first step to pulmonary blood-flow repair. The Melody in its current design is not intended to replace the surgically placed conduit but is instead intended to extend the life of that conduit and reduce the number of operations over the total lifetime of patients. Further research is required to improve the implantation techniques and outcome of percutaneous pulmonary valve replacement therapy and to extend it to all patients with a clinical indication to delay or avoid open heart surgery.

44 TRANSCATHETER REPLACEMENT OF THE TRICUSPID VALVE CONCLUSIONS II Transcatheter tricuspid valve in valve implantation using the Medronic pulmonary valve or the Edwards Sapien valve implants is a new techique that can be used as an effective alternative to surgical valve replacemt in selective high risk patients with disfunctioning biological tricuspid valves.however, further studies are required to document its efficasy, safety and long-term results in a larger patient population.

45 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE RESULTS (Melody valve-bonhoeffer: PICS 2008)

46 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE

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48 TRANSCATHETER TRICUSPID VALVE IN VALVE IMPLANTATION Godart et al TTVI : A multicenter French study Archives of Cardiovascular Disease 2014 Complications Embolization Endocarditis CAVB Valve failure Death

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51 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE EDWARDS SAPIEN VALVE Cobalt stent 20F DS?

52 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE COMPLICATIONS (Melody valve-bonhoeffer: PICS 2008) RPA obstruction: 1pt CA compression: 1pt Guide wire perforation: 1pt

53 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Stent fractures=7% Endocarditis=3% Conduit tears=5%

54 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE

55 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Future

56 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Melody valve

57 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Gore-Tex conduit; 1pt

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59 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE PATIENT POPULATION Pulmonary stenosis TOF + PA Truncus arteriosus TOF physiology TGA DORV Conduit failure worldwide

60 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE The lifetime for the Melody device is 2 years.

61 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE PRE-CATHETER ASSESMENT History ECG Holter monitoring Echocardiography 2/3 D + Doppler Cine MRI Flow studies

62 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE IMPLANTATION TECHIQUE Diagnostic cardiac cath Femoral venous approach BIB catheter 22 F delivery sheath

63 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE IMPLANTATION TECHIQUE Balloon inflation in the RVOT (exclude CA compression) Prestenting Redilation (HPB) Residual gradient Pulmonary valve-in-valve implantation (Residual stenosis-stent fracture)

64 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE POST-PROCEDURAL EVALUATION Hemodynamic evaluation Biplane cineangiography 2-D + Doppler echocardiography

65 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

66 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE Gore-Tex conduit; 1pt

67 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

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69 EDWARDS SAPIEN VALVE Implantation technique Previously placement of stent For accurate positioning Retroflex I delivery system

70 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE

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73 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Melody transcatheter pulmonary valve 18mm Contegra modifiedbovine jugular vein with valve segment Mounted on a NuMed Platinum Iridium Stent 28 mm length, Crimped down to 6mm-reexpanded 18mm up to 22mm

74 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE Ensemble TM Delivery System Marker Sheath Covered Sheath-Hemostasis Valve Hemostasis Adaptor Access Site Stopcock Marker Sheath Uncovered Inner Balloon Hub Outer Balloon Hub Guidewire Port Balloon size Indicator Tip Sheath Balloons (currently covered by the sheath) Catheter Shaft

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76 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE GREEK EXPERIENCE 22 patients Dysfunctioning aortic homograph: 17 pts (Stenotic regurgitant) Native RVOT: 3 pt Gore-Tex conduit: 1pt RVOT patch : 1pt Age: 8 31 years Weight: Kg

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78 TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE CONTANDICATIONS 1.Venous anatomy unable to accommodate 22 F introducer sheath 2. Implantation in the left heart 3. Unfavorable RVOT for good stent anchorage Large/Severely stenotic 4. Active infection/endocarditis 5. Pregnancy? 6. Allergy to aspirin or heparin