Transcatheter PV replacement: initial experience using selfexpandable
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1 Transcatheter PV replacement: initial experience using selfexpandable valves. Alejandro Peirone MD, FSCAI Private and Children`s Hospital of Córdoba, Argentina. October 13th; Buenos Aires.
2 Lecture title: Transcatheter PV replacement: initial experience using self-expandable valves. The following relationships exist related to this presentation: None
3 PV replacement Background Percutaneous PVR is a recognized alternative to repeated surgery after development of - significant PR - RV dilation - and / or RV dysfunction. The overall safety and effectiveness of the interventional procedure has compared favourably with surgical repair. Nevertheless, limitations for PVR using the current valves available exist mainly due to - large RVOT - native outflow tracts.
4 PV replacement RVOT anomalies 20.1% of all CHD pts) Tetralogy of Fallot Truncus Arteriosus d-tga Others With PS With PA RV PA Conduit RV PA Conduit RV PA Conduit RV PA Conduit Surgical correction of RVOT (non-conduit) Virtually all pts will require future procedure(s) to replace the conduit or the PV ~85% of dysfunctional RVOT pts ~15% of dysfunctional RVOT pts
5 PV replacement Medtronic Melody Pulmonary Valve 18 mm Contegra modified-bovine jugular vein with valve segment CP Platinum Iridium Numed stent 34 mm in lenght Catheter BIB (balloon in balloon): 18 mm, 20 mm and 22 mm. Ensemble 22F delivery system
6 PV replacement Medtronic Melody Pulmonary Valve Heavily calcified 17 mm aortic homograft After prestenting with 2 bare metal stents and TPV implant on a 20-mm delivery system
7 PV replacement Sapien and Sapien XT Transcatheter valves Trileaflet bovine pericardial tissue. PET fabric skirt F delivery sheath. Balloon-expandable cobalt chromium stent design Sapien Valve: 23 and 26 mm. Used with Retroflex I or III delivery system Sapien XT Valve: 23, 26 and 29 mm. Used on the NovaFlex delivery system
8 PV replacement Sapien and Sapien XT Transcatheter valves Dysfunctional (regurgitant) 29-mm Hancock II bioprosthesis Pre-stenting with a bare 10 ZIG CP stent Implantation of a 26-mm Sapien valve Courtesy Dr. Lee Benson
9 PV replacement New challenges Large RVOT with trans-annular patch
10 PV replacement History Developed by Dr. Qi-Ling Cao & Venus MedTech Team. First in-man implantation: female pt in 2011 in Hanoi. Vietnam Heart Institute. First pt in China: 14 yo girl in 2013 in Shanghai. Shanghai Zhongshan Hospital. Trial in China started in 2013 and 45 pts. Experince in LATAM: Universidad Católica de Chile 3 pts Hospital Privado de Córdoba 2 pts
11 Venus P-valve Venus P-Valve: Self-expandable Nitinol multi-level support frame. Tri-leaflet porcine pericardial tissue. Preserved in low-concentration solutions of buffered gluteraldehyde Fr catheter delivery system. The entire stent is covered (except the distal cells) by hand-sewn porcine pericardial tissue.
12 Venus P-valve The valve: Flared uncovered distal end secures anchoring at PA bifurcation with radiopaque markers. Flared covered proximal end allowing conformability with the dilated RVOT with two ears. Stent valve diameters range from 20 to 34 mm (in 2 mm increments) with each diameter available in 20, 30 and 35 mm straight sections lengths.
13 The valve: Venus P-valve
14 The valve: Venus P-valve
15 Venus P-valve The valve: Valve crimper The crimper is a non-patient contacting compression device. Symmetrically reduces the diameter/profile of the valve when loaded inside the catheter.
16 Venus P-valve The valve: Delivery system The delivery system consists of a Fr capsule and a 16 Fr 100 cm long shaft, with a rotating handle for deployment of the valve with a slow (white arrow) and fast valve (red arrow) deployment
17 Venus P-valve Animal lab experience
18 Venus P-valve Animal lab experience
19 Venus P-valve Animal lab experience
20 Venus P-valve Animal lab experience
21 Venus P-valve Animal lab experience Distal PA trunk position Proximal RVOT position
22 Venus P-Valve Selection criteria for Venus P-Valve:
23 Venus P-Valve Selection criteria: TT echocardiography is very important!!
24 Venus P-valve Selection criteria: RVOT MRI
25 Venus P-Valve The procedure: Balloon sizing LCA angiography
26 Venus P-valve The procedure: Position and initial deployment
27 The procedure: Venus P-valve
28 Venus P-valve The procedure: Initial angiogram (RAO 45 ) Final angiogram. Valve in situ
29 The procedure: Venus P-valve
30 Venus P-Valve Published data: Catheterization and Cardiovascular Interventions 2014; 84: pts Median age 33 years Mean body weight 54.8 kg
31 Venus P-Valve Published data: Cardiology in the Young 2016; 26: pts Median age 18.5 years Mean body weight 53.8 kg
32 Venus P-valve Published data: EuroIntervention 2016; 12: e pts Median age 14 years Mean body weight 88.8 kg
33 Venus P-valve Delivery system malfunction: Aborted case. Breaking of the capsule Worakan Promphan data. TCTAP 2016
34 Venus P-valve Delivery system malfunction: Piercing of the stent strut out of the capsule while uncovering the sheath Worakan Promphan data. TCTAP 2016
35 Venus P-valve Delivery system and valve modifications: Med Tech team data.
36 Venus P-valve Valve complication: RPA oclusion Prior RPA stenosis occluded by Venus P-valve needing stenting (Max LD 26 mm in lenght on a 15 x 30 mm Crystal balloon) Evelina London Children s Hospital Courtesy Dr. Shak Qureshi
37 Venus P-valve Suitability for Venus P-valve implantation
38 Venus P-valve Fluroscopy follow-up: Single wire fracture 4 cases 3 months) w/o hemodynamic consequences Worakan Promphan data. TCTAP 2016
39 Venus P-Valve Worldwide experience: 38 pts As of September 2016 Córdoba, Argentina 2 Hospital Privado Universitario Dr. A. Peirone
40 Venus P-Valve LATAM experience: 5 pts March to September pts (4 females) Mean age 17 years (13-25) weight 61.6 kgs (49-80) height 1.57 mts ( ) NYHA functional class II (all pts) PR Severe (all pts) Echocardiography Annulus 23.5 mm (19-26) RVOT 40.2 mm (34-43) MRI RVEDV index ml/m2 ( ) PR fraction 46.4 % (29-58) RV ejection fraction 47 % (42-53) Successful implantation All pts Fluoroscopy time 26.6 min ( )
41 Venus P-Valve LATAM experience: 5 pts Implanted valve diameters 26 (1), 28 (1), 30 (2) & 32 mm (1) lengths 30 (4) & 25 mm (1) No pt had a significant RVOT gradient or PR after the procedure Mean LOS 3 days (1-5) Complications: 2 pts had low-grade fever after implant. 1 pt had VT requiring electrical CV 1 pt w/ stent strut fracture on fluoroscopy w/ normal valve function F/U 3.4 months (1-5) PR is grade 0 in all pts Doppler PSG in RVOT 15.8 mm Hg (14-19)
42 Venus P-Valve The future Straight variation of the Venus P-Valve Courtesy Dr. S. Qureshi
43 PV replacement Lessons learned: Practical algorithm Dysfunctional RVOT RV-PA conduit or Bioprosthesis Transannular patch or native tracts mm Conduit/Bioprosthesis mm Conduit /Bioprostheis mm PV annulus Melody Pulmonary Valve Sapien and Sapien XT Pulmonary Valve Venus-P Valve
44 Venus P-Valve Conclusions: The Venus P-Valve can be implanted successfully and effectively in pts with severe PR and a large RVOT after transannular patch surgery. The valve restores early, sustained pulmonary competence with RV remodeling and improvement in clinical symptoms. Early results with this valve are encouraging. More extensive clinical trials are in progress and will likely provide more robust longer-term data on the valve functionality and durability.
45 Venus P-Valve Acknowledgments Gracias!
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