Incidence and Management of Early Implant Failure after Transcatheter Aortic Valve Implantation

Transcription

1 ESC Congress Aug Sep 2010 Stockholm - Sweden Incidence and Management of Early Implant Failure after Transcatheter Aortic Valve Implantation Gian Paolo Ussia, MD Director of Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Ferrarotto Hospital - University of Catania Italy

2 Background The main technical impediment in the current generation of TAVI devices is the inability to suitably reposition the implant in case of sub-optimal deployment This important limitation is being addressed in newer devices with the potential for recovery and repositioning Till these improved devices are available, operators have to manage early implant failure due to misplacement, underexpansion or migration of device with percutaneous techniques to ensure an optimal procedural and patient outcome and avoid the need for surgical bailout

3 CoreValve Revalving System Specifically designed for transcatheter delivery Single layer porcine pericardium Tri-leaflet configuration Tissue valve sutured to frame Standard tissue fixation techniques 200M cycle AWT testing completed Supra-annular valve function Intra-annular implantation and sealing skirt

4 Implant Step by Step I step II step III step

5 Device failure was defined as delivery system malfunction, prosthesis rupture or malfunctioning and intraprosthetic valve regurgitation. Procedural success was defined as device deployment with fall of transaortic peak-to-peak gradient, without any peri-procedural MACCE within 24 hr of prosthesis implantation. MACCEs were defined as the composite of death from any cause, myocardial infarction, stroke, urgent or emergency conversion to surgery, emergency percutaneous coronary intervention or major bleeding. Methods Endpoints & Definitions

6 Methods Endpoints & Definitions Early implant failure was identified as the presence of one or more of the following: 1. sub-optimal positioning too high or too low >8 mm with respect to the aortic annulus) resulting in more than 2+ peri-valvular leak 2. prosthesis under-expansion resulting in peri-valvular leak with hemodynamic instability; 3. intraprocedural prosthesis embolization.

7 Results From May 2007 thorough January 2010 a total of 110 patients underwent TAVI Early implant failure occurred in 18 patients (16.3%)

8 Results Baseline characteristics Overall (n = 110) Group 1 (n = 92) Group 2 (n = 18) Group1/Group 2 P value Age, mean ± SD, y 81±5 81±5 81± Female gender, n (%) 60 (56.4) 52 (56.5) 11 (61.1) Diabetes, n (%) 30 (27.1) 26 (28.3) 4 (22.2) Peripheral vascular disease, n (%) 10 (9.2) 8 (8.7) 2 (11.2) Porcelain aorta 20 (18.5) 19 (19.8) 1 (7.1) Congestive heart failure*, n (%) 52 (47.2) 48 (52.2) 4 (22.2) Previous myocardial infarction, n (%) 27 (24.0) 25 (27.2) 2 (11.1) Prior stroke, n (%) 8 (6.4) 7 (7.6) 1 (5.6) Prior TIA, n (%) 8 (6.4) 7 (7.6) 1 (5.6) Previous CABG, n (%) 12 (11.1) 11 (12.0) 1 (5.6) Previous PCI, n (%) 34 (30.5) 29 (31.5) 5 (27.8) COPD, n (%) 25 (23.1) 22 (23.9) 3 (16.7) CRF, n (%) 30 (27.7) 26 (28.3) 4 (22.2) Prior aortic valvuloplasty, n (%) 58 (52.8) 47 (51.1) 11 (61.1) Logistic EuroSCORE, mean ± SD, % 26.7± ± ± STS Score, mean ± SD, % 8.2±4 8.3±4 7.8±

9 Results Causes of Early implant Failure 22,2% 22,2% 44,4% prosthesis underexpansion high implantation low implantation valve migration 5,5%

10 Results Management of Early implant Failure 20% 18,2% 16% 14,5% 12% 8% 4% 5,5% 1,8% 1,8% 9,1% 3,6% 3,6% 3,6% 3,6% 0% First half Second half n=55 n=55 Two prosthesis implantation Post-implant dilatation prosthesis jump Snaring Total

11 Significant Paravalvular leaks judged by angio, hemodynamics and echocardiogram Asymmetric expansion of the valve in two orthogonal views (LAO-Cr & RAO-Ca) Rapid RV pacing Results Underexpansion 25 mm balloon for 26-mm CRS /28 mm balloon for 29-mm CRS Peri-valvular leak decreased in all patients No intraprosthetic regurgitation No damage of aortic root or other cardiac structures

12 Valve underexpansion Incomplete Apposition G.P. Ussia

13 Asymmetric Expansion LAO projection Correct expansion LAO-Cr RAO-Cr

14 Results Valve-in-Valve higher positioning of a 29 mm CRS new 29 mm CRS was introduced and positioned across the first prosthesis with the aid of a loop catheter No damage of aortic root or other cardiac structures

15 Results Snaring Technique snaring one of the two hooks of the prosthesis Pull the valve very slowly in a pull&wait manner Use the aortic diastolic pressure as maker of efficacy of the maneuver

16 Results Prosthesis jump

17 Results Clinical Outcomes Overall in-hospital and 30-day mortality were 9.8% and 12.0% respectively (cardiac death 1.2% and 3.4%, respectively) Among patients with successfully managed early implant failure, no in-hospital and 30-day death and MACCE were observed Cumulative 12-month MACCE rate was 5.6% In the study group MACCE occurred cumulatively in two patients; all other patients were alive and asymptomatic and did not experience any MACCE at follow up At 12-month mean NYHA class was similar in the two groups ( vs ; P ¼ 0.750)

18 Results Echo Outcomes 80 2, ,54 1,55 1,6 1,6 1,7 55,0 1,28 1,51 1,61 1,54 2 1, ,62 0,44 0,5 0 12,1 11,9 12,5 11,58 14,1 10, ,1 Pre Discharge 30-days 6-months 12-months Pre Discharge 30-days 6-months 12-months n=92 n=84 n=79 n=65 n=43 n=18 n=18 n=18 n=12 n=8 0 mmhg cmq

19 Conclusions TAVI with CRS can rarely be complicated by early implant failure Bailout percutaneous techniques are successful in most cases to manage these complications in safe and effective manner with no need of conversion to open-heart surgery Specific training and skills are mandatory The pts treated with bailout maneuvres had good early and mid-term clinical and echo outcomes

20 Thank you The Ferrarotto s heart valve team (Dir. Prof. Corrado Tamburino): Marco Barbanti, MD Massimiliano Mulè, MD Marilena Scarabelli, MD Mount Etna Valeria Cammalleri, MD Sebastiano Immè, MD Davide Capodanno, MD Patrizia Aruta, MD Anna Maria Pistritto, MD