ESC Congress 2010 28 Aug 2010-01 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
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
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
Implant Step by Step I step II step III step
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
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.
Results From May 2007 thorough January 2010 a total of 110 patients underwent TAVI Early implant failure occurred in 18 patients (16.3%)
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±5 0.722 Female gender, n (%) 60 (56.4) 52 (56.5) 11 (61.1) 0.720 Diabetes, n (%) 30 (27.1) 26 (28.3) 4 (22.2) 0.418 Peripheral vascular disease, n (%) 10 (9.2) 8 (8.7) 2 (11.2) 0.513 Porcelain aorta 20 (18.5) 19 (19.8) 1 (7.1) 0.113 Congestive heart failure*, n (%) 52 (47.2) 48 (52.2) 4 (22.2) 0.020 Previous myocardial infarction, n (%) 27 (24.0) 25 (27.2) 2 (11.1) 0.122 Prior stroke, n (%) 8 (6.4) 7 (7.6) 1 (5.6) 0.612 Prior TIA, n (%) 8 (6.4) 7 (7.6) 1 (5.6) 0.612 Previous CABG, n (%) 12 (11.1) 11 (12.0) 1 (5.6) 0.378 Previous PCI, n (%) 34 (30.5) 29 (31.5) 5 (27.8) 0.753 COPD, n (%) 25 (23.1) 22 (23.9) 3 (16.7) 0.372 CRF, n (%) 30 (27.7) 26 (28.3) 4 (22.2) 0.418 Prior aortic valvuloplasty, n (%) 58 (52.8) 47 (51.1) 11 (61.1) 0.462 Logistic EuroSCORE, mean ± SD, % 26.7±13.9 27.2±14.4 26.0±10.5 0.751 STS Score, mean ± SD, % 8.2±4 8.3±4 7.8±3 0.615
Results Causes of Early implant Failure 22,2% 22,2% 44,4% prosthesis underexpansion high implantation low implantation valve migration 5,5%
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
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
Valve underexpansion Incomplete Apposition G.P. Ussia
Asymmetric Expansion LAO projection Correct expansion LAO-Cr RAO-Cr
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
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
Results Prosthesis jump
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 (1.44 0.6 vs. 1.50 0.6; P ¼ 0.750)
Results Echo Outcomes 80 2,5 60 57,54 1,55 1,6 1,6 1,7 55,0 1,28 1,51 1,61 1,54 2 1,5 40 1 20 0,62 0,44 0,5 0 12,1 11,9 12,5 11,58 14,1 10,25 12 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
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
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