Complicanze durante TAVI. Brambilla Nedy IRCCS Policlinico San Donato
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1 Complicanze durante TAVI Brambilla Nedy IRCCS Policlinico San Donato
2 Number of Deaths One-half of all Mortality Occurs Within 30 Days % of All Mortality Days of follow-up Tamburino et al, Circulation 2011; 123:
3 Periprocedural Risk factors for increased mortality at 1 year Tamburino et al, Circulation 2011; 123:
4 What drives costs of TAVR? PARTNER A + B Valve $30,960 Complications $11,324 Everything Else $35,998 Implications Complications account for 24% of non-implant related costs substantial opportunity for savings Even greater opportunity for savings from maximizing efficiency of care for uncomplicated admissions (8 day LOS in PARTNER) Arnold SV et al. Circ Cardiovasc Interv 2014;7:829-36
5 Big Five Access site complications Stroke Coronary occlusion Residual aortic regurgitation Cardiac rhythm disturbances
6 Learning Curve Major Vascular Complications
7 ACC 2016 Relationship between procedure Volume and outcome for TAVR in US
8 Puncture and Sheath management
9 Iliac Bleeding
10 Percutaneous closure device failure 478 pts undergoing percutaneous S-XT implantation RESULTS Closure failure in 8% SFAR (sheath-to-fem-artery ratio) only multivariate predictor of closure failure (OR 5.40 per 1 increase, p=0.022, 95%CI ) No difference in 1 year survival between groups Nara et al, Am J Cardiol 2017;119:
11 14FR Equivalent System Sheath esheath ~22 FR (OD) 18FR CoreValve w/ 18FR Cook Sheath ~4 FR Reduction 14FR equiv. system (18FR OD) 18FR CoreValve Evolut R w/ InLine Sheath
12 Label size vs True sheath OD Manufacturer Device Valve Size Label Sheath Size True sheath OD Edwards Sapien 3 Medtronic Boston Scientific Boston Scientific Abbott Evolut R Lotus Symetis Portico 20, 23, 26 mm 14 F esheath 23 F 29 mm 16 F esheath 24.5 F 23, 26, 29 mm 14 F 18 F 34 mm 16 F 20 F 23 mm LIS - Small 22 F 25, 27 mm LIL - Large 24 F S, M, L NA 22 F 23, 25 mm 18 F 20.3 F 27, 29 mm 19 F 21.3 F
13 Edwards e-sheath
14 Iliac Perforation
15 Iliac Prosthesis
16 Cross-over balloon inflation
17 Challenging cross-over
18 Radial protection Superficial Femoral protection
19 Stroke Incidence = 2.8 % (adjusted HR 19.62) 95% CI , p=0.014) Italian Registry Ussia et al EHJ 2012
20 Disabling Stroke Disabling Stroke 10% 8% 6% TAVR 24 Months SAVR 95% CI for Difference 2.6% 4.5% -4.0, 0.1 4% 2% No. at Risk SAVR TAVR 0% Months Post-Procedure SURTAVI TRIAL ACC 2017
21 Over 53,000 US TAVR patients No significant decline in stroke rate over time Holmes D, et al. ACC 2016
22
23 CLEAN-TAVI shows Claret filters significantly reduce lesion number and volume Lesion Number per Patient Total Lesion Volume per Patient (n = 43) (n = 45) (n = 43) (n = 45) Claret Montage Cerebral Protection System significantly reduces new cerebral lesion number and volume at 7 days, as measured by DW-MRI
24 Embolic protection reduces stroke and mortality after TAVI 280 protected vs 522 unprotected pts with Claret Sentinel undergoing TAVI Non randomized data, propensity matched, 1 week neurologic follow up RESULTS 91.8 % positioning success rate Stroke rate lower in protected pts (1.4% vs 4.6%, p=0.03, OR 0.29, 95%CI ) Combined stroke and death end point less frequent in protected patients (2.1% vs 6.8%, p=0.01%, OR 0.30, 95%CI ) Seeger et al, JACC Cardiov Int 2017; 17:313-4
25 Stroke Prevention: Leaflet Calcium
26 Stroke Prevention: LV thrombus
27 TriGuard HDH during TAVI Navigation
28 Stroke Prevention: LV thrombus
29
30 Coronary protection for high risk occlusion cases
31 Final angio
32 AR paravalvular leak
33 Sizing and CT scan evaluation is crucial SAGITTAL DIAMETER MAX, MIN & MEAN AXIAL DIAMETERS CORONAL DIAMETER
34 Severe AR : Low implant Supraskirtal regurgitation
35 New Gen Transfemoral Valves Medtronic Evolut PRO Edwards Sapien 3 Abbott Portico Boston Symetis Boston Lotus
36 % Patients with Mod/Severe PVL 1 Month Moderate & Severe PVL TAVI Clinical Trials , , ,2 11,5 9, ,0 3,4 1,7 0,6 SAPIEN XT PARTNER II, Inop 1 SAPIEN PARTNER II Inop 1 CoreValve ADVANCE 2 CoreValve Extreme Risk 3 CoreValve High Risk 4 Portico CE Study 5 SAPIEN Direct 3 6 Flow DISCOVER 7 LOTUS REPRISE II & EXT 8 N=236 N=225 N=639 N=418 N=390 N=75 N=150 N=100 N=250 1 Leon M, ACC 2013, 2 Linke A, PCR Popma J, JACC 2014; 63(19): , 4 Adams D, N Engl J Med 2014; 370: Manoharan, et al. TCT Webb J, EuroPCR Schofer, JACC Ian Meredith, London Valves Results from different studies not directly comparable. Information provided for educational purpose only
37 LV free wall perforation
38 Emergent cardiac surgery during Transfemoral TAVI 212 emergency surgeries during TAVI at 79 centers (2013->2016) RESULTS Stable risk of 0.70% after 2014 LV perforation (28.3%) and anular rupture (21.2%) leading causes Procedural mortality after emergent surgery 34.6% Predictors of procedural mortality: age>85, anular rupture and immediate surgery 1 year survival rate of 114 pts discharged alive only 40.4% Eggrebecht et al, Eur Heart J 2017; in press
39 Pseudoaneurisma della continuità mitroaortica post TAVI
40 Pseudoaneurisma della continuità mitroaortica post TAVI
41 Pseudoaneurisma della continuità mitroaortica post TAVI Esclusione con device muscular VSD
42 be ready for everything because small mistakes may lead to big disasters!
43
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