Preventive Role of Embolic Protection Devices:

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Presentation transcript:

Preventive Role of Embolic Protection Devices: Silent Cerebral Injury after TAVI and the Preventive Role of Embolic Protection Devices: A Systematic Review and Meta-Analysis Matteo Pagnesi, MD; Enrico A. Martino, MD; Mauro Chiarito, MD; Antonio Mangieri, MD; Richard J. Jabbour, MD; Nicolas M. Van Mieghem, MD, PhD; Susheel K. Kodali, MD; Cosmo Godino, MD; Giovanni Landoni, MD; Antonio Colombo, MD; Azeem Latib, MD San Raffaele Scientific Institute, Milan, Italy

Potential conflicts of interest Speaker’s name: Matteo Pagnesi I do not have any potential conflict of interest

Background Overall stroke rate after TAVI: 1.5% at 24 h; 3.3% at 1 m; 4.3% at 6 m; 5.2% at 1 y (Eggebrecht et al. EuroIntervention 2014) 30-day major stroke 2.4% with 2nd generation THVs (Athappan et al. EuroIntervention 2016) 30-day all-stroke rate 5.5% in PARTNER IIA trial (Leon et al. New Eng J Med 2016) Most ischemic CVEs result from cerebral embolization of aortic debris or thrombotic material (Van Mieghem et al. Circulation 2013) Silent cerebral injury is dramatically more frequent than clinically apparent CVEs and has controversial prognostic significance EPDs may reduce the risk of early neurological injury during or after TAVI

Embolic protection devices Claret Montage and Sentinel CPS (Claret Medical, Santa Rosa, California) EMBOL-X system (Edwards Llifesciences, Irvine, California) TriGuard HDH device (Keystone Heart, Caesarea, Israel) Embrella Embolic Deflector system (Edwards Lifesciences, Irvine, California)

Aims To perform a pooled analysis of all prospective studies reporting DW-MRI outcomes after unprotected TAVI Evaluation of the incidence and features of TAVI-related silent cerebral injury To perform a meta-analysis of studies evaluating EPDs during TAVI Assessment of the efficacy of EPDs on DW-MRI endpoints

Study selection process

Pooled analysis Characteristics of the pooled studies Study Design n Approach Device Age (years) Male (%) Log EuroSCORE (%) Timing of DW- MRI (days) Kahlert et al. 2010 Prospective 32 TF 22 SAPIEN, 10 CoreValve 80.0 ± 3.0* 14 (44) 21.3 ± 9.0*† 3.5 ± 1.8*† Ghanem et al. 2010 22 CoreValve 79.3 ± 4.8 8 (37) 19.4 ± 13.5 2.2 ± 0.4 Arnold et al. 2010 25 TA SAPIEN 81.0 ± 5.0 10 (40) 32.3 ± 10.0 6.0 ± 2.0 Rodés-Cabau et al. 2011 60 29 TF, 31 TA SAPIEN/XT 83.0 ± 7.0 30 (50) 18.9 ± 12.8 4.0 ± 1.0 Astarci et al. 2011 35 21 TF, 14 TA 85.2 ± 4.4† 26 (74) 33.2 ± 16.2† 2 days Fairbairn et al. 2012 31 81.0 ± 5.9 11 (36) 23.9 ± 16.4 5.0 ± 1.5* Ghanem et al. 2013 111 16 SAPIEN, 95 CoreValve 80.0 ± 6.0 60 (54) 24.3 ± 14.7 3 days Knipp et al. 2013 27 82.2 ± 4.7 7 (26) 36.4 ± 13.2 11.7 ± 6.2 Astarci et al. 2013 44 26 TF, 18 TA 84.8 ± 5.1† 31 (71) 31.7 ± 15.3† 2-3 days 61 30 (49) 26.4 ± 18.1 3.0 ± 1.0 Alassar et al. 2015 85 64 TF, 18 TAo, 3 SC 4 SAPIEN, 81 CoreValve 81.0 ± 5.9* 46 (54) 26.7 ± 20.7* 6 days Uddin et al. 2015 71 65 TF, 5 SC, 1 CA 80.5 ± 6.3 31 (44) 18.2 ± 10.9 <7 days Samim et al. 2015 42 37 TF, 4 TA, 1 SC 26 SAPIEN XT, 16 CoreValve 81.3 ± 4.4* 25 (60) 13.2 ± 7.3* <4 days Bijuklic et al. 2015 87 19 SAPIEN XT, 68 SAPIEN 3 83.2 ± 6.1† 43 (49) 22.2 ± 15.6† 4.8 ± 2.4 Altisent et al. 2015 46 33 TF, 7 TA, 6 TAo SAPIEN XT 79.0 ± 8.1* 29 (63) 14.1 ± 9.9 6.5 ± 3.5 Fanning et al. 2015** 36 - 82.2 ± 6.6§ Leclercq et al. 2015** 28 SAPIEN 3 83.0 ± 5.9* 10 (36) 8.4 ± 3.2* <3 days Bijuklic et al. 2015** 152 23 SAPIEN XT, 87 SAPIEN 3, 35 DirectFlow, 7 others 2-4 days Lansky et al. 2015** TAo 29 SAPIEN/XT, 15 CoreValve 82.3†† 44 (66) 4.0 ± 2.0 Wendt et al. 2015 RCT 16 82.1 ± 4.1 8 (50) 39.5 ± 10.5 6.1 ± 2.8 Lansky et al. 2015 39 TF, TA SAPIEN/XT/3, CoreValve, others 82.3 ± 6.0 19 (49) Linke et al. 2014** 50 79.0 ± 4.0 23 (46) 14.6 ± 8.6 Van Mieghem et al. 2015** 33 SAPIEN XT/3, CoreValve, others 81.7 ± 6.7* 17 (52) 5.0 ± 0.0* Rodés-Cabau et al. 2014 11 83.7 ± 8.1* 8 (73) 19.3 ± 12.6* 3.7 ± 3.0* 37 22 SAPIEN XT, 15 CoreValve 81.0 ± 4.4* 21 (57) 13.1 ± 7.5* Pooled estimate rate (95% CI) 1225 81.6 (80.9-82.3) 50.0 (44.0-56.1) 22.9 (18.8-27.0) 4.5 (3.5-5.5)

Pooled analysis. Pooled DW-MRI outcomes

Pooled analysis Pooled DW-MRI outcomes 100 90 80 70 60 50 40 30 20 10 77.5% Patients with new cerebral lesions (%)

Meta-analysis Characteristics of the included studies Study Design Study Population EPD No EPD Approach N=384 (n=198) (n=186) Device EPD type Timing of DW-MRI (days) Age (y) EPD No EPD Wendt et al. 2015 RCT 30 14 16 TAo SAPIEN XT EMBOL-X 6.5 ± 2.6† 81.0 ± 5.0 82.1 ± 4.1 Lansky et al. 2015 85 46 39 82 TF, 3 TA 54 SAPIEN/XT/3, 26 CoreValve, 3 others TriGuard HDH 4.0 ± 2.0 82.5 ± 6.5 82.3 ± 6.0 Linke et al. 2014** 100 50 TF CoreValve Claret Montage CPS 2 days 80.0 ± 5.0 79.0 ± 4.0 Van Mieghem et al. 2015** 65 32 33 - 10 SAPIEN XT, 35 SAPIEN 3, 16 CoreValve, 4 others Claret Sentinel CPS 5.0 ± 0.0* 81.3 ± 3.7* 81.7 ± 6.7* Rodés-Cabau et al. 2014 Prospective 52 41 11 Embrella Embolic Deflector 3.2 ± 3.0*† 82.7 ± 5.2* 83.7 ± 8.1* Samim et al. 2015 Consecutive patients 15 37 33 SAPIEN XT, 19 CoreValve <4 days 81.3 ± 10.4* 81.0 ± 4.4* Primary endpoints Secondary endpoints Number of new lesions per patient Total lesion volume Number of patients with new lesions Single lesion volume

Primary endpoints Number of new lesions per patient Total lesion volume

Secondary endpoints Number of patients with new lesions Single lesion volume

Sub-group analysis Cerebral protection filters: Claret Sentinel/Montage; EMBOL-X Number of new lesions per patient Total lesion volume P interaction = 0.10 Embolic deflection systems: TriGuard HDH; Embrella Embolic Deflector P interaction = 0.23 Number of new lesions per patient Total lesion volume

Limitations Lack of patient-level data High heterogeneity: different populations, valves, approaches, and EPDs MRI-related limitations: 1.5-T vs 3-T MRI; high drop out rate; different timing of DW-MRI scan Only 4 RCTs out of 6 studies in the meta-analysis

Conclusions Silent cerebral injury after TAVI occurs in 77.5% of pts The main pooled DW-MRI outcomes are consistent with cerebral embolization (multiple, disseminated, ischemic lesions of different size) The use of EPDs is associated with significantly lower total lesion volume and single lesion volume Larger RCTs are needed before drawing definitive conclusions (SENTINEL, REFLECT)