Endocardial LAA Occlusion: Which Device for Which Patient? Roy Beinart, MD Davidai Arrhythmia Center The Leviev Heart Center Sheba Medical Center Sheba Medical Center Tel Hashomer The Leviev Heart Center
Disclosures None Sheba Medical Center Tel Hashomer The Leviev Heart Center
LAA Closure Devices Watchman, Boston Scientific ACP, St Jude Medical Flexible LAA, Coherex Medical
Watchman Device A self expanding system with a nitinol frame covered with a permeable 160 mm polyethylene terephthalate fabric on the LA side of the device. Ten active fixation hooks are placed around the circumference Sheba Medical Center Tel Hashomer The Leviev Heart Center
ACP Device Made of a flexible braided nitinol mesh. 2 major components: Distal lobe with 6 pairs of hooks Proximal disc (covers the ostium) A second-generation (Amulet) allows for larger LAAs to be treated: Has a slightly larger disc The waist and the lobe are longer The number of stabilizing wires is increased for improved device flexibility and stability. Sheba Medical Center Tel Hashomer The Leviev Heart Center
LAA Occlusion which device? The Anatomy Lesson of Dr. Nicolaes Tulp Rembrandt, Canvas, 1632
WATCHMAN Evidence-Based Medicine N=3394
Rate per 100 patient years PROTECT AF 4 Year: Results 6 5 4 3 2 1 0 40% lower 32% lower 60% lower P S = 96% P N > 99% P S = 99% 3.8 2.3 2.2 2.4 1.5 1.0 * Primary Efficacy All Stroke CV or Unexplained Death 63% lower P S = 98% 1.2 0.5 Disabling Stroke WATCHMAN N=463 P N = Posterior Probability for Non-Inferiority Ps = Posterior Probability for Superiority Disabling or fatal strokes were those with an MRS of 3-6 post stroke. Non-disabling were those with an MRS of 0-2 post stroke. For Bayesian analysis, a posterior probability of 97.5% represents non-inferiority; 95% represents superiority. * Warfarin N=244 All stroke (ischemic & hemorrhagic), cardiovascular death (limited to any cardiovascular & unexplained death), and systemic embolism Reddy, VY et al. JAMA. 2014; 312(19):1988-1998.
FDA Panel October 2014. WATCHMAN Periprocedural adverse events 12.0% 10.0% N=232 9.9% Success: 88%-95% N Total : 2,902 Patients with Safety Event (%) 8.0% 6.0% 4.0% N=231 4.8% N=566 N=269 N=579 4.1% 4.1% 3.8% N=1025 2.8% 2.0% 0.0% PROTECT AF CAP PREVAIL CAP2 EWOLUTION 1 st Half 2 nd Half All Device and/or procedure-related serious adverse events within 7 Days including composite of vascular complications such as cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications such as PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding 1
ACP Periprocedural adverse events Success: 97%-100% N Total : 1,832 12.0% 10.0% Patients with Safety Event (%) 8.0% 6.0% 4.0% 2.0% 0.0% N=131 0.8% Haburg-Bern N=100 2.0% Italian registry N=143 7.0% Initial European Experince N=100 6.0% N=20 0.0% Bern regisrty Initial Asian Experince N=52 4.0% Canadian registry N=204 2.9% ACP EU N=35 0.0% Spanish registry N=1047 4.7% Tzikas All Device and/or procedure-related serious adverse events within 7 Days including composite of vascular complications such as cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications such as PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding 1 FDA Panel October 2014.
WATCHMAN ACP Success 88%-95% 97%-100% Efficacy (Compared to Warfarin) All Stroke/CV Death/CE: RR 0.60 All cause mortality: RR 0.66 CV Mortality: RR 0.40 * NA Safety Events 2.8%-9.9% 0%-7% * PROTECT AF
LAA Anatomy
LAA Anatomy There are considerable variations in its size, shape, and relationship with adjacent cardiac and extra cardiac structures. The orifice of the appendage is usually oval. Round, triangular, and water-drop shapes are also observed. The distribution of number of lobes varies: 3 lobes 23% 4 lobes 3% 2 lobes 54% 1 lobes 20%
LAA Anatomy (2) The shapes of the LAA in patients with drug-refractory AF were classified into 4 morphological types: Chicken wing Cauliflower Windsock Cactus JACC Cardiovasc Imag 2014
LAA Anatomy (3) Cauliflower Windsock Cactus Chicken wing JACC Cardiovasc Imag 2014
LAA by TEE JACC Cardiovasc Imag 2015
DEVICE SIZING FOR ENDOLUMINAL OCCLUSION DEVICES JACC Cardiovasc Imag 2015
Specific Considerations With Regard to LAA Closure Size: Too small Too Large Main anchoring lobe long enough Shape: Severe angulation Specific morphologies ( Chicken wing ) Lobes that separate close to ostium ( Ostial Lobes )
A very large or very small LAA may be problematic for device placement
A very large or very small LAA may be problematic for device placement
A very large or very small LAA may be problematic for device placement. Watchman ACP Required landing zone diameters 17-31 mm (Available Sizes: 21-33 mm) 11-31 mm (Available Sizes: 16-34 mm)
The main anchoring lobe needs to be long enough to accommodate the selected device.
The main anchoring lobe needs to be long enough to accommodate the selected device. Watchman ACP Required depth of main anchoring lobe (in the axis of the device) 19 mm for the smallest device size (21 mm) The length of the device progressively increases as device diameter increases 10 mm
Specific morphologies (e.g., a chicken wing morphology)/ severe angulation between the ostium and the neck may need specific implantation strategies
Specific morphologies (e.g., a chicken wing morphology)/ severe angulation between the ostium and the neck may need specific implantation strategies ACP maybe superior to Watchman in severe angulation, due the flexibility of the central pin that allows a misalignment between the disc and the lobe.
A lobe that originates very close to the ostium may stay unsealed.
A lobe that originates very close to the ostium may stay unsealed.
A lobe that originates very close to the ostium may stay unsealed. In very ostial lobes ACP maybe superior due to the pacifier principle (Improved sealing with the disc)
Device size (mm) Lin s concordance correlation coefficient of 0.315 (95% confidence interval (CI) -0.175, 0.680; P=0.203) 20 25 30 35 Device size (mm) 15 20 25 30 Printed MDCT 3D models for prediction of LAAO size 3 experienced interventional cardiologists, were asked to use printed 3D LAA models in order to choose the appropriate device size. Watchman (N=16) ACP: (N=12) correlation coefficient : 0.315 correlation coefficient : 0.778 20 25 30 Average estimate (mm) 15 20 25 30 Average estimate (mm) reduced major axis line of perfect concordance reduced major axis line of perfect concordance Sheba Medical Center Tel Hashomer The Leviev Heart Center
Conclusions LAA morphology / geometry and size are variable, and therefore choosing the right device and right size maybe challenging. Inherent 3D modalities (3D echocardiography, MRI and MDCT) could be beneficial. 3D printing (based on MDCT datasets) may have a potential role of in pre-procedural planning.
Conclusions (2) The ACP and the Watchman devices have both shown efficacy and relative safety. The Watchman device was studied in more patients, and in a more robust way (a randomized controlled trial - PROTECT AF). There are hardly any anatomical contraindications for an attempt at LAA occlusion with an ACP. LAA anatomy dictates which device to choose - ACP maybe superior in very small/large LAAs / severe angulation/ Ostial lobes
Thank you Sheba Medical Center Tel Hashomer The Leviev Heart Center