VI Simposio Fronteras del Intervencionismo Cardiovascular 16 de Abril de 2015

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1 VI Simposio Fronteras del Intervencionismo Cardiovascular 16 de Abril de 2015 Oclusión Endovascular de la Orejuela Izquierda en qué momento nos hallamos? Dr. León Valdivieso Hospital Universitario

2 1 Atrial fibrillation (AF) affects 3% to 5% of the population older than 65 years and it is responsible for 15% to 20% of ischemic strokes. 1 Overall, the risk of stroke in patients with nonrheumatic AF is approximately 5% per year. 2 Atrial fibrillation increases the risk of stroke by a factor of 5. 1 Onalan. Stroke 2007;38; Maisel. NEJM 2009;360;

Review of 23 studies in which LAA was examined by autopsy, transesophageal echocardiography (TEE), or direct intraoperative inspection, intracardiac thrombus was identified in 13% of cases of both

3 Review of 23 studies in which LAA was examined by autopsy, transesophageal echocardiography (TEE), or direct intraoperative inspection, intracardiac thrombus was identified in 13% of cases of both nonvalvular and valvular AF. Furthermore, 57% of atrial thrombi in valvular AF occurred in the appendage, whereas in nonvalvular AF, 90% of left atrial thrombi were located in the atrial appendage. Onalan. Stroke 2007;38;

4 Warfarin cornerstone of therapy Assuming 51 ischemic strokes/1000 pt-yr Adjusted standard dose warfarin prevents 28 strokes at expense of 11 fatal bleeds Aspirin prevents 16 strokes at expense of 6 fatal bleeds Warfarin 60-70% risk reduction vs no treatment 30-40% risk reduction vs aspirin Cooper. Arch Int Med 2006;166 Lip. Thromb Res 2006;118

5 Protect AF Late Breaking Trial: Randomized Prospective Trial of Percutaneous LAA Closure vs Warfarin for Stroke Prevention in AF Holmes. ACC Summit 2009

Key Inclusion Criteria Age 18 years or older Documented non-valvular AF Eligible for long-term warfarin therapy, and no other conditions that would require long-term warfarin therapy Calculated

6 Key Inclusion Criteria Age 18 years or older Documented non-valvular AF Eligible for long-term warfarin therapy, and no other conditions that would require long-term warfarin therapy Calculated CHADS2 score > 1 Key Exclusion Criteria NYHA Class IV Congestive Heart Failure ASD and/or atrial septal repair or closure device Planned ablation procedure within 30 days of potential WATCHMAN Device implant Symptomatic carotid disease LVEF < 30% TEE Criteria: Suspected or known intracardiac thrombus (dense spontaneous echo contract) Holmes. ACC Summit 2009

7 Primary Efficacy Endpoint All stroke: ischemic or hemorrhagic deficit with symptoms persisting more than 24 hours or symptoms less than 24 hours confirmed by CT or MRI Cardiovascular and unexplained death: includes sudden death, MI, CVA, cardiac arrhythmia and heart failure Systemic embolization Primary Safety Endpoint Device embolization requiring retrieval Pericardial effusion requiring intervention Cranial bleeds and gastrointestinal bleeds Any bleed that requires 2uPRBC NB: Primary effectiveness endpoint contains safety events Holmes. ACC Summit 2009

8 Event-free probability Cierre percutáneo de la orejuela izquierda Events Total Rate Events Total Rate Rel. Risk Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) 900 pt-yr (6.4, 11.3) (2.2, 6.7) (1.18, 4.13) 1,0 0,9 0, Holmes. ACC Summit 2009 Intent-to-Treat Primary Safety Results Randomization allocation (2 device : 1 control) Device WATCHMAN Days Control Control ITT Cohort: patients analyzed based on their randomly assigned group (regardless of treatment received)

Event-free probability Cierre percutáneo de la orejuela izquierda 1,0 0,9 0,8 Device 0 365 730 1.095 Holmes.

9 Event-free probability Cierre percutáneo de la orejuela izquierda 1,0 0,9 0,8 Device Holmes. ACC Summit 2009 Intent-to-Treat Primary Efficacy Results Randomization allocation (2 device : 1 control) Events Total Rate Events Total Rate Rel. Risk Non- Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) inferiority Superiority 900 pt-yr (2.1, 5.2) (2.8, 7.6) (0.37, 1.41) Days Control WATCHMAN Control Posterior Probabilities ITT Cohort: patients analyzed based on their randomly assigned group (regardless of treatment received)

10 Risk/Benefit Analysis Intent-to-treat analysis Primary endpoint (intent to treat) achieved Other statistically significant endpoint findings Noninferiority for the primary efficacy event rate 32% lower in device group Noninferiority for stroke rate 26% lower in device group Superiority for hemorrhagic stroke 91% lower in device group Noninferiority for mortality rate 39% lower rate in device group Increased rate of primary safety events for the device group relative to the control group Most events in the device group were procedural effusions that decreased over the course of the study 87% of patients discontinued warfarin at 45 days Holmes. ACC Summit 2009

Pericardial Effusions by Experience Pericardial effusions most common safety issue Throughout PROTECT AF Trial, procedural modifications and training enhancements were implemented Procedural events

11 Pericardial Effusions by Experience Pericardial effusions most common safety issue Throughout PROTECT AF Trial, procedural modifications and training enhancements were implemented Procedural events would be expected to decrease over time Site implant group Any Serious No. % No. % Early patients (1-3) 13/ / Late patients ( 4) 27/ / Total 40/ / Continued ACCESS Registry Any Serious No. % No. % 1/ / Holmes. ACC Summit 2009

Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients With Non-Rheumatic Atrial Fibrillation Results From the International Multi-Center Feasibility Trials 111 ptes con

12 Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients With Non-Rheumatic Atrial Fibrillation Results From the International Multi-Center Feasibility Trials 111 ptes con contraindicación a ACO y al menos 1 factor de riesgo para stroke. Seguimiento 9.8 meses. Éxito de implante 108/111 (97.3%) MAEs iniciales 1 (0.9%) Pericardiocentesis 3 (2.7%) MAEs acumulados a 6 meses 2/97 (2.1%) Ostermayer. JACC 2005;46:9 14

Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy 5-Year Results of the PLAATO (Percutaneous

13 Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy 5-Year Results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study 64 ptes con contraindicación a ACO y al menos 1 factor de riesgo para stroke. Block. JACC Intv 2009;2:

14 Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy 5-Year Results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study 64 ptes con contraindicación a ACO y al menos 1 factor de riesgo para stroke. Block. JACC Intv 2009;2:

15 Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Éxito de implante 132/137 (96.4%) Stroke isquémico 3/137 (2.2%) Derrame pericárdico severo 5/137 (3.6%) Park. Cath Cardiovas Int 2011;77:700-6

16 A Quienes: - Alternativa en pacientes que pueden recibir ACO - Razonable su uso en pacientes que tienen contraindicación a la ACO o complicación hemorrágica asociada a la ACO - Debe estudiarse más a fondo en aquellos pacientes con factores de riesgo hemorrágico, con dificultad para ACO y el lugar a ocupar frente a los nuevos ACO.

17 Paciente masculino de 74 años. ACV isquémico en 1979 con paresia BC izquierda como secuela. FA paroxística bajo ACO con warfarina que fue suspendida en Enero/10 por HDA secundaria a úlcera duodenal. CHADS2 Score 2 HAS-BLED Score 3 LAA orificio 28 angio, 26 por ETE Landing zone angio 25, ETE 24

29 Control 12 meses. Asintomático, sin eventos cardiovasculares. Continúa bajo AAS. ECG: RS, HBAI ECO: Leve dilatación de AI. FEVI 55%. Control 36 meses. Asintomático. Bajo AAS. Sin eventos embólicos.

30 Gracias por su atención

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