Percutane structurele interventies. Hartoor sluiting (Watchman )
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2 Percutane structurele interventies Dr. Luc Muyldermans Dr. Yves Vandekerckhove Dr. Luc Missault Dr. Daniël Dendooven Dr. Patrick Coussement Prof. Mattias Duytschaever Prof. René Tavernier Dr. Philippe Debonnaire Prof. Sébastien Knecht Hartoor sluiting (Watchman )
3 Percutaneous LAA Closure in Atrial Fibrillation: Evidence based? Luc Missault, MD, DSc Cardiology St Jan Hospital Brugge
4 Inhoud 1. Evidentie update 2. Indicatie & patiënt selectie 3. Resultaten AZ Sint-Jan 4. Conclusies
5 Left Atrial Appendage (LAA): -Allows for pressure protection/ volume expansion -Different forms, ie single lobe or multiple lobes, windsock, chicken-wing, cauliflower or broccoli, cactus -if Afib: blood stasis++
6 1. Evidentie update
7 17% thrombus of which 90.5% in LAA Blackshear and Odell, Ann Thorac Surg 1996;61:
8 Sequential transesophageal echocardiography images demonstrating migration of left atrial appendage (LAA) thrombus. Parekh A et al. Circulation 2006;114:e513-e514
9 TEEs (horizontal plane) of the left atrium and left atrial appendage Clot resolution after 4 weeks of VKA Corrado G et al. Chest 1999;115:
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13 Risk trade-off
14 Attractive alternatives to VKA in AFib Pharmacological Drugs without(?) or with less risk of bleeds Drugs without need for monitoring ( stable ) Interventional Ablation? (Impact on TEP?) LAA closure? Both? More attractive to patients Effectiveness? Bleeding risk? Very attractive to patients! No bleeds in the long run Effectiveness? Safety/complications?
15 ARISTOTLE N = with AFib; apixaban (5 mg bid) vs warfarin (target INR of 2.0 to 3.0) After 1.8 years: apixaban: 21% reduction in the risk of stroke or systemic embolism, 31% reduction in bleeding, 11% reduction in all-cause mortality Granger et al, N Engl J Med 2011;365:
16 Attractive alternatives to VKA in AFib Pharmacological Drugs without(?) or with less risk of bleeds Drugs without need for monitoring ( stable ) Interventional Ablation? (Impact on TEP?) LAA closure? Both? More attractive to patients Effectiveness? Bleeding risk? Very attractive to patients! No bleeds in the long run Effectiveness? Safety/complications?
17 The WATCHMAN product is a device for percutaneous closure of the left atrial appendage WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover It is designed to be permanently implanted at or slightly distal to the opening of the LAA to trap potential emboli before they exit the LAA WATCHMAN LAA Closure Device Images on file at Boston Scientific Corporation Five sizes of device (21, 24, 27, 30 and 33 mm) allow for precise fit within ostium It is implanted via a transseptal approach by use of a catheterbased delivery system The delivery catheter is capable of recapturing the device if necessary Received CE mark in 2005 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law MFMER slide-17
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21 Watchman Clinical Studies STUDY PATIENTS SITES COMMENTS PROTECT AF 800 Continued Access Registry (CAP) 566 ASAP (55 US, 4 EU) 26 (24 US, 2 EU) 4 (4 EU) PREVAIL ,500 patient years of follow-up 27 months average follow-up per patient Enrollment complete, continue to follow patients for 5 years Significantly improved safety results Enrollment complete, continue to follow patients for 5 years Treat patients contra-indicated for warfarin Currently enrolling up to 150 patients Patients will be followed for 2 years Same endpoints as PROTECT AF Revised inclusion/exclusion criteria Initial enrollment November 2010 Enrollment up to 400 randomized, anticipated enrollment completion March, 2012 Total >2000
22 PROTECT AF Study Objective: Study Design: Primary Endpoint: Additional Endpoints: Patient Population: WATCHMAN n=463 Control n=244 Roll-in n=93 Number of Sites: Evaluate the efficacy and safety of the WATCHMAN LAA Closure Device as compared to long-term warfarin therapy in patients with non-valvular atrial fibrillation and CHADS 2 score > 1 Prospective, randomized (2 Device: 1 Control), non-inferiority study of the Watchman device compared to long-term warfarin therapy Non-inferiority of the WATCHMAN device to warfarin therapy for the composite of ischemic stroke, hemorrhagic stroke, systemic embolism and cardiovascular/unexplained death Life-threatening events including device embolization requiring retrieval, pericardial effusion requiring intervention, cranial and GI bleeding, and bleeding requiring transfusion > 2 units PRBCs 59 (55 U.S., 4 EU) Holmes, Lancet 2009; 374
23 PROTECT AF Clinical outcomes Holmes, Lancet 2009; 374
24 0.20 PROTECT AF Primary Efficacy Endpoint Primary Efficacy Endpoint (Stroke, Cardiovascular Death, Systemic Embolism) 0.15 Control Device Probability Days Since Randomization Control Device Holmes, Lancet 2009; 374 David R Holmes, Lancet Vol 374 August 15, 2009
25 Holmes, Lancet 2009; 374
26 PROTECT AF At least some procedural/safety concerns Technical issues/learning curve? Experienced interventionalists but using both a new unfamiliar procedure and a not yet mature technique?
27 Continued Access PROTECT AF (CAP Registry) Study Objective: Study Design: Allow continued access to the WATCHMAN LAA Closure Device to a subset of PROTECT AF centers for patients with non-valvular atrial fibrillation and CHADS 2 score > 1 Prospective, non-randomized study of the WATCHMAN device Primary Endpoint: Efficacy composite endpoint of ischemic stroke, hemorrhagic stroke, systemic embolism and cardiovascular/unexplained death Additional Endpoints: Patient Population: WATCHMAN n=566 Life-threatening events including device embolization requiring retrieval, pericardial effusion requiring intervention, cranial and GI bleeding, and bleeding requiring transfusion > 2 units PRBCs Number of Sites: 26 (24 U.S., 2 EU)
28 Performance Metrics Learning Curve Effect PROTECT-AF vs. CAP With experience procedure time decreased by 30% Implant success improved to 95% Warfarin cessation increased to 95% With increased operator experience The average procedure time reduced from 67 minutes to 50 minutes Implant success improved from 88% to 95% Discontinuation of Warfarin improved from 83% to 95% of patients Reddy, Circulation 2011; 110
29 PREVAIL: Rationale Concerns with early PROTECT AF safety results High initial rate of pericardial effusions and procedure related strokes Some WATCHMAN patients did not receive their assigned treatment (i.e., implant failures) Safety outcome of procedures performed by new operators Second randomized trial to confirm late PROTECT AF and CAP safety results (PREVAIL) Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law MFMER slide-29
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34 (/protect AF)
35 ASAP (ASpirin And Plavix) The average ASAP baseline CHADS 2 of 2.8 equates to a predicted ischemic stroke rate of % per year 3 strokes were observed over a follow-up of patient years (1.7 events per 100 patient years) The observed rate of 1.7 per 100 patient years in ASAP compares favorably to PROTECT-AF with 2.2 events per 100 patient years despite the difference in CHADS 2 score distribution Left Atrial Appendage Closure with the WATCHMAN device produced a significant reduction in the expected ischemic stroke rate for patients contra-indicated to Warfarin
36 2. Indicatie & patiënt selectie Different Clinical Scenarios for use of LAA closure device LAA Closure as a substitute for anticoagulation ( all ) On top of anticoagulation (embolism despite anticoagulation) LAA Closure for patients with contraindication for anticoagulation (relative or absolute) During ablation for AF ( complete AF treatment )
37 3. Resultaten AZ Sint-Jan Eerste jaar learning phase : onder supervisie van een bezoekende proctor in ons cathlab Na learning phase: ITT n=50; 46 implants 4 patienten niet ingeplant (2 te klein; 1 te groot ostium, 1 onstabiel en teruggetrokken) 1 patient twee sessies nodig (inferoposterieure transseptale punctie is cruciaal voor acces LAA) 1 pericardeffusie met shock
38 4. Conclusies -LAA closure techniek is beschikbaar -substantiele ervaring opgebouwd met resultaten vergelijkbaar tot beter dan in de trials (cfr veel beginnende centra in de trials (boosting)) -de indicatie op dit moment ligt vooral bij: falen van antico of contraindicatie voor antico -terugbetaling RIZIV
39 LAD Stenting + LAA Occlusion + ASD Closure + TAVI (Female, 88 years, LAD stenosis, atrial fibrillation, ASD, aortic stenosis) Amplatzer Cardiac Plug 24 mm Biomatrix Stent 3.0 x 18 mm Schneiter Elisabeth, , , Khattab, Windecker Amplatzer Septal Occluder 14 mm Medtronic CoreValve 26 mm Amplatzer TorqueVue Sheath 13 French Pacemaker Lead
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