Watchman and Structural update..the next frontier. Ari Chanda, MD Cardiology Associates of Fredericksburg
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1 Watchman and Structural update..the next frontier Ari Chanda, MD Cardiology Associates of Fredericksburg
2 Different Left Atrial Appendage (LAA) morphologies
3 Watchman (the device) Fabric Anchors
4 Device structure and sizes
5 Screening TEE scheduled as out patient before the procedure Thrombus Echo contrast
6 Establishing a device size
7 The implant procedure
8
9 Who are candidates? 1. History of intracranial bleeding (intracerebral or subdural) where benefits of LAAC outweigh risks 2. History of spontaneous bleeding other than intracranial (e.g. retroperitoneal bleeding) 3. Documented poor compliance with anticoagulant therapy 4. Inability or significant difficulty with maintaining patients in therapeutic anticoagulation range 5. Intolerance of warfarin and NOACs 6. High risk of recurrent falls 7. Cognitive impairment 8. Severe renal failure 9. Occupation related high bleeding risk (exposure to sharp objects, cuts) 10. Need for prolonged dual antiplatelet therapy 11. Increased bleeding risk not reflected by the HAS-BLED score (e.g. thrombocytopenia, cancer, or risk of tumor associated bleeding in case of systemic anticoagulation) 12. Other situations for which anticoagulation is inappropriate
10 Composite endpoint: stroke, systemic embolism, unexplained death Adverse events have decreased since initial trials The trade off Small procedural risk v/s risk of bleeding for the rest of pts life or high risk of stroke for the rest of pts life. Trial Primary Outcome Adverse Events PROTECT AF 707 pts 88% successful implant Composite endpoint 3/100 pt year in device group and 4.9/100 pt year in warfarin group Procedure related stroke 1.1%, pericardial effusion requiring drainage 4.8% Continued Access Protocol 460 pts 95% successful implant No strokes Pericardial effusion 2.2% PREVIAL trial 407 pts 95% successful implant Composite outcome non inferior to warfarin 6.4% in device vs 6.3% warfarin group. Procedural related stroke 0.4% Pericardial effusion needing drainage 1.5%
11 Aortic stenosis update Disease of the elderly The prevalence is more then it was expected in the past. High risk and moderate risk for surgery is a candidate for TAVR Shortness of breath Slowing down- I am just getting old Mid systolic murmur on examination Every elderly pt should be screen for this Ongoing trials Moderate aortic stenosis with CHF Asymptomatic severe aortic stenosis Low risk patients
12 Surgical Valve Replacement
13 Transcatheter Aortic Valve
14 Core Valve and Valve in Valve Valve in valve Low EF Low contrast technique 10ml
15
16 PFO update. And ASD 25 to 30% of the Americans have PFOs and most of the time its benign. Pts with stroke or TIA should have echo with bubble study If a PFO is seen, they need evaluation by cardiology and neurology Monitoring to see if they have AF or other factors for stroke If between age of 18 and 60 and Cryptogenic stroke FDA approved the use stating it is safe, effective and benefits out weighs the risk RESPECT trial final results PFO closure cannot prevent Strokes from non PFO related causes. 2 more trials similar results REDUCE CLOSE
17 Moderate sedation 30 min procedure Venous puncture Discharge next day PFO closure: the procedure
18 Mitral regurgitation and Mitraclip Degenerative MR: Mitral valve prolapse or flail leaflet Candidates: Significant degenerative MR 3+, symptomatic (exertional dyspnea), high risk for surgery- age, frailty, severe comorbidities (liver disease, pulmonary HTN etc) COPAT trial : Tens of thousands of patients will benefit from the treatment
19 Outcomes- real world data Procedural success rate 91.4% Procedural mortality: 0.1% Mortality 30 day 4.2% (high risk group) Mortality long terms: 15.8% There was symptom reduction in 60% of the pts Ref: Catheter Cardiovasc Interv 2014 Jul 1;84)1): Results of COAPT trial 4 th quarter of 2018 Results from Europe are promising and this will most likely see a significant amount of pts treated with mitral clip and other mitral valve interventions.
20 Questions? Thank you
RE: Proposed National Coverage Decision (NCD) Memorandum for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy (CAG-00445N)
December 10, 2015 Ms. Tamara Syrek-Jensen Director, Coverage & Analysis Group Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 RE: Proposed National Coverage Decision
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