A 66-year-old man with a history of Hereditary Hemorrhagic Telangiesctasia (HHT), coronary artery disease status post remote coronary artery bypass grafting, type II diabetes mellitus, hypertension and paroxysmal atrial fibrillation (AF) for several years was referred for the evaluation of risk of thromboembolism.
Prior workup for HHT has shown small pulmonary, and gastro-intestinal arterio-venous malformations. His history is notable for recurrent epistaxis, and lower gastro-intestinal bleeding while on aspirin, with multiple admissions and procedures. He reports fatigue and palpitations during the episodes of AF, but is able to tolerate all of his activities while in AF. He was treated with sotalol, which was not effective and was switched to amiodarone. Anticoagulation was thought to pose excessive risk of bleeding. Physical examination was unremarkable. EKG showed coarse AF with a ventricular rate of 69 beats per minute.
In view of the high bleeding risk, what is the most appropriate option to reduce this patient’s risk of thromboembolism related to AF?
The correct answer is: 3. Accept the thromboembolism risk, as there is no feasible option.
Left atrial appendage (LAA) occlusion or closure is an option for patients who do not wish to receive chronic anticoagulation therapy in the setting of AF. A few devices have been developed for that purpose.
The Watchman device has been shown to be non-inferior to warfarin therapy in patients with non-valvular AF for the prevention of thromboembolic cerebrovascular events.1 In the PROTECT AF study, most patients were treated with warfarin for 45 days to allow for endothelialization of the device and prevent thrombus formation. After stopping warfarin treatment, dual antiplatelet treatment with clopidogrel and aspirin was used until the six-month follow-up visit. Afterwards, aspirin was prescribed indefinitely.1 Preliminary results of the “Aspirin and Plavix study (ASAP) suggest that the Watchman can be safely implanted without initial exposure to warfarin, only clopidogrel and aspirin.2 The patient presented above was intolerant to oral anticoagulants and antiplatelet agents. Therefore, option 1 is not a feasible treatment strategy.
The AMPLATZER™ Cardiac Plug device has been used for percutaneous occlusion of the LAA, with a procedural complication rate comparable to that reported in the Protect AF trial.3,4 However, there are no large trials addressing the efficacy of the device over a long period of follow-up.3 According to manufacturer’s recommendations, aspirin is recommended for at least 6 months after the implant procedure. Moreover, clopidogrel (or an alternative anti-platelet agent) is also recommended, for undefined duration.5 The patient presented above was intolerant to oral anticoagulant, or antiplatelet agents, which would be indicated for at least 6 months after implantation. Therefore, option 4 is not a feasible treatment strategy.
The LARIAT is a novel suture device, which employs a snare technique that can be used for ligation of the LAA percutaneously. Technically it is FDA approved for suture placement and tissue approximation in surgical procedures, and has not been formally evaluated or approved for LAA closure. Theoretically, this device could be deployed without the need for exposure to antiplatelet agents or anticoagulants. Massumi et al. reported their initial single center experience, highlighting the short-term safety and efficacy associated with the implantation procedure.6 However, there are currently no reports on the long-term clinical outcomes after using this device. Deployment of the device requires trans-septal puncture, and percutaneous access to the pericardial space. Access to pericardial space would be very unlikely to obtain in our patient given the prior history of CABG. Thus option 2 is not a suitable option.
Surgical ligation of the left atrial appendage would be difficult, and would carry high operative risks given prior sternotomy and CABG. Thus option 5 is not a suitable option.
This patient’s CHADS2 score is 2 and CHADS2-VASC 4 and his annualized risk for cerebrovascular thromboembolism is substantial (around 5% per year). Unfortunately, this is a situation where options to reduce that risk are not feasible given intolerance to anticoagulants and antiplatelet agents. Thus, option 3 is the most appropriate.
Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009;374:534-542.
Reddy VY, Mobius-Winkler S, Miller MA, et al. Left Atrial Appendage Closure with the Watchman Device in Patients with a Contraindication for Oral Anticoagulation: ASA Plavix Feasibility Study with Watchman Left Atrial Appendage Closure Technology (ASAP Study). J Am Coll Cardiol 2013; S0735-1097(13)01415-0.
Park JW, Bethencourt A, Sievert H, et al. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv 2011;77:700-706.
Rodes-Cabau J, Champagne J, Bernier M. Transcatheter closure of the left atrial appendage: initial experience with the Amplatzer cardiac plug device. Catheter Cardiovasc Interv 2010;76:186-192.
Massumi A, Chelu MG, Nazeri A, et al. Initial experience with a novel percutaneous left atrial appendage exclusion device in patients with atrial fibrillation, increased stroke risk, and contraindications to anticoagulation. Am J Cardiol 2013;111:869-873.