Percutaneous Catheter-Based Left Atrial Appendage Ligation and Management of Periprocedural Left Atrial Appendage Perforation With the LARIAT Suture Delivery System

ABSTRACT: We report an 88-year-old male with coronary artery disease, previously placed left main coronary artery drug-eluting stent, and atrial fibrillation unable to tolerate anticoagulation with warfarin in addition to dual antiplatelet therapy who underwent percutaneous catheter-based ligation of the left atrial appendage. During the procedure, left atrial appendage perforation occurred with resultant pericardial effusion. The novel LARIAT suture delivery system (SentreHEART) allowed immediate and definitive management of this complication and effective ligation of the left atrial appendage. Prospective studies are needed to determine whether this is a safe and effective method for thromboembolism prophylaxis in patients with atrial fibrillation, but its novel design incorporates an immediate resolution to the most-feared complication of catheter-based left atrial appendage manipulation while effectively excluding the left atrial appendage via suture ligation.

J INVASIVE CARDIOL 2012;24(11): E289-E293

Key words: left atrial appendage, percutaneous left atrial appendage ligation, transseptal access, epicardial access, pericardial effusion
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Case Report. An 88-year-old Caucasian male with a history of coronary artery disease status post myocardial infarction, hypertension, and atrial fibrillation (AF) on chronic anticoagulation with warfarin was evaluated for percutaneous catheter-based left atrial appendage (LAA) ligation. He had previously undergone percutaneous coronary intervention of his distal left main coronary artery with a drug-eluting stent (DES) and also had percutaneous coronary intervention of his mid right coronary artery with a DES. Due to the presence of a DES in his left main coronary artery, dual-antiplatelet therapy was recommended indefinitely. Based on current guidelines, anticoagulation with warfarin was also recommended with a goal international normalized ratio of 2.0 to 3.0 because of a CHADS2 risk score of 2, which correlates to an adjusted annual stroke rate of approximately 4%.^1,2 While on this “triple therapy,” the patient suffered a life-threatening pulmonary hemorrhage with his international normalized ratio in the therapeutic range. Due to his elevated bleeding risk on dual antiplatelet therapy and anticoagulation with warfarin, alternative treatments for thromboembolism prophylaxis were evaluated. LAA ligation was determined to be a viable option, but an open surgical procedure was deemed to be too high risk. The WATCHMAN device (Atritech), the only device currently being investigated in the United States for percutaneous catheter-based LAA occlusion, was not a possibility because it is not used in patients in whom warfarin is contraindicated. As a result, a novel percutaneous catheter-based approach was employed for epicardial suture-based ligation of the LAA.

Procedural summary. The preprocedural workup began with a computed tomography angiogram to assess LAA anatomy, orientation, size, and proximity to left circumflex coronary artery. All were deemed acceptable for device use. The patient was subsequently brought to the cardiac catheterization laboratory in a fasting state and was placed under general anesthesia. A transesophageal echocardiography (TEE) probe was inserted into the esophagus and preprocedural images were obtained.

Preparations were made for epicardial access to the LAA via the subxiphoid approach and trans-septal access to the left atrium via the femoral vein, which are both required for the LARIAT suture delivery system (SentreHEART). The pericardium was accessed with a 17-gauge needle (Pajunk) using standard techniques previously described in the literature for access to a healthy pericardium.^3,4 Ideal epicardial access for the LARIAT suture delivery system involves a subxiphoid approach with the access needle oriented towards the patient’s left shoulder and entering the epicardial space along the anterior border of the heart. Once the epicardial space is accessed, a 0.035˝ J-wire was placed into the pericardium and the access was sequentially dilated to 14 Fr. Transseptal access was gained using a standard technique for placement of the 8.5 Fr SL1 guide catheter into the left atrium in close proximity to the LAA via the right femoral vein. Standard heparin bolus was administered once pericardial and transseptal access was achieved and local protocol was followed to maintain an activated clotting time of greater than 200 seconds.

The LARIAT suture delivery system has four components: a 0.025˝ endocardial FindrWIRE, a 0.035˝ epicardial FindrWIRE, an EndoCATH over-the-wire occlusion balloon, and a LARIAT snare with pre-tied suture. Following preparation to evacuate all air, the EndoCATH occlusion balloon and endocardial FindrWIRE were advanced together through the 8.5 Fr SL1 transseptal catheter under fluoroscopic guidance in the anteroposterior view. The SL1 guide catheter allowed direct placement of the EndoCATH/endocardial FindrWIRE combination into the LAA. The endocardial FindrWIRE is advanced to the anterior most aspect of the LAA to make LARIAT delivery easier. Once in place, position was confirmed by TEE and an appendagram was performed through the guide wire lumen of the EndoCATH, which has a distal side hole that allows contrast delivery, with the endocardial FindrWIRE remaining in place (Figure 1). Once in position, the endocardial FindrWIRE was secured by closure of the rotating hemostasis valve.

After placement of the endocardial FindrWIRE in the LAA apex, the 0.035˝ epicardial FindrWIRE was back-loaded into the LARIAT suture delivery device, and both were advanced through the 14 Fr soft-tipped epicardial guide cannula. The distal tip of the LARIAT device and the FindrWIRE were advanced under fluoroscopic guidance until the magnet located on the endocardial and epicardial FindrWIRZ attracted and attached to each other, stabilizing the LAA, and then the occlusion balloon was inflated at the ostium of the LAA (Figure 2). The position of the occlusion balloon was confirmed by angiography and TEE.

The radiopaque snare of the LARIAT that contains the pre-tied suture was fully opened and advanced over the appendage (Figure 3). A radio-opaque marker on the distal tip of the LARIAT was aligned with the proximal marker of the EndoCATH occlusion balloon that had been positioned at the origin of the LAA. This was the initial placement for closure of the LAA.

With the snare still open around the LAA, the EndoCATH was inflated at the LAA ostium and visualized using TEE and fluoroscopy. Unexpectedly, during final adjustments prior to suture deployment, a repeat appendagram was performed and showed extravasation of fluid into the pericardial space (Figure 4). At this point, the snare was closed as planned to ligate the LAA simultaneously treating the LAA perforation.

On confirmation of LAA capture and closure in the desired location, the EndoCATH was reinflated before suture release. The inflated occlusion balloon acts as a platform for the suture release position and ensures that slippage off of the LAA cannot happen during tightening. After initial tightening of the suture, the EndoCATH balloon was deflated and a followup appendagram was performed through the guide wire lumen of the EndoCATH, confirming primary closure. The EndoCATH and 0.025˝ FindrWIRE were removed form the LAA as a single component and withdrawn from the transseptal guide catheter. Additional tightening of the suture was performed, and the final result was confirmed with left atriagram (Figure 5). Ligation of the LAA was also confirmed by color Doppler TEE; Figures 6 and 7 show before and after images. The LARIAT device and 0.035˝ FindrWIRE were then removed and exchanged for a pigtail catheter, which was left in the pericardium attached to a drainage bag.

The patient was monitored overnight and had less than 50 milliliters of fluid drained from the pericardium so the pigtail catheter was removed. The patient was ambulated and discharged later that day.

Discussion. AF is the most common cardiac dysrhythmia in adults, affecting more than 2 million people in the United States.⁵ An estimated 75,000 strokes per year in the United States are attributed to AF and occur as a result of cardiac emboli.¹ More than 90% of these emboli originate in the LAA.⁶ Chronic anticoagulation with warfarin provides a relative risk reduction of stroke of 64% compared with placebo, but up to 20% of patients with AF have a relative or absolute contraindication to this mode of therapy.^7,8

Patients with AF who cannot tolerate anticoagulation with warfarin have limited options for stroke prevention. Dual antiplatelet therapy, which our patient was on, is not an adequate alternative and has been shown to be inferior to warfarin.⁹ Newer pharmacologic therapies are available but were not considered in our patient because they would also increase this patient’s chance of bleeding while on dual antiplatelet therapy. To limit the risk of stroke from AF in our patient, which has been shown to be as high as 36.2% in octogenarians, we pursued nonpharmacologic therapies.¹⁰

Nonpharmacologic options for stroke prevention in these patients with AF are surgical ligation of the LAA or percutaneous catheter-based occlusion of the LAA with the WATCHMAN device. Surgical excision or ligation of the LAA is a class 1 recommendation for patients with AF who are undergoing mitral valve surgery.¹ The effectiveness, however, of current surgical techniques for LAA ligation have been called into question with up to 60% of cases having residual color Doppler flow by TEE into the LAA at a mean of 8 months followup.¹¹ More recently, data presented for the AtriClip (AtriCure), which can be used for ligation of the LAA during open surgical procedures, suggest that it is safe and effective with a 95% procedural success rate at 3 months, but the longer-term results of the study are still pending.¹² Regardless, if the patient does not have a concomitant condition that requires open-heart surgery, this would not be a practical or recommended approach.

Currently, only one percutaneous catheter-based approach is being studied in the United States for percutaneous LAA exclusion, and that is the WATCHMAN device. The WATCHMAN device was evaluated in the PROTECT AF trial and was shown to be noninferior to warfarin in terms of the primary efficacy endpoint of stroke, cardiovascular death, and systemic embolism with a 91% success rate with device implantation.¹³ The primary safety endpoint of major bleeding, pericardial effusion, procedure related stroke, and device embolization, however, occurred more commonly in the WATCHMAN group with serious pericardial effusion being the most common procedure-related complication, occurring in 4.8% of patients.¹³ Overall, the relatively steep learning curve and relatively high rate of procedure-related complications have hampered the widespread use of this device.

Our patient was not a candidate for surgical ligation and was not a candidate for the WATCHMAN device because these patients still require 45 days of warfarin anticoagulation after device implantation to allow adequate time for endothelialization of the device. As a result, the LARIAT device was chosen and deployed successfully. TEE images postprocedure showed complete exclusion of the LAA. LAA perforation in our case most likely occurred while placing the EndoCATH FindrWIRE into the LAA or from tension applied to the wall of the LAA with the magnet wires attached. Again, however, this was easily managed as a result of the device design.

There are other potential complications with the use of this device, which include right atrial perforation, left atrial perforation, and pericardial effusion with or without tamponade. “Dry” pericardial access also portends the risk of right ventricular perforation and cardiac tamponade. Complications related to vascular access may also occur with use of large-bore sheaths in the femoral vein. The LARIAT device is designed to work with LAAs of less than or equal to 40 mm. Other limitations for use are previous open-heart surgery, presence of existing pericardial adhesions, or a superiorly oriented LAA. The proximity of the left circumflex artery to the LAA also needs to be considered when deploying the device.

Percutaneous catheter-based epicardial suture ligation of LAA has been shown to be safe and effective in a canine model and has also been shown to be feasible in humans.^14,15 Current solutions for patients who cannot tolerate anticoagulation for thromboembolism prophylaxis are limited. Most are not candidates for surgical ligation, and risk of procedural complications of current iterations of the WATCHMAN device may outweigh the benefits for its widespread use.

This case report is unique in that it shows a feared procedural complication of LAA manipulation, perforation, and highlights the unique design of this device which allows immediate resolution to the problem. In our case, the suture delivery and tightening were enough to seal the perforation. If suture delivery had not solved our problem, pericardial access was already in place for immediate drainage to avoid cardiac tamponade while a more definitive solution was pursued. In our case, LAA ligation with the LARIAT device was very effective, but before widespread use of this device occurs, prospective studies are needed to show that it is a viable alternative to chronic anticoagulation, surgical LAA ligation and other percutaneous catheter-based LAA occlusion devices for the prevention of thromboembolic stroke in patients with AF.

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From Swedish Medical Center, Heart and Vascular Institute, Seattle, Washington.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted April 11, 2012, provisional acceptance given May 30, 2012, final version accepted July 6, 2012
Address for correspondence: Ranjith Shetty, MD, Swedish Medical Center, Cherry Hill Campus, 500 17th Avenue, Seattle, WA 98122. Email: shettyr23@yahoo.com