Left Atrial Appendage Occlusion Pilot Study of a Fourth-Generation, Minimally Invasive Device

Author(s):  
Hideyuki Fumoto ◽  
A. Marc Gillinov ◽  
Roberto M. Saraiva ◽  
Tetsuya Horai ◽  
Tomohiro Anzai ◽  
...  

Objective Exclusion of the left atrial appendage is proposed to reduce the risk of stroke in patients with atrial fibrillation. The aim of this study was to evaluate the feasibility and efficacy of a fourth-generation atrial exclusion device developed for minimally invasive applications. Methods The novel atrial exclusion device consists of two polymer beams and two elastomeric bands that connect the two beams at either end. Fifteen mongrel dogs were implanted with the device at the base of the left atrial appendage through a median sternotomy and were evaluated at 30 (n = 7), 90 (n = 6), and 180 (n = 2) days after implantation by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histology. Results Left atrial appendage exclusion was completed without hemodynamic instability. Coronary angiography revealed that the left circumflex artery was patent in all cases. A new endothelial tissue layer developed, as expected, on the occluded orifice of the left atrium. Conclusions This novel atrial exclusion device achieved easy, reliable, and safe exclusion of the left atrial appendage, with favorable histological results in a canine model for up to 6 months. Clinical application could provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.

Author(s):  
John R. Doty ◽  
Stephen E. Clayson

Objective Surgical ablation with radiofrequency is a safe and effective treatment for atrial fibrillation. Recent advances in instrumentation have allowed for the application of bipolar radiofrequency through a minimally invasive approach using small bilateral thoracotomies for pulmonary vein isolation, destruction of autonomic ganglia, and excision of the left atrial appendage (GALAXY procedure). Methods Thirty-two patients underwent surgical ablation of atrial fibrillation with the GALAXY procedure over a 43-month period. Data were collected in a prospective manner during hospitalization and at 1-, 3-, 6-, and 12-month intervals for rhythm, medications, and subsequent interventions. Results There were no operative mortality, no myocardial infarction, and no stroke. One patient required reexploration for bleeding. Mean follow-up was 28 months (range, 4–43 months). Freedom from atrial fibrillation at 12 and 24 months, respectively, was 90% and 67% for patients with paroxysmal fibrillation and 80% and 63% for patients with persistent atrial fibrillation. Of the patients who were not in sinus rhythm, four reverted to atrial fibrillation and two reverted to atrial flutter. Conclusions The GALAXY procedure is a safe and effective, minimally invasive method for treatment of isolated (lone) atrial fibrillation. The operation provides excellent short-term freedom from atrial fibrillation and should be considered in patients with isolated paroxysmal atrial fibrillation.


Author(s):  
Nathan E. Smith ◽  
Jeevan Joseph ◽  
John Morgan ◽  
Saqib Masroor

Objective Atrial fibrillation (AF) is the primary cardiac abnormality associated with ischemic stroke. Atrial fibrillation affects 2.7 million people with a stroke rate of 3.5% per year. Most of the emboli in patients with nonvalvular AF originate in the left atrial appendage (LAA). Surgical exclusion of the LAA decreases the yearly risk of stroke to 0.7% when combined with a Maze procedure. Traditional oversewing the LAA from inside the left atrium is associated with a significant number of recanalizations of LAA. An alternate technique is epicardial clipping, which has been approved through sternotomy for permanent exclusion of LAA. We present our initial experience of epicardial clipping of the LAA using a minimally invasive approach. Methods Between May 2012 and December 2015, a total of 24 consecutive patients underwent minimally invasive, echo-guided epicardial clipping. Indications for the procedure were persistent (n = 12) or paroxysmal (n = 12) AF in patients who could not tolerate full anticoagulation because of a combination of gastrointestinal bleeding (n = 7), hemorrhagic stroke (n = 5), ischemic stroke (n = 5), intramuscular bleeding (n = 3), falls (n = 2), urinary tract bleeding (n = 2), subdural hematoma (n = 1), traumatic aortic intramural hematoma (n = 1), and lifestyle and career practices inconsistent with anticoagulation (n = 1). The clipping was performed through three 5-mm ports in the left seventh intercostal space (n = 22) or a 5-cm incision in the fifth intercostal space (n = 2). Echocardiography was performed to exclude the presence of LAA thrombus and to confirm exclusion of LAA before final deployment of the clip. Results The mean age was 73.6 years. The mean CHA2DS2VASC score was 4.7 and the mean HAS-BLED score was 3.8. The mean postoperative length of stay was 6.4 days. One patient died of stroke-related complications 10 days after successful clipping, and two patients required thoracentesis to drain recurrent pleural effusions. All patients had successful exclusion of LAA defined as residual sac of less than 1 cm. Conclusions Isolated epicardial left atrial clipping is a safe treatment option in high-risk patients with AF. Long-term success in preventing stroke is still to be determined, but short-term results are very encouraging.


2016 ◽  
Vol 74 (3) ◽  
pp. 219-222
Author(s):  
Maximiliano A. Hawkes ◽  
Lucía Pertierra ◽  
Federico Rodriguez-Lucci ◽  
Virginia A. Pujol-Lereis ◽  
Sebastián F. Ameriso

ABSTRACT Left atrial appendage occlusion (LAAO) appears as a therapeutic option for some atrial fibrillation patients not suitable for oral anticoagulation because an increased hemorrhagic risk or recurrent ischemic events despite anticoagulant treatment. Methods Report of consecutive atrial fibrillation patients treated with LAAO with Amplatzer Cardio Plug because contraindication or failure of oral anticoagulation with acenocumarol. CHA2DS2VASC, HAS-BLED, NIHSS, mRS, procedural complications and outcome were assessed. Seven patients (73 ± 6 year-old) were treated after intracerebral (n = 5) and gastrointestinal (n = 1) hemorrhages or ischemic stroke recurrence while on acenocumarol (n = 1). Results Mean follow up was 18 months. Baseline CHA2DS2Vasc y HAS-BLED scores were 5.6 ± 0.7 and 4.1 ± 0.3 respectively. There were no strokes or deaths. There was only one non-serious adverse event. Conclusion LAAO with ACP appears as a feasible therapeutic option for stroke prevention in patients with atrial fibrillation and failure or contraindication to acenocumarol.


1996 ◽  
Vol 37 (3P2) ◽  
pp. 749-753 ◽  
Author(s):  
I. Sakamoto ◽  
K. Hayashi ◽  
N. Matsunaga ◽  
Y. Ogawa ◽  
Y. Matsuoka ◽  
...  

Purpose: The value of coronary angiography in the diagnosis of thrombus in the left atrial appendage (LAA) was retrospectively analyzed. Material and Methods: The study covers 34 patients in whom coronary angiography showed coronary neovascularity in LAA with coronary artery-left atrial fistula indicating LAA thrombus. All 34 patients underwent transthoracic echocardiography within one week of coronary angiography. Open-heart surgery was undertaken 2–31 months after angiography in 28 patients. Results: Coronary neovascularity and coronary artery-left atrial fistula arose from the left circumflex artery in 28 patients, and from the left circumflex artery and the right coronary artery in the remaining 6 patients. By echocardiography, LAA thrombus was detected in only one of the 34 patients. In 18 of the 28 patients who underwent open-heart surgery, LAA thrombus was found at surgery to have resolved. Conclusion: Coronary angiography is useful in the diagnosis of LAA thrombus, and coronary neovascularity and fistula formation may indicate that the thrombus can spontaneously resolve.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
CH Heeger ◽  
RMS Meyer-Saraei ◽  
TF Fink ◽  
VS Sciacca ◽  
JV Vogler ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Although pulmonary vein isolation (PVI) is an effective treatment strategy for patients with paroxysmal atrial fibrillation (AF), it is associated with limited success rates in patients with persistent AF (PersAF). In this context the left atrial appendage (LAA) was recently identified as a target of catheter ablation especially in PVI non-responders. Although effective, this strategy may cause electromechanical dissociation and was therefore assumed to be associated with an increased risk of thromboembolism despite oral anticoagulation (OAC). Since RF based LAAI showed increased rates of thromboembolism and stable LAAI is difficult to achieve in some cases, Cryoballoon-based LAAI might offer a valuable option to achieve safe and durable LAAI. Recently the fourth generation cryoballoon was introduced. Additionally, the 40% shorter tip potentially increases the safety profile as well as efficacy of CB-based LAAI. Objective To assess safety and efficacy on CB2 vs CB4 based LAAI. Methods Cryoballoon based PVI and LAAI was performed in 20 patients with PersAF and long-standing PersAF. The first 10 consecutive patients were treated by the second-generation cryoballoon (CB2) the last 10 patients were treated by the CB4. LAAI was performed by utilizing a bonus freeze protocol (freezing time 300 seconds + another 300 seconds after LAAI). Results Stable LAAI was achieved after a mean of 2.6+/- 1.7 cryoballoon applications with a mean minimal temperature of -52+/-6 °C. Unless one phrenic nerve palsy (5.6%) of the left phrenic nerve no further periprocedural complications occurred. Successful LAAI was performed in 19/20 (95%). TEE after 6 weeks detected LAA thrombus in 3/10 (30%) patients (CB2 group) and 3/10 patients (30%) (CB4 group), p = 0.99. Successful LAA-closure was performed in 16/20 patients (80%) after a mean of 75+/-59 days. The LAA was durable isolated in 8/9 patients (89%, CB2) and 6/8 patients (75%, CB4), p = 0.56). AF recurrence after 6 weeks was 1/10 (10%, CB2) and 3/9 (33%, CB4), p = 0.26. Conclusions Here we used – to our knowledge – for the first time a CB4 for LAAI, followed by a combined check for LAAI and LAA-closure after 6 weeks, compared to the CB2. LAAI was successfully isolated by both cryo-balloons in the majority of patients. Hence the use of newest cryo-balloon generation for LAAI seems a safe and successful procedure compared to earlier balloon generations. However, a relatively high rate of LAA-Thrombus was detected after LAAI. Therefore, LAA closure is mandatory in this population.


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