Left atrial appendage closure devices

Left atrial appendage closure devices

Anticoagulation for prevention of stroke is a well established modality of treatment in atrial fibrillation. But a significant number of them have bleeding complications. Hence the option of left atrial appendage closure with multiple types of devices have been developed. Left atrial appendage with its sluggish flow is the most common location for thrombus formation in atrial fibrillation.

Following devices have been used with varying success:

1. Watchman
2. Amplatzer Cardiac Plug/Amulet
3. Lariat suture ligation
4. Atriclip

PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) [1] randomized patients with non valvular AF if they had at least one of stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or age 75 years or more. This was a randomized, multicentre non inferiority trial. Warfarin was eventually discontinued in the intervention group while it was continued with target INR 2 – 3 in the control group. Initial results showed non inferiority, with higher primary safety events in the intervention group. 2.3 year follow up data was reported later [2] was also similar. Warfarin was continued for about 45 days after device implantation followed by clopidogrel for 4.5 months and lifelong aspirin.

Amplatzer Cardiac Plug/Amulet real-world registry included 1,088 patients [3]. Of these patients with non valvular atrial fibrillation 82.8% had an absolute or relative contraindication to long-term anticoagulation while 72.4% had a previous major bleeding episode. Device could be successfully implanted in 99% of cases.

Lariat suture ligation requires both endocardial transseptal and epicardial access. Pillarisetti J et al have shown lower leaks at 1 year with Lariat compared to Watchman, with no difference in the rates of cerebrovascular accidents [4]. As the Lariat electrically isolates the left atrial appendage, it may also reduce the AF burden.

Atriclip is an epicardial surgical closure device which and be used in both open and minimally invasive approaches. It has been shown to reduce the risk of stroke in those undergoing cardiac surgery when the device was deployed epicardially during open heart surgery [5].

References

1. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. 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 Aug 15;374(9689):534-42.
2. Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9.
3. Landmesser U, Schmidt B, Nielsen-Kudsk JE, Lam SCC, Park JW, Tarantini G, Cruz-Gonzalez I, Geist V, Della Bella P, Colombo A, Zeus T, Omran H, Piorkowski C, Lund J, Tondo C, Hildick-Smith D. Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention. 2017 Sep 20;13(7):867-876.
4. Pillarisetti J, Reddy YM, Gunda S, Swarup V, Lee R, Rasekh A, Horton R, Massumi A, Cheng J, Bartus K, Badhwar N, Han F, Atkins D, Bommana S, Earnest M, Nath J, Ferrell R, Bormann S, Dawn B, Di Biase L, Mansour M, Natale A, Lakkireddy D. Endocardial (Watchman) vs epicardial (Lariat) left atrial appendage exclusion devices: Understanding the differences in the location and type of leaks and their clinical implications. Heart Rhythm. 2015 Jul;12(7):1501-7.
5. Caliskan E, Sahin A, Yilmaz M, Seifert B, Hinzpeter R, Alkadhi H, Cox JL, Holubec T, Reser D, Falk V, Grünenfelder J, Genoni M, Maisano F, Salzberg SP, Emmert MY. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. 2018 Jul 1;20(7):e105-e114.