Novel nonpharmacologic approaches for stroke prevention in atrial fibrillation: results from clinical trials

Figures & data

Table 1 Characteristics and results of the main clinical trials in left atrial appendage closure, including safety and efficacy

Device and study	Patients, n	Follow-up, months	Procedural success, %	Procedural complications, %	Incidence of stroke at follow-up, %
Percutaneous Left Atrial Appendage Transcatheter Occlusion
Sievert et al^Citation29	15	1	100	6.7% nonfatal hemopericardium	0
Ostermayer et al^Citation30	111	9.8	97.3	0.9% cardiac tamponade, 0.9% femoral artery perforation, 4.5% nonfatal hemopericardium	2.2
Bayard et al^Citation27	291	12	NS	3.4% cardiac tamponade, 0.3% death	3
Block et al^Citation34	64	60	95.3	1.5% cardiac tamponade	3.8
Park et al^Citation35	73	24	97.3	1.4% death caused by device embolization, 1.4% nonfatal hemopericardium, 1.4% periprocedural stroke	0
Ussia et al^Citation36	20	40	90	5% nonfatal hemopericardium	0
Bayard et al^Citation32	180	9.6	90	3.3% nonfatal cardiac tamponade, 0.6% device embolization, 1.1% death	2.3
Watchman
Sick et al^Citation20	75	24	88	2.6% cardiac tamponade, 4% hemopericardium, 2.6% device embolization, 5.3% thrombus formation on device	0
Holmes et al^Citation38	707	18	91	4.9% hemopericardium, 0.7% device embolization, 3.7% thrombus formation on device	2.3
Amplatzer
Cardiac plug
Meier et al^Citation70	16	4	93.75	6.25% device embolization, 5% coronary air embolism, 5% esophageal injury resulting from TEE	0
Lam et al^Citation48	20	12	95		0
Lopez-Minguez et al^Citation49	35	21	97.14	2.8% arteriovenous fistulas, 2.8% of gastrointestinal bleed, 14.28% thrombus formation on device	2.8
Park et al^Citation47	137	NS	96	3.6% hemopericardium, 1.4% device embolization	2.2
Amulet
Freixa et al^Citation52	25	3	96	None reported	0
LARIAT^®
Bartus et al^Citation59	13	NS	92.3	None reported	0
Bartus et al^Citation60	89	12	95	3.3% access related	0
Stone et al^Citation61	27	4	92.6	3.7% left atrial appendage perforation, 11.1% pericarditis	3.7

Abbreviations: NS, not stated; TEE, trans esophageal echocardiogram.

Table 2 Technical characteristics of the devices

Device	Deployment	Sizes	Device selection	Anticoagulation
Percutaneous Left Atrial Appendage Transcatheter Occlusion	Endovascular	15–32 mm	20%–40% larger than the left atrial appendage ostium diameter	No
Watchman	Endovascular	21, 24, 27, and 30 mm	10%–20% larger than the left atrial appendage ostium diameter	Yes (45 days)
Amplatzer cardiac plug	Endovascular	16–30 mm	10%–20% larger than the left atrial appendage orifice	No
Amulet	Endovascular	16–34 mm	3–6 mm larger than left atrial appendage ostium	No
Lariat	Endo-epicardial	W40 × H20 × L70 mm	N/A	No

Abbreviations: N/A, not available; W, width; H, height; L, length.

Figure 1 Watchman left atrial appendage system from above (A) and below (B).

Figure 2 Amplatzer cardiac plug.

Notes: Note the different shape compared with the Watchman device. In the Amplatzer cardiac plug device, the fixing lobe is separated, allowing the disc to fully cover the left atrial appendage ostium.

Figure 3 Fluoroscopic image of the final positioning steps of the Amplatzer cardiac plug device.

Figure 4 Amplatzer Amulet.

Notes: Note the increased length of the distal lobe and the diameter of the proximal disc. Note the amulet has the screw inside while the ACP has a screw through it.

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