Table 4 Review of device success and peri-procedural and late complications from published clinical experience with percutaneously or minimally-invasively delivered LARIAT suture delivery device with greater than ten patients

Bartus et al. (2011)

83 % (10/12)

1 failure to complete ligation due to inadequate TEE guidance, 1 pericardial adhesion preventing access

6/6 patients undergoing 60 days follow-up TEE had durable ligation

1 patient with pectus excavatum required thoracotomy for device removal

NR

85.7 [22–335]

NR

Bartus et al. (2013)

92 % (85/92)

3 pericardial adhesions preventing access, 1 pericardial adhesion preventing device advancement, 2 peri-procedural complications requiring termination, 1 anatomical contraindication to trans-septal puncture

85/85 patients undergoing 30 days TEE follow-up had durable ligation while 65/65 patients undergoing 1 yr TEE follow-up had durable ligation

1 epigastric artery laceration requiring cauterization, 1 RV puncture requiring pericardial drainage, 1 perforation during trans-septal access requiring pericardial drainage, 1 adhesion preventing advancement of LARIAT device, 3 adhesions preventing access, 2 severe pericarditis

2 non-embolic CVA, 2 SCD remote from procedure, 1 late effusion, 1 LA thrombus noted at 1 yr follow-up TEE resolving with warfarin therapy

45 [36–55]

NR

Massumi et al. (2013)

100 % (20/20)

None

17/17 patients undergoing follow-up TEE at a mean of 96 days had durable ligation. In 6/17 patients, a residual pouch was noted with smooth walls in 5 and few pectinate muscles in 1

1 RV puncture requiring surgical intervention, 1 cardiac tamponade requiring pericardiocentesis, 1 prolonged intubation, 3 pericarditis with 1 requiring repeat pericardiocentesis

3 pericarditis, 1 death due to sepsis and pulmonary embolism occurring 50 days after ligation thought un-related to the procedure

83 ± 21

3.7 ± 3

Stone et al. (2013)

93 % (25/27)

2 peri-procedural complication requiring termination

22/22 patients undergoing TEE follow-up at a mean of 40 days had durable ligation

1 LAA laceration treated with reversal of anti-coagulation followed by surgical MAZE and appendage ligation, 1 CVA attributed to trans-septal sheath thrombus occurring in setting of sub-therapeutic ACT with no major neurologic sequelae after neurovascular rescue, 3 pericarditis

1 CVA 33 days post-procedure, thought secondary to arch atheroma, 1 pleural effusion

73 ± 18

2.8 ± 1.6

Price and Gibson (2014)

94 % 144/154

2 pericardial adhesions preventing access, 2 pericardial adhesions preventing device advancement, 2 difficult anatomy precluding ligation, 2 peri-procedural complications requiring termination

59/63 patients undergoing follow-up TEE had durable ligation with 4 having a >4 mm leak. Thrombus in the LA was noted in 3 patients undergoing TEE and 1 patient undergoing CT

3 patients required surgical exploration (2 for RV puncture, 1 for LAA perforation), 1 patient death due to nosocomial pneumonia post-procedure, 16 pericardial effusions, 4 pleural effusions

At a mean of 112 days follow-up, 2 cardiovascular deaths, 1 non-cardiovascular death, 2 CVAs, 3 pericardial effusions, 3 pleural effusions, 4 patients with thrombus noted in LA by TEE or CT

NR

NR

Miller et al. (2014)

95 % (39/41)

2 peri-procedure LAA perforation requiring emergent surgery

39/39 patients undergoing follow-up TEE had durable ligation

4 LAA lacerations (2 required exploratory surgery, 1 managed with pericardiocentesis, 1 managed with ligation), 13 pericardial effusions, 7 pericarditis, 4 pleural effusions

1 CVA, 5 pericardial effusions, 2 pericarditis, 2 pleural effusions

127 ± 50

NR