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Table 4 Pre- and postprocedural regimens, complications and outcomes

From: Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

 

Major procedure-related

complications (n= / %)

Minor procedure-related

complications (n= / %)

Follow up time / Outcome (AE) (n= / %)

Chen et al. (2019) [21]

Total: n = 0 / 0%

0%

6 months:

Total: n = 0 / 0%;

Stroke/TIA: n = 0 / 0%;

TFD: n = 0 / 0%;

RF > 5 mm: n = 0 / 0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

RF < 5 mm: n = 9 / 30.0%;

Minor Bleeding: n = 0 / 0%

Feng et al. (2019) [22]

Total: n = 1 / 5.9%;

Death: n = 0 / 0%;

PerTam: n = 1 / 5.9%

n = 2 / 11.8% (haematoma)

12 months:

Total: n = 0 / 0%;

Stroke/TIA: n = 0 / 0%;

TFD: n = 0 / 0%;

RF > 5 mm: n = 0 / 0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

RF < 5 mm: n = 2 / 11.8%;

Minor Bleeding: n = 0 / 0%;

n = 1 / 5.9% sudden cardiac death at 545 days

Reinsch et al. (2018) [19]

Total: n = 0 / 0%;

Death: n = 0 / 0%

0%

6 months:

Total: n = 0 / 0%;

Stroke/TIA: 0%;

TFD: 0%;

RF > 5 mm: 0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

RF < 5 mm: 0%;

Minor Bleeding: n = 0 / 0%

Park et al. (2018) [18]

Total: n = 4 / 6.7%;

Death: n = 1 / 1.7%;

PerTam: n = 3 / 5.0%;

PerTam requiring surgery with fatal outcome: n = 1 / 1.7%;

Pseudoaneurysm of right AFC requiring surgical repair: n = 1 / 1.7%

0%

12 months:

Total: n = 5 / 6.7%;

Stroke/TIA: n = 2 / 1.6%;

TFD: 0%;

RF > 5 mm: n = 3 / 5%a;

Major bleeding: 0%;

Device embolization: n = 0 / 0%

RF < 5 mm: n = 14 / 24.6%;

Minor bleeding: n = 5 / 5%

Death unrelated to LAAC: 3%

Kleinecke et al. (2018) [17]

Total: n = 0 / 0%;

Death: n = 0 / 0%

0%

N/A

Cruz-Gonzalez et al. (2017) [20]

Total: n = 0 / 0%;

Death: n = 0 / 0%

0%

N/A

Chen et al. (2018) [9]

Total: n = 0 / 0%;

Death: n = 0 / 0%

0%

6 months:

Total: n = 0 / 0%;

Stroke/TIA: 0%;

TFD: 0%;

RF > 5 mm: 0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

Zhou et al. (2017) [16]

Total: n = 0 / 0%;

Death: n = 0 / 0%

0%

N/A

Huang et al. (2017) [15]

Total: n = 5 / 3.3%;

Death: n = 0 / 0%;

PerTam: n = 2 / 1.3;

Stroke: n = 1 / 0.7%;

Major bleeding: n = 1 / 0.7%

n = 4 / 2.6%

(Femoral hematoma: n = 2;

Arteriovenous fistula: n = 1

Pseudoaneurysm; n = 1)

12 months:

Total: n = 5 / 3.9%;

Stroke: n = 3 / 2.0%;

TFD: n = 2 / 1.3%;

RF > 5 mm: 0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

Death unrelated to LAAC: n = 1 / 1.3%

Available TEE at 12 months:

n = 121

No RF: n = 102 / 84.3%;

RF 1–3 mm: n = 18 / 14.9%;

RF > 3 mm: n = 1 / 0.8%

Jie et al. (2016) [14]

N/A

N/A

N/A

Total /

Overall mean

Total: n = 10 / 2.9%;

Death: n = 1 / 0.3%;

PerTam: n = 6 / 1.7%;

Stroke: n = 1 / 0.3%;

Major bleeding / Vascular complications: n = 2 / 0.6%

Total: n = 6 / 1.7%

Total: n = 10 / 3.3%;

Stroke/TIA: n = 5 / 1.7%;

TFD: n = 2 / 0.7%;

RF > 5 mm: n = 3 / 1.0%;

Major Bleeding: n = 0 / 0%;

Device embolization: n = 0 / 0%

  1. a: After the detection of RF > 5 mm at TEE at 1 month (3 cases), DAPT was switched to OAC. In 2 patients with persisting RF > 5 mm after 12 months, successful percutaneous closure of the leak with an Amplatzer vascular plug was undertaken
  2. Abbreviations
  3. AE: adverse events
  4. AFC: Arteria femoralis communis
  5. DAPT: dual antiplatelet therapy (aspirin plus clopidogrel)
  6. N/A Not available
  7. PC Pericardiocentesis
  8. PE Pericardial effusion
  9. PerTam Pericardial tamponade
  10. RF Residual flow
  11. TFD Thrombus formation on the device