Adverse events
No severe intra-procedural complications, including PE/PT, device embolization, air embolism, thromboembolism, and death, occurred in either group. Delayed PE/PT developed in five patients in the CM group and in two patients in the MM group (Table 3). Umbrellas that were not fully open were found in all of the five patients with delayed PE/PT in the CM group, while fully open umbrellas were found in the two patients with delayed PE/PT in the MM group (Figure 3). In the CM group, moderate PE was found by echocardiography in the 9th patient with persistent AF on day 15 who underwent isolated LAAC and in the 52nd patient with paroxysmal AF who received combined treatment 2 days after the procedure. Both of these patents were managed conservatively without further complications. Delayed PT occurred in three patients who received the combined procedure requiring intervention in the CM group. Sero-haemorrhagic liquid (haemoglobin value was close to that in blood) was drained in all of these patients. The 31st patient with PAF developed PT on day 8 after the operation. She was successfully treated with pericardiocentesis with no long-term sequelae. The 42nd patient with persistent AF developed PT on day 18 after the procedure and was treated with pericardiocentesis. The 59th patient with PAF suffered from progressive dyspnoea from 8 h after the procedure in the night and received pericardiocentesis 15 h after the procedure. Cardiac arrest occurred in preparation of pericardiocentesis. The patient died 7 days after the procedure owing to multi-organ failure. In the MM group, the 110thpatient with persistent AF who received the combined procedure developed PT on day 51 after the procedure and was successfully treated with pericardiocentesis. The 174th patient with PAF who underwent the combined procedure developed PT 30 min after the procedure. Pericardiocentesis was performed immediately in this patient. Surgical management of PT was required because blood continually flowed out through the pigtail catheter. A small branch of the left circumflex artery was bleeding, which was likely perforated by a small shoulder hook of the device, was explored during surgery. Excision of the LAA and coronary artery suture were performed. The patient was discharged in a good condition on day 20 after surgery.
The delayed PE/PT rate was significantly lower in the MM group than in the CM group (8.6% vs 1.2%, log-rank P=0.005). An umbrella that was not fully open was the only factor associated with delayed PE/PT events in univariate analysis (HR: 0.038, 95% CI: 0.007–0.194; P<0.001) and in the multivariable Cox model (HR: 0.026, 95% CI 0.004–0.183; P<0.001) after adjusting for age, sex, type of AF, type of procedure, HAS-BLED score, type of anticoagulants, mean number of recaptures, device position, LAA anatomy, the umbrella diameter divided by the land zone diameter (measured at RAO 30°, CAU 20° projection) ratio and the cover diameter divided by the orifice diameter (measured at RAO 30°, CAU 20° projection) ratio (Tables 4, 5).
The 68th patient had an ischaemic stroke 2 days after the procedure. Severe stenosis of the basilar artery was found as the cause of the stroke event. The 114th patient with the combined procedure suffered from gastrointestinal bleeding 24 days after the operation owing to an intestinal tumour. Minor complications included a haematoma at the puncture site in one patient with isolated LAAC in the CM group and in two patients with the combined procedure in the MM group, and a pseudoaneurysm at the puncture site in one patient with combined treatment in the MM group. No device embolization, device-related thrombus, stroke, death, atrio-oesophageal fistula, or pulmonary vein stenosis was observed during 3 months of follow-up.