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.