Co-Author(s):
Michael Pope, BM - EP Research Fellow, Oxford University Hospitals NHS
Foundation Trust
Milena Leo, MD - Cardiology Consultant, Oxford University Hospitals NHS
Foundation Trust
Timothy Betts, MD - Cardiology Consultant, Oxford University Hospital
NHS Foundation Trust
Oxford University Hospital NHS Foundation Trust
Headley way, Oxford, OX39DU, UK
Introduction | Objectives: The Watchman (WM) device has robust periprocedural safety and efficacy
(PREVAIL, PROTECT and EWOLUTION registry). The new iteration,
Watchman-FLX (WM-FLX), has an improved design enabling implantation in
shallower appendages and can be recaptured after full or partial
deployment. However, there is no comparative data on its safety and
efficacy. This study sought to compare the 30-day periprocedural safety
and efficacy in patients undergoing left atrial appendage occlusion
(LAAO) device implantation with a WM or a WM-FLX in a large UK tertiary
centre.
Methods: This retrospective study included all patients in our institution from
January 2010 to December 2020 planned for implantation of a WD or WD-FLX
device. Adverse events at 30-days were identified by reviewing
electronic patient records, procedural and imaging reports
Results: A total of 193 consecutive patients (74±8 years old, 73% males, 81%
previous major or life-threatening bleed, 42% previous ischaemic
stroke, CHA2DS2-VASc score 4.4±1.2,
HASBLED score 3.2±0.8) were included, 138 patients in the WM group and
54 in the WM-FLX group. There were no significant differences in
baseline demographics. The acute procedural success was similar (97.8%
WM and 98.2% WM-FLX, p=0.8) but a shorter fluoroscopy time (12.4 vs.
5.82 minutes, p =0.01), total procedure time (56.1 vs. 44.4 minutes, p =
0.01) and length of stay (1.4 vs. 0.8 days, p < 0.01) was
observed in the WM-FLX group. Complete seal was achieved in 92% of
patients with a WM and 96% of patients with a WM-FLX(p=0.7); 1 patient
in the WM group had a moderate leak. The mean number of device
redeployments was also similar (0.60 WM vs 0.3 WM-FLX, p=0.50). At
30-days, no significant difference was observed in the rate of major and
minor procedural complication rate between the WM and WM-FLX groups (4.3
vs 1.8% [p=0.7] and 4.3% vs 0 [p=0.2], respectively).
Conclusions: The WM-FLX has similar excellent safety and effectiveness at acutely
sealing the LAA as the WM in safety and efficacy and was associated with
shorter fluoroscopy and procedure times.
AFS 2021-50