Demographic characteristics
LAAO procedure were performed in 51 patients (34 male and 17 female) with mean age of 64.4±10.0. Of all the patients, the 29.4% (15/51) of patients have concomitant CAD. The anticoagulation policies before LAAO were highly heterogeneous, including Vitamin K antagonist, aspirin, clopidogrel, rivaroxaban or dabigatran. Compared to NVAF patients without CAD, patients with CAD were older (62.4±10.6yrs vs. 69.1±6.5yrs, p=0.026) and more likely to have other chronic disease, such as diabetes mellitus (DM) (11.1% vs. 53.3%, p=0.001), chronic heart failure (CHF) (13.9% vs. 40.0%, p=0.041) or chronic obstructive pulmonary disease (COPD) (2.8% vs. 26.7%, p=0.01). The risk of thromboembolism based on CHA2DS2 score (2.5±1.4 vs. 2.0±1.3, p<0.001) or CHA2DS2-VASc score (3.1±1.6 vs. 5.2±1.1, p<0.001) and the risk of hemorrhage based on HAS-BLED score (2.2±1.2 vs. 3.1±1.0, p=0.009) were significantly higher in CAD group (Table 1).
Procedure results
The devices were implanted successfully in 50 patients, with a procedural success rate of 98% (50/51). There was no procedure related stroke, bleeding or cardiac tamponade. One patient did not wake up from general anesthesia, and died 7days after procedure due to procedure related thromboembolism. The incidence of pericardial effusion was 15.7% (8/51).
The mean diameter of the LAA ostium was 23.3±3.7mm, and the most popular morphology of LAA was cactus with 2-3 lobes. Watchman was the first selected device, with which majority (47/92.2%) of patients were implanted. Two common sizes of watchman were 27mm (20/39.2%) and 30mm (13/25.5%). The rate of device compression was 20.4±4.6. The 32 (62.7%) patients presented trivial residual leak (≤1mm), and no large residual leak (>5mm) was observed. The LAmbre device was implanted in 4 patients (7.8%) as an alternative for the shallow or broad profile of LAA which was not suitable for occlusion with Watchman. Among 51 NVAF patients, 4 patients received combined procedures with Watchman device implantation after AF ablation, and 4 patients underwent combined procedures with transcatheter closure of ASD with Amplatzer device post LAAO with Wachaman device successfully. After LAAO all patients were prescribed rivaroxaban (22/44%) or dabigatran (28/56%) for 3 months as temporary anticoagulation protocols, followed by aspirin monotherapy.
Transesophageal echocardiography characteristics
There were no significant differences in lobes, morphology, and dimension of LAA between CAD group and non-CAD group, while EF values were obviously lower in patients with CAD. Meanwhile, there were no significant differences in device type, residual leak immediately after procedure, and post LAAO anticoagulation medications between two groups (Table 2).
Follow-up results
During 12-month follow-up period, there were no hemorrhagic stroke or major bleeding. Two patients developed device related thrombus (DRT) that resolved by additional anticoagulation without any ischemic events. Two patients experienced transient ischemic stroke. There were three patients died overall: one for procedure related thromboembolism, one for pneumonia, and one for pancreatic cancer. There were no statistical difference in incidence of stroke, bleeding, DRT and cardiovascular death between the CAD group and non-CAD group during the whole follow-up. Nevertheless the all-cause death (n=0 vs. n=3/21.4%, p=0.006) in CAD group was particularly higher, which could be ascribed to the more critical state of illness (Table 3).
Compared with NVAF combined CAD patients who accepted long-term NOACs treatment as thromboembolism prophylaxis, there were no obviously differences in stroke rate and mortality in NVAF combined CAD patients accepted LAAO group, whereas a further reduction of hemorrhage (n=5/20% vs. n=0, p=0.039) was shown(Table 4).
In patients with end-point events, CHA2DS2-VASc score, HAS-BLED score and mean LVEF had no difference from patients without end-point events (CHA2DS2-VASc p=0.051; HAS-BLED p=0.995; LVEF p=0.853). The LAA pulsed wave peak velocity, which reflected the LAA function, obviously decreased in patients with end-point events (45.00±13.06 vs. 62.61±11.89 cm/s p=0.001). Worth to say, the percentage of moderate or severe LASEC in end-point events group was significantly higher than without end-point events group (46.6% vs. 13.8%, p=0.01, Fig1 and Fig2). In SEC positive group, the patients’ LAA pulsed wave peak velocity was importantly decreased than SEC negative group (45.83±9.42 vs. 64.62±11.20 cm/s, p<0.001), meaning the functional degeneration of LAA. A significantly correlation (p<0.001, r=0.580) was detected between moderate or severe LASEC and the composite end points (death, stroke, bleeding and DRT).