https://doi.org/10.1007/s00392-024-02526-y
1Universitätsklinikum Schleswig-Holstein Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin Lübeck, Deutschland; 2Schön Klinik Neustadt Klink für Innere Medizin und Kardiologie Neustadt in Holstein, Deutschland; 3Friedrich-Ebert-Krankenhaus Neumünster GmbH Medizinische Klinik Neumünster, Deutschland
Background:
Previous studies have shown efficacy and safety of EkoSonic Endovascular System (EKOS) in the treatment of intermediate-high risk (IHR) pulmonary embolism (PE). However, it is not specified whether there are differences between treatment within regular working hours (RW) or working on duty (OD) regarding safety and efficacy.
Objective:
To compare safety and efficacy of EKOS in IHR-PE within RW or OD.
Methods:
A total of 154 consecutive patients with IHR- PE undergoing EKOS-lysis at 3 centers (University Heart Center Lübeck, FEK Neumünster, Schön Klinik Neustadt) were enrolled. The working time was defined as RW and OD according to the working hours of the individual clinic.
The primary safety endpoints were mortality and complications, which were divided into bleeding complications and non-bleedings-complications. All bleeding complications were again divided into procedure-related or non-procedure-related. The secondary efficacy endpoints were reduction in right ventricle/left ventricle (RV/LV) ratio, systolic pulmonary artery pressure (sPAP) and increase in TAPSE.
Results:
Of 154 patients, 99 EKOS-lysis were performed at RW, while 55 were done OD. There were no significant differences among baseline characteristics and peri-procedural data between both groups. Overall mean age was 64±13.8 years, with 80(51.9%) female patients. All patients were at least diagnosed as IHR-PE with a mean Wells-Score of 3.29±1.33.
Door-to-EKOS-lysis (44.5±96.2h vs. 31.9±70h; p=0.012), as well as CT-to-EKOS-lysis time (18.8±40.9h vs. 4.28±6.38h; p=0.002) were both significantly lower OD.
In total, less overall complications were seen OD hours (20(20.2%) vs. 4(7.3%); p=0.034). Hereby, overall bleeding complications were seen significantly less often OD (18(18.2%) vs. 3 (5.5%); p=0.027). Procedure-related bleedings occurred in 13(13.1%) vs. 2(3.6%) (p=0.432), while non-procedure-related bleedings were seen in 5(5.1%) vs. 1(1.8%) patients (p=0.182). Other complications occurred in 2(2%) vs. 1(1.8%) patients (p=0.732).(Figure 1,2)
During index hospitalization, death occurred in 10(6.5%) patients with no statistically significance between the groups (8(8.1%) vs. 2(3.6%); p=0.283).
Regarding efficacy, both groups showed a significant reduction of the RV/LV ratio when comparing admission to discharge. During RW, mean RV/LV ratio at admission was 1.21±0.196 vs. at discharge 0.897±0.166 (p<0.001). While OD, RV/LV ratio at admission vs. at discharge was 1.25±0.293 vs. 0.907±0.211 (p<0.001) (Figure 3).
sPAP reduction was significant in both groups (RW:45.9±12.2 vs. 32.7±10.9; p<0.001, OD: 44.5±9.65 vs. 33.6±12.9; p<0.001). At admission, TAPSE was 17.5±5.42, while at discharge 21.2±4.22; p<0.001 during RW, while OD 16.8±5.35 vs. 21.8±4.14; p<0.001.
Nevertheless, there were no statistically differences when comparing the RV/LV ratio reduction (p=0.739), difference in TAPSE (p=0.311) and sPAP (p=0.733) between admission and discharge between both groups.
Conclusion:
Performing EKOS-lysis in IHR patients during OD hours seems to be safe and similar effective with even lower rates of complications (especially significantly less bleedings) with equal efficacy parameters between the on and off hour groups. Therefore, all patients with central IHR-PE should be treated without delay by an experienced PERT team also during off hours.
Figure 1:Complication overview
Figure 2: Bleeding complications
Figure 3: RV/LV ratio