Hemocompatibility-related Adverse Event
Conditions
Keywords
hemocompatibility-related adverse event
Brief summary
The goal of this observational study is to investigate the impact of oral warfarin anticoagulation combined with or without aspirin on the incidence of non-surgical hemocompatibility-related adverse events (HRAEs) and survival in advanced heart failure patients after implantation of the fully magnetic levitation left ventricular assist device (CH-VAD). The main question it aims to answer is : The incidence of non-surgical HRAEs and survival treated with oral warfarin anticoagulation combined with or without aspirin in Chinese CH-VAD implanted advanced heart failure patients. CH-VAD has been approved in China for the treatment of patients with advanced heart failure.
Detailed description
This was a multi-center, retrospective observational study including patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025. Patients who died during the index hospitalization were excluded. Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) were also excluded to avoid exposure misclassification. Patients were divided into two groups: those receiving aspirin in addition to warfarin (ASA+VKA) versus those receiving warfarin alone (VKA only). Warfarin was started once the patient was clinically stable and able to tolerate oral medication, with a target international normalized ratio (INR) of 2.0-2.5. For patients receiving aspirin, the dose was 100 mg daily. The primary endpoint was a composite of survival free of major nonsurgical HRAEs at 12 months. Nonsurgical events were defined as any event occurring \> 14-days post implant to avoid perioperative confounding. The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism.
Interventions
DEVICECH-VAD
Patients who underwent CH-VAD implantation.
Sponsors
Zhejiang Provincial People's Hospital
Sichuan Provincial People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shanghai Zhongshan Hospital
Jiangsu Provincial People's Hospital
Ruijin Hospital
Sir Run Run Shaw Hospital
Henan Provincial Chest Hospital
Wuhan Asia Heart Hospital
First Affiliated Hospital of Zhejiang University
Second Hospital of Jilin University
Chinese Academy of Medical Sciences, Fuwai Hospital
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025.
Exclusion criteria
* Patients who died during the index hospitalization. * Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint was survival free from non-surgical HRAEs at 12 months, estimated using Kaplan-Meier methods. | Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days. | The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism. Nonsurgical events were defined as any event occurring \> 14-days post implant to avoid perioperative confounding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints were the individual components of the composite. | Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days. | The composite was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism. Nonsurgical events were defined as any event occurring \> 14-days post implant to avoid perioperative confounding. |
Countries
China
Outcome results
None listed