Premature Ventricular Complexes, Ventricular Tachycardia (VT)
Conditions
Keywords
Ablation
Brief summary
The investigators aim to characterize patients presenting with a severe ventricular tachycardia (VT) and premature ventricular complex (PVC)-ablation-related complication including patient characteristics, procedural details and subsequent management of the complication by gathering existing patient-level data.
Interventions
None listed
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Centers : Centers participating in the present collaborative study group. Invitation to participate will be based either upon personal referral of one of the investigator, previous collaboration or based on a meta-analytic review of the literature published on the subject within the past 20 years. * Patients: Females and males of \>18 years undergoing any type of VT/PVC ablation. While we will accept redo-procedure we will ask for a unique patient-identifier to link procedures belonging to the same patients together. * Interventions: VT/PVC ablation (first intervention or re-do) as routinely performed by the participating centers * Outcomes: Severe complications, defined as hemodynamic instability requiring mechanical intensive-care management, tamponade, stroke, cardiac arrest, myocardial infarction, phrenic nerve palsies, major bleeding requiring transfusion, vascular or cardiac complication requiring surgery, procedure-related death. * Setting: Observational cohort studies, registries, retrospective cohort studies. Data stemming from RCTs (Randomized controlled trials) will not be collected as they likely do not represent a "real-life" setting. * Length of follow-up: Peri-procedural complications * Years considered: Not limited to a specific time-frame, but to reflect common ablation practices, we will focus on data from the 20 past years. * Number of patients provided : No lower limit of patients provided per dataset or ablation volume per year to include high- as well as low-volume centers
Exclusion criteria
* Refusal of the center to participate. * Less than 10 procedures available in the dataset (no case reports) * Missing essential baseline characteristics, missing collection of sufficient details regarding each complication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive characterization of patients | up to 30 days | characterizing features: * hemodynamic instability requiring mechanical intensive-care management * tamponade * stroke * cardiac arrest * myocardial infarction * coronary artery dissection * phrenic nerve palsy * major bleeding as per the International Society on Thrombosis and Haemostasis (ISTH) * vascular or cardiac complication requiring surgery or interventional management (interventional radiology, angiology) * iatrogenic atrio-ventricular block requiring device implantation or upgrade. * procedure-related death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of each severe complication | up to 30 days | — |
| Difference in baseline characteristics between the patients who experienced a complication and the ones who did not | up to 30 days | — |
| The contribution of important baseline and procedural characteristics to the occurrence of a severe complication | up to 30 days | — |
| Impact of center-specific data on the occurrence and management of these complications | up to 30 days | Case-load of the centers, number of electrophysiologists, geographic hospital location, routine use of ICE (Intracardiac Echocardiography) |
Countries
Austria, Canada, China, Croatia, France, Germany, Greece, Israel, Italy, Singapore, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTMichael Kühne, Prof. Dr. med.
CONTACTPatrick Badertscher, PD Dr. med.
PRINCIPAL_INVESTIGATORMichael Kühne, Prof. Dr. med.
University Hospital, Basel, Switzerland
Outcome results
None listed