Prospective Cologne Bonn Registry for Extraction of Pacemaker and ICD Leads Observing Outcomes Using Different Extraction Tools in Patients Needing Lead Removal

What this Trial Is About

Researchers are conducting the KOBES registry, a prospective clinical registry including all patients undergoing complex lead extraction procedures for pacemakers and implantable cardioverter defibrillators ICDs at the Cologne Bonn lead extraction center. The registry focuses on patients with leads implanted for more than 6 months, collecting detailed data before, during, and after the procedure to better understand outcomes and procedural success. This observational study records information in a hybrid operating room setting with cardiothoracic backup available. The study evaluates the use of different extraction devices and tools during lead removal procedures. Data collected includes preoperative patient characteristics such as cardiac function, previous surgeries, infections, and comorbidities intraoperative factors like anesthesia type, tools used, and complications and postoperative details including hospital stay and complications. The registry aims to monitor procedural success within one week and complications up to one year after extraction. Participants will provide written informed consent, and their data will be pseudonymized and entered into a database reviewed independently by a monitoring board. Assessments include diagnostic tests like echocardiography, blood cultures, and imaging studies, as well as recording of any complications or additional interventions. This registry allows ongoing observation and data collection over time to better understand outcomes for patients undergoing lead extraction.

Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads