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

Evangelic Hospital Kalk Cologne

Status: Enrolling

Conditions: Defibrillators, Implantable; Pacemaker, Artificial; Infections

Treatments: Device: Extraction tools

Study type: Observational

Funder types: Other

Identifiers

NCT06597578

2023KÖB

Details and patient eligibility

About

The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads > 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative/procedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.

Full description

The following parameters will be included in the registry Preoperative

General:

• pacemaker / ICD indication
• Ejektionsfraktion
• previous cardiac surgery / TAVR
• specific cardiac disease: IHD, CMP (DCM, HCM, andere), Primary electrical disease if ICD:
• primary / secondary prevention concomitant disease:HTN, DM
• CRF; GFR (ml/min)
• if yes: dialysis ?
• anticoagulation / antithrombotic therapy: Ja/Nein

Indication:

• infection (local/systemic), classification
• blood culture positive/negative
• swab positive
• classification
• TEE: pos/neg
• Device malfunction
• Phlebography y/n
• Vascular access y/n
• Number of Leads and Type
• uni/bipolar / age / abandoned leads
• ICD-leads: single-/dual-coil, age / abandoned leads

Intraoperative:

General:

• type of anaethesia
• TEE y/n
• Safety wire y/n
• temporary pacing wire y/n

Access:

• Subclavia r/l/bil
• Femoral: y/n; if yes: planned / Bailout: geplant Tools
• LLD: y/n; Number
• Mechanical sheath and type
• Laser sheath
• Additional tools: Loop-Snare / Needle-Eye Snare / Rat-Tooth Result : extraction: complete / partial / failed
• procedural success: y/n
• infection: procedural / clinial success
• Safety lead y/n
• temporary pacing wire in situ Intraoperative complications
• vascular injury
• pericardial effusion / tamponade
• pericardiocentesis
• occlusion ballon
• thoracotomy
• Intraoperative catecholamines
• death

Postoperative:

• duration
• hospital stay
• postoperative active system
• transvenous / epicardial / capsule/ subcutaneous / extravascular
• type of pacemaker
• type of ICD
• Wenn ja: transvenös / subkutan

Postoperative complications:

• hematoma / seroma / fistula
• further interventions: Revision / hematoma/ reinfection

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines

Exclusion criteria

• None