Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.

N/ANot Yet RecruitingNCT07530107

IRCCS Ospedale San Raffaele300 enrolled

Overview

The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Cardiac Implantable Electronic Device (CIED)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years. * Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020. Exclusion Criteria: * Lack of active status of follow-up

Outcomes

Primary Outcomes

Major clinical adverse outcomes

Cardiovascular mortality

Time frame: 1 year and 5 years follow up

Major clinical adverse outcomes

cardiovascular rehospitalization

Time frame: 1 year and 5 years follow up

Major clinical adverse outcomes

all-cause mortality

Time frame: 1 year and 5 years follow up

Secondary Outcomes

need of re-implantation of CIED for patients who underwent TLE

Eventual re-implantation after TLE, during the sane or a following hospitalization. Timing between TLE and re-implantation

Time frame: discharge, 1 and 5 years

Central Contacts

SImone Gulletta, MD

CONTACT

02 2643 7484 gulletta.simone@hsr.it

Data from ClinicalTrials.gov

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