TauroPace (Tauropharm, Bavaria Germany), a taurolidine solution for combating cardiac implantable electronic device (CIED) infection, was compared with a historical control of 3% hydrogen peroxide (H2O2) in a prospective observational study. The device pocket was irrigated, and all hardware accessible within (leads, suture sleeves, pulse generator) was wiped with H2O2, TauroPace, or taurolidine in a galenic formulation during any invasive CIED procedure at the study centre. Only CIED procedures covered by TauroPace or H2O2 from 1 January 2017 to 28 February 2022 were included for analysis. Patients who underwent >1 procedure were censored for the last treatment group and reassigned at the next procedure. The primary endpoint was major CIED infection within 3 months. The secondary endpoints were CIED infection beyond 3 months, adverse events potentially related to the antimicrobial solutions, CIED system, procedure, and death, till the end of follow-up. TauroPace covered 654 procedures on 631 patients, and H2O2 covered 551 procedures on 532 patients. The TauroPace group had more patient risk factors for infection than the H2O2 group (P = 0.0058) but similar device and procedure-specific risk factors (P = 0.17). Cardiac implantable electronic device infection occurred in 0/654 (0%) of the TauroPace group and 6/551 (1.1%) of the H2O2 group (P = 0.0075). Death occurred in 23/654 (3.5%) of the TauroPace group and 14/551 (2.5%) of the H2O2 group (P = 0.33). Non-infection related adverse events were rarer in the TauroPace (3.8%) than the H2O2 (6.0%) group (P = 0.0802). TauroPace is safe but more effective than H2O2 in reducing CIED infection. ClinicalTrials.gov Identifier: NCT05576194
4 October 2024 in Journal of Cardiothoracic Surgery
Introduction: Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections. Methods: This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan–Meier statistics were employed to analyze event rates. Results: From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed. Conclusions: TP appears to be effective and safe in preventing CIED infections. ClinicalTrials.gov Identifier: NCT04735666.
We reported the novel use of a taurolidine-containing antimicrobial solution in the successful salvage of a partially exposed and polymicrobially infected cardiac implantable electronic device pulse generator in a frail patient unfit for lead extraction. The old, salvaged device was entirely internalized, and there were no signs of recurrent infection at 9 months follow-up.
Ventricular assist devices (VADs) are used to provide mechanical circulatory support to patients with end-stage heart failure. The driveline connecting the external power source to the pump(s) of the intra-corporal VAD breaches the protective skin barrier and provides a track for microbes to invade the interior of the patient’s body. Driveline infection constitutes a major and potentially fatal vulnerability of VAD therapy. Driveline infection cannot traditionally be salvaged and requires the extraction of the entire VAD system. We report here the successful eradication of a VAD driveline infection with a taurolidine-containing antimicrobial solution used for preventing the infection of cardiac implantable electronic devices. If replicated in more cases, the novel treatment concept described here may provide a valuable alternative management strategy of salvage rather than explantation for VAD driveline infection.
Left bundle branch block (LBBB) causes immediate electrical and mechanical dys-synchrony of the left ventricle (LV) and gradual structural damages in the Purkinje cells and myocardium. Mechanical dys-synchrony reduces the LV ejection fraction (EF) instantly, but only to ≈55% in an otherwise normal heart. Because of the heart's in-built functional redundancy, a patient with LBBB does not always notice the heart's reduced efficiency straight away. After a variable period of time (which could be from days to decades), the patient may become symptomatic with heart failure (HF), which classifies as HF with preserved EF≥50% (HFpEF). The LVEF drops further due to continuous adverse remodeling and inefficient cardiac contraction. The patient transits into HF with moderately reduced EF35-50% (HFmrEF) and then reduced EF≤35% (HFrEF) over 5-21 years. Cardiac resynchronization therapy (CRT) is currently only indicated in guidelines for HFrEF and LBBB. LBBB shortens the median survival of HFmrEF patients by 5.5 years. Randomized controlled trials (RCTs) have shown CRT improves echocardiographic indices for HFmrEF with LBBB. CRT in HFpEF with LBBB is a promising but under-explored/utilized therapy. There have been anecdotal reports that CRT produced symptom relief in patients debilitated by HFpEF with LBBB, who constitute ≈6% of all HF patients and an adequate pool of potential RCT participants. Conduction system pacing in the form of left bundle branch area pacing is an emerging pacing strategy that might reverse and forestall the deleterious effects of LBBB.
Background: Cardiac implantable electronic devices (CIEDs) are commonly used to treat cardiac arrhythmias and prevent sudden cardiac death. Complications of CIED therapy include component malfunction, lead dislodgement, skin erosion and infection. Infection can result in significant morbidity and even mortality. The recommended treatment of CIED skin erosion and infection is urgent complete device extraction. When this is infeasible due to patient or resource factors, an attempt could be made to salvage the exposed or infected CIED system by debridement of all the infected necrotic tissues and irrigation of the pocket and contaminated hardware with anti-septic/antibiotic solutions. Taurolidine, when dissolved in an aqueous solution, produces a broad spectrum of antimicrobial actions and may be used as a novel irrigation agent during CIED salvage. Case presentation: This report describes the first use of a taurolidine-containing solution for pocket irrigation and in situ hardware sterilisation that resulted in the successful salvage of a CIED infected with multi-resistant Staphylococcus epidermidis. Conclusions: A taurolidine-containing antimicrobial solution can be a safe and effective alternative to traditional antiseptic/antibiotic solutions for pocket irrigation and in situ hardware sterilisation during CIED salvage, and may produce better clinical outcomes by some unique mechanisms of action such as inhibition of biofilm formation and neutralisation of endotoxins, with little risk of inducing and encountering resistance.