Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection.

AIMS: 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. METHODS AND RESULTS: 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). CONCLUSION: TauroPace is safe but more effective than H2O2 in reducing CIED infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05576194.

The European TauroPace™ Registry.

BACKGROUND: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic mesh envelope resulted in significant reduction in infections related to cardiac implantable electronic devices. The adjunctive use of taurolidine for this purpose is relatively novel and not considered in the guidelines. The required evidence may consist of a set of clinical studies. METHODS: The European TauroPaceTM registry (ETPR) prospectively evaluates every consecutive invasive procedure involving any CIED with adjunct TauroPace™ use in the contributing centres. As the estimation of the infection rate needs to be defensible, only interventions registered prior to the procedure will be followed-up. The endpoint is a major cardiac implantable electronic device infection according to the novel CIED infection criteria (1). Secondary endpoints comprise all-cause mortality, complications, adverse events of all grades, and major CIED infections during all follow-up examinations. The follow-up times are three months, twelve months, and eventually 36 months, as acute, subacute, and long-term CIED infections are of interest. RESULTS: As the rate of CIED infections is expected to be very low, this registry is a multicentre, international project that will run for several years. Several reports are planned. The analyses will be included in the case number calculations for future randomised controlled trials. CONCLUSIONS: The ETPR will accumulate large case numbers to estimate small event rates more precisely; we intend to follow up on participants for years to reveal possible late effects.

Use of Taurolidine in a Patient With a Cardiac Implantable Electronic Device Protrusion.

We report the successful salvage of cardiac implantable electronic device pulse generator protrusion sealed by the surrounding skin in a frail patient presenting 5 months after the last surgical revision. (Level of Difficulty: Advanced.).

Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old.

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.

Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine.

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.

Coronary Artery Dimensions in Endurance Athletes by Computed Tomography Angiography: A Quantitative Analysis.

(1) Background: The athlete's heart may develop permanent vessel enlargement. The purpose of our study was to define normal values for coronary artery dimensions of endurance athletes by coronary computed tomography angiography (CTA). (2) Methods: Ninety-eight individuals (56.2 ± 11 years) were included into this retrospective matched case-controlled-study. Endurance athletes had regular training volumes of ≥1 h per unit, ≥3-7 times per week (either cycling, running or mountain-endurance). Athletes were matched for age and gender with sedentary controls using propensity score. Quantitative CTA analysis included coronary vessel dimensions (two diameters and area) of the LM, LAD, CX and RCA for all AHA-16-segments. (3) Results: Proximal LAD area and diameter (p = 0.019); proximal/mid CX (diameter and area; p = 0.026 and p = 0.018/p = 0.008 and p = 0.009); mid RCA diameter and area; and proximal RCA diameter were significantly larger in endurance athletes (p < 0.05). The left main area (p = 0.708) and diameter (p = 0.809) as well as the mid LAD and distal segments were not different. We present the histograms and data for normal values ±1 and ± 2 SD. (4) Conclusions: Endurance athletes have larger proximal LAD, proximal/mid CX and RCA vessel dimensions, while LM and distal segments are similar. Hence, dilated coronary arteries in endurance athletes ("Athlete's arteries") have to be distinguished from diffuse ectatic segments developing during Kawasaki disease or multisystemic inflammation syndrome after COVID-19.

Differences in coronary vasodilatory capacity and atherosclerosis in endurance athletes using coronary CTA and computational fluid dynamics (CFD): Comparison with a sedentary lifestyle.

BACKGROUND: The aim was to assess the effect of endurance exercise on coronary vasodilatory capacity and atherosclerosis by coronary computed tomography angiography (CTA) and computational fluid dynamic (CFD) modelling. METHODS: 100 subjects (age 56.2y±11, 29 females) who underwent coronary CTA were included into this retrospectively matched cohort study. Endurance athletes (≥1 h per unit and ≥3 times per week training) were compared to controls with a sedentary lifestyle, and within subgroups with and without sublingual nitroglycerin preparation. CTA image analysis included coronary stenosis severity (CADRADS), total (segment involvement score = SIS) and mixed plaque burden (G-score), high-risk plaque criteria, the coronary artery calcium score (CACS) and CFD analysis including Fractional Flow Reserve (FFRCT), myocardial mass (M), total vessel lumen volume (V) and volume-to-mass (V/M) ratio. RESULTS: The prevalence of atherosclerosis by CTA was 65.4 % and >50 % coronary stenosis was found in 17.3 % of athletes. Coronary stenosis severity (CADRADS), total and mixed non-calcified plaque burden (SIS and G-score) were lower in athletes (p = 0.003 and p < 0.001) but not CACS (p = 0.055) and less high-risk plaques were found (p < 0.001). The G-score was correlated with distal FFRCT (p = 0.025). V/M-ratio was different between athletes who received nitroglycerin compared with those who did not (V/M: 21.1 vs. 14.8; p < 0.001), but these differences were not observed in the control subjects. CONCLUSION: Endurance training improves coronary vasodilatory capacity and reduces high-risk plaque and mixed non-calcifed plaque burden as assessed by coronary CTA angiography. Our study may advocate coronary CTA with FFRCT for evaluation of coronary artery disease in endurance athletes.