ABSTRACT
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.
Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Prosthesis-Related Infections , Registries , Taurine , Thiadiazines , Humans , Thiadiazines/therapeutic use , Taurine/analogs & derivatives , Taurine/therapeutic use , Male , Female , Prosthesis-Related Infections/prevention & control , Aged , Defibrillators, Implantable/adverse effects , Pacemaker, Artificial/adverse effects , Middle Aged , Europe , Prospective Studies , Anti-Infective Agents, Local/therapeutic useABSTRACT
BACKGROUND: The association between QRS narrowing and response to cardiac resynchronization therapy (CRT) has been investigated by several studies, but their findings remain inconclusive. Aim of our study was to explore the relationship between QRS Index and echocardiographic response to CRT. METHODS: This multicenter, retrospective analysis included 326 consecutive patients (mean age was 70.0±10.1 years old; males 76.7%) who underwent CRT-D implantation in primary and secondary prevention between 2018 and 2020. The estimation of QRS shortening after CRT-D implantation was precisely assessed through the QRS Index, calculated as follows: [(QRS duration before implantation - paced QRS duration)/QRS duration before implantation]*100. RESULTS: After a mean follow-up of 12.7±4.5 months, 55.2% (180/326) of the patients showed an echocardiographic response to CRT. The median [25-75th] QRS Index was 3.85% [-14.1% - +13.9%]. The best predictive cut-off value of QRS Index was 1.40% (sensitivity 70.4%, specificity 64.5%, AUC 0.70). In patients with left bundle branch block, the median [25-75th] QRS Index was 9.85% [+3.87% - +16.7%]. In this subgroup, the AUC was 0.737 and the best predictive cut-off of QRS Index was 2.20% (sensitivity 78.3%, specificity 67%). The multivariable model showed that only left ventricular ejection fraction and QRS Index were independently associated with CRT response (respectively OR 0.92, CI 95% 0.86-0.98, P=0.01 and OR 1.057, CI 95% 1.026-1.089, P<0.001). CONCLUSIONS: The QRS Index tightly correlated with CRT response. Only LVEF and QRS Index were independently associated with echocardiographic response to CRT.
Subject(s)
Cardiac Resynchronization Therapy , Male , Humans , Middle Aged , Aged , Aged, 80 and over , Stroke Volume/physiology , Ventricular Function, Left , Electrocardiography , Retrospective Studies , Treatment Outcome , EchocardiographyABSTRACT
BACKGROUND: Sarcopenia is the core component of frailty; however, its role in patients undergoing transcatheter aortic valve replacement (TAVR) is a matter of debate. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). AIMS: We aim to evaluate the QoL of sarcopenic and non-sarcopenic patients with severe AS undergoing TAVR. METHODS: TASQ was prospectively administered to patients undergoing TAVR. All patients completed the TASQ before TAVR and at a 3-month follow-up. The study population was divided in two groups according to sarcopenic status. The primary endpoint was the TASQ score in the sarcopenic and non-sarcopenic cohorts. RESULTS: In total, 99 patients were eligible for the analysis. In both sarcopenic (n = 56) and non-sarcopenic (n = 43) cohorts, significant changes were observed in the overall TASQ score and in all but one (i.e., health expectations) of the individual domains (p < 0.01). Sarcopenic and non-sarcopenic patients showed substantial improvements across TASQ subscores. The mean change in overall TASQ score at three months revealed a significant improvement in both cohorts (p < 0.01). Health expectations worsened in sarcopenic patients at the 3-month follow-up (p = 0.06). CONCLUSIONS: The TASQ questionnaire revealed changes in QoL after TAVR, regardless of patients' sarcopenic status. Health status improved substantially in both sarcopenic and non-sarcopenic patients following TAVR. Lack of improvement in health expectations seems to depend on patients' expectations regarding the procedure and specific aspects in the evaluation of the outcome.
ABSTRACT
BACKGROUND: External electrical cardioversion (EEC) has been suggested as a cause of myocardial damage, but results from several previously published studies are conflicting. HYPOTHESIS: The purpose of the study was to evaluate myocardial electrical injury caused by EEC. METHODS: After elective EEC for atrial fibrillation (AF), cardiac troponin I (cTnI) was measured in 193 consecutive patients attending the Cardiology Department of the San Maurizio Hospital of Bolzano for elective EEC of AF over a period of 13 months. External electrical cardioversion was performed by one of the attending cardiologists with a synchronized monophasic defibrillator. Blood sample for cTnI was taken 18-20 h after EEC. RESULTS: Of 193 patients, 183 (95%) were successfully cardioverted. Mean number of shocks was 1.46 and the mean total energy discharged per procedure was 379.4 +/- 229.2 J. Cardiac troponin remained under the limit of confidence for all patients with a mean value of 0.017 +/- 0.021 mcrg/l. No correlation between total energy delivered and cTnI was found. In the subgroup of patients with low ejection fraction, none had elevated cTnI, and no difference in cTnI values between these and patients with an ejection fraction > 40% was found. CONCLUSIONS: The results of our analysis indicate that EEC caused no myocardial injury even in patients with low ejection fraction.