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Since the arrival of leadless pacemakers (LPs), they have become a cornerstone in remedial treatment of bradycardia and atrioventricular (AV) conduction disorders, as an alternative to transvenous pacemakers. Even though clinical trials and case reports show indisputable benefits of LP therapy, they also bring some doubts. Together with the positive results of the MARVEL trials, AV synchronization has become widely available in LPs, presenting a significant development in leadless technology. This review presents the Micra AV (MAV), describes major clinical trials, and introduces the basics of AV synchronicity obtained with the MAV and its unique programming options.
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Lipopolisacáridos , Marcapaso Artificial , Humanos , Diseño de Equipo , Bradicardia/diagnóstico , Bradicardia/terapia , Estimulación Cardíaca Artificial/métodosRESUMEN
BACKGROUND: Implantable cardioverter-defibrillators (ICD)/cardiac resynchronization therapy with defibrillation (CRT-D) recipients may be susceptible to the arrhythmic effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. AIMS: We aimed to evaluate characteristics and outcomes of patients hospitalized for ICD/CRT-D shocks during the pandemic compared to the pre-pandemic period. METHODS: This retrospective study analyzed medical records of patients hospitalized for ICD/CRT-D shock in the pre-pandemic (January 1, 2018-December 31, 2019) and pandemic periods (March 4, 2020-March 3, 2022). Survival data were obtained on October 24, 2022. RESULTS: In total, 198 patients (average age 65.6 years) had 138 pre-pandemic and 124 pandemic visits. Of these patients, 115 were hospitalized during pre-pandemic, 108 during the pandemic, and 25 in both periods. No significant differences were noted in age, sex, number of shocks, or appropriateness of therapy between these periods. During the pandemic, during 14 hospital stays of patients with SARS-CoV-2, 8 (57.1%) received electrical shocks, compared to 12 (10.9%) with negative SARS-CoV-2 tests (P <0.001). The in-hospital mortality rate was 2 of 115 patients hospitalized during the pre-pandemic and 7 of 108 during pandemic periods (4 patients with and 3 without SARS-CoV-2 [P = 0.10]). During the follow-up, there were 66 deaths. Cox regression analysis showed that survival decreased with age and heart failure decompensation in medical history but increased with higher ejection fraction. The pandemic alone was not a survival predictor. However, SARS-CoV-2 infection, older age, and heart failure decompensation in medical history predicted worse outcomes during the pandemic period. CONCLUSIONS: The pandemic did not increase the number of hospital visits due to ICD/CRT-D discharges. SARS-CoV-2 infection predicts increased mortality in patients with ICD/CRT-D shocks.
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COVID-19 , Desfibriladores Implantables , Insuficiencia Cardíaca , Humanos , Anciano , Estudios Retrospectivos , Pandemias , COVID-19/terapia , SARS-CoV-2 , Insuficiencia Cardíaca/terapia , Servicio de Urgencia en HospitalRESUMEN
Introduction: Redox imbalance and oxidative stress are involved in the pathogenesis of arrhythmias. They also play a significant role in pathogenesis of heart failure (HF). In patients with HFand implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D), the direct current shocks may be responsible for additional redox disturbances and additionally increase arrhythmia risk. However, the precise role of oxidative stress in potentially fatal arrhythmias and shock induction remains unclear. Methods: 36 patients with diagnosed HF and implanted ICD/CRT-D were included in this study. Patients were qualified to the study group in case of registered ventricular arrhythmia and adequate ICD/CRT-D intervention. The control group consisted of patients without arrhythmia with elective replacement indicator (ERI) status. Activity of superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx), glutathione (GSH) in erythrocyte (RBC), SOD, GPx activity and reactive oxygen/nitrogen species (ROS/RNS) concentration in plasma were determined. The values were correlated with glucose, TSH, uric acid, Mg and ion concentrations. Results: In the perishock period, we found a significant decrease in RBC and extracellular (EC) SOD and RBC CAT activity (p = 0.0110, p = 0.0055 and p = 0.0002, respectively). EC GPx activity was also lower (p = 0.0313). In all patients, a decrease in the concentration of all forms of glutathione was observed compared to the ERI group. Important association between ROS/RNS and GSH, Mg, TSH and uric acid was shown. A relationship between the activity of GSH and antioxidant enzymes was found. Furthermore, an association between oxidative stress and ionic imbalance has also been demonstrated. The patients had an unchanged de Haan antioxidant ratio and glutathione redox potential. Conclusion: Here we show significant redox disturbances in patients with HF and ICD/CRT-D interventions. Oxidative stress may be an additional risk factor for the development of arrhythmia in patients with HF. The detailed role of oxidative stress in ventricular arrhythmias requires further research already undertaken by our team.
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BACKGROUND: Transvenous lead extraction (TLE) is recommended in cases of local and systemic infections related to cardiac implantable electronic devices (CIEDs). Additionally, TLE is indicated in the event of lead damage or CIED malfunction. The extraction procedure is associated with a risk of life-threatening complications. OBJECTIVES: The aim of the EVO registry was to assess the safety and efficacy of birotational Evolution tool usage. MATERIAL AND METHODS: This registry study was prospectively conducted in 8 high-volume implantation centers in Poland. The study included 133 patients aged 63.5 ±15.1 years, and 76.69% were male. Indications for the procedure were: local or systemic infection (33.1%) and lead dysfunction (66.9%). The number of leads extracted varied from 1 (39.84%) to 3 (9.77%). RESULTS: Clinical procedural success was achieved in 99.1% of cases. A total of 226 leads were extracted, and 206 used the Evolution system. Two procedural strategies were identified while using the Evolution system: (1) usage of locking stylet, propylene sheaths and the Evolution system (118 leads, 52%) - group A; (2) usage of locking stylet and Evolution (88 leads, 39%) - group B. There were no differences in the number of complications between these 2 groups. The extraction time was significantly shorter (p = 0.02) in group B than in group A. Major complications occurred in 5.2% of cases with 2 intraprocedural deaths. Minor complications occurred in 1.5% of patients. CONCLUSIONS: The registry confirmed the efficacy and relative safety of the birotational Evolution sheath. Using the rotational sheath as a first attempt significantly reduces extraction time without compromising its safety.
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Desfibriladores Implantables , Marcapaso Artificial , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Desfibriladores Implantables/efectos adversos , Remoción de Dispositivos , Empleo , Marcapaso Artificial/efectos adversos , Estudios Prospectivos , Sistema de Registros , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Transluminal lead extraction (TLE) is a well-established procedure for the removal of damaged or infected pacing systems. Despite its high efficacy, the procedure is associated with significant risks, some of which may contribute to severe life-threatening complications. Herein, we present the case of a 90-year-old female who was 100% pacemaker-dependent (PM-dependent) and had ventricular lead fragmentation after the TLE procedure. In this elderly patient, after taking into account the whole clinical context-age, frailty syndrome, infection, and high peri- and postprocedural risks-we decided on MICRA VR implantation as well as leaving the remains of the ventricular lead in the right heart chambers. A Leadless pacemaker (LP) is an excellent alternative to PM-dependent individuals, in whom implantation of permanent transvenous PM is precluded due to multiple infectious and non-infectious issues.
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Anciano Frágil , Marcapaso Artificial , Anciano , Anciano de 80 o más Años , Remoción de Dispositivos , Femenino , Humanos , PlomoRESUMEN
BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR). AIMS: To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES). METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR). RESULTS: Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02). CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.
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Angioplastia Coronaria con Balón , Reestenosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Catéteres Cardíacos , Materiales Biocompatibles Revestidos , Reestenosis Coronaria/etiología , Reestenosis Coronaria/cirugía , Stents Liberadores de Fármacos/efectos adversos , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.
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Background: Data regarding management of patients with unprotected left main coronary artery in-stent restenosis (LM-ISR) are scarce. Objectives: This study investigated the safety and effectiveness of percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) for the treatment of unprotected LM-ISR. Methods: Consecutive patients who underwent PCI or CABG for unprotected LM-ISR were enrolled. The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE), defined as cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and stroke. Results: A total of 305 patients were enrolled, of which 203(66.6%) underwent PCI and 102(33.4%) underwent CABG. At 30-day follow-up, a lower risk of cardiac death was observed in the PCI group, compared with the CABG-treated group (2.1% vs. 7.1%, HR 3.48, 95%CI 1.01-11.8, p = 0.04). At a median of 3.5 years [interquartile range (IQR) 1.3-5.5] follow-up, MACCE occurred in 27.7% vs. 29.6% (HR 0.82, 95%CI 0.52-1.32, p = 0.43) in PCI- and CABG-treated patients, respectively. There were no significant differences between PCI and CABG in cardiac death (9.9% vs. 18.4%; HR 1.56, 95%CI 0.81-3.00, p = 0.18), MI (7.9% vs. 5.1%, HR 0.44, 95%CI 0.15-1.27, p = 0.13), or stroke (2.1% vs. 4.1%, HR 1.79, 95%CI 0.45-7.16, p = 0.41). TVR was more frequently needed in the PCI group (15.2% vs. 6.1%, HR 0.35, 95%CI 0.15-0.85, p = 0.02). Conclusions: This analysis of patients with LM-ISR revealed a lower incidence of cardiac death in PCI compared with CABG in short-term follow-up. During the long-term follow-up, no differences in MACCE were observed, but patients treated with CABG less often required TVR. Visual overview: A visual overview is available for this article. Registration: https://www.clinicaltrials.gov; Unique identifier: NCT04968977.
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[Figure: see text].