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Chemotherapy is the cornerstone of antineoplastic treatment in patients with malignancies. The cardiotoxic effect of antineoplastic therapy has been known for many decades. Part of chemotherapy-induced cardiotoxicity is the development of heart rhythm disturbances. This short review aims to provide a compact overview for the clinical cardiologist of the dysrhythmic potential created by antineoplastic agents in cancer survivors.
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BACKGROUND: Cephalic vein cutdown (CVC) and subclavian vein puncture (SVP) are the most commonly used access sites for transvenous lead placement of cardiac implantable electronic devices (CIEDs). Limited knowledge exists about the long-term patency of the vascular lumen housing the leads. METHODS: Among the 2703 patients who underwent CIED procedures between 2005 and 2013, we evaluated the phlebographies of 162 patients scheduled for an elective CIED replacement (median of 6.4 years after the first operation). The phlebographies were divided into four stenosis types: Type I = 0%, Type II = 1-69%, Type III = 70-99%, and Type IV = occlusion. Due to the fact that no standardized stenosis categorization exists, experienced physicians in consensus with the involved team made the applied distribution. The primary endpoint was the occurrence of stenosis Type III or IV in the CVC group and in the SVP group. RESULTS: In total, 162 patients with venography were enrolled in this study. The prevalence of high-degree stenosis was significantly lower in the CVC group (7/89, 7.8%) than in the SVP group (15/73, 20.5%, p = 0.023). In the CVC group, venographies showed a lower median stenosis (33%) than in the SVP group (median 42%). CONCLUSIONS: The present study showed that the long-term patency of the subclavian vein is higher after CVC than after SVP for venous access in patients with CIED.
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BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).
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Oxigenación por Membrana Extracorpórea , Infarto del Miocardio , Choque Cardiogénico , Humanos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Estudios Retrospectivos , Riesgo , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Resultado del Tratamiento , Revascularización MiocárdicaRESUMEN
Serious clinical complications (SCC; CTCAE grade ≥ 3) occur frequently in patients treated for hematological malignancies. Early diagnosis and treatment of SCC are essential to improve outcomes. Here we report a deep learning model-derived SCC-Score to detect and predict SCC from time-series data recorded continuously by a medical wearable. In this single-arm, single-center, observational cohort study, vital signs and physical activity were recorded with a wearable for 31,234 h in 79 patients (54 Inpatient Cohort (IC)/25 Outpatient Cohort (OC)). Hours with normal physical functioning without evidence of SCC (regular hours) were presented to a deep neural network that was trained by a self-supervised contrastive learning objective to extract features from the time series that are typical in regular periods. The model was used to calculate a SCC-Score that measures the dissimilarity to regular features. Detection and prediction performance of the SCC-Score was compared to clinical documentation of SCC (AUROC ± SD). In total 124 clinically documented SCC occurred in the IC, 16 in the OC. Detection of SCC was achieved in the IC with a sensitivity of 79.7% and specificity of 87.9%, with AUROC of 0.91 ± 0.01 (OC sensitivity 77.4%, specificity 81.8%, AUROC 0.87 ± 0.02). Prediction of infectious SCC was possible up to 2 days before clinical diagnosis (AUROC 0.90 at -24 h and 0.88 at -48 h). We provide proof of principle for the detection and prediction of SCC in patients treated for hematological malignancies using wearable data and a deep learning model. As a consequence, remote patient monitoring may enable pre-emptive complication management.
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BACKGROUND: Residual mitral regurgitation (MR) is thought to be an important predictor of long-term survival following transcatheter edge-to-edge repair (TEER). Intraprocedural MR assessment using transesophageal echocardiography could be limited by image quality, hemodynamics, and patient sedation. The MitraScore is a validated multimodal approach for intraprocedural MR assessment during TEER. OBJECTIVES: This study aimed to assess the impact of residual MR using the MitraScore on 1-year mortality. METHODS: Patients undergoing mitral TEER were eligible for inclusion in the prospective, multicenter MITRA-PRO registry (A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation). Patients with a MitraScore ≤3 were defined as patients with mild residual MR after mitral TEER, whereas a MitraScore ≥4 was considered as relevant residual MR. Mortality, rehospitalization, and major adverse events were assessed 1 year after TEER. RESULTS: A MitraScore ≤3 was found in 1,059 patients (71.0%), whereas 432 patients revealed a MitraScore ≥4 (29.0%). One-year mortality was significantly lower in patients with nonrelevant residual MR (MitraScore ≤3 14.6% vs MitraScore≥4 22.1%). An almost linear relationship between intraprocedural MitraScore after TEER and mortality was observed. The combined clinical endpoint of mortality and rehospitalization within the 1-year follow-up was also significantly lower in the MitraScore ≤3 group (31.5%) than in the MitraScore ≥4 group (40.8%). A subgroup analysis confirmed the predictive value of the MitraScore in patients with primary, secondary, or mixed MR etiologies. CONCLUSIONS: Residual MR assessed by intraprocedural MitraScore after TEER predicts 1-year mortality and rehospitalization. Therefore, the multimodal MitraScore improves MR assessment during mitral TEER and might improve patient survival.(A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation [MITRA-PRO]; DRKS00012288).
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/etiología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Resultado del Tratamiento , Sistema de Registros , Cateterismo Cardíaco/métodosRESUMEN
Aim: To evaluate the effects of a multimodal intervention (including exercise training, psychosocial interventions, nutrition coaching, smoking cessation program, medical care) on the health and long-term cardiovascular disease (CVD) mortality risk of company employees with pre-diabetes or diabetes mellitus (DM) at high CVD risk. Methods: In the PreFord study, German company employees (n=4196) participated in a free-of-charge CVD mortality risk screening at their workplace. Based on their European Society of Cardiology - Systematic Coronary Risk Evaluation score (ESC-SCORE), they were subdivided into three risk groups. High-risk patients (ESC-SCORE≥5%) were randomly assigned to a 15-week lifestyle intervention or usual care control group. Data from patients with pre-DM/DM were analyzed intention-to-treat (ITT: n=110 versus n=96) and per protocol (PP: n=60 versus n=52). Results: Body mass index, glycated hemoglobin, total cholesterol, low-density lipoprotein, triglyceride levels as well as systolic and diastolic blood pressure improved through the intervention (ITT, PP: p<0.001). The ESC-SCORE markedly decreased from pre- to post-intervention (ITT, PP: p<0.001). ESC-SCORE changes from baseline differed significantly between the groups, with the intervention group achieving more favorable results in all follow-up visits 6, 12, 24 and 36 months later (at each time point: ITT: p<0.001; PP: p ≤ 0.010). Conclusion: The study demonstrates the feasibility of attracting employees with pre-DM/DM at high CVD mortality risk to participate in a multimodal lifestyle program following a free CVD mortality risk screening at their workplace. The lifestyle intervention used in the PreFord study shows high potential for improving health of company employees with pre-DM/DM in the long term. ISRCTN23536103.
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Enfermedades Cardiovasculares , Diabetes Mellitus , Estado Prediabético , Humanos , Estudios de Seguimiento , Factores de Riesgo , Estilo de Vida , Enfermedades Cardiovasculares/prevención & controlRESUMEN
BACKGROUND: Pulsed field ablation (PFA) is a new, non-thermal technology in the treatment of atrial fibrillation (AF). Early investigations have shown a promising safety profile with durable pulmonary vein isolation (PVI) and large antral lesions. However, clinical data remains scarce. METHODS: We investigated a cohort of 43 patients. Twenty-three patients underwent PVI with PFA in our hospital and we analyzed them with regard to procedural characteristics and with regard to the size of acute antral lesion which was estimated by using an electroanatomical map of the left atrium (LA). We compared these data with data of 20 patients who had undergone cryoballon (CB) PVI in our hospital. RESULTS: We could show acute isolation of all veins in all patients (100% PFA, 100% CB). Post-ablation high-density mapping revealed no early reconnection (0%). The acute antral lesion size of PFA was significantly higher compared to the CB (67.03 ± 12.69% vs. 57.39 ± 10.91%, p = 0.01). In the PFA group, we found no acute phrenic nerve injury, no major or minor bleeding, and no tamponade but one (4.34%) patient suffered from a stroke. Transient hypotension was observed frequently as well as transient bradycardia or asystole episodes requiring right ventricular pacing. In the CB group, no complications occurred. Furthermore, we discuss practical issues on PFA procedures. CONCLUSIONS: PFA is a promising technology with high acute PV isolation rate and large antral lesions compared to CB. However, larger trials with more patients and data on long-term freedom of AF but also complications are needed.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Humanos , Criocirugía/métodos , Resultado del Tratamiento , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Atrios Cardíacos/cirugía , Ablación por Catéter/métodos , RecurrenciaRESUMEN
BACKGROUND: Wearable cardioverter-defibrillators (WCDs) are a well-established tool to bridge the recovery time of left ventricular ejection fraction (LVEF) until the implantation of an implantable cardioverter defibrillator (ICD), as recommended by the current guidelines. Besides their function to detect and treat malignant arrhythmias, WCDs may be used as a telemonitoring system. In this study, we sought to illustrate and discuss the telemonitoring potential of WCDs and to analyze physical activity in specific patient cohorts. METHODS AND RESULTS: We retrospectively included 140 patients with reduced LVEF who were prescribed WCDs in our clinic. We analyzed the patients' physical activity (n = 105 with a WCD compliance above 21 h/day), body position and resting position. We found a reduced physical activity in women and in patients over the age of 65 compared to younger patients. Furthermore, the patients who were overweight or obese showed significantly reduced physical activity compared to the patients with a normal weight (6365 ± 3572 vs. 4972 ± 2476 vs. 7045 ± 3521, p = 0.02). CONCLUSION: WCDs may be used as a telemonitoring and intervention tool in patients with reduced LVEF. Specific patient groups may benefit from guidance from their treating physician regarding physical activity.
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Introduction: Cryoballoon (CB) guided pulmonary vein isolation (PVI) is an established procedure in the treatment of atrial fibrillation (AF). Transseptal access is an indispensable step during PVI and may be associated with severe complications. For specific interventions, specific puncture sites of the fossa ovalis are advantageous. Here, we analyzed the potential impact of a transesophageal echocardiography (TOE) guided transseptal puncture on nadir temperatures in CB PVI. Methods and Results: We retrospectively analyzed 209 patients undergoing CB PVI in our hospital. The use of TOE had been at the operator's discretion. No TOE-related complications such as perforation of the pharynx or esophagus or loss of teeth were noted. Concerning the applied freezes, we found significantly lower nadir temperatures in all PVs in the TOE group than in the non-TOE group. Procedure time and fluoroscopy time and complications were similar in both groups. Conclusion: TOE-guided TSP in CB PVI is safe and feasible. Our study found significantly lower nadir temperatures of CB freezes after TOE-guided TSP which potentially underscores the value of a more infero-anterior puncture site.
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PURPOSE: Intensive treatment protocols for aggressive hematologic malignancies harbor a high risk of serious clinical complications, such as infections. Current techniques of monitoring vital signs to detect such complications are cumbersome and often fail to diagnose them early. Continuous monitoring of vital signs and physical activity by means of an upper arm medical wearable allowing 24/7 streaming of such parameters may be a promising alternative. METHODS: This single-arm, single-center observational trial evaluated symptom-related patient-reported outcomes and feasibility of a wearable-based remote patient monitoring. All wearable data were reviewed retrospectively and were not available to the patient or clinical staff. A total of 79 patients (54 inpatients and 25 outpatients) participated and received standard-of-care treatment for a hematologic malignancy. In addition, the wearable was continuously worn and self-managed by the patient to record multiple parameters such as heart rate, oxygen saturation, and physical activity. RESULTS: Fifty-one patients (94.4%) in the inpatient cohort and 16 (64.0%) in the outpatient cohort reported gastrointestinal symptoms (diarrhea, nausea, and emesis), pain, dyspnea, or shivering in at least one visit. With the wearable, vital signs and physical activity were recorded for a total of 1,304.8 days. Recordings accounted for 78.0% (63.0-88.5; median [interquartile range]) of the potential recording time for the inpatient cohort and 84.6% (76.3-90.2) for the outpatient cohort. Adherence to the wearable was comparable in both cohorts, but decreased moderately over time during the trial. CONCLUSION: A high adherence to the wearable was observed in patients on intensive treatment protocols for a hematologic malignancy who experience high symptom burden. Remote patient monitoring of vital signs and physical activity was demonstrated to be feasible and of primarily sufficient quality.
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Neoplasias Hematológicas , Dispositivos Electrónicos Vestibles , Estudios de Factibilidad , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/terapia , Humanos , Estudios Retrospectivos , Signos VitalesRESUMEN
BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.
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Estenosis de la Válvula Aórtica/cirugía , Enfermedades Vasculares Periféricas/cirugía , Reemplazo de la Válvula Aórtica Transcatéter , Dispositivos de Cierre Vascular , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Arteria Femoral/cirugía , Hemorragia/etiología , Hemostasis/fisiología , Humanos , Masculino , Suturas/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Dispositivos de Cierre Vascular/efectos adversosRESUMEN
Introduction: Atrioventricular nodal reentrant tachycardia (AVNRT) is a common supraventricular tachycardia. Current guidelines recommend electrophysiology study (EPS) and ablation, which have been proven to show high success rates with very low complication rates. Usually, ablation of AVNRT is performed conventionally using only fluoroscopy. Electroanatomical mapping systems (EMS) are widely used in complex arrhythmias. One of their advantages is their potential in decreasing the need of fluoroscopy time (FT). In this study we analyzed patients undergoing either conventional AVNRT ablation or by using an EMS with a fluoroscopy integrating system (FIS). Materials and Methods: We included 119 patients who underwent AVNRT ablation in our study. Eighty-nine patients were ablated conventionally using only fluoroscopy, 30 patients were ablated using EMS + FIS. Results: We found that the use of EMS + FIS led to a significant reduction of FT (449.90 ± 217.21 vs. 136.93 ± 109.28 sec., p < 0.001) and dose-area-product (DAP, 268.27 ± 265.20 vs. 41.07 ± 27.89 µGym2, p < 0.001) without affecting the procedure time (PT, 66.55 ± 13.3 vs. 67.33 ± 13.81 min, p = 0.783). Furthermore, we found no significance with regard to complications. Conclusion: The use of EMS+FIS is safe and feasible. It leads to a significant reduction of both FT and DAP without affecting PT and safety. Hence, EMS + FIS is beneficial for both the operator and the patients by reducing the radiation exposure.
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BACKGROUND: In patients with reduced left ventricular ejection fraction (LVEF) who are at risk of sudden cardiac death, a wearable cardioverter-defibrillator (WCD) is recommended as a bridge to the recovery of LVEF or as a bridge to the implantation of a device. In addition to its function to detect and treat malignant arrhythmia, WCD can be used via an online platform as a telemonitoring system to supervise patients' physical activity, compliance, and heart rate. METHODS: We retrospectively analyzed 173 patients with regard to compliance and heart rate after discharge. RESULTS: Mean WCD wearing time was 59.75 ± 35.6 days; the daily wearing time was 21.19 ± 4.65 h. We found significant differences concerning the patients' compliance. Men showed less compliance than women, and younger patients showed less compliance than patients who were older. Furthermore, we analyzed the heart rate from discharge until the end of WCD prescription and found a significant decrease from discharge to 4, 8, or 12 weeks. CONCLUSION: WCD can be used as a telemonitoring system to help the involved heart failure unit or physicians attend to and adjust the medical therapy. Furthermore, specific patient groups should be educated more intensively with respect to compliance.
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BACKGROUND: Fast anatomical mapping (FAM) of the left atrium and pulmonary veins (PV) during PV isolation (PVI) generates anatomical information about the carina region additionally. We aimed to investigate the utility of these data in relation to conduction abilities of the intervenous carina. METHODS: We investigated 71 patients with drug-refractory atrial fibrillation (AF) who underwent first-time circumferential PVI using an electroanatomical mapping system. Carina width between ipsilateral PV was measured using FAM and an integrated distance measurement tool. Encirclings were divided into carina ablation and noncarina ablation groups based on the necessity of carina ablation to achieve PVI. RESULTS: In total, 142 encirclings were analyzed and first-pass isolation was observed in 102 (72%) encirclings. Nonfirst-pass PVI solely due to a gap on the line or persistent carina conduction was observed in 10 (7%) and 30 (21%) encirclings, respectively. Encirclings were classified into a carina ablation group (n = 30, 21%) and noncarina ablation group (n = 112, 79%). Carina width was significantly larger in the carina ablation vs nonarina ablation group (right: 11.9 ± 1.5 mm vs 8 ± 1.4 mm, P < .001/left: 12.1 ± 1.3 mm vs 8.1 ± 1.1 mm, P < .001) requiring additional carina ablation. CONCLUSION: Carina-related PV conduction is a common finding after the first-pass ablation during PVI. Measurement of carina width using FAM is feasible and its value correlates with the necessity of carina ablation to achieve PVI.
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Pulmonary vein isolation (PVI) has become a cornerstone therapy in the treatment of atrial fibrillation (AF). Patients with overweight or obesity suffer more often from AF, and studies investigating the safety and feasibility of PVI in these patients have shown varying results. In this study we analyzed PVI performed with the 2nd generation cryoballoon (CB) with regard to safety, procedure and fluoroscopy time in patients with normal weight, overweight and obesity. We analyzed 228 consecutive patients treated with CB PVI in our hospital in 2018 and 2019. Fifty nine (25.88%) patients presented with normal weight (body mass index (BMI) of <25), 115 (50.44%) patients with overweight (BMI between 25 and 29.9) and 54 (23.68%) were obese patients (BMI >30). All pulmonary veins (PV) were isolated successfully. Concerning procedural parameters, neither complications, procedural time, nor fluoroscopy time differed significantly. There was a significant increase of dose area product (DAP) in obese patients compared to normal weight and overweight patients (2035.5 ± 1930.1 µGym2 vs. 975.3 ± 814.9 vs. 1325.1 ± 2081.3, p = 0.001) but no significant difference between overweight and normal weight patients (p = 0.611). Our follow-up data of 168 patients (73.68%) observed for 12 months showed no differences in the recurrence of AF in the three BMI groups [80.9% vs. 83.3% (p = 0.733) vs. 86.55% (p = 0.460)]. In conclusion, CB PVI in overweight and obese patients is safe with similar levels of complications and recurrence of AF as patients of normal weight. However, obese patients and operators are exposed to higher radiation doses.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Criocirugía/efectos adversos , Humanos , Obesidad/complicaciones , Obesidad/diagnóstico , Obesidad/epidemiología , Venas Pulmonares/diagnóstico por imagen , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.
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Oxigenación por Membrana Extracorpórea , Infarto del Miocardio/terapia , Revascularización Miocárdica/métodos , Puente de Arteria Coronaria/métodos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/métodos , Fibrinolíticos/uso terapéutico , Humanos , Infarto del Miocardio/complicaciones , Infarto del Miocardio/mortalidad , Pronóstico , Estudios Prospectivos , Calidad de Vida , Tamaño de la Muestra , Choque Cardiogénico/etiología , Choque Cardiogénico/mortalidadRESUMEN
PURPOSE: We sought to establish the technical feasibility of VT-mapping with high-density catheters in patients with Mitraclips, requiring a hemodynamic support. METHODS: A 73-year-old man with ischemic cardiomyopathy and reduced left ventricular ejection fraction (LVEF ~ 20%) was presented due to syncope and adequate shock of his ICD. Due to severe mitral valve regurgitation (MR), two Mitraclips were implanted earlier. The decision for catheter ablation was made in line with current guidelines. Given the increased PAAINESD score, the use of hemodynamic support was required. To employ an Impella pump via the retrograde transaortic approach, LV-mapping and VT-ablation were necessary to be performed via the transseptal approach, which was challenging due to the presence of Mitraclips. The MV passage with the steerable sheath was guided by a quadripolar catheter and 3D transoesophageal echo (TEE). After the 12F steerable sheath had passed the MV, the quadripolar catheter was exchanged by a high-density (HD) Grid® catheter. Hereafter, the Impella pump was placed retrogradely in the LV, and voltage-mapping of the LV and ablation was performed. RESULTS: At the end of the procedure, the Impella pump could be removed in stable hemodynamic conditions. The follow-up after 3, 6, and 12 months showed no new VT episodes. CONCLUSIONS: This case demonstrates the feasibility of the transseptal approach of VT mapping used HD Grid catheter and retrograde hemodynamic support with Impella Pump for VT treatment in patients after Mitraclips implantation. To avoid a damage of the MV and Mitraclips, 3D-TEE is advisable.
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Ablación por Catéter , Taquicardia Ventricular , Anciano , Catéteres , Hemodinámica , Humanos , Masculino , Volumen Sistólico , Taquicardia Ventricular/cirugía , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
BACKGROUND: We investigated the feasibility and safety of a framerate of 1 frame per second ("fps") for fluoroscopy and cine-angiography, to lower radiation exposure for patients and personnel in cardiac electrophysiology ("EP"). METHOD: Analysis of 2521 EP procedures, 899 (36%) with the lowest available conventional framerate (3.75 fps) and 1622 (64%) procedures performed with a framerate lowered further to 1.0 fps (by looping a 1 Hz square pulse to the ECG trigger) performed between 01/2016 and 01/2020. RESULTS: Procedures performed with 1.0 fps had the same acute procedural success rates (p = 0.20) and adverse event rates (p = 0.34) as the 3.75 fps group. There was no difference in total X-ray operation time (p = 0.40). The dose-area-product (DAP) was significantly reduced from 638 to 316 cGy*cm2 (p < < 0.0001) for all procedure types together, and for each subgroup. In a multivariable linear regression model, total X-ray operation time (estimate 38 cGy*cm2 /min) and body mass index (estimate 32 cGy*cm2 / index point) and a framerate of 1.0 fps (-314 cGy*cm2 against 3.75 fps) were independent predictors of a lower DAP (p-value of t-statistic for all << 0.0001). CONCLUSIONS: A framerate of 1.0 fps is safe and feasible in cardiac electrophysiology procedures. It was associated with a significant reduction of radiation exposure for patient and personnel.
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Técnicas Electrofisiológicas Cardíacas , Exposición a la Radiación , Estudios de Factibilidad , Fluoroscopía , Humanos , Dosis de Radiación , Exposición a la Radiación/prevención & control , Radiografía Intervencional , Estudios Retrospectivos , Rayos XRESUMEN
Proper measurement of the QT interval on the 12-lead body-surface ECG is challenging in daily practice. Even more difficult is its correct estimation in the presence of repolarization abnormalities, arrhythmias or bundle-branch blocks (BBB). The QT interval results from two parts of the ECG: (1) the QRS complex, describing the excitation of the ventricles and (2) the JT interval, describing the repolarisation of the ventricles. Prolongation of the QRS width - like in the presence of BBB - entails prolongation of the QT interval, making the estimation of the true repolarisation time challenging. The US recommendations for the standardization and interpretation of the ECG suggest focusing on the JT interval in presence of BBB. However, in clinical practice physicians have become more familiar with the interpretation of QT-interval measurements than with the interpretation of the JT Interval. In the last decade, a simple formula for the estimation of the "modified QT interval" in the presence of left or right BBB has been developed and evaluated. In this formula, the modified QT interval is calculated by subtracting 50% of the length of the BBB-QRS from the measured QT interval (QTm = QTBBB - 50% QRSBBB). Subsequently, rate-correction formula should be applied as usual. In this review, we discuss the determination of the QT-interval in the presence of BBB and summarize the origin and application of the modified QT-interval formula.
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Atrial fibrillation (AF) is the most common arrhythmia and has a major impact on morbidity and mortality; however, detection of asymptomatic AF is challenging. This study sims to evaluate the sensitivity and specificity of non-invasive AF detection by a medical wearable. In this observational trial, patients with AF admitted to a hospital carried the wearable and an ECG Holter (control) in parallel over a period of 24 h, while not in a physically restricted condition. The wearable with a tight-fit upper armband employs a photoplethysmography technology to determine pulse rates and inter-beat intervals. Different algorithms (including a deep neural network) were applied to five-minute periods photoplethysmography datasets for the detection of AF. A total of 2306 h of parallel recording time could be obtained in 102 patients; 1781 h (77.2%) were automatically interpretable by an algorithm. Sensitivity to detect AF was 95.2% and specificity 92.5% (area under the receiver operating characteristics curve (AUC) 0.97). Usage of deep neural network improved the sensitivity of AF detection by 0.8% (96.0%) and specificity by 6.5% (99.0%) (AUC 0.98). Detection of AF by means of a wearable is feasible in hospitalized but physically active patients. Employing a deep neural network enables reliable and continuous monitoring of AF.