Formation of thermal coagulum on multielectrode catheters during phased radiofrequency energy ablation of persistent atrial fibrillation.

BACKGROUND: Radiofrequency ablation (RFA) can unfavorably cause coagulum on the ablation electrode. The aim of this study was to assess this phenomenon on three different multielectrode catheters used to treat persistent atrial fibrillation with duty-cycled RFA. METHODS AND RESULTS: Twenty-six consecutive patients have been treated with the pulmonary vein ablation catheter (PVAC) and the multiarray ablation catheter (MAAC). In 13 patients, additional ablation with the multiarray septal catheter (MASC) has been performed. The multichannel RF generator GENius™ (Medtronic Inc., Minneapolis, MN, USA) independently delivered energy in a bipolar and unipolar mode (ratio of 4/1, 2/1, or 1/1) to any of the electrodes. Versions 14.2, 14.3, and 14.4 of the generator were used. Coagulum presence was determined postablation by careful visual inspection of the catheter electrodes. No coagulum formation was visualized on the PVACs. Coagulum formation was visualized in 59% of the electrodes of the MAACs using a 2/1 mode and the 14.2 software version versus 69% using the 14.4 version and a 2/1 mode (P = 0.7) versus 14% of the electrodes applying a 1/1 ratio and the 14.4 software version (P < 0.001). CONCLUSIONS: Duty-cycled RFA in 2/1 bipolar/unipolar ratio generates a substantial frequency of coagulum formation on the multielectrode catheters MAAC and MASC. The use of the 14.4 version of the software to drive the RF generator and the use of energy in the default 1/1 bipolar/unipolar ratio could significantly reduce the frequency of coagulum formation, but so far, could not completely overcome it. The PVAC did not form coagulum, regardless of generator version or energy ratio used.

Acetazolamide in Decompensated Heart Failure with Volume Overload trial (ADVOR): baseline characteristics.

AIMS: To describe the baseline characteristics of participants in the Acetazolamide in Decompensated Heart Failure with Volume Overload (ADVOR) trial and compare these with other contemporary diuretic trials in acute heart failure (AHF). METHODS AND RESULTS: ADVOR recruited 519 patients with AHF, clinically evident volume overload, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) and maintenance loop diuretic therapy prior to admission. All participants received standardized loop diuretics and were randomized towards once daily intravenous acetazolamide (500 mg) versus placebo, stratified according to study centre and left ventricular ejection fraction (LVEF) (≤40% vs. >40%). The primary endpoint was successful decongestion assessed by a dedicated score indicating no more than trace oedema and no other signs of congestion after three consecutive days of treatment without need for escalating treatment. Mean age was 78 years, 63% were men, mean LVEF was 43%, and median NT-proBNP 6173 pg/ml. The median clinical congestion score was 4 with an EuroQol-5 dimensions health utility index of 0.6. Patients with LVEF ≤40% were more often male, had more ischaemic heart disease, higher levels of NT-proBNP and less atrial fibrillation. Compared with diuretic trials in AHF, patients enrolled in ADVOR were considerably older with higher NT-proBNP levels, reflecting the real-world clinical situation. CONCLUSION: ADVOR is the largest randomized diuretic trial in AHF, investigating acetazolamide to improve decongestion on top of standardized loop diuretics. The elderly enrolled population with poor quality of life provides a good representation of the real-world AHF population. The pragmatic design will provide novel insights in the diuretic treatment of patients with AHF.

Prognostic Value and Reproducibility of AI-assisted Analysis of Lung Involvement in COVID-19 on Low-Dose Submillisievert Chest CT: Sample Size Implications for Clinical Trials.

PURPOSE: To compare the prognostic value and reproducibility of visual versus AI-assisted analysis of lung involvement on submillisievert low-dose chest CT in COVID-19 patients. MATERIALS AND METHODS: This was a HIPAA-compliant, institutional review board-approved retrospective study. From March 15 to June 1, 2020, 250 RT-PCR confirmed COVID-19 patients were studied with low-dose chest CT at admission. Visual and AI-assisted analysis of lung involvement was performed by using a semi-quantitative CT score and a quantitative percentage of lung involvement. Adverse outcome was defined as intensive care unit (ICU) admission or death. Cox regression analysis, Kaplan-Meier curves, and cross-validated receiver operating characteristic curve with area under the curve (AUROC) analysis was performed to compare model performance. Intraclass correlation coefficients (ICCs) and Bland- Altman analysis was used to assess intra- and interreader reproducibility. RESULTS: Adverse outcome occurred in 39 patients (11 deaths, 28 ICU admissions). AUC values from AI-assisted analysis were significantly higher than those from visual analysis for both semi-quantitative CT scores and percentages of lung involvement (all P<0.001). Intrareader and interreader agreement rates were significantly higher for AI-assisted analysis than visual analysis (all ICC ≥0.960 versus ≥0.885). AI-assisted variability for quantitative percentage of lung involvement was 17.2% (coefficient of variation) versus 34.7% for visual analysis. The sample size to detect a 5% change in lung involvement with 90% power and an α error of 0.05 was 250 patients with AI-assisted analysis and 1014 patients with visual analysis. CONCLUSION: AI-assisted analysis of lung involvement on submillisievert low-dose chest CT outperformed conventional visual analysis in predicting outcome in COVID-19 patients while reducing CT variability. Lung involvement on chest CT could be used as a reliable metric in future clinical trials.

Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure.

AIMS: The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up. METHODS: Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t0); 142 CHF patients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t1) with a final evaluation at 79 months (time point: t2). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t1 - t2). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs. RESULTS: Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group ( p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) ( p = 0.87). DISCUSSION: An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHF patients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038 ).

Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance.

Background Biatrial, extensive, and complex ablation strategies have been published for the treatment of neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block. We have developed a less extensive and more specific approach compared with previously published cardioneuroablation strategies, called cardio-neuromodulation. It is based on tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus, preferentially through a right-sided approach. Methods Patients with syncope were enrolled between December 2016 and December 2017. They were assigned to group A if they had a positive head-up tilt test and to group B if they presented with a pause ≥3 seconds. The area to target during cardio-neuromodulation was designed offline on a computed tomographic scan. Slow heart rates and pauses were compared during 24-hour rhythm registration at baseline, at 1-month follow-up, and 6-month follow-up. Syncope burden was assessed before the procedure and at 3- and 6-month follow-up. Results Twenty patients underwent cardio-neuromodulation through a right-sided approach (12 in group A, 8 in group B). The first application of radiofrequency energy led to a P-P interval shortening >120 ms in all 20 patients. After a mean±SD ablation time of 7±4 minutes and mean ablated surface area of 11±6 mm2, the P-P interval shortened by 219±160 ms ( P<0.001). The number of beats <50/min during 24-hour rhythm registration was reduced by a median of 100% at 6-month follow-up ( P<0.001). Syncope burden was reduced by 95% at 6-month follow-up ( P<0.001). Conclusions These data indicate that cardio-neuromodulation, through a right-sided and computed tomographic-guided procedure, is safe, fast, and highly reproducible in preventing inappropriate functional sinus bradycardia and syncope recurrence.

Epicardial pacing: a single-centre study on 321 leads in 138 patients.

OBJECTIVE: This study presents the long-term outcome of 321 epicardial leads in 138 patients. METHODS AND RESULTS: All leads were Medtronic CapsureEpi model 4965 steroid eluting leads. The 1-, 3-, and 5-year patient survival was 91%, 83% and 77%, respectively.Twenty-seven patients died. In 25/27 deaths a pacing-related death could be excluded. Strangulation of the heart by an abandoned epicardial lead was the cause of death in one child. One other patient died suddenly at the age of 3 years. Failures occurred in 57 of 321 epicardial leads (18%). For all 321 leads, the 1-, 3- and 5-year freedom from failure was 91%, 85% and 71%, respectively. The cumulative proportion of patients without any lead defect was 85% after I year, 76% after 3 years and 62% after 5 years. The percentage of patients without serious adverse events at 1, 3, and 5 years was 97%, 91%, 85%, respectively. Lead fracture was the cause of failure in 15 leads of 9 patients. An important increase in pacing threshold occurred in 35 leads of 30 patients. Other failures were: diaphragmatic stimulation, infection, excessive traction and strangulation. Eighteen failures were repaired by 11 surgical interventions in 9 patients.Thirty-nine defects were corrected non-invasively in 31 patients. CONCLUSIONS: The use of steroid-eluting epicardial leads has proven to be an adequate option. In paediatric cardiology, the epicardial approach remains an indispensable tool for achieving a life-long pacing.

Acute myocardial infarction due to spontaneous postpartum multi-vessel coronary artery dissection.

Spontaneous coronary artery dissection is a rare cause of myocardial infarction in young, otherwise healthy people. We present a case report of a 37-year-old woman, without cardiovascular risk factors, who survived a major acute myocardial infarction due to multi-vessel spontaneous coronary artery dissection which was complicated by cardiogenic shock in the third week postpartum. She fully recovered with medical therapy in combination with angioplasty. .

Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study.

AIMS: Chronic heart failure (CHF) patients are frequently rehospitalized within 6 months after an episode of fluid retention. Rehospitalizations are preventable, but this requires an extensive organization of the healthcare system. In this study, we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners (GPs) and a heart failure clinic could reduce mortality and rehospitalization rate. METHODS AND RESULTS: One hunderd and sixty CHF patients [mean age 76 ± 10 years, 104 males, mean left ventricular ejection fraction (LVEF) 35 ± 15%] were block randomized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring (TM) or usual care (UC). The TM group measured body weight, blood pressure, and heart rate on a daily basis with electronic devices that transferred the data automatically to an online database. Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded. All-cause mortality was significantly lower in the TM group as compared with the UC group (5% vs. 17.5%, P = 0.01). The total number of follow-up days lost to hospitalization, dialysis, or death was significantly lower in the TM group as compared with the UC group (13 vs. 30 days, P = 0.02). The number of hospitalizations for heart failure per patient showed a trend (0.24 vs. 0.42 hospitalizations/patient, P = 0.06) in favour of TM. CONCLUSION: Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization, death, or dialysis in CHF patients. These findings need confirmation in a large trial.