DOACs vs Vitamin K Antagonists During Cardiac Rhythm Device Surgery: A Multicenter Propensity-Matched Study.

BACKGROUND: There is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined. OBJECTIVES: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted). METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring. RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis. CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.

Feasibility of double-blinded, placebo-controlled interventional study for assessing catheter ablation efficacy in persistent atrial fibrillation: Insights from the ORBITA AF feasibility study.

BACKGROUND: To date, there are no randomized, double-blinded clinical trials comparing catheter ablation to DC cardioversion (DCCV) with medical therapy in patients with persistent atrial fibrillation (PersAF). Conducting a large-scale trial to address this question presents considerable challenges, including recruitment, blinding, and implementation. We conducted a pilot study to evaluate the feasibility of conducting a definitive placebo-controlled trial. METHODS: This prospective trial was carried out at Barts Heart Centre, United Kingdom, employing a randomized, double-blinded, placebo-controlled design. Twenty patients with PersAF (duration <2 years) were recruited, representing 10% of the proposed larger trial as determined by a power calculation. The patients were randomized in a 1:1 ratio to receive either PVI ± DCCV (PVI group) or DCCV + Placebo (DCCV group). The primary endpoint of this feasibility study was to evaluate patient blinding. Patients remained unaware of their treatment allocation until end of study. RESULTS: During the study, 35% of patients experienced recurrence of PersAF prior to completion of 12 months follow-up. Blinding was successfully maintained amongst both patients and medical staff. The DCCV group had a trend to higher recurrence and repeat procedure rate compared to the PVI group (recurrence of PersAF 60% vs 30%; p = .07 and repeat procedure 70% vs 40%; p = .4). The quality of life experienced by individuals in the PVI group showed improvement, as evidenced by enhanced scores on the AF specific questionnaire (AF PROMS) (3 [±4] vs 21 [±8]) and SF-12 mental-component raw score (51.4 [±7] vs 43.24 [±15]) in patients who maintained sinus rhythm at 12 months. CONCLUSION: This feasibility study establishes the potential for conducting a blinded, placebo-controlled trial to evaluate the efficacy of PVI versus DCCV in patients with PersAF.

Catheter ablation of atrial fibrillation with a multi-electrode radiofrequency balloon; first and early two centre experience in Europe.

INTRODUCTION: The Heliostar™ ablation system is a novel RF balloon ablation technology with an integrated three-dimensional mapping system. Here, we describe our early experience and procedural outcomes using this technology for atrial fibrillation catheter ablation. METHODS: We sought to comprehensively assess the first 60 consecutive patients undergoing pulmonary vein isolation using the novel HELISOTAR™ RF balloon technology including procedural outcomes. A comparison of the workflow between two different anaesthetic modalities (conscious sedation [CS] vs. general anaesthesia [GA]) was made. Procedural data were collected prospectively from two high-volume centers (Barts Heart Centre, UK and University Hospital of Zurich, Zurich). A standardized approach for catheter ablation was employed. RESULTS: A total of 35 patients had the procedure under CS and the remaining under GA. Mean procedural and fluoroscopy times were 84 ± 33 min and 1.1 min. The median duration of RF energy application was 7 (5-9.8) mins per patient. All veins were successfully isolated, and the median isolation time was 10 (7-15) seconds. Our cohort's rate of procedural complications was low, with no mortality within 30 days postprocedure. CONCLUSION: Our early experience shows that catheter ablation using the Heliostar™ technology can be performed efficiently and safely; however, long-term data is yet to be established. Low fluoroscopy requirements, short learning curves and use of this technology with CS is possible, including the use of an oesophageal temperature probe.

PolarX Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation.

AIM: Evaluate the novel PolarX Cryoballoon in atrial fibrillation (AF) catheter ablation through a propensity-matched comparison with the Arctic Front Advance (AFA). The aim was also to identify cryoablation metrics that are predictive of successful pulmonary vein isolation (PVI) with the PolarX Cryoballoon. METHODS AND RESULTS: This prospective multi-centre study included patients that underwent cryoablation for AF. All patients underwent PVI with reconnection assessed after a 30-min waiting period and adenosine. Safety, efficacy, and cryoablation metrics were compared between PolarX and a propensity-matched AFA cohort. Seventy patients were included with 278 veins treated. In total, 359 cryoablations were performed (1.3 ± 0.6 per vein) to achieve initial PVI with 205 (73.7%) veins isolating with a single cryoablation. Independent predictors for achieving initial PVI included temperature at 30 s [odds ratio (OR) 1.26; P = 0.003] and time to reach -40°C (OR 1.88; P < 0.001) with an optimal cut-off of ≤-38.5°C at 30 s [area under the curve (AUC) 0.79; P < 0.001] and ≤-40°C at ≤32.5 s (AUC 0.77; P < 0.001), respectively. Of the 278 veins, 46 (16.5%) veins showed acute reconnection. Temperature at 30 s (≤-39.5°C, OR 1.24; P = 0.002), nadir temperature (≤-53.5°C, OR 1.35; P = 0.003), and time to isolation (≤38.0 s, OR 1.18; P = 0.009) were independent predictors of sustained PVI. Combining two of these three targets was associated with reconnection in only 2-5% of PVs. Efficacy and safety of the PolarX Cryoballoon were comparable to AFA Cryoballoon, however, cryoablation metrics were significantly different. CONCLUSIONS: The PolarX Cryoballoon has a different cryoablation profile to AFA Cryoballoon. Prospective testing of these proposed targets in large outcomes studies is required.

Risk factors for developing pacing induced LV dysfunction: Experience from a tertiary center in the UK.

BACKGROUND: The risk factors for developing pacing induced left ventricular dysfunction (LVD) in patients with high burden of right ventricular pacing (RVP) is poorly understood. Therefore, in the present study, we aimed to assess the determinants of pacing induced LVD. METHODS: Our data were retrospectively collected from 146 patients with RVP > 40% who underwent generator change (GC) or cardiac resynchronization therapy (CRT) upgrade between 2016 and 2019 who had left ventricular ejection fraction (EF) ≥50% at initial implant. RESULTS: A total of 75 patients had CRT upgrade due to pacing induced LVD (EF < 50%) and 71 patients with preserved LV function (EF ≥ 50%) had a GC. Primary indication for pacing in both groups was complete heart block. Male predominance (p = .008), prior myocardial infarction (MI) (p = .001), atrial fibrillation (AF) (p = .009), chronic kidney disease (CKD) (p = .005), and borderline low systolic function (BLSF) (EF 50%-55%) (p = .04) were more prevalent in the CRT upgrade group. Presence of AF (odds ratio [OR] = 3.05, 95% confidence interval [CI] 1.42-6.58; p = .004), BLSF (OR = 3.8, 95% CI 1.22-11.8; p = .02), and male gender (OR = 2.41, 95% CI 1.14-5.08; p = .02) were independent predictors for RVP induced LVD. Age (OR = 1.08, 95% CI 1.02-1.14; p = .005) and BLSF (OR = 5.33, 95% CI 1.26-22.5; p = .023) were independent predictors of earlier development of LVD after implant. CONCLUSIONS: Our results suggested that AF, BLSF, and male gender are predictors for development of pacing induced LVD in patients with high RVP burden. LVD can occur at any time after pacemaker implant with BLSF and increasing age associated with earlier development of LVD.

Incidence and Prognostic Impact of New-Onset Atrial Fibrillation in Patients with Severe Covid-19: A Retrospective Cohort Study.

BACKGROUND: Corona virus disease 2019 (COVID-19) contributes to cardiovascular complications including arrhythmias due to high inflammatory surge. Nevertheless, the common types of arrhythmia amongst severe COVID-19 is not well described. New onset atrial fibrillation(NOAF) is frequentlyseen in critically ill patients and therefore we aim to assess the incidence of NOAF in severe COVID -19and its association with prognosis. METHODS: This is a retrospective multicentre study including 109 consecutive patients admitted to intensive care units (ICU) with confirmed COVID-19 pneumonia and definitive outcome (death or discharge). The study period was between 11th March and 5th May 2020. RESULTS: Median age of our population was 59 years (IQR 53-65) and 83% were men. Nearly three-fourth of the population had two or more comorbidities. 14.6% developed NOAF during ICU stay with increased risk amongst older age and with underlying chronic heart failure and chronic kidney disease. NOAF developed earlier during the course of severe COVID-19 infection amongst non-survivors than those survived the illness andstrongly associated with increased in-hospital death (OR 5.4; 95% CI 1.7-17; p=0.004). CONCLUSIONS: In our cohort with severe COVID-19, the incidence of new onset atrial fibrillation is comparatively lower than patients treated in ICU with severe sepsis in general. Presence of NOAF has shown to be a poor prognostic marker in this disease entity.

Communication in the intensive care unit during COVID-19: early experience with the Nightingale Communication Method.

OBJECTIVE: To assess the utility and frequency of use of the Nightingale Communication Method, during the early operational phase of the Nightingale Hospital London (NHL) 4000-bed field hospital's intensive care unit. DESIGN: Survey-based cross-sectional assessment. SETTING: The intensive care unit at the Nightingale London hospital. PARTICIPANTS: Staff working in the clinical area and therefore requiring full personal protective equipment (PPE). INTERVENTION: Survey of all staff members sampled from a single shift at the Nightingale Hospital. This investigated perceived utility and actual use of identification methods (name and role labels on visors and gowns, coloured role identification tapes) and formal hand signals as an adjunctive communication method. MAIN OUTCOME MEASURE: Self-reported frequency of use and perceived utility of each communication and personnel identification adjunct. RESULTS: Fifty valid responses were received (72% response rate), covering all clinical professional groups. Prominent name/role identifications and coloured role identification tapes were very frequently used and were perceived as being highly useful. Formal hand signals were infrequently used and not perceived as being beneficial, with respondents citing use of individual hand signals only in specific circumstances. CONCLUSION: PPE is highly depersonalizing, and interpersonal identification aids are very useful. Despite being difficult, verbal communication is not completely prohibited, which could explain the low utility of formal hand signals. The methods developed at the Nightingale hospital have enhanced communication in the critical care, field hospital setting. There is potential for wider application to a variety of healthcare settings, in both the current situation and future pandemic scenarios.

Rare and challenging case of stroke as a manifestation of non bacterial thrombotic endocarditis in an underlying ovarian clear cell carcinoma.

Non bacterial thrombotic endocarditis presenting as a stroke is a rare presentation as a result of an underlying occult ovarian clear cell adenocarcinoma. Embolic events secondary to non bacterial thrombotic endocarditis are potentially a life-threatening condition if not diagnosed and treated promptly. High clinical suspicion for an underlying neoplasm is one of the key elements to be considered in the management of non bacterial thrombotic endocarditis. Systemic anticoagulation will treat as well as prevent further thromboembolic events.