Radiofrequency ablation-Real-time visualization of lesions and their correlation with underlying parameters.

BACKGROUND: Lesion durability and transmurality are crucial for successful radiofrequency (RF) ablation. This study provides a model of real-time RF lesion visualization and insights into the role of underlying parameters, as local impedance (LI). METHODS: A force-sensing, LI-sensing catheter was used for lesion creation in an ex vivo model involving cross-sections of porcine cardiac preparations. During 60 s of RF application, one measurement per second was performed regarding lesion size and available ablation parameters. In total, 1847 measurements from n = 36 lesions were performed. Power (20-50 W) and contact force (1-5 g, 10-15 g, 20-25 g) were systematically alternated. RESULTS: Lesion formation was most prominent in the first seconds of RF application during which nonlinear lesion growth was observed (max. 1.08 mm/s for lesion depth and 2.71 mm/s for lesion diameter). Power levels determined the extent of lesion formation in the early phase. After 20 s, lesion size growth velocity approaches 0.1 mm/s at all power levels. LI changes were also highest in the first seconds (up to - 12 Ω/s) and decreased to less than - 0.1Ω/s after prolonged application. CONCLUSION: Lesion formation in irrigated RF ablation is a nonlinear process. Final lesion size resulting from an RF application is mainly influenced by high rates of lesion growth in the first seconds of ablation. LI seems to be a good surrogate for differentiating changes in lesion formation.

First clinical data on artificial intelligence-guided catheter ablation in long-standing persistent atrial fibrillation.

INTRODUCTION: Despite advanced ablation strategies and major technological improvements, treatment of persistent atrial fibrillation (AF) remains challenging and the underlying pathophysiology is not fully understood. This study analyzed the multiple procedure outcome and safety of catheter ablation of spatiotemporal dispersions (DISPERS) detected by artificial intelligence (AI)-guided software in patients with long-standing persistent AF. METHODS AND RESULTS: The Volta VX1 software was used for 50 consecutive patients undergoing catheter ablation for persistent AF. First, high-density mapping (78% biatrial) with a multipolar mapping catheter was performed. In addition to pulmonary vein isolation (PVI), ablation of DISPERS was performed aiming at homogenizing, dissecting, isolating, or connecting DISPERS areas to nonconducting anatomical structures. Follow-up contained regular visits at our outpatient clinic at 1, 3, 6, and 12 months including 7-day Holter electrocardiograms. Patients were mainly suffering from long-standing persistent AF (mean AF duration 50.30 ± 54.28 months). Following PVI, ablation of left atrial and right atrial DISPERS areas led to AF cycle length prolongation (mean of 162.0 ± 16.6 to 202.2 ± 21.6 ms after) and AF termination to atrial tachycardia (AT) or sinus rhythm (SR) in 12 patients (24%). No stroke or pericardial effusion occurred; major groin complications (pseudoaneurysm n = 1, atrioventricular fistula n = 1) were detected in two patients. After a blanking period of 6 weeks, recurrence of any atrial arrhythmia was documented in 26 patients (52%). The majority of patients presented with organized AT (n = 15) while AF was present in n = 9 patients and AT/AF was observed in n = 2 patients. Twenty-two patients underwent reablation. During a mean follow-up of 363.14 ± 187.42 days and after an average of 1.46 ± 0.68 procedures, 82% of patients remained in stable SR. CONCLUSION: DISPERS-guided ablation using machine learning software (the Volta VX1 software) in addition to PVI in long-standing persistent AF ablation resulted in high long-term success rates regarding AF and AT elimination. Most arrhythmia recurrences were reentrant AT. After a total of 1.46 ± 0.68 procedures, freedom from AF/AT was 82%. Despite prolonged procedure times complication rates were low. Randomized studies are necessary to evaluate long-term efficacy of dispersion-guided ablation using AI.

Renal function and periprocedural complications in patients undergoing left atrial catheter ablation: A comparison between uninterrupted direct oral anticoagulants and phenprocoumon administration.

BACKGROUND: Data regarding uninterrupted oral anticoagulation in patients with chronic kidney disease (CKD) during catheter ablation for left atrial arrhythmias is limited. This study aimed to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulants (DOAC) compared with uninterrupted phenprocoumon in patients with CKD undergoing left atrial catheter ablation. METHODS AND RESULTS: We conducted a retrospective single-center study of patients who underwent left atrial catheter ablation between 2016 and 2019 with underlying chronic kidney disease (glomerular filtration rate (GFR) between 15 and 45 ml/min). The primary objective of this study was to investigate whether direct oral anticoagulant (DOAC) therapy or warfarin presents a superior safety profile in patients with chronic kidney disease (CKD) undergoing left atrial catheter ablation. We compared periprocedural complications (arteriovenous fistula, aneurysm, significant hematoma (> 5 cm)) and/or bleeding (drop in hemoglobin of >2 g/dl, pericardial effusion, retroperitoneal bleeding, other bleeding, stroke) between patients receiving either uninterrupted DOAC or warfarin therapy. Secondary analysis included patient baseline characteristics as well as procedural data. A total of 188 patients (female n = 108 (57%), mean age 75.3 ± 8.1 years, mean GFR 36.8 ± 6 ml/min) were included in this study. Underlying arrhythmias were atrial fibrillation (n = 104, 55.3%) and atypical atrial flutter (n = 84, 44.7%). Of these, n = 132 patients (70%) were under a DOAC medication, and n = 56 (30%) were under phenprocoumon. Major groin complications including pseudoaneurysm and/or AV fistula occurred in 8.9% of patients in the phenprocoumon group vs. 11.3% of patients in the DOAC group, which was not statistically significant (p = 0.62). Incidence of cardiac tamponade (2.3% vs. 0%; p = 0.55) and stroke (0% vs. 0%) were low in both DOAC and phenprocoumon groups with similar post-procedural drops in hemoglobin levels (1.1±1 g/dl vs 1.1±0.9 g/dl; p = 0.71). CONCLUSION: The type of anticoagulation had no significant influence on bleeding or thromboembolic events as well as groin complications in this retrospective study. Despite observing an increased rate of groin complications, the uninterrupted use of DOAC or phenprocoumon during left atrial catheter ablation in patients with CKD appears to be feasible and effective.

Myocardial injury and inflammation following pulsed-field ablation and very high-power short-duration ablation for atrial fibrillation.

INTRODUCTION: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) is an established treatment strategy for atrial fibrillation (AF). To improve PVI efficacy and safety, high-power short-duration (HPSD) ablation and pulsed-field ablation (PFA) were recently introduced into clinical practice. This study aimed to determine the extent of myocardial injury and systemic inflammation following PFA, HPSD, and standard RFA using established biomarkers. METHODS: We included 179 patients with paroxysmal AF receiving first-time PVI with different ablation technologies: standard RFA (30-40 W/20-30 s, n = 52), power-controlled HPSD (70 W/5-7 s, n = 60), temperature-controlled HPSD (90 W/4 s, n = 32), and PFA (biphasic, bipolar waveform, n = 35). High-sensitivity cardiac troponin T (hs-cTnT), creatine kinase (CK), CK MB isoform (CK-MB), and white blood cell (WBC) count were determined before and after ablation. RESULTS: Baseline characteristics were well-balanced between groups (age 63.1 ± 10.3 years, 61.5% male). Postablation hs-cTnT release was significantly higher with PFA (1469.3 ± 495.0 ng/L), HPSD-70W (1322.3 ± 510.6 ng/L), and HPSD-90W (1441.2 ± 409.9 ng/L) than with standard RFA (1045.9 ± 369.7 ng/L; p < .001). CK and CK-MB release was increased with PFA by 3.4-fold and 5.8-fold, respectively, as compared to standard RFA (p < .001). PFA was associated with the lowest elevation in WBC (Δ1.5 ± 1.5 × 109 /L), as compared to standard RFA (Δ3.8 ± 2.5 × 109 /L, p < .001), HPSD-70W (Δ2.7 ± 1.7 × 109 /L, p = .037), and HPSD-90W (Δ3.6 ± 2.5 × 109 /L, p < .001). CONCLUSION: Among the four investigated ablation technologies, PFA was associated with the highest myocardial injury and the lowest inflammatory reaction.

Combined telemonitoring and telecoaching for heart failure improves outcome.

Telemedicine has been shown to improve the outcome of heart failure (HF) patients in addition to medical and device therapy. We investigate the effectiveness of a comprehensive telehealth programme in patients with recent hospitalisation for HF on subsequent HF hospitalisations and mortality compared to usual care in a real-world setting. The telehealth programme consists of daily remote telemonitoring of HF signs/symptoms and regular individualised telecoaching sessions. Between January 2018 and September 2020, 119,715 patients of a German health insurer were hospitalised for HF and were eligible for participation in the programme. Finally, 6065 HF patients at high risk for re-hospitalisation were enroled. Participants were retrospectively compared to a propensity score matched usual care group (n = 6065). Median follow-up was 442 days (IQR 309-681). Data from the health insurer was used to evaluate outcomes. After one year, the number of hospitalisations for HF (17.9 vs. 21.8 per 100 patient years, p < 0.001), all-cause hospitalisations (129.0 vs. 133.2 per 100 patient years, p = 0.015), and the respective days spent in hospital (2.0 vs. 2.6 days per year, p < 0.001, and 12.0 vs. 13.4, p < 0.001, respectively) were significantly lower in the telehealth than in the usual care group. Moreover, participation in the telehealth programme was related to a significant reduction in all-cause mortality compared to usual care (5.8 vs. 11.0 %, p < 0.001). In a real-life setting of ambulatory HF patients at high risk for re-hospitalisation, participation in a comprehensive telehealth programme was related to a reduction of HF hospitalisations and all-cause mortality compared to usual care.

Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

BACKGROUND: Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. AIMS: This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. METHODS: Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. RESULTS: Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. CONCLUSIONS: Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Cardiologist-Directed Sedation Management in Patients Undergoing Transvenous Lead Extraction: A Single-Centre Retrospective Analysis.

BACKGROUND: The demand for transvenous lead extraction (TLE) has increased. In line with this, the safety of such procedures has also increased. Traditionally, TLE is performed under resource-intensive general anaesthesia. This study aims to evaluate the safety and outcomes of Cardiologist-lead deep sedation for TLE. METHODS: We retrospectively analysed 328 TLE procedures performed under deep sedation from 2016 to 2019. TLE procedures were performed by experienced electrophysiologists. Sedation was administered by a specifically trained cardiologist (bolus midazolam/fentanyl and propofol infusion). Procedural sedation data including blood pressure, medication administration and sedation time were collected. Complications related to sedation and the operative component of the procedure were analysed retrospectively. RESULTS: The sedation-associated complication rate during TLE was 22.0%. The most common complication (75% of complications) was hypotension requiring noradrenaline, followed by bradycardia requiring atropine (13% of complications). Additionally, the unplanned presence of an anaesthesiologist was needed in one case (0.3%). Deep sedation was achieved with midazolam (mean dose 42.9 ± 26.5 µg/kg), fentanyl (mean dose 0.4 ± 0.6 µg/kg) and propofol (mean dose 3.5 ± 1.2 mg/kg/h). There was no difference in medication dosage between those with a sedation-associated complication and those without. Sedation-associated complications appeared significantly more in patients with reduced LVEF (p = 0.01), renal impairment (p = 0.01) and a higher American Society of Anaesthesiologists (ASA) class (p = 0.01). CONCLUSION: Deep sedation for TLE can be safely performed by a specifically trained cardiologist, with a transition to general anaesthesia required in only 0.3% of cases. We continue to recommend the on-call availability of an anaesthesiologist and cardiac surgeon in case of major complications.

The influence of electrode-tissue-coverage on RF lesion formation and local impedance: Insights from an ex vivo model.

BACKGROUND: The influence of power, duration and contact force (CF) on radiofrequency (RF) lesion formation is well known, whereas data on local impedance (LI) and electrode-tissue-coverage (ETC) is scarce. The objective was to investigate their effect on lesion formation in an ex vivo model. METHODS AND RESULTS: An ex vivo model was developed utilizing cross-sections of porcine heart preparations and a force-sensing, LI-measuring catheter. N = 72 lesion were created systematically varying ETC (minor/full), CF (1-5 g, 10-15 g, 20-25 g) and power (20 W, 30 W, 40 W, 50 W). In minor ETC, the distal tip of the catheter was in electric contact with the tissue, in full ETC the whole catheter tip was embedded within the tissue. Lesion size and all parameters were measured once per second (n = 3320). LI correlated strongly with lesion depth (r = -0.742 for ΔLI; r = 0.781 for %LI-drop). Lesions in full ETC were significantly wider and deeper compared to minor ETC (p < .001) and steam pops were more likely. Baseline LI, ΔLI, and %LI-drop were significantly higher in full ETC (p < .001). In lesions resulting in steam pops, baseline LI, and ΔLI were significantly higher. The influence of CF on lesion size was higher in minor ETC than in full ETC. CONCLUSIONS: ETC is a main determinant of lesion size and occurrence of steam pops. Baseline LI and LI-drop are useful surrogate parameters for real-time assessment of ETC and ΔLI correlates strongly with lesion size.

Incidence and Predictors of Ventricular Arrhythmias in Transthyretin Amyloid Cardiomyopathy.

BACKGROUND: Wild-type transthyretin amyloid cardiomyopathy (wtATTR-CM) is characterized by heart failure, conduction abnormalities and arrhythmias. The incidence of ventricular arrhythmias, particularly ventricular tachycardias (VTs), in wtATTR-CM is unclear. With the development of targeted therapies and improved overall prognosis, there is an unmet need to identify patients at high risk for VTs who might benefit from ICD therapy. METHODS: Between 2017 and 2022, 72 patients diagnosed with wtATTR-CM were prospectively evaluated for the presence of ventricular arrhythmias using a Holter ECG. VTs were defined as >3 consecutive beats with a heart rate > 100 beats per minute originating from a ventricle. RESULTS: The incidence of VTs was 44% (n = 32/72) in unselected wtATTR-CM patients. Patients with VT showed significantly more severe left ventricular (LV) hypertrophy (septum diameter 21 ± 2.6 vs. 19 ± 3.0 mm, p = 0.006), reduced LV ejection fraction (47 ± 8 vs. 52 ± 8%, p = 0.014) and larger left atria (32 ± 7 vs. 28 ± 6 mm2, p = 0.020), but no differences in cardiac markers such as NTproBNP and troponin. In a multivariable model, LV hypertrophy (LV mass indexed, OR = 1.02 [1.00-1.03], p = 0.031), LV end-diastolic diameter (OR = 0.85 [0.74-0.98], p = 0.021) and LV end-systolic diameter (OR = 1.19 [1.03-1.349], p = 0.092) were predictive for VT occurrence with an area under the receiver operating characteristic of 0.76 [0.65-0.87]. CONCLUSIONS: The incidence of ventricular arrhythmia in wtATTR-CM is high and is associated with an advanced stage of left ventricular disease. Further studies are needed evaluating the role of VTs in predicting sudden cardiac death and the benefit of ICD therapy in wtATTR-CM.

High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?

AIMS: Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new 'high-power' charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. METHODS AND RESULTS: A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350 kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%-2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%-0.6%). The effective magnetic field along the charging cable was 38.65 µT and at the charging station was 77.9 µT. CONCLUSIONS: The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.

Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity.

Aims: Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM). Methods and results: The retrospective study included de-identified US patients who received either SM-RM or BM-RM capable of implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (Abbott, USA). Patients in SM-RM and BM-RM groups were propensity-score matched on age and gender, device type, implant year, and month. Compliance with RM was quantified as the proportion of patients enrolling in the RM system (Merlin.net™) and transmitting data at least once. Connectivity was measured by the median number of days between consecutive transmissions per patient. Of the initial 9714 patients with SM-RM and 26 679 patients with BM-RM, 9397 patients from each group were matched. Remote monitoring compliance was higher in SM-RM; significantly more patients with SM-RM were enrolled in RM compared with BM-RM (94.4 vs. 85.0%, P < 0.001), similar number of patients in the SM-RM group paired their device (95.1 vs. 95.0%, P = 0.77), but more SM-RM patients transmitted at least once (98.1 vs. 94.3%, P < 0.001). Connectivity was significantly higher in the SM-RM, with patients transmitting data every 1.2 (1.1, 1.7) vs. every 1.7 (1.5, 2.0) days with BM-RM (P < 0.001) and remained better over time. Significantly more SM-RM patients utilized patient-initiated transmissions compared with BM-RM (55.6 vs. 28.1%, P < 0.001). Conclusion: In this large real-world study, patients with SM-RM demonstrated improved compliance and connectivity compared with BM-RM.

Safety profile and long-term efficacy of very high-power short-duration (60-70 W) catheter ablation for atrial fibrillation: results of a large comparative analysis.

AIMS: This retrospective study sought to compare complication rates and efficacy of power-controlled very high-power short-duration (vHPSD) and conventional catheter ablation in a large cohort of patients with atrial fibrillation (AF). METHODS AND RESULTS: We analyzed 1115 consecutive patients with AF (38.7% paroxysmal, 61.3% persistent) who received first-time catheter ablation at our centre from 2015 to 2021. Circumferential pulmonary vein isolation ± additional substrate ablation using an irrigated-tip catheter was performed with vHPSD (70 W/5-7 s or 60 W/7-10 s) in 574 patients and with conventional power (30-35 W/15-30 s) in 541 patients. Baseline characteristics were well-balanced between groups (mean age 65.1 ± 11.2 years, 63.4% male). The 30-day incidence of cardiac tamponade [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598], pericardial effusion ≥ 10 mm [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598] and transient ischaemic attack [1/574 (0.17%) vs. 2/541 (0.37%), P = 0.529] was not significantly different between vHPSD and conventional ablation. No stroke, atrio-esophageal fistula, cardiac arrest or death occurred. Procedure (122.2 ± 46.8 min vs. 155.0 ± 50.5 min, P < 0.001), radiofrequency (22.4 ± 19.3 min vs. 52.9 ± 22.0 min, P < 0.001), and fluoroscopy (8.1 ± 7.2 vs. 9.2 ± 7.4, P = 0.016) duration were significantly shorter in the vHPSD group. At 12 months follow-up, freedom of any atrial arrhythmia was 44.1% vs. 34.2% (P = 0.010) in persistent AF and 78.1% vs. 70.2% in paroxysmal AF (P = 0.068). CONCLUSION: vHPSD ablation is as safe as conventional ablation and is associated with an improved long-term efficacy in persistent AF.

REACT DX registry: Real world REACTion to atrial high rate episodes detected in implantable cardioverter-defibrillator recipients with a DX lead.

BACKGROUND: Atrial fibrillation (AF) is associated with significant morbidity and is predicted by atrial high rate events. The early detection of AF is paramount to timely interventions to reduce the morbidity of AF. The DX ICD system combined with Home Monitoring® allows for continuous atrial rhythm monitoring without the need for a dedicated atrial lead. OBJECTIVE: To establish the reaction to and timing of reactions to the detection of atrial high rate episodes (AHRE). METHODS: A prospective cohort of DX ICD systems was followed up and the response to AHREs was collected and evaluated. RESULTS: A total of 234 patients were enrolled; an AHRE ⩾ 6 min was detected in 13.7% of patients (n= 32) within a mean follow-up duration of 16 months. A high rate of oral anticoagulation (OAC) prescription was seen with the detection of AHREs in patients with a not-low risk CHA2DS2-VASc score. There was a delay in this prescription highlighting the potential to improve the timeliness of patient care in this group of patients. CONCLUSIONS: The DX ICD system provides rapid and ongoing atrial rhythm monitoring such that physicians are rapidly aware of AHRE without the need for a dedicated atrial lead, but local protocols are needed to improve the response time of anti-coagulation prescription.

Ultrasound-Guided Access Reduces Vascular Complications in Patients Undergoing Catheter Ablation for Cardiac Arrhythmias.

Background: Femoral vascular access using the standard anatomic landmark-guided method is often limited by peripheral artery disease and obesity. We investigated the effect of ultrasound-guided vascular puncture (UGVP) on the rate of vascular complications in patients undergoing catheter ablation for atrial or ventricular arrhythmias. Methods: The data of 479 patients (59% male, mean age 68 years ± 11 years) undergoing catheter ablation for left atrial (n = 426; 89%), right atrial (n = 28; 6%) or ventricular arrhythmias (n = 28; 6%) were analyzed. All patients were on uninterrupted oral anticoagulants and heparin was administered intravenously during the procedure. Femoral access complications were compared between patients undergoing UGVP (n = 320; 67%) and patients undergoing a conventional approach (n = 159; 33%). Complication rates were also compared between patients with a BMI of >30 kg/m2 (n = 136) and patients with a BMI < 30 kg/m2 (n = 343). Results: Total vascular access complications including mild hematomas were n = 37 (7.7%). In the conventional group n = 17 (10.7%) and in the ultrasound (US) group n = 20 (6.3%) total vascular access complications occurred (OR 0.557, 95% CI 0.283−1.096). UGVP significantly reduced the risk of hematoma > 5 cm (OR 0.382, 95% CI 0.148, 0.988) or pseudoaneurysm (OR 0.160, 95% CI 0.032, 0.804). There was no significant difference between the groups regarding retroperitoneal hematomas or AV fistulas (p > 0.05). In patients with BMI > 30 kg/m2, UGVP led to a highly relevant reduction in the risk of total vascular access complications (OR 0.138, 95% CI 0.027, 0.659), hematomas > 5 cm (OR 0.051, 95% CI 0.000, 0.466) and pseudoaneurysms (OR 0.051, 95% CI 0.000, 0.466). Conclusion: UGVP significantly reduces vascular access complications. Patients with a BMI > 30 kg/m2 seem to particularly profit from a UGVP approach.

Deep sedation with propofol in patients undergoing left atrial ablation procedures-Is it safe?

Background: Catheter ablation for atrial fibrillation (AF) or left atrial tachycardia is well established. To avoid body movement and pain, sedative and analgesic agents are used. Objective: The aim was to investigate safety of sedation/anti-pain protocol administered by electrophysiology (EP) staff. Methods: A total of 3211 consecutive patients (61% male) undergoing left atrial ablation for paroxysmal AF (37.1%), persistent AF (35.3%) or left atrial tachycardia (27.6%) were included. Midazolam, fentanyl, and propofol were administered by EP staff. In case of respiratory depression, endotracheal intubation (eIT) or noninvasive ventilation (NIV) was implemented. Risk factors for eIT or NIV were analyzed. Results: Mean doses of propofol, midazolam, and fentanyl were 33.7 ± 16.7 mg, 3 ± 11.1 mg, and 0.16 ± 2.2 mg, respectively. Norepinephrine was administered in 396 of 3211 patients (12.3%) because of blood pressure drop (mean arterial pressure <60 mm Hg). NIV was necessary in 47 patients (1.5%) and eIT in 1 patient (0.03%). Procedure duration, high body mass index (BMI), high CHADS2-VASC2 score, high age, low glomerular filtration rate, diabetes mellitus, and low baseline oxygen saturation were associated with NIV or eIT. The only independent predictor for NIV/eIT was high BMI (>30.1 ± 9.0 kg/m2). Therefore, patients with a BMI of ≥30 had a 40% higher risk for the need of NIV/eIT during the procedure in our study. Conclusion: Sedation/anti-pain control including midazolam, propofol, and fentanyl administered by EP staff is safe, with only 1.53% requirement of NIV/eIT. High BMI (>30 kg/m2) emerged as an independent predictor for eIT/NIV.

Patient Characteristics, Procedural Characteristics, and Outcomes in Patients Having Lead Extraction in a High-Volume Center.

The rate of transvenous lead extraction (TLE) is increasing, with an increasing rate of complex devices being implanted. TLE is now a routine part of cardiac device management and up-to-date data on the safety and efficacy of TLE with modern tools and techniques is essential to management decisions regarding noninfectious indications for lead extraction. We present a contemporary, prospective review of TLE at our high-volume cardiac center. All patients who underwent TLE from June 2016 to June 2019 were enrolled in our local database, and baseline clinical data, procedural information, and outcome data were collected. In total, 561 leads were explanted (n = 153) or extracted (n = 408) from 341 patients over the study period. Patients were predominantly male (71%), with a mean age of 65 ± 17 years. The most common indication for lead removal was lead failure (45.2%, n = 154), followed by infection of the pocket or device (29.3%, n = 100). In total, complete success was achieved in 96.4% (n = 541) leads, clinical success in a further 2.1% (n = 12), and failure only in 1.4% (n = 8). There was an overall complication rate of 0.9% (3/341) for major complications and 1.5% (5/341) for minor complications. There were no deaths. In conclusion, our data suggest that there are ongoing improvements in the safety profile and success rates of lead extraction undertaken by experienced operators. The major complication rate now is <1%.

A prospective case-control validation of procalcitonin as a biomarker diagnosing pacemaker and implantable cardioverter-defibrillator pocket infection.

BACKGROUND: The diagnosis of device infections, especially pocket infections, is challenging and relies primarily on clinical presentation. The prospective DIRT (Device associated Infections Role of new diagnostic Tools) study identified procalcitonin (PCT) as the most promising biomarker among other 14 biomarkers to aid the diagnosis of pocket infection. It also identified an optimized cut-off value of 0.05 ng/ml for a localized generator pocket infection. AIMS: The present study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection in an independent cohort. METHODS: We prospectively enrolled 81 patients with pocket infections and 81 controls matched for age and renal function presenting for elective device exchange or lead revision. Patients with concomitant infectious or inflammatory diseases, end-stage renal failure, current active malignancy, or receiving immunosuppressive therapy were excluded. RESULTS: An elevated PCT over 0.05 ng/ml was found in 68% (n = 55) of pocket infections and 24% (n = 19) of controls, corresponding to a sensitivity of 68% and a specificity of 77% for diagnosing a pocket infection. In receiver operating characteristic (ROC) analysis, PCT showed an area under the curve of 0.75 (95% confidence interval, 0.68-0.83; P < 0.001). Sensitivity remained high with antibiotic pretreatment (65% compared to 69% without pretreatment) and in cases with minimal inflammatory signs (67% compared to 70% with extensive inflammation). CONCLUSION: Our study validates the cut-off value of 0.05 ng/ml PCT for diagnosis of a pocket infection, even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

BACKGROUND: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. METHODS: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. FINDINGS: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054). INTERPRETATION: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events. FUNDING: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center.

Catheter ablation in adult congenital heart disease on uninterrupted oral anticoagulation: Is it safe? Data from a large single-center study.

BACKGROUND: Catheter ablation in adult congenital heart disease (ACHD) patients is a critical treatment strategy for complex arrhythmias including atrial fibrillation (AF) and atrial tachycardia (AT). In addition to vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) are increasingly used in this patient population. OBJECTIVE: The purpose of this study was to assess the safety of catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC, examining thromboembolic, bleeding, and vascular access complications. METHODS: Retrospective analysis of 234 ACHD patients with simple (n = 83), moderate (n = 66), or complex (n = 85) CHD (mean age 46 years) undergoing 368 ablation procedures on uninterrupted oral anticoagulation with VKA (45.4%) or DOAC (54.6%) was undertaken. Arrhythmias were AF in 97, right AT in 181, left AT in 65, or a combination of AF and AT in 25. RESULTS: No thromboembolic complications occurred. Major complications occurred in 4 patients (1.1%; 1 VKA, 3 DOAC), including retroperitoneal hematoma in 2 and arteriovenous (AV) fistula requiring surgical treatment in 2. Minor bleeding or vascular access complications occurred in 46 cases (12.5%), including hematomas >5 cm in 26, AV fistulas (not requiring surgical intervention) in 13, and pseudoaneurysms in 7 (thrombin injection in 3/7). Overall, no significant difference was found between DOAC (14.9%) and VKA groups (12.0%; P = .411). CONCLUSION: Catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC is feasible and safe. No thromboembolic events occurred, and major bleeding or vascular access complications were rare. No significant differences regarding minor bleeding or vascular access complications between patients on DOAC or VKA were found.

Role of the Ambulatory Assessed Apnea-Hypopnea Index for Predicting Recurring Atrial Fibrillation After Ablation Therapy.

Catheter ablation is an effective treatment for atrial fibrillation (AF). Obstructive sleep apnea (OSA) is a known risk factor for recurrent AF. The apnea-hypopnea index (AHI) is a measurement tool to screen patients for OSA. We sought to evaluate if the ambulatory assessed AHI is associated with AF recurrence following AF catheter ablation. 187 patients with paroxysmal (n = 155) or early persistent (n = 32) AF presenting for catheter ablation were included in the study. AHI was determined prior to ablation using an ambulatory screening device. All patients underwent pulmonary vein isolation (PVI). In patients with early persistent AF (17%) additional ablation of complex fractionated atrial electrograms (CFAE) was performed. Clinical follow-up was available after 3 and 12 months including 7-day Holter-ECG. All 187 patients (60.3 ± 11.4 years, 64.2% male) completed the 3 months follow-up and 170 patients the 12 months follow-up. A pathological AHI ≥15 was found in 45/187 (24.1%) patients. Additional CFAE did not differ between patients with an AHI ≥15 and AHI <15 (p = 0.663). After 3 months, 12/41 (29.3%) patients with AHI ≥15 showed recurrent AF compared to 24/146 (16.4%) patients with AHI <15 (p = 0.066). After 12 months, AHI ≥15 was associated with a significant higher rate of AF recurrence of 47.4% (18/38) versus 26.5% (35/132) in patients with AHI <15 (p = 0.014). In the logistic regression analysis AHI ≥15 was an independent predictor of recurrent AF at 12 months (p = 0.011). In conclusion, ambulatory assessed AHI ≥15 is associated with increased risk for AF recurrence following catheter ablation. OSA screening should be performed in AF patients as it might influence catheter ablation success.