Device infection in patients undergoing pacemaker or defibrillator surgery: risk stratification using the PADIT score.

BACKGROUND: The use of an antibacterial envelope is cost-effective for patients at high risk of developing cardiac implantable electronic device (CIED) infection. The identification of these high-risk patients may be facilitated using a clinical risk score. The aim of the current study is to evaluate the PADIT score for identifying high-risk patients in patients undergoing a CIED procedure in a tertiary academic center. METHODS: This was a retrospective single-center study of consecutive patients undergoing a CIED procedure between January 2016 and November 2021. Patients who received an antibacterial envelope were excluded from this study. The primary endpoint was hospitalization for a CIED infection in the first year after the procedure. RESULTS: A total of 2333 CIED procedures were performed in the study period (mean age 61.6 ± 16.3 years, male sex 64.5%, previous CIED infection 1.7%, immunocompromised 5.4%). The median PADIT score was 4 (interquartile range, 2-6). CIED infection occurred in 10 patients (0.43%). The PADIT score had good discrimination in predicting major CIED infection (C-statistic 0.70; 95% confidence interval [CI] 0.54 to 0.86, P = 0.03). Using an optimal PADIT score cut-off value of 7, the risk of CIED infection was higher in the patients with a PADIT score of ≥ 7 in comparison to those with a lower PADIT score (1.23% vs. 0.26%, P = 0.02; odds ratio 4.8, 95% CI 1.4 to 16.6, P = 0.01). CONCLUSIONS: The PADIT score is a clinically useful score for identifying patients at high risk of developing CIED infection. The use of an antibacterial envelope in these high-risk patients may be cost-effective.

Impact of undiagnosed obstructive sleep apnea on atrial fibrillation recurrence following catheter ablation (OSA-AF study).

Background: Sleep-disordered breathing (SDB) may hamper the outcome of catheter ablation of atrial fibrillation (AF). However, SDB is underdiagnosed in clinical practice and the relevancy of undiagnosed SDB on the outcome of catheter ablation is unclear. Objective: To evaluate if undiagnosed SDB has an impact on AF recurrence after catheter ablation. Methods: In this single-center cohort study we enrolled patients who had a catheter ablation of AF 12 to 18 months prior to enrolment. Patients with diagnosed SDB at the time of catheter ablation were excluded. Enrolled patients underwent screening using WatchPAT (WP). SDB was defined as an apnea-hypopnea index (AHI) ≥ 15. Results: A total of 164 patients were screened for eligibility. After exclusion of patients with previously diagnosed SDB (n = 30), 104 of 134 eligible patients were enrolled and underwent SDB screening. The median AHI was 11.5 (interquartile range 6.8-21.9) and 39 patients (38%) had SDB which was undiagnosed during the first year after ablation. AF recurrence in the first year after catheter ablation occurred in 40 patients (38%). The risk of AF recurrence was higher in the group with undiagnosed SDB in comparison to those without SDB (51% versus 31%, P = 0.04). Interestingly, the prevalence of AF recurrence was similar between patients with previously diagnosed and undiagnosed SDB (51% versus 50%, P = 0.92). Conclusion: A significant proportion of patients undergoing catheter ablation of AF have undiagnosed SDB which is associated with a twofold higher risk of AF recurrence. SDB screening may improve patient counselling regarding the efficacy of catheter ablation.

Performance and Robustness Testing of a Non-Invasive Mapping System for Ventricular Arrhythmias.

Background: The clinical value of non-invasive mapping system depends on its accuracy under common variations of the inputs. The View Into Ventricular Onset (VIVO) system matches simulated QRS complexes of a patient-specific anatomical model with a 12-lead ECG to estimate the origin of ventricular arrhythmias. We aim to test the performance of the VIVO system and its sensitivity to changes in the anatomical model, time marker placement to demarcate the QRS complex and body position. Methods: Non-invasive activation maps of idiopathic premature ventricular complexes (PVCs) using a patient-specific or generic anatomical model were matched with the location during electrophysiological studies. Activation maps were analyzed before and after systematically changing the time marker placement. Morphologically identical PVCs recorded in supine and sitting position were compared in a subgroup. Results: Non-invasive activation maps of 48 patients (age 51 ± 14 years, 28 female) were analyzed. The origin of the PVCs as determined by VIVO system matched with the clinical localization in 36/48 (75%) patients. Mismatches were more common for PVCs of left than right ventricular origin [11/27 (41%) vs. 1/21 (5%) of cases, p < 0.01]. The first 32 cases were analyzed for robustness testing of the VIVO system. Changing the patient-specific vs. the generic anatomical model reduced the accuracy from 23/32 (72%) to 15/32 (47%), p < 0.05. Time marker placement in the QRS complex (delayed onset or advanced end marker) or in the ST-segment (delaying the QRS complex end marker) resulted in progressive shifts in origins of PVCs. Altered body positions did not change the predicted origin of PVCs in most patients [clinically unchanged 11/15 (73%)]. Conclusion: VIVO activation mapping is sensitive to changes in the anatomical model and time marker placement but less to altered body position.

Efficacy and safety of direct oral anticoagulants in patients undergoing elective electrical cardioversion: A real-world patient population.

BACKGROUND: Direct oral anticoagulants (DOACs) have emerged as the preferred choice of oral anticoagulation in patients with atrial fibrillation. Randomized trials have demonstrated the efficacy and safety of DOAC in patients undergoing electrical cardioversion (ECV); however, there is limited real-world data. OBJECTIVE: To evaluate the outcome of patients undergoing an elective ECV for atrial tachyarrhythmia in a tertiary referral center who were treated with DOAC or vitamin K antagonist (VKA) without routine trans esophageal echocardiography (TEE). METHODS: This was a retrospective single-center cohort study of consecutive patients undergoing an elective ECV for atrial tachyarrhythmia from January 2013 to February 2020. The primary endpoints were thromboembolism (composite of stroke, transient ischemic attack or systemic embolism) and major bleeding events within 60 days. RESULTS: A total of 1431 ECV procedures were performed in 920 patients. One-third of the procedures were performed under DOAC (N = 488, 34%) and the remainder of the procedures was performed under VKA (N = 943, 66%). There were no differences between groups with regard to demographic variables (mean age 62.4 ± 11.7, 72% men) and mean CHA2DS2-VASc score (2.3 ± 1.6); however, the VKA group had a higher proportion of patients with co-morbidity. Thromboembolism occurred in 0.41% in the DOAC group versus 0.64% in the VKA group (P = 0.72). Major bleeding events occurred in 0.41% in the DOAC group versus 0.11% in the VKA group (P = 0.27). CONCLUSION: In a real-world population, the rates of thromboembolism and major bleeding events were low after elective ECV in patients using DOAC or VKA, even without routine TEE.

Extensive scar modification for the treatment of intra-atrial re-entrant tachycardia in patients after congenital heart surgery.

BACKGROUND: Catheter ablation is an important therapeutic option for atrial tachycardias in patients with CHD. As a result of extensive scarring and surgical repair, multiple intra-atrial re-entrant tachycardia circuits develop and serve as a substrate for arrhythmias. The best ablation approach for patients with multiple intra-atrial re-entrant tachycardias has not been investigated. Here, we compared substrate-based ablation using extensive scar modification to conventional ablation. METHODS: The present study included patients with surgically corrected CHD that underwent intra-atrial re-entrant tachycardia ablation. Extensive scar modification was defined as substrate ablation based on a dense voltage map, aimed to eliminate all potentials in the scar region. The control group had activation mapping-based ablation. A clinical composite endpoint was assessed. Points were given for type, number, and treatment of intra-atrial re-entrant tachycardia recurrence. RESULTS: In 40 patients, 63 (extensive scar modification 13) procedures were performed. Acute procedural success was achieved in 78%. Procedural duration was similar in both groups. Forty-nine percent had a recurrence within 1 year. During a 5-year follow-up (2.5-7.5 years), 46% required repeat catheter ablation. Compared to baseline, clinical composite endpoint significantly decreased by 46% after 12 months (p = 0.001). Acute procedural success, procedural parameters, recurrence and repeat ablation were similar between extensive scar modification and activation mapping-based ablation. CONCLUSION: Catheter ablation using extensive scar modification for intra-atrial re-entrant tachycardias occurring after surgically corrected CHD illustrated similar short- and long-term outcomes and procedural efficiency compared to catheter ablation using activation mapping-based ablation. The choice of ablation approach for multiple intra-atrial re-entrant tachycardia should remain at the discretion of the operator.

Minimally interrupted novel oral anticoagulant versus uninterrupted vitamin K antagonist during atrial fibrillation ablation.

PURPOSE: The safety and efficacy of a minimally interrupted novel oral anticoagulant (NOAC) strategy at the time of atrial fibrillation (AF) ablation is uncertain. The purpose of this study was to compare rates of bleeding and thromboembolic events between minimally interrupted NOAC and uninterrupted vitamin K antagonist (VKA) in patients undergoing AF ablation. METHODS: This was a retrospective single-center cohort study of consecutive patients who underwent AF catheter ablation between January 2013 and April 2017. Endpoints included major bleeding, clinically relevant non-major bleeding and systemic thromboembolic event from the time of ablation through 30 days. Bleeding events were defined by the Bleeding Academic Research Consortium (BARC) and International Society on Thrombosis and Haemostasis (ISTH). RESULTS: A total of 637 patients were included in the analysis, 520 patients used uninterrupted VKA and 117 patients minimally interrupted NOAC (dabigatran: n = 68; apixaban: n = 30; rivaroxaban, n = 14; edoxaban, n = 5). The rate of clinically relevant non-major bleeding was lower in the NOAC group in comparison to the VKA group (BARC type 2: 2.6% versus 8.3%, P = 0.03; ISTH: 0% versus 3.8%, P = 0.03). Rates of major bleeding were similar between groups (BARC type 3 to 5: 3.4% versus 4.2%, P = NS; ISTH: 6.0% versus 8.7%, P = NS; for NOAC and VKA groups, respectively). Rates of systemic embolism were 0% with minimally interrupted NOAC, and 0.6% with uninterrupted VKA (P = NS). CONCLUSIONS: In patients undergoing AF ablation, anticoagulation with minimally interrupted NOAC was associated with fewer clinically relevant non-major bleeding events in comparison with uninterrupted VKA without compromising thromboembolic safety.

Coupling interval variability of premature ventricular contractions in patients with different underlying pathology: an insight into the arrhythmia mechanism.

PURPOSE: Coupling interval (CI) variability of premature ventricular contractions (PVCs) is influenced by the underlying arrhythmia mechanism. The aim of this study was to compare CI variability of PVCs in different myocardial disease entities, in order to gain insight into their arrhythmia mechanism. METHODS: Sixty-four patients with four underlying pathologies were included: idiopathic (n = 16), non-ischemic dilated cardiomyopathy (NIDCM) (n = 16), familial cardiomyopathy (PLN/LMNA) (n = 16), and post-MI (n = 16)-associated PVCs. The post-MI group was included as a reference, on account of its known re-entry mechanism. On Holter registrations, the first 20 CIs of the dominant PVC morphology were measured manually after which median ΔCI and mean SD of CI/√R-R (= CI of PVC corrected for underlying heart rate) were obtained. Two observers independently measured PVC CIs on pre-selected Holter registrations in order to determine inter- and intra-observer reliability. RESULTS: The largest ΔCI was seen in the PLN/LMNA group (220 ms (120-295)), the lowest in the idiopathic group (120 ms (100-190)). The ΔCI in the PLN/LMNA group was significantly larger than the post-MI group (220 ms (120-295) vs 130 ms (105-155), p = 0.023). Mean SD of CI/√R-R in the PLN/LMNA group was also significantly higher than in the post-MI group (p = 0.044). Inter- and intra-observer reliability was good (ICC = 0.91 vs 0.86 and 0.96 vs 0.77, respectively). CONCLUSIONS: Low ΔCI and SD of CI/√R-R of idiopathic and NIDCM PVCs suggest that the underlying arrhythmia mechanisms might be re-entry or triggered activity. Abnormal automaticity or modulated parasystole are unlikely mechanisms. High CI variability in PLN/LMNA patients suggests that the re-entry and triggered activity are less likely mechanisms in this group.

Ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation as the first procedure versus a stepwise approach (EPILOGUE) - study protocol for a randomized controlled trial.

BACKGROUND: The role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation. METHODS/DESIGN: The EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety. DISCUSSION: This study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT. TRIAL REGISTRATION: NL4816807814v02.