Outcome and safety of intraoperative defibrillation testing during device replacement: the Simpler trial.

AIMS: Intraoperative defibrillation testing (DT) during implant or replacement of implantable cardioverter-defibrillators (ICDs) has been a matter of debate for many years. This debate was put to rest by the Simple and Nordic ICD trials, and the practice of testing during new implantations has essentially been almost abandoned. Old registries demonstrated an increased incidence of significant findings in DT during replacements. The aim of the present study was to evaluate frequency of significant findings and safety of DT in subjects undergoing device replacement. METHODS AND RESULTS: A prospective observational multi-centre study included consecutive patients undergoing ICD generator replacement. The primary outcome was a failure to terminate induced ventricular fibrillation (VF) with a single shock 10 J below the maximal capacity of the device. Secondary outcomes included complications of DT. Patients were followed-up at 1- and 6-months post-procedure. A total of 92 patients were eligible, and consented to the study, of which 84 underwent DT during battery replacement. The median age was 68 years and 79.8% were males. Induction of VF was successful in 84 patients as was a successful conversion on the first attempt in all. There were no procedure-related complications. During follow up one patient had two appropriate ICD shock events. In four patients, ICD programming was changed. None suffered inappropriate shock. There was no evidence of lead malfunction. Two deaths occurred, none of which was related to arrhythmia. CONCLUSION: The present study found DT was not associated with complications in patients undergoing ICD generator replacement but produced no clinically important information.

Targeted left ventricular lead positioning to the site of latest activation in cardiac resynchronization therapy: a systematic review and meta-analysis.

AIMS: Several studies have evaluated the use of electrically- or imaging-guided left ventricular (LV) lead placement in cardiac resynchronization therapy (CRT) recipients. We aimed to assess evidence for a guided strategy that targets LV lead position to the site of latest LV activation. METHODS AND RESULTS: A systematic review and meta-analysis was performed for randomized controlled trials (RCTs) until March 2023 that evaluated electrically- or imaging-guided LV lead positioning on clinical and echocardiographic outcomes. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization, and secondary endpoints were quality of life, 6-min walk test (6MWT), QRS duration, LV end-systolic volume, and LV ejection fraction. We included eight RCTs that comprised 1323 patients. Six RCTs compared guided strategy (n = 638) to routine (n = 468), and two RCTs compared different guiding strategies head-to-head: electrically- (n = 111) vs. imaging-guided (n = 106). Compared to routine, a guided strategy did not significantly reduce the risk of the primary endpoint after 12-24 (RR 0.83, 95% CI 0.52-1.33) months. A guided strategy was associated with slight improvement in 6MWT distance after 6 months of follow-up of absolute 18 (95% CI 6-30) m between groups, but not in remaining secondary endpoints. None of the secondary endpoints differed between the guided strategies. CONCLUSION: In this study, a CRT implantation strategy that targets the latest LV activation did not improve survival or reduce heart failure hospitalizations.

Electrocardiographic findings in patients with arrhythmogenic cardiomyopathy and right bundle branch block ventricular tachycardia.

AIMS: Little is known about patients with right bundle branch block (RBBB)-ventricular tachycardia (VT) and arrhythmogenic cardiomyopathy (ACM). Our aims were: (i) to describe electrocardiogram (ECG) characteristics of sinus rhythm (SR) and VT; (ii) to correlate SR with RBBB-VT ECGs; and (iii) to compare VT ECGs with electro-anatomic mapping (EAM) data. METHODS AND RESULTS: From the European Survey on ACM, 70 patients with spontaneous RBBB-VT were included. Putative left ventricular (LV) sites of origin (SOOs) were estimated with a VT-axis-derived methodology and confirmed by EAM data when available. Overall, 49 (70%) patients met definite Task Force Criteria. Low QRS voltage predominated in lateral leads (n = 37, 55%), but QRS fragmentation was more frequent in inferior leads (n = 15, 23%). T-wave inversion (TWI) was equally frequent in inferior (n = 28, 42%) and lateral (n = 27, 40%) leads. TWI in inferior leads was associated with reduced LV ejection fraction (LVEF; 46 ± 10 vs. 53 ± 8, P = 0.02). Regarding SOOs, the inferior wall harboured 31 (46%) SOOs, followed by the lateral wall (n = 17, 25%), the anterior wall (n = 15, 22%), and the septum (n = 4, 6%). EAM data were available for 16 patients and showed good concordance with the putative SOOs. In all patients with superior-axis RBBB-VT who underwent endo-epicardial VT activation mapping, VT originated from the LV. CONCLUSIONS: In patients with ACM and RBBB-VT, RBBB-VTs originated mainly from the inferior and lateral LV walls. SR depolarization and repolarization abnormalities were frequent and associated with underlying variants.

The prevalence of left and right bundle branch block morphology ventricular tachycardia amongst patients with arrhythmogenic cardiomyopathy and sustained ventricular tachycardia: insights from the European Survey on Arrhythmogenic Cardiomyopathy.

AIMS: In arrhythmogenic cardiomyopathy (ACM), sustained ventricular tachycardia (VT) typically displays a left bundle branch block (LBBB) morphology while a right bundle branch block (RBBB) morphology is rare. The present study assesses the VT morphology in ACM patients with sustained VT and their clinical and genetic characteristics. METHODS AND RESULTS: Twenty-six centres from 11 European countries provided information on 954 ACM patients who had ≥1 episode of sustained VT spontaneously documented during patients' clinical course. Arrhythmogenic cardiomyopathy was defined according to the 2010 Task Force Criteria, and VT morphology according to the QRS pattern in V1. Overall, 882 (92.5%) patients displayed LBBB-VT alone and 72 (7.5%) RBBB-VT [alone in 42 (4.4%) or in combination with LBBB-VT in 30 (3.1%)]. Male sex prevalence was 79.3%, 88.1%, and 56.7% in the LBBB-VT, RBBB-VT, and LBBB + RBBB-VT groups, respectively (P = 0.007). First RBBB-VT occurred 5 years after the first LBBB-VT (46.5 ± 14.4 vs 41.1 ± 15.8 years, P = 0.011). An implanted cardioverter-defibrillator was more frequently implanted in the RBBB-VT (92.9%) and the LBBB + RBBB-VT groups (90%) than in the LBBB-VT group (68.1%) (P < 0.001). Mutations in PKP2 predominated in the LBBB-VT (65.2%) and the LBBB + RBBB-VT (41.7%) groups while DSP mutations predominated in the RBBB-VT group (45.5%). By multivariable analysis, female sex was associated with LBBB + RBBB-VT (P = 0.011) while DSP mutations were associated with RBBB-VT (P < 0.001). After a median follow-up of 103 (51-185) months, death occurred in 106 (11.1%) patients with no intergroup difference (P = 0.176). CONCLUSION: RBBB-VT accounts for a significant proportion of sustained VTs in ACM. Sex and type of pathogenic mutations were associated with VT type, female sex with LBBB + RBBB-VT, and DSP mutation with RBBB-VT.

Characteristics of Second-Line Investigations of Middle-Aged Athletes Who Failed Preparticipation Examinations.

OBJECTIVE: The role of exercise testing during preparticipation examinations (PPEs) of middle-aged athletes is uncertain. This study examined the characteristics of disqualifications after an initial PPE that includes an exercise test in competitive athletes older than 30 years. We investigated disqualification rates and reasons, second-line investigations performed, and final decisions regarding competitive sports participation. DESIGN: Chart review. SETTING: Sports medicine clinic. PARTICIPANTS: Athletes aged >30 years that performed an exercise test as part of their annual PPE at our sports medicine clinic (n = 866). INDEPENDENT VARIABLES: Age, sex, height, weight, sport type, cardiovascular risk factors, and abnormal PPE findings. MAIN OUTCOME MEASURES: Additional investigations performed, approval/disqualification regarding competitive sports participation. RESULTS: The initial disqualification rate of athletes was 9.8%. Three (3.6%) athletes were disqualified following questionnaire and physical examination, 19 (22.4%) because of resting electrocardiogram findings, and 65 (76.5%) following the exercise test. After additional work-up, only 5 athletes (0.4%) were ultimately found ineligible for competitive sports. From those, only 2 athletes (0.2%) were disqualified because of exercise test findings, which were episodes of supraventricular tachycardia and not ischemia-related. CONCLUSIONS: The addition of an exercise test to the PPE of middle-aged athletes is of limited value. If exercise testing of older athletes is performed, arrhythmias are probably of higher significance than ST-T changes.

[RECOMMENDATIONS FOR CHANGING CARDIOVASCULAR SCREENING OF ATHLETES WHO ARE REQUIRED FOR PRE-PARTICIPATION SCREENING UNDER THE SPORTS LAW - A POSITION PAPER ON BEHALF OF THE ISRAEL HEART SOCIETY].

INTRODUCTION: For many years routine screening of athletes in Israel includes frequently performed ECGs and exercise tests that overload the system with questionable benefits. The purpose of the current document is to reevaluate the need for pre-participation testing and establish new evidence-based guidelines. It should be noted that our proposal for a change of approach relates only to subjects whose health questionnaire is normal, who do not have a family history of sudden and unexpected death at an early age, or a family history of hereditary heart disease and whose physical examination from a cardiovascular point of view is normal.

Mobile health applications for the detection of atrial fibrillation: a systematic review.

AIMS: Atrial fibrillation (AF) is the most common sustained arrhythmia and an important risk factor for stroke and heart failure. We aimed to conduct a systematic review of the literature and summarize the performance of mobile health (mHealth) devices in diagnosing and screening for AF. METHODS AND RESULTS: We conducted a systematic search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Forty-three studies met the inclusion criteria and were divided into two groups: 28 studies aimed at validating smart devices for AF diagnosis, and 15 studies used smart devices to screen for AF. Evaluated technologies included smartphones, with photoplethysmographic (PPG) pulse waveform measurement or accelerometer sensors, smartbands, external electrodes that can provide a smartphone single-lead electrocardiogram (iECG), such as AliveCor, Zenicor and MyDiagnostick, and earlobe monitor. The accuracy of these devices depended on the technology and the population, AliveCor and smartphone PPG sensors being the most frequent systems analysed. The iECG provided by AliveCor demonstrated a sensitivity and specificity between 66.7% and 98.5% and 99.4% and 99.0%, respectively. The PPG sensors detected AF with a sensitivity of 85.0-100% and a specificity of 93.5-99.0%. The incidence of newly diagnosed arrhythmia ranged from 0.12% in a healthy population to 8% among hospitalized patients. CONCLUSION: Although the evidence for clinical effectiveness is limited, these devices may be useful in detecting AF. While mHealth is growing in popularity, its clinical, economic, and policy implications merit further investigation. More head-to-head comparisons between mHealth and medical devices are needed to establish their comparative effectiveness.

Predictors of short-term mortality in patients undergoing a successful uncomplicated extraction procedure.

BACKGROUND: The prognosis of patients with untreated cardiac implantable electronic device (CIED) infection is poor. Whether removal of all leads by a successful transvenous lead extraction (TLE) procedure changes the prognosis is unclear. OBJECTIVE: To identify predictors of mortality in patients with CIED infection despite successful TLE. METHODS: Retrospective single-center analysis of prospectively collected database from consecutive patients undergoing TLE at our center. Predictors for mortality were identified and a score predicting high mortality rate was calculated. RESULTS: A total of 371 consecutive patients underwent TLE, of whom 337 (90.8%) had complete hardware removal. Most were extracted due to infectious causes (81.3%). Approximately one-third (35%) died during a mean follow-up of 1056 ± 868 days. There was significantly higher mortality observed in the infectious group. Multivariate logistic regression models for infectious group only identified creatinine and albumin measurements as risk markers for 30 days mortality (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.19-2.38; P = .003 and OR, 0.4; 95% CI, 0.16-0.97; P = .039, respectively). A risk score was created based on cutoff values of creatinine ≥2md/dL (1 point) and albumin ≤3.5 g/dL (1 point). A value of 2 points predicted a 50% chance of 30-day mortality and a 75% chance of 1-year mortality (P < .0001 for both). CONCLUSIONS: Creatinine and albumin can be used as a combined risk score to successfully identify patients at risk of death despite undergoing a successful TLE procedure for infectious reasons. This score could help decision making when contemplating on conservative antibiotic treatment vs TLE.

The efficacy of the LinoxSmart DX ICD lead from a single center experience.

PURPOSE: The Biotronik LinoxSmart DX implanted cardioverter defibrillator (ICD) lead is a novel VDD lead with the advantage of integrated atrial sensing dipole combined with a special augmentation and filtering mechanisms. We sought to determine the efficacy of the Biotronik LinoxSmart DX ICD lead. METHODS: Non-randomized consecutive patients implanted with Biotronik LinoxSmart DX lead at Sheba Medical Center were included in this study. Electrical parameters and arrhythmic events were recorded during follow up of one year. RESULTS: Seventy-three patients (69 males (94.5%), mean age 61 ± 12 years) were included. All patients were successfully implanted with a Biotronic VR-T DX device and LinoxSmart DX ICD lead (DX-17 in 37% and DX-15 in 63% patients). Mean P wave amplitude at time of implantation was 3.66 ± 2.9 mV and improved significantly throughout the follow-up (5.29 ± 4.39 mV, p = 0.009). Appropriate atrial sensing (defined as P wave amplitude of ≥0.8 mV) rate of 100% at implantation significantly decreased to 89% (p = 0.015) at 12 months. Three out of 67 (4.5%) patients without a known history of atrial fibrillation had documented new onset paroxysmal atrial fibrillation. Appropriate shocks occurred in 4 (5.5%) patients. One patient with atrial sensing less than 0.4 mV had inappropriate shock. CONCLUSIONS: Among patients implanted with the Biotronik LinoxSmart DX ICD lead in our single center, appropriate atrial sensing rate decreased over 12 months. Larger studies are needed to evaluate the reliability of long term appropriate atrial sensing.

Comparison of outcomes in infected cardiovascular implantable electronic devices between complete, partial, and failed lead removal: an ESC-EHRA-EORP ELECTRa (European Lead Extraction ConTrolled) registry.

AIMS: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved. METHODS AND RESULTS: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]. CONCLUSION: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.

Time-to-first appropriate shock in patients implanted prophylactically with an implantable cardioverter-defibrillator: data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS).

AIMS: Data on predictors of time-to-first appropriate implantable cardioverter-defibrillator (ICD) therapy in patients with Brugada Syndrome (BrS) and prophylactically implanted ICD's are scarce. METHODS AND RESULTS: SABRUS (Survey on Arrhythmic Events in BRUgada Syndrome) is an international survey on 678 BrS patients who experienced arrhythmic event (AE) including 252 patients in whom AE occurred after prophylactic ICD implantation. Analysis was performed on time-to-first appropriate ICD discharge regarding patients' characteristics. Multivariate logistic regression models were utilized to identify which parameters predicted time to arrhythmia ≤5 years. The median time-to-first appropriate ICD therapy was 24.8 ± 2.8 months. A shorter time was observed in patients from Asian ethnicity (P < 0.05), those with syncope (P = 0.001), and those with Class IIa indication for ICD (P = 0.001). A longer time was associated with a positive family history of sudden cardiac death (P < 0.05). Multivariate Cox regression revealed shorter time-to-ICD therapy in patients with syncope [odds ratio (OR) 1.65, P = 0.001]. In 193 patients (76.6%), therapy was delivered during the first 5 years. Factors associated with this time were syncope (OR 0.36, P = 0.001), spontaneous Type 1 Brugada electrocardiogram (ECG) (OR 0.5, P < 0.05), and Class IIa indication (OR 0.38, P < 0.01) as opposed to Class IIb (OR 2.41, P < 0.01). A near-significant trend for female gender was also noted (OR 0.13, P = 0.052). Two score models for prediction of <5 years to shock were built. CONCLUSION: First appropriate therapy in BrS patients with prophylactic ICD's occurred during the first 5 years in 76.6% of patients. Syncope and spontaneous Type 1 Brugada ECG correlated with a shorter time to ICD therapy.

Performance of the Linox implantable cardioverter defibrillator leads: A single-center experience.

BACKGROUND: An early failure of Biotronik Linox implantable cardioverter defibrillator (ICD) leads has been reported from several centers. AIM: To compare the performance of Linox ICD leads with different other ICD leads as a report of the Sheba Medical Center experience. METHODS: All patients who had implantation of Linox ICD leads between 2007 and 2016 were included in this study. ICD lead failure was defined as low- or high-voltage impedance; failure to capture, sense, or defibrillate; or the presence of nonphysiological signals not due to external interference. The survival probability of Linox leads was determined and compared to Medtronic Sprint Quattro ICD leads. RESULTS: A total of 340 patients (age 64.4 ± 1.8 years) were included in this analysis. They were followed up to 105 months (mean 45.7 ± 7, median 44 (Interquartile range (IQR) 26-63) months). Twelve patients (3.5%) met the criteria for lead failure within 61.2 ± 22.9 months (median 66.5 [IQR 48-85 months]) post implantation. Noise with inappropriate ventricular arrhythmias detection, with or without therapy, was seen in 10 patients (83%). High pacing thresholds and high impedances were detected in two patients (17%). The survival probability of Linox leads at 60 months (97.3%) was similar to the survival probability of Sprint Quattro leads (98.2%) (P = .58). Nevertheless, the survival probability at 105 months was much lower (81% vs 97%, Linox ICD lead and Sprint Quattro lead, respectively, P = .0039). CONCLUSION: Linox ICD leads have higher late failure rates compared to Sprint Quattro leads. These findings need to be confirmed in larger scale studies.

Diagnostic and Clinical Significance of T Wave Inversion in Athletes.

BACKGROUND: Electrocardiography abnormalities are a common finding in athletes. To facilitate the differentiation of physiological adaptation versus pathological remodeling, a series of guidelines has emerged in the past decade that attempt to improve specificity while maintaining a high sensitivity. Recently, T wave inversion in the athletic population gained more attention, resulting in accelerated research leading to novel findings not yet integrated into clinical practice. We aim to simplify the knowledge to date and integrate it into one easy to use practical flowchart.

Decline in effort capacity with age: Echocardiographic stress analysis in the elderly.

BACKGROUND: The present study was designed to assess the underlying mechanism of decline in effort capacity seen with aging. METHODS: We analyzed 250 healthy senior patients (≥65 years) with an ejection fraction ≥60% who underwent a stress echocardiogram test. The seniors (aged 65-94) were divided into 3 equal age groups (groups 1, 2, and 3), and their echo characteristics at rest and peak exercise (measured and calculated) were compared. RESULTS: Diastolic function at rest declined significantly (E lateral, E septal, E/E', A) with age, while other rest parameters were similar. There was a significant reduction in peak cardiac output (CO) associated with age (time × age group interaction; P < .05), which was attributed to the combination an attenuated stroke volume (SV) and heart rate (HR) response. The decline in effort capacity with age was the product of the combined effect of cardiac (reduced LVEDV and HR response) and noncardiac (reduction in arteriovenous difference; P = .02 for interaction) causes. CONCLUSION: The cardiovascular system undergoes several age-related changes. Decline in effort capacity is an ongoing process of aging and consists of several changes in the cardiac and noncardiac systems, comprising a decline in CO and its components, specifically the peak exercise LVEDV, peak heart rate, and the ability of the muscles to extract enough oxygen for the necessary effort.

Catheter Ablation as First-Line Therapy in Persistent Atrial Fibrillation: Patient Characteristics and Clinical Outcomes.

BACKGROUND: In patients with persistent atrial fibrillation (PerAF), antiarrhythmic drugs (AADs) are considered a first-line rhythm-control strategy, whereas catheter ablation is a reasonable alternative. OBJECTIVES: This study sought to examine the prevalence, patient characteristics, and clinical outcomes of patients with PerAF who underwent catheter ablation as a first or second-line strategy. METHODS: This multicenter observational study included consecutive patients with PerAF who underwent first-time ablation between January 2020 and September 2021 in 9 medical centers in the United States. Patients were divided into those who underwent ablation as first-line therapy and those who had ablation as second-line therapy. Patient characteristics and clinical outcomes were compared between the groups. RESULTS: A total of 2,083 patients underwent first-time ablation for PerAF. Of these, 1,086 (52%) underwent ablation as a first-line rhythm-control treatment. Compared with patients treated with AADs as first-line therapy, these patients were predominantly male (72.6% vs 68.1%; P = 0.03), with a lower frequency of hypertension (64.0% vs 73.4%; P < 0.001) and heart failure (19.1% vs 30.5%; P < 0.001). During a mean follow-up of 325.9 ± 81.6 days, arrhythmia-free survival was similar between the groups (HR: 1.13; 95% CI: 0.92-1.41); however, patients in the second-line ablation strategy were more likely to continue receiving AAD therapy (41.5% vs 15.9%; P < 0.001). CONCLUSIONS: A first-line ablation strategy for PerAF is prevalent in the United States, particularly in men with fewer comorbidities. More data are needed to identify patients with PerAF who derive benefit from an early intervention strategy.

Mode and Characteristics of Arrhythmia Initiation in Idiopathic Ventricular Fibrillation: A THESIS Substudy.

BACKGROUND: There is limited information on the mode of arrhythmia initiation in idiopathic ventricular fibrillation (IVF). A non-pause-dependent mechanism has been suggested to be the rule. OBJECTIVES: The aim of this study was to assess the mode and characteristics of initiation of polymorphic ventricular tachycardia (PVT) in patients with short or long-coupled PVT/IVF included in THESIS (THerapy Efficacy in Short or long-coupled idiopathic ventricular fibrillation: an International Survey), a multicenter study involving 287 IVF patients treated with drugs or radiofrequency ablation. METHODS: We reviewed the initiation of 410 episodes of ≥1 PVT triplet in 180 patients (58.3% females; age 39.6 ± 13.6 years) with IVF. The incidence of pause-dependency arrhythmia initiation (prolongation by >20 ms of the preceding cycle length) was assessed. RESULTS: Most arrhythmias (n = 295; 72%) occurred during baseline supraventricular rhythm without ambient premature ventricular complexes (PVCs), whereas 106 (25.9%) occurred during baseline rhythm including PVCs. Nine (2.2%) arrhythmias occurred during atrial/ventricular pacing and were excluded from further analysis. Mode of PVT initiation was pause-dependent in 45 (15.6%) and 64 (60.4%) of instances in the first and second settings, respectively, for a total of 109 of 401 (27.2%). More than one type of pause-dependent and/or non-pause-dependent initiation (mean: 2.6) occurred in 94.4% of patients with ≥4 events. Coupling intervals of initiating PVCs were <350 ms, 350-500 ms, and >500 ms in 76.6%, 20.72%, and 2.7% of arrhythmia initiations, respectively. CONCLUSIONS: Pause-dependent initiation occurred in more than a quarter of arrhythmic episodes in IVF patients. PVCs having long (between 350 and 500 ms) and very long (>500 ms) coupling intervals were observed at the initiation of nearly a quarter of PVT episodes.

Complicated Pocket Infection in Patients Undergoing Lead Extraction: Characteristics and Outcomes.

Cardiac implantable electronic device (CIED) infection can present with pocket or systemic manifestations, both necessitating complete device removal and pathogen-directed antimicrobial therapy. Here, we aim to characterize those presenting with both pocket and systemic infection. A retrospective analysis of CIED extraction procedures included 300 patients divided into isolated pocket (n = 104, 34.7%), complicated pocket (n = 54, 18%), and systemic infection (n = 142, 47.3%) groups. The systemic and complicated pocket groups frequently presented with leukocytosis and fever > 37.8, as opposed to the isolated pocket group. Staphylococcus aureus was the most common pathogen in the systemic and complicated pocket groups (43.7% and 31.5%, respectively), while Coagulase-negative staphylococci (CONS) predominated (31.7%) in the isolated pocket group (10.6%, p < 0.001). No differences were observed in procedural success or complications rates. Kaplan-Meier survival analysis found that at three years of follow-up, the rate of all-cause mortality was significantly higher among patients with systemic infection compared to both pocket groups (p < 0.001), with the curves diverging at thirty days. In this study, we characterize a new entity of complicated pocket infection. Despite the systemic pattern of infection, their prognosis is similar to isolated pocket infection. We suggest that this special category be presented separately in future publications of CIED infections.

Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections.

BACKGROUND: Present guidelines endorse complete removal of cardiovascular implantable electronic devices (pacemakers/defibrillators), including extraction of all intracardiac electrodes, not only for systemic infections, but also for localized pocket infections. OBJECTIVES: The authors evaluated the efficacy of delivering continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) into the infected subcutaneous device pocket, obviating the need for device/lead extraction. METHODS: The CITA group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, 9 patients declined lead extraction because of prohibitive operative risk, and 6 patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction, but opted for CITA treatment, were compared with 81 patients with pocket infection and similar characteristics who underwent device/lead extraction as primary therapy. RESULTS: A total of 80 patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (n = 68 of 80) of patients, who remained free of infection (median follow-up 3 years [IQR: 1.0-6.8 years]). In the case-control study of CITA vs device/lead extraction, cure rates were higher after device/lead extraction than after CITA (96.2% [n = 78 of 81] vs 84.6% [n = 55 of 65]; P = 0.027). However, rates of serious complications were also higher after extraction (n = 12 [14.8%] vs n = 1 [1.5%]; P = 0.005). All-cause 1-month and 1-year mortality were similar for CITA and device/lead extraction (0.0% vs 3.7%; P = 0.25 and 12.3% vs 13.6%; P = 1.00, respectively). Extraction was avoided in 90.8% (n = 59 of 65) of extraction-eligible patients treated with CITA. CONCLUSIONS: CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction. (Salvage of Infected Cardiovascular Implantable Electronic Devices [CIED] by Localized High-Dose Antibiotics; NCT01770067).