The axillary vein puncture for implantable cardiac defibrillator implantation: 14 years of experience. Analysis of the results.

BACKGROUND: Axillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients. A simplified AVP technique is described. METHODS: All the patients who consecutively underwent "de novo" ICD implantation, from March 2006 to December 2020 at the University of Verona, were considered. Leads insertion was routinely performed through an AVP, according to a simplified technique. Outcome and complications have been retrospectively analyzed. RESULTS: The study population consisted of 1711 consecutive patients. Out of 1711 patients, 38 (2.2%) were excluded because they were implanted with Medtronic Sprint Fidelis lead. Out of 1673 ICD implantations, 963 (57.6%) were ICD plus cardiac resynchronization therapy, 434 (25.9%) were dual-chamber defibrillators, and 276 (16.5%) were single-chamber defibrillators, for a total of 3879 implanted leads. The AVP success rate was 99.4%. Acute complications occurred in 7/1673 (0.42%) patients. Lead failure (LF) occurred in 20/1673 (1.19%) patients. Comparing the group of patients with lead failure with the group without LF, the presence of three leads inside the vein was significantly associated with LF, and the multivariate analysis confirmed three leads in place as an independent predictor of LF. CONCLUSION: AVP, according to our simplified technique, is safe, effective, has a high success rate, and a very low complication rate. The incidence of LF was exceptionally low. The advantages of AVP are maintained over time in a population of ICD recipients.

Prognostic significance of remotely monitored nocturnal heart rate in heart failure patients with reduced ejection fraction.

BACKGROUND: Elevated resting heart rate is a risk factor for cardiovascular events. OBJECTIVE: The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices. METHODS: We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on ß-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF). RESULTS: The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P = .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P ≤ .0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P < .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P = .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min). CONCLUSION: In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on ß-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity.

Correlation between epicardial adipose tissue and atrial fibrillation burden in coronary artery bypass graft surgery.

AIMS: Recent studies suggest an association between epicardial adipose tissue (EAT) and atrial fibrillation. The aim of the study is to evaluate the quantitative and qualitative characteristics of EAT in relation to atrial fibrillation burden after coronary artery bypass graft (CABG). METHODS: This prospective single-centre study included patients undergoing CABG. The patients underwent transthoracic echocardiography and collection of a bioptic sample containing right appendage and EAT during CABG for histological characterization. After surgery, clinical and telemetry data were collected. RESULTS: Fifty-six consecutive patients were enrolled. The mean postsurgical hospitalization was 7.9 ±â€Š3.7 days. Twenty-two patients had at least one episode of atrial fibrillation. In the atrial fibrillation group, there was a bigger atrial volume, a higher degree of diastolic disfunction, a thicker layer of EAT and an older median age in comparison with the group that did not develop it. EAT with a cut-off of 4 mm was a predictor of atrial fibrillation with an odds ratio (OR) of 1.49 (confidence interval (CI) 1.09-2.04), 73% of sensibility and 89% of specificity. From the histological analyses, the patients with atrial fibrillation had a significantly higher percentage of fibrosis. At univariate analysis, atrial volume [OR 1.05, CI 1.01-1.09, P = 0.022], E/A rate (OR 0.04, CI 0.02-0.72 P = 0.29), the percentage of fibrosis (OR 1.12, CI 1.00-1.25, P = 0.045) and age (OR 1.17, CI 1.07-1.28, P = 0.001) were predictors of atrial fibrillation. At multivariate analysis, atrial volume (P = 0.027), fibrosis (P = 0.003) and age (P = 0.039) were independent predictors of atrial fibrillation. CONCLUSION: Postcardiac surgical atrial fibrillation is frequent. EAT thickness, atrial volume, fibrosis and age are predictors of postcardiac surgical atrial fibrillation.

The Interplay of PR Interval and AV Pacing Delays Used for Cardiac Resynchronization Therapy in Heart Failure Patients: Association with Clinical Response in a Retrospective Analysis of a Large Observational Study.

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 ± 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63−0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41−4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor?

AIMS: Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D). METHODS: In 95 Italian cardiological centres, after a screening period of 6 months, patients were categorized according to VT/VF occurrence and CRT response, defined as LV end-systolic volume relative reduction >15% or LV ejection fraction absolute increase >5%. The main endpoint was death or HF hospitalizations. RESULTS: Among 1308 CRT-D patients (80% male, mean age 66 years), at 6 months, follow-up 71% were identified as CRT responders and 12% experienced appropriate VT/VF detections. The main endpoint was significantly and independently associated with previous myocardial infarction, New York Heart Association Class, VT/VF occurrence and with CRT response. CRT nonresponder patients who suffered VT/VF in the screening period had a risk of death or HF hospitalizations [HR = 7.82, 95% confidence interval (CI) = 3.95-15.48] significantly (P < 0.001) higher than CRT responders without VT/VF occurrence. This risk is mitigated without VT/VF occurrence (HR = 3.47, 95% CI = 2.03-5.91, P < 0.001) or in case of CRT response (HR = 3.11, 95% CI = 1.44-6.72, P = 0.004). CONCLUSION: Our data show that both CRT response and occurrence of VT/VF independently contribute to the risk of death or HF-related hospitalizations in CRT-D patients. Early VT/VF occurrence may be identified as a marker of disease severity than can be mitigated by CRT response both in terms of all-cause mortality and long-term VT/VF onset. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00147290 and NCT00617175.

The Impact of COVID-19 Pandemic and Lockdown Restrictions on Cardiac Implantable Device Recipients with Remote Monitoring.

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019-31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias (p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

Detection of subclinical atrial fibrillation after cryptogenic stroke using implantable cardiac monitors.

BACKGROUND: Implantable cardiac monitor (ICM) revealed subclinical atrial fibrillation (SCAF) in up to 30% of cryptogenic stroke (CS) patients in randomized trials. However, real world data are limited. OBJECTIVES: We investigated SCAF occurrence, treatments, clinical outcomes and predictors of SCAF in a multicenter real-world population subjected to ICM after CS. METHODS: From September 2016 to November 2019, 20 Italian centers collected data of consecutive patients receiving ICM after CS and followed with remote and outpatient follow-up according to clinical practice. All device-detected AF events were confirmed by the cardiologist to diagnose SCAF. RESULTS: ICM was implanted in 334 CS patients (mean age±SD 67.4±11.5 years, 129 (38.6%) females, 242 (76.1%) with CHA2DS2-VASC score≥4). During a follow-up of 23.6 (IQR 14.6-31.5) months, SCAF was diagnosed in 92 (27.5%) patients. First episode was asymptomatic in 81 (88.1%). SCAF daily burden ≥5 minutes was 22.0%, 24.1% and 31.5% at 6, 12, and 24 months after ICM implantation. Median time to first day with AF was 60 (IQR 18-140) days. Female gender, age>69 years, PR interval>160 ms and cortical-subcortical infarct type at enrolment were independently associated with an increased risk of SCAF. CONCLUSIONS: In a real-world population, ICM detected SCAF in more than a quarter of CS patients. This experience confirms the relevance of implanting CS patients, for maximizing the possibilities to detect AF, following failure of Holter monitoring, according to guidelines. However, there is need to demonstrate that shift to oral anticoagulation following SCAF detection is associated with reduced risk of recurrent stroke.

Leadless pacemaker through tricuspid bioprosthetic valve: Early experience.

BACKGROUND: Leadless pacemaker (LP) therapy has been proved effective in cases where traditional transvenous right pacing (TRP) failed. TRP through a bioprosthetic tricuspid valve (BTV) has always been considered an unpreferable solution because of possible deleterious effect of permanent pacing leads on BTV function and specifically on tricuspid regurgitation (TR). Very limited data exist about the feasibility and safety of LP implantation in this setting. METHODS: We describe two cases of LP implantation through BTV in patients with failure of epicardial pacemaker implanted after cardiac surgery. The focus is on technical description of the procedure and on electrical and echocardiographic evaluation at implantation and at the follow-up. RESULTS: In both cases, skilled and careful handling of the delivery system as well as proper use of X-ray oblique views was determinant for atraumatic successful valve crossing. Likewise, an accurate selection of the deployment site inside the right ventricle, far enough from the valve to avoid valvular dysfunction, was important for successful implantation. Electrical parameters of LP were satisfying at implantation and at the follow-up. The echocardiogram after implantation and at the follow-up showed no mechanical interference of LP with prosthetic valve, no significant TR, and absence of significant changes in the biventricular function. CONCLUSION: Our data seem to support feasibility and safety of this type of procedure in skilled hands, allowing efficacious pacing without valvular dysfunction or right ventricular (RV) physiology impairment.

Role of Provocable Brugada ECG Pattern in The Correct Risk Stratification for Major Arrhythmic Events.

The so-called Brugada syndrome (BS), first called precordial early repolarization syndrome (PERS), is characterized by the association of a fascinating electrocardiographic pattern, namely an aspect resembling right bundle branch block with a coved and sometime upsloping ST segment elevation in the precordial leads, and major ventricular arrhythmic events that could rarely lead to sudden death. Its electrogenesis has been related to a conduction delay mostly, but not only, located on the right ventricular outflow tract (RVOT), probably due to a progressive fibrosis of the conduction system. Many tests have been proposed to identify people at risk of sudden death and, among all, ajmaline challenge, thanks to its ability to enhance latent conduction defects, became so popular, even if its role is still controversial as it is neither specific nor sensitive enough to guide further invasive investigations and managements. Interestingly, a type 1 pattern has also been induced in many other cardiac diseases or systemic diseases with a cardiac involvement, such as long QT syndrome (LQTS), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM) and myotonic dystrophy, without any clear arrhythmic risk profile. Evidence-based studies clearly showed that a positive ajmaline test does not provide any additional information on the risk stratification for major ventricular arrhythmic events on asymptomatic individuals with a non-diagnostic Brugada ECG pattern.

Clinical and economic impact of multipoint left ventricular pacing: A comparative analysis from the Italian registry on multipoint pacing in cardiac resynchronization therapy (IRON-MPP).

INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.

Chronic venous obstruction during cardiac device revision: Incidence, predictors, and efficacy of percutaneous techniques to overcome the stenosis.

BACKGROUND: In recent years, upgrade and revision procedures of cardiac implantable electronic devices (CIEDs) have become increasingly frequent. Patency of the access veins is critical for procedural success. OBJECTIVE: The purpose of this study was to determine the incidence of venous obstruction at the time of system revision, to identify predictors of venous stenosis, and to evaluate the efficacy and safety of percutaneous techniques for overcoming stenosis. METHODS: All patients admitted to our division from January 2004 to January 2017 for CIED revision with the intent to add 1 or more leads were included. Each patient underwent ipsilateral contrast venography. The degree of venous stenosis was determined with the support of quantitative coronary angiography and categorized as significant (75%-90%), subocclusive (90%-99%), or occlusive (100%). RESULTS: Of 227 patients, 61 (27%) showed a stenosis >75%. Different techniques were performed to overcome stenosis: direct vein access, distal venous puncture central to the stenosis, and percutaneous venoplasty in 25 (41%), 26 (43%) and 9 (15%) cases. respectively. All procedures were successful, without major complications. At multivariate analysis, having 3 leads before revision (odds ratio 0.444; 95% confidence interval 0.212-0.920; P = .029) and a previous system revision with lead insertion (odds ratio 0.323; 95% confidence interval 0.124-0.841; P = .021) were independent predictors of venous stenosis. CONCLUSION: Chronic venous obstruction is a relatively frequent finding after CIED implantation. The number of implanted leads seems to be an independent predictor of venous obstruction. In case of stenosis, the preprocedural angiography-guided structured approach allowed preservation of both contralateral access and functioning leads.

Impact of multipoint pacing on projected battery longevity in cardiac resynchronization therapy. An IRON-MPP study sub-analysis.

BACKGROUND: Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials. OBJECTIVE: Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up. METHODS: The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V. RESULTS: Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P < .001) and 0.71 years (P < .001) reduction in projected longevity, respectively. CONCLUSION: In this long-term real-world registry, early MPP activation is associated with less than a 1-year reduction in projected battery life compared to single-site biventricular pacing.

Troubleshooting in PM Leadless: How to manage an indissoluble knot.

A 77-year-old patient, with permanent atrial fibrillation, underwent successful Micra transcatheter pacing system (MTPS) implantation. Once begun the pull-back of the tether, an increasing resistance was felt by the operator until complete blockage. A challenging recapture of MTPS into the delivery system was performed. The retrieved MTPS showed an indissoluble knot close to the docking button that blocked the running of the tether, and a long clot inside the delivery system. The new design of internal handle components of MTPS recently updated seems to favor clot formation. We suggest a reconsideration of the standard recommendations about delivery system flushing and design of the inner flushing tube system.

Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY-X4 study.

BACKGROUND: Various lead designs have been developed to accommodate different coronary sinus anatomies. Our objectives were to compare electrical parameters of straight and spiral left ventricular leads, to evaluate capture thresholds and impedances using different pacing vectors, and to study evolution of thresholds over time. METHODS: The RALLY-X4 study enrolled patients implanted with a lead from the Acuity X4 family (straight, spiral short, or spiral long). Electrical parameters (including capture thresholds from all 17 vectors) were measured at baseline and follow-up. RESULTS: Data from 795 patients who were successfully implanted were analyzed. Straight and spiral leads had similar proportions of patients with thresholds <2.5 V/0.4 ms using the distal electrode (61-65% of patients) or from at least one of the proximal (E2-E4) electrodes (81-83% of patients). Unipolar vectors had significantly lower thresholds and impedances than bipolar vectors, with similar measurements compared to extended bipolar configurations. Capture thresholds increased with more proximal electrodes for all leads. Over a mean follow-up of 1 year, a slight decrease in capture thresholds was observed. CONCLUSION: Straight and spiral quadripolar leads allow to obtain clinically acceptable capture thresholds from at least one of the proximal electrodes in >80% of patients. Pacing vectors significantly affect electrical parameters, with higher thresholds in more proximal electrodes and lower thresholds with unipolar and extended bipolar configurations. Capture thresholds slightly decreased over a mean follow-up of 1 year.

Safety and efficacy of a cardiologist-only approach to deep sedation for electrical cardioversion.

AIMS: Electrical cardioversion is still the preferred method to restore sinus rhythm in patients with atrial fibrillation. The main disadvantage is that electrical cardioversion requires deep sedation, generally administered by anaesthesiologists, for safety concern. An exclusively cardiologic management of deep sedation should have the advantage to reduce resources and time consumed. METHODS: All consecutive patients admitted to our division with persistent atrial fibrillation or atrial flutter to undergo elective electrical cardioversion from June 2002 to December 2016 were included. The sedation protocol was managed only by cardiologists and involved the administration of a 5-mg bolus of midazolam, followed by increasing doses of propofol to achieve the desired sedation level. Exclusion criteria were strictly observed. Complications were recorded. A retrospective analysis on a deidentified database has been performed. RESULTS: A total of 1188 electrical cardioversions were scheduled in our centre. A total of 1195 patients were scheduled in our centre, of whom 1188 met inclusion criteria. Electrical cardioversion was performed in 1073 cases (90.3%). Electrical cardioversion was successful in restoring sinus rhythm in 1030 (96.0%) patients. Immediate recurrence of atrial fibrillation occurred in 89 patients (8.3%). 99/1073 (9.22%) patients underwent trans-oesophagel echocardiography before cardioversion. Deep sedation, according to our protocol, was effective in 100% of cases. Midazolam was administered at a dosage of 5 mg to all patients, while propofol was administered at a dosage ranging from 20 to 80 mg (25.1 ±â€Š11.0 mg SD). No anaesthesia-related complications were observed, neither significant respiratory depression requiring intubation nor anaesthesiologist support. CONCLUSION: The exclusively cardiological procedure of deep sedation seems to be safe and effective.

Subaxillary approach to cardiac electronic device implantation using a single surgical incision: a single-centre experience.

OBJECTIVES: Pacemakers and implantable cardioverter defibrillators have become more common in younger individuals, owing to broader indications and technological advances. Our goal was to report our long-term experience of implanting cardiac devices in young adults via a subaxillary approach with a hidden single incision, to minimize the aesthetic impact of the device. METHODS: From 2003 to 2012, 23 patients underwent cardiac device implantation via a subaxillary approach while they were under general anaesthesia. The axillary vein was punctured under contrast-medium radiological guidance. The devices were positioned into the pocket under the pectoralis major muscle and over the fascia that envelopes the pectoralis minor muscle, through a lateral surgical access along the midaxillary line. RESULTS: Twenty-two single- and dual-chamber implantable cardioverter defibrillator and 1 dual-chamber pacemaker were implanted (mean age 32.2 ± 13.4 years). All procedures were successfully performed without complications; overall hospitalization after implantation was 3.3 days. During mean a follow-up of 65 ± 18 months, no deaths, infections or device migrations occurred. Two ventricular lead dislodgements requiring repositioning occurred within 1 month, and 1 defibrillation lead fracture occurred 5 years after implantation. All patients were extremely satisfied with the aesthetic result. A mild increase in the pacing threshold (0.88 ± 0.6 V at 0.4/0.5 ms at implantation vs 1.00 ± 0.3 V at 0.4/0.5 ms at 2-year follow-up, P = 0.063) and a statistically significant decrease in the pacing impedance (637 ± 161 ohm at implantation vs 499 ± 81 ohm at 2-year follow-up, P = 0.001) were observed, without any consequences. CONCLUSIONS: The subaxillary approach is a safe, feasible technique that requires a simple surgical procedure. The implantable cardioverter defibrillator functions properly at implantation and at long-term follow-up.

Redo procedures and chronic renal dysfunction are associated with higher risk of cardiac electronic device infections.

BACKGROUND: Infection is a major complication of pacemaker (PM) and implantable cardioverter-defibrillator (ICD) implantation. The present study sought to analyze the incidence rate of device infections, to investigate possible relationships between first implantations/repeated procedures and infection rates, and to identify some main risk factors associated with infection of cardiac implantable electronic devices (CIED). METHODS: In a single center retrospective observational study, records of 3899 consecutive patients having undergone PM and ICD implantation, cardiac resynchronization therapy (CRT) or revision (device/lead replacements or upgrades) and between 2002 and 2012 were obtained. RESULTS: Over a mean follow-up period of 66±14 months, a total of 50 patients were identified as having CIED infection (0.85% per procedure and 1.28% per patient). Chronic renal dysfunction and repeated procedures were independently associated with higher risk of CIED infection on multivariate analysis (respectively, OR 1.30, 95% CI: 1.16-1.57, P<0.0001; OR 1.23, 95% CI: 1.12-1.42, P<0.0001). Staphylococcal species was responsible for the bulk of CIED infections (70% of all positive cultures). Coagulase-negative staphylococci were found more frequently than staphylococcus aureus (30% vs. 12%). CONCLUSIONS: The infection rate after cardiac electronic device procedures was low over the follow-up period. Repeated procedures and chronic renal dysfunction were associated with higher risk of CIED infection. Staphylococcal species were mainly responsible for device infections.