Prevention and Risk Assessment of Cardiac Device Infections in Clinical Practice.

The implantation of cardiac electronic devices (CIEDs), including pacemakers and defibrillators, has become increasingly prevalent in recent years and has been accompanied by a significant rise in cardiac device infections (CDIs), which pose a substantial clinical and economic burden. CDIs are associated with hospitalizations and prolonged antibiotic therapy and often necessitate device removal, leading to increased morbidity, mortality, and healthcare costs worldwide. Approximately 1-2% of CIED implants are associated with infections, making this a critical issue to address. In this contemporary review, we discuss the burden of CDIs with their risk factors, healthcare costs, prevention strategies, and clinical management.

Sporadic high pacing and shock impedance on remote monitoring in hybrid implantable cardioverter-defibrillator systems: Clinical impact and management.

BACKGROUND: Sporadic high impedance values without other anomalies detected by remote monitoring of hybrid cardiac implantable electronic device systems have been described recently. The clinical significance and related hazard of this phenomenon are not fully understood. OBJECTIVE: The purpose of this study was to describe the prevalence, management, and outcomes associated with hybrid implantable cardioverter-defibrillator (ICD) systems. METHODS: We collected data on patients with sporadic high lead impedance alert on remote monitoring who had undergone implantation with a hybrid ICD system between January 2015 and December 2019. Pacing thresholds, sensing and impedance values, and temporal pattern of impedance values were collected by remote monitoring, at implantation, and during an in-office visit. RESULTS: Among 92 patients receiving a hybrid ICD, 15 (16.3%) had high impedance alert on remote monitoring (14 Boston Scientific and 1 St. Jude Medical ICD canisters paired with Medtronic or Biotronik DF-1 leads). Four patients had a cardiac resynchronization therapy-defibrillator (CRT-D), 7 a dual-chamber ICD, and 4 a single-chamber ICD. Three patients presented with high atrial lead impedance, 7 high right ventricular lead impedance, 1 high left ventricular impedance, and 2 high shock impedance values. All patients underwent follow-up by remote monitoring. Sporadic high impedance values were not associated with an adverse outcome or need for revision in all but 1 patient, who had continuously increasing pacing thresholds due to lead microfracture. CONCLUSION: In the absence of clear signs of lead fracture or connection issues, sporadic high pacing and shock impedance in hybrid implantable defibrillator systems can be safely managed by close follow-up.

Prevalence and predictor factors of severe venous obstruction after cardiovascular electronic device implantation.

AIMS: Despite not being uncommon, limited evidence exists about predisposing factors for venous obstruction in patients with implantable electronic devices. We aimed to assess the prevalence of severe venous obstruction in patients with intravenous devices and identify predictor factors. METHODS AND RESULTS: A total of 184 patients underwent venography to detect venous obstruction associated with the inserted lead. Vessel obstruction was graded as venous occlusion (complete flow interruption), severe obstruction (narrowing >90%), or mild-moderate obstruction (narrowing 50-90%). Severe venous obstruction/occlusion prevalence was 11.4% (n = 21) and was always asymptomatic. Collateral circulation was found in 80.9% of patients with severe obstruction/occlusion. Twelve patients (6.5%) had 3 leads. The rates of patients with secondary prevention of sudden cardiac death as indication for implantable devices and of those of patients with 3 leads were significantly greater in the group with severe obstruction/occlusion than in the non-severe obstruction/occlusion group (respectively, P = 0.004 and P = 0.03). Logistic analysis adjusted for venous thromboembolic risk factors confirmed that secondary prevention of sudden cardiac death as indication for implantable devices [odds ratio (OR), 7.1; 95% confidence interval (CI): 1.4-35.3; P = 0.017] and the presence of 3 leads (OR, 8.5; 95% CI: 1.75-41.35; P = 0.008) were predictors of severe obstruction/occlusion. CONCLUSION: In patients with implantable devices, severe venous obstruction prevalence is not negligible and the lack of symptoms does not exclude it. The presence of three leads and sudden cardiac death as indication for implantable devices seem to be associated with the presence of severe venous obstruction/occlusion.

Effect of daily remote monitoring on pacemaker longevity: a retrospective analysis.

BACKGROUND: Energy demand of remote monitoring in cardiac implantable electronic devices has never been investigated. Biotronik Home Monitoring (HM) is characterized by daily transmissions that may affect longevity. OBJECTIVE: The aim of the study was to retrospectively compare longevity of a specific dual-chamber pacemaker model in patients with HM on and patients with HM off. METHODS: Hospital files of 201 patients (mean age 87 ± 10 years, 78 men) who had received a Biotronik Cylos DR-T pacemaker between April 2006 and May 2010 for standard indication were reviewed. In 134 patients (67%), HM was activated. The primary end point was device replacement due to battery depletion. RESULTS: The median follow-up period was 56.4 months (interquartile range 41.8-65.2 months). The estimated device longevity was 71.1 months (95% confidence interval [CI] 69.1-72.3 months) in the HM-on group and 60.4 months (CI 55.9-65.1 months) in the HM-off group (P < .0001). The frequency of inhospital visits with significant device reprogramming was higher in the HM-on group than in the HM-off group (33.3% vs 25.0%, respectively; P = .03). Lower ventricular pulse amplitude (2.3 ± 0.4 V vs 2.7 ± 0.5 V; P < .0001) and pacing percentage (49% ± 38% vs 64% ± 38%; P = .02), both calculated as time-weighted averages, were observed with HM on as compared with HM off. Patient attrition was significantly lower in the HM-on group (9.7%; 95% CI 3.0%-28.7%) than in the HM-off group (45.6%; 95% CI 30.3%-64.3%) (P < .0001). CONCLUSION: In normal practice, energy demand of HM, if present, was overshadowed by programming optimization likely favored by continuous monitoring. Pacemakers controlled remotely with HM showed an 11-month longer longevity. Patient retention was superior.

Can we predict and prevent adverse events related to high-voltage implantable cardioverter defibrillator lead failure?

BACKGROUND: In 2007, great concern arose regarding failure of implantable cardioverter defibrillator (ICD) leads from several manufacturers. OBJECTIVE: Of this analysis was to evaluate the incidence and predictors of Sprint Fidelis lead failure in order to find the best clinical strategy to prevent lead-related adverse events. METHODS: Four hundred fourteen patients (357 male, 67 ± 12 years) with ICD equipped with right ventricular Sprint Fidelis leads were followed up in our institution. RESULTS: Over a median follow-up of 35 months (25th-75th percentile = 27-47 months) and a total follow-up of 1,231 patient-years, lead failures occurred in 40 of 414 (9.7%) patients. The annual rate was 3.2% per patient-year. Thirty-five (87.5%) failures were caused by pacing-sensing connector fracture. The risk of lead fracture was higher in patients younger than 70 years (odds ratio = 2.31; 95% confidence interval = 1.14-4.68, p = 0.02). Among 30 patients with pacing-sensing conductor failure and available device diagnostics for failure alerting, the diagnostic parameter which first responded to lead failure was the sensing integrity counter in 15 of 30 (50%), pacing impedance in 12 of 30 (40%), and non-sustained ventricular tachycardia in 3 of 30 (10%). The median time (25th-75th percentile) between diagnostics alert and lead failure-related adverse events or failure acknowledgment was 2.2 (0.3-13.0) days. Twenty-two patients suffered inappropriate shocks due to lead failure. In 50% of patients, daily monitoring by device diagnostics would have alerted physicians to impending lead failure at least 1 day in advance. CONCLUSIONS: Automatic algorithms based on device diagnostics may detect impending lead failure in nearly 50% of cases. Remote monitoring may prevent failure-related adverse events.

Outpatient oesophageal-precordial electrical cardioversion of atrial fibrillation: an effective and safe technique to restore sinus rhythm.

OBJECTIVE: External electrical cardioversion is commonly used in the management of atrial fibrillation (AF), but usually involves general anaesthesia. We tested the efficacy, safety and tolerability of a minimally invasive cardioversion technique, not requiring general anaesthesia, performed on an outpatient basis. METHODS: We performed outpatient oesophageal cardioversion in 87 consecutive patients (mean age: 67.5 +/- 9.6 years; weight: 77.47 +/- 12.34 kg; left atrium diameter: 46.25 +/- 6.85 mm; LVEF: 55.5 +/- 16%) with persistent AF (mean duration: 6.99 +/- 11.55 months). A biphasic shock was delivered via an oesophageal decapolar lead (cathode) and two precordial patches (anode) under a mild sedation (midazolam 2.5-5 mg). In the first 25 patients, a step-up protocol (from 10 to 100 J) was performed whereas, in the other 62, a first shock at 50 J and a second one at 100 J, were delivered. RESULTS: Patients described the level of discomfort caused by the procedure according a five-grade scale. Cardioversion was achieved in 97.7% of patients using a mean effective energy of 51.2 +/- 15.7 J. In 88.5% of patients, sinus rhythm was restored by using 50 J or less. No complications occurred and no patient required hospital admission. Mean discomfort score was 1.56 +/- 0.74 out of 5. Sinus rhythm persisted in 62.6% of patients at the 1-month follow-up. CONCLUSIONS: Outpatient oesophageal cardioversion is a safe, acceptable and effective way to cardiovert patients with AF. It may be a useful alternative to external cardioversion. A relatively high starting energy (50 J) was demonstrated to be superior to a low-energy step-up technique.

Physiologic pacing for atrial fibrillation prevention in sinus node disease: long-term results.

BACKGROUND: Physiologic pacing has been demonstrated to be effective in preventing atrial fibrillation recurrences in patients with sinus bradycardia. Aim of the study was to evaluate long-term incidence of atrial fibrillation in a large population of patients affected by sinus node disease receiving physiologic pacing. Furthermore, predictors of arrhythmia recurrence and effect of pacing mode were investigated. POPULATION: Four hundred twenty-five patients (220 Male, 77 +/- 9 years) were retrospectively analyzed: implanted system was AAI in 20.5% and DDD in 79.5%. Thirty-four percent had atrial fibrillation before implant. RESULTS: Follow-up lasted on average 51 +/- 36 months (median 42, range 1 month-18 years). Sixty-six percent were on antiarrhythmic drug therapy. After 5 years, 89% survived, 74.5% had at least one episode of atrial fibrillation, 39.9% were submitted to electrical cardioversion, 67.2% were hospitalized because of cardiac causes, 33.3% developed permanent atrial fibrillation. Primary conduction system disease and valvular heart disease were independent predictors for atrial fibrillation recurrence. Preimplant atrial fibrillation predicted arrhythmia recurrence during the follow-up, but it did not predict development of permanent atrial fibrillation. AAI pacing, when compared with DDD, was associated to a lower rate of atrial fibrillation recurrences (AAI 28.7%, DDD 53.3%, P < 0.001). CONCLUSION: In spite of expected benefits of physiologic pacing, the development of atrial fibrillation and permanent atrial fibrillation were quite common. The additional benefits of multifunction pacemakers designed to prevent and treat atrial fibrillation should be evaluated in controlled studies.

Is dual defibrillator better than conventional DDD pacing in brady-tachy syndrome? Results of the ICARUS Trial (Internal Cardioversion Antitachypacing and Prevention: Resource Utilization Study).

AIM OF THE STUDY: To compare the impact of dual defibrillator versus conventional DDD pacing on quality of life and hospitalizations in patients with sinus node disease and recurrent symptomatic atrial fibrillation. STUDY DESIGN: Prospective, parallel, controlled trial. METHODS: Sixty-three patients (41 M, mean age 71 +/- 8 years) with sinus node disease and at least three symptomatic episodes of atrial fibrillation during the last year were enrolled. Thirty-one consecutive patients received a dual defibrillator (group A) and 32 standard DDD pacing (group B). In group A, 12 patients received an external remote-control device in order to shock themselves in case of atrial fibrillation, while 19 were scheduled for early in-hospital manual shock. Seventy-five percent had been hospitalized during the last year and 57% had required electrical cardioversion. Atrial fibrillation was persistent in 63.5% and paroxysmal in 37.5%. The follow-up lasted 1 year. RESULTS: Atrial fibrillation recurred in 83.3% in group A and 79.3% in group B (p = ns). Electrical cardioversion was applied in 54.8% in group A and in 21.9% in group B (p < 0.05). On the whole, 89.5% of electrical cardioversions were delivered in the defibrillator group (p < 0.0001). In the whole population 27.0% patients had cardiac-related hospitalization (31.2% in the pacemaker group and 22.6% in the defibrillator group, p = n.s.). In patients with persistent atrial fibrillation, cardiac-related hospitalization rate was significantly lower in the group A (0% vs. 30%, p < 0.05). Considering Symptom Check List, symptoms significantly improved in the whole population, but symptom number and frequency improved significantly only in the group A. Similarly, SF-36 questionnaire scores showed a little higher quality of life improvement in the group A. CONCLUSIONS: Dual defibrillator showed consistent trends toward a higher effectiveness when compared with standard DDD pacing. Dual defibrillator was associated to reduced in-patient cardioversions and to better quality of life. All-cause hospitalizations were reduced only in patients with persistent atrial fibrillation.

Transesophageal low-energy cardioversion of atrial fibrillation without fluoroscopy outside the electrophysiology laboratory.

BACKGROUND: Low-energy internal cardioversion (LEIC) is a safe and effective procedure for the restoration of sinus rhythm in patients with atrial fibrillation refractory to external cardioversion. However, the procedure needs fluoroscopy and the use of the electrophysiology laboratory, even when the esophageal approach is utilized. The aim of this study was to assess the efficacy, safety and tolerability of a new simplified procedure of esophageal LEIC performed without fluoroscopy, outside the electrophysiology laboratory. METHODS: Thirty consecutive patients (23 males, 7 females) with persistent atrial fibrillation were submitted to LEIC using a step-up protocol (by steps of 50 V, starting from 200 V). Twenty (66%) were resistant to external cardioversion. A large surface area lead (cathode) was positioned within the esophagus, 45 cm from the nasal orifice. A second large surface area lead (anode) was positioned in the right atrium via the right internal jugular vein without fluoroscopic control. Synchronization of delivery of the shock with the QRS was achieved by means of two cutaneous electrodes positioned on the thoracic wall. RESULTS: Sinus rhythm was restored in 28 patients (93%) with a mean delivered energy of 15.2 +/- 7.5 J (range 5-27 J) and a mean impedance of 48.3 +/- 5.6 Ohm. No complication occurred during and after the procedure that was well tolerated under sedation. CONCLUSIONS: This new technique of performing esophageal LEIC is effective and seems to be safe and well tolerated. In this way internal cardioversion can be performed without fluoroscopy, outside the electrophysiology laboratory.

Relations between monophasic action potential duration and refractoriness after cardioversion of persistent atrial fibrillation: results in wash-out and amiodarone-treated patients.

BACKGROUND: The relation between repolarization and refractoriness has been clinically evaluated both in the atrium and ventricle. However, this relation has not been carefully investigated in the atria of patients with persistent atrial fibrillation after cardioversion. METHODS: We determined the refractoriness and monophasic action potential duration at 90% of repolarization (MAP90), at 5 pacing cycle lengths (300 to 700 ms) and in 5 right atrial sites after internal cardioversion of persistent atrial fibrillation in 27 patients. RESULTS: The effective refractory periods (ERPs) were longer in amiodarone-treated patients (group 1) than in wash-out patients (group 2) (211.3 +/- 26.4 vs 199.1 +/- 24.3 ms, p < 0.002) as well as the MAP90 (243.6 +/- 36.8 vs 223.1 +/- 29.2 ms, p < 0.001). Linear regression analysis showed a direct relation between the MAP90 and ERP changes induced by different pacing cycle lengths (r = 0.77 and r = 0.92 in the amiodarone and wash-out patients, respectively). The ERP/MAP90 ratio was similar at all pacing cycle lengths in both wash-out and amiodarone groups and was always < 1. The mean ERP and MAP90 were shorter in the lateral right atrial sites than in the atrial roof and septum in both group 1 and group 2 patients (p < 0.001). CONCLUSIONS: A linear correlation was found between ERP and MAP90 in response to changes in pacing cycle lengths. Postrepolarization refractoriness was not observed after cardioversion of persistent atrial fibrillation. Pretreatment with oral amiodarone does not affect these electrophysiological features or the dispersion of ERP and MAP90 in the right atrium after sinus rhythm restoration.