Comparative Analysis of Procedural Outcomes and Complications Between De Novo and Upgraded Cardiac Resynchronization Therapy.

OBJECTIVES: This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges. BACKGROUND: CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation. METHODS: All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique. RESULTS: Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p < 0.01), with a male predominance (75% vs. 66%; p < 0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p = 0.28) or 90-day complications (5.1% vs. 4.6%; p = 0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p < 0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p = 1.0). CONCLUSIONS: Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies.

Risk Factors and Long-Term Survival of Octogenarians and Nonagenarians Undergoing Transvenous Lead Extraction Procedures.

INTRODUCTION: Transvenous lead extraction (TLE) has become a frequently used tool for the management of complications related to pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices. However, it is still a matter of debate whether the lead extraction procedure is a safe treatment choice in the elderly. METHODS: We collected the clinical information from 3,810 patients undergoing TLE in 2 high-volume centers (Poland and Italy) between 2006 and 2017. We tested risk factors, effectiveness, safety and long-term survival in 3 groups of patients: those aged 80-89.99 years, ≥90 years and 30-79.99 years. RESULTS: Lower BMI, lower levels of hemoglobin and more comorbidities characterized the patients, whose ages ranged from 80 to 89.99 years. Those aged ≥90 years most often had single-chamber pacemakers. Octogenarians and nonagenarians were more often undergoing TLE due to infectious indications (57.19 and 74.29 vs. 45.35% in younger individuals). Lead age and the number of leads extracted were comparable in the 3 groups. In octogenarians, leads were more often removed using standard extraction techniques: simple traction and mechanical dilatators, whereas in nonagenarians TLE was more complex. The duration of the procedure was shorter in older patients, while clinical and procedural effectiveness was similar to that in younger individuals. The rate of major complications related to TLE did not differ between octogenarians and younger subjects (2.0 vs. 1.38%, p = ns), and the number of procedure-related risk factors was smaller in older people. Nonagenarians did not develop any major complication related to TLE. Long-term mortality after TLE was similar among octogenarians and nonagenarians (39.67 and 40.00%) but higher than in younger patients (24.41; p < 0.001 and 0.05). CONCLUSIONS: Lead extraction procedures appear effective and safe in octogenarians and nonagenarians, comparable to younger individuals. Procedure-related risk in the elderly is not associated with most of the typical risk factors encountered in younger subjects, but only with the higher number of pacemaker, implantable cardiac defibrillator and cardiac resynchronization therapy device procedures before TLE. Long-term survival after TLE was found to be similar among octogenarians and nonagenarians being about 60% at over 3 years of follow-up. Age alone should not be considered a risk factor for the occurrence of major complications or procedure-related death, and therefore it should not prevent candidacy for TLE.

Síndrome de marcapasos: cuál es el mecanismo? / Pacemaker syndrome: what is the mechanism?

Resumen Presentamos un caso de síndrome de marcapasos asociado a la ausencia de sincronía aurículo-ventricular, debido a la colocación invertida e inadvertida de los electrodos, en una paciente portadora de bloqueo aurículo-ventricular completo; para su diagnóstico, es fundamental un cuidadoso análisis del electrocardiograma, las imágenes con rayos X y los electrogramas intracavitarios.

Abstract Pacemaker syndrome: what is the mechanism? We present the case of pacemaker syndrome related to the absence of atrioventricular synchrony, due to inverted and inadvertent placement of the electrodes, in a patient with complete atrioventricular block. A careful analysis of the electrocardiogram, X-ray images and intracavitary electrograms are essential for its diagnosis.

Retrieval of a retained guide wire from the deltoid muscle-A rare and delayed presentation post cardiac resynchronization therapy lead replacement.

BACKGROUND AND AIMS: Fracture and retention of a guidewire after cardiac resynchronization therapy device implantation has not been reported in the literature so far, although it is an uncommon but known complication during cardiac interventions like percutaneous coronary interventions and other cardiac catheterization procedures. METHODS: A 53 years old female patient presented with severe pain over the left arm and shoulder for a period of 1 to 2 days. The patient had a history of dilated cardiomyopathy with severe left ventricular dysfunction and underwent cardiac resynchronization therapy device implant 3 years back with subsequent lead replacement 6 months back due to lead dysfunction. On evaluation, a coronary guidewire which might have fractured and been retained inadvertently during previous surgical procedure, was discovered in her deltoid muscle. Her symptoms were attributed to the guide wire which may have been aggravated by the movements of her arm. Emergency surgical exploration was done and the guidewire was removed. RESULTS AND CONCLUSION: We are reporting a case of unlikely and unusual delayed presentation of retained intervention guide-wire post cardiac resynchronization therapy, which was retrieved from the left deltoid muscle.

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted. BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population. METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II. RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type. CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.

Pain During "Noncomplex" Electrophysiological Studies and Cardiac Rhythm Device Surgery.

BACKGROUND: There are only limited data about peri-interventional pain during cardiac electrophysiological procedures without analgosedation. In this study, peri-interventional pain and recollection of it after the intervention were evaluated. METHODS: A total of 101 patients (43 electrophysiological/ablation procedures and 58 device surgeries) reported pain on a numerical rating scale (NRS; 0-10) before (pre), during (peri), and after (post) the intervention. Maximum pain (maxNRS) and the average of pain (meanNRS) were used for statistical analysis. Peri-interventional pain was compared with postinterventional data of the recollection of peri-interventional pain (peri-post). Patients were allocated into 2 groups (with 51 and 50 patients, respectively) to evaluate the mode of patient-staff interaction on pain recollection. Depressive, anxiety, and somatic symptom scales (Patient Health Questionnaire-15, Generalized Anxiety Disorder-7, and Patient Health Questionnaire-15) were used to analyze their influence on pain recollection. RESULTS: In total, 49.6% of patients (n = 50) complained of moderate to severe pain (maxNRS) at least once during the procedure. The comparison between peri and peri-post data revealed the following (median (range)-maxNRS, peri: 3 (0-10) versus peri-post: 4 (0-9) (ns), and meanNRS, peri: 1.4 (0-7) versus peri-post: 2.0 (0-6) (ns). The mode of patient-staff interaction had no influence on pain. No effect was found for psychosocial factor concerning pain and the recollection of pain. The results of the linear regression showed no influence of low-dose midazolam on recollection of pain. CONCLUSION: Half of the patients reported moderate to severe pain at least once during cardiac electrophysiological procedures without analgosedation. However, on average, patients reported only low pain levels. Postinterventional derived data on discomfort reflect the peri-interventional situation.

The never-ending story of CIED infection prevention: Shall we WRAP-IT and go?

CIED infection is perceived as substantial, ranging from 1% to 4% in literature depending on different studies and on the population profile, and can appear either as surgical site or endovascular infection or both. Several factors have been found to be associated to CIED infection, that can be summarized as patient-related (clinical profile, associated comorbidities, ongoing treatment as anticoagulants and immunosuppressants), Procedure-related (complexity of CIED surgery, type of surgery, previous pocket exploration), and center-/operator-related (center/operator volume). Thus, it is difficult to disentangle the extent of benefit that any intervention may offer to decrease this threatened complication, owing to its multifaceted complexity. The recently completed PADIT and WRAP-IT trials have significantly improved our knowledge in this field (nearly 20 000 patients enrolled), reporting an infection rate of 1% to 1.2% in control-arm patients and a 20% to 67% infection decrease when incremental antibiotic prophylaxis is added on top of optimized preventative strategies. Observational registries highlighted that participation in a prospective survey of CIED infection dramatically decrease infection rate by optimization of antisepsis protocols and operator awareness, that explains the low event rate observed in PADIT and WRAP-IT. While this consideration prompts each center to engage into a proactive infection prevention program, it makes a point in favor of antibiotic prophylaxis delivered locally in 7 days or more, as enabled by TYRX in the WRAP-IT trial. However, care sustainability (the number needed to treat in the most favorable WRAP-IT scenario is 100) suggests further analysis to understand the settings (patient- or procedure-related) most likely to benefit by such an enhanced prevention strategy.

Unscheduled Emergency Visits after Cardiac Devices Implantation: Comparison between Cardioverter Defibrillators and Cardiac Resynchronization Therapy Devices in less than one year of Follow Up / Consultas Não Programadas em Emergência após Implante de Dispositivos Cardíacos: Comparativo entre Cardiodesfibriladores e Ressincronizadores em Seguimento Inferior a 1 Ano

Abstract Background: The use of Cardiovascular Implantable Electronic Devices (CIED), such as the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT), is increasing. The number of leads may vary according to the device. Lead placement in the left ventricle increases surgical time and may be associated with greater morbidity after hospital discharge, an event that is often confused with the underlying disease severity. Objective: To evaluate the rate of unscheduled emergency hospitalizations and death after implantable device surgery stratified by the type of device. Methods: Prospective cohort study of 199 patients submitted to cardiac device implantation. The groups were stratified according to the type of device: ICD group (n = 124) and CRT group (n = 75). Probability estimates were analyzed by the Kaplan-Meier method according to the outcome. A value of p < 0.05 was considered significant in the statistical analyses. Results: Most of the sample comprised male patients (71.9%), with a mean age of 61.1 ± 14.2. Left ventricular ejection fraction was similar between the groups (CRT 37.4 ± 18.1 vs. ICD 39.1 ± 17.0, p = 0.532). The rate of unscheduled visits to the emergency unit related to the device was 4.8% in the ICD group and 10.6% in the CRT group (p = 0.20). The probability of device-related survival of the variable "death" was different between the groups (p = 0.008). Conclusions: Patients after CRT implantation show a higher probability of mortality after surgery at a follow-up of less than 1 year. The rate of unscheduled hospital visits, related or not to the implant, does not differ between the groups.

Resumo Fundamento: O uso de dispositivos cardíacos eletrônicos implantáveis (DCEI) como o cardiodesfibrilador (CDI) e terapia de ressincronização cardíaca (TRC) - é cada vez maior. O número de eletrodos de estimulação e desfibrilação varia de acordo com o dispositivo. A colocação do eletrodo no ventrículo esquerdo aumenta o tempo cirúrgico podendo associar-se a maior morbidade no acompanhamento após alta hospitalar, evento muitas vezes confundível com a gravidade da patologia base. Objetivo: Avaliar a taxa de internação não programada na emergência e óbito após cirurgia de dispositivos implantáveis estratificados pelo tipo de aparelho. Métodos: Estudo de coorte prospectivo analisando 199 pacientes submetidos à implante de dispositivos cardíacos. Os grupos foram divididos de acordo com o tipo de dispositivo: CDI (n = 124) e TRC (n = 75). Estimativas de probabilidades foram analisadas pelo método de Kaplan-Meier de acordo com o desfecho. Valor de p < 0,05 foi considerado significativo nas análises estatísticas. Resultados: A maioria da amostra era do sexo masculino (71,9%) - idade média de 61,1 ± 14,2. A fração de ejeção do ventrículo esquerdo foi similar entre os grupos (TRC 37,4 ± 18,1 vs. CDI 39,1 ± 17,0; p = 0,532). A taxa de visita não programada na emergência relacionada ao dispositivo foi de 4,8% no grupo CDI e de 10,6% no grupo TRC (p = 0,20). A probabilidade de sobrevida relacionada ao dispositivo da variável "óbito" mostrou-se diferente entre os grupos (p = 0,008). Conclusões: Paciente após o implante de TRC apresenta maior probabilidade de mortalidade após o procedimento cirúrgico no seguimento menor que 1 ano. A taxa de visita hospitalar não programada, relacionadas ou não ao implante, não difere entre os grupos.

Unscheduled Emergency Visits after Cardiac Devices Implantation: Comparison between Cardioverter Defibrillators and Cardiac Resynchronization Therapy Devices in less than one year of Follow Up.

BACKGROUND: The use of Cardiovascular Implantable Electronic Devices (CIED), such as the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT), is increasing. The number of leads may vary according to the device. Lead placement in the left ventricle increases surgical time and may be associated with greater morbidity after hospital discharge, an event that is often confused with the underlying disease severity. OBJECTIVE: To evaluate the rate of unscheduled emergency hospitalizations and death after implantable device surgery stratified by the type of device. METHODS: Prospective cohort study of 199 patients submitted to cardiac device implantation. The groups were stratified according to the type of device: ICD group (n = 124) and CRT group (n = 75). Probability estimates were analyzed by the Kaplan-Meier method according to the outcome. A value of p < 0.05 was considered significant in the statistical analyses. RESULTS: Most of the sample comprised male patients (71.9%), with a mean age of 61.1 ± 14.2. Left ventricular ejection fraction was similar between the groups (CRT 37.4 ± 18.1 vs. ICD 39.1 ± 17.0, p = 0.532). The rate of unscheduled visits to the emergency unit related to the device was 4.8% in the ICD group and 10.6% in the CRT group (p = 0.20). The probability of device-related survival of the variable "death" was different between the groups (p = 0.008). CONCLUSIONS: Patients after CRT implantation show a higher probability of mortality after surgery at a follow-up of less than 1 year. The rate of unscheduled hospital visits, related or not to the implant, does not differ between the groups.

Strangulation of the heart presenting as sudden cardiac death: A deadly but forgotten complication of epicardial pacing device.

Strangulation of the heart appears to be an exceedingly rare mechanical phenomenon that can develop with epicardial pacing wires in individuals undergoing somatic growth. Over the passage of time, owing to size mismatch between a fixed wire length and dynamically growing heart, the epicardial wire may embed around the heart resulting in the progressive over-pressurizing of involved cardiac structures. Depending on the location of the peak constriction pressures, cardiac strangulation may damagingly affect coronary circulation, heart valves function, or physiologic filling of the heart chambers, with risk of myocardial ischemia, decreased cardiac output, acute cardiac failure, ventricular arrhythmias and death. We report a case of a 29-year-old male with sudden cardiac death owing to cardiac strangulation with epicardial pacing wire that had been retained in place almost 30 years. At autopsy, an enlarged and abnormally contoured heart was found to be strangulated by an epicardial pacing wire; histopathologic examination confirmed hypertrophy of the myocardial fibers, myofiber disarrangement, and replacement-type fibrolipomatosis. In addition, this article consolidates the available literature on cardiac strangulation by an epicardial wire and highlight relevant clinical and medico-legal features for the forensic professionals.

A lost cable: «reel¼ syndrome / Un cable suelto: síndrome del «carrete¼

Abstract: Lead dislodgement syndromes (twiddler, ratchet or reel syndromes) are rare causes of cardiac stimulation device malfunction that can occur most commonly early after device implantation. In most cases, lead replacement (due to extensive damage) or reposition (due to displacement) is needed. We present a case of reel syndrome involving the left ventricular lead of a (AU)

Resumen: Los síndromes de desprendimiento de los cables (síndrome de "tweedler", trinquete o carrete) son causas raras de disfunción del dispositivo de estimulación cardiaca, que generalmente ocurren en el periodo temprano después del implante. En la mayoría de los casos, se requiere el reemplazo del cable (debido a daños extensos) o el reposicionamiento (debido al desplazamiento). Presentamos un caso de síndrome del carrete que involucra de manera exclusiva el cable ventricular izquierdo de un dispositivo de resincronización-desfibrilador cardiaco.(AU)

Prognosis associated with redo cardiac resynchronization therapy following complete device and lead extraction due to device-related infection.

Aims: An increase in the number of cardiac resynchronization therapy (CRT) device implantations worldwide has led to a consequent increase in the number of infections associated with the device, making extraction of the CRT device inevitable. Redo CRT implantation after treatment and recovery following device extraction is challenging. This study aimed to evaluate the success rate, complications, and long-term prognosis of redo CRT implantation, including the rates of subclavian, cava, and coronary sinus (CS) vein thrombosis as well as re-infection. Methods and results: Between 2007 and 2014, 1712 lead extractions were performed in 537 patients with device-related infection at Heart Center Brandenburg. Of the 537 patients, 125 (23%) underwent CRT device and lead extraction, including extraction of the left ventricular lead from the coronary sinus. Of these 125, 62 (50%) patients underwent redo CRT implantation (mean age, 68 ± 10 years); 34 patients had coronary artery disease (CAD) while 28 had dilated cardiomyopathy (DCM). The mean left ventricular ejection fraction was 27% ± 7%. The mean QRS duration of the left bundle branch block was 158 (range, 147-162) ms, and 25 patients had atrial fibrillation (AF). All these patients were followed up for a median duration of 29.6 (range, 15-43) months. In 53 of the 62 patients (85%), the CRT system was successfully re-implanted; however, the original CS vein could be used again only in 28 (45%) patients. The all-cause mortality rate was 7.1% after 1 year, and it was significantly higher in patients whose N-terminal pro B-type natriuretic peptide level was ≥3,000 pg/mL (P < 0.001), those who were aged ≥64 years (P = 0.028), those who had CAD (P = 0.042) or chronic kidney insufficiency (P = 0.001), those with AF (P = 0.001) and those whose blood cultures were positive for Staphylococcus aureus (P = 0.014). Conclusion: Redo CRT implantation after device extraction owing to device-related infection has a low success rate and shows a higher rate of re-infection than that observed in patients who undergo CRT implantation for the first time. Further, patients whose blood cultures are positive for S. aureus show a particularly poor outcome.

Sudden visual loss after cardiac resynchronization therapy device implantation.

PURPOSE: To report a case of sudden decrease in visual acuity possibly due to a cardiogenic embolism in a patient who underwent cardiac resynchronization therapy (CRT) device implantation. METHODS: A 62-year-old man with severe left ventricular systolic dysfunction and a left bundle branch block was referred to our department because of a sudden decrease in visual acuity. Nine days earlier, he had undergone cardiac transapical implantation of a CRT device, which was followed, 2 days later, by an inflammatory reaction. The patient underwent several general and ophthalmologic examinations, including multimodal imaging. RESULTS: At presentation, right eye (RE) best-corrected visual acuity (BCVA) was counting fingers and RE pupil was hyporeactive. Fundus examination revealed white-centered hemorrhagic dots suggestive of Roth spots. Fluorescein angiography showed delay in vascular perfusion during early stage, late hyperfluorescence of the macula and optic disk, and peripheral perivascular leakage. The first visual field test showed complete loss of vision RE and a normal left eye. Due to suspected giant cell arteritis, temporal artery biopsy was performed. Thirty minutes after the procedure, an ischemic stroke with right hemisyndrome and aphasia occurred. The RE BCVA worsened to hands motion. Four months later, RE BCVA did not improve, despite improvement in fluorescein angiography inflammatory sign. CONCLUSIONS: We report a possible cardiogenic embolism secondary to undiagnosed infective endocarditis causing monocular visual loss after CRT device implantation. It remains unclear how the embolus caused severe functional damage without altering the retinal anatomical structure.

Utility of Frailty Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy.

OBJECTIVES: The aim of this study was to evaluate the impact of frailty in the elderly on response to cardiac resynchronization therapy (CRT). BACKGROUND: CRT has been shown to improve symptoms and outcome of patients with congestive heart failure (HF) and impaired left ventricular ejection fraction (LVEF). The impact of frailty on the results of CRT is unknown. METHODS: Frailty defined as <14 of 17 points using the ONCODAGE (Outil de dépistage gériatrique en oncologie) G8 score was assessed before device implantation in candidates for CRT who were >70 years of age. The primary endpoint was the response to CRT, defined as an improvement of >5% of the LVEF and the absence of hospitalization for HF or cardiovascular death at 9 months. RESULTS: Ninety-two of 151 included patients (61%) were frail, and 89 (59%) were responders. Frailty was more frequent in nonresponders: 45 of 62 (73%) versus 47 of 89 (53%) (p = 0.014) and was identified as an independent predictor of nonresponse to CRT (R = 0.30; 95% confidence interval: 0.02 to 0.59; p = 0.039). Frailty was associated with a higher cumulative probability of hospitalization for HF (log-rank p = 0.032) and of all-cause death (log-rank p = 0.033). A G8 score <10.25 correlated with hospitalization for HF or death at 9 months (area under the curve: 0.75; 95% confidence interval: 0.63 to 0.87; cutoff <10.25; 77% sensitivity, 63% specificity). CONCLUSIONS: Frailty is as an independent predictor of nonresponse to CRT. Frail patients implanted with CRT devices have a higher risk of hospitalization for HF and mortality. Routine comprehensive geriatric assessment at the time of screening for device therapy should be recommended to optimize management. (Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy [FRAILTY]; NCT02369419).

The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden.

AIMS: To evaluate if the increased thromboembolic risk in female patients may be related to a higher burden of atrial fibrillation (AF). METHODS AND RESULTS: Data collected in a prospective observational research of patients implanted with a cardiac implantable electrical device (CIED) were analysed. We included 2398 patients: 489 (20.4%) were female and 1909 (79.6%) were male (oral anticoagulants treatment in 23.2%, independent of gender). During the follow-up (mean 42.8, median 37.7 months), 26 thromboembolic events occurred in 22 patients, with an incidence rate ratio of both stroke and stroke/transient ischemic attack (TIA) significantly higher in females compared with males [2.00, 95% confidence interval (CI) 1.53-2.61, P< 0.001 for stroke; 1.77 (95% C1.37-2.31, P< 0.001 for stroke/TIA]. An AF burden ≥5 min was a common finding (44% of patients), with no difference between men and women. The maximum daily AF burden and the time to evolution in permanent AF did not differ according to gender. The results of multivariate Cox regression showed that female gender, as well as history of CABG, were significant independent predictors of stroke and female gender was also an independent predictor of stroke/TIA. CONCLUSIONS: Among patients implanted with a CIED, an AF burden of at least 5 min is a common finding, (44% of patients). Female patients have a risk of stroke and TIAs that is around two-fold that of male patients, but this increased risk cannot be ascribed to a higher burden of AF or to differences in the evolution to permanent AF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01007474.

Infection and readmission rate of cardiac implantable electronic device insertions: An observational single center study.

BACKGROUND: Infection is one of the most serious complications following surgical placement of cardiac implantable electronic devices (CIEDs). Infection prevention efforts are necessary in reducing CIED infectious outcomes. These devices, however, are commonly inserted in higher risk patients, which may explain the ongoing risk of surgical site infection (SSI) in this population. The rates of CIED infection and utilization vary widely in the literature. The definitions of infection may also vary between clinical definitions and the National Healthcare Safety Network (NHSN) criteria. METHODS: The primary objective of this study was to review patient data to identify risk factors for infection and readmission after CIED placement at an academic medical center. The secondary objectives were to compare the rates of SSI identified by NHSN criteria compared to that obtained by applying clinical infection definitions. RESULTS: The overall rate of infection (SSI) was 1.9%, which was identical in both the clinical definition and NHSN reported data. The 30 day readmission rate and the 90 day readmission rate were 12.7% and 25.6% respectively with the most readmissions related to the patients' underlying medical conditions. A lower ejection fraction (EF) was identified as an independent risk factor for readmission, inpatient procedures, smoking and device infection were also significantly associated with readmission after CIED insertion.

Síndrome de Reel recorrente após implante de cardiodesfibrilador à esquerda e à direita / Recurrent Reel Syndrome after left and right implantation of cardioverter defibrillator

A síndrome de Reel é uma complicação rara que ocorre após o implante de dispositivos intracardíacos, sendo definida como retração e deslocamento dos cabos-eletrodos em decorrência de rotação do gerador em seu eixo sagital. Recorrências após medidas preventivas durante o reposicionamento não são comuns. Relata-se o caso de uma paciente com deslocamento recorrente de cabos-eletrodos após implante de cardiodesfibrilador a despeito de diversas medidas adotadas para prevenir novos deslocamentos e implante do dispositivo pela veia subclávia tanto esquerda como direita, com fixação do gerador à fáscia subpeitoral.

The Reel Syndrome is a rare complication that occurs after implantation of intracardiac devices, defined as lead retraction and displacement due to generator rotation on its sagittal axis. Recurrences after preventive measures during repositioning are not common. We report the case of a patient with recurrent lead displacement after defibrillator implantation in spite of several measures taken to prevent further device displacement and implantation both by left and right subclavian vein with attachment of the generator to the subpectoral fascia.

Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis.

Infectious complications after cardiac implantable electronic device (CIED) implantation are increasing over time and are associated with substantial mortality and healthcare costs. The aim of this study was to systematically summarize the literature on risk factors for infection after pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantation. Electronic searches (up to January 2014) were performed in PubMed, Scopus, and Web of Science databases. Sixty studies (21 prospective, 9 case-control, and 30 retrospective cohort studies) met the inclusion criteria. The average device infection rate was 1-1.3%. In the meta-analysis, significant host-related risk factors for infection included diabetes mellitus (odds ratio (OR) [95% confidence interval] = 2.08 [1.62-2.67]), end-stage renal disease (OR = 8.73 [3.42-22.31]), chronic obstructive pulmonary disease (OR = 2.95 [1.78-4.90]), corticosteroid use (OR = 3.44 [1.62-7.32]), history of the previous device infection (OR = 7.84 [1.94-31.60]), renal insufficiency (OR = 3.02 [1.38-6.64]), malignancy (OR = 2.23 [1.26-3.95]), heart failure (OR = 1.65 [1.14-2.39]), pre-procedural fever (OR = 4.27 [1.13-16.12]), anticoagulant drug use (OR = 1.59 [1.01-2.48]), and skin disorders (OR = 2.46 [1.04-5.80]). Regarding procedure-related factors, post-operative haematoma (OR = 8.46 [4.01-17.86]), reintervention for lead dislodgement (OR = 6.37 [2.93-13.82]), device replacement/revision (OR = 1.98 [1.46-2.70]), lack of antibiotic prophylaxis (OR = 0.32 [0.18-0.55]), temporary pacing (OR = 2.31 [1.36-3.92]), inexperienced operator (OR = 2.85 [1.23-6.58]), and procedure duration (weighted mean difference = 9.89 [0.52-19.25]) were all predictors of CIED infection. Among device-related characteristics, abdominal pocket (OR = 4.01 [2.48-6.49]), epicardial leads (OR = 8.09 [3.46-18.92]), positioning of two or more leads (OR = 2.02 [1.11-3.69]), and dual-chamber systems (OR = 1.45 [1.02-2.05]) predisposed to device infection. This systematic review on risk factors for CIED infection may contribute to developing better infection control strategies for high-risk patients and can also help risk assessment in the management of device revisions.