Incidence and Predictors of Appropriate Implantable Cardioverter Defibrillator Therapy in Japanese Ischemic Heart Disease Patients.

BACKGROUND: Although the efficacy of an implantable cardioverter defibrillator (ICD) in preventing sudden cardiac death is well established, the incidence and predictors of appropriate ICD therapy in Japanese ischemic heart disease (IHD) patients remain unclear. METHODS AND RESULTS: We retrospectively studied Japanese 141 IHD patients undergoing transvenous ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) implantation for primary or secondary prevention at Hirosaki University Hospital. Over a mean (±SD) follow-up period of 5.5±2.8 years, the incidence of appropriate ICD therapy was similar in the primary and secondary prevention groups, although it was relatively more frequent in the first 2 years in the secondary prevention group. Four patients died due to sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), mainly due to post-shock pulseless electrical activity. Once patients had received their first appropriate ICD therapy, 49.2% received second appropriate ICD therapy within 6 months. Cox proportional hazard analysis revealed that sustained VT as an index life-threatening ventricular tachyarrhythmia before ICD/CRT-D implantation was an independent predictor of appropriate ICD therapy, but VF was not. CONCLUSIONS: The incidence of appropriate ICD therapy was comparable in primary and secondary prevention among Japanese IHD patients. We need to recognize the high-risk period for second appropriate ICD therapy after the first therapy and sustained VT as index life-threatening ventricular tachyarrhythmia as a risk factor for appropriate ICD therapy.

Real-world data of patients affected by advanced heart failure treated with implantable cardioverter defibrillator and left ventricular assist device: Results of a multicenter observational study.

BACKGROUND: Left ventricular assist device (L-VAD) implantation is increasingly used in patients with heart failure (HF) and most patients also have an implantable cardioverter defibrillator (ICD). Limited data are available on the incidence of ICD therapies and complications in this special setting. The aim of this study was to analyze the real-world incidence and predictors of ICD therapies, complications and interactions between ICD and L-VAD. METHODS: We conducted a multicenter retrospective observational study in patients with advanced HF implanted with ICD and a continuous-flow L-VAD, followed-up in five advanced HF centers in Northern Italy. RESULTS: A total of 234 patients (89.7% male, median age 59, 48.3% with ischemic etiology) were enrolled. After a median follow-up of 21 months, 66 patients (28.2%) experienced an appropriate ICD therapy, 22 patients (9.4%) an inappropriate ICD therapy, and 17 patients (7.3%) suffered from an interaction between ICD and L-VAD. The composite outcome of all ICD-related complications was reported in 41 patients (17.5%), and 121 (51.7%) experienced an L-VAD-related complication. At multivariable analysis, an active ventricular tachycardia (VT) zone and a prior ICD generator replacement were independent predictors of ICD therapies and of total ICD-related complications, respectively. CONCLUSIONS: Real-world patients with both L-VAD and ICD experience a high rate of ICD therapies and complications. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of unnecessary ICD therapies, thus sparing the need for ICD generator replacement, a procedure associated to a high risk of complications.

Right Ventricular Free Wall Strain and Effect of Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure.

BACKGROUND: Patients with nonischemic systolic heart failure have an increased risk of malignant ventricular arrhythmias and sudden cardiovascular death. Because the risk is less pronounced than for patients with ischemic cause of heart failure more discriminating tools are needed to identify patients most likely to benefit from implantable cardioverter-defibrillator (ICD) implantation. Right ventricular (RV) dysfunction is associated with a worse prognosis, but whether RV free wall strain (RV-FWS) measured with echocardiography can identify the patients most likely to benefit from ICD implantation is not known. METHODS AND RESULTS: In this extended follow-up analysis of the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH) trial, RV-FWS was measured with echocardiography in 445 patients before randomization. RV dysfunction was defined as an RV-FWS of greater than -20%. The primary end point was all-cause mortality. The median RV-FWS was -18% (quartiles -23% to -14%), and RV dysfunction was measured in 255 patients (57%). During a median follow-up of 5.7 years, 170 patients (38%) died. There was a statistically significant interaction between RV dysfunction and the effect of ICD implantation (P = .003), also after adjusting for known cardiovascular risk factors (P = .01). ICD implantation significantly decreased all-cause mortality in patients with RV dysfunction (hazard ratio 0.54, 95% confidence interval 0.36-0.80, P = .002), but not in patients with normal RV function (hazard ratio 1.34, 95% confidence interval 0.84-2.12, P = .22). CONCLUSIONS: In patients with nonischemic systolic heart failure, RV dysfunction on echocardiography was associated with a greater effect of ICD implantation and could be used to select patients with benefit from ICD treatment.

Clinical outcomes of implantable cardioverter-defibrillator therapy in noncompaction cardiomyopathy: a systematic review and meta-analysis.

A subgroup of patients with noncompaction cardiomyopathy (NCCM) is at increased risk of ventricular arrhythmias and sudden cardiac death (SCD). In selected patients with NCCM, implantable cardioverter-defibrillator (ICD) therapy could be advantageous for preventing SCD. Currently, there is no complete overview of outcome and complications after ICD therapy in patients with NCCM. This study sought to present an overview using pooled data of currently available studies. Embase, MEDLINE, Web of Science, and Cochrane databases were searched and returned 915 studies. After a thorough examination, 12 studies on outcome and complications after ICD therapy in patients with NCCM were included. There were 275 patients (mean age 38.6 years; 47% women) with NCCM and ICD implantation. Most of the patients received an ICD for primary prevention (66%). Pooled analysis demonstrates that the appropriate ICD intervention rate was 11.95 per 100 person-years and the inappropriate ICD intervention rate was 4.8 per 100 person-years. The cardiac mortality rate was 2.37 per 100 person-years. ICD-related complications occurred in 10% of the patients, including lead malfunction and revision (4%), lead displacement (3%), infection (2%), and pneumothorax (2%). Patients with NCCM who are at increased risk of SCD may significantly benefit from ICD therapy, with a high appropriate ICD therapy rate of 11.95 per 100 person-years and a low cardiac mortality rate of 2.37 per 100 person-years. Inappropriate therapy rate of 4.8 per 100 person-years and ICD-related complications were not infrequent and may lead to patient morbidity.

Transvenous lead extraction of implantable cardioverter-defibrillators: A comprehensive outcome-and risk factor analysis.

BACKGROUND: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD). OBJECTIVES: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE. METHODS: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed. RESULTS: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality. CONCLUSIONS: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.

HeartInsight: from SELENE HF to implementation in clinical practice.

There is strong evidence that remote monitoring in cardiac implantable electronic devices can detect device malfunctions earlier than conventional monitoring and that it can be useful for detecting cardiac arrhythmias, while little data are available for an improved management of heart failure (HF). HeartInsight is a new remote monitoring algorithm developed and validated in the SELENE HF study that combines information from a diverse set of sensors integrated into one alert to detect worsening HF with promising accuracy. However, the shift from detecting technical issues or arrhythmia episodes to early predicting clinical events underscores the need to understand how to properly integrate these tools into the clinical workflow by defining an organizational model and shared guidelines for the management of HF alerts. Here, we critically discuss issues that will be raised by the implementation of this 'enhanced' remote monitoring approach to HF care in daily clinical practice.

Low Risk of Inappropriate Shock Among Pediatric Patients With an Implantable Cardioverter Defibrillator: A Single Center Experience.

Implantable cardioverter-defibrillators (ICD) are increasingly being used among the pediatric population for indications of both primary and secondary prevention. There is limited long-term data on the outcomes of pediatric patients following ICD implantation. The aim of this study was to investigate the characteristics of this population, burden of appropriate and inappropriate shock and complication rate in a large tertiary pediatric medical center. Included were children under the age of 18 years who underwent ICD implantation and had clinical follow up at our center. Data were retrospectively collected between study period 2005-2020. Primary outcome was the incidence of ICD shock appropriate and inappropriate. Secondary outcome was defining our patient population characteristics. Our cohort included 51 patients who underwent ICD implantation. Mean age at implantation was 10.9 ± 4.7 years and average follow-up time was 67 months. Diagnoses of implanted patients were: 28 (55%) patients with syndromes with risk for sudden death, cardiomyopathy in 14 patients (27%) and congenital heart disease (CHD) in 9 patients (18%). Forty-two (82%) patients had an ICD implanted for secondary prevention after experiencing a life-threatening arrhythmia and 9 (18%) for primary prevention. An endocardial system was implanted in 39 (76%) patients and an epicardial systems in 12 (24%) patients. A total of 20 (39%) patients received appropriate shocks for ventricular fibrillation(VF). 5 patients received inappropriate shocks, 4 due to sinus tachycardia and 1 due to rapidly conducted atrial fibrillation. Those who received an inappropriate shock had a significantly shorter ICD-programmed VF detection cycle length compared to those who did not receive an inappropriate shock (320 ms versus 270 ms, p = 0.062). This single center study demonstrates a high rate of appropriate ICD shocks (39%) and a low rate of inappropriate ICD shocks. Accurate programming of ICD devices in the pediatric population is paramount to avoid inappropriate ICD shocks.

Effectiveness of Implantable Cardioverter Defibrillator in Patients With Non-Ischemic Heart Failure With Systolic Dysfunction　- Subanalysis of the Nippon Storm Study.

BACKGROUND: The prospective observational Nippon Storm Study aggregated clinical data from Japanese patients receiving implantable cardioverter-defibrillator (ICD) therapy. This study investigated the usefulness of prophylactic ICD therapy in patients with non-ischemic heart failure (NIHF) enrolled in the study.Methods and Results: We analyzed 540 NIHF patients with systolic dysfunction (left ventricular ejection fraction <50%). Propensity score matching was used to select patient subgroups for comparison; 126 patients were analyzed in each of the primary (PP) and secondary (SP) prophylaxis groups. The incidence of appropriate ICD therapy during follow-up in the PP and SP groups was 21.4% and 31.7%, respectively (P=0.044). The incidence of electrical storm (ES) was higher in SP than PP patients (P=0.024). Cox proportional hazard analysis revealed that increased serum creatinine in SP patients (hazard ratio [HR] 1.18; 95% confidence interval [CI] 1.02-1.33; P=0.013) and anemia in PP patients (HR 0.92; 95% CI 0.86-0.98; P=0.008) increased the likelihood of appropriate ICD therapy, whereas long-lasting atrial fibrillation in PP patients (HR, 0.64 [95% CI, 0.45-0.91], P=0.013) decreased that likelihood. CONCLUSIONS: In propensity score-matched Japanese NIHF patients, the incidence of appropriate ICD therapy and ES was significantly higher in SP than PP patients. Impaired renal function in SP patients and anemia in PP patients increased the likelihood of appropriate ICD therapy, whereas long-lasting atrial fibrillation reduced that likelihood in PP patients.

Clinical impact of nocturnal ventricular tachyarrythmias in electrical storm.

BACKGROUND: The incidence of electrical storm (ES) is significantly higher during the daytime. However, the association between nocturnal ventricular tachyarrythmias during ES and prognosis remains unclear. Therefore, this study aimed to investigate the clinical characteristics and outcomes of ES with midnight ventricular tachyarrythmias. METHODS: We included 48 consecutive patients who had an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted between 2010 and 2020 and those who had experienced the onset of an out-of-hospital ES episode. According to the midnight (0:00 a.m.-6:00 a.m.) occurrence of ventricular arrythmia events consisting of ventricular tachycardia (VT) and ventricular fibrillation (VF), we divided them into two groups (with-midnight group: n = 27, without-midnight group: n = 21). The clinical characteristics and outcomes of the two groups were compared. RESULTS: The patients in the with-midnight group were mostly males, had longer QRS duration, and longer corrected QT-interval than those in the without-midnight group (p < .05). The incidence of all-cause death, especially heart failure death, was higher in the with-midnight group than in the without-midnight group (p < .01). Multivariate analysis showed that the presence of midnight VT/VF during ES was the only independent risk factors for heart failure death (HR = 18.9, 95%CI = 1.98-181, p = .011). CONCLUSIONS: The presence of midnight VT/VF during ES might be associated with the poor prognosis. The loss of a sympathetic circadian pattern of VT/VF distribution during ES might suggest advanced stages of the cardiac disease.

Electromagnetic interference induced ventricular tachycardia in left ventricular assist device.

Left ventricular assist devices (LVAD) have been increasingly utilized end-stage heart failure despite guidelinedirected medical therapy (due to limited organ availability) as a bridge to transplant or destination therapy, with improved overall survival.Majority of patients undergoing LVAD implantation have pre-existing implantable cardioverter-defibrillator (ICD) in-situ.We present a case of device-device interaction resulting in EMI inducing recurrent inappropriate device therapies inducing ventricular arrhythmia followed by the inappropriate triggering of noise reversion mode, thereby inhibiting device therapies.With the increase in number of end-stage heart failure patients with ICDs in situ (and limited organ availability) undergoing LVAD implantation, it is imperative to recognize potential device-device interactions to avoid unwarranted invasive interventions.

The friend within? The implantable cardioverter defibrillator between saving lives and chronically impairing them.

This article considers the way in which a medical technology, the implantable cardioverter defibrillator (ICD), by preventing fatal outcomes, in this case sudden death, deriving from cardiac diseases, and specifically hypertrophic cardiomyopathy, contributes to the development of a particular type of chronicity. While biomedicine celebrates technological advances in treatments and naturalises chronicity, focussing on life expectancy as a victory over the 'acute' aspects of the disease, the way in which patients live with the disease is left unquestioned. The article follows Smith-Morris's (2010) perspective in seeing chronicity as the never-ending process of identifying with one's disease, adding a focus on the role played by an embodied technology in relation to it. Based on participant observation in a clinical setting and interviews with clinicians, the article interrogates three key themes in the chronicity of cardiac patients implanted with an ICD: risk, quality of life and choice. The data shows a constant tension between managing a one-off potentially fatal 'acute' risk and life with serious disruptions due to the limitations imposed by the implanted device. The article argues that patients' resources for facing the life and identity disrupted by the disease are limited by ideas of what living a diseased body is, which acritically follow discourses of 'patient choice' and a 'technological imperative' to avoid risk.

Efficacy of antitachycardia pacing alert by remote monitoring of implantable cardioverter-defibrillators for out-of-hospital electrical storm.

BACKGROUND: Remote monitoring (RM) has been shown to reduce all-cause mortality in patients with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (ICD/CRT-D). Not all devices transmit an alert for antitachycardia pacing (ATP) therapy, and it is unknown whether differences of RM alert affect the outcomes of electrical storm (ES). METHODS: We enrolled 42 patients with ICD/CRT-D whose out-of-hospital ES were detected by RM between 2013 and 2020. We divided their 54 episodes into two groups (ATP-alert-on; 22, ATP-alert-off; 32), and clinical outcomes were compared between the two groups. RESULTS: In 35 of 54 episodes of ES, ventricular tachycardia (VT) could be terminated within 24 h of ES onset just by ATP (ATP-alert-on: 14, ATP-alert-off: 21); however, many patients subsequently received shock delivery for VT. Among the 35 episodes, only in ATP-alert-on group, seven patients were prompted to visit our hospital without ICD shock through confirmation of ES by ATP-alert. Episodes that led to shock delivery 24 h or longer after the ES onset were significantly less common in the ATP-alert-on group (ATP-alert-on: 1/14, ATP-alert-off: 9/21, p = .03). Although there were no significant differences in the number of shock deliveries between episodes in the two groups, the number of ATP deliveries were significantly fewer in the ATP-alert-on group (12[7-26] vs. 29[16-53] in ATP-alert-off group, p = .03). Multivariate logistic regression analyses showed that the only ATP-alert significantly reduced ATP deliveries (HR = 0.14, 95%CI = 0.04-0.57, p = .003). CONCLUSION: Remote monitoring with an ATP-alert function during electrical storm may reduce appropriate ICD therapy through prompting early review.

Device nurse intervention facilitates the patients' adaptation to cardiac shock devices in the remote monitoring era.

BACKGROUND: A substantial number of patients with shock devices (implantable cardioverter defibrillators [ICDs] or ICDs with resynchronization [CRTDs]) experience psychological distress. OBJECTIVE: We investigated the device nurse telephone intervention's effect on improving the patient's adaptation to shock devices, quality of life (QOL), and anxiety in the remote monitoring era. METHODS: The patient's adaptation to the device, health-related QOL, and anxiety were investigated by the modified Implanted Devices Adjustment-Japan score (IDAS), Short Form-36, and State-Trait Anxiety Inventory (STAI) before and 1-year after the device nurse telephone intervention, performed every 3 months. A total of 95 patients (median age 69 years and 25 females) participated. Sixty patients had ICDs and 35 CRTDs. Structural heart disease was observed in 72 patients, and idiopathic ventricular arrhythmias in the others. The mean left ventricular ejection fraction was 46% ± 15%. The median duration since the device implantation was 5.2 years. RESULTS: The total IDAS score significantly improved from 28.42 ± 7.11 at baseline to 26.77 ± 7.68 (p = 0.0076) at 1 year. Both the state and trait anxiety significantly improved (from 38.9 ± 9.6 to 35.3 ± 9.0 [<0.0001] and 38.8 ± 10.3 to 36.2±9.8 [p = 0.0044], respectively). The prevalence of patients with a state and trait anxiety of more than 40 decreased from 44 (46%) and 38 (40%) patients before the study to 27 (28 %) and 32 (34 %) at 1 year. The SF-36 mental component summary score significantly increased (50.8 ± 8.3 at baseline to 53.1 ± 7.7 at 1 year, p = 0.0031). CONCLUSIONS: The device nurse intervention facilitated the patient's adaptation to the shock device, increased the health-related QOL, and reduced the patient's anxiety.

Clinical characteristics and risk factors of arrhythmia during follow-up of patients with idiopathic ventricular fibrillation.

AIMS: The current knowledge of idiopathic ventricular fibrillation (IVF) is limited. We aimed to investigate the nature of IVF, including clinical assessment and later diagnosis, and risk factors of implantable cardioverter defibrillator (ICD) therapy in the follow-up period. METHODS: Between 2007 and 2019 we systematically identified all patients from Rigshospitalet, Denmark, with a resuscitated sudden cardiac arrest (SCA) with no identifiable cause. All patients were followed routinely in the ICD outpatient clinic and the majority also in an inherited heart disease outpatient clinic. Outcomes were analysed with Cox regressions models and cumulative incidence curves. RESULTS: We identified 84 patients with an initial diagnosis of IVF; of these, three (3.6%) patients were later diagnosed with a cardiac disease. The remaining IVF patients (n = 81, median age 45 years; men 71.6%) were followed a median follow-up of 5.2 years (interquartile range, 2.0-7.6). A total of 24 (29.6%) patients had appropriate ICD therapy and 12 (14.8%) patients had inappropriate ICD therapy. No predominant type of ventricular arrhythmia at first appropriate ICD therapy was observed. Early repolarization at baseline was not associated with an increased risk of appropriate ICD therapy (P = .842). Repeated cardiac arrest at index SCA increased the risk of appropriate ICD therapy (hazard ratio, 2.63 [95% CI, 1.08-6.40; P = .033]). CONCLUSION: Most patients remained idiopathic throughout the follow-up period and the overall long-term prognosis of IVF was good. Repeated cardiac arrest at index SCA was a risk factor of appropriate ICD therapy and early repolarization was not associated with an increased risk of appropriate ICD therapy.

Effect of ICD implantation on cardiovascular outcomes in patients with cardiac amyloidosis: A systematic review and meta-anaylsis.

INTRODUCTION: Cardiac amyloidosis is associated with a high rate of sudden cardiac death (SCD). Whether implantable cardioverter-defibrillator (ICD) use in such patients prevents SCD is uncertain. This study assesses outcomes of ICD use in patients with cardiac amyloidosis. METHODS: A systematic review and meta-analysis of data were performed after searching multiple databases and scientific sites pertaining to ICD use and cardiac amyloidosis. Of 8260 citations identified, six studies comprising 194 patients met inclusion criteria. RESULTS: Mean values and frequencies of patient characteristics were as follows: mean NT-proBNP: 6867.9 pg/mL, mean left ventricular ejection fraction: 48.1%, heart failure: 67%, nonsustained ventricular tachycardia: 51%, syncope: 21%, and secondary prevention: 33%. During the mean follow-up period of 18.21 months, 18% of patients received appropriate ICD treatment and 5% received inappropriate ICD treatment. The mortality rate was 31%. Two studies assessed the difference between patients with appropriate ICD treatment and patients with absence of appropriate ICD treatment. There was no difference between the two groups when stratified on multiple selected third variables except for two subgroups. Male gender was associated with a higher rate of appropriate ICD treatment, whereas New York Heart Association class III or IV heart failure patients was associated with a lower rate of appropriate ICD treatment. CONCLUSION: The frequency of appropriate ICD treatment in cardiac amyloidosis is low and is not predicted by nonsustained ventricular tachycardia. Male gender is associated with appropriate ICD treatment. New York Heart Association class III or IV heart failure is associated with lower rate of appropriate ICD treatment.

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.

Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was "very" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.

Recurrent syncope after a finger injury and induced monomorphic ventricular tachycardia: Really Brugada syndrome?

Brugada syndrome is an arrhythmogenic disease with often fatal outcome in otherwise healthy and young individuals. Anamnesis and ECG are cornerstones in a syncope workup. In our case, a 27-year-old male presented to the emergency department due to recurrent syncope. Repeated 12­lead-ECGs revealed a type 2 Brugada pattern. A positive drug challenge suggested a Brugada syndrome and electrophysiological testing reproducibly induced monomorphic ventricular tachycardia. Consequently, an ICD was implanted for secondary prevention. On 2-year follow-up, the patient remained free from other arrhythmic events or ICD interventions.

Long-term performance and lead failure analysis of the Durata defibrillation lead compared to its previous model, the recalled Riata defibrillation lead.

INTRODUCTION: Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice. METHODS AND RESULTS: A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%). CONCLUSION: Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice.

Cardiac resynchronization therapy and outcomes in patients with left ventricular assist devices: a systematic review and meta-analysis.

The impact of cardiac resynchronization therapy (CRT) on clinical outcome in patients with a continuous-flow left ventricular assist device (LVAD) is currently not well understood. We conducted a systematic literature review and meta-analysis with an intention to summarize all published clinical evidence. We searched MEDLINE and EMBASE databases through March 2018 for studies that compared the outcomes in patients with LVAD and CRT. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated using a random-effects model, inverse variance method. The between-study heterogeneity was assessed using the Q statistic and I2. A total of seven studies that included 1157 (575 CRT; 582 non-CRT) patients were identified. Our meta-analysis did not demonstrate a significant difference in the risk of mortality (pooled OR = 1.21, 95% CI 0.90-1.63, P = 0.21), ventricular arrhythmia incidence (pooled OR = 1.36, 95% CI 0.99-1.86, P = 0.06), hospitalization (pooled OR = 1.36, 95% CI 0.59-3.14, P = 0.48), or implantable cardioverter defibrillator therapies (pooled OR = 1.08, 95% CI 0.51-2.30, P = 0.84) among the CRT group compared with the non-CRT group. There was high heterogeneity with an I2 of 75% for ICD therapies. Among LVAD patients, CRT combined did not significantly affect mortality, re-hospitalization, ventricular arrhythmia incidence, and ICD therapies.

The Medtronic Sprint Fidelis® lead history revisited-Extended follow-up of passive leads.

BACKGROUND: Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow-up. Aim of this study was to give insights into passive lead survival with a follow-up of 10 years. METHODS: In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow-ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow-up), time of lead revision (in non-SFL-related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low-voltage impedance to >1500 or high-voltage impedance to >100 Ω; >300 nonphysiological short VV-intervals. RESULTS: We identified 145 patients. Age at implant was 60 ± 12 years with a median follow-up of 10.2 (interquartile range [IQR]: 5.0-11.2) years. Thirty-five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2-12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32-2.87, P < 0.001). CONCLUSIONS: During very long-term follow-up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years.