Implantable Defibrillator Patients Research Articles

Device programming and SMART pass algorithm activation in subcutaneous implantable defibrillator patients: data from a remote monitoring database

Abstract Background In subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients, a previous study demonstrated very low rates of delivered shocks and inappropriate shocks on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice has been little studied, as the activation status of the SMART Pass filter, that was implemented to reduce inappropriate shocks and enhanced over time. Purpose We assessed device programming during follow-up and the rate of detected arrhythmias in a cohort of consecutive S-ICD recipients. Methods We analyzed data from 670 S-ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th-75th percentile: 16-51). The enhanced SMART Pass version was available for all patients after October 2022. It makes the deactivation monitor less sensitive to premature ventricular contractions or other transient amplitude changes while maintaining arrhythmia sensitivity and specificity, and it was expected to reduce unintentional deactivation rate. Results At the last remote data transmission, the median programmed conditional zone cut-off was set to 210 bpm (25th-75th percentile: 200-220), the shock zone cut-off was 250 bpm (25th-75th percentile: 240-250), and the SMART Pass was enabled in 586 (87%) patients. During follow-up, 194 automatic deactivation events (0.10/patient-year) were reported in 118 (18%) patients. The SMART Pass-disabled time was 13% of the total observation period. Shocks were delivered in 129 (19%) patients (rate: 0.13/patient-year), and untreated arrhythmias were recorded in 136 (20%) patients (rate: 0.14/patient-year). The rate of shocks was lower when SMART Pass was enabled – 0.12/patient-year (95% CI: 0.10-0.14) versus 0.20 (95%CI: 0.15-0.26) (p=0.002), as it was the rate of untreated arrhythmias – 0.12/patient-year (95% CI: 0.11-0.14) versus 0.23 (95%CI: 0.18-0.30) (p=0.001). The enhanced SMART Pass version was associated with a lower rate of deactivations – 0.04/patient-year (95%CI: 0.02-0.05) versus 0.14 (95% CI: 0.12-0.16) (p<0.001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95%CI: 0.28-0.53) and 0.40 (95%CI: 0.30-0.55), respectively (p<0.001)). Conclusions In current clinical practice, S-ICD implantation centers often program high cut-off rates for arrhythmia detection. Most patients have SMART Pass consistently enabled during follow-up. This is associated with significantly lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with lower deactivation rate, and with further decrease in treated and untreated detected arrhythmias.

Cardiac defibrillator implantation in patients with syncope and inducible ventricular arrhythmia: insights from the German Device Registry

History of syncope is an independent predictor for sudden cardiac death. Programmed stimulation may be considered for risk stratification, but data remain sparse among different populations. Here, we analyzed the prognostic value of inducible ventricular arrhythmia (VA) regarding clinical outcome in patients with syncope undergoing defibrillator implantation. Among 4196 patients enrolled in the prospective, multi-center German Device Registry, patients with syncope and inducible VA (n = 285, 6.8%) vs. those with a secondary preventive indication (n = 1885, 45.2%), defined as previously documented sustained ventricular tachycardia or ventricular fibrillation, serving as a control group were studied regarding demographics, device implantation and post-procedural adverse events. Patients with syncope and inducible VA (64.9 ± 14.4 years, 81.1% male) presented less frequently with congestive heart failure (15.1% vs. 29.1%; p < 0.001) and any structural heart disease (84.9% vs. 89.3%; p = 0.030) than patients with a secondary preventive indication (65.0 ± 13.8 years, 81.0% male). Whereas dilated cardiomyopathy (16.8% vs. 23.8%; p = 0.009) was less common, hypertrophic cardiomyopathy (5.6% vs. 2.8%; p = 0.010) and Brugada syndrome (2.1% vs. 0.3%; p < 0.001) were present more often. During 1-year-follow-up, mortality (5.1% vs. 8.9%; p = 0.036) and the rate of major adverse cardiac or cerebrovascular events (5.8% vs. 10.0%; p = 0.027) were lower in patients with syncope and inducible VA. Among patients with inducible VA, post-procedural adverse events including rehospitalization (27.6% vs. 21.7%; p = 0.37) did not differ between those with vs. without syncope. Taken together, patients with syncope and inducible VA have better clinical outcomes than patients with a secondary preventive defibrillator indication, but comparable outcomes to patients without syncope, which underlines the relevance of VA inducibility, potentially irrespective of a syncope.

Cardiac defibrillator implantation in patients with syncope and inducible ventricular arrhythmia: insights from the German DEVICE registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Programmed ventricular stimulation may be considered for risk stratification of sudden cardiac death. The history of syncope is an independent predictor for appropriate device discharge and sudden cardiac death, but data remain sparse among different populations. Purpose The aim of this study was to assess the prognostic value of previous syncope and inducible ventricular arrhythmia (VA) during programmed stimulation in patients undergoing defibrillator implantation. Methods Among 4,196 patients enrolled in the prospective, multi-centre German DEVICE Registry undergoing defibrillator implantation, patients with syncope and inducible VA (n=285, 6.8%) vs. those with a secondary preventive indication (n=1,885, 45.2%) serving as a control group were studied. In an additional analysis of patients with inducible VA, those with vs. without (n=86, 2.1%) previous syncope were compared. Results Patients with syncope and inducible VA (64.9±14.4 years, 81.1% male) presented less often with congestive heart failure (15.1% vs. 29.1%; P&amp;lt;0.001) and any underlying structural heart disease (84.9% vs. 89.3%; P=0.030) with a higher left ventricular ejection fraction (43.7±14.2% vs. 38.1±14.2%; P&amp;lt;0.001) than patients with a secondary preventive indication (65.0±13.8 years, 81.0% male). Whereas dilated cardiomyopathy (16.8% vs. 23.8%; P=0.009) was less common in patients with syncope and inducible VA, hypertrophic cardiomyopathy (5.6% vs. 2.8%; P=0.010) and Brugada syndrome (2.1% vs. 0.3%; P&amp;lt;0.001) were found more frequently. Device implantation was performed more often urgently in patients with syncope and inducible VA (46.4% vs. 22.5%; P=0.005). During 1 year of follow-up, mortality (5.1% vs. 8.9%; P=0.036) and the rate of major adverse cardiac or cerebrovascular events (5.8% vs. 10.0%; P=0.027) were lower in patients with previous syncope and inducible VA compared to patients with a secondary preventive indication. Among patients with inducible VA, post-procedural adverse events including rehospitalization (27.6% vs. 21.7%; P=0.37), defibrillator shocks (16.0% vs. 15.0%; P=0.85) and recurrent syncope (3.0% vs. 0%; P=0.32) did not differ between those with vs. without syncope. Conclusions Patients with a history of syncope and inducible VA present less frequently with most cardiac comorbidities resulting in better outcomes following defibrillator implantation than patients with a secondary preventive indication. Nevertheless, patients with inducible VA experience a relevant number of post-procedural adverse events not differing between those with vs. without syncope, which underlines the importance of VA inducibility, potentially irrespective of the history of syncope.

In-hospital predictors for primary prevention of sudden death after acute myocardial infarction with cardiac dysfunction

BackgroundCurrent guidelines recommend prophylactic defibrillator implantation in patients with acute myocardial infarction (AMI) and left ventricular ejection fraction (LVEF) ≤40 % or LVEF ≤35 % plus heart failure symptoms or inducible ventricular tachyarrhythmias during an electrophysiology study at 40 days after AMI or 90 days after revascularization. In-hospital predictors of sudden cardiac death (SCD) after AMI during the index hospitalization remain unsettled. We sought to examine in-hospital predictors of SCD in patients with AMI and LVEF ≤40 % evaluated during the index hospitalization. MethodsWe retrospectively evaluated 441 consecutive patients with AMI and LVEF ≤40 % admitted to our hospital between 2001 and 2014 (77 % male gender; median age: 70 years; median hospitalization length: 23 days). The primary endpoint was a composite of SCD or aborted SCD at ≥30 days after AMI onset (composite arrhythmic event). LVEF and QRS duration (QRSd) on electrocardiography were measured at a median of 12 days and 18 days, respectively. ResultsDuring a median follow-up of 7.6 years, the incidence of composite arrhythmic events was 7.3 % (32 of 441 patients). In multivariable analysis, QRSd ≥100 msec (beta-coefficient = 1.54, p = 0.003), LVEF ≤23 % (beta-coefficient = 1.14, p = 0.007), and onset-reperfusion time > 5.5 h (beta-coefficient = 1.16, p = 0.035) were independent predictors of composite arrhythmic events. The combination of these 3 factors was associated with the highest rate of composite arrhythmic events compared with 0–2 factors (p < 0.001). ConclusionsThe combination of QRSd ≥100 msec, LVEF ≤23 %, and onset-reperfusion time > 5.5 h during the index hospitalization provides precise risk stratification for SCD in patients early after AMI.

Reduction in inappropriate therapies through device programming in subcutaneous implantable defibrillator patients: data from clinical practice.

In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200-220) and the shock zone cut-off was 230 bpm (IQR: 210-250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230-250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25-0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD. URL: http://clinicaltrials.gov/Identifier: NCT02275637.

Can the Norton Scale Score Be Used as an Adjunct Tool for Implantable Defibrillator Patient Selection? A Retrospective Single-Center Cohort Study.

(1) Background: Implantable cardioverter defibrillators (ICDs) have become the standard of care in the prevention of sudden cardiac death, yet studies have shown that competing causes of death may limit ICD benefits. The Norton scale is a pressure ulcer risk score shown to have prognostic value in other fields. The purpose of this study was to assess the use of the Norton scale as an aid for ICD patient selection; (2) Methods: The study was comprised of consecutive patients who underwent defibrillator implantation at Sheba Medical Center between 2008 and 2016. A competing risk analysis was performed to assess the likelihood of death prior to device therapy; (3) Results: 695 patients were included. A total of 59 (8.5%) patients had low admission Norton scale score (ANSS) (≤14), 81 (11.7%) had intermediate ANSS (15−17), and the remainder (79.8%) had high (18−20) ANSS. The cumulative probability of all-cause mortality within one year of ICD implantation in patients with low ANSS was 30%, compared with 20% and 7% among the intermediate- and high-ANSS groups, respectively. Moreover, the one-year mortality rate without ICD therapy in low-ANSS patients was over four-fold compared with that of high-ANSS patients (33% versus 7%, p < 0.0001); (4) Conclusions: The Norton scale could be a useful additional tool in predicting the life expectancy of ICD candidates, thereby improving patient selection.

Biventricular pacemaker and defibrillator implantation in patients with chronic heart failure in China.

AimsThis study aims to investigate the current status of biventricular pacemaker and defibrillator implantation in chronic heart failure (CHF) patients with indications for primary prevention of sudden cardiac death (SCD) in China and the effects of cardiac resynchronization therapy (CRT)‐pacemaker (P) and CRT‐defibrillator (D) implantation on the clinical prognosis of CHF among patients undergoing CRT.Methods and resultsOverall, 798 consecutive patients who had devices implanted (implantable cardioverter defibrillator: 199, CRT‐D: 362, and CRT‐P: 237) from May 2012 to July 2013 in POSCD‐China, a multicentric prospective cohort study, were enrolled. The primary endpoint was all‐cause death, and the secondary endpoint was SCD. In total, 71.3% of patients had non‐ischaemic CHF. The mean follow‐up time was 27.7 ± 12.0 months, and death occurred in 158 cases, with 35 cases of SCD. CHF was the main cause of death (68.4%), followed by sudden death (22.2%). In the CRT‐P group, the SCD rate was 8.0%, which was much higher than that in the CRT‐D (3.3%) and implantable cardioverter defibrillator (2.0%) groups. No significant differences were identified in the all‐cause death rate between the CRT‐D and CRT‐P groups (CRT‐D vs. CRT‐P, 20.4% vs. 19.4%, P = 0.840).ConclusionsIn China, among CHF patients with indications for primary prevention of SCD who received device implantation, non‐ischaemic CHF was the main aetiology, and the most important cause of death was heart failure. No differences in all‐cause death were observed between the CRT‐D and CRT‐P groups, but the CRT‐D group had a lower SCD rate than the CRT‐P group.

Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial

ObjectiveTo examine the gradual association between self-reported health status and mortality in patients with heart failure (HF) as current research has focused on poor health status and increased risk of mortality. MethodThis is a substudy of the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic HF) trial in which 1116 patients were randomized to receive or not receive an implantable cardioverter-defibrillator. Health status was assessed by a single question of the Short-Form 36. Patients were classified as having excellent/very good, good, fair (reference) or poor health status. We assessed the association between health status and mortality using multivariable Cox proportional hazard models. ResultsSelf-reported health status was completed by 943 (84%) patients at randomization with a median follow-up of 67 months and a health status distribution of; excellent/very good (n = 79, 8%), good (n = 369, 39%), fair (n = 409, 43%), and poor (n = 86, 9%). All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57). The gradual difference yielded a crude hazard ratio (HR) of 0.40, 95% CI 0.20–0.80 (adjusted HR 0.47 (95% CI 0.23–0.95) for excellent/ very good health status, HR 0.71, 95% CI 0.52–0.97 (adjusted HR 0.78 (95% CI 0.56–1.08) for good health status. Poor being worse than fair health status yielded a crude HR of 1.07, 95% CI 0.67–1.69. ConclusionExcellent/very good self-reported health status as assessed by a single question was associated with lower long-term mortality in patients with HF.

Exploring the acceptability of implantable defibrillators in patients with cardiac dystrophinopathy and carers

ObjectiveUnlike for patients with other forms of cardiomyopathies, those with severe ventricular dysfunction due to Duchenne muscular dystrophy (DMD) are not offered implantable cardioverter-defibrillator (ICD) therapy routinely. This prospective study...

Myocardial fibrosis and the effect of primary prophylactic defibrillator implantation in patients with non-ischemic systolic heart failure—DANISH-MRI

Patients with non-ischemic systolic heart failure have an increased risk of sudden cardiac death (SCD). Myocardial fibrosis, detected as late gadolinium enhancement (LGE) with cardiac magnetic resonance (CMR), has been shown to predict all-cause mortality. We hypothesized that LGE can identify patients with non-ischemic heart failure who will benefit from ICD implantation. In this prospective observational sub-study of the Danish Study to Assess the Efficacy of ICDs in Patients with Nonischemic Systolic Heart Failure on Mortality (DANISH), 252 patients underwent CMR. LGE was quantified by the full width/half maximum method. The primary endpoint was all-cause mortality. LGE could be adequately assessed in 236 patients, median age was 61 years and median duration of heart failure was 14 months; there were 108 patients (46%) randomized to ICD. Median follow-up time was 5.3 years. Median left ventricular ejection fraction on CMR was 35%. In all, 50 patients died. LGE was present in 113 patients (48%). The presence of LGE was an independent predictor of all-cause mortality (HR 1.82; 95% CI 1.002-3.29; P = .049) after adjusting for known cardiovascular risk factors. ICD implantation did not impact all-cause mortality, for either patients with LGE (HR 1.18; 95% CI 0.59-2.38; P = .63), or for patients without LGE (HR 1.00; 95% CI 0.39-2.53; P = .99), (P for interaction =0.79). In patients with non-ischemic systolic heart failure, LGE predicted all-cause mortality. However, in this cohort, LGE did not identify a group of patients who survived longer by receiving an ICD.

P4533Duration of heart failure and effect of defibrillator implantation in patients with non-ischemic systolic heart failure

Abstract Introduction Patients with non-ischemic systolic heart failure have increased risk of sudden cardiac death (SCD) and death from progressive pump failure. Whether the risk of SCD changes over time is unknown. We seek to investigate the relationship between duration of heart failure, mode of death, and effect of implantable cardioverter defibrillator (ICD) implantation. Methods We examined the risk of all-cause death and SCD according to the duration of heart failure among patients with non-ischemic systolic heart failure enrolled in the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH) trial. Patients were divided according to quartiles of heart failure duration (Q1 ≤8 months, Q2 9 ≤18 months, Q3 19 ≤65 months, Q4 ≥66 months). Results A total number of 1116 patients were included. Patients with the longest duration of heart failure were older, more often men, had more comorbidity, and more often received cardiac resynchronizing therapy device. Doubling of heart failure duration was an independent predictor of both all-cause mortality (HR 1.26 95% CI 1.17–1.37, p&lt;0.0001), and SCD (HR 1.29 95% CI 1.11–1.49, p=0.0009). The proportion of deaths caused by SCD was not different between heart failure quartiles (p=0.91), and the effect of ICD implantation on all-cause mortality was not modified by the duration of heart failure (p=0.59). Duration of heart failure and death Conclusions Duration of heart failure predicted both all-cause mortality and risk of SCD independently of other risk indicators. However, the proportion of death caused by SCD did not change with longer duration of heart failure and the effect of ICD was not modified by the duration of heart failure. Acknowledgement/Funding The work was sponsored by The Danish Heart Foundation (Hjerteforeningen) and the Lundbeck Foundation (Lundbeckfonden). The DANISH trial was supported

P1026The correlation between the PRAETORIAN Score in Subcutaneous Implantable Defibrillator Patients and the Defibrillation Threshold

P1026The correlation between the PRAETORIAN Score in Subcutaneous Implantable Defibrillator Patients and the Defibrillation Threshold

Defibrillation testing and clinical outcomes after implantable cardioverter–defibrillator implantation in patients in atrial fibrillation at the time of implant: An analysis from the SIMPLE trial

The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy or reduce mortality. There are no data regarding the risk of complications, including stroke, among patients with atrial fibrillation (AF) who undergo DT. The purpose of this prospectively planned substudy of SIMPLE was to evaluate the effect of DT vs no DT on clinical outcomes among patients with AF. We compared efficacy (failed appropriate shock/arrhythmic death) and safety between patients who had AF on their immediate preprocedural ECG to the rest of the study patients. Then among patients with AF we compared these outcomes between patients randomized to DT vs no DT. Of the 2500 patients enrolled in SIMPLE, 251 (10%) were in AF immediately before ICD implant. AF patients had an increased risk of failed appropriate shock/arrhythmic death (adjusted hazard ratio [HR] 1.64; 95% confidence interval [CI] 1.13-2.39; P = .009) and higher all-cause mortality (adjusted HR 1.58; 95% CI 1.2-2.08; P = .001). Among AF patients, perioperative complications and stroke did not significantly differ between DT vs no-DT groups (9.2% vs 5.4%; P = .2; and 1.7% vs 1.5%; P >.999, respectively). Failed appropriate shock or arrhythmic death occurred in 35 of 251 AF patients (14%), and the no-DT group proved not inferior to the DT group (HR 0.58; 95% CI 0.30-1.15; Pnoninferiority = .006). ICD recipients with AF are at increased risk for adverse outcomes; however, DT does not improve arrhythmic survival or shock efficacy. There is no evidence that DT increased the occurrence of perioperative stroke.

Implantable Defibrillators in Patients with Chronic Kidney Disease: Think Twice

Implantable cardioverter-defibrillators (ICDs) can prolong survival in various patient populations, as shown in secondary prevention trials and primary

295Myocardial fibrosis and the effect of defibrillator implantation in patients with non-ischemic systolic heart failure - DANISH-MRI

295Myocardial fibrosis and the effect of defibrillator implantation in patients with non-ischemic systolic heart failure - DANISH-MRI

British Society for Heart Failure: 7th nurse training day

British Journal of Cardiac NursingVol. 12, No. 5 Meeting ReportBritish Society for Heart Failure: 7th nurse training dayWendy Bannister, Jenny Hibberd, Jayne Masters, Clare WeaverWendy BannisterSearch for more papers by this author, Jenny HibberdSearch for more papers by this author, Jayne MastersSearch for more papers by this author, Clare WeaverSearch for more papers by this authorWendy Bannister; Jenny Hibberd; Jayne Masters; Clare WeaverPublished Online:5 May 2017https://doi.org/10.12968/bjca.2017.12.5.255AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Christakis NA, Lamont EB (2000) Extent and determinants of error in doctors' prognoses in terminally ill patients: prospective cohort study. BMJ 320(7233): 469–72 Crossref, Google ScholarKøber L, Thune JJ, Nielsen JC et al.; DANISH Investigators (2016) Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. New Engl J Med 375(13): 1221–30. doi: https://doi.org/10.1056/NEJMoa1608029 Crossref, Google ScholarNational Comprehensive Cancer Network (2003) Distress management. Clinical practice guidelines. J Natl Compr Canc Netw 1(3): 344–74 Crossref, Google ScholarPonikowski P, Voors AA, Anker SD et al. (2016) 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 37(27): 2129–200. doi: https://doi.org/10.1093/eurheartj/ehw128 Crossref, Google ScholarRollnick S, Miller W (2008) Motivational Interviewing in Health Care. 3rd edn. Guildford Press, New York Google ScholarSteinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA (2000) Factors considered important at the end of life by patients, family, physicians, and other care providers. JAMA 284(19): 2476–82 Crossref, Google Scholar FiguresReferencesRelatedDetails 2 May 2017Volume 12Issue 5ISSN (online): 2052-2207 Metrics History Published online 5 May 2017 Published in print 2 May 2017 Information© MA Healthcare LimitedAcknowledgementsThe day concluded with the programme directors thanking both delegates and faculty for their contributions to the day. The Society would also like to gratefully acknowledge the support provided by the Friends of the BSH (Abbott, Bayer, Medtronic, Novartis Pharmaceuticals, Roche Diagnostics, Servier Laboratories, Vifor Pharma).PDF download

Implantable Cardioverter-defibrillator for Primary Prevention of Sudden Cardiac Death in Non-ischemic Cardiomyopathy

The insertion of implantable cardioverter-defibrillators (ICD) in patients with non-ischemic cardiomyopathy (NICM) has been recommended by recent guidelines. However, current evidence shows limited benefits to inserting ICDs in patients with NICM. Recently, the defibrillator implantation in patients with non-ischemic systolic heart failure (DANISH) trial, a large randomized trial of more than 1,100 patients with NICM, was conducted to compare the primary prevention of all-cause mortality between optimal medical therapy, cardiac resynchronization therapy, and ICD implantation. The DANISH trial revealed no differences in all-cause mortality between the groups after 5 years. However, in patients younger than 68 years of age, the rate of death from any cause was significantly lower in the ICD group compared to the control group. In addition, the rate of sudden cardiac death was lower in the ICD group compared to the control group in patients under 68 years. The results of DANISH will likely change guidelines about the insertion of ICD in patients with NICM, and encourage the use of ICD in patients with NICM. Keywords: Implantable cardioverter-defibrillator; Non-ischemic cardiomyopathy; Sudden cardiac death; Primary prevention 중심 단어: ì‚½ìž í˜• ì œì„¸ë™ê¸°; 비허혈성 심근병증; 심장돌연사; ì¼ì°¨ì  예방

Preoperative ICD risk score variables predict 30-day readmission after implantable cardioverter defibrillator implantation in patients with heart failure

ObjectiveTo determine if preoperative ICD Risk Score for Adverse Outcome (ICD-RSAO) would predict need for hospital 30-day readmission. BackgroundPre-analysis of National Cardiovascular Data Registry ICD database identified preoperative predictors of adverse outcomes associated with ICD implantation. MethodsLogistic regression, descriptive statistics and Chi-square were used to examine the relationship between ICD-RSAO and 30-day readmission after ICD implantation. ResultsBUN >30, history of lung disease, NYHA Class IV and device implant during inpatient stay were predicative of 30-day readmission (P = 0.001; 95% CI = 0.58–0.79). Patients with a combination of two or more of four variables were more likely to be readmitted (Hosmer–Lemeshow (χ2 = 3.44, P = 0.49), c-statistic = 0.71, and Nagelkerke R2 = 0.15). ConclusionPatients who have elevated BUN's, NYHA Class IV, chronic lung disease and ICD implantation during a concomitant hospital admission are at increased risk for readmission and need early follow up.

Outcome of Subcutaneous Implantable Cardioverter Defibrillator Implantation in Patients with End-Stage Renal Disease on Dialysis.

Although the subcutaneous ICD (S-ICD®) is an attractive alternative in patients with end-stage renal disease (ESRD), data on S-ICD outcomes in dialysis patients are lacking. Patients with cardiomyopathy undergoing S-ICD implantation in our center were stratified by need for chronic dialysis at the time of implant. The primary endpoint was incidence of death, heart failure hospitalization or appropriate S-ICD shocks, and secondary endpoints were incidence of inappropriate shocks or implant related complications requiring surgical re-intervention. Mean follow-up was longer in the nondialysis cohort (514 ± 495 vs. 227 ± 233 days, P = 0.006), so all endpoints were analyzed using time-dependent comparisons and reported as annual event rates. Out of 79 S-ICD implants included in this analysis, 27 patients were on dialysis. Dialysis patients were older and more likely to be diabetic. Mean ejection fraction across the entire cohort was 26.9% without significant difference between dialysis and nondialysis groups. Although not significant, the incidence of the primary endpoint was higher in the dialysis cohort (23.8%/year vs. 10.9%/year, P = 0.317), driven primarily by a higher rate of appropriate shocks. The rate of inappropriate shocks was similar between groups (dialysis 6.0%/year vs. nondialysis 6.8%/year, P = 0.509). No patients in the dialysis cohort had complications requiring surgical re-intervention versus 6 patients in the nondialysis cohort (P = 0.086). Our data suggest that S-ICD implantation in dialysis patients is not associated with an excess risk of implant related complications or inappropriate shocks.

Information provision, satisfaction and emotional distress in patients with an implantable cardioverter-defibrillator

The implantable cardioverter-defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death due to ventricular arrhythmias [ 1 Moss A. Hall W. Cannom D. et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996; 335: 1933-1940 Crossref PubMed Scopus (3569) Google Scholar , 2 Bardy G.H. Lee K.L. Mark D.B. et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005; 352: 225-237 Crossref PubMed Scopus (5302) Google Scholar , 3 The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997; 337: 1576-1584 Crossref PubMed Scopus (3004) Google Scholar ]. Although the majority of patients adapts well to living with an ICD, 1 in 4 patients report anxiety and depression [ [4] Sears S.F. Conti J.B. Quality of life and psychological functioning of ICD patients. Heart. 2002; 87: 488-493 Crossref PubMed Google Scholar ]. Sufficient understanding of the reasons for ICD implantation, its benefits, side effects, and impact on daily life plays a major role in adaptation. Adequate information provision and psycho-education may facilitate adaptation and reduce emotional distress [ 5 Vazquez L.D. Conti J.B. Sears S.F. Female-specific education, management, and lifestyle enhancement for implantable cardioverter defibrillator patients: the FEMALE-ICD study. Pacing Clin Electrophysiol. 2010; 33: 1131-1140 Crossref PubMed Scopus (38) Google Scholar , 6 Dunbar S.B. Dougherty C.M. Sears S.F. et al. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families: a scientific statement from the American Heart Association. Circulation. 2012; 126: 2146-2172 Crossref PubMed Scopus (158) Google Scholar , 7 Dunbar S.B. Langberg J.J. Reilly C.M. et al. Effect of a psychoeducational intervention on depression, anxiety, and health resource use in implantable cardioverter defibrillator patients. Pacing Clin Electrophysiol. 2009; 32: 1259-1271 Crossref PubMed Scopus (81) Google Scholar , 8 Eads A.S. Sears S.F.J. Sotile W.M. Conti J.B. Supportive communication with implantable cardioverter defibrillator patients: seven principles to facilitate psychosocial adjustment. J Cardiopulm Rehabil Prev. 2000; 20: 109-114 Crossref Scopus (22) Google Scholar ]. Paradoxically, recent surveys indicate that many patients have insufficient knowledge about their ICD and associated challenges [ 9 Cinar F.I. Tosun N. Kose S. Evaluation of an education and follow-up programme for implantable cardioverter defibrillator-implanted patients. J Clin Nurs. 2013; 22: 2474-2486 Crossref PubMed Scopus (15) Google Scholar , 10 Groarke J. Beirne A. Buckley U.N.A. et al. Deficiencies in patients' comprehension of implantable cardioverter defibrillator therapy. Pacing Clin Electrophysiol. 2012; 35: 1097-1102 Crossref PubMed Scopus (23) Google Scholar ].