Wearable cardioverter-defibrillator (life-vest): A feasible bridging treatment in adult congenital heart disease

BackgroundWearable cardioverter-defibrillators (WCDs) are currently used in patients at temporarily heightened risk for sudden cardiac death (SCD) who are temporarily unable to receive an implantable cardioverter-defibrillator (ICD). WCD can safely record and terminate life-threatening arrhythmias through a non-invasive electrode-based system. The current clinical indications for WCD use are varied and keep evolving as experience with this technology increases.MethodsWe reviewed and explored the data behind indications for WCD use and discuss its usefulness in congenital heart disease (CHD) patients.ResultsWe considered 8 consecutive patients (mean age 35.25 years, range 18–51 years, average duration of WCD use 4 months, range 3–6 months) with complex CHD, in which a WCD was used between June 2018 and January 2022. No sustained ventricular arrhythmias requiring shocks were recorded in the observation period. No inappropriate shocks were recorded. All the patients showed a good compliance and a very high mean wear time per day (21.2 ± 1 h a day). Four patients implanted a permanent device (3 CRT-D, 1 ICD), three underwent cardiac surgery at the end of the WCD period and one is still on the waiting list for the operation.ConclusionsLarger trial could confirm the possible conceivable benefit from an extended use of the WCD in certain populations with complex CHD as in our case series, especially in patients with life-treating ventricular arrhythmias waiting for surgery for residual cardiac defects or in the early phases following the surgical/hemodynamic interventions, patients with tachycardiomyopathy expected to improve after the arrhythmias are removed and patients awaiting implantation of an ICD at high risk due to active infection.     

Outpatient treatment with the wearable cardioverter defibrillator: clinical experience in two Dutch centres

Introduction

The latest European Society of Cardiology Guidelines recommend consideration of a wearable cardioverter-defibrillator (WCD) for patients with a poor left ventricular ejection fraction (LVEF) who are at risk of sudden arrhythmic death but are not eligible for an implantable defibrillator. For these patients a WCD can be an alternative to long-term hospitalisation.

Purpose

To evaluate the use of WCD therapy in these patient groups in two Dutch centres.

Methods

All consecutive patients treated with the WCD between 2009 and 2016 were included from two centres in the Netherlands. Data on events and compliance were collected retrospectively through home monitoring systems and adjudicated by the investigators.

Results

A total of 79 patients were treated with a WCD. Common indications were newly diagnosed cardiomyopathy without optimal medical treatment in 46 patients (58.2%) and bridge to implantable cardioverter-defibrillator (ICD) implant in 33 patients (41.8%). Bridge to implant indications consisted of contraindications for immediate implantation such as infections (e.?g. previous device-related infections) and radiotherapy. Compliance was over 97% per day (median 23.3?h, 22.6–23.7), during a median of 79 days (50.0–109.8.0). Two patients (2.6%) received an appropriate shock (annual rate 13.6%), there was 1 (1.3%) inappropriate shock (annual rate 6.7%). In 24 patients (52.2%) without optimal medical treatment, the LVEF was sufficiently improved and ICD implant was avoided. Eight (10.1%) patients did not receive an ICD. In 45 patients an ICD was implanted (57.0%).

Conclusion

WCD therapy provides a safe and effective treatment in outpatient setting for patients at high risk for sudden cardiac death and reduces the number of ICDs implanted.

     

Sudden death and its predictors in myocardial infarction survivors in an Indian population

ObjectiveThis study was conducted to assess the incidence of sudden cardiac death (SCD) in post myocardial infarction patients and to determine the predictive value of various risk markers in identifying cardiac mortality and SCD.MethodsLeft ventricular function, arrhythmias on Holter and microvolt T wave alternans (MTWA) were assessed in patients with prior myocardial infarction and ejection fraction ≤ 40%. The primary outcome was a composite of cardiac death and resuscitated cardiac arrest during follow up. Secondary outcomes included total mortality and SCD.ResultsFifty-eight patients were included in the study. Eight patients (15.5%) died during a mean follow-up of 22.3 ± 6.6 months. Seven of them (12.1%) had SCD. Among the various risk markers studied, left ventricular ejection fraction (LVEF) ≤ 30% (Hazard ratio 5.6, 95% CI 1.39 to 23) and non-sustained ventricular tachycardia (NSVT) in holter (5.7, 95% CI 1.14 to 29) were significantly associated with the primary outcome in multivariate analysis. Other measures, including QRS width, heart rate variability, heart rate turbulence and MTWA showed no association.ConclusionsAmong patients with prior myocardial infarction and reduced left ventricular function, the rate of cardiac death was substantial, with most of these being sudden cardiac death. Both LVEF ≤30% and NSVT were associated with cardiac death whereas only LVEF predicted SCD. Other parameters did not appear useful for prediction of events in these patients. These findings have implications for decision making for the use of implantable cardioverter defibrillators for primary prevention in these patients.     

The efficacy of the LinoxSmart DX ICD lead from a single center experience

PurposeThe Biotronik Linox^Smart DX implanted cardioverter defibrillator (ICD) lead is a novel VDD lead with the advantage of integrated atrial sensing dipole combined with a special augmentation and filtering mechanisms. We sought to determine the efficacy of the Biotronik Linox^Smart DX ICD lead.MethodsNon-randomized consecutive patients implanted with Biotronik Linox^Smart DX lead at Sheba Medical Center were included in this study. Electrical parameters and arrhythmic events were recorded during follow up of one year.ResultsSeventy-three patients (69 males (94.5%), mean age 61 ± 12 years) were included. All patients were successfully implanted with a Biotronic VR-T DX device and Linox^Smart DX ICD lead (DX-17 in 37% and DX-15 in 63% patients). Mean P wave amplitude at time of implantation was 3.66 ± 2.9 mV and improved significantly throughout the follow-up (5.29 ± 4.39 mV, p = 0.009). Appropriate atrial sensing (defined as P wave amplitude of ≥0.8 mV) rate of 100% at implantation significantly decreased to 89% (p = 0.015) at 12 months. Three out of 67 (4.5%) patients without a known history of atrial fibrillation had documented new onset paroxysmal atrial fibrillation. Appropriate shocks occurred in 4 (5.5%) patients. One patient with atrial sensing less than 0.4 mV had inappropriate shock.ConclusionsAmong patients implanted with the Biotronik Linox^Smart DX ICD lead in our single center, appropriate atrial sensing rate decreased over 12 months. Larger studies are needed to evaluate the reliability of long term appropriate atrial sensing.     

Long-term,real world experience of ventricular tachycardia and granulomatous cardiomyopathy

BackgroundGranulomatous cardiomyopathy (GCM) is relatively uncommon in patients presenting with ventricular tachycardia (VT). Sarcoidosis and tuberculosis are the most common causes of GCM with VT. The aim of study was to evaluate their clinical characteristics and the long-term outcomes.MethodsWe retrospectively analyzed patients from March 2004 to January 2020, presenting with VT and subsequently diagnosed to have GCM. Patients were divided into three groups (sarcoid, tuberculosis and indeterminate) based on serologic tests, imaging and histopathology. The response to anti-arrhythmic and disease specific therapy on long-term follow-up were analyzed.ResultsThere were 52 patients, comprising 27 males and 25 females, age 40 ± 10 years. The follow-up period was 5.9 ± 3.9 years. Sarcoidosis was diagnosed in 20 (38%); tuberculosis (TB) in 15(29%) and 17(33%) patients were indeterminate. Left ventricular ejection fraction (LVEF) of the entire cohort was 0.45 ± 0.14. Erythrocyte Sedimentation Rate(ESR) was found to be significantly higher in TB(43.6 ± 18.4) patients vs sarcoid(18.9 ± 6.7)p < 0.0001, but not the indeterminate group (36.2 ± 21.1), p = 0.3. Implantable Cardioverter Defibrillator (ICD) implantation was performed in 12/20(60%) patients in the sarcoid group, in 4/15(27%) patients in the TB group and in 10/17(59%) patients in the indeterminate group. At a mean follow-up of six years, VT recurrences were noted in 6, 2, and 7 patients in the sarcoid, TB and indeterminate groups respectively.ConclusionDespite the advances in diagnostic modalities for tuberculosis and sarcoidosis, in real-world practice, almost one-third of the patients with VT and GCM have uncertain etiology. Long term outcomes of patients presenting with GCM and VT with mild left ventricle dysfunction treated appropriately seems favorable.     

Pediatric SubQ-ICD implantation,a single center review of the inter-muscular technique

IntroductionPediatric patients with cardiomyopathies are at risk for sudden death and may need implantable cardioverter defibrillators (ICD’s), but given their small size and duration of use, children are at increased risk for complications associated with ICD use. The subcutaneous ICD presents a favorable option for children without pacing indications. Unfortunately, initial pediatric studies have demonstrated a high complication rate, likely due to the 3-incision technique employed.Material and methodsPatients with ICD but no pacing indication were retrospectively reviewed after implantation of subcutaneous ICD via the two-incision technique. In half of the patients, 10-J impedance test was also performed to compare with impedance obtained after defibrillation threshold testing with 65-J.ResultsTwelve patients were included. The median age was 14 years (range 10–16 years) with eight males included (72.7%). The median weight was 55 kg (range 29 kg–75.1 kg). Follow-up had a median of 11.5 months (range 2–27 months). The median body mass index was 18.4 kg/m squared (range 15.5–27.9 kg/m squared). One patient suffered a minor complication after tearing off the incisional adhesive strips early and required a non-invasive repair in clinic. Shock impedance had a median of 55 J (range 48–68 J). There was one appropriate shock/charge and no inappropriate shocks during follow-up.ConclusionThe two-incision, intermuscular technique appears to have a lower acute complication rate than prior reports, in our cohort of 12 pediatric patients.     

Do all patients with implantable cardioverter defibrillator need a generator change? A health service evaluation of patients who underwent generator changes from a single tertiary center

BackgroundThe patient characteristics, therapy received and outcomes after one or more implantable cardioverter defibrillator (ICD) generator changes from contemporary practice is not well known.MethodsWe conducted a health service evaluation of patients who underwent ICD implantation and generator change. Patients who had generator changes from February 2016 to October 2019 were identified from our database and electronic records were reviewed for patient characteristics, number of generator changes, receipt of therapy and death.ResultsOur database included 88 patients with a generator change. A total of 22 patients (25.0%) received dual chamber ICD, 10 patients (11.4%) received single chamber ICD, 54 patients (61.3%) received cardiac resynchronization therapy defibrillator and 2 patients (2.3%) received subcutaneous ICD. A second generator change occurred in 18 patients and a third generator changes was performed in 6 patients. There were 29 deaths and a follow up period of 9.4 ± 2.9 years. From implant to initial generator change 39 patients had appropriate antitachycardia pacing (ATP), 6 patient had inappropriate ATP, 29 patients had appropriate shocks and 5 patients had an inappropriate shock. Between the 1st and 2nd generator change and the 2nd and 3rd there were no cases of inappropriate ATP or shock. Overall, 42 patients out of the 88 had appropriate therapy (47.7%) and 7 patients had inappropriate therapy (8.0%).ConclusionsMost patients with ICDs do not receive therapy and a minority have inappropriate therapy which typically occur before the first generator change as we observed no inappropriate therapy beyond the first generator change.     

First experience with the wearable cardioverter defibrillator in the Netherlands

The implantable cardioverter defibrillator (ICD) has significantly improved survival in patients with an increased risk of sudden cardiac death (SCD). The wearable cardioverter defibrillator (WCD) is an alternative to the ICD in patients with a transient ICD indication or those in whom an ICD temporarily cannot be implanted. We describe here the technical details of the WCD and report three patients who were treated with a WCD in an outpatient setting. The WCD allowed the cardiac condition of two patients to improve to such an extent that permanent ICD implantation was deemed unnecessary. This new form of therapy may result in significant cost reduction, avoidance of unnecessary ICD implantation, and increased patient satisfaction.     

Change in myocardial function after resuscitated sudden cardiac arrest and its impact on long-term mortality and defibrillator implantation

BackgroundThe impact of left ventricular ejection fraction (LVEF) changes after sudden cardiac arrest (SCA) on implantable defibrillator (ICD) utilization and long-term survival is not known. We therefore evaluated the influence of LVEF on these parameters in SCA survivors.MethodsData were collected on consecutive SCA survivors who had ≥1 echocardiogram after SCA and who survived to hospital discharge (n = 655). The median time from baseline to first follow-up echocardiogram was 162 days. LVEF ≥50% was defined as normal. Patients were classified into 4 groups according to baseline (LVEFb) and follow-up (LVEFf) myocardial function: normal LVEFb and LVEFf (group1, n = 261); reduced LVEFb and normal LVEFf (group 2, n = 104); normal LVEFb but reduced LVEFf (group 3, n = 41); and reduced LVEFb and LVEFf (group 4, n = 249). All-cause mortality and time to ICD implantation were examined in all groups.ResultsOver a median follow up of 4.3 years, death occurred in 279 (42%) of patients. Compared with patients in group 1, patients with any reduced LVEF at any time (groups 2–4) had significantly higher mortality, even after adjusting for unbalanced covariates (HR = 1.44, 95.0% CI 1.05–1.95, p = 0.022). ICDs were most commonly implanted in patients with persistently reduced LVEF (group 4: HR = 1.72, 95% CI = 1.26–2.35, p = 0.001).ConclusionWe demonstrate that, in survivors of SCA, a reduced LVEF at or after the index event is associated with higher mortality but that patients with persistently reduced LVEF were most likely to receive ICD therapy. These findings have implications on the management of SCA survivors.     

PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design

Background

Many adult congenital heart disease (ACHD) patients are at risk of sudden cardiac death (SCD). An implantable cardioverter-defibrillator (ICD) may prevent SCD, but the evidence for primary prevention indications is still unsatisfactory.

Study Design

PREVENTION-ACHD is a prospective study with which we aim to prospectively validate a new risk score model for primary prevention of SCD in ACHD patients, as well as the currently existing guideline recommendations. Patients are screened using a novel risk score to predict SCD as well as current ICD indications according to an international Consensus Statement. Patients are followed up for two years. The primary endpoint is the occurrence of SCD and sustained ventricular arrhythmias. The Study was registered at ClinicalTrials.gov (NCT03957824).

Conclusion

PREVENTION-ACHD is the first prospective study on SCD in ACHD patients. In the light of a growing and aging population of patients with more severe congenital heart defects, more robust clinical evidence on primary prevention of SCD is urgently needed.

     

Under-Utilization of Implantable Cardioverter Defibrillators in Patients with Heart Failure - The Current State of Sudden Cardiac Death Prophylaxis

BackgroundDespite ACC/AHA guidelines indicating implantable cardioverter defibrillator (ICD) as class I therapy for primary prevention of sudden cardiac death in patients with EF≤35%, ICD utilization rates in real world practice have been low.ObjectiveTo determine the rate of ICD implantation at a tertiary care academic center and to assess the reasons for under-utilization of the same.MethodsReview of a prospectively collected database which included all patients diagnosed with an EF≤35% was performed to assess the rate of ICD implantation and mortality. Reasons for non-implantation of ICD were then assessed from detailed chart review.ResultsA total of 707 patients (age 69.4 ± 14.1 years) with mean EF of 26±7% were analyzed. Only 28% (200/707) of patients had ICDs implanted. Mortality was lower in the group with ICD (25% vs 37%, p=0.004). When patients who either died or were lost to follow-up prior to 2005 were excluded, ICD utilization rate was still low at 37.6%. The most common reason for non-implantation of ICD was physicians not discussing this option with their patients. Patient refusal was the second most common reason.ConclusionsICD Implantation rates for primary prevention of SCD in patients with EF≤35% is low. Physician and patient education should be addressed to improve the utilization rates.Key words: Implantable cardioverter-defibrillator, Outcomes, sudden cardiac death     

Debate: Do all patients with heart failure require implantable defibrillators to prevent sudden death?

Sudden death is a major cause of mortality in patients with ventricular dysfunction. The highest risk occurs among patients with less severe functional impairment. Current methods of risk stratification are inadequate, and a rational therapy for prevention of sudden death is not available. The implantable cardioverter-defibrillator (ICD) has proven to be more effective than drugs in reducing sudden-death risk in some subsets of patients. Empiric ICD therapy, targeting the general population with mild to moderate heart failure, will maximize the impact of such a strategy to prevent sudden death and improve long-term survival.     

The risk of ventricular arrhythmias in a Dutch CRT population: CRT-defibrillator versus CRT-pacemaker

Background

Patients eligible for cardiac resynchronisation therapy (CRT) have an indication for primary prophylactic implantable cardioverter defibrillator (ICD) therapy. However, response to CRT might influence processes involved in arrhythmogenesis and therefore change the necessity of ICD therapy in certain patients.

Method

In 202 CRT-defibrillator patients, the association between baseline variables, 6-month echocardiographic outcome (volume response: left ventricular end-systolic volume decrease < ≥15 % and left ventricular ejection fraction (LVEF) ≤ >35 %) and the risk of first appropriate ICD therapy was analysed retrospectively.

Results

Fifty (25 %) patients received appropriate ICD therapy during a median follow-up of 37 (23–52) months. At baseline ischaemic cardiomyopathy (hazard ratio (HR) 2.0, p = 0.019) and a B-type natriuretic peptide level > 163 pmol/l (HR 3.8, p < 0.001) were significantly associated with the risk of appropriate ICD therapy. After 6 months, 105 (52 %) patients showed volume response and 51 (25 %) reached an LVEF > 35 %. Three (6 %) patients with an LVEF > 35 % received appropriate ICD therapy following echocardiography at ± 6 months compared with 43 patients (29 %) with an LVEF ≤ 35 % (p = 0.001). LVEF post-CRT was more strongly associated to the risk of ventricular arrhythmias than volume response (LVEF > 35 %, HR 0.23, p = 0.020).

Conclusion

Assessing the necessity of an ICD in patients eligible for CRT remains a challenge. Six months post-CRT an LVEF > 35 % identified patients at low risk of ventricular arrhythmias. LVEF might be used at the time of generator replacement to identify patients suitable for downgrading to a CRT-pacemaker.     

Ultrasound-guided axillary vein puncture for cardiac devices implantation in patients under antithrombotic therapy

BackgroundUltrasound-guided axillary venous puncture (UGAVP) for cardiac devices implantation has been developed because of its rapidity, safety and potential long-term lead protection. Early work excluded defibrillators (ICD), cardiac resynchronization therapy (CRT) and upgrade procedures. Compared to the cephalic approach, in previous studies, there was a greater use of pressure dressings with this technique, suggesting a higher risk of bleeding.AimsTo assess UGAVP in patients under antithrombotic therapy (ATT) undergoing cardiac devices implantation including CRT/ICD.MethodsProspectively, consecutive patients eligible for a pacemaker or ICD implantation were included. All procedures were performed by a single operator, experienced with UGAVP for femoral access, and fluoroscopy-guided axillary vein access. Guidewires insertion time (from lidocaïne administration), and complications were systematically studied.ResultsFrom 457 cardiac device implantations, 200 patients (77.8 ± 10 y, male 58%) 360 leads were implanted by UGAVP including 36 ICD, 54 CRT and 14 upgrade procedures. A majority (90%) was under ATT: Vitamin K Antagonist or Heparin (n = 58, 29%), direct oral anticoagulant (n = 46, 23%), dual antithrombotic therapy (n = 18, 9%) and single antiplatelet drug (n = 82, 41%). UGAVP was successful in 95.78%. Mean insertion time for 1.8 guidewires per patient was 4.68 ± 3.6 min. No complication (no hematoma) was observed during the follow-up (mean of 45 ± 10 months). Guidewires insertion time reached its plateau after 15 patients.ConclusionUGAVP is fast, feasible and safe for patients under ATT undergoing device implantation including CRT/ICD and upgrade procedures, with a short learning curve.     

Influence of time between last myocardial infarction and prophylactic implantable defibrillator implant on device detections and therapies. Routine Practice data from the SEARCH MI registry

ABSTRACT: BACKGROUND: A multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to asses patients' outcomes and ICD interventions in patients with a previous MI and depressed LV function, treated with an ICD according to MADIT II results. In this analysis, we evaluate the influence of the time elapsed between last myocardial infarction (MI) and prophylactic cardioverter defibrillator (ICD) implant on device activations. METHODS: 643 patients with left ventricular dysfunction (mean LVEF 26 +/- 5%) and NYHA class I-III were prospectively followed for 1.8 +/- 1.2 years in a multicenter registry. The population was divided into 3 groups according to the time between last MI and ICD implant: [1] from 40 days to less than 1.5 years; [2] from 1.5 to less than 7 years and [3] at least 7 years. RESULTS: The cumulative incidence of ventricular tachyarrhymias and appropriate device therapy (ATP or shock) were higher in patients implanted longer time from last MI (Gray's Test p = 0.002 and p = 0.013 respectively). No significant differences were seen in all cause mortality (Gray's Test p = 0.618) or sudden cardiac death across the MI stratification groups (Gray's Test p = 0.663). CONCLUSIONS: Patients implanted with an ICD longer after the MI have a higher chance of presenting ventricular tachyarrhythmias and appropriate ICD therapy, while no differences were seen in overall mortality. These observations may be important for improving patient targeting in sudden death prevention.     

QRS、QT、QTc及LVEF预测心源性猝死的价值分析

摘要 目的：探讨QRS时限值（QRS）、QT间期延长（QT）、QTc间期（QTc）及左室射血分数（LVEF）预测心源性猝死的价值分析。方法：选择2018年1月至2019年12月川北医学院附属医院心血管内科治疗的356例心源性猝死患者进行研究,设为病例组,并选择同期体检的健康人200例作为对照组,分析QRS、QT、QTc及LVEF水平变化情况及其预测价值。结果：病例组QRS、QTc水平显著高于对照组,QT、LVEF水平显著低于对照组,差异显著（P＜0.05）;轻度QRS、QTc显著低于中度、重度患者,QT、LVEF水平显著高于中度、重度患者;中度患者QRS、QTc显著低于重度患者,QT、LVEF水平显著高于重度患者,差异显著（P＜0.05）;ROC结果显示,QRS预测心源性猝死的AUC为0.989,灵敏度△为84.59%,特异度为87.68%,截断值为115.59ms;QT预测心源性猝死的AUC为0.944,灵敏度85.12%,特异度为88.45%,截断值为21.69ms;QTc预测心源性猝死的AUC为0.984,灵敏度为86.05%,特异度为88.61%,截断值为416.39ms,LVEF预测心源性猝死的AUC为0.997,灵敏度87.15%,特异度为89.05%,截断值为45.63%,（P＜0.05）。结论：QRS、QT、QTc及LVEF在心源性猝死患者中检查,可显著提高心源性猝死临床诊断效能。     

Assessment of Recanalization of Chronic Total Occlusions on Left Ventricular Function in Patients With or Without Previous Myocardial Infarction by Real-time Three-Dimensional Echocardiography

The changes of left ventricular ejection fraction (LVEF) were assessed after successful recanalization of chronic total occlusions (CTO) with or without previous myocardial infarction (MI) by real-time three-dimensional echocardiography (RT3DE). 32 patients with a successfully recanalyzed CTO were included in the present prospective study. The patients were divided into group 1 without previous MI and group 2 with previous MI in the territories of total occlusion vessel that was recanalized. In addition, there was a subgroup composed of 14 patients with collateral flow or retrograde flow in group 2. In all patients, LVEF was determined by RT3DE at baseline and after 6 weeks. In group 1, the evolution of LVEF increased significantly from 59.9 ± 7.2–67.5 ± 8.7% (P < 0.05). In group 2, the evolution of LVEF increased from 48.6 ± 6.1–50.1 ± 6.4%, however, it was without statistic significance (P > 0.05). The evolution of LVEF increased from 46.8 ± 7.1–53.0 ± 7.2% (P < 0.05) in the subgroup of group 2. Left ventricular function in patients with CTO can be feasibility and actually evaluated by RT3DE. The influence of recanalization of CTO on the improvement of left ventricular function was different between MI and non-MI patients. The left ventricular function did not improve in MI patients, but improved significantly in the patients having rich collateral circulation.     

Transvenous Lead Extraction (TLE) Procedure: Experience from a Tertiary Care Center in Thailand

BackgroundTransvenous Lead Extraction (TLE) is a standard treatment for some late Cardiac Implantable Electronics Device (CIED) complications. The outcome of transvenous lead extraction procedure in Thailand is not robust.MethodsA Single-center retrospective cohort of TLE procedures performed at Ramathibodi hospital between January 2008 and December 2020 was studied.ResultsThere were 157 leads from 105 patients who underwent lead removal procedure during the specified period. Data analysis was performed from 79 TLE patients due to incomplete data and lead explant procedure of the excluded subjects. Mean patients’ age was 57.7 ± 18.7 years, with 70.9% male. There were 82 pacemaker leads, 35 ICD leads, and 5 CS leads (mean number of leads were 1.54 ± 0.66 per patient), with mean implanted duration of 87.8 ± 68.2 months. Main indication for TLE was infection-related, which accounted for 67.1% of the cases.Overall clinical success rate was 97.5%. Mean operative time was 163.8 ± 69.5 min. Major complications occurred in 4 patients (5.1%) with one in-hospital mortality from severe sepsis.ConclusionTLE using laser sheath and rotating mechanical sheath for transvenous lead extraction is effective and safe, even outside high-volume center.     

Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator

Background

Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy.

Methods/design

The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women.

Conclusion

The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

     

Infarct-related chronic total coronary occlusion and the risk of ventricular tachyarrhythmic events in out-of-hospital cardiac arrest survivors

IntroductionChronic total coronary occlusion (CTO) has been identified as a risk factor for ventricular arrhythmias, especially a CTO in an infarct-related artery (IRA). This study aimed to evaluate the effect of an IRA-CTO on the occurrence of ventricular tachyarrhythmic events (VTEs) in out-of-hospital cardiac arrest survivors without ST-segment elevation.MethodsWe conducted a post hoc analysis of the COACT trial, a multicentre randomised controlled trial. Patients were included when they survived index hospitalisation after cardiac arrest and demonstrated coronary artery disease on coronary angiography. The primary endpoint was the occurrence of a VTE, defined as appropriate implantable cardioverter-defibrillator (ICD) therapy, sustained ventricular tachyarrhythmia or sudden cardiac death.ResultsA total of 163 patients from ten centres were included. Unrevascularised IRA-CTO in a main vessel was present in 43 patients (26%). Overall, 61% of the study population received an ICD for secondary prevention. During a follow-up of 1 year, 12 patients (7.4%) experienced at least one VTE. The cumulative incidence rate of VTEs was higher in patients with an IRA-CTO compared to patients without an IRA-CTO (17.4% vs 5.6%, log-rank p = 0.03). However, multivariable analysis only identified left ventricular ejection fraction < 35% as an independent factor associated with VTEs (adjusted hazard ratio 8.7, 95% confidence interval 2.2–35.4). A subanalysis focusing on CTO, with or without an infarct in the CTO territory, did not change the results.ConclusionIn out-of-hospital cardiac arrest survivors with coronary artery disease without ST-segment elevation, an IRA-CTO was not an independent factor associated with VTEs in the 1st year after the index event.Supplementary InformationThe online version of this article (10.1007/s12471-021-01578-3) contains supplementary material, which is available to authorized users.