Hospital utilisation and the costs associated with complications of ICD implantation in a contemporary primary prevention cohort.

INTRODUCTION: Implantation of an implantable cardioverter defibrillator (ICD) is standard care for primary prevention of sudden cardiac death. However, ICD-related complications are increasing as the population of ICD recipients grows. METHODS: ICD-related complications in a national DO-IT Registry cohort of 1442 primary prevention ICD patients were assessed in terms of additional use of hospital care resources and costs. RESULTS: During a median follow-up of 28.7 months (IQR 25.2-33.7) one or more complications occurred in 13.5% of patients. A complication resulted in a surgical intervention in 53% of cases and required on average 3.65 additional hospital days. The additional hospital costs were €6,876 per complication or €8,110 per patient, to which clinical re-interventions and additional hospital days contributed most. Per category of complications, infections required most hospital utilisation and were most expensive at an average of €22,892. The mean costs were €5,800 for lead-related complications, €2,291 for pocket-related complications and €5,619 for complications due to other causes. We estimate that the total yearly incidence-based costs in the Netherlands for hospital management of ICD-related complications following ICD implantation for primary prevention are €2.7 million. CONCLUSION: Complications following ICD implantation are related to a substantial additional need for hospital resources. When performing cost-effectiveness analyses of ICD implantation, including the costs associated with complications, one should be aware that real-world complication rates may deviate from trial data. Considering the economic implications, strategies to reduce the incidence of complications are encouraged.

Implantable defibrillator therapy and mortality in patients with non-ischaemic dilated cardiomyopathy : An updated meta-analysis and effect on Dutch clinical practice by the Task Force of the Dutch Society of Cardiology.

BACKGROUND: Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit of ICD therapy with or without cardiac resynchronisation therapy (CRT) in patients with NICMP. In addition, data were compared with real-world clinical data to perform a risk/benefit analysis. METHODS: Relevant randomised clinical trials (RCTs) published in meta-analyses since DANISH, and in PubMed, EMBASE and Cochrane databases from 2016 to 2020 were identified. The benefit of ICD therapy stratified by CRT use was assessed using random effects meta-analysis techniques. RESULTS: Six RCTs were included in the meta-analysis. Among patients without CRT, ICD use was associated with a 24% reduction in mortality (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.62-0.93; P = 0.008). In contrast, among patients with CRT, a CRT-defibrillator was not associated with reduced mortality (HR: 0.74, 95% CI 0.47-1.16; P = 0.19). For ICD therapy without CRT, absolute risk reduction at 3­years follow-up was 3.7% yielding a number needed to treat of 27. CONCLUSION: ICD use significantly improved survival among patients with NICMP who are not eligible for CRT. Considering CRT, the addition of defibrillator therapy was not significantly associated with mortality benefit compared with CRT pacemaker.

Implantable cardioverter defibrillators at the end of life: future perspectives on clinical practice.

The implantable cardioverter defibrillator (ICD) is effective in terminating life-threatening arrhythmias. However, in the last phase of life, ICD shocks may no longer be appropriate. Guidelines recommend timely discussion with the patient regarding deactivation of the shock function of the ICD. However, research shows that such conversations are scarce, and some patients experience avoidable and distressful shocks in the final days of life. Barriers such as physicians' lack of time, difficulties in finding the right time to discuss ICD deactivation, patients' reluctance to discuss the topic, and the fragmentation of care, which obscures responsibilities, prevent healthcare professionals from discussing this topic with the patient. In this point-of-view article, we argue that healthcare professionals who are involved in the care for ICD patients should be better educated on how to communicate with patients about ICD deactivation and the end of life. Optimal communication is needed to reduce the number of patients experiencing inappropriate and painful shocks in the terminal stage of their lives.

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.

ICDs at higher age and clinical risk factors.

BACKGROUND: The implantable cardioverter defibrillator (ICD) is effective in preventing sudden cardiac death. However, in elderly patients (aged 75 years or older) the role of ICDs is still not well-defined and controversial. METHODS: We retrospectively analysed all clinical and survival data of all ICD patients who were ≥75 years at the date of implantation in the Erasmus MC, Rotterdam, the Netherlands and the University Hospital, Basel, Switzerland. Kaplan-Meier survival analysis was performed, and mortality predictors were identified. Mortality of the cohort was compared with a random sample of patients aged 60-70 years originating from the same database and to an age- and sex-matched cohort of Dutch persons. RESULTS: The study cohort consisted of 179 patients aged 75 years or older who were implanted between February 1999 and July 2008. The median follow-up time was 2.0 (IQR 2.8) years. Survival rates after 1, 2 and 3 years were 87, 82, 75 %, respectively. Survival was similar for primary and secondary prevention. Mortality in this study population could be predicted by combining four clinical risk factors: QRS duration >120 ms, NYHA class > II, renal failure and atrial fibrillation (AF). Survival was worse compared with the group of ICD patients aged 60-70 years and to the age- and sex-matched group of elderly persons. However, survival was not significantly worse when comparing elderly ICD patients without additional risk factors to the general population. CONCLUSIONS: Elderly patients still have an acceptable survival probability independent of prevention indication, certainly if there are no additional clinical risk factors. The presence or absence of additional clinical risk factors should be taken into account when making the decision for implantation, since they strongly correlate with survival.

Clinical outcome of ablation for long-standing persistent atrial fibrillation with or without defragmentation.

OBJECTIVE: To assess the outcome and associated risks of atrial defragmentation for the treatment of long-standing persistent atrial fibrillation (LSP-AF). METHODS: Thirty-seven consecutive patients (60.4 ± 7.3 years; 28 male) suffering from LSP-AF who underwent pulmonary vein isolation (PVI) and linear ablation were compared. All patients were treated with the Stereotaxis magnetic navigation system (MNS). Two groups were distinguished: patients with (n = 20) and without (n = 17) defragmentation. The primary endpoint of the study was freedom of AF after 12 months. Secondary endpoints were AF termination, procedure time, fluoroscopy time and procedural complications. Complications were divided into two groups: major (infarction, stroke, major bleeding and tamponade) and minor (fever, pericarditis and inguinal haematoma). RESULTS: No difference was seen in freedom of AF between the defragmentation and the non-defragmentation group (56.2 % vs. 40.0 %, P = 0.344). Procedure times in the defragmentation group were longer; no differences in fluoroscopy times were observed. No major complications occurred. A higher number of minor complications occurred in the defragmentation group (45.0 % vs. 5.9 %, P = 0.009). Mean hospital stay was comparable (4.7 ± 2.2 vs. 3.4 ± 0.8 days, P = 0.06). CONCLUSION: Our study suggests that complete defragmentation using MNS is associated with a higher number of minor complications and longer procedure times and thus compromises efficiency without improving efficacy.

Long-term performance of the St Jude Riata 1580-1582 ICD lead family.

OBJECTIVE: Safety concerns about the Riata ICD shock lead were recently raised, with insulation failure due to conductor externalisation. Its incidence and presentation were assessed, and predictors of insulation failure and lead survival of the Riata 1580-1582 were studied, retrospectively, before the official recall. METHODS: All 374 patients at the Erasmus Medical Center between July 2003 and December 2007 with a 1580, 1581 or 1582 shock lead. RESULTS: The majority of the patients were male (78 %), with a median age of 60 years (IQR 52-70); primary prevention in 61 %. Median follow-up was 60.3 months (IQR 35.5-73.2), with 117 (31 %) patients dying. Electrical abnormalities (mainly noise, 65 %) were observed in 20/257 patients (7.8 %). Definite conductor externalisation was confirmed with fluoroscopy or chest X-ray in 16 patients, and in one after extraction. One patient presented with a drop in the high-voltage impedance trend with a short circuit of the ICD system during defibrillation testing, and needed to be shocked externally. In 8 more patients, conductor externalisation was found during an elective procedure. No predictors of externalisation could be found, except for the use of single coil (p = 0.02). Median time to conductor externalisation was 5 years (IQR 3.1-6.2). Lead externalisation was observed in 5.4 % (95 % CI 3.1-9.3) at 5 years and 22.7 % (95 % CI 13.6-36.6) at 8 years. CONCLUSION: A high incidence of insulation defects associated with conductor externalisation in the Riata ICD lead family is observed. The mode of presentation is diverse. This type of insulation failure can lead to failure of therapy delivery.

Prevalence of anxiety and risk associated with ventricular arrhythmia in patients with an implantable cardioverter defibrillator.

BACKGROUND: Anxiety has been associated with adverse clinical outcomes in patients who have received an implantable cardioverter defibrillator (ICD). However, results are inconclusive likely due to different measures being used to assess anxiety. Hence, the current study aims to examine the prevalence and the association between anxiety, ventricular tachyarrhythmia's (VTa's) and all-cause mortality, respectively. METHODS: Patients who received an ICD for the first time were recruited from 6 Dutch referral hospitals as part of the WEBCARE trial. Patients filled in validated questionnaires (GAD-7, STAI-S, HADS-A, ANX4, ICDC, FSAS) to assess their baseline anxiety symptomatology. Logistic regression analysis and Cox Regression analysis were performed to examine the association between anxiety with 1) VTa's and 2) mortality, respectively. RESULTS: A total of 214 Patients were included in the analysis with mean age 58.9 and 82.7% being male. The prevalence rates of anxiety varied depending on which questionnaire was used 12.4% (GAD-7), 17.5% (HADS-A), and 28.1% (STAI-S). (Cox) Regression analysis revealed that none of the anxiety measures was associated with VTa's or all-cause mortality in the current sample. Stratifying the sample by gender, the analysis showed that GAD-7, STAI-S, and ANX4 scores were associated with increased risk of VTa's but only in male patients. CONCLUSIONS: Prevalence rates of anxiety varied depending on the measurement tool used. No significant association between anxiety and VTa's and all-cause mortality was observed in the total sample. GAD-7, STAI-S, and ANX4 were associated with increased risk for VTa's but only in male patients.

Personality traits, ventricular tachyarrhythmias, and mortality in patients with an implantable cardioverter defibrillator: 6 years follow-up of the WEBCARE cohort.

OBJECTIVE: Risk stratification within the ICD population warrants the examining of the role of protective- and risk factors. Current study examines the association between Type D personality, pessimism, and optimism and risk of ventricular tachyarrhythmias (VTa's) and mortality in patients with a first-time ICD 6 years post implantation. METHODS: A total of 221 first-implant ICD patients completed questionnaires on optimism and pessimism (Life Orientation Test) and Type D personality (Type D scale DS14) 10 to 14 days after implantation. VTa's and all-cause mortality 6 years post implant comprised the study endpoints. RESULTS: Ninety (40.7%) patients had experienced VTa's and 37 (16.7%) patients died, 12 (5.4%) due to a cardiac cause. Adjusted logistic regression analysis showed that pessimism was significantly associated with increased risk of VTa's (OR = 1.09; 95% CI = 1.00-1.19; p = .05). Type D personality (OR = 1.05; 95% CI = 0.47-2.32; p = .91) and optimism (OR = 1.00; 95% CI = 0.90-1.12; p = .98) were not associated with VTa's. None of the personality types were associated with mortality. CONCLUSION: Pessimism was associated with VTa's but not with mortality. No significant association with either of the endpoints was observed for Type D personality and optimism. Future research should focus on the coexistent psychosocial factors that possibly lead to adverse cardiac prognosis in this patient population.

Remote monitoring in implantable defibrillator therapy.

The major device manufacturers have introduced systems for remote patient monitoring. These remote monitoring systems promise more efficient patient management, especially in today's clinical setting with the growing number of defibrillator implantations. The aim of this article is to present the role of remote patient monitoring in implantable cardioverter-defibrillator follow-up, its potential benefits and its barriers to widespread diffusion. (Neth Heart J 2008;16:53-6.).

Hybrid pharmacological and ablative therapy for the management of symptomatic atrial fibrillation.

BACKGROUND: Hybrid therapy for atrial fibrillation class 1C and class III antiarrhythmic drugs (AAD) can convert atrial fibrillation (AF) into an isthmus-dependent atrial flutter (AFL) in more than 10% of patients. Hybrid pharmacological and ablative therapy offers a safe and effective approach to achieving and maintaining sinus rhythm. We evaluated the efficacy of this hybrid approach in the management of paroxysmal or persistent AF. METHODS: Eighteen patients with symptomatic AF treated with AAD and typical anticlockwise/clockwise AFL underwent radiofrequency (RF) ablation of AFL with an anatomical approach. RESULTS: RF ablation was successful in all patients. All but one patient continued with AAD. Four patients (22%) had recurrences of AFL. Two of them also had a recurrence of AF. Another three patients had recurrences of AF only, and finally, one patient developed an atrial tachycardia more than one year after the procedure. In conclusion, 11 patients (61%) did not experience recurrences of AF/AFL after tricuspid valve annulus (TV)-inferior caval vein (IVC) isthmus ablation with continuing antiarrhythmic drugs. CONCLUSION: Hybrid pharmacological and ablative therapy is a safe and effective treatment for the management of patients with symptomatic AF.

Electrical isolation of pulmonary veins using cryothermal energy: study design and initial results.

In the September 2003 issue of the Netherlands Heart Journal, the wrong figures where inserted in this article. The article is reprinted here with the correct figures. BACKGROUND: Atrial fibrillation (AF) is the most frequently encountered arrhythmia. Radiofrequency pulmonary vein (PV) ablation is promising for symptomatic paroxysmal AF, but is associated with a significant risk of PV stenosis. OBJECTIVES: To assess the efficacy of cryothermal PV ablation and the incidence of PV stenosis. METHODS: Highly symptomatic patients with paroxysmal or persistent AF were eligible for cryothermal ablation. Multislice spiral CT scans were performed before, and three months after ablation. AF burden was assessed using transtelephonic ECG recording and by telephone enquiry. RESULTS: An attempt was made to isolate 27 PVs in 15 patients. In total, 20 PVs could be isolated (74% acute success). No significant difference in PV diameter was seen before and after ablation. Five out of 12 patients with paroxysmal AF were completely without AF after one ablation procedure. An additional two patients reported a significant reduction in symptoms. In the three patients with persistent AF no improvement was reported. CONCLUSION: Cryothermal PV ablation was effective in isolation of the targeted PVs. It appears to be safe, as no PV stenosis was seen in this study three months after the ablation. Taking into account a learning curve, we consider the clinical results to be very promising.

Electrical isolation of pulmonary veins using cryothermal energy: study design and initial results.

BACKGROUND: Atrial fibrillation (AF) is the most frequently encountered arrhythmia. Radiofrequency pulmonary vein (PV) ablation is promising for symptomatic paroxysmal AF, but is associated with a significant risk of PV stenosis. OBJECTIVES: To assess the efficacy of cryothermal PV ablation and the incidence of PV stenosis. METHODS: Highly symptomatic patients with paroxysmal or persistent AF were eligible for cryothermal ablation. Multislice spiral CT scans were performed before, and three months after ablation. AF burden was assessed using transtelephonic ECG recording and by telephonic enquiry. RESULTS: An attempt was made to isolate 27 PVs in 15 patients. In total, 20 PVs could be isolated (74% acute success). No significant difference in PV diameter was seen before and after ablation. Five out of 12 patients with paroxysmal AF were completely without AF after one ablation procedure. An additional two patients reported a significant reduction in symptoms. In the three patients with persistent AF no improvement was reported. CONCLUSION: Cryothermal PV ablation was effective in isolation of the targeted PVs. It appears to be safe, as no PV stenosis was seen in this study three months after the ablation. Taking into account a learning curve, we consider the clinical results to be very promising.

Clinical benefit, survival and adverse events in patients with implantable cardioverter defibrillators: the initial Rotterdam experience.

BACKGROUND: The implantable cardioverter defibrillator (ICD) has become a widely accepted therapy for patients with severe life-threatening ventricular tachyarrhythmias. The aim of this study was to illustrate the possible advantages of ICDs with respect to survival and clinical events. METHODS AND RESULTS: Between 1998 and 2000, 92 patients (aged 58±15 years; ejection fraction 36±15%; coronary artery disease 71%) were treated with an ICD in combination with an endocardial lead system. Benefit of the ICD was estimated as the difference between total cardiac death and the projected death rate of fast ventricular tachyarrhythmias (>200 bpm), assuming that most fast ventricular tachyarrhythmias would have been fatal without termination by the ICD. Adverse events were classified according to European standards. The cardiac mortality rate was 5.5% and 9.8%, at one and two years respectively. The recurrence rate of fast VT (>200 bpm) was 22.4% and 30.2%, at one and two years respectively. The observed difference between cardiac death and projected death was very significant (p=0.002) and suggests a clear benefit from ICD implantation. Low ejection fraction (<35%) and NYHA class ≥II correlated with a higher projected death. The most common adverse event was inappropriate therapy (18%). CONCLUSION: The results from our small series support the existing data that especially patients with poor ejection fraction (<35%) benefit from ICD implantation. The adverse event rate was low. However, inappropriate therapy remains a matter of concern. Given the high workload of correct screening and follow-up, we expect that the actual number of centres in the Netherlands permitted to implant ICDs will be unable to cope with the widening spectrum of ICD indications.

Use of remote monitoring in the management of system-related complications in implantable defibrillator patients.

Remote monitoring of implantable defibrillators (ICDs) is designed to minimise regular follow-up visits and to facilitate early detection of adverse events. With the increased rate of ICD implantations in today's clinical setting and multiple device advisories, which pose management challenges, this approach becomes very attractive. The aim of this article is to present the role of remote monitoring in the detection of system-related complications, its potential benefits and its barriers in the outpatient management of ICD patients.

Adenosine testing after cryoballoon pulmonary vein isolation improves long-term clinical outcome.

BACKGROUND: Adenosine infusion after pulmonary vein isolation (PVI) with radiofrequency energy reveals dormant muscular sleeves and predicts atrial fibrillation (AF) recurrence. The aim of our study was to determine whether adenosine could reveal dormant PV sleeves after cryoballoon isolation and study its effect on long-term recurrence of AF. METHODS: Patients with paroxysmal AF underwent cryoballoon PVI. After PVI, adenosine 25 mg was infused to test for dormant muscular sleeves in each vein. If reconnection under adenosine was shown, further cryoballoon ablation was performed until no more reconnection occurred. Follow-up was performed with ECG, 24-h Holter recording, and a symptom questionnaire at three monthly intervals. Transtelephonic Holter monitoring was performed for 1 month before and 3 months after PVI. Patients who underwent cryoballoon PVI without adenosine administration were used as controls for comparison. RESULTS: In the study group (n = 34, 24 males), adenosine revealed dormant sleeves in 9/132 (8 %) veins, and 7/34 (21 %) patients. All but one vein was further treated until the dormant sleeves were isolated. During a mean follow-up of 520 ± 147 days, 23/34 (68 %) patients were free of AF without antiarrhythmic drugs (AADs). In the control group (n = 65, 46 males), 29/65 (46 %) were free of AF without AADs. There were significantly less AF recurrences in the study group (p = 0.04). CONCLUSIONS: Adenosine administration after cryoballoon PVI reveals dormant muscular sleeves in 21 % of patients. Clinical follow-up shows that adenosine testing is effective in reducing AF recurrence after cryoballoon ablation.

Remote monitoring and follow-up of cardiovascular implantable electronic devices in the Netherlands : An expert consensus report of the Netherlands Society of Cardiology.

Remote monitoring of cardiac implanted electronic devices (CIED: pacemaker, cardiac resynchronisation therapy device and implantable cardioverter defibrillator) has been developed for technical control and follow-up using transtelephonic data transmission. In addition, automatic or patient-triggered alerts are sent to the cardiologist or allied professional who can respond if necessary with various interventions. The advantage of remote monitoring appears obvious in impending CIED failures and suspected symptoms but is less likely in routine follow-up of CIED. For this follow-up the indications, quality of care, cost-effectiveneness and patient satisfaction have to be determined before remote CIED monitoring can be applied in daily practice. Nevertheless remote CIED monitoring is expanding rapidly in the Netherlands without professional agreements about methodology, responsibilities of all the parties involved and that of the device patient, and reimbursement. The purpose of this consensus document on remote CIED monitoring and follow-up is to lay the base for a nationwide, uniform implementation in the Netherlands. This report describes the technical communication, current indications, benefits and limitations of remote CIED monitoring and follow-up, the role of the patient and device manufacturer, and costs and reimbursement. The view of cardiology experts and of other disciplines in conjunction with literature was incorporated in a preliminary series of recommendations. In addition, an overview of the questions related to remote CIED monitoring that need to be answered is given. This consensus document can be used for future guidelines for the Dutch profession.

Health care utilisation after defibrillator implantation for primary prevention according to the guidelines in 2 Dutch academic medical centres.

BACKGROUND: The benefit of implantable defibrillators (ICDs) for primary prevention remains debated. We analysed the implications of prophylactic ICD implantation according to the guidelines in 2 tertiary hospitals, and made a healthcare utilisation inventory. METHODS: The cohort consisted of all consecutive patients with coronary artery disease (CAD) or dilated cardiomyopathy (DCM) receiving a primary prophylactic ICD in a contemporary setting (2004-2008). Follow-up was obtained from hospital databases, and mortality checked at the civil registry. Additional data came from questionnaires sent to general practitioners. RESULTS: There were no demographic differences between the 2 centres; one had proportionally more CAD patients and more resynchronisation therapy (CRT-D). The 587 patients were followed over a median of 28 months, and 50 (8.5%) patients died. Appropriate ICD intervention occurred in 123 patients (21%). There was a small difference in intervention-free survival between the 2 centres. The questionnaires revealed 338 hospital admissions in 52% of the responders. Device-related admissions happened on 68 occasions, in 49/276 responders. The most frequently reported ICD-related admission was due to shocks (20/49 patients); for other cardiac problems it was mainly heart failure (52/99). Additional outpatient visits occurred in 19%. CONCLUSION: Over a median follow-up of 2 years, one fifth of prophylactic ICD patients receive appropriate interventions. A substantial group undergoes readmission and additional visits. The high number of admissions points to a very ill population. Overall mortality was 8.5%. The 2 centres employed a similar procedure with respect to patient selection. One centre used more CRT-D, and observed more appropriate ICD interventions.

The role of remote monitoring in the reduction of inappropriate implantable cardioverter defibrillator therapies.

Implantable cardioverter defibrillators (ICDs) with the integrated Home Monitoring feature use dedicated mobile phone and internet links to provide the physicians and technicians in the ICD clinic with the essential device- and arrhythmia-related data stored in the ICD diagnostic memory. Various counters, graphs and intracardiac electrograms are automatically transmitted via Home Monitoring each day to allow prompt, remote presentation of arrhythmias or detection of technical problems. One of the most inconvenient side-effects of the ICD therapy is inappropriate intervention of the device. Home Monitoring data can help the physician to identify and subsequently reduce the incidence of inappropriate ICD therapy.