Abstract Background Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The ...subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both device types in previous studies was hampered by dissimilar patient characteristics. Objectives This retrospective study compares long-term clinical outcomes of S-ICD and TV-ICD therapy in a propensity-matched cohort. Methods The authors analyzed 1,160 patients who underwent S-ICD or TV-ICD implantation in 2 high-volume hospitals in the Netherlands. Propensity matching for 16 baseline characteristics, including diagnosis, yielded 140 matched pairs. Clinical outcomes were device-related complications requiring surgical intervention, appropriate and inappropriate ICD therapy, and were reported as 5-year Kaplan-Meier rate estimates. Results All 16 baseline characteristics were balanced in the matched cohort of 140 patients with S-ICDs and 140 patients with TV-ICDs (median age 41 years interquartile range: 30 to 52 years and 40% women). The complication rate was 13.7% in the S-ICD group versus 18.0% in the TV-ICD group (p = 0.80). The infection rate was 4.1% versus 3.6% in the TV-ICD groups (p = 0.36). Lead complications were lower in the S-ICD arm compared with the TV-ICD arm, 0.8% versus 11.5%, respectively (p = 0.03). S-ICD patients had more nonlead-related complications than TV-ICD patients, 9.9% versus 2.2%, respectively (p = 0.047). Appropriate ICD intervention (antitachycardia pacing and shocks) occurred more often in the TV-ICD group (hazard ratio HR: 2.42; p = 0.01). The incidence of appropriate (TV-ICD HR: 1.46; p = 0.36) and inappropriate shocks (TV-ICD HR: 0.85; p = 0.64) was similar. Conclusions The complication rate in patients implanted with an S-ICD or TV-ICD was similar, but their nature differed. The S-ICD reduced lead-related complications significantly, at the cost of nonlead-related complications. Rates of appropriate and inappropriate shocks were similar between the 2 groups.
Large randomized trials demonstrated the beneficial effect of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) treatments in selected patients. ...Data on long-term follow-up of patients outside the setting of clinical trials are scarce.
The aim of this study was to evaluate the long-term outcome of ICD and CRT-D recipients.
All patients who underwent ICD (n = 1729 57%) or CRT-D (n = 1326 43%) implantation at the Leiden University Medical Center since 1996 were evaluated. Follow-up visits were performed every 3-6 months, and events were registered. Cumulative incidence curves of device therapy and device-related complications were adjusted for the competing risk of all-cause mortality.
After a median follow-up of 5.1 years (25th-75th percentile 3.1-7.8 years), 842 patients (28%) died. The cumulative incidence of all-cause mortality was 49% (95% confidence interval CI 45%-54%) in ICD recipients after 12 years of follow-up and 55% (95% CI 52%-58%) in CRT-D recipients after 8 years of follow-up. A total of 1081 patients (35%) received appropriate defibrillator therapy. The cumulative incidence of appropriate therapy in ICD patients was 58% (95% CI 54%-62%) after 12 years of follow-up and 39% (95% CI 35%-43%) in CRT-D patients after 8 years of follow-up. Twelve-year cumulative incidences of adverse events were 20% (95% CI 18%-22%) for inappropriate shock, 6% (95% CI 5%-8%) for device-related infection, and 17% (95% CI 14%-21%) for lead failure.
After long-term follow-up of ICD (12 years) and CRT-D (8 years) recipients, 49% of ICD recipients and 55% of CRT-D recipients had died. Appropriate ICD therapy was received by the majority (58%) of ICD recipients and by almost 40% of CRT-D recipients.
Intrathoracic impedance measurement has been introduced in the InSync Sentry biventricular implantable cardioverter-defibrillator and may permit the early identification of pulmonary fluid ...accumulation secondary to left-sided heart failure (HF). An audible alarm (the OptiVol alert) can be triggered when the impedance index increases to greater than a predefined level of 60 Ω · day. The aim of this study was to evaluate the clinical value of the OptiVol alert and its prediction for decompensated HF. One hundred fifteen consecutive patients (mean New York Heart Association class 2.8 ± 0.5, mean left ventricular ejection fraction 26 ± 8%) who received InSync Sentry biventricular implantable cardioverter-defibrillators were included. When presenting with the OptiVol alert, current hemodynamic status was evaluated. During follow-up (mean 9 ± 5 months), there were 45 presentations with the OptiVol alert in 30 patients. Clinical signs and symptoms of HF were present in only 15 patients (33%), whereas in the remaining patients, clinical signs of HF were absent (p <0.05). Receiver-operating characteristic curve analysis showed that increasing the threshold for the OptiVol alert provided a substantial increase in specificity for the detection of HF, with the optimal cut-off value identified at 120 Ω · day, yielding sensitivity of 60% and specificity of 73%. In conclusion, intrathoracic impedance measurement as present in the InSync Sentry biventricular implantable cardioverter-defibrillator may be a useful tool for monitoring pulmonary fluid status. The proposed threshold for the OptiVol alert of 60 Ω · day is very sensitive but not specific for the assessment of HF; adjustment of threshold settings may yield a superior balance between sensitivity and specificity.
Objectives The purpose of this study was to evaluate the impact of upgrading implantable cardioverter-defibrillator (ICD) therapy to cardiac resynchronization therapy (CRT) combined with ...defibrillator (CRT-D) on the occurrence of ventricular arrhythmia (VA) and appropriate ICD therapies. Background CRT has been shown to improve left ventricular (LV) systolic function and induce reverse LV remodeling. In addition, it has been hypothesized that CRT may reduce the incidence of VA. Methods Heart failure patients receiving an upgrade from ICD to CRT-D were evaluated. Patients were considered responders to CRT if LV end-systolic volume reduced ≥15% at 6 months of follow-up. Episodes of VA, triggering device therapy (anti-tachycardia pacing and shocks) were recorded before and after upgrade for the overall population. In addition, these outcomes were compared between CRT responders and nonresponders during the follow-up period after CRT response was assessed. Results One hundred fifteen patients (93 males 81%, age 65 ± 12 years) were evaluated during a mean follow-up of 54 ± 34 months before CRT-D upgrade and 37 ± 27 months after upgrade. In CRT responders (n = 70), the frequency of VA requiring appropriate device therapy demonstrated a trend toward a decrease from 0.51 ± 0.79 to 0.30 ± 0.59 per patient per year after CRT-D upgrade (p = 0.052). In CRT nonresponders (n = 45), the frequency of VA requiring appropriate device therapy significantly increased from 0.40 ± 0.69 to 1.21 ± 2.53 per patient per year after CRT-D upgrade (p = 0.014). Conclusions After upgrade from ICD to CRT-D, nonresponders to CRT showed a significant increase in VA burden requiring appropriate device therapy.
Cardiac device infections (CDIs) are a serious complication associated with the implantation of cardiac rhythm devices. However, the effect of CDI on the subsequent risk of mortality is unknown.
To ...assess the prognostic importance of CDI in recipients of implantable cardioverter-defibrillator and cardiac resynchronization therapy - defibrillator.
All patients who received their initial implantable cardioverter-defibrillator/cardiac resynchronization therapy - defibrillator between January 2000 and September 2009 were included. During follow-up, the occurrence of CDI and all-cause mortality were noted. The prognostic importance of the first CDI on mortality was assessed by modeling CDI as a time-dependent covariate in the Cox proportional hazards model.
A total of 2476 patients (79% men; mean age 62 ± 13 years) were included in this analysis. During follow-up, CDI occurred in 64 (2.6%) patients. The 1-year mortality following first CDI was 16.9% (95% confidence interval 6.7%-27.1%). Experiencing the first CDI was associated with a 1.9-fold (hazard ratio 1.87; 95% confidence interval 1.07-3.26) increased risk of mortality compared to patients who did not experience CDI. After controlling for possible confounders, this increased to a 2.4-fold (hazard ratio 2.40; 95% confidence interval 1.35-4.28) increased risk of mortality.
In a large cohort of patients who receive implantable cardioverter-defibrillator/cardiac resynchronization therapy - defibrillator after their initial implant, the 3-year incidence of CDI was 2.6%. The occurrence of CDI was associated with substantial 1-year mortality, and patients experiencing CDI had a more than 2-fold increased risk of mortality compared with patients who remained free from CDI.
Objectives This study aimed to assess the prevalence of different types of atrial fibrillation (AF) and their prognostic importance in implantable cardioverter-defibrillator (ICD) patients. ...Background The prevalence of AF has taken epidemic proportions in the population with cardiovascular disease. The prognostic importance of different types of AF in ICD patients remains unclear. Methods Data on 913 consecutive patients (79% men, mean age 62 ± 13 years) receiving an ICD at the Leiden University Medical Center were prospectively collected. Among other characteristics, the existence and type of AF (paroxysmal, persistent, or permanent) were assessed at implantation. During follow-up, the occurrence of appropriate or inappropriate device therapy as well as mortality was noted. Results At implantation, 73% of patients had no history of AF, 9% had a history of paroxysmal AF, 7% had a history of persistent AF, and 11% had permanent AF. During 833 ± 394 days of follow-up, 117 (13%) patients died, 228 (25%) patients experienced appropriate device discharge, and 139 (15%) patients received inappropriate shocks. Patients with permanent AF exhibited more than double the risk of mortality, ventricular arrhythmias triggering device discharge, and inappropriate device therapy. Patients with paroxysmal or persistent AF did not show a significant increased risk of mortality or appropriate device therapy but demonstrated almost 3 times the risk of inappropriate device therapy. Conclusions In the population currently receiving ICD treatment outside the setting of clinical trials, a large portion has either a history of AF or permanent AF. Both types of AF have prognostic implications for mortality and appropriate as well as inappropriate device discharge.
Abstract Super-response to cardiac resynchronization therapy CRT is associated with significant left ventricular LV reverse remodelling and improved clinical outcome. The study aimed to: 1) to ...evaluate whether LV reverse remodelling remains sustained during long-term follow-up in super-responders and, 2) analyse the association between the course of LV reverse remodelling and ventricular arrhythmias. Of all primary prevention super-responders to CRT were selected. Super-response was defined as LV end systolic volume LVESV reduction of ≥30% 6 months after device implantation. Cox regression analysis was performed to investigate the association of LV ejection fraction LVEF as time-dependent variable with ICD therapy and mortality. A total of 171 super-responders to CRT-D were included (mean age 67±9 years; 66% male; 37% ischemic heart disease). Here of 129 patients received at least 1 echocardiographic evaluation after a median follow-up of 62 months (25th – 75th percentile 38 - 87). LV end-diastolic volume LVEDV, LVESV and LVEF after 6 months follow-up were comparable with those after 62 months follow-up (respectively p=0.90; p=0.37; p=0.55). Changes in LVEF during follow-up in super-responders were independently associated with appropriate ICD therapy (HR 0.94 95%CI 0.90-0.98 p=0.005) and all-cause mortality (HR 0.95 95%CI 0.91-1.00 p=0.04). A 5% increase in LVEF was associated with a 1.37 times lower risk of appropriate ICD therapy and a 1.30 times lower risk of mortality. In conclusion, LV reverse remodelling in super-responders to CRT remains sustained during long-term follow-up. Changes in LVEF during follow-up were associated with mortality and ICD therapy.
One of the major drawbacks of implantable cardioverter-defibrillator (ICD) treatment is the limited device service life. Thus far, data concerning ICD longevity under clinical circumstances are ...scarce. In this study, the ICD service life was assessed in a large cohort of ICD recipients.
To assess the battery longevity of ICDs under clinical circumstances.
All patients receiving an ICD in the Leiden University Medical Center were included in the analysis. During prospectively recorded follow-up visits, reasons for ICD replacement were assessed and categorized as battery depletion and non-battery depletion. Device longevity and battery longevity were calculated. The impact of device type, generation, manufacturer, the percentage of pacing, the pacing output, and the number of shocks on the battery longevity was assessed.
Since 1996, 4673 ICDs were implanted, of which 1479 ICDs (33%) were replaced. Mean device longevity was 5.0 ± 0.1 years. A total of 1072 (72%) ICDs were replaced because of battery depletion. Mean battery longevity of an ICD was 5.5 ± 0.1 years. When divided into different types, mean battery longevity was 5.5 ± 0.2 years for single-chamber ICDs, 5.8 ± 0.1 for dual-chamber ICDs, and 4.7 ± 0.1 years for cardiac resynchronization therapy-defibrillators (P <.001). Devices implanted after 2002 had a significantly better battery longevity as compared with devices implanted before 2002 (5.6 ± 0.1 years vs 4.9 ± 0.2 years; P <.001). In addition, large differences in battery longevity between manufacturers were noted (overall log-rank test, P <.001).
The majority of ICDs were replaced because of battery depletion. Large differences in longevity exist between different ICD types and manufacturers. Modern ICD generations demonstrated improved longevity.
Transvenous left ventricular (LV) lead placement for cardiac resynchronization therapy-defibrillator (CRT-D) delivery is unsuccessful in 8% to 10% of cases. These patients might benefit from an ...epicardial lead. However, data on long-term epicardial lead performance are scarce. Furthermore, extracting an epicardial lead requires a rethoracotomy.
The purpose of this study was to determine data on almost a decade of experience with epicardial leads and investigate the safety of partially leaving this lead in place after device infection.
All adult patients receiving an epicardial lead (Medtronic CapSure Epi, model 4968) for CRT-D in the Leiden University Medical Center were included. Leads were implanted during a standalone procedure or in combination with other cardiothoracic procedures. Electrical lead parameters were assessed at implantation and every 6 months thereafter. In case of device infection the epicardial lead was cut off parasternal, just outside the thoracic cavity, leaving the distal part of the lead in place.
Two-hundred sixteen patients were included with a median follow-up of 3 years (25th-75th percentile 1.0-5.5). LV pacing threshold decreased within 6 months after implantation 1.1 V (95% confidence interval CI 0.9-1.2) vs 0.8 V (95% CI 0.7-0.9), P = .01 and stabilized thereafter. Mean LV electrogram was 15.2 ± 7.5 mV, and average lead impedance was 633.5 ± 174.0 Ω. Five-year cumulative incidence was 1.6% for lead failure and 9.6% for device infection. The retained epicardial lead caused skin erosion in 3 patients and fistula formation in 1.
This study demonstrates that epicardial LV leads have an excellent long-term performance. Partially retaining the lead after device infection was associated with a risk of reinfection with limited long-term clinical implications for the patient.
Although data on the mode of death of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) patients have been examined in randomized clinical ...trials, in routine clinical practice data are scarce. To provide reasonable expectations and prognosis for patients and physicians, this study assessed the mode of death in routine clinical practice.
To assess the mode of death in ICD/CRT-D recipients in routine clinical practice.
All patients who underwent an ICD or CRT-D implantation at the Leiden University Medical Center, the Netherlands, between 1996 and 2010 were included. Patients were divided into primary prevention ICD, secondary prevention ICD, and CRT-D patients. For patients who died during follow-up, the mode of death was retrieved from hospital and general practitioner records and categorized according to a predetermined classification: heart failure death, other cardiac death, sudden death, noncardiac death, and unknown death.
A total of 2859 patients were included in the analysis. During a median follow-up of 3.4 years (interquartile range 1.7-5.7 years), 107 (14%) primary prevention ICD, 253 (28%) secondary prevention ICD, and 302 (25%) CRT-D recipients died. The 8-year cumulative incidence of all-cause mortality was 39.9% (95% confidence interval 37.0%-42.9%). Heart failure death and noncardiac death were the most common modes of death for all groups. Sudden death accounted for approximately 7%-8% of all deaths.
For all patients, heart failure and noncardiac death are the most common modes of death. The proportion of patients who died suddenly was low and comparable for primary and secondary ICD and CRT-D patients.
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