Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

Lee, Douglas S.; Hardy, Judy; Yee, Raymond; Healey, Jeffrey S.; Birnie, David H.; Simpson, Christopher S.; Crystal, Eugene; Mangat, Iqwal; Nanthakumar, Kumaraswamy; Wang, Xuesong; Krahn, Andrew D.; Dorian, Paul; Austin, Peter C.; Tu, Jack V.

doi:10.1161/circheartfailure.115.002414

Cited by 54 publications

(63 citation statements)

References 36 publications

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“…Nevertheless, therapy rates in our cohort are comparable to those reported in recent observational studies in Canada, Europe, and the United States 30, 31, 32, 33. In the OMNI (Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices) study, for example, 25% received an appropriate therapy over a mean of 39 months compared with 20% over 27 months in the LS‐ICD 33.…”

Section: Discussionsupporting

confidence: 83%

Device Therapies Among Patients Receiving Primary Prevention Implantable Cardioverter‐Defibrillators in the Cardiovascular Research Network

Greenlee

Peterson

et al. 2018

JAHA

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BackgroundPrimary prevention implantable cardioverter‐defibrillators (ICDs) reduce mortality in selected patients with left ventricular systolic dysfunction by delivering therapies (antitachycardia pacing or shocks) to terminate potentially lethal arrhythmias; inappropriate therapies also occur. We assessed device therapies among adults receiving primary prevention ICDs in 7 healthcare systems.Methods and ResultsWe linked medical record data, adjudicated device therapies, and the National Cardiovascular Data Registry ICD Registry. Survival analysis evaluated therapy probability and predictors after ICD implant from 2006 to 2009, with attention to Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups: left ventricular ejection fraction, 31% to 35%; nonischemic cardiomyopathy <9 months’ duration; and New York Heart Association class IV heart failure with cardiac resynchronization therapy defibrillator. Among 2540 patients, 35% were <65 years old, 26% were women, and 59% were white. During 27 (median) months, 738 (29%) received ≥1 therapy. Three‐year therapy risk was 36% (appropriate, 24%; inappropriate, 12%). Appropriate therapy was more common in men (adjusted hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.43–2.35). Inappropriate therapy was more common in patients with atrial fibrillation (adjusted HR, 2.20; 95% CI, 1.68–2.87), but less common among patients ≥65 years old versus younger (adjusted HR, 0.72; 95% CI, 0.54–0.95) and in recent implants (eg, in 2009 versus 2006; adjusted HR, 0.66; 95% CI, 0.46–0.95). In Centers for Medicare and Medicaid Services Coverage With Evidence Development analysis, inappropriate therapy was less common with cardiac resynchronization therapy defibrillator versus single chamber (adjusted HR, 0.55; 95% CI, 0.36–0.84); therapy risk did not otherwise differ for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups.ConclusionsIn this community cohort of primary prevention patients receiving ICD, therapy delivery varied across demographic and clinical characteristics, but did not differ meaningfully for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups.

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Section: Discussionsupporting

confidence: 83%

Device Therapies Among Patients Receiving Primary Prevention Implantable Cardioverter‐Defibrillators in the Cardiovascular Research Network

Greenlee

Peterson

et al. 2018

JAHA

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“…The negative impact on mortality of ventricular tachycardia or ventricular fibrillation needing shocks has been consistently seen in different primary prevention clinical trials . Studies to define predictors of shocks and mortality have been done in primary prevention patients with aims to shift clinicians’ focus toward mitigating such risks . Although it has been consistently demonstrated that secondary prevention patients have higher incidence of shocks, there is not a large amount of comparative data with primary prevention patients’ outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Programming strategies for primary prevention patients were not standardized in the implanting centers, but previous reports of our group have shown that the shocks and ATP incidence rates were similar to the contemporary studies with delayed detection therapy groups, so an impact on mortality risk based on this is very unlikely. The score used to control for baseline differences was designed and validated on a sample derived from a primary prevention cohort and was extended to the secondary prevention sample in the analysis . Our analysis was focused on assessing outcome after a single ICD shock or ATP and did not evaluate multiple shocks or ATPs.…”

Section: Discussionmentioning

confidence: 99%

“…According to the design of the Ontario ICD Database, only the first appropriate ATP was recorded, and ATPs were not recorded if there was a preceding appropriate ICD shock. We included the following covariates in the model: implant indication (primary versus secondary), left ventricular ejection fraction, and the individual components of a validated mortality prediction score for ICD patients that we previously published (age, ischemic heart disease, previous revascularization procedure, previous heart failure hospitalization, New York Heart Association status III–IV, pre‐existing permanent pacemaker system, systolic blood pressure, diabetes mellitus, smoker, chronic obstructive lung disease, home oxygen therapy, cancer, angiotensin‐converting enzyme inhibitor or angiotensin receptor blocker treatment, creatinine, serum sodium, and hemoglobin) . To examine whether the risk of death differed between primary and secondary prevention ICD patients, we added an interaction term between the occurrence of appropriate ICD therapy (shock or ATP) and implant indication.…”

Section: Methodsmentioning

confidence: 99%

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Mortality Implications of Appropriate Implantable Cardioverter Defibrillator Therapy in Secondary Prevention Patients: Contrasting Mortality in Primary Prevention Patients From a Prospective Population‐Based Registry

Almehmadi

Porta‐Sánchez

et al. 2017

JAHA

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BackgroundWe sought to examine the mortality impact of appropriate implantable cardioverter defibrillator (ICD) therapy between patients who received ICD for primary versus secondary prevention purposes.Methods and ResultsFrom a prospective, population‐based registry, we identified 7020 patients who underwent de novo ICD implantation between February 2007 and May 2012 in Ontario, Canada. The primary outcome was all‐cause mortality. We used multivariable Cox proportional hazard modeling to adjust for differences in baseline characteristics and analyzed the mortality impact of first appropriate ICD therapy (shock and antitachycardia pacing [ATP]) as a time‐varying covariate. There were 1929 (27.5%) patients who received ICDs for secondary prevention purposes. The median follow‐up period was 5.02 years. Compared with those with secondary prevention ICDs, patients with primary prevention ICDs had more medical comorbidities, and lower ejection fraction. Patients who experienced appropriate ICD shock or ATP had greater risk of death compared with those who did not, irrespective of implant indication. In the primary prevention group, the adjusted hazard ratios of death for appropriate shock and ATP were 2.00 (95% CI: 1.72–2.33) and 1.73 (95% CI: 1.52–1.97), respectively. In the secondary prevention group, the adjusted hazard ratios of death for appropriate ICD shock and ATP were 1.46 (95% CI: 1.20–1.77) and 1.38 (95% CI: 1.16–1.64), respectively.ConclusionsDespite having a more favorable clinical profile, occurrence of appropriate ICD shock or ATP in patients with secondary prevention ICDs was associated with similar magnitudes of mortality risk as those with primary prevention ICDs. A heightened degree of care is warranted for all patients who experience appropriate ICD shock or ATP therapy.

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“…34 Using multivariable regression statistics of the primary endpoint, we will be able to calculate an adequately powered hazard ratio of the ICD survival effect (as the primary measure of ICD benefit) in the overall cohort and predefined subgroups. 50,57,59,60 Cost-effectiveness in the overall trial population and in subgroups and the variation in EU countries can be analysed. Concerning these outcomes, the results will be able to confirm known independent risk factors and possibly detect new ones.…”

Section: Discussionmentioning

confidence: 99%

Rationale and design of the EU‐CERT‐ICD prospective study: comparative effectiveness of prophylactic ICD implantation

et al. 2018

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AimsThe clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU‐CERT‐ICD) aims to assess its current clinical value.Methods and resultsThe EU‐CERT‐ICD is a prospective investigator‐initiated non‐randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non‐randomized control group). The primary endpoint is all‐cause mortality; the co‐primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost‐effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12‐lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years.ConclusionsThe EU‐CERT‐ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.

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Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

Abstract: Supplemental Digital Content is available in the text.

Cited by 54 publications

References 36 publications

Device Therapies Among Patients Receiving Primary Prevention Implantable Cardioverter‐Defibrillators in the Cardiovascular Research Network

Device Therapies Among Patients Receiving Primary Prevention Implantable Cardioverter‐Defibrillators in the Cardiovascular Research Network

Mortality Implications of Appropriate Implantable Cardioverter Defibrillator Therapy in Secondary Prevention Patients: Contrasting Mortality in Primary Prevention Patients From a Prospective Population‐Based Registry

Rationale and design of the EU‐CERT‐ICD prospective study: comparative effectiveness of prophylactic ICD implantation

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