Trial‐generated profiles for implantation of electrical devices in outpatients with heart failure: real‐world prevalence and 1‐year outcome

Boriani, Giuseppe; Rapezzi, Claudio; Diemberger, Igor; Gonzini, Lucio; Gorini, Marco; Lucci, Donata; Sinagra, Gianfranco; Cooke, Robin M. T.; Pasquale, Giuseppe Di; Tavazzi, Luigi; Maggioni, Aldo P.

doi:10.1111/j.1365-2753.2008.01118.x

Cited by 9 publications

(6 citation statements)

References 21 publications

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“…This is in accordance to the current approach proposed for a comprehensive validation of effective impact of innovative therapies, based on combination of high quality clinical trials and prospective registries [6]. Either the potentially worse outcome of patients with a profile similar to that of controlled trials but not selected according to trial’s exclusion criteria [7], or the need to verify how treatments affect patient’s outcomes when applied in an unselected context, are at the basis of current interest on prospective registries [6]. …”

Section: Discussionsupporting

confidence: 76%

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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

Boriani

Botto

Lunati

et al. 2012

BMC Cardiovasc Disord

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BackgroundA multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to assess 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.Methods643 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.ResultsThe 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).ConclusionsPatients 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.

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Section: Discussionsupporting

confidence: 76%

“…Nowadays there is increasing interest on two important issues: first, assessment of therapy in routine clinical practice [6,7] and second, identification of subgroups of patients with a higher chance of getting benefit from ICD therapy [8,9] or at the opposite with poor prognosis after myocardial infarction [10]. …”

Section: Introductionmentioning

confidence: 99%

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

Boriani

Botto

Lunati

et al. 2012

BMC Cardiovasc Disord

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“…The Italian Network on Congestive Heart Failure registry provides the most representative unselected "realworld" patients with HF. 15 Overall, 7% of 4,977 patients enrolled from 1995 and 2000 fulfilled historical criteria, excluding those with atrial arrhythmia and bradycardia pacing. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF) prospectively examined the records of patients with systolic HF or previous myocardial infarctions and LVEFs 35% across the United States, 16,18 of whom 8.9% (1,373 of 15,381) were eligible for CRT on the basis of NYHA class III or IV and QRSd !120 ms. 16 However, more than half the denominator was excluded because of missing QRSd or NYHA class.…”

Section: Resultsmentioning

confidence: 99%

Review of Eligibility for Cardiac Resynchronization Therapy

Hawkins

Bennett

Andrade

et al. 2015

The American Journal of Cardiology

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“…29 This is consistent with the findings in our study in which the estimated utilization rate was 16% and mortality in the no-ICD group was 18% at 2 years versus 10% in the ICD group. In a study from the Italian Network on CHF, Boriani et al 31 found that approximately half of the patients fulfilled criteria for primary prevention ICDs. The 1-year mortality in this group was higher when compared with the control population of the clinical trials supporting the notion that the real-world population is different from those entering clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Use of Primary Prevention Implantable Cardioverter-Defibrillators in a Population-Based Cohort Is Associated With a Significant Survival Benefit

Parkash

Sapp

Basta

et al. 2012

Circ: Arrhythmia and Electrophysiology

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Background— Underuse of implantable defibrillators has been previously noted in patients at risk for sudden cardiac death, as well as for survivors of sudden cardiac death. We sought to determine the utilization rates in a primary prevention implantable cardioverter-defibrillator (ICD)–eligible population and mortality in this group compared with a group that had undergone implantation of this therapy. Methods and Results— A retrospective cohort of patients from April 1, 2006, to December 31, 2009, was used to define a primary prevention ICD-eligible population. Two groups were compared on the basis of ICD implantation (no-ICD versus ICD). The primary outcome measure was mortality. Of the 717 patients found to be potentially eligible for a primary prevention ICD, 116 (16%) were referred. The remaining cohort of 601 patients were compared with an existing cohort of primary prevention ICD patients (n=290). A significant survival benefit was associated with primary prevention ICD implantation (hazard ratio, 0.46; 95% CI [0.33–0.64]; P <0.0001). When adjusted for prespecified variables known to be associated with overall mortality and propensity score, a similar survival benefit was seen (hazard ratio, 0.59; 95% CI [0.40–0.87]; P =0.01). Appropriate ICD therapy occurred in 26% of those in the ICD group, during a mean follow-up of 2.7 years. Conclusions— A significant mortality benefit was observed for patients who underwent primary prevention ICD implantation compared with those who did not. Vigilance is required to ensure that patients eligible for primary prevention ICDs are appropriately referred and assessed to allow such patients to benefit from this life-saving therapy.

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Trial‐generated profiles for implantation of electrical devices in outpatients with heart failure: real‐world prevalence and 1‐year outcome

Abstract: As many as half the IN-CHF outpatients fulfilled current criteria for device implantation. Various subgroups had higher 1-year mortality than patients in trial control arms - a finding that may not be entirely attributable to differences in drug therapy (especially beta blockers).

Cited by 9 publications

References 21 publications

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

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

Review of Eligibility for Cardiac Resynchronization Therapy

Use of Primary Prevention Implantable Cardioverter-Defibrillators in a Population-Based Cohort Is Associated With a Significant Survival Benefit

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