Use of implantable cardioverter-defibrillators for primary prevention in older patients: A systematic literature review and meta-analysis

Background: Randomized clinical trials (RCTs) have demonstrated the efficacy of implantable cardioverter-defibrillators (ICDs) in reducing sudden cardiac death (SCD) in specific patient populations. However, patients ≥ 65 years were under-represented in these trials and the overall benefit of ICDs may be diminished in older patients due to competing risks for death. We evaluate the published data on ICD efficacy at reducing all-cause mortality in patients ≥ 65 years and in patients ≥ 75 years. Methods: We searched MEDLINE to identify RCTs and observational studies of ICDs that provided age-based outcome data for primary prevention of SCD. The primary endpoint was mortality evaluated by a meta-analysis of the RCTs using a random-effects model. Secondary endpoints included operative mortality, long-term complications and quality of life. Results: The enrollment of patients ≥ 65 years in RCTs was limited (range: 33% in DEFINITE to 56% in MUSTT). Combining data from four RCTs (n = 3,562) revealed that primary prevention ICD therapy is efficacious in reducing all-cause mortality in patients ≥ 65 years (HR 0.66; 95% CI 0.50–0.87; test of heterogeneity: X2 = 5.26; p = 0.15). For patients ≥ 75 years, combining data from four RCTs (n = 579) revealed that primary prevention ICD therapy remains efficacious in reducing all-cause mortality (HR 0.73; 95% CI 0.51–0.974; p = 0.03). There appears to be no difference in ICD-related, operative, in-hospital, or long- -term complications among older patients compared to younger patients, although it remains unclear if older patients have a better quality of life with an ICD than younger patients. Conclusions: Although the overall evidence regarding ICD efficacy in patients ≥ 65 years is limited and divergent, and the evidence available for patients ≥ 75 years is even more sparse, our meta-analysis suggests that primary prevention ICDs may be beneficial in older patients. Our findings need to be validated by future studies, particularly ones examining ICD complications and quality of life. (Cardiol J 2011; 18, 5: 503–514

Applying Patient-Reported Outcome Methodology to Capture Patient-Reported Health Data: Report From an NIH Collaboratory Roundtable

Patient-reported health data provide information for pragmatic clinical trials that may not be readily available from electronic health records or administrative claims data. In this report, we present key considerations for collecting patient-reported health information in pragmatic clinical trials, which are informed by best practices from patient-reported outcome research. We focus on question design and administration via electronic data collection platforms with respect to 3 types of patient-reported health data: medication use, utilization of health care services, and comorbid conditions. We summarize key scientific literature on the accuracy of these patient-reported data compared with electronic health record data. We discuss question design in detail, specifically defining the concept to be measured, patient understanding of the concept, recall periods of the question, and patient willingness to report. In addition, we discuss approaches for question administration and data collection platforms, which are key aspects of successful patient-reported data collection

Rate versus rhythm control and outcomes in patients with atrial fibrillation and chronic kidney disease: Data from the GUSTO-III Trial

Background: Atrial fi brillation (AF) and chronic kidney disease (CKD) have both beenshown to portend worse outcomes after acute myocardial infarction (MI); however, the benefi tof a rhythm control strategy in patients with CKD post-MI is unclear.Methods: We prospectively studied 985 patients with new-onset AF post-MI in theGUSTO-III trial, of whom 413 (42%) had CKD (creatinine clearance < 60 mL/min).A rhythm control strategy, defi ned as the use of an antiarrhythmic medication and/orelectrical cardioversion, was used in 346 (35%) of patients.Results: A rhythm control strategy was used in 34% of patients with CKD and 36% of patientswith no CKD. At hospital discharge, sinus rhythm was present in 487 (76%) of patients treatedwith a rate control strategy, vs. 276 (80%) in those treated with rhythm control (p = 0.20). CKDwas associated with a lower odds of sinus rhythm at discharge (unadjusted OR 0.56, 95% CI0.38–0.84, p < 0.001). However, in multivariable analyses, treatment with a rhythm controlstrategy was not associated with discharge rhythm (HR 1.068, 95% CI 0.69–1.66, p = 0.77),30-day mortality (HR 0.78, 95% CI 0.54–1.12, p = 0.18) or mortality from day 30 to 1 year(HR 1.00, 95% CI 0.59–1.69, p = 0.99). CKD status did not signifi cantly impact the relationshipbetween rhythm control and outcomes.Conclusions: Treatment with a rhythm or rate control strategy does not signifi cantly impactshort-term or long-term mortality in patients with post-MI AF, regardless of kidney disease status.Future studies to investigate the optimal management of AF in CKD patients are needed

Hospital Variation and Characteristics of Implantable Cardioverter-Defibrillator Use in Patients With Heart Failure Data From the GWTG-HF (Get With The Guidelines–Heart Failure) Registry

ObjectivesThe aim of this study was to describe hospital variation and factors associated with adherence to guidelines for implantable cardioverter-defibrillator (ICD) therapy.BackgroundStudies have shown incomplete application of ICD therapy in eligible heart failure (HF) patients.MethodsNew or discharge prescription rates for ICD therapy (ejection fraction ≤30% without documented ICD contraindications) for hospitals were calculated from participants in the GWTG-HF (Get With The Guidelines–Heart Failure) registry during January 2005 to June 2007. With hierarchical modeling, hospitals' patient case-mix adjusted ICD rate and hospital factors associated with ICD use were determined. The association of ICD rate and other quality of care indicators and procedure use was determined.ResultsOverall use of ICD in-hospital or planned implantation rate was 20%. This rate ranged widely among hospitals, from 1% among the lowest tertile to 35% among the top tertile (p < 0.01). After adjusting for patient case mix, independent hospital characteristics associated with higher ICD use were percutaneous coronary intervention, coronary artery bypass grafting, and heart transplant capability as well as larger hospital bed size (p < 0.01). Hospital Centers for Medicare and Medicaid Services/Joint Commission on the Accreditation of Healthcare Organizations performance measures (discharge instructions, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker use, smoking cessation; p ≥ 0.05) were similar across ICD, whereas higher ICD-rate hospitals had higher adherence to GWTG-HF performance measures (beta-blocker use, evidence-based beta-blocker use, aldosterone-antagonist, hydralazine/nitrate; p < 0.05) except warfarin in patients with atrial fibrillation (p = 0.18).ConclusionsThere is significant unexplained hospital variation in the use of ICD therapy among potentially eligible HF patients. However, hospitals that use ICD therapy more often also have more rapidly adopted other newer evidence-based HF therapies

Zastosowanie wszczepialnych kardiowerterów- -defibrylatorów w profilaktyce pierwotnej u pacjentów w podeszłym wieku. Systematyczny przegląd piśmiennictwa i metaanaliza

Wstęp: W randomizowanych badaniach klinicznych (RCT) wykazano skuteczność zastosowania wszczepialnych kardiowerterów-defibrylatorów (ICD) w zapobieganiu nagłym zgonom sercowym (SCD) w określonych grupach chorych. Jednak w badaniach tych oceniano niewielkie grupy chorych &ge; 65. roku życia, a całkowite korzyści z wszczepienia ICD wśród starszych pacjentów mogą być ograniczone ze względu na zwiększone ryzyko zgonu. Na podstawie aktualnego piśmiennictwa oceniono, na ile wszczepienie ICD zmniejsza ryzyko zgonu z jakiejkolwiek przyczyny u pacjentów &ge; 65. roku życia oraz w wieku &#8805; 75 lat. Metody: Danych z RCT oraz badań obserwacyjnych oceniających profilaktykę pierwotną SCD, w zależności od wieku, poszukiwano w bazie MEDLINE. Za pierwszorzędowy punkt końcowy przyjęto śmiertelność ocenianą w metaanalizach lub RCT z zastosowaniem modelu &#8243;random-effects&#8243;. Za drugorzędowe punkty końcowe przyjęto śmiertelność związaną z zabiegiem operacyjnym, powikłania odległe oraz jakość życia (QoL). Wyniki: Do RCT nie włączano zbyt licznych grup pacjentów &ge; 65. roku życia (od 33% badanej populacji w badaniu DEFINITE do 56% w badaniu MUSTT). Na podstawie zsumowanych danych z 4 RCT (n = 3562) wykazano, że wszczepienie ICD w profilaktyce pierwotnej skutecznie zapobiega śmiertelności całkowitej u chorych w wieku &ge; 65 lat [współczynnik hazardu (HR): 0,66; 95% przedział ufności (CI): 0,50&#8211;0,87; test niejednorodności X2 = 5,26; p = 0,15). U pacjentów &ge; 75. roku życia zsumowane dane z 4 badań RCT (n = 579) również potwierdziły skuteczność ICD w profilaktyce pierwotnej w zapobieganiu śmiertelności całkowitej (HR: 0,73; 95% CI: 0,51&#8211;0,974; p = 0,03). Wydaje się, że powikłania związane z ICD, z zabiegiem operacyjnym, wewnątrzszpitalne oraz odległe nie różnią się istotnie w grupach pacjentów w podeszłym wieku w porównaniu z młodszymi chorymi, jednak pozostaje niejasne, czy u starszych osób wszczepienie ICD poprawia jakość życia bardziej niż u młodszych chorych. Wnioski: Choć dane dotyczące skuteczności ICD u pacjentów &ge;65. roku życia są ograniczone i rozbieżne, a dostępne informacje na temat chorych w wieku &ge; 75 lat &#8212; jeszcze bardziej niepełne, wyniki niniejszej metaanalizy sugerują, że pacjenci w podeszłym wieku mogą odnieść korzyści z wszczepienia ICD w ramach profilaktyki pierwotnej. Rezultaty autorów metaanalizy powinny zostać zweryfikowane w kolejnych badaniach, zwłaszcza oceniających powikłania związane z ICD oraz jakość życia

Sex Differences in Left Ventricular Electrical Dyssynchrony and Outcomes with Cardiac Resynchronization Therapy

BACKGROUND: Women seem to derive more benefit from cardiac resynchronization therapy (CRT) than men, even after accounting for the higher burden of risk factors for nonresponse often observed in men. OBJECTIVE: To assess for sex-specific differences in left ventricular (LV) electrical dyssynchrony as a contributing electrophysiological explanation for the greater degree of CRT benefit among women. METHODS: We compared the extent of baseline LV electrical dyssynchrony, as measured by the QRS area (QRSA), among men and women with left bundle branch block (LBBB) undergoing CRT at Duke University (n = 492, 35% women) overall and in relation to baseline QRS characteristics using independent sample t tests and Pearson correlation coefficients. Cox regression analyses were used to relate sex, QRSA, and QRS characteristics to the risk of cardiac transplantation, LV assist device implant, or death. RESULTS: Although the mean QRS duration (QRSd) did not differ by sex, QRSA was greater for women vs men (113.8 μVs vs 98.2 μVs, P < .001), owing to differences in the QRSd <150 ms subgroup (92.3 ± 28.7 μVs vs 67.6 ± 26.2 μVs, P < .001). Among those with nonstrict LBBB, mean QRSd was similar but QRSA was significantly greater among women than men (96.0 ± 25.0 μVs vs 63.6 ± 26.2 μVs, P < .001). QRSA was similar among men and women with strict LBBB (P = .533). Female sex was associated with better long-term outcomes in an unadjusted model (hazard ratio 0.623, confidence interval 0.454–0.857, P = .004) but sex no longer predicted outcomes after accounting for differences in QRSA. CONCLUSIONS: Our study suggests that sex-specific differences in LV dyssynchrony contribute to greater CRT benefit among women. Standard QRSd and morphology assessments seem to underestimate the extent of LV electrical dyssynchrony among women with LBBB

Sudden cardiac death in patients with ischemic heart failure undergoing coronary artery bypass grafting results from the STICH randomized clinical trial (Surgical Treatment for Ischemic Heart Failure)

Background—The risk of sudden cardiac death (SCD) in patients with heart failure following CABG has not been examined in a contemporary clinical trial of surgical revascularization. This analysis describes the incidence, timing and clinical predictors of SCD after CABG. Methods—Patients enrolled in the Surgical Treatment of Ischemic Heart Failure (STICH) trial who underwent CABG with or without surgical ventricular reconstruction (SVR) were included. We excluded patients with prior ICD and those randomized only to medical therapy. The primary outcome was SCD as adjudicated by a blinded committee. A Cox model was used to examine and identify predictors of SCD. The Fine and Gray method was used to estimate the incidence of SCD accounting for the competing risk of other deaths. Results—Over a median follow-up of 46 months, 113 patients of 1411 patients who received CABG without (n = 934) or with SVR (n = 477) had SCD; 311 died of other causes. The mean LVEF at enrollment was 28±9%. The 5-year cumulative incidence of SCD was 8.5%. Patients who had SCD and those who did not die were younger and had fewer comorbid conditions than those who died for reasons other than SCD. In the first 30 days after CABG, SCD (n=5) accounted for 7% of all deaths. The numerically greatest monthly rate of SCD was in the 31-90 day time period. In a multivariable analysis including baseline demographics, risk factors, coronary anatomy and LV function, ESVI and BNP were most strongly associated with SCD. Conclusions—The monthly risk of SCD shortly after CABG among patients with a low LVEF is highest between the first and third month, suggesting that risk stratification for SCD should occur early in the postoperative period, particularly in patients with increased preoperative ESVI and/or BNP

Assessment of the quality of existing patient educational tools focused on sudden cardiac arrest: a systematic evaluation by the Sudden Cardiac Arrest Thought Leadership Alliance

Background Conveying contemporary treatment options for those at risk of sudden cardiac arrest (SCA) is challenging. The purpose of the present research was to evaluate the quality and usability of available patient educational tools relevant to SCA and its treatment options, such as implantable cardioverter defibrillators (ICDs). We hypothesized that this review would identify gaps in areas of information for the enhancement of patient education and decision-making materials. Methods We used a formal instrument to assess specific domains of content, development, and effectiveness of 18 available SCA and ICD educational tools. The multidisciplinary review panel included two electrophysiologists, two general cardiologists, a cardiac psychologist, a health services researcher, and a patient advocate. Results Of the 18 education tools, four were rated as “good, may need revisions, but sufficient for use�, 12 were rated as “marginal, needs revision prior to use�, and two were rated as “poor, inadequate for use�. None of the tools were rated as being of “very good� or “excellent� quality. Conclusion There appear to be opportunities to improve the quality and completeness of existing educational tools for patients with SCA and ICD. While many tools have been developed, they fall below current standards for supporting informed medical decision-making

2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias

Ventricular arrhythmias are an important cause of morbidity and mortality and come in a variety of forms, from single premature ventricular complexes to sustained ventricular tachycardia and fibrillation. Rapid developments have taken place over the past decade in our understanding of these arrhythmias and in our ability to diagnose and treat them. The field of catheter ablation has progressed with the development of new methods and tools, and with the publication of large clinical trials. Therefore, global cardiac electrophysiology professional societies undertook to outline recommendations and best practices for these procedures in a document that will update and replace the 2009 EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias. An expert writing group, after reviewing and discussing the literature, including a systematic review and meta-analysis published in conjunction with this document, and drawing on their own experience, drafted and voted on recommendations and summarized current knowledge and practice in the field. Each recommendation is presented in knowledge byte format and is accompanied by supportive text and references. Further sections provide a practical synopsis of the various techniques and of the specific ventricular arrhythmia sites and substrates encountered in the electrophysiology lab. The purpose of this document is to help electrophysiologists around the world to appropriately select patients for catheter ablation, to perform procedures in a safe and efficacious manner, and to provide follow-up and adjunctive care in order to obtain the best possible outcomes for patients with ventricular arrhythmias