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The Patient with Renal Dysfunction
Published in Andreas P. Kalogeropoulos, Hal A. Skopicki, Javed Butler, Heart Failure, 2023
Alexandros Briasoulis, Ily Kristine T. Yumul-Non, Paulino Alvarez
Among patients with advanced CKD, the benefit of a primary prevention implantable cardioverter-defibrillator (ICD) is uncertain. A meta-analysis of three randomized, controlled trials (Multicenter Automatic Defibrillator Implantation Trial [MADIT] I, MADIT-II and Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]) did not find any survival benefit in patients with CKD stage 4 and 5.80 In another meta-analysis, including the aforementioned three trials and Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE), it was also shown that patients with extensive medical comorbidities, including CKD, experience less benefit from primary prevention ICDs.81 Therefore, implantation should be carefully considered but not withheld if indications are met.
Heart failure with reduced ejection fraction in older adults
Published in Wilbert S. Aronow, Jerome L. Fleg, Michael W. Rich, Tresch and Aronow’s Cardiovascular Disease in the Elderly, 2019
Given the nearly exponential increase in the risk of sudden cardiac death as LVEF decreases below 30%, it is not surprising that several studies have shown a benefit of an implantable cardioverter-defibrillator (ICD) in patients with systolic HF. In the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II), prophylactic implantation of an ICD in patients with a prior myocardial infarction and LVEF <30% reduced all-cause mortality from 20% to 14% over a 20-month mean follow-up (157). Of the 1232 MADIT II patients, 370 were <60 years, 426 were 60–69 years, and 436 were ≥70 years (number of patients ≥80 years unknown), and the benefit of an ICD was significant in those <60 and ≥70 years old. Although HF was not required for study entry and the baseline history of HF was not reported, approximately 75% of patients were receiving diuretics.
Implantable cardioverter defibrillators
Published in Ever D. Grech, Practical Interventional Cardiology, 2017
Dominic Rogers, Abdallah Al-Mohammad
The Multicenter Automatic Defibrillator Implantation Trial (MADIT), enrolled patients with a prior MI, LVEF < 35%, non-sustained VT and inducible, non-suppressible VT on electrophysiological study (EPS). MADIT randomised the patients to amiodarone therapy or ICD and showed a 54% reduction in mortality in the ICD group.21 There were some methodical issues with the trial, and some questioned its validity. However, publication of the Multicenter Unsustained Tachycardia Trial (MUSTT), which enrolled patients with coronary artery disease, LVEF < 40%, nonsustained VT and inducible, nonsuppressible VT on EPS showed a survival benefit from ICD comparable with MADIT.22
Cost-effectiveness analysis of implantable cardiac devices in patients with systolic heart failure: a US perspective using real world data
Published in Journal of Medical Economics, 2020
Dhvani Shah, Xiaoxiao Lu, Victoria F. Paly, Stelios I. Tsintzos, Damian M. May
A few studies have previously demonstrated the cost-effectiveness of CRT in the US. Using data from the 5-year follow-up of the REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) trial, Gold et al.33 showed that CRT is cost-effective in patients with mild HF, from a US Medicare perspective. The study also demonstrated that early implantation of CRT-D has cost parity with late implantation, while also increasing patient survival. Another analysis used the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial data to show that the clinical benefits of CRT-P and CRT-D can be achieved at a reasonable cost in patients with advanced heart failure16. A further analysis using data from the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) trial showed that, compared to ICD, CRT-D was cost-effective within a 4-year time horizon in minimally symptomatic patients with reduced cardiac ejection fraction and wide QRS complex.
Targeting sudden death in heart failure with preserved ejection fraction: promise or pipedream?
Published in Expert Review of Cardiovascular Therapy, 2018
Ravi B. Patel, Muthiah Vaduganathan
Targeted therapy of SCD has typically referred to ICD placement in the HF population. Despite this traditional perception, neurohormonal pharmacotherapies, which serve as the cornerstone for treatment of HFrEF, exhibit impressive reductions in SCD. It is possible that pharmacotherapies under investigation in HFpEF may demonstrate similar benefits. Indeed, several medical therapies that are currently under active study in HFpEF (sodium-glucose cotransporter 2 inhibitors [ClinicalTrials.gov Identifiers: NCT03057951 and NCT03619213], sacubitril/valsartan [ClinicalTrials.gov Identifier: NCT01920711], and spironolactone [ClinicalTrials.gov Identifier: NCT02901184]) have shown promise in SCD reduction in other high-risk CV populations. SD was numerically lower in patients treated with spironolactone compared with placebo in patients enrolled in the Americas region of the TOPCAT trial, but this difference did not reach statistical significance [9]; spironolactone may be considered in well-selected patients with HFpEF. Finally, the ongoing Multicenter Automatic Defibrillator Implantation Trial–Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD) trial, which will evaluate subcutaneous ICD therapy in patients with diabetes mellitus, prior myocardial infarction, and LVEF of 36–50%, may have important implications in future device trials of enriched cohorts of populations with borderline or preserved LVEF [15].
Reduced occurrence of appropriate therapy for ventricular arrhythmias after beta-blocker uptitration following implant of a primary prevention CRT-defibrillator
Published in Acta Cardiologica, 2020
Pieter Martens, Matthias Dupont, Wilfried Mullens
Beta-blockers significantly reduce the occurrence of sudden cardiac death (SCD) in randomised controlled trials [1,2]. In a retrospective analysis of the Multicenter Automatic Defibrillator Implantation Trial-II (MADIT-II), primary prevention implantable cardioverter defibrillator (ICD)-patients treated with higher doses of beta-blockers had significantly less appropriate therapy [3,4]. Also, following appropriate therapy, it is common practice to uptitrate the beta-blocker dose [5]. However, little is known about the pre-emptive effect of uptitrating beta-blockers in patients implanted with a primary prevention ICD who have never experienced an episode of appropriate therapy. In these patients, uptitration of beta-blockers is not systematically performed though often possible. Optimization of medical therapy, however, is standard of care in patients before cardiac resynchronisation therapy (CRT). However, only 19% of patients receiving CRT are able to tolerate the maximal dose of beta-blockers at the time of implant [6,7]. However, following CRT-implantation, protection against bradycardia and reverse remodelling allows for uptitration of beta-blockers, which has been associated with a lower risk for heart failure hospitalisation and all-cause mortality [7,8]. However, it is unclear if uptitration of beta-blockers following CRT-defibrillator (CRT-D) implant also reduces the occurrence of appropriate therapy. Reduction of the occurrence of appropriate therapy is important as it is associated with emotional stress, temporary ineligibility to drive, and increased risk for subsequent heart failure hospitalisation and mortality [5]. We specifically studied a primary prevention CRT-D population, in which the incentive to uptitrate a beta-blocker is perhaps lower from a ventricular arrhythmia perspective but still present to maximise reverse remodelling.