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905 Cost Effectiveness of Cardiac Resynchronization Therapy (CRT) for Mild to Moderate Heart Failure

Authors:
ference between treatment and control on all ABP parameters,
both at the 12 week primary outcome and at any other time point.
For example, the change in 24HR SBP/DBP at 12 weeks between
treatment and control was only 0.0/0.4 mmHg (/7.2/4.7),
p0.96 for SBP and p0.63 for DBP (the blood pressure values
have been corrected and respective p-values included). This study
had 81% power to detect a 24 hour systolic BP difference of 6.0
mmHg with 37 participants per group.
CONCLUSIONS: MBSR was found to be ineffective in lowering BP
by 6 mmHg or more among stage-1 unmedicated hypertensives.
Revisiting the literature, most positive studies using meditation
techniques for blood pressure lowering included many subjects
taking anti-hypertensive therapy. In 2 negative studies all subjects
were drug naïve. Therefore, it seems probable that studies finding
a reduction in BP may have been confounded by improved med-
ication adherence. While it is disappointing that the HARMONY
study did not find a blood pressure lowering effect on drug naïve
hypertensives, mind-body interventions may improve BP control
among the medicated. Our next steps include using MBSR as
adjunctive therapy for better BP control, as well assessing its use in
improving drug adherence/persistence.
905
COST EFFECTIVENESS OF CARDIAC RESYNCHRONIZATION
THERAPY (CRT) FOR MILD TO MODERATE HEART FAILURE
GA Wells, D Coyle, K Coyle, M Talajic, A Tang
Ottawa, Ontario
BACKGROUND: The objective of this study was to assess the cost
effectiveness of ICD-CRT versus ICD alone in patients with left
ventricular dysfunction and a wide QRS complex. In a recent
randomized controlled trial (RAFT), the addition of CRT to an
implantable cardiodefibrillator (ICD) in this group of patients was
shown to reduce rates of death and hospitalization for heart failure.
METHODS: Analysis assessed the health care related costs and
quality adjusted life years for both the ICD-CRT and ICD
groups over a 40 year time horizon. The time horizon was
facilitated by a Markov model developed by combining data for
the 1798 patients enrolled within the RAFT with long term
data on the longevity of the devices. Costs and benefits in terms
of quality adjusted life years (QALYs) were discounted at 3%
per annum. Health care resources included the initial device
plus device replacements, cardiovascular and non cardiovascu-
lar related hospitalizations in addition to drug costs, physician
visits and long term care. Resource use was weighted by appro-
priate unit costs from the USA. Uncertainty concerning cost
effectiveness was assessed through Monte Carlo simulation and
deterministic sensitivity analysis.
RESULTS: Models for Canadian resource utilization and costing
have been developed and are currently being conducted. For
the US models, the use of ICD-CRT was estimated to lead to
an average increase in costs of $35,308 and an average increase
in QALYs of 1.07. The incremental cost per QALY gained was
$33,025. ICD-CRT was not cost effective for patients with
atrial fibrillation and those with preexisting ventricular pacing.
CONCLUSIONS: ICD-CRT is cost effective for the population
studied within the RAFT clinical trial.
Abstracts S419
... Resynchronization-Defibrillation for Heart Failure C ardiac-resynchronization therapy (CRT) has been shown to reduce both mortality and heart-failure outcomes in patients with symptomatic heart failure, a reduced ejection fraction, and a wide QRS complex despite optimal medical therapy, [1][2][3][4][5] and it has been established as standard care in appropriate patients. 6 The implantation of a CRT device is a lifelong intervention for such patients, and clinical decision making is dependent on studies of the long-term outcomes of CRT. ...
... The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) was a multicenter, double-blind, randomized, controlled trial that aimed to determine whether the addition of CRT to an implantable cardioverter-defibrillator (ICD), along with optimal medical therapy, would result in lower mortality and fewer hospitalizations for heart failure than an ICD and optimal medical therapy alone. 1 The trial included patients with a left ventricular ejection fraction of 30% or less, a QRS complex duration of more than 120 msec, and New York Heart Association (NYHA) class II or III heart failure. Patients with a right bundle-branch block, nonspecific intraventricular conduction delays, right ventricular pacing, or atrial fibrillation were not excluded. ...
... The design, protocol, and results of RAFT have been published previously. 1 The protocol and statistical analysis plan are available with the full text of this article at NEJM.org. All patients provided written informed consent to participate in the original RAFT trial. ...
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Background: The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known. Methods: We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device. Results: The trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group. Conclusions: Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.).
... The worse outcome of CRT in patients with non-LBBB pattern than with LBBB pattern might be due to less dyssynchrony manifested as shorter QRSd and unfavorable patient characteristics for CRT outcome, such as more ischemic etiology and predominance of male patients among patients with non-LBBB pattern. [2,11,12,16] Another important reason for worse outcome of CRT in patients with non-LBBB pattern is that the current CRT technique positioning the LV electrode to the anterolateral or inferolateral area is devised to eliminate dyssynchrony caused by LBBB pattern, but it is not appropriate in patients with pure, typical RBBB pattern [without associated left hemiblock or without being an atypical RBBB, defined as the absence of characteristic S waves (S wave of greater duration than R wave or > 40 ms) in leads I and aVL] and may not be appropriate in patients with NICD pattern to eliminate dyssynchrony. [17−19] The worse outcome after CRT applying the current CRT technique of HF patients with non-LBBB pattern compared with LBBB pattern in large randomized studies is not surprising at all, because the comparison of QRS morphology subgroups in these trials was biased, as the comparison of subgroups was unfair, because the applied CRT technique, originally devised to eliminate dyssynchrony in patients with LBBB pattern is ineffective in patients with pure, typical RBBB pattern and its effectivity is elusive in patients with NICD pattern, had not even the chance before the start of these trials to be equally effective in the investigated QRS morphology subgroups. ...
... Thus, the likelihood that a patient with NICD pattern predicted as an expected R with the new ECG dyssynchrony criteria will be a clinical NR after CRT is identical to that of a patient with LBBB pattern. Thus, the most important novel finding of our study was that our novel ECG dyssynchrony criteria may have a great value in the selection of patients with NICD pattern (the second greatest group of CRT candidates, comprising 10%-35% of them [2,3,5,12] ) and a QRSd of 130−149 ms, in whom the indication of CRT is questionable according to the current guidelines, who might benefit from CRT. If our results will be confirmed in future prospective, multicenter studies by independent investigators, our novel ECG dyssynchrony criteria may improve patient selection for CRT, mostly the selection of patients with NICD pattern, and decrease the number of NRs to CRT. ...
Article
Full-text available
Cardiac resynchronization therapy (CRT) is an evidence-based effective therapy of symptomatic heart failure with reduced ejection fraction refractory to optimal medical treatment associated with intraventricular conduction disturbance, that results in electrical dyssynchrony and further deterioration of systolic ventricular function. However, the non-response rate to CRT is still 20%-40%, which can be decreased by better patient selection. The main determinant of CRT outcome is the presence or absence of significant ventricular dyssynchrony and the ability of the applied CRT technique to eliminate it. The current guidelines recommend the determination of QRS morphology and QRS duration and the measurement of left ventricular ejection fraction for patient selection for CRT. However, QRS morphology and QRS duration are not perfect indicators of electrical dyssynchrony, which is the cause of the not negligible non-response rate to CRT and the missed CRT implantation in a significant number of patients who have the appropriate substrate for CRT. Using imaging modalities, many ventricular dyssynchrony criteria were devised for the detection of mechanical dyssynchrony, but their utility in patient selection for CRT is not yet proven, therefore their use is not recommended for this purpose. Moreover, CRT can eliminate only mechanical dyssynchrony due to underlying electrical dyssynchrony, for this reason ECG has a greater role in the detection of ventricular dyssynchrony than imaging modalities. To improve assessment of electrical dyssynchrony, we devised two novel ECG dyssynchrony criteria, which can estimate interventricular and left ventricular intraventricular dyssynchrony in order to improve patient selection for CRT. Here we discuss the results achieved by the application of these new ECG dyssynchrony criteria, which proved to be useful in predicting the CRT response in patients with nonspecific intraventricular conduction disturbance pattern (the second greatest group of CRT candidates), and the significance of other new ECG dyssynchrony criteria in the potential improvement of CRT outcome.
... Typ přístroje může být bez možnosti vygenerování výboje (CRT -P), nebo CRT s kombinací ICD (CRT -D). V současnosti máme k dispozici data z velkých studií, která prokázala pozitivní vliv resynchronizační terapie u pacientů s HFrEF (27,28 ...
... ICD is more effective than anti-arrhythmic medications in reducing the risk of sudden cardiac death in individuals with HF. [37]. Among patients with NYHA class II or III HF, a wide QRS (part of electrocardiographic wave) complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure [38]. ...
Article
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Heart failure is a complex clinical syndrome caused by the progression to severe stages of various cardiac diseases, characterized by high morbidity and mortality. With the increasing aging of the population and the poor control of high-risk factors for heart failure such as hypertension and diabetes, the incidence of heart failure remains high. Therefore, there is widespread global attention regarding the various treatments for heart failure. Currently, pharmacological therapy, associated device therapy, interventional therapy, and end-stage surgical related therapy are the main clinical treatments for heart failure. Heart failure treatment is gradually evolving to be more precise, safe, and effective, as traditional therapies can no longer match clinical needs. A number of cutting-edge research studies are being conducted on the treatment of heart failure, based on the different pathogenesis and causes of heart failure, to treat patients with heart failure in a multifaceted and integrated way. This article summarizes the current clinical treatment of heart failure and the latest therapeutic advances in heart failure in current research to further promote the standardized management and treatment of heart failure and improve patient prognosis.
... Эффективность СРТ продемонстрирована в многочисленных клинических исследованиях и метаанализах при кардиомиопатии как ишемического, так и неишемического генеза [127,[265][266][267][268][269][270][271]. Данные европейского обзорного регистра свидетельствуют о более низкой смертности у пациентов с комбинированными устройствами СРТ-Д*** [272]. ...
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Russian Society of Cardiology (RSC). With the participation of Russian Scientific Society of Clinical Electrophysiology, Arrhythmology and Cardiac Pacing, Russian Association of Pediatric Cardiologists, Society for Holter Monitoring and Noninvasive Electrocardiology. Approved by the Scientific and Practical Council of the Russian Ministry of Health.
... The prolongation of QRS (120 ms or more) occurs in 14.0% to 47.0% of HF patients and the ventricular conduction disturbance, most commonly left bundle branch block (LBBB), is present in approximately one-third of HF, leading to mechanical dyssynchrony (MD) of ventricles [6,8]. Prospective randomized studies of patients with both ischemic HF (IHF) and non-ischemic HF (NIHF) have shown that CRT translates into long-term clinical benefits, such as improved quality of life, increased functional capacity, reduction in hospitalization for HF, and overall mortality [9][10][11]. These patients qualified as responders to CRT [12,13]. ...
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Introduction: The cardiac resynchronization therapy (CRT) improves outcome in patients with heart failure (HF). However approximately 30% of patients are non-responsive to CRT. The purpose of this study was to investigate the role of the left ventricle (LV) mechanical dyssynchrony (MD) and scar burden assessment as predictors of CRT response. Methods: We included in the study 56 sinus rhythm patients (male 35 [62.5 %], mean age 57.0 ± 11.5 years) with ischemic or nonischemic HF, and left bundle branch block with QRS duration ≥ 150 ms who underwent CRT-D implantation. Echocardiography, full physical examination, myocardial perfusion imaging (MPI) with Tc-methoxy-isobutyl-isonitrile and gated blood pool single-photon emission computed tomography (gBPS) were performed at baseline and at 6-month follow-up. Patients were grouped based on the response to CRT assessed by echocardiography. Results: Forty-five patients (80.3 %) were responder (RESP) and 11 (19.7 %) were non-responder (non-RESP) to CRT. RESP patients had higher LV anterior wall standard deviation (LV AW_SD) (p=0.0001) and lower summed rest score (SRS) (p=0.018) than non-RESP subjects. In multivariate logistic regression, LV AW_SD (adjusted odds ratio [OR] 1.5275; 95% confidence interval [CI] 1.1472-2.0340; p=0.0037), SRS (OR 0.7299; 95% CI 0.5627-0.9469; p=0.0178) and HF non-ischemic etiology (OR 20.1425; 95% CI 1.2719-318.9961; p=0.0331) were independent predictors of CRT response. Conclusion: Ventricle dyssynchrony and scar burden assessed by cardiac gBPS and MPI are associated with response to CRT. Further investigations of their predictive significance are warranted.
... See Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT), and Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) all showed benefit with CRT pacing in patients with reduced ejection fractions, symptoms of heart failure, and wide QRS complexes. [27][28][29] The current recommendations suggest the use of BiV CRT if the QRS duration is more than 150 ms with a left bundle branch block morphology. 30 However, some patients will not respond to CRT even in normal sinus rhythm with more than 95% paced beats, which has posed a clinical dilemma. ...
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The use of cardiovascular implantable electronic devices (CIEDs) has proved to be the most successful device‐based therapy to reduce morbidity and mortality of cardiovascular disease over decades. The evolution of power supplies always promotes the development of CIEDs from historical perspectives. However, with the increased demands of therapy energy, modern CIEDs still face huge challenges in terms of longevity, size, and reliability of power supplies. Recent advances in batteries and novel energy devices have provided promising approaches to improve power supplies and enhance the therapeutic capabilities of CIEDs. In this review, we will summarize the therapy energy in different types of CIEDs tailored to specific cardiovascular diseases and discuss the design criterion of implantable batteries. After overviewing the evolution of batteries, we will discuss emerging cutting‐edge power technologies, including new battery systems, wearable power management platforms, wireless energy transfer, and leadless and unsealed devices. image
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Background: The RAID (Ranolazine Implantable Cardioverter-Defibrillator) randomized placebo-controlled trial showed that ranolazine treatment was associated with reduction in recurrent ventricular tachycardia (VT) requiring appropriate implantable cardioverter-defibrillator (ICD) therapy. Objectives: This study aimed to identify groups of patients in whom ranolazine treatment would result in the highest reduction of ventricular tachyarrhythmia (VTA) burden. Methods: Andersen-Gill analyses were performed to identify variables associated with risk for VTA burden among 1,012 patients enrolled in RAID. The primary endpoint was VTA burden defined as VTA episodes requiring appropriate treatment. Results: Multivariate analysis identified 7 factors associated with increased VTA burden: history of VTA, age ≥65 years, New York Heart Association functional class ≥III, QRS complex (≥130 ms), low ejection fraction (<30%), atrial fibrillation (AF), and concomitant antiarrhythmic drug (AAD) therapy. The effect of ranolazine on VTA burden was seen among patients without concomitant AAD therapy (HR [HR]: 0.68; 95% CI: 0.55-0.84; P < 0.001), whereas no effect was seen among those who are concomitantly treated with other AADs (HR: 1.33; 95% CI: 0.90-1.96; P = 0.16); P = 0.003 for interaction. In patients with cardiac resynchronization therapy (CRT) ICDs, ranolazine treatment was associated with a 36% risk reduction for VTA recurrence (HR: 0.64; 95% CI: 0.47-0.86; P < 0.001), whereas among patients with ICDs without CRT no significant effect was noted (HR: 0.94; 95% CI: 0.74-1.18; P = 0.57); P = 0.047 for interaction. Conclusions: In patients with high risk for VTA, ranolazine is effective in reducing VTA burden, with significantly greater effect in CRT-treated patients, those without AF, and those not treated with concomitant AADs. In patients already on AADs or those with AF, the addition of ranolazine did not affect VTA burden. (Ranolazine Implantable Cardioverter-Defibrillator Trial [RAID]; NCT01215253).
Chapter
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Congestive heart failure (CHF) is a serious health problem affecting all nations of world. Its impact is increasing with increasing individual age. Ventricular dyssynchrony is well known to contribute to pathophysiological deterioration in more than one-third of CHF subjects. The therapeutic choices of CHF witnessed long decades of stagnant periods and a relative paucity of effective treatment. The discovery of the electrical therapy that is capable of reversing ventricular dyssynchrony, in the form of cardiac resynchronization therapy (CRT), is a true revolution in the timeline of CHF management. Despite the early enthusiasm associated with CRT implantations started in 2001, we know from the last two decades’ experience that non-responders constitute to nearly 40% of all CRT patients. This chapter is devoted to reviewing the past, present and future of CRT with special attention on better intelligent detection of the electrical substrate responsive to CRT as well as optimizing the choice of CRT subjects using the latest knowledge in electrocardiographic and state-of-art imagining technologies. Novel future directions are discussed with new scientific philosophies capable of optimizing CRT. Promising new implants techniques such as endocardial pacing of the left ventricle, His bundle pacing as well as His-optimized cardiac resynchronization therapy are discussed.
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