A variable proportion of cardiac resynchronization therapy (CRT) patients do not benefit from treatment (termed `non-responders'). The problem of non-response to CRT might become increasingly ...important, because it is anticipated that larger groups of heart failure patients are indicated to the therapy. This article will discuss the definition of response to CRT, the parameters related to response to CRT, and finally whether response to CRT might be predicted. The effort to improve patient selection in order to maximize human and financial resource utilization has fallen short so far. It is, however, conceivable that rather than the identification of a `universally' applicable cut-off value, risk strata-in which inclusion of method for determination of left ventricular volumes, etiology, QRS duration and morphology, etc-might better serve the goal of defining non-responders. Potentially simple clinical scores might help in refining outcome and by doing so, allow to more precisely measure response to CRT in daily practice in the individual patient at the time of CRT implantation. Although sophisticated cardiac imaging modalities have been intensively utilized for improving patient outcome, it seems that many mechanical dyssynchrony measures suffer from technical limitations and from difficult interpretation of the complex signals, which lack reproducibility outside highly specialized laboratories. (Circ J 2011; 75: 521-527)
20 Years of Cardiac Resynchronization Therapy Leyva, Francisco, MD; Nisam, Seah, PhD; Auricchio, Angelo, MD, PhD
Journal of the American College of Cardiology,
09/2014, Volume:
64, Issue:
10
Journal Article
Peer reviewed
Open access
Abstract Cardiac resynchronization therapy (CRT) is an accepted treatment for patients with heart failure (HF), impaired left ventricular (LV) function, and a wide QRS complex. It has been ...revolutionary for patients with advanced HF whose only previous option was cardiac transplantation, and it is now a realistic option for patients with mild HF. The development of CRT also has united the previously disparate cardiological subspecialties of electrophysiology and HF. This review, written on the occasion of the 20th anniversary of the first clinical use of CRT for HF, takes a historical perspective on CRT’s evolution from “bench to bedside.” We also comment on the task faced by electrophysiologists and HF specialists as they make this life-saving therapy available to an increasing number of eligible patients.
Objectives The purpose of this study was to assess the effect of remote patient monitoring (RPM) on the outcome of chronic heart failure (HF) patients. Background RPM via regularly scheduled ...structured telephone contact between patients and health care providers or electronic transfer of physiological data using remote access technology via remote external, wearable, or implantable electronic devices is a growing modality to manage patients with chronic HF. Methods After a review of the literature published between January 2000 and October 2008 on a multidisciplinary heart failure approach by either usual care (in-person visit) or RPM, 96 full-text articles were retrieved: 20 articles reporting randomized controlled trials (RCTs) and 12 reporting cohort studies qualified for a meta-analysis. Results Respectively, 6,258 patients and 2,354 patients were included in RCTs and cohort studies. Median follow-up duration was 6 months for RCTs and 12 months for cohort studies. Both RCTs and cohort studies showed that RPM was associated with a significantly lower number of deaths (RCTs: relative risk RR: 0.83, 95% confidence interval CI: 0.73 to 0.95, p = 0.006; cohort studies: RR: 0.53, 95% CI: 0.29 to 0.96, p < 0.001) and hospitalizations (RCTs: RR: 0.93, 95% CI: 0.87 to 0.99, p = 0.030; cohort studies: RR: 0.52, 95% CI: 0.28 to 0.96, p < 0.001). The decrease in events was greater in cohort studies than in RCTs. Conclusions RPM confers a significant protective clinical effect in patients with chronic HF compared with usual care.
The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association ...(EHRA) in order to identify the safety and efficacy of the current practice of TLE.
European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV ≥ 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% 95% CI 1.3-2.1% (58/3510 pts) including a mortality of 0.5% 95% CI 0.3-0.8% (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% 95% CI 1.0-1.8%). Complete clinical and radiological success rates were 96.7% 95% CI 96.1-97.3% and 95.7% 95% CI 95.2-96.2%, respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% 95% CI 1.9-3.0% vs. 4.1% 95% CI 2.7-6.0%, P = 0.0146; and 1.2% 95% CI 0.8-1.6% vs. 2.5% 95% CI 1.5-4.1% P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres.
The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres.
Objectives This study evaluated the safety, efficacy, and effect of MitraClip treatment on symptoms and left ventricular (LV) remodeling in nonresponders to cardiac resynchronization therapy (CRT). ...Background Moderate to severe functional mitral regurgitation (FMR) frequently persists after CRT, contributing to reduced or no response to CRT. Percutaneous repair with the MitraClip has been proposed as an additional therapeutic option in select patients with significant FMR. Methods Fifty-one severely symptomatic CRT nonresponders with significant FMR (grade ≥2, 100%) underwent MitraClip treatment. Changes in New York Heart Association functional class, degree of FMR, LV ejection fraction (EF), and LV end-diastolic/end-systolic volumes (EDV/ESV) before and after (3, 6, and 12 months) MitraClip implantation were recorded. Mortality data, including cause of death, were collected. Results MC treatment was feasible in all patients (49% 1 clip, 46% 2 clips). There were 2 periprocedural deaths. Median follow-up was 14 months (25th to 75th percentile: 8 to 17 months). New York Heart Association functional class improved acutely at discharge (73%) and continued to improve progressively during follow-up (regression model, p < 0.001). The proportion of patients with significant residual FMR (grade ≥2) progressively decreased during follow-up (regression model, p < 0.001). Reverse LV remodeling and improved LVEF were detected at 6 months, with further improvement at 12 months (regression model, p = 0.001, p = 0.008, and p = 0.031 for ESV, EDV, and LVEF, respectively). Overall 30-day mortality was 4.2%. Overall mortality during follow-up was 19.9 per 100 person-years (95% confidence interval: 10.3 to 38.3). Nonsurvivors had more compromised clinical baseline conditions, longer QRS duration, and a more dilated heart. Conclusions FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.
“Nonresponse” to cardiac resynchronization therapy (CRT) is recognized, but definition(s) applied in practice, treatment(s), and their consequences are little known.
The authors sought to assess ...nonresponse in the prospective, international, ADVANCE CRT registry (Advance Cardiac Resynchronization Therapy Registry).
Each subject’s response was assessed at 6 months post-implantation using site-specific definitions and compared with the independently derived clinical composite score (CCS). Treatment(s) and hospitalization(s) were tracked during the following 6 months.
Of 1,524 subjects enrolled in 69 centers (68 ± 12 years of age, 32% female, ischemic disease 39%), 74.3% received CRT-defibrillator devices, using mainly quadripolar LV leads (75%) deployed laterally (78%). Indications for CRT were wider than past trials. Among 1,327 evaluable subjects, site-defined nonresponse was 20.0% (greater age, comorbidities, ischemic cardiomyopathy, non-left bundle branch block, and lower %CRT pacing vs. responders). Site definitions used mainly clinical criteria (echocardiography infrequently), and underestimated nonresponders by 35% compared with CCS (58% sensitivity vs. CCS). Overall, more site-defined nonresponders received treatment (55.9% vs. 38.3% of responders; p < 0.001) using medication changes and heart failure education, but device programming less frequently. Intensification of in-clinic/remote evaluations and involvement of heart failure specialists remained minimal. Remarkably, 44% of site-defined nonresponders received no additional treatment. Frequency and duration of hospitalizations, and death, among site-defined nonresponders was significantly higher than responders.
A high incidence of CRT nonresponders persists despite good patient selection and LV lead position, but site identification methods have modest sensitivity. Following diagnosis, nonresponders are often passively managed, without specialty care, with poor outcome. ADVANCE CRT exposes a vulnerable group of heart failure patients. (Advance Cardiac Resynchronization Therapy Registry ADVANCE CRT; NCT01805154)
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Abstract
Cardiac resynchronization therapy (CRT) is an established non-pharmacological treatment for selected heart failure patients with wide QRS duration. However, there is a persistent number of ...non-responders throughout. The prediction of the CRT response is paramount to adequately select the correct patients for CRT. One of the expanding fields of research is the development of biomarkers that predict the response to CRT. A review of the available literature on biomarkers in CRT patients has been performed to formulate a critical appraisal of the available data. The main conclusion of our review is that biomarker research in this patient population is very fragmented and broad. This results in the use of non-uniform endpoints to define the CRT response, which precludes an in-depth comparison of the available data. To improve research development in this field, a uniform definition of the CRT response and relevant endpoints is necessary to better predict the CRT response.
Abstract Aim We compared the time to initiation of cardiopulmonary resuscitation (CPR) by lay responders and/or first responders alerted either via Short Message Service (SMS) or by using a mobile ...application-based alert system (APP). Methods The Ticino Registry of Cardiac Arrest collects all data about out-of-hospital cardiac arrests (OHCAs) occurring in the Canton of Ticino. At the time of a bystander’s call, the EMS dispatcher sends one ambulance and alerts the first-responders network made up of police officers or fire brigade equipped with an automatic external defibrillator, the so called “traditional” first responders, and − if the scene was considered safe − lay responders as well. We evaluated the time from call to arrival of traditional first responders and/or lay responders when alerted either via SMS or the new developed mobile APP. Results Over the study period 593 OHCAs have occurred. Notification to the first responders network was sent via SMS in 198 cases and via mobile APP in 134 cases. Median time to first responder/lay responder arrival on scene was significantly reduced by the APP-based system (3.5 2.8-5.2) compared to the SMS-based system (5.6 4.2-8.5 min, p 0.0001). The proportion of lay responders arriving first on the scene significantly increased (70% vs. 15%, p<0.01) with the APP. Earlier arrival of a first responder or of a lay responder determined a higher survival rate. Conclusions The mobile APP system is highly efficient in the recruitment of first responders, significantly reducing the time to the initiation of CPR thus increasing survival rates.
Background
Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A ...European Society of Cardiology (ESC) CRT survey conducted in 2008–2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow‐up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.
Methods and results
A survey of the clinical practice of CRT‐P and CRT‐D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web‐based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter‐defibrillator and 30% were CRT‐P rather than CRT‐D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.
Conclusion
CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow‐up strategy.
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