Predictors of the efficacy of His bundle pacing in patients with a prolonged PR interval: A stratified analysis of the HOPE-HF randomized controlled trial.

AIMS: The randomized, double-blind, placebo-controlled HOPE-HF trial assessed the benefit of atrio-ventricular (AV) delay optimization delivered using His bundle pacing. It recruited patients with left ventricular ejection fraction ≤40%, PR interval ≥200 ms, and baseline QRS ≤140 ms or right bundle branch block. Overall, there was no significant increase in peak oxygen uptake (VO2max) but there was significant improvement in heart failure specific quality of life. In this pre-specified secondary analysis, we evaluated the impact of baseline PR interval, echocardiographic E-A fusion, and the magnitude of acute high-precision haemodynamic response to pacing, on outcomes. METHODS AND RESULTS: All 167 randomized participants underwent measurement of PR interval, acute haemodynamic response at optimized AV delay, and assessment of presence of E-A fusion. We tested the impact of these baseline parameters using a Bayesian ordinal model on VO2max, quality of life and activity measures. There was strong evidence of a beneficial interaction between the baseline acute haemodynamic response and the blinded benefit of pacing for VO2 (Pr 99.9%), Minnesota Living With Heart Failure (MLWHF) (Pr 99.8%), MLWHF physical limitation score (Pr 98.9%), EQ-5D visual analogue scale (Pr 99.6%), and exercise time (Pr 99.4%). The baseline PR interval and the presence of baseline E-A fusion did not have this reliable ability to predict the clinical benefit of pacing over placebo across multiple endpoints. CONCLUSIONS: In the HOPE-HF trial, the acute haemodynamic response to pacing reliably identified patients who obtained clinical benefit. Patients with a long PR interval (≥200 ms) and left ventricular impairment who obtained acute haemodynamic improvement with AV-optimized His bundle pacing were likely to obtain clinical benefit, consistent across multiple endpoints. Importantly, this gradation can be reliably tested for before randomization, but does require high-precision AV-optimized haemodynamic assessment to be performed.

Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial.

AIMS: Excessive prolongation of PR interval impairs coupling of atrio-ventricular (AV) contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His bundle pacing allows AV delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV optimized His pacing is preferable to no-pacing, in a double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200 ms and either QRS ≤140 ms or right bundle branch block. METHODS AND RESULTS: Patients had atrial and His bundle leads implanted (and an implantable cardioverter-defibrillator lead if clinically indicated) and were randomized to 6 months of pacing and 6 months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. Overall, 167 patients were randomized: 90% men, 69 ± 10 years, QRS duration 124 ± 26 ms, PR interval 249 ± 59 ms, LVEF 33 ± 9%. Neither peak oxygen uptake (+0.25 ml/kg/min, 95% confidence interval [CI] -0.23 to +0.73, p = 0.3) nor LVEF (+0.5%, 95% CI -0.7 to 1.6, p = 0.4) changed with pacing but Minnesota Living with Heart Failure quality of life improved significantly (-3.7, 95% CI -7.1 to -0.3, p = 0.03). Seventy-six percent of patients preferred His bundle pacing-on and 24% pacing-off (p < 0.0001). CONCLUSION: His bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months.

Implementation of NICE clinical guideline 95 on chest pain of recent onset: experience in a district general hospital.

The National Institute for Health and Care Excellence (NICE) CG95 clinical guideline on chest pain of recent onset was published in 2010. There is debate over whether the proposed strategy improves patient care and its implications on service costs. Following a six-month pilot, 472 consecutive patient records were audited for pre-test probability of significant coronary artery disease, investigations performed and outcomes. Low- and moderate-risk patients had an unexpectedly low rate of coronary disease and revascularisation. Computerised tomography coronary angiography (CTCA) and stress echocardiography performed similarly, though the latter was more resource intensive. High-/very high-risk patients frequently required revascularisation and greater than 10% of each group had prognostically significant disease, going against the recommendation that very high risk patients do not undergo angiography. There were frequent protocol deviations and training clinic staff in the new approach was challenging. In conclusion, implementing NICE CG95 is feasible but presents challenges. Staff require training to follow the protocol consistently. Functional testing had no benefits over anatomical testing with CTCA, which may allow cost savings in some departments.

A user-centred home monitoring and self-management system for patients with heart failure: a multicentre cohort study.

AIMS: Previous generations of home monitoring systems have had limited usability. We aimed to develop and evaluate a user-centred and adaptive system for health monitoring and self-management support in patients with heart failure. METHODS AND RESULTS: Patients with heart failure were recruited from three UK centres and provided with Internet-enabled tablet computers that were wirelessly linked with sensor devices for blood pressure, heart rate, and weight monitoring. Patient observations, interviews, and concurrent analyses of the automatically collected data from their monitoring devices were used to increase the usability of the system. Of the 52 participants (median age 77 years, median follow-up 6 months [interquartile range, IQR, 3.6-9.2]), 24 (46%) had no, or very limited prior, experience with digital technologies. It took participants about 1.5 min to complete the daily monitoring tasks, and the rate of failed attempts in completing tasks was <5%. After 45 weeks of observation, participants still used the system on 4.5 days per week (confidence interval 3.2-5.7 days). Of the 46 patients who could complete the final survey, 93% considered the monitoring system as easy to use and 38% asked to keep the system for self-management support after the study was completed. CONCLUSION: We developed a user-centred home monitoring system that enabled a wide range of heart failure patients, with differing degrees of IT literacy, to monitor their health status regularly. Despite no active medical intervention, patients felt that they benefited from the reassurance and sense of connectivity that the monitoring system provided.

"SHOUT" to improve the quality of care delivered to patients with acute kidney injury at Great Western Hospital.

Acute kidney injury (AKI) affects up to 20% of all patients admitted to hospital, and is associated with a higher risk of adverse clinical outcomes, increased healthcare costs, as well as long term risks of chronic kidney disease and end stage renal failure. The aim of this project was to improve the quality of care for patients with AKI admitted to the acute medical unit (AMU) at the Great Western Hospital (GWH). We assessed awareness and self reported confidence among physicians in our Trust, in addition to basic aspects of care relevant to AKI on our AMU. A multifaceted quality improvement strategy was developed, which included measures to improve awareness such as a Trust wide AKI awareness day, and reconfiguring the admission proforma on our AMU in order to enhance risk assessment, staging, and early response to AKI. Ancillary measures such as the dissemination of flashcards for lanyards containing core information were also used. Follow up assessments showed that foundation year one (FY1) doctors' self reported confidence in managing AKI increased from 2.8 to 4.2, as measured on a five point Likert scale (P=0.0003). AKI risk assessment increased from 13% to 57% (P=0.07) following a change in the admission proforma. Documentation of the diagnosis of AKI increased from 66% to 95% (P=0.038) among flagged patients. Documentation of urine dip results increased from 33% to 73% (P=0.01), in addition to a rise in appropriate referral for specialist input, although this was not statistically significant. Our results suggest that using the twin approaches of improving awareness, and small changes to systemic factors such as modification of the admission proforma, can lead to significant enhancements in the quality of care of patients with AKI.

A retained pulmonary artery catheter fragment incidentally found lodged in the right heart 16 years after its insertion.

Sixteen years after a long admission for a serious occupational accident, a 38-year-old man presented with intermittent atypical chest pain. Upon investigations a retained fragment of a pulmonary artery catheter was found in the right ventricle. Throughout the years between his accident and the current presentation he did not have any symptoms or signs of complications associated with the retained catheter such as arrhythmia, sepsis or thromboembolism. Upon presenting his case at the medical/surgical multidisciplinary meeting it was decided that the probability of complications occurring at this stage was low as the catheter fragment would have endothelialised and the risk of retrieval would outweigh the benefits. This scenario highlighted the importance of understanding the possible long-term complications of retained catheter fragments, the importance of being aware of the limitation of these devices and the need to be more vigilant in the emergency setting.

Prognostic significance of myocardial fibrosis in hypertrophic cardiomyopathy.

OBJECTIVES: We investigated the significance of fibrosis detected by late gadolinium enhancement cardiovascular magnetic resonance for the prediction of major clinical events in hypertrophic cardiomyopathy (HCM). BACKGROUND: The role of myocardial fibrosis in the prediction of sudden death and heart failure in HCM is unclear with a lack of prospective data. METHODS: We assessed the presence and amount of myocardial fibrosis in HCM patients and prospectively followed them for the development of morbidity and mortality in patients over 3.1 +/- 1.7 years. RESULTS: Of 217 consecutive HCM patients, 136 (63%) showed fibrosis. Thirty-four of the 136 patients (25%) in the fibrosis group but only 6 of 81 (7.4%) patients without fibrosis reached the combined primary end point of cardiovascular death, unplanned cardiovascular admission, sustained ventricular tachycardia or ventricular fibrillation, or appropriate implantable cardioverter-defibrillator discharge (hazard ratio [HR]: 3.4, p = 0.006). In the fibrosis group, overall risk increased with the extent of fibrosis (HR: 1.18/5% increase, p = 0.008). The risk of unplanned heart failure admissions, deterioration to New York Heart Association functional class III or IV, or heart failure-related death was greater in the fibrosis group (HR: 2.5, p = 0.021), and this risk increased as the extent of fibrosis increased (HR: 1.16/5% increase, p = 0.017). All relationships remained significant after multivariate analysis. The extent of fibrosis and nonsustained ventricular tachycardia were univariate predictors for arrhythmic end points (sustained ventricular tachycardia or ventricular fibrillation, appropriate implantable cardioverter-defibrillator discharge, sudden cardiac death) (HR: 1.30, p = 0.014). Nonsustained ventricular tachycardia remained an independent predictor of arrhythmic end points after multivariate analysis, but the extent of fibrosis did not. CONCLUSIONS: In patients with HCM, myocardial fibrosis as measured by late gadolinium enhancement cardiovascular magnetic resonance is an independent predictor of adverse outcome. (The Prognostic Significance of Fibrosis Detection in Cardiomyopathy; NCT00930735).

Heart failure: the challenge of selecting patients for implantable cardioverter defibrillator therapy.

Patients with heart failure die predominantly of progressive pump failure or sudden cardiac death. Therefore, it is attractive to believe that an implantable cardioverter defibrillator (ICD) will dramatically reduce mortality by reducing sudden death. However, unfortunately it is not that simple; sudden death is not the same as ICD-preventable death. While ICD prophylaxis always reduces arrhythmic death, it does not always reduce all-cause mortality due to competing risks. Importantly, an arrhythmia may be a marker for heart failure decompensation, with patients at increased risk of heart failure death following shock therapy. Randomized trials have now demonstrated the potential benefits of ICDs in selected patients with left ventricular dysfunction, yet they have also failed to demonstrate benefit in populations where one might have expected to see benefit (e.g., early post-myocardial infarction). Device therapy can offer heart failure patients much more than just a simple shock box. The addition of a left ventricular lead to allow biventricular pacing (cardiac resynchronization therapy) improves symptoms and prolongs life in selected patients with QRS prolongation. Newer technologies allow remote monitoring through the device, which offers the potential to recognize heart failure decompensation or arrhythmias early so that appropriate treatment can be instituted. However, deciding which patient should receive an ICD remains one of the most challenging questions in cardiovascular medicine.