A systematic approach towards implementing value-based health care in heart failure: Understandings from retrospective analysis methods in South London.

BACKGROUND: Value-Based Health Care (VBHC) is an evolving model of healthcare delivery aimed at achieving better patient outcomes at lower costs to the healthcare provider. The practise of VBHC requires efficient information systems with good reporting capability and subsequent outcome measuring. Information systems within the National Health Service (NHS) are often multiple and not necessarily integrated to one another. We therefore developed a systematic approach to collecting, validating and analysing data from multiple sources and information systems, with the aim of designing and endorsing an automatic system to capture health outcomes data in heart failure to support future VBHC models. METHODS: A retrospective cohort of heart failure patients with reduced ejection fraction undergoing Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) procedures within a limited geographical area in South London were evaluated. A purpose built database was created to integrate, transform and validate health care data from multiple information systems. RESULTS: Validation analysis shows that our implemented methodology has produced a robust dataset. Our limited cohort of 134 patients does not allow for any complex statistical analysis however has identified some important themes related to outcomes and costs. CONCLUSION: We have created a validated database specific to our Trust that can be upscaled locally with ease and transferred to other health diseases. Due to variations in local procedure from one Trust to another, this methodology now requires implementation across multiple sites to understand differences in transformation of data and outcome measuring.

Noninvasive electrocardiographic assessment of ventricular activation and remodeling response to cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) produces acute changes in electric resynchronization that can be measured noninvasively with electrocardiographic body surface mapping (ECGi). The relation between baseline acute electrophysiology metrics and their manipulation with CRT and reverse remodeling is unclear. OBJECTIVE: To test (ECGi) derived parameters of electrical activation as predictors of volumetric response to CRT. METHODS: ECGi was performed in 21 patients directly following CRT implant. Activation parameters (left ventricular total activation time [LVtat], global biventricular total activation time [VVtat], global left/right ventricular electrical synchrony [VVsync], and global left ventricular dispersion of activation times [LVdisp]) were measured at baseline and following echocardiographically optimized CRT. Remodeling response (>15% reduction left ventricular end-systolic volume) was assessed 6 months post CRT. RESULTS: Patients were aged 68.9 ± 12.1 years, 81% were male, and 57% were ischemic. Baseline measures of dyssynchrony were more pronounced in left bundle branch block (LBBB) vs non-LBBB. ECGi demonstrated a trend of greater interventricular dyssynchrony between responders and nonresponders that did not reach statistical significance (VVsync: -45.7 ± 22.4 ms vs -25.1 ± 29.3 ms, P = .227). Remaining activation parameters were similar between responders and nonresponders (VVtat 101 ± 22.0 ms vs 98.9 ± 23.4 ms, P = .838; LVtat 86.4 ± 17.1 ms vs 85.1 ± 27.7 ms, P = .904; LVdisp 28.2 ± 6.3 ms vs 27.0 ± 8.7 ms, P = .726). In volumetric responders activation parameters were significantly improved with CRT compared to nonresponders: VV sync (-45.67 ± 22.41 ms vs 2.33±18.87 ms, P = .001), VVtat (101 ± 22.04 ms vs 71 ± 14.01 ms, P = .002), LVtat (86.44 ± 17.15 ms vs 67.67 ± 11.31 ms, P = .006), and LVdisp (28.22 ± 6.3 ms vs 21.56 ± 4.45 ms, P = .008). CONCLUSION: Baseline ECGi activation times did not predict CRT volumetric response. Volumetric responders exhibited significant improvements in ECGi-derived metrics with CRT. ECGi does not select CRT candidates but may be a useful adjunct to guide left ventricle lead implants and to perform postimplant CRT optimization.

Clinical effectiveness of a dedicated cardiac resynchronization therapy pre-assessment clinic incorporating cardiac magnetic resonance imaging and cardiopulmonary exercise testing on patient selection and outcomes.

BACKGROUND: Pre-procedural assessment of patients undergoing cardiac resynchronization therapy (CRT) is heterogenous and patients implanted with unfavorable characteristics may account for non-response. A dedicated CRT pre-assessment clinic (CRT PAC) was developed to standardize the review process and undertake structured pre-procedural evaluation. The aim of this analysis was to determine the effectiveness on patient selection and outcomes. METHODS: A prospective database of consecutive patients attending the CRT PAC between 2013 and 2018 was analyzed. Pre-operative assessment included cardiac magnetic resonance (CMR) and cardiopulmonary exercise testing (CPET). Patients were considered CRT responders based on improvement in clinical composite score (CCS) and/or reduction in left ventricular end-systolic volume (LVESV) ≥ 15% at 6-months follow-up. RESULTS: Of 252 patients reviewed in the CRT PAC during the analysis period, 192 fulfilled consensus guidelines for implantation. Of the patients receiving CRT, 82% showed improvement in their CCS and 57% had a reduction in LVESV ≥ 15%. The presence of subendocardial scar on CMR and a peak VO2 ≤ 12 ml/kg/min on CPET predicted CRT non-response. Two patients were unsuitable for CRT as they had end-stage heart failure and died during follow-up. The majority of patients initially deemed unsuitable for CRT did not suffer from unexpected hospitalization for decompensated heart failure or died from cardiovascular disease; only 8 patients (13%) received CRT devices during follow-up because of symptomatic left ventricular systolic impairment. CONCLUSION: A dedicated CRT PAC is able to appropriately select patients for CRT. Pre-procedural investigation/imaging can identify patients unlikely to respond to, or may not yet be suitable for CRT.

Economic evaluation of a dedicated cardiac resynchronisation therapy preassessment clinic.

INTRODUCTION: Patient evaluation before cardiac resynchronisation therapy (CRT) remains heterogeneous across centres and it is suspected a proportion of patients with unfavourable characteristics proceed to implantation. We developed a unique CRT preassessment clinic (CRT PAC) to act as a final review for patients already considered for CRT. We hypothesised that this clinic would identify some patients unsuitable for CRT through updated investigations and review. The purpose of this analysis was to determine whether the CRT PAC led to savings for the National Health Service (NHS). METHODS: A decision tree model was made to evaluate two clinical pathways; (1) standard of care where all patients initially seen in an outpatient cardiology clinic proceeded directly to CRT and (2) management of patients in CRT PAC. RESULTS: 244 patients were reviewed in the CRT PAC; 184 patients were eligible to proceed directly for implantation and 48 patients did not meet consensus guidelines for CRT so were not implanted. Following CRT, 82.4% of patients had improvement in their clinical composite score and 57.7% had reduction in left ventricular end-systolic volume ≥15%. Using the decision tree model, by reviewing patients in the CRT PAC, the total savings for the NHS was £966 880. Taking into consideration the additional cost of the clinic and by applying this model structure throughout the NHS, the potential savings could be as much as £39 million. CONCLUSIONS: CRT PAC appropriately selects patients and leads to substantial savings for the NHS. Adopting this clinic across the NHS has the potential to save £39 million.

Economic impact of introducing TYRX amongst patients with heart failure and reduced ejection fraction undergoing implanted cardiac device procedures: a retrospective model based cost analysis.

BACKGROUND AND AIMS: Infection is a serious and expensive complication of Cardiac Implantable Electronic Device (CIED) procedures. A retrospective based cost analysis was performed to estimate Trust level savings of using the TYRX antibacterial envelope as a primary prevention measure against infection in a tertiary referral centre in South London, UK. METHODS: A retrospective cohort of heart failure patients with reduced ejection fraction undergoing Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) procedures were evaluated. Decision-analytic modelling was performed to determine economic savings of using the envelope during CIED procedure vs CIED procedure alone. RESULTS: Over a 12 month follow-up period following CIED procedure, the observed infection rate was 3.14% (n = 5/159). The average cost of a CIED infection inpatient admission was £41,820 and, further to economic analysis, the additional costs attributable to infection was calculated at £62,213.94. A cost saving of £624 per patient by using TYRX during CIED procedure as a primary preventative measure against infection was estimated. CONCLUSIONS: TYRX would be a cost-saving treatment option amongst heart failure patients undergoing ICD and CRT device procedures based on analysis in the local geographical area of South London. If upscaled to the UK population, we estimate potential cost savings for the National Health Service (NHS).

A cost effectiveness study establishing the impact and accuracy of implementing the NICE guidelines lowering plasma NTproBNP threshold in patients with clinically suspected heart failure at our institution.

AIMS: The 2014 National Institute of Clinical Excellence (NICE) guidelines on the management of acute heart failure recommended using a plasma NT-proBNP threshold of 300pg/ml to assist in ruling out the diagnosis of heart failure (HF), updating previous guidelines recommending using a threshold of 400pg/ml. NICE based their recommendations on 6 studies performed in other countries. This study sought to determine the diagnostic and economic implications of using these thresholds in a large unselected UK population. METHODS: Patient and clinical demographics were recorded for all consecutive suspected HF patients over 12months, as well as clinical outcomes including time to HF hospitalisation and time to death (follow up 15.8months). RESULTS: Of 1995 unselected patients admitted with clinically suspected HF, 1683 (84%) had a NTproBNP over the current NICE recommended threshold, of which 35% received a final diagnosis of HF. Lowering the threshold from 400 to 300pg/ml would have involved screening an additional 61 patients and only would have identified one new patient with HF (sensitivity 0.985, NPV 0.976, area under the curve (AUC) at 300pg/ml 0.67; sensitivity 0.983, NPV 0.977, AUC 0.65 at 400pg/ml). The economic implications of lowering the threshold would have involved additional costs of £42,842.04 (£702.33 per patient screened, or £ 42,824.04 per new HF patient). CONCLUSION: Applying the recent updated NICE guidelines to an unselected real world population increases the AUC but would have a significant economic impact and only identified one new patient with heart failure.

Non-invasive Model-Based Assessment of Passive Left-Ventricular Myocardial Stiffness in Healthy Subjects and in Patients with Non-ischemic Dilated Cardiomyopathy.

Patient-specific modelling has emerged as a tool for studying heart function, demonstrating the potential to provide non-invasive estimates of tissue passive stiffness. However, reliable use of model-derived stiffness requires sufficient model accuracy and unique estimation of model parameters. In this paper we present personalised models of cardiac mechanics, focusing on improving model accuracy, while ensuring unique parametrisation. The influence of principal model uncertainties on accuracy and parameter identifiability was systematically assessed in a group of patients with dilated cardiomyopathy ([Formula: see text]) and healthy volunteers ([Formula: see text]). For all cases, we examined three circumferentially symmetric fibre distributions and two epicardial boundary conditions. Our results demonstrated the ability of data-derived boundary conditions to improve model accuracy and highlighted the influence of the assumed fibre distribution on both model fidelity and stiffness estimates. The model personalisation pipeline-based strictly on non-invasive data-produced unique parameter estimates and satisfactory model errors for all cases, supporting the selected model assumptions. The thorough analysis performed enabled the comparison of passive parameters between volunteers and dilated cardiomyopathy patients, illustrating elevated stiffness in diseased hearts.

Limited availability of cardiac rehabilitation for heart failure patients in the United Kingdom: findings from a national survey.

BACKGROUND: Participation of patients with heart failure in cardiac rehabilitation in the UK is low. This study investigated the availability of cardiac rehabilitation services for patients with heart failure in the UK and the views of service coordinators on ideal service models. DESIGN: Our study was a cross-sectional national postal survey that was mailed to 342 service coordinators in the UK between April and June 2009. METHODS: We developed a 38-item questionnaire to survey all cardiac rehabilitation service coordinators on the National Audit of Cardiac Rehabilitation register in the UK in 2009. RESULTS: The survey response rate was 71% (244/342). Forty three per cent (105/244) of coordinators did not accept patients with heart failure to their cardiac rehabilitation services. Most coordinators who did accept patients with heart failure offered their services to patients with a variety of cardiac conditions, though referral criteria and models of care varied widely. Services inconsistently used New York Heart Association classes and left ventricular ejection fraction measures to select patients. Few offered separate dedicated heart failure programmes (14%; 33/244) but where these existed they ran for longer than programmes which included patients with heart failure alongside other cardiac patients (10.9 vs 8.5 weeks; F = 4.04; p = 0.019). Few offered home-based options for patients with heart failure (11%; 27/244). Coordinators accepting patients with heart failure to their cardiac rehabilitation services tended to agree that patients with heart failure should be included in services alongside other cardiac patients (χ(2) = 6.2; p = 0.013). CONCLUSIONS: There is limited access for patients with heart failure to cardiac rehabilitation in the UK. Local policies on referral and selection criteria differ and reflect coordinators' views rather than clinical guidance.

Multi-site left ventricular pacing as a potential treatment for patients with postero-lateral scar: insights from cardiac magnetic resonance imaging and invasive haemodynamic assessment.

AIMS: Multi-site left ventricular (LV) pacing may be superior to single-site stimulation in correcting dyssynchrony and avoiding areas of myocardial scar. We sought to characterize myocardial scar using cardiac magnetic resonance imaging (CMR). We aimed to quantify the acute haemodynamic response to single-site and multi-site LV stimulation and to relate this to the position of the LV leads in relation to myocardial scar. METHODS: Twenty patients undergoing cardiac resynchronization therapy had implantation of two LV leads. One lead (LV1) was positioned in a postero-lateral vein, the second (LV2) in a separate coronary vein. LV dP/dtmax was recorded using a pressure wire during stimulation at LV1, LV2, and both sites simultaneously (LV1 + 2). Patients were deemed acute responders if ΔLV dP/dtmax was ≥ 10%. Cardiac magnetic resonance imaging was performed to assess dyssynchrony as well as location and burden of scar. Scar anatomy was registered with fluoroscopy to assess LV lead position in relation to scar. RESULTS: LV dP/dtmax increased from 726 ± 161 mmHg/s in intrinsic rhythm to 912 ± 234 mmHg/s with LV1, 837 ± 188 mmHg/s with LV2, and 932 ± 201 mmHg/s with LV1 and LV2. Nine of 19 (47%) were acute responders with LV1 vs. 6/19 (32%) with LV2. Twelve of 19 (63%) were acute responders with simultaneous LV1 + 2. Two of three patients benefitting with multi-site pacing had the LV1 lead positioned in postero-lateral scar. CONCLUSION: Multi-site LV pacing increased acute response by 16% vs. single-site pacing. This was particularly beneficial in patients with postero-lateral scar identified on CMR.