Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease.

AIMS: We aimed to perform a cost analysis of drug coated balloon (DCB)-only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications. BACKGROUND: DCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost-effectiveness of DCB-only angioplasty for treatment of de novo coronary artery disease as compared with second generation DES. METHODS: We compared total costs of patients treated with DCB or DES for first presentation of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or stable angina due to de novo disease between January 1, 2018 and November 15, 2019. We defined total cost as the sum of (1) procedural devices-cost, (2) procedural staff-cost, (3) post-percutaneous coronary intervention hospital stay cost, and (4) antiplatelet regime cost. A cost minimization analysis was performed to compare the costs of DCB and DES. RESULTS: We present 1952 all-comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1236 lesions) treated with DES for de novo coronary artery disease. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 vs. £3143.98). However, the cost per lesion treated was calculated to be £15.51 cheaper in the DCB group (£3007.56 vs. £3023.07). The results were consistent irrespective of duration of long-term antiplatelet medications. CONCLUSION: We have compared the cost-effectiveness of DCB-only angioplasty to DES-angioplasty and showed that the per patient and per lesion results were not different and hence cost should not be implicated in the decision to choose DCB or DES.

Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)-only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI. OBJECTIVES: The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI. METHODS: All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching. RESULTS: Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score-matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR. CONCLUSIONS: DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972).

The Importance of Mitral Valve Prolapse Doming Volume in the Assessment of Left Ventricular Stroke Volume with Cardiac MRI.

There remains a debate whether the ventricular volume within prolapsing mitral valve (MV) leaflets should be included in the left ventricular (LV) end-systolic volume, and therefore factored in LV stroke volume (SV), in cardiac magnetic resonance (CMR) assessments. This study aims to compare LV volumes during end-systolic phases, with and without the inclusion of the volume of blood on the left atrial aspect of the atrioventricular groove but still within the MV prolapsing leaflets, against the reference LV SV by four-dimensional flow (4DF). A total of 15 patients with MV prolapse (MVP) were retrospectively enrolled in this study. We compared LV SV with (LV SVMVP) and without (LV SVstandard) MVP left ventricular doming volume, using 4D flow (LV SV4DF) as the reference value. Significant differences were observed when comparing LV SVstandard and LV SVMVP (p < 0.001), and between LV SVstandard and LV SV4DF (p = 0.02). The Intraclass Correlation Coefficient (ICC) test demonstrated good repeatability between LV SVMVP and LV SV4DF (ICC = 0.86, p < 0.001) but only moderate repeatability between LV SVstandard and LV SV4DF (ICC = 0.75, p < 0.01). Calculating LV SV by including the MVP left ventricular doming volume has a higher consistency with LV SV derived from the 4DF assessment. In conclusion, LV SV short-axis cine assessment incorporating MVP dooming volume can significantly improve the precision of LV SV assessment compared to the reference 4DF method. Hence, in cases with bi-leaflet MVP, we recommend factoring in MVP dooming into the left ventricular end-systolic volume to improve the accuracy and precision of quantifying mitral regurgitation.

Current quality of life assessment tools may not fully address dermatological adverse events from anti-cancer therapies.

Supportive oncodermatology is a burgeoning new field within dermatology tasked with caring for the unique dermatologic needs of patients with cancer. Patients with dermatologic adverse events (dAEs) from localized and systemic anti-cancer therapies commonly experience significant distress and reduced health-related quality of life (HRQoL). Emerging dAEs is often overlooked by clinicians and researchers, despite their considerable impacts on treatment completion and patient self-esteem. Specific HRQoL issues experienced by cancer patients with dAEs include psychosocial distress and treatment interruption or cessation. Existing HRQoL assessment indices unfortunately fall short when assessing HRQoL in patients with dAEs from anti-cancer therapies due to the lack of specificity to patients' symptoms and inability to fully encompass the unique needs of this population. Additionally, the variability in HRQoL assessments across studies is substantial, suggesting the need for a standardized HRQoL measure. Here, we review the burden of dAEs and the existing validated tools used to measure them, while outlining strategies for modification to achieve optimal HRQoL assessment in patients with dAEs from anti-cancer therapies and address the HRQoL gap in supportive oncodermatology. Amongst the current tools, Skindex-16 most closely addresses the required skin-specific HRQoL metrics, but still lacks a few key cancer-specific measures. Other general HRQoL tools are well-tailored to cancer patients, but lack skin-specific questions.

Kat-ARC accelerated 4D flow CMR: clinical validation for transvalvular flow and peak velocity assessment.

BACKGROUND: To validate the k-adaptive-t autocalibrating reconstruction for Cartesian sampling (kat-ARC), an exclusive sparse reconstruction technique for four-dimensional (4D) flow cardiac magnetic resonance (CMR) using conservation of mass principle applied to transvalvular flow. METHODS: This observational retrospective study (2020/21-075) was approved by the local ethics committee at the University of East Anglia. Consent was waived. Thirty-five patients who had a clinical CMR scan were included. CMR protocol included cine and 4D flow using Kat-ARC acceleration factor 6. No respiratory navigation was applied. For validation, the agreement between mitral net flow (MNF) and the aortic net flow (ANF) was investigated. Additionally, we checked the agreement between peak aortic valve velocity derived by 4D flow and that derived by continuous-wave Doppler echocardiography in 20 patients. RESULTS: The median age of our patient population was 63 years (interquartile range [IQR] 54-73), and 18/35 (51%) were male. Seventeen (49%) patients had mitral regurgitation, and seven (20%) patients had aortic regurgitation. Mean acquisition time was 8 ± 4 min. MNF and ANF were comparable: 60 mL (51-78) versus 63 mL (57-77), p = 0.310). There was an association between MNF and ANF (rho = 0.58, p < 0.001). Peak aortic valve velocity by Doppler and 4D flow were comparable (1.40 m/s, [1.30-1.75] versus 1.46 m/s [1.25-2.11], p = 0.602) and also correlated with each other (rho = 0.77, p < 0.001). CONCLUSIONS: Kat-ARC accelerated 4D flow CMR quantified transvalvular flow in accordance with the conservation of mass principle and is primed for clinical translation.

Diagnostic accuracy of handheld cardiac ultrasound device for assessment of left ventricular structure and function: systematic review and meta-analysis.

OBJECTIVE: Handheld ultrasound devices (HUD) has diagnostic value in the assessment of patients with suspected left ventricular (LV) dysfunction. This meta-analysis evaluates the diagnostic ability of HUD compared with transthoracic echocardiography (TTE) and assesses the importance of operator experience. METHODS: MEDLINE and EMBASE databases were searched in October 2020. Diagnostic studies using HUD and TTE imaging to determine LV dysfunction were included. Pooled sensitivities and specificities, and summary receiver operating characteristic curves were used to determine the diagnostic ability of HUD and evaluate the impact of operator experience on test accuracy. RESULTS: Thirty-three studies with 6062 participants were included in the meta-analysis. Experienced operators could predict reduced LV ejection fraction (LVEF), wall motion abnormality (WMA), LV dilatation and LV hypertrophy with pooled sensitivities of 88%, 85%, 89% and 85%, respectively, and pooled specificities of 96%, 95%, 98% and 91%, respectively. Non-experienced operators are able to detect cardiac abnormalities with reasonable sensitivity and specificity. There was a significant difference in the diagnostic accuracy between experienced and inexperienced users in LV dilatation, LVEF (moderate/severe) and WMA. The diagnostic OR for LVEF (moderate/severe), LV dilatation and WMA in an experienced hand was 276 (95% CI 58 to 1320), 225 (95% CI 87 to 578) and 90 (95% CI 31 to 265), respectively, compared with 41 (95% CI 18 to 94), 45 (95% CI 16 to 123) and 28 (95% CI 20 to 41), respectively, for inexperienced users. CONCLUSION: This meta-analysis is the first to establish HUD as a powerful modality for predicting LV size and function. Experienced operators are able to accurately diagnose cardiac disease using HUD. A cautious, supervised approach should be implemented when imaging is performed by inexperienced users. This study provides a strong rationale for considering HUD as an auxiliary tool to physical examination in secondary care, to aid clinical decision making when considering referral for TTE. TRIAL REGISTRATION NUMBER: CRD42020182429.

Left Ventricular Blood Flow Kinetic Energy Assessment by 4D Flow Cardiovascular Magnetic Resonance: A Systematic Review of the Clinical Relevance.

Background: There is an emerging body of evidence that supports the potential clinical value of left ventricular (LV) intracavity blood flow kinetic energy (KE) assessment using four-dimensional flow cardiovascular magnetic resonance imaging (4D flow CMR). The aim of this systematic review is to summarize studies evaluating LV intracavity blood flow KE quantification methods and its potential clinical significance. Methods: A systematic review search was carried out on Medline, Pubmed, EMBASE and CINAHL. Results: Of the 677 articles screened, 16 studies met eligibility. These included six (37%) studies on LV diastolic function, another six (37%) studies on heart failure or cardiomyopathies, three (19%) studies on ischemic heart disease or myocardial infarction and finally, one (6%) study on valvular heart disease, namely, mitral regurgitation. One of the main strengths identified by these studies is high reproducibility of LV blood flow KE hemodynamic assessment (mean coefficient of variability = 6 ± 2%) for the evaluation of LV diastolic function. Conclusions: The evidence gathered in this systematic review suggests that LV blood flow KE has great promise for LV hemodynamic assessment. Studies showed increased diagnostic confidence at no cost of additional time. Results were highly reproducible with low intraobserver variability.

Management of metastatic bone disease in the elderly with bisphosphonates and receptor activator of NF-kB ligand inhibitors: effectiveness and safety.

The life expectancy of Western populations has risen in the last few decades, resulting in a steep increase in the number of elderly cancer patients. Metastatic bone disease (MBD) is an important problem in such patients as it is associated with the development of skeletal-related events (SREs), such as fractures and spinal cord compression. These complications do not only deteriorate the quality of life of affected patients, but can also reduce expected survival. Due to the fact that elderly patients have an increased risk of SREs, maintaining bone health and implementing effective treatments for managing MBD is of vital importance. Bisphosphonates have been shown to be effective in reducing the risk of SREs considerably in patients with MBD. Moreover, they have been shown to reduce pain and improve the quality of life of affected patients. Bisphosphonates should be used with caution in elderly patients due to the fact that their use can bring about renal function deterioration. Several preventive measures need to be followed in order to minimise the risk of this complication. Denosumab is a monoclonal antibody inhibiting receptor activator of NF-kB ligand and has shown superiority over zoledronic acid in reducing the risk of SREs. In the three comparative trials between denosumab and zoledronic acid, survival and disease progression were similar between the two groups. Denosumab has been shown not to affect renal function and can therefore be safely used in the elderly. Osteonecrosis of the jaws is a devastating complication that may occur after treatment with either denosumab or zoledronic acid. The incidence rates between the two are comparable and percentage differences not statistically significant. In the three randomised trials, hypocalcaemia occurred more frequently in denosumab-treated patients than in those managed with zoledronic acid, with the corresponding percentages being 5.5-13% versus 3.4-6%. In order to minimise the risk of osteonecrosis of the jaws and hypocalcaemia, all precautionary measures and treatment guidelines should be followed closely. Several studies have investigated the cost-effectiveness of denosumab versus zoledronic acid when used for SRE prevention. These studies reported contradictory results due to the application of different analytical perspectives and model parameters.

International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases.

BACKGROUND: The objective of this international field study was to test the reliability, validity, and responsiveness of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 module to assess health-related quality of life (HRQOL) in patients with bone metastases. METHODS: Patients undergoing a variety of bone metastases-specific treatments were accrued. The QLQ-BM22 was administered with the QLQ-C30 at baseline and at 1 follow-up time point internationally. A debriefing questionnaire was administered to determine patient acceptability and understanding. RESULTS: Large-scale field testing of the QLQ-BM22 in addition to the QLQ-C30 took place in 7 countries: Brazil, Canada, Cyprus, Egypt, France, India, and Taiwan. A total of 400 patients participated. Multitrait scaling analyses confirmed 4 scales in the 22-item module. The scales were able to discriminate between clinically distinct patient groups, such as between those with a poor and those with a better performance status. The QLQ-BM22 was well received in all 7 countries, and the majority of patients did not recommend any significant changes from the module in its current form. CONCLUSIONS: The final QLQ-BM22 module contains 22 items and 4 scales assessing Painful Sites, Painful Characteristics, Functional Interference, and Psychosocial Aspects. Results confirmed the validity, reliability, cross-cultural applicability, and sensitivity of the 22-item EORTC QLQ-BM22. It is therefore recommended that the QLQ-BM22 be used in addition to the QLQ-C30 in clinical trials to assess HRQOL in patients with bone metastases.

Combination ibandronate and radiotherapy for the treatment of bone metastases: clinical evaluation and radiologic assessment.

PURPOSE: Ibandronate is a single-nitrogen, noncyclic bisphosphonate with proven efficacy for reducing metastatic bone pain. In this study, we assessed the palliative effects of combined ibandronate and radiotherapy. METHODS AND MATERIALS: Forty-five patients with bone metastases from various solid tumors received external-beam radiotherapy, 30-40 Gy over 3-4.5, weeks combined with 10 cycles of monthly intravenous ibandronate, 6 mg. RESULTS: After combined therapy, mean bone pain scores (graded from 0 to 10) were reduced from 6.3 at baseline to 0.8 after 3 months, with further reductions at later time points (all p < 0.001). Opioid use decreased from 84% of patients at baseline (38/45) to 24% (11/45) at 3 months, with further subsequent reductions (all p < 0.001). Mean performance status and functioning scores also significantly improved. Bone density (assessed by computed tomography scan) increased by 20% vs. baseline at 3 months, 46% at 6 months, and 73% at 10 months (all p < 0.001). Lesion improvement was also demonstrated by magnetic resonance imaging. Treatment was well tolerated with no renal toxicity. CONCLUSIONS: In this pilot study, combined radiotherapy and ibandronate provided substantial bone pain relief and increased bone density. Computed tomography-based or magnetic resonance imaging-based evaluations offer objective methods for assessing therapeutic outcomes.