Coronary risk of patients with valvular heart disease: prospective validation of CT-Valve Score.

OBJECTIVE: To prospectively validate the CT-Valve score, a new risk score designed to identify patients with valvular heart disease at a low risk of coronary artery disease (CAD) who could benefit from multislice CT (MSCT) first instead of coronary angiography (CAG). METHODS: This was a prospective cohort study of patients referred for valve surgery in the Capital Region of Denmark and Odense University Hospital from the 1 February 2015 to the 1 February 2017. MSCT was implemented for patients with a CT-Valve score ≤7 at the referring physician's discretion. Patients with a history of CAD or chronic kidney disease were excluded. The primary outcome was the proportion of patients needing reevaluation with CAG after MSCT and risk of CAD among the patients determined to be low to intermediate risk. RESULTS: In total, 1149 patients were included. The median score was 9 (IQR 3) and 339 (30%) had a score ≤7. MSCT was used for 117 patients. Of these 29 (25%) were reevaluated and 9 (7.7%) had CAD. Of the 222 patients with a score ≤7 that did not receive an MSCT, 14 (6%) had significant CAD. The estimated total cost of evaluation among patients with a score ≤7 before implementation was €132 093 compared with €79 073 after, a 40% reduction. Similarly, estimated total radiation before and after was 608 mSv and 362 mSv, a 41% reduction. Follow-up at a median of 32 months (18-48) showed no ischaemic events for patients receiving only MSCT. CONCLUSION: The CT-Valve score is a valid method for determining risk of CAD among patients with valvular heart disease. Using a score ≤7 as a cut-off for the use of MSCT is safe and cost-effective.

Clinical Evaluation of Onrad, A New Low-cost Version of TomoTherapy that Uses Only Static Beams.

OBJECTIVE: This study evaluated the clinical feasibility of a new low-cost TomoTherapy system (OnradTM) and compared it with low-cost linear accelerator models (linacs). METHODS: Various aspects of treatment and cost were compared between Onrad and linacs for 3-dimensional radiotherapy (3DCRT). Dosimetric comparisons of 10 patients each with breast, stage III lung, prostate, head and neck, and cervical cancers were carried out (total 100 plans). RESULTS: Onrad had advantages in terms of availability of long treatment fields and a smaller mechanical footprint. For breast cancers and lung cancers, target dose homogeneity in Onrad plans was better than that in 3DCRT. In the prostate plans, Onrad plans provided superior D95, conformity and homogeneity. The rectum doses of Onrad plans were lower than those with 3DCRT. Onrad plans provided superior homogeneity and D95 in head and neck cancer. The mean dose and V10-40 Gy of the parotid glands was lower using Onrad. In the cervical cancer plans, target doses were similar with both systems. Normal tissue doses were equal. CONCLUSIONS: Onrad is useful in the clinical setting. Onrad can achieve favorable or comparable dose distributions compared with those of 3DCRT in actual clinical treatment of breast, lung, prostate, head and neck, and cervical cancers.

PET-PANC: multicentre prospective diagnostic accuracy and health economic analysis study of the impact of combined modality 18fluorine-2-fluoro-2-deoxy-d-glucose positron emission tomography with computed tomography scanning in the diagnosis and management of pancreatic cancer.

BACKGROUND: Pancreatic cancer diagnosis and staging can be difficult in 10-20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer. OBJECTIVE: To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer. DESIGN: A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy. PARTICIPANTS: Patients with suspected pancreatic malignancy. INTERVENTIONS: All patients to undergo PET/CT following standard diagnostic work-up. MAIN OUTCOME MEASURES: The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients' diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours. RESULTS: Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUVmax.) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity (p = 0.01) and specificity (p = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all scenarios (p < 0.0002). PET/CT correctly changed the staging of pancreatic cancer in 56 patients (p = 0.001). PET/CT influenced management in 250 (45%) patients. PET/CT stopped resection in 58 (20%) patients who were due to have surgery. The benefit of PET/CT was limited in patients with chronic pancreatitis or other pancreatic tumours. PET/CT was associated with a gain in quality-adjusted life-years of 0.0157 (95% confidence interval -0.0101 to 0.0430). In the base-case model PET/CT was seen to dominate MDCT alone and is thus highly likely to be cost-effective for the UK NHS. PET/CT was seen to be most cost-effective for the subgroup of patients with suspected pancreatic cancer who were thought to be resectable. CONCLUSION: PET/CT provided a significant incremental diagnostic benefit in the diagnosis of pancreatic cancer and significantly influenced the staging and management of patients. PET/CT had limited utility in chronic pancreatitis and other pancreatic tumours. PET/CT is likely to be cost-effective at current reimbursement rates for PET/CT to the UK NHS. This was not a randomised controlled trial and therefore we do not have any information from patients who would have undergone MDCT only for comparison. In addition, there were issues in estimating costs for PET/CT. Future work should evaluate the role of PET/CT in intraductal papillary mucinous neoplasm and prognosis and response to therapy in patients with pancreatic cancer. STUDY REGISTRATION: Current Controlled Trials ISRCTN73852054 and UKCRN 8166. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

BACKGROUND: Stroke after cardiac surgery is a severe complication with a persistently high incidence of 1.4 - 9.7%. Postoperative strokes are mainly embolic and can be provoked by manipulation and clamping of the aorta during cardiac surgery, resulting in the mobilization of atherothrombotic material and calcifications from the aortic wall. Computed tomography (CT) can offer preoperative visualization of aortic calcifications with low radiation exposure. We hypothesize that preoperative knowledge regarding the location and extent of aortic calcifications can be used to optimize surgical strategy and decrease postoperative stroke rate. METHODS/DESIGN: The CRICKET study (ultra low-dose chest CT with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery) is a prospective multicenter randomized clinical trial to evaluate whether non-contrast chest CT before cardiac surgery can decrease postoperative stroke rate by optimizing surgical strategy. Patients scheduled to undergo cardiac surgery aged 18 years and older are eligible for inclusion. Exclusion criteria are pregnancy, a chest/cardiac CT in the past three months, emergency surgery, concomitant or prior participation in a study with ionizing radiation and unwillingness to be informed about incidental findings. Subjects (n = 1.724) are randomized between routine care, including a chest x-ray, or routine care with an additional low dose chest CT. The primary objective is to investigate whether the postoperative in-hospital stroke rate is reduced in the CT arm compared to the routine care arm of the randomized trial. The secondary outcome measures are altered surgical approach based on CT findings and cost-effectiveness.

Current role of cardiac and extra-cardiac pathologies in clinically indicated cardiac computed tomography with emphasis on status before pulmonary vein isolation.

PURPOSE: The aim of this study was to assess the incidence of cardiac and significant extra-cardiac findings in clinical computed tomography of the heart in patients with atrial fibrillation before pulmonary vein isolation (PVI). MATERIALS AND METHODS: 224 patients (64 ±â€Š10 years; male 63 %) with atrial fibrillation were examined by cardiac 64-slice multidetector CT before PVI. Extra-cardiac findings were classified as "significant" if they were recommended to additional diagnostics or therapy, and otherwise as "non-significant". Additionally, cardiac findings were documented in detail. RESULTS: A total of 724 cardiac findings were identified in 203 patients (91 % of patients). Additionally, a total of 619 extra-cardiac findings were identified in 179 patients (80 % of patients). Among these extra-cardiac findings 196 (32 %) were "significant", and 423 (68 %) were "non-significant". In 2 patients (1 %) a previously unknown malignancy was detected (esophageal cancer and lung cancer, local stage, no metastasis). 203 additional imaging diagnostics followed to clarify the "significant" findings (124 additional CT, costs 38 314.69 US dollars). Overall, there were 3.2 cardiac and 2.8 extra-cardiac findings per patient. Extra-cardiac findings appear significantly more frequently in patients over 60 years old, in smokers and in patients with a history of cardiac findings (p <0.05). CONCLUSION: Cardiac CT scans before PVI should be screened for extracardiac incidental findings that could have important clinical implications for each patient.

Cost-effectiveness analysis of 64-slice computed tomography vs. cardiac catheterization to rule out coronary artery disease before non-coronary cardiovascular surgery.

AIMS: To explore the cost-effectiveness of two alternative strategies to rule out significant coronary artery disease (CAD) in the pre-operative evaluation of non-coronary cardiovascular surgery: initial pre-operative coronary 64-slice computed tomography angiography (CCTA) vs. invasive coronary angiography (ICA). METHODS AND RESULTS: These diagnostic strategies are compared from the clinical and payee's perspective, on the basis of the results of four European studies including 490 patients, by an analytic model of a decision tree in terms of the cost-effectiveness as the percentage of catheterizations, complications, and deaths avoided. These studies show that 71.2% of the ICA and 3.56% of the post-ICA complications could have been avoided by an initial pre-operative CCTA with a saving of €411/patient. The sensitivity analysis did not find relevant differences in terms of the cost-effectiveness when we established the indication of ICA vs. CCTA in relation to the amount of coronary calcium and when ICA was always performed by radial access. However, the lack of team experience in CCTA increased the economical and biological cost due to involving an ICA and the exposure to double ionizing radiation sources. CONCLUSION: In experienced groups, the diagnostic strategy with initial pre-operative CCTA is better than the strategy with initial ICA because it is capable of ruling out significant CAD avoiding ICA and post-ICA morbidity-mortality, with an important saving in the cost of the diagnostic process.

Pre-operative CT coronary angiography in patients with mitral valve prolapse referred for surgical repair: comparison of accuracy, radiation dose and cost versus invasive coronary angiography.

BACKGROUND: The aims of this study are to evaluate the accuracy of low dose multidetector computed tomography coronary angiography (MDCT) versus invasive coronary angiography (ICA) in ruling out CAD in patients with mitral valve prolapse and severe mitral regurgitation (MVP) before cardiac surgery and to compare the overall effective radiation dose (ED) and cost of a diagnostic approach in which conventional ICA should be performed only in patients with significant CAD as detected by MDCT. METHODS: Eighty patients with MVP and without history of CAD were randomized to MDCT (Group 1) or ICA (Group 2) to rule out CAD before surgery. However, ICA was also performed as gold standard reference in Group 1 to test the diagnostic accuracy of MDCT. A diagnostic work-up A in whom all patients underwent low-dose MDCT as initial diagnostic test and those with positive findings were referred for ICA was compared with work-up B in which all patients were referred for ICA according to the standard of care in terms of ED and cost. RESULTS: The two groups were homogeneous in terms of gender, age and body mass index. The overall feasibility and accuracy in a patient-based model were 99% and 93%, respectively. The overall ED and costs were significantly lower in diagnostic work-up A compared to diagnostic work-up B. CONCLUSIONS: The accuracy of low dose MDCT for ruling out the presence of significant CAD in patients undergoing elective valve surgery for mitral valve prolapse is excellent with a reduction of overall radiation dose exposure and costs.

Relationship between routine multi-detector cardiac computed tomographic angiography prior to reoperative cardiac surgery, length of stay, and hospital charges.

While multi-detector cardiac computed tomography angiography (MDCCTA) prior to reoperative cardiac surgery (RCS) has been associated with improved clinical outcomes, its impact on hospital charges and length of stay remains unclear. We studied 364 patients undergoing RCS at Washington Hospital Center between 2004 and 2008, including 137 clinically referred for MDCCTA. Baseline demographics, procedural data, and perioperative outcomes were recorded at the time of the procedure. The primary clinical endpoint was the composite of perioperative death, myocardial infarction (MI), stroke, and hemorrhage-related reoperation. Secondary clinical endpoints included surgical procedural variables and the perioperative volume of bleeding and transfusion. Length of stay was determined using the hospital's electronic medical record. Cost data were extracted from the hospital's billing summary. Analysis was performed on individual categories of care, as well as on total hospital charges. Data were compared between subjects with and without MDCCTA, after adjustment for the Society of Thoracic Surgeons score. Baseline characteristics were similar between the two groups. MDCCTA was associated with shorter procedural times, shorter intensive care unit stays, fewer blood transfusions, and less frequent perioperative MI. There was additionally a trend towards a lower incidence of the primary endpoint (17.5 vs. 24.2 %, p = 0.13) primarily due to a lower incidence of perioperative MI (0 vs. 5.7 %, p = 0.002). MDCCTA was also associated with lower median recovery room [$1,325 (1,250-3,302) vs. $3,217 (1,325-5,353) p < 0.001] and nursing charges [$6,335 (3,623-10,478) vs. $6,916 (3,915-14,499) p = 0.03], although operating room charges were higher [$24,100 (22,300-29,700) vs. $23,500 (19,900-27,700) p < 0.05]. Median total charges [$127,000 (95,000-188,000) vs. $123,000 (86,800-226,000) p = 0.77] and length of stay [9 days (6-19) vs. 11 days (7-19), p = 0.21] were similar. Means analysis demonstrated a strong trend towards lower mean total hospital charges [$163,000 (108,426) vs. $192,000 (181,706), p = 0.06] in the MDCCTA group. In conclusion, preoperative MDCCTA is associated with a number of improved perioperative outcomes and does not significantly effect the length of stay or total hospital charges during the index hospitalization.

Cost-effectiveness of computed tomographic angiography before reoperative coronary artery bypass grafting: a decision-analytic model.

BACKGROUND: The risks of repeat thoracotomy can be reduced if thoracic multidetector computed tomographic angiography (CTA) is used to guide preventive surgical strategies (PSS: peripheral cardiopulmonary bypass, circulatory arrest, and non-median sternotomy). We sought to define the cost-effectiveness of CTA using a Markov model. METHODS AND RESULTS: We studied outcomes and costs of CTA and non-CTA strategies in a modeled cohort of 10 000 patients undergoing redo coronary artery bypass grafting. Rates of PSS implementation were anticipated to follow identification of risk by CTA. Transitions, costs, and utilities were informed by our experience and the literature. Sensitivity analyses included testing a range of costs of CTA and PSS on model outcome. In the reference case, cost and quality-adjusted life years accrued with the use of CTA ($74 869, 4.63 quality-adjusted life-years) were slightly higher than nonuse ($73 471, 4.59 quality-adjusted life-years), yielding an incremental cost-effectiveness ratio of $34 950/quality-adjusted life-years. Cost of PSS (equipment and operating time) was the most significant determinant of incremental cost-effectiveness ratio. In the reference case (cost of CTA ≈$300), identification and avoidance of potential procedural difficulties with CTA rendered it cost-effective if the cost of PSS was <$12 000. Across a range of CTA costs, incremental cost-effectiveness ratio was not materially influenced by outcomes across a broad range of imputed values. CONCLUSIONS: The cost of CTA appears justified in the setting of isolated reoperative coronary artery bypass grafting, because it aids in appropriate selection of PSS. The cost-effectiveness of this imaging seems more influenced by the costs of subsequent PSS than by the cost of CTA.

An evidence-based guide for coronary calcium scoring in asymptomatic patients without coronary heart disease.

As public awareness and clinical use of CAC screening increases, physicians should, at a minimum, know the following information: 1) The presence of CAC indicates underlying CHD but does not predict luminal obstruction. 2) Non-contrast, prospectively ECG-gated cardiac EBCT and MDCT are sensitive, reproducible, rapid, and essentially equivalent imaging techniques commonly used to screen for CAC. 3) Currently, CAC screening is appropriate for all intermediate- risk patients and low-risk patients with a family history of premature CHD, and might be appropriate for all low-risk women. 4) The risks associated with CAC screening are a small but measurable excess risk of cancer and the risk of unnecessary downstream tests and procedures. 5) A CAC score of zero has a very high negative predictive value for CHD events. 6) Increasingly positive (non-zero) CAC scores are directly proportional to increased CHD event risk, and a CAC score >100 or greater than the 75th percentile indicates high risk. 7) Repeat screening to determine CAC progression or regression is not currently recommended.

Cost-effectiveness of adding FDG-PET or CT to the diagnostic work-up of patients with stage III melanoma.

OBJECTIVE: The aim of this prospective study was to assess predictive value of fludeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) and to analyze their cost-effectiveness in several diagnosis-treatment combinations. BACKGROUND: The incidence of melanoma continues to rise. A proportion will present or recur with lymph node metastases (American Joint Committee on Cancer/Union for International Cancer Control stage III). To detect distant metastases, CT and/or FDG-PET are available. However, few studies have assessed their value and costs in stage III. METHODS: All consecutive patients with melanoma with palpable, proven lymph node metastases (2003-2008) referred for examination with FDG-PET and CT were prospectively included. Sensitivity, specificity, and accuracy, and positive predictive value (PPV) and negative predictive value (NPV) were calculated. In economic evaluation, the costs of diagnostic work-up with and without FDG-PET and CT were compared. RESULTS: Overall, 253 patients with melanoma were included. FDG-PET showed a higher sensitivity than CT: 86.1% compared with 78.2%. Specificity was higher for CT (93.7%) compared with FDG-PET (93.1%). Overall, FDG-PET showed a higher PPV and NPV. Cost-consequence analysis showed that adding CT (True-Positive upstaging in 61 patients) to diagnostic work-up decreased cost by 5.5%, adding FDG-PET (True-Positive upstaging in 68 patients) increased cost by 7.2%, and adding both (True-Positive upstaging in 78 patients) increased cost by 15.1%. CONCLUSIONS: In this study, FDG-PET had higher sensitivity and predictive value, whereas CT had a higher specificity. Adding one of these diagnostic tools improved the staging of stage III patients with less than 10% cost increase. A proposal for stage-specific use of imaging modalities for clinicians caring for patients with melanoma is presented.