The incremental value of coronary artery calcium score in predicting long-term prognosis and defining the warranty period of normal adenosine stress-only myocardial perfusion imaging using CZT SPECT.

BACKGROUND: Normal stress-only (SO) myocardial perfusion imaging (MPI) using SPECT reduces imaging time and radiation dose with a good prognosis. However, the long-term prognostic value of combining coronary artery calcium score (CACS) with SO MPI to determine the warranty period remains unknown. Hence, we assessed the incremental prognostic value of CACS and its impact on the warranty period of normal SO MPI using SPECT. METHODS: We retrospectively included 1375 symptomatic patients without a history of coronary artery disease (CAD) and a normal SO MPI using adenosine who underwent simultaneous CAC scoring. Annual major adverse cardiac events (MACE) rates were calculated for CACS categories: 0, 1-399, 400-999, and ≥1000. RESULTS: The mean age was 60.0 ± 11.8 years (66.9% female) with a median follow-up of 10.3 [IQR 9.6-10.9] years. The warranty period for annual MACE rate for normal SO SPECT extended the total follow-up time in years. MACE rate categorized by CAC categories demonstrated an increase in MACE rates with increasing CACS; CACS 0 and CACS 1-399 were associated with a 10-year warranty period, CACS 400-999 had a warranty period of 4 years and no warranty period could be given for CACS≥1000 (5.9 % at 1 year). CONCLUSIONS: CACS as an adjunct to normal pharmacological SO MPI provides additional prognostic information and aids in determining a warranty period.

Diagnostic value of regional myocardial flow reserve measurements using Rubidium-82 PET : Disclosures none.

PURPOSE: Visual assessment of Rubidium (Rb-82) PET myocardial perfusion images is usually combined with global myocardial flow reserve (MFR) measurements. However, small regional blood flow deficits may go unnoticed. Our aim was to compare the diagnostic value of regional with global MFR in the detection of obstructive coronary artery disease (oCAD). METHODS: We retrospectively included 1519 patients referred for rest and regadenoson-induced stress Rb-82 PET/CT without prior history of oCAD. MFR was determined globally, per vessel territory and per myocardial segment and compared using receiver-operating characteristic analysis. Vessel MFR was defined as the lowest MFR of the coronary territories and segmental MFR as the lowest MFR of the 17-segments. The primary endpoint was oCAD on invasive coronary angiography. RESULTS: The 148 patients classified as having oCAD had a lower global MFR (median 1.9, interquartile range [1.5-2.4] vs. 2.4 [2.0-2.9]), lower vessel MFR (1.6 [1.2-2.1] vs. 2.2 [1.9-2.6]) and lower segmental MFR (1.3 [ 0.9-1.6] vs. 1.8 [1.5-2.2]) as compared to the non-oCAD patients (p < 0.001). The area under the curve for segmental MFR (0.81) was larger (p ≤ 0.005) than of global MFR (0.74) and vessel MFR (0.78). CONCLUSIONS: The use of regional MFR instead of global MFR is recommended as it improves the diagnostic value of Rb-82 PET in the detection of oCAD.

Performance of digital PET/CT compared with conventional PET/CT in oncologic patients: a prospective comparison study.

PURPOSE: Digital PET systems (dPET) improve lesion detectability as compared to PET systems with conventional photomultiplier tubes (cPET). We prospectively studied the performance of high-resolution digital PET scans in patients with cancer, as compared with high- and standard-resolution conventional PET scans, taking the acquisition order into account. METHODS: We included 212 patients with cancer, who were referred for disease staging or restaging. All patients underwent FDG-PET/CT on a dPET scanner and on a cPET scanner in a randomized order. The scans were acquired immediately after each other. Three image reconstructions were generated: 1) standard-resolution (4 × 4 × 4 mm3 voxels) cPET, 2) high-resolution (2 × 2 × 2 mm3 voxels) cPET, and 3) high-resolution dPET. Two experienced PET readers visually assessed the three reconstructions side-by-side and ranked them according to scan preference, in an independent and blinded fashion. RESULTS: On high-resolution dPET, the PET readers detected more lesions or they had a higher diagnostic confidence than on high- and standard-resolution cPET (p < 0.001). High-resolution dPET was preferred in 90% of the cases, as compared to 44% for high-resolution cPET and 1% for standard-resolution cPET (p < 0.001). However, for the subgroup of patients where dPET was made first (n = 103, 61 ± 10 min after FDG administration) and cPET was made second (93 ± 15 min after FDG administration), no significant difference in preference was found between the high-resolution cPET and dPET reconstructions (p = 0.41). CONCLUSIONS: DPET scanners in combination with high-resolution reconstructions clinically outperform cPET scanners with both high- and standard-resolution reconstructions as the PET readers identified more FDG-avid lesions, their diagnostic confidence was increased, and they visually preferred dPET. However, when dPET was made first, high-resolution dPET and high-resolution cPET showed similar performance, indicating the positive effect of a prolonged FDG uptake time. Therefore, high-resolution cPET in combination with a prolonged FDG uptake time can be considered as an alternative.

Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: A mixed methods study.

BACKGROUND: Wireless continuous vital sign monitoring by wearable devices have recently become available for patients on general wards to promote timely detection of clinical deterioration. Many continuous monitoring systems use conventional threshold alarm settings to alert nurses in case of deviating vital signs. However, frequent false alarms often lead to alarm fatigue and inefficiencies in the workplace. The aim of this study was to determine the feasibility of continuous vital sign monitoring without the use of alarms, thereby exclusively relying on interval trend monitoring. METHODS: This explanatory sequential mixed methods study was conducted at an abdominal surgical ward of a tertiary teaching hospital. Heart rate and respiratory rate of patients were measured every minute by a wearable sensor. Trends were visualized and assessed six times per day by nurses and once a day by doctors during morning rounds. Instead of using alarms we focused exclusively on regular vital sign trend analysis by nurses and doctors. Primary outcome was feasibility in terms of acceptability by professionals, assessed by the Usefulness, Satisfaction and Ease of Use questionnaire and further explored in two focus groups, as well as fidelity. RESULTS: A total of 56 patients were monitored and in 80.5% (n = 536) of nurses' work shifts the trends assessments were documented. All deviating trends (n = 17) were recognized in time. Professionals (N = 46) considered continuous monitoring satisfying (4.8±1.0 on a 1-7 Likert-scale) and were willing to use the technology. Although insight into vital sign trends allowed faster anticipation and action upon changed patient status, professionals were neutral about usefulness (4.4±1.0). They found continuous monitoring easy to use (4.7±0.8) and easy to learn (5.3±1.0) but indicated the need for gaining practical experience. Nurses considered the use of alarms for deviating vital signs unnecessary, when trends were regularly assessed and reported. CONCLUSION: We demonstrated that continuous vital signs trend monitoring without using alarms was feasible in the general ward setting, thereby avoiding unnecessary alarms and preventing alarm fatigue. When monitoring in a general ward setting, the standard use of alarms may therefore be reconsidered.

Feasibility of continuous monitoring of vital signs in surgical patients on a general ward: an observational cohort study.

OBJECTIVE: To determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward. DESIGN: Observational cohort study. SETTING: Tertiary teaching hospital. PARTICIPANTS: Postoperative abdominal surgical patients (n=30) and nurses (n=23). INTERVENTIONS: Patients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2 min. Values and trends were visualised and alerts sent to the nurses. OUTCOMES: System fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires. RESULTS: Thirty patients were monitored for a median duration of 81 hours (IQR 47-143) per patient, resulting in 115 217 measurements per parameter. In total, 19% (n=21 311) of heart rate, 51% (n=59 184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10 269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1-4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2-4.8) and satisfaction 3.7 (IQR 3.2-4.8), but agreed on ease of learning at 5.0 (IQR 4.0-5.8). Neutral scores were mostly related to the perceived limited fidelity of the system. CONCLUSIONS: Continuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses' ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.

Current Evidence for Continuous Vital Signs Monitoring by Wearable Wireless Devices in Hospitalized Adults: Systematic Review.

BACKGROUND: Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE: The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS: A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS: In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS: Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Comparison of maximal Rubidium-82 activities for myocardial blood flow quantification between digital and conventional PET systems.

BACKGROUND: PET-based myocardial blood flow (MBF) quantification can be inaccurate when using high tracer activities. Our aim was to derive the maximal Rubidium-82 activity for MBF assessment using a new digital PET system and compare the results with conventional analog systems. METHODS: 1.8 GBq Rubidium-82 was injected into the cardiac insert of an anthropomorphic torso phantom. Data were acquired for 10 min using an Ingenuity TF (Philips Healthcare), Discovery 690 (D690, GE Healthcare), and digital PET prototype system (Philips Healthcare). The dynamic ranges, defined as the maximal measured activity in the reconstructed images deviating < 10% from the true present activity, were determined in all scans. RESULTS: The dynamic ranges were 312 MBq for Ingenuity TF, 650 MBq for D690, and 654 MBq for digital PET prototype. CONCLUSIONS: The maximal Rb-82 activity for MBF assessment using digital PET prototype is higher than that for its analog counterpart (Ingenuity TF), but seems comparable to the D690.

Minimal starting time of data reconstruction for qualitative myocardial perfusion rubidium-82 positron emission tomography imaging.

OBJECTIVE: Qualitative positron emission tomography (PET) myocardial perfusion imaging (MPI) scans are reconstructed with a delay after an injection of rubidium-82 (Rb) to ensure blood pool clearance and sufficient left ventricle to myocardium contrast. Our aim was to derive the minimal starting time of data reconstruction (STDR) after an injection of Rb for which the diagnostic value and image quality remained unaffected. MATERIALS AND METHODS: We retrospectively included 23 patients who underwent rest-stress Rb PET MPI using 740 MBq. Patients fulfilling one of the two criteria indicating a slow blood pool clearance (ejection fraction <50% and/or cardiac output <3 l/min) were included in a consecutive manner. PET images using five different STDRs (1:15-2:15 min) were reconstructed and compared with reference images (STDR of 2:30 min). Differences in the summed rest score greater than or equal to 3 and total perfusion deficit greater than 3% were considered to significantly influence the diagnostic value. In addition, image quality was scored by two experts as not interpretable, inferior, adequate, or excellent. RESULTS: The summed rest score differed greater than or equal to 3 from the reference in seven or more patients (≥30%) using STDR less than or equal to 2:00 min (P<0.02). STDR less than or equal to 1:30 min resulted in six or more patients (≥26%) with a total perfusion deficit difference greater than 3% (P<0.03).In addition, STDR less than or equal to 2:00 min resulted in a lower image quality (P<0.002) and STDR less than or equal to 2:15 min resulted in greater than or equal to two scans with noninterpretable image quality. CONCLUSION: STDR less than or equal to 2:15 min resulted in lower diagnostic value or insufficient image quality for qualitative PET MPI using 740 MBq Rb. An STDR of 2:30 min can be considered for clinical adoption.

Value of automatic patient motion detection and correction in myocardial perfusion imaging using a CZT-based SPECT camera.

BACKGROUND: Correction of motion has become feasible on cadmium-zinc-telluride (CZT)-based SPECT cameras during myocardial perfusion imaging (MPI). Our aim was to quantify the motion and to determine the value of automatic correction using commercially available software. METHODS AND RESULTS: We retrospectively included 83 consecutive patients who underwent stress-rest MPI CZT-SPECT and invasive fractional flow reserve (FFR) measurement. Eight-minute stress acquisitions were reformatted into 1.0- and 20-second bins to detect respiratory motion (RM) and patient motion (PM), respectively. RM and PM were quantified and scans were automatically corrected. Total perfusion deficit (TPD) and SPECT interpretation-normal, equivocal, or abnormal-were compared between the noncorrected and corrected scans. Scans with a changed SPECT interpretation were compared with FFR, the reference standard. Average RM was 2.5 ± 0.4 mm and maximal PM was 4.5 ± 1.3 mm. RM correction influenced the diagnostic outcomes in two patients based on TPD changes ≥7% and in nine patients based on changed visual interpretation. In only four of these patients, the changed SPECT interpretation corresponded with FFR measurements. Correction for PM did not influence the diagnostic outcomes. CONCLUSION: Respiratory motion and patient motion were small. Motion correction did not appear to improve the diagnostic outcome and, hence, the added value seems limited in MPI using CZT-based SPECT cameras.

Minimizing rubidium-82 tracer activity for relative PET myocardial perfusion imaging.

OBJECTIVES: Recommended rubidium-82 activities for relative myocardial perfusion imaging (MPI) using present-generation PET scanners may be unnecessarily high. Our aim was to derive the minimum activity for a reliable relative PET MPI assessment. MATERIALS AND METHODS: We analyzed 140 scans from 28 consecutive patients who underwent rest-stress MPI-PET (Ingenuity TF). Scans of 852, 682, 511, and 341 MBq were simulated from list-mode data and compared with a reference scan using 1023 MBq. Differences in the summed rest score, total perfusion deficit, and image quality were obtained between the reference and each of the simulated rest scans. Combined stress-rest scans obtained at a selected activity of 682 MBq were diagnostically interpreted by experts and outcome was compared with the reference scan interpretation. RESULTS: Differences in summed rest score more than or equal to 3 were found using 682, 511, and 341 MBq in two (7%), four (14%), and five (18%) patients, respectively. Differences in total perfusion deficit more than 7% were only found at 341 MBq in one patient. Image quality deteriorated significantly only for the 341 MBq scans (P<0.001). Interpretation of stress-rest scans did not differ between 682 and 1023 MBq scans. CONCLUSION: A significant reduction in administered Rb-82 activity is feasible in relative MPI. An activity of 682 MBq resulted in reliable diagnostic outcomes and image quality, and can therefore be considered for clinical adoption.

Coronary artery calcification detection with invasive coronary angiography in comparison with unenhanced computed tomography.

OBJECTIVE: The presence of extensive coronary artery calcifications (CAC) influences treatment decisions, particularly for revascularization. However, important CAC might be missed with invasive coronary angiography (ICA). Our aim was to determine the accuracy of ICA in the identification of CAC using computed tomography (CT) as reference standard. PATIENTS AND METHODS: Overall, 349 consecutive patients who underwent both CT-based CAC-scoring and invasive coronary angiography within 60 days were retrospectively included. Two experienced operators classified CAC on ICA, without knowledge of CT-based CAC scoring, for each of the four main vessels as (0) absent, (1) mild, (2) moderate, or (3) dense calcifications. These scores were correlated with the CT-based Agatston CAC-scores, the noninvasive reference standard. The sensitivity, specificity, and accuracy of identified CAC using ICA were derived. Calcifications identified as moderate or dense on ICA or with a vessel-based Agatston score of more than 100 were considered important. RESULTS: CT classified 671 (48%) of the 1396 vessels as having moderately or densely calcified vessels (Agatston score >100), whereas this was 137 (9.8%) using ICA (P<0.001). A significant correlation was found between the CT-based and ICA-based CAC-scores for all vessels (P<0.001). The sensitivity in detecting any CAC by means of ICA was 43% with a specificity of 92% and an accuracy of 55%. The sensitivity of important CAC identification by ICA was 19%, the specificity 99%, and the accuracy 61%. CONCLUSION: The accuracy of ICA for the identification of calcifications is very low as only 19% of the relevant calcifications was identified. Preprocedural assessment of CAC with CT could be considered to improve the treatment approach.

Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations.

PURPOSE: New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. METHODS: In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. RESULTS: The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm2 for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm2 for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). CONCLUSIONS: Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected.

An Empirical Comparison of Discrete Choice Experiment and Best-Worst Scaling to Estimate Stakeholders' Risk Tolerance for Hip Replacement Surgery.

BACKGROUND: Previous studies have been inconclusive regarding the validity and reliability of preference elicitation methods. OBJECTIVE: The aim of this study was to compare the metrics obtained from a discrete choice experiment (DCE) and profile-case best-worst scaling (BWS) with respect to hip replacement. METHODS: We surveyed the general US population of men aged 45 to 65 years, and potentially eligible for hip replacement surgery. The survey included sociodemographic questions, eight DCE questions, and twelve BWS questions. Attributes were the probability of a first and second revision, pain relief, ability to participate in sports and perform daily activities, and length of hospital stay. Conditional logit analysis was used to estimate attribute weights, level preferences, and the maximum acceptable risk (MAR) for undergoing revision surgery in six hypothetical treatment scenarios with different attribute levels. RESULTS: A total of 429 (96%) respondents were included. Comparable attribute weights and level preferences were found for both BWS and DCE. Preferences were greatest for hip replacement surgery with high pain relief and the ability to participate in sports and perform daily activities. Although the estimated MARs for revision surgery followed the same trend, the MARs were systematically higher in five of the six scenarios using DCE. CONCLUSIONS: This study confirms previous findings that BWS or DCEs are comparable in estimating attribute weights and level preferences. However, the risk tolerance threshold based on the estimation of MAR differs between these methods, possibly leading to inconsistency in comparing treatment scenarios.

Clinical pedicle screw accuracy and deviation from planning in robot-guided spine surgery: robot-guided pedicle screw accuracy.

STUDY DESIGN: A retrospective chart review was performed for 112 consecutive minimally invasive spinal surgery patients who underwent pedicular screw fixation in a community hospital setting. OBJECTIVE: To assess the clinical accuracy and deviation in screw positions in robot-assisted pedicle screw placement. SUMMARY OF BACKGROUND DATA: Accuracy of pedicle screw placement in in vivo studies varies widely, especially when minimally invasive techniques are used. Robotic guidance was recently introduced to increase screw placement accuracy but still reported accuracies vary. METHODS: Reproducibility of the surgeon's plan using robotic guidance was assessed by fusing individual vertebras from the preoperative computed tomography (CT) containing the planning with a postoperative CT. Deviation in entry point and difference in angle of insertion was measured on axial and sagittal planes. Grading of pedicle screw placement was performed on postoperative CTs using the Gertzbein-Robbins classification. RESULTS: CT-to-CT fusion succeeded for 178 screws, but these appeared to be random, with no apparent selection bias. Mean deviation in entry point was 2.0 ± 1.2 mm. Mean difference in angle of insertion was 2.2° ± 1.7° on the axial plane and 2.9° ± 2.4° on the sagittal plane. Assessment of pedicle screw accuracy showed that 477 of 487 screws (97.9%) were safely placed (<2 mm, category A+B), 8 screws in category C and 1 in category D. None of the screws necessitated resurgery for revised placement. CONCLUSION: Preoperative planning of robotic guidance is reproduced intraoperatively within acceptable deviations. We conclude that robotic guidance allows for highly accurate execution of the preoperative plan, leading to accurate screw placement. LEVEL OF EVIDENCE: 3.

Minimizing patient-specific tracer dose in myocardial perfusion imaging using CZT SPECT.

UNLABELLED: Myocardial perfusion imaging (MPI) with SPECT is widely adopted in clinical practice but is associated with a relatively high radiation dose. The aim of this study was to determine the minimum product of tracer dose and scan time that will maintain diagnostic value for cadmium zinc telluride (CZT) SPECT MPI. METHODS: Twenty-four patients underwent clinically indicated stress MPI using CZT SPECT and a body weight-dependent (3 MBq/kg) (99m)Tc-tetrofosmin tracer dose. Data were acquired for 8 min in list mode. Next, images were reconstructed using 2-, 4-, 6-, and 8-min time frames. Differences between the 8-min reference scan and the shorter scans were determined in segmental uptake values (using the 17-segment cardiac model), ejection fraction, and end-diastolic volume. A 5% difference in segmental uptake was considered to significantly influence the diagnostic value. Next, the quality of the 4-, 6-, and 8-min scans was scored on a 4-point scale by consensus by 3 experienced nuclear medicine physicians. The physicians did not know the scan time or patient information. RESULTS: Differences in segmental uptake values, ejection fraction, and end-diastolic volume were greater for shorter scans than for the 8-min reference scan. On average, the diagnostic value was influenced in 7.7 segments per patient using the 2-min scans, in comparison to 2.0 and 0.8 segments per patient using the 4- and 6-min scans, respectively. In addition, the 4-min scans led to a significantly reduced image quality compared with the 8-min scans (P < 0.05). This was not the case for the 6-min scan. CONCLUSION: Six minutes was the shortest acquisition time in stress MPI using CZT SPECT that did not affect the diagnostic value for a tracer dose of 3 MBq/kg. Hence, the patient-specific product of tracer dose and scan time can be reduced to a minimum of 18 MBq·min/kg, which may lower the effective radiation dose for patients to values below 1 mSv.