Multicenter Evaluation of the Feasibility of Clinical Implementation of SPECT Myocardial Blood Flow Measurement: Intersite Variability and Imaging Time

Abstract

Background: Single-center studies have shown that single photon emission computed tomography myocardial blood flow (MBF) measurement is accurate compared with MBF measured with microspheres in a porcine model, positron emission tomography, and angiography. Clinical implementation requires consistency across multiple sites. The study goal is to determine the intersite processing repeatability of single photon emission computed tomography MBF and the additional camera time required. Methods: Five sites (Canada, Italy, Japan, Germany, and Singapore) each acquired 25 to 35 MBF studies at rest and with pharmacological stress using technetium-99m-tetrofosmin on a pinhole-collimated cadmium-zinc-telluride–based cardiac single photon emission computed tomography camera with standardized list-mode imaging and processing protocols. Patients had intermediate to high pretest probability of coronary artery disease. MBF was measured locally and at a core laboratory using commercially available software. The time a room was occupied for an MBF study was compared with that for a standard rest/stress myocardial perfusion study. Results: With motion correction, the overall correlation in MBF between core laboratory and local site was 0.93 (range, 0.87–0.97) at rest, 0.90 (range, 0.84–0.96) at stress, and 0.84 (range, 0.70–0.92) for myocardial flow reserve. The local-to-core difference in global MBF (bias -MBF ) was 5.4% (−3.8% to 14.8%; median [interquartile range]) at rest and 5.4% (−6.2% to 19.4%) at stress. Between the 5 sites, bias -MBF ranged from −1.6% to 11.0% at rest and from −1.9% to 16.3% at stress; the interquartile range in bias -MBF was between 9.3% (4.8%–14.0%) and 22.3% (−10.3% to 12.0%) at rest and between 17.0% (−11.3% to 5.6%) and 33.3% (−10.4% to 22.9%) at stress and was not significantly different between most sites. Both bias and interquartile range were like previously reported interobserver variability and less than the SD of the test-retest difference of 30%. The overall difference in myocardial flow reserve was 1.52% (−10.6% to 11.3%). There were no significant differences between with and without motion correction. The average additional acquisition time varied between sites from 44 to 79 minutes. Conclusions: The average bias -MBF and bias -MFR values were small with standard deviations substantially less than the test-retest variability. This demonstrates that MBF can be measured consistently across multiple sites and further supports that this technique can be reliably implemented. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03427749.