Comparison of Angiographic and Intravascular Ultrasound Vessel Measurements in Infra-Popliteal Endovascular Interventions: The Below-the-Knee Calibration Study.

BACKGROUND: Endovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions. PURPOSE: To compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions. METHODS: Twenty consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regard to vessel diameter or lesion length. Digital subtraction angiography and IVUS imaging were collected pre- and post-PTA and images were sent to an independent core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of <0.05 was considered significant. RESULTS: The overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 mm vs. 3.47 ± 0.72 mm for IVUS (mean difference was -0.50 mm, (95% CI: -0.80, -0.20; p = 0.14). As expected, in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA, it was 3.17 ± 1.34 mm vs. 3.55 ± 0.76 mm in IVUS, (mean difference was -0.38 mm, (95% CI: -0.79, 0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA, it was 2.64 ± 1.06 mm vs. 3.33 ± 0.67 mm in IVUS, (mean difference was -0.69 mm, (95% CI: -1.04, 0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size. CONCLUSION: Angiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices.

Diagnostic comparison of automatic and manual TIMI frame-counting-generated quantitative flow ratio (QFR) values.

Quantitative flow ratio (QFR) is a computational measurement of FFR (fractional flow reserve), calculated from coronary angiography. Latest QFR software automates TIMI frame counting (TFC), which occurs during the flow step of QFR analyses, making the analysis faster and more reproducible. The objective is to determine the diagnostic performance of QFR values obtained from analyses using automatic TFC compared to those obtained from analyses using manual TFC. This was a single-arm clinical trial that used the prospective analysis of the coronary angiographic image series of 97 patients who underwent evaluation of stable coronary artery disease with FFR/iFR at MedStar Washington Hospital Center in Washington, DC, USA. Automatic and manual TFC QFR values were obtained from the analyses of each of the 97 patients' image series, with manual TFC QFR values as the current gold standard for comparison. The diagnostic performance of automatic TFC QFR values was measured as follows: sensitivity was 0.87 (95% CI 0.66-0.97) and specificity was 1.00 (95% CI 0.9514-1.00), positive predictive value (PPV) was 1.00 (95%CI 1.00-1.00), while the NPV was 0.96 (95% CI 0.96-0.99). Overall accuracy was 96.91% (95% CI 91.23%-99.36%). The agreement as illustrated by the Bland-Altman plot shows a bias of 0.0023 (SD 0.0208) and narrow limits of agreement (LOA): Upper LOA 0.0573 and Lower LOA - 0.0528. The area under curve (AUC) was 0.996. QFR values generated from automatic TFC are comparable to those generated from manual TFC in diagnostic capability. The most recent software update produces values equivalent to those of the previous manual option, and can therefore be used interchangeably.

High-definition intravascular ultrasound: current clinical uses.

Intravascular ultrasound (IVUS) provides grayscale images of the entire vessel wall, and its technology has recently been improved, resulting in more accurate tissue characterization. Compared with conventional IVUS, high-definition (HD) IVUS provides better resolution, better image quality, faster acquisition and integration of processing tools for more efficient cath lab workflow. HD-IVUS includes transducers with higher frequencies (≥ 45 MHz), allowing a higher near field resolution combined with enough tissue penetration for a more precise assessment of the entire vessel wall. HD-IVUS preserves the potential advantages of conventional (40 MHz) IVUS over optical coherence tomography by adding a substantially higher spatial resolution. For this reason, this technology has generated increasing interest among interventional cardiologists and researchers to provide better detailed morphological evaluation on complicated plaques in acute coronary syndrome patients and better stent optimization. In this review, we provide the state-of-the-art on this technology and its current clinical applications.

Comparison of Quantitative Flow Ratio and Invasive Physiology Indices in a Diverse Population at a Tertiary United States Hospital.

BACKGROUND: Quantitative flow ratio (QFR) is a technology to evaluate the coronary stenosis significance on 3-dimensional quantitative coronary angiography. The aim of this study is to evaluate and compare the QFR versus fractional flow reserve (FFR) and/or instantaneous free-wave ratio (iFR) in a US population with a fair African American population representation. METHODS AND RESULTS: This was a retrospective, observational and single-center study that enrolled 100 patients who underwent coronary angiography. The diagnostic performance of QFR in terms of sensitivity was 0.80 (95%CI 0.64-0.97) and specificity was 0.95 (95% CI 0.90-1.00), the positive predictive value (PPV) was 0.83 (0.68-0.98), while the negative predictive value (NPV) was 0.94 (0.88-0.99). The overall accuracy was 0.91 and area under the curve (AUC) was 0.92 (95% CI 0.87-0.97). The R-squared was 0.54 and the Bland-Altman plot showed a bias of 0.0016 (SD 0.063) and limits of agreement (LOA): Upper LOA 0.13 and Lower LOA -0.12. In African Americans (n = 33), accuracy, AUC, sensitivity, specificity (94%; 0.90 [0.80-1.00]; 0.90 [0.71-1.00]; 0.96 [0.87-1.00], respectively) were better than those for the overall population. CONCLUSIONS: In a US-based representative population, vessel QFR accuracy and agreement with FFR as reference is high. Diagnostic performance of QFR in African Americans is also excellent.