BACKGROUND There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de... Show moreBACKGROUND There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD).OBJECTIVES This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB.METHODS This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain.RESULTS Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean +/- SD angiographic net gains were 0.25 +/- 0.40 mm with SCBs vs 0.48 +/- 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (P-noninferiority = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (0.00 +/- 0.32 mm vs 0.32 +/- 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 +/- 0.15 following treatment with SCBs and 0.91 +/- 0.09 following PCBs (P = 0.026); a fractional flow ratio <= 0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively.CONCLUSIONS The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo. Show less
Huang, J.Y.; Tu, S.X.; Masuda, S.; Ninomiya, K.; Dijkstra, J.; Chu, M.; ... ; Wijns, W. 2022
ObjectivesThe objective of the present study was to compare plaque burden (PB) calculated from optical coherence tomography (OCT) using deep learning (DL) with PB derived from co-registered... Show moreObjectivesThe objective of the present study was to compare plaque burden (PB) calculated from optical coherence tomography (OCT) using deep learning (DL) with PB derived from co-registered intravascular ultrasound (IVUS). BackgroundA DL algorithm was developed for automated plaque characterization and PB quantification from OCT images. However, the performance of this algorithm for PB quantification has not been validated. MethodsFive-year follow-up OCT and IVUS images from 15 patients implanted with bioresorbable vascular scaffold (BVS) at baseline were analyzed. Precise co-registration for 72 anatomical slices was achieved utilizing unique BVS radiopaque markers. PB derived from OCT DL and IVUS were compared. OCT cross-sections were divided into four subgroups with different media visibility level. The impact of media visibility on the numerical difference between OCT-derived and IVUS-derived PB was investigated. The stent sizes selected by OCT DL and IVUS were compared. ResultsSixty-four paired OCT and IVUS cross-sections were compared. OCT DL showed good concordance with IVUS for PB assessment (ICC = 0.81, difference = -3.53 +/- 6.17%, p < 0.001). The numerical difference between OCT DL-derived PB and IVUS-derived PB was not substantially impacted by missing segments of media visualization (p = 0.21). OCT DL showed a diagnostic accuracy of 92% in identifying PB > 65%. The stent sizes selected by OCT DL were smaller compared to the ones selected by IVUS (difference = 0.30 +/- 0.34 mm, p < 0.001). ConclusionsThe DL algorithm provides a feasible and reliable method for automated PB estimation from OCT, irrespective of media visibility. OCT DL showed good diagnostic accuracy in identifying PB > 65%, revealing its potential to complement conventional OCT imaging. Show less
Aims Long-term risk stratification and surgical timing remain suboptimal in concomitant aortic and mitral (double) valve surgery. This study sought to examine the predictors, changes, and... Show moreAims Long-term risk stratification and surgical timing remain suboptimal in concomitant aortic and mitral (double) valve surgery. This study sought to examine the predictors, changes, and prognostic implications of right ventricular (RV) remodelling in patients undergoing double-valve surgery. Methods and results In 152 patients undergoing double-valve surgery, four RV remodelling patterns were characterized using transthoracic echocardiography: normal RV size and systolic function (Pattern 1); dilated RV (tricuspid annulus diameter >35 mm) with normal systolic function (Pattern 2); normal RV size with systolic dysfunction (percentage RV fractional area change <35%; Pattern 3); and dilated RV with systolic dysfunction (Pattern 4). The primary endpoint was the composite of heart failure hospitalization and all-cause mortality. Patterns 1, 2, 3, and 4 RV remodelling were present in 41, 20, 23, and 16% of patients, respectively. Patients with Stage 4 RV remodelling had worse renal function, higher EuroSCORE II, and impaired left ventricular ejection fraction. During a 3.7-year median follow up, 45 adverse events occurred. Patterns 3 and 4 RV remodelling were associated with significantly higher adverse event rates compared with Pattern 1 (37 and 75% vs. 11%, P < 0.01) and had incremental prognostic value when added to clinical parameters and EuroSCORE II (chi(2) increased from 30 to 66, P < 0.01). At 1 year after surgery (n = 100), Patterns 3 and 4 RV remodelling had a higher risk of adverse events compared with Pattern 1. Conclusion Right ventricular remodelling was strongly related to adverse outcomes and deserves consideration as part of the risk and decision-making algorithms in double-valve surgery. Show less
Heterogeneous neointimal response has been observed after implantation of all generations of coronary stents. Our aim was assessing local factors of shear stress (SS) and plaque characteristics in... Show moreHeterogeneous neointimal response has been observed after implantation of all generations of coronary stents. Our aim was assessing local factors of shear stress (SS) and plaque characteristics in neointimal response after implantation of bioresorbable scaffolds (BRS) in bifurcations. Ten patients from the BIFSORB pilot study were analysed. Follow-up optical frequency domain imaging (OFDI) was performed at 1 month and 2 years. Coronary lumen and BRS structure were reconstructed by fusion of OFDI and angiography and were used for subsequent flow simulation. Plaque arc degree and SS were quantified using post-procedural OFDI data and were matched with follow-up OFDI using anatomical landmarks. Strut-level and segment-level analysis were performed for 1-month and 2-year follow-up respectively. A total of 444 struts (54 jailing struts) were included at 1-month follow-up. Time-average SS (TASS) was significantly lower for covered struts than for uncovered struts in non-bifurcation segments (TASS: 1.81 +/- 1.87 vs. 3.88 +/- 3.72 Pa, p < 0.001). The trend remained the same for jailing struts, although statistically insignificant (TASS: 10.85 +/- 13.12 vs. 13.64 +/- 14.48 Pa, p = 0.328). For 2-year follow-up, a total of 66 sub-regions were analysed. Neointimal hyperplasia area (NTA) was negatively correlated with TASS in core-segments (rho = - 0.389, p = 0.037) and positively correlated with plaque arc degree in non-core segments (rho = 0.387, p = 0.018). Slightly stronger correlations with NTA were observed when combining TASS and plaque arc degree in both core segments (rho = - 0.412, p = 0.026) and non-core segments (rho = - 0.395, p = 0.015). Hemodynamic microenvironment and baseline plaque characteristics may regulate neointimal response after BRS implantation in bifurcation. These findings underline the combined role of plaque characteristics and local hemodynamics in vessel healing after stent implantation. Show less
Merino, J.; Dashti, H.S.; Li, S.X.; Sarnowski, C.; Justice, A.E.; Graff, M.; ... ; Tanaka, T. 2019
In many species, the offspring of related parents suffer reduced reproductive success, a phenomenon known as inbreeding depression. In humans, the importance of this effect has remained unclear,... Show moreIn many species, the offspring of related parents suffer reduced reproductive success, a phenomenon known as inbreeding depression. In humans, the importance of this effect has remained unclear, partly because reproduction between close relatives is both rare and frequently associated with confounding social factors. Here, using genomic inbreeding coefficients (F-ROH) for >1.4 million individuals, we show that F-ROH is significantly associated (p < 0.0005) with apparently deleterious changes in 32 out of 100 traits analysed. These changes are associated with runs of homozygosity (ROH), but not with common variant homozygosity, suggesting that genetic variants associated with inbreeding depression are predominantly rare. The effect on fertility is striking: F-ROH equivalent to the offspring of first cousins is associated with a 55% decrease [95% CI 44-66%] in the odds of having children. Finally, the effects of F-ROH are confirmed within full-sibling pairs, where the variation in F-ROH is independent of all environmental confounding. Show less
Li, M.; Li, Y.; Weeks, O.; Mijatovic, V.; Teumer, A.; Huffman, J.E.; ... ; CHARGE Blood Pressure Working Grp 2017
