Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries

OBJECTIVES: To validate a simplified core laboratory intravascular ultrasound (IVUS) analysis method based on frames with visually determined minimal lumen areas (MLAs) as compared with a comprehensive (per frame) analysis method. BACKGROUND: IVUS‐guided percutaneous coronary intervention has proven to be superior to angiography‐guided stenting. In clinical practice, cross‐sections with visually determined MLA are measured to determine lesion severity or minimal stent area (MSA), however, its accuracy has not been compared with a comprehensive per frame analysis method. METHODS: A total of 50 stented coronary segments of anonymized core lab datasets were analyzed using a comprehensive analysis method and reanalyzed by two core lab analysts using the simplified method including a maximum of seven frames to be analyzed (the visually determined MSA, the first and last frame, and the MLA of each reference segment). The main parameters of interest were MSA, MLA in the reference segments, and plaque burden. RESULTS: The simplified method showed moderate agreement for measurement of the proximal MLA (7.51 ± 2.52 vs. 6.32 ± 1.88 mm(2), intraclass correlation coefficient [ICC] = 0.73), good agreement for the distal MLA (5.41 ± 1.85 vs. 5.11 ± 1.38 mm(2), ICC = 0.84) and plaque burden proximal (0.49 ± 0.12 vs. 0.50 ± 0.11, ICC = 0.88), and excellent agreement for the MSA (5.35 ± 1.05 vs. 5.32 ± 0.99 mm(2), ICC = 0.94) and plaque burden distal (0.47 ± 0.14 vs. 0.47 ± 0.12, ICC = 0.92), when compared with the comprehensive analysis method. Inter‐ and intraobserver analysis revealed good‐to‐excellent agreement for all parameters. CONCLUSIONS: Measuring poststenting IVUS cross‐sections with visually determined MLAs by experienced core lab analysts is an accurate and reproducible method to identify MLAs

Long-term clinical outcomes in patients with non-ST-segment Elevation Acute Coronary Syndrome and ST-segment elevation myocardial infarction with thrombolysis in myocardial infarction 0 flow

Background: Thrombolysis in Myocardial Infarction (TIMI) 0 flow often characterizes ST-segment Elevation Myocardial Infarction (STEMI) patients, but may also feature in non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). Since recanalization usually occurs later in NSTE-ACS patients, the aim of this study was to assess whether patients presenting with NSTE-ACS and TIMI 0 flow have worse clinical outcomes as compared to patients presenting with STEMI and TIMI 0 flow. Methods: A single-center retrospective cohort study was conducted with patients treated for NSTE-ACS and STEMI with TIMI 0 flow at diagnostic angiogram between January 2015 and December 2019. The two patient groups were 1:1 matched using a propensity score logistic regression model. The primary outcome was Major Adverse Cardiac Events (MACE), a composite of all-cause mortality, any myocardial infarction, coronary artery bypass graft, urgent target vessel revascularization or stroke during long term follow-up. Results: The total population consisted of 1255 ACS patients, of which 249 NSTE-ACS and 1006 STEMI patients. After propensity score matching, 234 NSTE-ACS patients were matched with 234 STEMI patients. In this matched population, the mean age was 62.6 (±12.4) years and 75.2 % of the patients was male. The median follow-up time was 3.2 years. MACE rates during follow-up were similar between the two matched groups (HR = 0.84 [95 % CI 0.60 – 1.12] with p = 0.33) with cumulative event-free survival of 63.3 % in the NSTE-ACS group vs 59.3 % in the STEMI group at 6 year follow-up. Conclusion: In this retrospective study, a culprit lesion with TIMI 0 flow has similar clinical outcome in NSTE-ACS and STEMI patients. Further research is warranted to determine optimal the timing of PCI in NSTE-ACS patients with TIMI 0 flow.</p

Procedural Performance of Ultrathin, Biodegradable Polymer-Coated Stents Versus Durable Polymer-Coated Stents Based on Intracoronary Imaging

OBJECTIVE: Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging.METHODS: A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma.RESULTS: A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA.CONCLUSIONS: No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.</p

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry.

BACKGROUND New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. METHODS We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. RESULTS In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2-85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p ​< ​0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 ​mm [IQR 2.2-5.1] vs. 4.1 ​mm [IQR 2.8-6.0], p ​= ​<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79-0.96], p ​= ​<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84-0.98], p ​= ​0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79-1.21], p ​= ​0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35-3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21-13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83-0.97], p ​< ​0.01), annulus area (OR 1.003 [95% CI 1.001-1.005], p ​= ​0.04), NCC implantation depth (OR 1.13 [95% CI 1.07-1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03-2.27], p ​= ​0.04) were associated with new-PPI. CONCLUSION MS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 ​mm defined a high-risk group for PPI (>20%), MS length 3-7 ​mm intermediate risk for PPI (10-20%) and MS length > 7 ​mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR