Geographic proximity to cardiovascular clinical trial sites: A National analysis in the United States.

INTRODUCTION: Suboptimal geographical access to cardiovascular clinical trial sites (CV-CTS) may be a cause of inadequate demographic representation in contemporary trials. Thus, we investigate access to CV-CTS in the US. METHODS: We obtained the location of CV-CTS from Clinicaltrials.gov. We calculated the distance in kilometers from each ZIP code to the nearest CV-CTS, stratifying our results based on urban/rural setting, sex and race. RESULTS: We identified a total of 10,506 studies in 4,630 US ZIP codes (10.5 %), of those only 237 (5 %) were rural. The overall median CV-CTS distance was 5.8 km (IQR: 2.7, 15.8). For urban residents, this distance was 4.5 km (IQR: 2.3, 9.2), while for rural residents, it was 24.2 km (IQR: 13.8, 42.2). RESULTS: We revealed important disparities involving geographical proximity to cardiovascular clinical trial sites. Increasing the representation of these populations in clinical trials is paramount to improving the applicability of their findings to real-world settings.

In-Stent Restenosis Overview: From Intravascular Imaging to Optimal Percutaneous Coronary Intervention Management.

Despite ongoing progress in stent technology and deployment techniques, in-stent restenosis (ISR) still remains a major issue following percutaneous coronary intervention (PCI) and accounts for 10.6% of all interventions in the United States. With the continuous rise in ISR risk factors such as obesity and diabetes, along with an increase in the treatment of complex lesions with high-risk percutaneous coronary intervention (CHIP), a substantial growth in ISR burden is expected. This review aims to provide insight into the mechanisms, classification, and management of ISR, with a focus on exploring innovative approaches to tackle this complication comprehensively, along with a special section addressing the approach to complex calcified lesions.

Long-Term Intracoronary Structural and Vasomotor Assessment of the ABSORB Bioresorbable Vascular Scaffold.

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction.

Treatment of In-Stent Restenosis Using Excimer Laser Coronary Atherectomy and Bioresorbable Vascular Scaffold Guided by Optical Coherence Tomography.

The rate of in-stent restenosis (ISR) has become increasingly prevalent with the exponential growth in stent implantation due to an aging population and a higher life expectancy, in addition to the high rates of obesity and diabetes. In this prospective, single operator, all-comer study, we sought to analyze the performance of ELCA followed by bioresorbable vascular scaffold (BVS) placement in patients undergoing percutaneous coronary intervention (PCI) for ISR. A total of 13 patients had ISR treated with a combination of ELCA and BVS, with 9 patients having matched OCT pre, post ELCA and post BVS. Mean age was 65 ± 11.22 and 83% of the patients were male. Hypertension and dyslipidemia were present in 100% of the patients and smoking and diabetes in 50%. After the procedure, we did not detect residual stenosis over 10% in any patient, resulting in a technical success of 100%. No patients had MACE during their hospital stay or within the next six months, resulting in a procedure success of 100%. The mean lumen area increased 0.35 mm2 from pre procedure to post ELCA and 3.58 mm2 from post ELCA to post BVS. The final difference, from pre procedure to post BVS, was a 3.93 mm2 lumen area gain. The mean lumen diameter increased 0.11 mm from baseline to ELCA, 0.95 mm from post laser to BVS implantation and 1.06 mm from pre procedure to post BVS. The NIH area reduced 0.48 mm2 from pre to post ELCA, 1.13mm2 from post ELCA to BVS implantation and 1.61 mm2 from baseline to post BVS implantation. We conclude that ELCA is a safe and feasible debulking method to approach ISR, with high rates of post-procedural BVS success, within six months follow-up.

Comparison of Stent Expansion Using a Volumetric Versus the Conventional Method Through Optical Coherence Tomography in an All-Comers Population.

INTRODUCTION: A volumetric approach to measure stent expansion derived from optical coherence tomography (OCT) is superior in regards to clinical outcomes when compared to the conventional method. The current software already performs a semi-automatic assessment and it is available as a clinical tool, however data is still scarce. We evaluated the stent expansion analysis that uses a volumetric vessel model, called minimum expansion index - MEI and compared to the conventional model, which utilizes the minimum stent area expansion (MSAx) indexed to the references, and its potential impact on procedural decision-making strategy in percutaneous coronary intervention. METHODS: This was a prospective, all-comers single center study, from all patients undergoing OCT-guided PCI between September 2018 and May 2019. We utilized the APTIVUE™ OPTIS 5.2 software (Abbott, Santa Clara, CA) to evaluate MEI and MSAx measurements after reference adjustments. RESULTS: We included 100 patients with mean age of 64 ± 12.5 years, 68% were men, and the main arteries analyzed through OCT were LAD (48%), RCA (31%) and LCx (21%). The mean MEI was 77.6% ± 16.7% and the mean MSAx was 71.6% ± 16.9%. MEI location differed from MSAx in 70% of cases, and in those cases the mean distance between MEI and MSAx was 15.3 mm ± 12.4 mm. In 53% of the times, the stent underexpansion based on MEI was located proximally to the MSAx by 18.1 mm ± 11.8 mm. Furthermore, in 42% of the total cases, MEI would change the intervention strategy based on the stent underexpansion being in a different location ≥10 mm in comparison to MSAx (34%) associated with the discrepancy between expansion indexes for MEI and MSAx (22%). CONCLUSION: We concluded that MEI location did not correlate to the conventional MSAx in two thirds of the cases. Moreover, compared to MEI, the MSAx assessment yielded lower expansion values in different stent positions, potentially changing the appropriate post-stent optimization, which thus would impact the decision-making strategy in almost half of the patients.

An assessment of the quality of optical coherence tomography image acquisition.

Optical coherence tomography (OCT) provides excellent image resolution, however OCT optimal acquisition is essential but could be challenging owing to several factors. We sought to assess the quality of OCT pullbacks and identify the causes of suboptimal image acquisition. We evaluated 784 (404 pre-PCI; 380 post-PCI) coronary pullbacks from an anonymized OCT database from our Cardiovascular Imaging Core Laboratory. Imaging of the region-of-interest (ROI-lesion or stented segment plus references) was incomplete in 16.1% pullbacks, caused by pullback starting too proximal (63.7%), inappropriate pullback length (17.1%) and pullback starting too distal (11.4%). The quality of image acquisition was excellent in 36.3% pullbacks; whereas 4% pullbacks were unanalyzable. Pullback quality was most commonly affected by poor blood displacement from inadequate contrast volume (27.4%) or flow (25.6%), followed by artifacts (24.1%). Acquisition mode was 'High-Resolution' (54 mm) in 74.4% and 'Survey' (75 mm) in 25.6% of cases. The 54 mm mode was associated with incomplete ROI imaging (p = 0.020) and inadequate contrast volume (p = 0.035). We observed a substantial frequency of suboptimal image acquisition and identified its causes, most of which can be addressed with minor modifications during the procedure, ultimately improving patient outcomes.