Non-traumatic (spontaneous) superficial femoral artery dissection: A case report.

Non-traumatic or spontaneous dissection of the superficial femoral artery is an extremely rare entity, being more common in the external iliac artery in relation to intensive physical activity, pregnancy, among others. It has a variable clinical presentation. The diagnosis is made through angio-tomography (Angio-CT), angio-resonance (Angio-MR) and/or arteriography, the last one being diagnostic and therapeutic. The case of a 62-year-old female patient with a history of high blood pressure who consulted due to intense pain in the left lower limb is discussed. The diagnosis of dissection was made through arteriography and she underwent endovascular repair, showing favorable results.

Comparison of Small Blood Vessel Diameter with Intravascular Ultrasound and Coronary Angiography for Guidance of Percutaneous Coronary Intervention.

Major cardiovascular events (MACEs) are a cause of major mortality worldwide. The narrowing and blockage of coronary arteries with atherosclerotic plaques are diagnosed and treated with percutaneous coronary intervention (PCI). During this procedure, coronary angiography (CAG) remains the most widely used guidance modality for the evaluation of the affected blood vessel. The measurement of the blood vessel diameter is an important factor to consider in order to decide if stent colocation is suitable for the intervention. In this regard, a small blood vessel (<2.75 mm) is majorly left without stent colocation; however, small vessel coronary artery disease (SvCAD) is a significant risk factor for the recurrence of MACEs, maybe due to the lack of a standardized treatment related to the diameter of the affected blood vessel; therefore, a more precise measurement is needed. The use of CAG for the measurement of the blood vessel diameter has some important limitations that can be improved with the use of newer techniques such as intravascular ultrasound (IVUS), although at higher costs, which might explain its underuse. To address differences in blood vessel diameter measurements and identify specific cases where IVUS might be of additional benefit for the patient, we conducted a retrospective study in patients who underwent PCI for MACEs with affection for at least one small blood vessel. We compared the measurements of the affected small blood vessels' diameter obtained by CAG and IVUS to identify cases of reclassification of the affected blood vessel; additionally, we underwent a multivariate analysis to identify risk factors associated with blood vessel reclassification. We included information from 48 patients with a mean ± SD age of 69.1 ± 11.9 years; 70.8% were men and 29.2% were women. The mean diameter with CAG and IVUS was 2.1 mm (95% CI 1.9-2.2), and 2.8 (2.8-3.0), respectively. The estimated difference was of 0.8 mm (95% CI 0.7-0.9). We found a significant positive low correlation in diameter measurements of small blood vessels obtained with CAG and IVUS (r = 0.1242 p = 0.014). In total, 37 (77%) patients had a reclassification of the affected blood vessel with IVUS. In 21 cases, the affected blood vessel changed from a small to a medium size (2.75-3.00 mm), and in 15 cases, the affected vessel changed from a small to a large size (<3.00 mm). The Bland-Altman plot was used to evaluate agreement in measurements with CAG and IVUS. The change in blood vessel classification with IVUs was important for the decision of intervention and stent collocation. The only variable associated with reclassification of blood vessels after adjustment in a multivariate analysis was T2D (type 2 diabetes) (p = 0 0.035). Our findings corroborate that blood vessels might appear smaller with CAG, especially in patients with T2D; therefore, at least in these cases, the use of IVUS is recommended over CAG.

Quantitative coronary three-dimensional geometry and its association with atherosclerotic disease burden and composition.

BACKGROUND: Isolate features of the coronary anatomy have been associated with the pathophysiology of atherosclerotic disease. Computational methods have been described to allow precise quantification of the complex three-dimensional (3D) coronary geometry. The present study tested whether quantitative parameters that describe the spatial 3D coronary geometry is associated with the extension and composition of the underlying coronary artery disease (CAD). METHODS: Patients with CAD scheduled for percutaneous intervention were investigated with coronary computed tomography angiography (CCTA), and invasive coronary angiography, and virtual histology intravascular ultrasound (IVUS-VH). For all target vessels, 3D centerlines were extracted from CCTA images and processed to quantify 23 geometric indexes, grouped into 3 main categories as follows: (i) length-based; (ii) curvature-based, torsion-based, and curvature/torsion-combined; (iii) vessel path-based. The geometric variables were compared with IVUS-VH parameters assessing the extent and composition of coronary atherosclerosis. RESULTS: A total of 36 coronary patients (99 vessels) comprised the study population. From the 23 geometric indexes, 18 parameters were significantly (p < 0.05) associated with at least 1 IVUS-VH parameter at a univariate analysis. All three main geometric categories provided parameters significantly related with atherosclerosis variables. The 3D geometric indexes were associated with the degree of atherosclerotic extension, as well as with plaque composition. Geometric features remained significantly associated with all IVUS-VH parameters even after multivariate adjustment for clinical characteristics. CONCLUSIONS: Quantitative 3D vessel morphology emerges as a relevant factor associated with atherosclerosis in patients with established CAD.

Extensive right coronary artery thrombosis in a patient with COVID-19: A case report.

BACKGROUND: Occurring in approximately 30% of hospitalized patients, cardiovascular complications that take place during the course of coronavirus disease 2019 (COVID-19) have been shown to cause morbidity and mortality. This case is the first report of extensive right coronary artery (RCA) thrombosis that was evaluated by intracoronary imaging and intracoronary invasive physiology in a patient with COVID-19. CASE SUMMARY: A 62-year-old woman presented with flu-like symptoms; ten days later, she presented with inferior ST-segment elevations, chest pain, dyspnea, nausea and vomiting. The patient was diagnosed with COVID-19 following a positive test result. Emergency angiography of the RCA and its branches indicated intraluminal filling defects, suggesting a thrombus. Intravascular ultrasound confirmed a subacute thrombus in the RCA, the right posterior descending branch and the right posterior ventricular (RPV) branch. There was also an acute thrombus in the RPV branch and atherosclerosis in the RCA. Dual antiplatelet/ anticoagulation therapy was administered. After 7 d, angiography revealed complete disappearance of the thrombi. Optical coherence tomography confirmed this with the exception of a small thrombus in the RPV branch and atherosclerotic plaque in the RCA. The atherosclerotic RCA was measured using the resting full-cycle ratio, indicating no impairment to coronary physiology. The patient was discharged on the 11th day of hospitalization and remained asymptomatic through the 6-mo follow-up. CONCLUSION: This was the first report of RCA thrombosis in a patient with COVID-19. Dual antiplatelet/anticoagulation therapy was successful.

Pulmonary Arterial Remodeling Is Related to the Risk Stratification and Right Ventricular-Pulmonary Arterial Coupling in Patients With Pulmonary Arterial Hypertension.

BACKGROUND: Pulmonary arterial (PA) stiffness has an essential contribution to the right ventricular (RV) failure pathogenesis. A comprehensive and multiparameter risk assessment allows predicting mortality and guiding treatment decisions in PA hypertension (PAH). We characterize PA remodeling with intravascular ultrasound (IVUS) in prevalent and stable patients with PAH according to the ESC/ERS risk table and analyze the RV-PA coupling consequences. METHODS: Ten control subjects and 20 prevalent PAH adult patients underwent right heart catheterization (RHC) with simultaneous IVUS study. We estimated cardiac index (CI), pulmonary vascular resistance, and compliance (PVR, PAC) by standard formulas. From IVUS and RHC data, PA diameter, wall thickness/luminal diameter ratio, and indexes of stiffness (pulsatility, compliance, distensibility, incremental elastic modulus - Einc-, and the stiffness index ß) were measured. We evaluated RV-PA coupling by the ratio of tricuspid annular plane systolic excursion to systolic pulmonary arterial pressure (TAPSE/sPAP). The individual average risk was calculated by assigning a score of 1 (low-risk -LR-), 2 (intermediate-risk -IR-), and 3 (high-risk -HR-) for each of seven variables (functional class, six-minute walking test, brain natriuretic peptide, right atrial area and pressure, CI, and PA oxygen saturation) and rounding the average value to the nearest integer. RESULTS: All PA segments interrogated showed increased vessel diameter, wall cross-sectional area (WCSA), and stiffness in patients with PAH compared to control subjects. 45% corresponded to LR, and 55% corresponded to IR PAH patients. The different measurements of PA stiffness showed significant correlations with TAPSE/sPAP (r = 0.6 to 0.76) in PAH patients. The IR group had higher PA stiffness and lower relative WCSA than LR patients (P < 0.05), and it is associated with a lower PAC and TAPSE/sPAP (P < 0.05). CONCLUSION: In prevalent PAH patients, the severity of proximal PA remodeling is related to the risk stratification and associated with PAC and RV-PA coupling impairment beyond the indirect effect of the mean PA pressure. The concomitant assessment of IVUS and hemodynamic parameters at diagnosis and follow-up of PAH patients could be a feasible and safe tool for risk stratification and treatment response of the PA vasculopathy during serial hemodynamic measurements.

Coronary arterial geometry: A comprehensive comparison of two imaging modalities.

The characterization of vascular geometry is a fundamental step towards the correct interpretation of coronary artery disease. In this work, we report a comprehensive comparison of the geometry featured by coronary vessels as obtained from coronary computed tomography angiography (CCTA) and the combination of intravascular ultrasound (IVUS) with bi-plane angiography (AX) modalities. We analyzed 34 vessels from 28 patients with coronary disease, which were deferred to CCTA and IVUS procedures. We discuss agreement and discrepancies between several geometric indexes extracted from vascular geometries. Such an analysis allows us to understand to which extent the coronary vascular geometry can be reliable in the interpretation of geometric risk factors, and as a surrogate to characterize coronary artery disease.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Contemporary nationwide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter-directed thrombolysis for proximal deep venous thrombosis.

OBJECTIVE: Outflow venous stenting as an adjunct to catheter-directed thrombolysis (CDT) is performed to prevent recurrent thrombosis and to reduce the risk of post-thrombotic syndrome. Historical data show that stenting improves outcomes of surgical thrombectomy in patients with iliofemoral deep venous thrombosis (DVT), and recent observational data suggest that stenting improves long-term outcomes of CDT. However, the impact of stenting during CDT on acute safety outcomes is unknown. We sought to investigate the contemporary trends, safety outcomes, and resource utilization of adjunctive stent placement in patients undergoing CDT. METHODS: Patients with proximal lower extremity and caval DVT were identified within the National Inpatient Sample from January 2005 to December 2013. From this data set, we stratified our patients into three groups: patients who received CDT alone, patients who received CDT plus angioplasty, and patients who received CDT plus angioplasty with stenting. We used an inverse probability treatment weighting algorithm to create three weighted cohorts. Cochran-Armitage test was used to evaluate the trends of stent placement among patients treated with CDT. The primary outcome was a composite end point of all-cause mortality, gastrointestinal bleed, or intracranial hemorrhage. RESULTS: A total of 138,049 patients were discharged with a principal diagnosis of proximal and caval DVT; 7097 of these patients received CDT (5.1%). From this group, 2854 (40.2%) were treated with CDT alone, 2311 (32.6%) received adjunctive angioplasty alone, and 1932 (27.2%) received adjunctive angioplasty and stent. Adjunctive stenting had a significantly lower rate of primary composite outcome compared with CDT alone (2.7% vs 3.8%; P = .04). Stent placement was associated with a similar length of stay compared with angioplasty and CDT alone groups (6.8 vs 6.9 vs 7.1 days, respectively; P = .94) and higher in-hospital charges ($115,164.01 ± $76,985.31 vs $98,089.82 ± $72,921.94 vs $80,441.63 ± $74,024.98; P < .001). CONCLUSIONS: This nationwide study suggests that one in four patients undergoing CDT is treated with adjunctive stent placement in the United States. This observational study showed that adjunctive stenting does not adversely affect the acute safety outcomes of CDT; however, it was associated with increased hospital charges.

Intravascular ultrasound for cardiac allograft vasculopathy detection.

Cardiac allograft vasculopathy (CAV) after heart transplantation is a fibro-proliferative process affecting coronary arteries of the graft in up to 46.8% of the cases during the first 10 years post-transplantation. It is one of the main causes of graft loss and death. Due to graft denervation, CAV causing ischemia is usually clinically silent until the disease is far advanced. In this study, we compared coronary angiography with intravascular ultrasound (IVUS) for CAV detection. OUTCOMES: A total of 114 patients with HTx who underwent coronary angiography and IVUS between March 2018 and March 2019 were included. Mean follow-up was 87 ± 61 month. Lesions documented by coronary angiography were found in only 27 (24%) of the 114 patients. IVUS revealed ISHLT CAV 0 in 87 patients (76.3%); ISHLT CAV1 in 15 (13,1%) and ISHLT CAV2 and CAV3 in 6 patients (5.2%) each. Among 328 IVUS images, maximum intimal thickness (MIT) >0.5 mm was obtained in 60 vessels (52%) with 24 patients having three-vessel and 19 two-vessel involvement. CONCLUSION: As an adjunct to conventional coronary angiography to detect angiographically silent CAV in heart transplant patients, IVUS is a reliable and safe technique with a low complication rate. Large multicenter studies are necessary to confirm these findings and the potential long-term clinical impact of early detection in clinically and angiographically silent phase.

Role of non-statin lipid-lowering therapy in coronary atherosclerosis regression: a meta-analysis and meta-regression.

BACKGROUND: Several studies have investigated the association between non-statin lipid-lowering therapy and regression of atherosclerosis. However, these studies were mostly small and their results were not always robust. The objectives were: (1) to define if a dual lipid-lowering therapy (statin + non-statin drugs) is associated with coronary atherosclerosis regression, estimated by intravascular ultrasound (IVUS); (2) to assess the association between dual lipid-lowering-induced changes in low density lipoprotein cholesterol (LDL-C) and non-high-density-lipoprotein cholesterol (non-HDL-C) levels and atherosclerosis regression. METHODS: A meta-analysis including trials of non-statin lipid-lowering therapy, reporting LDL-C, non-HDL-C and total atheroma volume (TAV) with a minimum of 6 months of follow-up was performed. The primary endpoint was defined as the change in TAV measured from baseline to follow-up, comparing groups of subjects on statins alone versus combination of statin and non-statin drugs. The random-effects model and meta-regression were performed. RESULTS: Eight eligible trials of non-statin lipid-lowering drugs (1759 patients) were included. Overall, the dual lipid-lowering therapy was associated with a significant reduction in TAV [- 4.0 mm3 (CI 95% -5.4 to - 2.6)]; I2 = 0%]. The findings were similar in the stratified analysis according to the lipid-lowering drug class (ezetimibe or PCSK9 inhibitors). In the meta-regression, a 10% decrease in LDL-C or non-HDL-C levels, was associated, respectively, with 1.0 mm3 and 1.1 mm3 regressions in TAV. CONCLUSION: These data suggests the addition of ezetimibe or PCSK9 inhibitors to statin therapy results in a significant regression of TAV. Reduction of coronary atherosclerosis observed with non-statin lipid-lowering therapy is associated to the degree of LDL-C and non-HDL-C lowering. Therefore, it seems reasonable to achieve lipid goals according to cardiovascular risk and regardless of the lipid-lowering strategy used (statin monotherapy or dual treatment).

An Uncommon Cause of ST-Segment Elevation Myocardial Infarction: Intramural Coronary Artery Hematoma After Blunt Chest Trauma.

Intramural coronary hematoma (IMCH) is a rare cause of acute myocardial infarction (MI). We aim to review the current knowledge and share our experience with the diagnosis and management of a patient presenting with traumatic IMCH leading to an acute ST-segment elevation MI. (Level of Difficulty: Intermediate.).

Rol del ultrasonido intravascular en el diagnóstico de la disección coronaria espontánea / Role of intravascular ultrasound in the diagnosis of spontaneous coronary artery dissection / Papel da ultrassonografia intravascular no diagnóstico da dissecção espontânea das coronárias

Resumen: El diagnóstico de disección coronaria espontánea como causa de síndrome coronario agudo ha aumentado desde el surgimiento de las técnicas de imagen intracoronaria. Aún así, continúa siendo una entidad subdiagnosticada. La evidencia en relación con el tratamiento es escasa, pero la conducta conservadora ha demostrado resultados favorables en pacientes seleccionados. Presentamos el caso de una paciente de 55 años en la que se diagnostica infarto de miocardio sin elevación del ST. En la cineangiocoronariografía se sospecha como mecanismo causal la disección coronaria espontánea, lo cual se confirma mediante ultrasonido intravascular. Se optó por un tratamiento conservador con buena evolución.

Summary: The diagnosis of spontaneous coronary artery dissection as a cause of acute coronary syndrome has increased since the arise of intravascular imaging techniques. However, it still remains an underdiagnosed entity. Evidence related to its management is scarce, but conservative strategies have shown favorable outcomes in selected patients. We present the case of a 55-year-old female patient who is diagnosed with a non-ST segment elevation myocardial infarction. Spontaneous coronary artery dissection is suspected in the coronary angiography and then confirmed by intravascular ultrasound. Conservative management was selected, with favorable clinical outcomes.

Resumo: O diagnóstico de dissecção coronariana espontânea como causa da síndrome coronariana aguda aumentou com o surgimento das técnicas de imagem intracoronariana. Apesar disso é uma entidade subdiagnosticada. A evidência sobre o tratamento é escassa, mas o tratamento conservador mostrou resultados favoráveis em pacientes selecionados. Apresentamos o caso de um paciente de 55 anos com diagnóstico de infarto do miocárdio sem supradesnivelamento do segmento ST. Suspeita-se de dissecção coronariana espontânea na angiografia, confirmada por ultrassonografia intravascular. Se optou por tratamento conservador com boa evolução.

Optical coherence tomography versus intravascular ultrasound in patients with myocardial infarction: a diagnostic performance study of pre-percutaneous coronary interventions

Accurate coronary measurements are important in guiding percutaneous coronary intervention. Intravascular ultrasound is a widely accepted diagnostic modality for coronary measurement before percutaneous coronary intervention. The spatial resolution of optical coherence tomography is 10 times larger than that of intravascular ultrasound. The objective of the study was to compare quantitative and qualitative parameters of frequency domain optical coherence tomography (FDOCT) with those of intravascular ultrasound and coronary angiography in patients with acute myocardial infarction. Diagnostic parameters of coronary angiography, intravascular ultrasound, and FDOCT of 250 patients with coronary artery disease who required admission diagnosis were included in the analyses. Minimum lumen diameter detected by FDOCT was larger than that detected by quantitative coronary angiography (2.11±0.1 vs 1.89±0.09 mm, P<0.0001, q=34.67) but smaller than that detected by intravascular ultrasound (2.11±0.1 vs 2.19±0.11 mm, P<0.0001, q=12.61). Minimum lumen area detected by FDOCT was smaller than that detected by intravascular ultrasound (3.41±0.01 vs 3.69±0.01 mm2, P<0.0001). FDOCT detected higher numbers of thrombus, tissue protrusion, dissection, and incomplete stent apposition than those detected by intravascular ultrasound (P<0.0001 for all). More accurate and sensitive results of the coronary lumen can be detected by FDOCT than coronary angiography and intravascular ultrasound (level of evidence: III).

Intravascular ultrasound is a key diagnostic tool in subclavian vein varicosity.

Varicose veins of the neck are far less common than lower extremity varicosities. Often, neck varicosities can be a sign of a more central venous obstruction. Here, we describe a patient with no risk factors for central venous obstruction who presented with a recurrent left subclavian vein (LSV) varicosity causing significant pain and discomfort that was recalcitrant to repeated phlebectomy. Venography revealed a dilated LSV with no significant venographic stenosis in the LSV or brachiocephalic vein. Intravascular ultrasound subsequently revealed a culprit hypertrophied valve that was successfully treated with valvuloplasty, resulting in durable resolution of the patient's symptoms, suggesting that intravascular ultrasound was essential in the diagnosis and treatment of this hypertrophied valve.

Radial-Biased Tracking Method to Assess Tissue Displacement in Intravascular Ultrasound Sequences: A Phantom Framework Evaluation.

OBJECTIVES: We created and evaluated a pixel-tracking method capable of accurately identify the displacement of tissue in intravascular ultrasound (IVUS) images. METHODS: Our proposed pixel-tracking method assessed the horizontal and vertical displacement of tissue from a numerical phantom of IVUS sequences. The proposed tracking method is based on a block-matching framework, comparing 2 distinct frames within a selected region by normalized cross-correlation. Our method, specialized for IVUS applications, reduced the tracking area by implementing a limiting radius and a radial bias during the search. RESULTS: The method was evaluated by using 54 numerical phantom image sequences from 9 distinct arterial models, resulting in different arteries with atherosclerotic plaques under a range of pressures. The ground truth reference coordinates of the tracked tissue were extracted from each numerical phantom sequence. Our results were compared to 8 other methods present in the literature. The mean absolute tracking errors ± SD for our method were 15.56 ± 19.46 and 13.04 ± 13.82 µm for the horizontal and vertical directions, respectively, between 2 subsequent frames, and 162.58 ± 305.93 and 102.22 ± 130.61 µm from lower to higher pressures in the range of 6 frames (n = 42,036). CONCLUSIONS: Our application-specific pixel-tracking method showed promising results and no statistically significant tracking error (P = .954), comparable to state-of-the-art methods present in the literature. Application-specific tracking methods have advantages over general methods by turning tissue-specific behavior into a directional bias in the tracking algorithm.

Coronary fractional flow reserve derived from intravascular ultrasound imaging: Validation of a new computational method of fusion between anatomy and physiology.

OBJECTIVES: To evaluate the diagnostic performance of a novel computational algorithm based on three-dimensional intravascular ultrasound (IVUS) imaging in estimating fractional flow reserve (IVUSFR ), compared to gold-standard invasive measurements (FFRINVAS ). BACKGROUND: IVUS provides accurate anatomical evaluation of the lumen and vessel wall and has been validated as a useful tool to guide percutaneous coronary intervention. However, IVUS poorly represents the functional status (i.e., flow-related information) of the imaged vessel. METHODS: Patients with known or suspected stable coronary disease scheduled for elective cardiac catheterization underwent FFRINVAS measurement and IVUS imaging in the same procedure to evaluate intermediate lesions. A processing methodology was applied on IVUS to generate a computational mesh condensing the geometric characteristics of the vessel. Computation of IVUSFR was obtained from patient-level morphological definition of arterial districts and from territory-specific boundary conditions. FFRINVAS measurements were dichotomized at the 0.80 threshold to define hemodynamically significant lesions. RESULTS: A total of 24 patients with 34 vessels were analyzed. IVUSFR significantly correlated (r = 0.79; P < 0.001) and showed good agreement with FFRINVAS , with a mean difference of -0.008 ± 0.067 (P = 0.47). IVUSFR presented an overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 91%, 89%, 92%, 80%, and 96%, respectively, to detect significant stenosis. CONCLUSION: The computational processing of IVUSFR is a new method that allows the evaluation of the functional significance of coronary stenosis in an accurate way, enriching the anatomical information of grayscale IVUS.

Serial intravascular ultrasound evaluation of the DESolve™ novolimus-eluting bioresorbable coronary scaffold system.

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. METHODS: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm2 vs. 7.35 ± 1.53 mm2 , P < 0.002; and 101.19 ± 20.9 mm3 vs. 118.51 ± 26.6 mm3 , P = 0.001). Late lumen loss was 0.22 ± 0.30 mm at 6 months and 0.33 ± 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

First in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous PLLA bioresorbable scaffold in the absence of anti-proliferative drugs: Two-year imaging results in humans.

OBJECTIVES: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA bioresorbable scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS: A total of 10 patients undergoing single scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS: At 6 months, mean intra-scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION: At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.