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BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.). [ABSTRACT FROM AUTHOR]

Background: Inflammation and thrombosis are often linked mechanistically and are associated with adverse events after transcatheter aortic valve replacement (TAVR). High residual platelet reactivity (HRPR) is especially common when clopidogrel is used in this setting, but its relevance to immune activation is unknown. We sought to determine whether residual activity at the purinergic receptor P2Y12 (P2Y12) promotes prothrombotic immune activation in the setting of TAVR., Methods: This was a randomized trial of 60 patients (enrolled July 2015 through December 2018) assigned to clopidogrel (300mg load, 75mg daily) or ticagrelor (180mg load, 90 mg twice daily) before and for 30 days following TAVR. Co-primary endpoints were P2Y12-dependent platelet activity (Platelet Reactivity Units; VerifyNow) and the proportion of inflammatory (cluster of differentiation [CD] 14+/CD16+) monocytes 1 day after TAVR., Results: Compared to clopidogrel, those randomized to ticagrelor had greater platelet inhibition (median Platelet Reactivity Unit [interquartile range]: (234 [170.0-282.3] vs. 128.5 [86.5-156.5], p < 0.001), but similar inflammatory monocyte proportions (22.2% [18.0%-30.2%] vs. 25.1% [22.1%-31.0%], p = 0.201) 1 day after TAVR. Circulating monocyte-platelet aggregates, soluble CD14 levels, interleukin 6 and 8 levels, and D-dimers were also similar across treatment groups. HRPR was observed in 63% of the clopidogrel arm and was associated with higher inflammatory monocyte proportions. Major bleeding events, pacemaker placement, and mortality did not differ by treatment assignment., Conclusions: Residual P2Y12 activity after TAVR is common in those treated with clopidogrel but ticagrelor does not significantly alter biomarkers of prothrombotic immune activation. HRPR appears to be an indicator (not a cause) of innate immune activation in this setting., Competing Interests: David A. Zidar reports research grant support from AstraZeneca, honoraria from GSK/Pfizer and Medtronic. Steven Filby is a consultant for Boston Scientific. Nicholas T. Funderburg is a consultant for Gilead. Mehdi Shishebhor is a consultant for Abbott Vascular, Medtronic, Terumo, Philips, and Boston Scientific. Sahil A. Parikh serves on the advisory Board of Abbott, Boston Scientific, Medtronic, Philips, Janssen, Cordis, Efemoral, and Advanced Nanotechnologies; receives research support from Abbott, Boston Scientific, surmodics, shockwave, and trireme; and is a consultant for Inari, Penumbra, Abiomed, and Terumo. Guilherme Attizzani is a consultant and advisory board member of Medtronic and Abbott Vascular. Daniel I. Simon reports honoraria from Medtronic.

In the era of emerging options for mitral valvular intervention, we sought to characterize the relative utilization, outcomes, and posthospital dispositions of patients referred for transcatheter mitral valve repair (TMVRepair) and surgical mitral valve procedures (SMVP), by cancer-status. Leveraging the National Inpatient Sample, a representative national dataset, ICD-9 codes for all adults >18 years with co-morbid mitral regurgitation, and cancer without metastatic disease admitted from 2003 to 2015 were queried. TMVRepair was performed in 700 hospitalizations from 2012 to 2015, whereas SMVP was utilized during 12,863 hospitalizations from 2003 to 2015. During follow-up, we observed a proportional increase in TMVRepair utilization among cancer patients (vs noncancer), particularly in 2015 (14.2% vs 8.2%, p <0.0001). There was no difference in in-hospital mortality (1.4% vs 1.8%, p = 0.71), ischemic stroke (0.7% vs 0.6%, p = 0.97), major bleeding (8.6% vs 10.9%, p = 0.36), and home discharge (62.1% vs 65.7%, p = 0.45) by cancer-status among patients who underwent TMVRepair; but, cost of care was increased ($52,325 vs $48,832, p <0.0001). Similarly, there was no difference in in-hospital mortality (3.1% vs 3.4%, p = 0.36), ischemic stroke (2.6% vs 3.1%, p = 0.16) as well as the cost-of-care ($58,106 vs $58,844, p = 0.49) among those who underwent SMVP across the same period; but, cancer was associated with increased major bleeding (34.9% vs 30.5%, p <0.0001), and lower likelihood of home discharge (32.8% vs 38.6%, p <0.0001). In conclusion, TMVRepair and SMVP were associated with comparable in-hospital mortality and outcomes in cancer versus noncancer patients. However, cancer patients treated with SMVP experienced more frequent bleeding related complications compared with noncancer patients., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The Absorb bioresorbable vascular scaffold (BVS) promised to avoid some of the disadvantages of its metal predecessors. Even though it has been taken off the market, limited data is available about its use in coronary chronic total occlusion (CTO) and its performance in overlap segments, which would be of special research interest due to its large thickness. This data is still pertinent since the platform of bioresorbable devices has not been abandoned, with several companies working on it. We aimed to compare healing and performance between overlap (OL) and non-overlap regions (NOL) of CTO lesions treated with BVS, using optical coherence tomography (OCT). Fourteen patients with overlapping BVS were included from the GHOST-CTO registry, resulting in 25 OL and 38 NOL regions. OCT based parameters were compared between OL and NOL groups at baseline (post-implantation) and 12-month follow-up. The mean age was 61.7 ± 7.2 years and 12 (86%) were males. Twelve (86%) patients underwent PCI for stable coronary artery disease and 2 (14%) had unstable angina. At 12-month follow-up, mean lumen area decreased in both NOL and OL regions, but the decrease was significantly larger in the OL region (NOL - 0.7 ± 1.33 vs. OL - 2.4 ± 1.54 mm 2 ; p = 0.002). Mean scaffold area increased in both regions, but increased significantly more in NOL ( + 1.1 ± 1.54 vs. + 0.4 ± 1.16 mm 2 ; p = 0.016). The percent of uncovered struts was lower in the OL group (5.0 ± 6.6% vs. 3.75 ± 8.7%, p = 0.043), whereas the percentage of malapposed struts was similar (0.3 ± 0.5% vs. 0.7 ± 2.3%, p = 0.441). Neointimal hyperplasia (NIH) was more pronounced in the OL region (0.13 ± 0.04 vs. 0.24 ± 0.10 mm 2 , p = 0.001). The OL and NOL segments showed comparable healing in terms of coverage and malapposition. However, NIH was more prominent in OL region. The long-term clinical implications of these findings needs further evaluation. The present study provides important insights for future development of BVS technology.

Objectives: To investigate the effect of TAVR technique on in-hospital and 30-day outcomes in patients with aortic stenosis (AS) and reduced ejection fraction (EF)., Background: Patients with AS and concomitant low EF may be at risk for adverse hemodynamic effects from general anesthesia utilized in transcatheter aortic valve replacement (TAVR) via the conventional strategy (CS). These patients may be better suited for the minimally invasive strategy (MIS), which employs conscious sedation. However, data are lacking that compare MIS to CS in patients with AS and concomitant low EF., Methods: In this retrospective study, we identified all patients with low EF (<50%) undergoing transfemoral MIS-TAVR vs CS-TAVR between March 2011 and May 2018. Our primary endpoint was defined as the composite of in-hospital mortality and major periprocedural bleeding or vascular complications., Results: Two hundred and seventy patients had EF <50%, while 154 patients had EF ≤35%. Overall, a total of 236 patients were in the MIS group and 34 were in the CS group. Baseline characteristics between the two groups were similar except for Society of Thoracic Surgeons (STS) score (MIS 8.4 ± 5.1 vs CS 11.7 ± 6.8; P<.01). There were no differences between the two groups in incidence of the primary endpoint (MIS 5.5% vs CS 8.8%; odds ratio for MIS, 0.60; 95% confidence interval, 0.16-2.23; P=.45)., Conclusions: In patients with severe AS and reduced EF, MIS was not associated with adverse in-hospital or 30-day clinical outcomes compared with CS. In these patients, MIS may be a suitable alternative to CS without compromising clinical outcomes.

Background: Bone marrow-derived progenitor cells likely contribute to both endothelial- and smooth muscle cell-dependent healing responses in stent-injured vessel sites. This study aimed to assess mobilization of progenitor cells and vessel healing after zotarolimus-eluting (ZES) and everolimus-eluting (EES) stents., Methods and Results: In 63 patients undergoing coronary stent implantation, we measured circulating CD34 + CD133 + CD45low cells and serum levels of biomarkers relevant to stem cell mobilization. In 31 patients of them, we assessed vessel healing within the stented segment using optical coherence tomography (OCT) imaging. The CD34 + CD133 + CD45low cells increased 68 ± 59% 7 days after bare metal stent (BMS), 10 ± 53% after ZES ( P  < 0.01 vs BMS), 3 ± 49% after EES ( P  < 0.001 vs BMS), compared with baseline. Percent change in CD34 + CD133 + CD45low cells was positively correlated with that in stromal cell-derived factor (SDF)-1α ( R  = 0.29, P  = 0.034). Percentage of uncovered struts was higher in the EES group (14.4 ± 17.3%), compared with the BMS (0.7 ± 1.3, P  < 0.01) and ZES (0.4 ± 0.5, P  < 0.01) groups. The change in CD34 + CD133 + CD45low cells showed positive correlation with OCT-quantified mean neointimal area ( R  = 0.48, P < 0.01). Finally, circulating mononuclear cells obtained from 5 healthy volunteers were isolated to determine the effect of sirolimus, zotarolimus and everolimus on vascular cell differentiation. The differentiation of mononuclear cells into endothelial-like cells was dose-dependently suppressed by sirolimus, zotarolimus, and everolimus., Conclusions: Mobilization of progenitor cells was suppressed, and differentiation of mononuclear cells into endothelial-like cells was inhibited, in association with increased number of uncovered stent struts, even after second generation drug-eluting stenting. These data suggest that new approaches are necessary to enhance stent healing.

Prosthetic valve endocarditis is a very grave and often terminal disease. Surgical valve replacement remains the cornerstone treatment for this disease. However, it is often contraindicated. Herein, we describe the implantation under direct visualization of a self-expandable transcatheter heart valve in a prohibitive surgical risk patient with homograft aortic valve endocarditis., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction: The use of fractional flow reserve (FFR) as the gold standard for functional assessment of intermediate coronary stenosis has been well documented. Intracoronary imaging techniques such as intravascular ultrasound (IVUS) have been used for additional coronary lesion resolution and some of its anatomic parameters have been studied as having possible correlation with FFR, particularly IVUS minimal lumen area (MLA). We performed a comprehensive review of the available literature in the area., Evidence Acquisition: A Pubmed search was performed for all the literature involving comparison of diagnostic accuracy of IVUS-MLA with FFR., Evidence Synthesis: An extensive description of all the available data regarding IVUS-MLA diagnostic value regarding the FFR of stenotic lesions, for both non-left main (non-LM) and left main (LM) lesions., Conclusions: For non-LM lesions IVUS-MLA cutoff values to identify specific FFR thresholds have marked heterogeneity and perform particularly poorly in terms of specificity and positive predictive value. For LM lesions IVUS-MLA performs better and shows a better correlation with FFR, though more data is needed to confirmed that trend.

Objectives: To compare angiographic and optical coherence tomography (OCT) data pertinent to thrombi, along with the histologic characteristics of aspirated thrombi in patients presenting with ST elevation myocardial infarction (STEMI) with or without inflammation, as assessed by C-reactive protein (CRP) and myeloperoxidase (MPO)., Methods: In the OCTAVIA (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty) study, 140 patients with STEMI referred for primary percutaneous intervention were enrolled. The patients underwent OCT assessment of the culprit vessel, along with blood sampling of CRP and MPO, and histologic analysis of the thrombus., Results: Biomarkers were available for 129 patients, and histology and immunohistochemistry of the thrombi were available for 78 patients. Comparisons were made using the median thresholds of CRP and MPO (2.08 mg/L and 604.124 ng/mL, respectively). There was no correlation between CRP and MPO levels in the whole population (p = 0.685). Patients with high CRP levels had higher thrombus grades and more frequent TIMI flow 0/1 compared with those with low CRP levels (5 [1st quartile 3; 3rd quartile 5] vs. 3.5 mg/L [1; 5], p = 0.007, and 69.3 vs. 48.5%, p = 0.04, respectively). Patients with high MPO levels more commonly had early thrombi than had those with low MPO levels (42.5 vs. 20.0%, p = 0.04)., Conclusions: CRP and MPO were not correlated in STEMI patients, possibly reflecting different pathogenic mechanisms, with CRP more related to thrombus burden and MPO to thrombus age., (© 2016 S. Karger AG, Basel.)

The ventricular partitioning device known as Parachute is the first and only percutaneously implantable device aimed at restoration of normal left ventricular geometry in humans. Since its conception, this technology has undergone extensive animal and human testing, with proved feasibility and safety, and is currently being studied in a pivotal randomized clinical trial. This article discusses ventricular remodeling and therapies attempted in the past, details the components of the ventricular partitioning device, describes the implanting technique, and reviews the most current experience of this device in humans., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Aim: Aim of the study was to report on the feasibility and early safety and efficacy of Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) for coronary artery bifurcations (CABs) treatment at a single high-volume center., Methods: All patients treated with Absorb implantation at our institution from March 2013 to March 2014 were enrolled in the prospective, single-center, ongoing, all-comers registry, which has the main purpose of evaluating the safety and efficacy of Absorb implantation in unselected patients treated in daily practice. In-hospital and at follow-up clinical outcomes of 46 patients undergoing treatment with Absorb in 46 CAB lesions were reported in the present study., Results: Treated CAB lesions involved the left main in 13.0% of cases, the left anterior descending artery in 65.0%, the left circumflex in 19.6%, and the right coronary artery in 2.2%. Bifurcations were classified as true (47.8%) and non-true (52.2%) according to the Medina classification. The provisional and the two-BVS techniques were used in 78.3% and 21.7%, respectively. Two-BVS techniques included: mini-crush 13.0%; reverse culotte 2.2%; T-stenting 2.2%; and V-stenting 4.3%. No in-hospital adverse events occurred. At 6 months no adverse events occurred. Only one case of target lesion revascularization was observed at day 227. No stent thrombosis occurred during follow-up., Conclusion: Our preliminary experience suggested that CABs treatment with Absorb is feasible and associated with promising immediate and short-term clinical outcomes. However, larger studies with long-term follow-up are needed to adequately address the safety and efficacy of BVS use in CABs.

FD-OCT is a new imaging technique that allows unprecedented in vivo microlevel assessment of human carotid plaque morphologic patterns and stent-vessel interactions. Prior reports describing the use of this technique have used balloon occlusion of the target vessel or iodinated contrast media to facilitate imaging. We report, for the first time, in vivo FD-OCT imaging of human carotid arteries without the use of iodinated contrast material or balloon occlusion techniques.

Frequency domain optical coherence tomography (FD-OCT) has shown promise to evaluate coronary devices in clinical trials, however, little is known about its application in clinical practice. This prospective, single center initiative planned for 100 % FD-OCT utilization in all patients undergoing coronary interventions during a 60-day period. Operators pre-specified the planned intervention based on angiography alone. FD-OCT success was defined as acquisition of good quality images enabling adequate quantification of vessel dimensions and lesion/percutaneous coronary intervention (PCI) assessment. Impact on management occurred when angiography-based planning was altered based on FD-OCT data. There were 297 FD-OCT acquisitions performed in 155 vessels from 150 patients. There were no FD-OCT procedural related cardiac adverse events and success was obtained in 85.7 % of all target vessels (pre-PCI = 76.8 % vs. post-PCI = 90.1 %, p = 0.004). Success on the first pullback occurred in 80.3 % overall (61.9 % in the initial operator experience and 85.5 % after the third procedure). FD-OCT impact on management was 81.8 % pre-PCI and 54.8 % post-PCI. Stent malapposition was detected in 39.2 % (89.4 % underwent further intervention) and edge dissection in 32.5 % (21.1 % treated with stent). FD-OCT success and management impact were similar in ACS and non-ACS patients (82.1 vs. 81.1 %, p = 1.000, and 62.5 vs. 65.1 %, p = 0.854, respectively). FD-OCT is safe, can successfully be incorporated into routine practice, and alters procedural strategy in a high proportion of patients undergoing PCI.

Objectives: To test the local delivery of sirolimus nanoparticles following percutaneous transluminal coronary angioplasty (PTCA) to treat in-stent restenosis (ISR) in a swine model., Background: Coronary bare-metal stent (BMS) implantation reduces major adverse cardiac events when compared with PTCA; however, ISR rates remain high., Methods: Eighteen swine underwent BMS deployment guided by intravascular ultrasound (IVUS). Of these, 16 developed ISR (1 stent/swine) and underwent angioplasty with a noncompliant balloon (PTCA-NC). The animals were then randomized into four groups for local infusion of sirolimus nanoparticles through a porous balloon catheter, as follows: (1) PTCA-NC alone (control); (2) PTCA-NC + (polylactic acid)-based nanoparticle formulation (anionic 1); (3) PTCA-NC + (polylactic-co-glycolic acid)-based nanoparticle formulation (anionic 2); and (4) PTCA-NC + Eudragit RS nanoparticle formulation (cationic). Coronary angiography and IVUS follow-up were performed 28 days after ISR treatment., Results: There was one episode of acute coronary occlusion with the cationic formulation. Late area loss was similar in all groups at 28 days according to IVUS. However, luminal volume loss (control = 20.7%, anionic 1 = 4.0%, anionic 2 = 6.7%, cationic = 9.6%; P = 0.01) and neointimal volume gain (control = 68.7%, anionic 1 = 17.4%, anionic 2 = 29.5%, cationic = 31.2%; P = 0.019) were significantly reduced in all treatment groups, especially in anionic 1., Conclusions: PTCA-NC followed by local infusion of sirolimus nanoparticles was safe and efficacious to reduce neointima in this model, and this strategy may be a promising treatment for BMS ISR. Further studies are required to validate this method in humans., (Copyright © 2012 Wiley Periodicals, Inc.)

Background and Purpose: Carotid artery-related stroke is largely an embolic disease that has been correlated with inflammation, plaque rupture, and thrombus formation in "vulnerable" atherosclerotic plaque. Nevertheless, current guidelines for carotid revascularization in asymptomatic patients rely on the calculation of stenosis for risk assessment, a parameter that has been viewed with increasing skepticism. Intravascular OCT is an imaging technique that offers high axial resolution (10 μm), allowing an unprecedented micron-level assessment of human carotid plaque morphology. This observational article reports the first successful use of the newest iteration of this technology, FDOCT without balloon occlusion to assess human carotid artery disease and carotid stent-vessel interaction in vivo., Materials and Methods: Four patients with asymptomatic carotid artery disease and ambiguous noninvasive and/or angiographic data underwent carotid FDOCT to assess risk and to formulate a treatment strategy., Results: Findings include the unexpected demonstration of TCFAs, plaque rupture, thrombus, inflammation, and marked tissue prolapse through stent struts in patients without high-risk factors by conventional criteria, as well as low-risk features in a patient with a high-risk noninvasive study. The procedures were performed without safety issues or special accommodations for vessel occlusion., Conclusions: The present study demonstrates the technical feasibility of FDOCT in cervical carotid arteries. As such, this technology holds the promise of not only clarifying ambiguous data in individual patients but of providing data that might call for a future paradigm shift in the assessment of asymptomatic carotid artery disease.

Fractional flow reserve (FFR) and intravascular imaging respectively provide hemodynamic and anatomical assessments of angiographic intermediate stenoses. Frequency domain optical coherence tomography (FD-OCT) is a promising high-resolution imaging modality, but its clinical use in determining severity of coronary disease has yet to be determined. There, we set out to determine the role of FD-OCT to complement FFR in the evaluation of intermediate coronary artery stenoses. FD-OCT was planned in 176 consecutive interventional procedures at our institution to delineate the proper use of FD-OCT in clinical practice. The decision to use other invasive assessments was at the discretion of the operator. This report describes an early series of the 14 patients who underwent FFR of 18 target stenoses in addition to FD-OCT. FD-OCT was successfully performed without complications in all cases. Fractional flow reserve was <0.80 in four patients, with minimal lumen areas and reference vessel diameters ranging from 1.03 to 3.47 mm(2) and 2.60 to 2.94 mm by FD-OCT, respectively. FD-OCT was important to rule out plaque rupture, erosion and thrombosis and to help guide decision to defer PCI in six patients with acute coronary syndrome and FFR > 0.80. FD-OCT was also valuable to guide PCI strategy in tandem lesions with an FFR < 0.80. This initial experience with FD-OCT suggests a potential complementary role of physiological and anatomical assessment to guide decision making in complex clinical scenarios. Future investigations are warranted to validate these findings and define the role of FD-OCT in assessing intermediate lesions.