Comparison of adenosine-independent pressure indices to fractional flow reserve in stent-jailed bifurcation side branches.

OBJECTIVES AND BACKGROUND: This study aims to evaluate whether the high correlation and classification agreement of the instantaneous wave-free ratio (iFR) and the resting distal coronary to aortic pressure ratio (Pd /Pa ) with the fractional flow reserve (FFR) can be confirmed in stent-jailed side branches (J-SB). METHODS: Consecutive patients (n = 49) undergoing provisional stenting were prospectively enrolled and a physiological assessment of the J-SB (n = 51) was performed. FFR, iFR, and Pd /Pa were measured and the hemodynamic relevance was determined using cutoff values of ≤0.80, ≤0.89, and ≤0.92, respectively. RESULTS: Both iFR (r = 0.75) and Pd /Pa (r = 0.77) correlated closely with FFR. Classification agreement with FFR was 78% for iFR (81% sensitivity, 77% specificity) and 75% for Pd /Pa (63% sensitivity and 80% specificity). However, angiographic diameter stenosis and pressure indices correlated poorly. For a threshold of ≥70% stenosis, agreement concerning hemodynamic relevance was found in 59% for FFR, 69% for iFR, and 61% for Pd /Pa . CONCLUSION: As reported for other lesion types, FFR and the adenosine-independent pressure indices iFR and Pd /Pa show close correlation and a high classification agreement of approximately 75%-80% in J-SB. Therefore, iFR can be regarded as a recommendable alternative to FFR for the guidance of provisional stenting in bifurcation lesions.

Determination of optimal fluoroscopic angulations for aorto-coronary ostial interventions from coronary computed tomography angiography.

BACKGROUND: An optimal aorto-coronary angiographic projection, characterized by an orthogonal visualization of the proximal coronary artery, is crucial for interventional success. We determined the distribution of optimal C-arm positions and assessed their feasibility by invasive coronary angiography. METHODS: Orthogonal aorto-coronary ostial angulations were determined in 310 CT data sets. In 100 patients undergoing subsequent invasive angiography, we assessed if the CT-predicted angulations were achievable by the C-arm system. If the predicted projection was not achievable due to mechanical constraints of the C-arm system, the most close, achievable angulation was determined. Patient characteristics were analyzed regarding the distribution of optimal angulations and its feasibility by the C-arm system. RESULTS: For the left ostium, CT revealed a mean angulation of LAO 23 â€‹± â€‹21°/cranial 25 â€‹± â€‹23° (90% of patients with a LAO/cranial angulation, 3% LAO/caudal, 4% RAO/cranial, 3% RAO/caudal) and were achievable by the C-arm system in 87% of patients. For the right ostium, the mean CT-predicted orthogonal angulation was LAO 36 â€‹± â€‹37°/cranial 36 â€‹± â€‹51° (84% LAO/cranial, 2% LAO/caudal, 14% RAO/caudal) and achievable by the C-arm system in 45% of patients. For the left ostium, a higher body weight was associated with a steeper LAO/cranial angulation being less feasible by the C-arm system due to mechanical constraints. CONCLUSIONS: Orthogonal aorto-left coronary angulations show a relative narrow distribution predominately in LAO/cranial position whereas a wider range of angulations was found for the right coronary ostium. The feasibility of CT-predicted angulations by the C-arm system is more restricted for the right than the left coronary ostium.

Dual-axis rotational coronary angiography versus conventional coronary angiography: a randomized comparison.

BACKGROUND: Dual-axis of rotational coronary angiography (RA), with one single cine acquisition during continuous C-arm motion along a pre-described path, is an alternative to conventional coronary angiography (CA). We assessed the performance of RA versus CA in a modern, experienced cath lab setting. METHODS: Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography were randomized to CA (n = 35) or dual-axis RA (n = 32). CA was performed with four left and two right coronary artery acquisitions with manual contrast medium injection. In RA, one cine acquisition each was performed for the left (5 projections) and right coronary artery (3 projections) with a fixed amount of contrast medium applied by a power injector. In both groups, single cine acquisitions in additional angulations were performed to fully interpret the coronary system, if necessary. Procedural parameters and outcome were compared. RESULTS: Mean age was 63 ± 12 years (64% males). Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173). Fluoroscopy duration (CA: 3 ± 3 min, RA: 3 ± 2 min, p = 0.748) and dose area product (CA: 1291 ± 761 µGym2, RA: 1476 ± 679 µGym2, p = 0.235) did not differ significantly between both groups. For CA, the amount of contrast medium (42 ± 13 vs. 46 ± 8 ml, p = 0.022) and procedure time (8 ± 5 vs. 11 ± 3 min, p < 0.001) were significantly lower. No major adverse event occurred during hospital stay. CONCLUSIONS: Dual-axis RA represents a feasible and safe alternative method to CA for obtaining coronary angiograms. However, no superiority was observed when performed by an experienced interventionalist with a modern system.

Individual Lesion-Level Meta-Analysis Comparing Various Doses of Intracoronary Bolus Injection of Adenosine With Intravenous Administration of Adenosine for Fractional Flow Reserve Assessment.

BACKGROUND: Intravenous infusion of adenosine is considered standard practice for fractional flow reserve (FFR) assessment but is associated with adverse side-effects and is time-consuming. Intracoronary bolus injection of adenosine is better tolerated by patients, cheaper, and less time-consuming. However, current literature remains fragmented and modestly sized regarding the equivalence of intracoronary versus intravenous adenosine. We aim to investigate the relationship between intracoronary adenosine and intravenous adenosine to determine FFR. METHODS: We performed a lesion-level meta-analysis to compare intracoronary adenosine with intravenous adenosine (140 µg/kg per minute) for FFR assessment. The search was conducted in accordance to the Preferred Reporting for Systematic Reviews and Meta-Analysis statement. Lesion-level data were obtained by contacting the respective authors or by digitization of scatterplots using custom-made software. Intracoronary adenosine dose was defined as; low: <40 µg, intermediate: 40 to 99 µg, and high: ≥100 µg. RESULTS: We collected 1972 FFR measurements (1413 lesions) comparing intracoronary with intravenous adenosine from 16 studies. There was a strong correlation (correlation coefficient =0.915; P<0.001) between intracoronary-FFR and intravenous-FFR. Mean FFR was 0.81±0.11 for intracoronary adenosine and 0.81±0.11 for intravenous adenosine (P<0.001). We documented a nonclinically relevant mean difference of 0.006 (limits of agreement: -0.066 to 0.078) between the methods. When stratified by the intracoronary adenosine dose, mean differences between intracoronary and intravenous-FFR amounted to 0.004, 0.011, or 0.000 FFR units for low-dose, intermediate-dose, and high-dose intracoronary adenosine, respectively. CONCLUSIONS: The present study documents clinically irrelevant differences in FFR values obtained with intracoronary versus intravenous adenosine. Intracoronary adenosine hence confers a practical and patient-friendly alternative for intravenous adenosine for FFR assessment.

OCT-assessment of scaffold resorption: Analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.

BACKGROUND: The aim of this study was to analyze individual differences in resorption of bioresorbable vascular scaffolds (BRS) through optical coherence tomography (OCT) analysis and to identify factors potentially influencing the resorption process. METHODS: Between April 2016 and July 2017 clinically driven invasive coronary angiography and OCT examinations were performed in 36 patients who had previously been treated with a total of 48 BRS (ABSORB BVS, Abbott Vascular, Santa Clara, CA). For each scaffold, a new BRS-RESORB-INDEX (BRI) was calculated. RESULTS: The mean time interval since implantation was 789 ± 321 days. In OCT, BRS struts remained detectable in all 48 BRS. Normalized light intensity as a marker for the resorption of BRS struts increased with time in a linear fashion (Spearman Rho: p < .001, correlation coefficient = .90; R2 [linear] = .91). Multivariable analysis identified diabetes (BRI of patients with diabetes vs. patients without diabetes: 0.34 ± 0.13 vs. 0.58 ± 0.22; p = .002) and presence of Peri-strut low intensity areas (PSLIA, BRI of 10 patients with PSLIA vs. 26 patients without PSLIA: 0.44 ± 0.21 vs. 0.61 ± 18; p = .027) as independent predictors for a prolonged BRS resorption, whereas the resorption rate in ACS patients (STEMI, NSTEMI, and unstable angina; n = 13) was significantly higher as compared to patients without ACS (0.62 ± 0.17 vs. 0.43 ± 0.24; p = .012). CONCLUSION: In humans, BRS resorption rate is significantly influenced by numerous factors. Our data suggest that diabetes and PSLIA are associated with a prolonged resorption process, whereas in ACS patients, BRS resorption appears to be significantly faster.

Major coronary evaginations following implantation of bioresorbable vascular scaffolds - Clinical and OCT characteristics.

BACKGROUND: Coronary evaginations can occur after implantation of bioresorbable vascular scaffolds (BRS) and may be associated with scaffold thrombosis. Aim of this study was to clarify the clinical manifestation, extent and time course of coronary artery remodeling in vessel segments that develop angiographically detectable evaginations following BRS implantation through optical coherence tomography (OCT) analysis. METHODS: In 8 patients, 10 BRS (Absorb, Abbott Vascular, Santa Clara, CA, USA) which displayed coronary evaginations in clinically driven late invasive coronary angiograms were identified and findings were compared to 10 BRS in 8 patients without coronary evaginations. Vessel and device geometry was analyzed in serial OCT cross-sections at a spacing of 200 µm. Measured BRS dimensions were normalized to the reference vessel size at implantation. RESULTS: In OCT, major evaginations on average affected 24 ±â€¯19% of the scaffold length. Scaffolds with major evaginations had a significantly larger lumen area than scaffolds without evaginations (mean normalized lumen area 1.19 ±â€¯0.58 vs. 0.77 ±â€¯0.38; p < 0.001), and also displayed a significantly larger scaffold area (mean normalized scaffold area: 1.36 ±â€¯0.6 vs. 1.13 ±â€¯0.43; p < 0.001), and scaffold diameter (mean normalized scaffold diameter: 1.17 ±â€¯0.33 vs.1.04 ±â€¯0.19; p < 0.001). Lumen area (r = 0.47; p < 0.001), scaffold area (r = 0.52; p < 0.001), and scaffold diameter (r = 0.74; p < 0.001) in the evagination group were positively correlated to the time since scaffold implantation. CONCLUSION: Coronary evaginations following BRS implantation are associated with an increased scaffold area, indicating that the scaffold follows the outward remodeling of the artery. The process affects the entire scaffold length and seems to be continuously progressing following implantation.

Effect of non-compliant balloon postdilatation on magnesium-based bioresorbable vascular scaffolds.

BACKGROUND: Optimal implantation results of bioresorbable scaffolds (BRS) are typically assumed to require postdilatation with non-compliant (NC) balloons to achieve full scaffold apposition and minimize event rates. We systematically evaluated the mechanical effect of NC balloon postdilatation on magnesium-based BRS (Magmaris®, Biotronik AG, Bülach, Switzerland) in vivo. METHODS: In 35 patients, 40 Magmaris® BRS were implanted to treat 37 de novo coronary artery stenoses. A systematic implantation protocol was followed. After appropriately sized NC balloon predilatation (1:1:1 vessel:balloon:scaffold ratio), Magmaris® BRS were implanted with a pressure of 10 atm, followed by NC balloon postdilatation at nominal BRS size (standardized at 16 atm). OCT was performed before and after postdilatation and OCT images were analyzed at a spacing of 0.2 mm to measure BRS dimensions and determine apposition as well as to detect strut fractures. RESULTS: PCI with Magmaris® BRS (mean diameter: 3.21 ± 0.32 mm; mean length: 20 ± 4 mm) was successful in all cases, in one case a non-flow-limiting distal edge dissection occurred after implantation and before postdilatation. NC balloon postdilatation led to significantly larger mean scaffold diameter (3.21 ± 0.32 mm vs. 2.80 ± 0.39 mm, P < 0.001), abluminal scaffold area (7.92 ± 1.43 mm2 vs. 6.72 ± 1.28 mm2 , P < 0.001) and lumen area (7.58 ± 1.1 mm2 vs. 6.83 ± 1.12 mm2 , P < 0.001). Incomplete scaffold apposition area was significantly lower if postdilatation was performed (0.01 ± 0.04 mm2 vs. 0.17 ± 0.11 mm2 , P < 0.001). Strut fractures could neither be observed before nor after postdilatation. CONCLUSION: NC balloon postdilatation of Magmaris® BRS is required to achieve optimal expansion. It significantly reduces malapposition and can safely be performed without relevant rates of strut fracture.

Outcome after new generation single-layer polytetrafluoroethylene-covered stent implantation for the treatment of coronary artery perforation.

AIMS: Coronary artery perforation (CAP) is a rare but severe complication during percutaneous coronary intervention (PCI). Implantation of covered stents (CS) represents a potentially life-saving treatment. Concerns exist regarding limited efficacy and high stent thrombosis (ST) rates related to early generation CS. The aim of this study was to evaluate angiographic and clinical outcomes of patients with CAP treated with a new generation single-layer polytetrafluoroethylene (PTFE)-CS. METHODS: Between May 2013 and November 2017, we identified a total of 61 patients who underwent implantation of 71 single layer PTFE-CS after CAP. We analyzed angiographic results at follow up (including binary angiographic restenosis [BAR] and late-lumen-loss [LLL]) and clinical outcomes in hospital and at follow up, including target lesion revascularization (TLR), cardiovascular-, and all-cause mortality, myocardial infarction (MI) and stent thrombosis (ST). RESULTS: Procedural success was achieved in all but two patients (96.7%). Procedure related MI, occurred in 19 cases (31.1%), in hospital death occurred in five cases (8.2%). At follow-up, TLR occurred in 11 cases (18.0%), two patients (3.3%) died from non-cardiovascular cause, there was no case of MI or ST. CONCLUSIONS: In this retrospective analysis, implantation of a new generation PTFE-CS, for the treatment of CAP showed high technical success rates. Although, periprocedural MI-and in-hospital-death rates remain not inconsiderable, new generation PTFE-CS showed favorable angiographic and clinical efficacy and high safety profile, especially with regard to thrombotic events.

Application of a central iliac arteriovenous coupler device in severe treatment-resistant hypertension: a 3.5-year follow-up.

OBJECTIVE: In patients with resistant hypertension, percutaneous placement of an iliac arteriovenous coupler device leads to a reduction of blood pressure (BP) via decreased total vascular resistance and improved arterial compliance. However, long-term efficacy and safety need to be further explored. We report on the first case of 3.5-year follow-up in a patient who underwent implantation of an iliac arteriovenous coupler device. RESULTS: A patient with resistant hypertension was admitted to hospital. Despite treatment with six anti-hypertensive drugs, his BP was poorly controlled. Previously, he had undergone renal denervation, which did not cause a significant BP decrease. Therefore, an arteriovenous coupler device was implanted, leading to an immediate and significant BP decrease. The patient was discharged with an office BP of 122/71 mmHg. After 3 months, there was a sustained BP decrease (-14/9 mmHg), whereas later, it was fluctuant (office BP: 147-173/85-95 mmHg, ABPM: 153-166/81-94 mmHg) probably due to medication non-adherence confirmed by a urinary toxicological screening test. Follow-up right heart catheterization showed changes in hemodynamic parameters related to volume congestion, which were accompanied by progressive dyspnea and weight gain. This was controlled by an optimized diuretic therapy. Additionally, an invasive closure maneuver was performed, leading to an immediate BP increase after closure and a similar decrease after re-opening of the anastomosis, verifying its proper long-term function. CONCLUSION: The implantation of an iliac arteriovenous coupler device appears to be a promising and effective method to decrease BP and therefore reduce cardiovascular risk in patients with severe, treatment-resistant hypertension.

Percutaneous coronary intervention of unprotected left main stenoses - Procedural data and outcome depending on SYNTAX I Score.

BACKGROUND: We hypothesized that SYNTAX I score is a predictor for procedure complexity in left main PCI. Procedure complexity, duration and contrast load may contribute to adverse outcome of complex left main percutaneous coronary intervention (PCI). METHODS: In 105 consecutive patients who underwent PCI of unprotected left main coronary artery stenoses between 2014 and 2016, clinical parameters as well as PCI characteristics and follow-up data were analyzed. RESULTS: The mean SYNTAX I score was 29 ±â€¯12, with 66 patients having a SYNTAX I score ≤ 32 and 39 patients a SYNTAX I score > 32. In patients with high SYNTAX I score vs. low-to-intermediate SYNTAX I score, single stent techniques were performed significantly less frequently (18% vs. 68%; p < 0.001), while Crush (44% vs. 5%; p < 0.001) and Culotte techniques (20% vs. 5%; p = 0.003) were performed significantly more frequently. Procedural success was achieved in all 105 cases without periprocedural mortality. During follow up, repeat PCI was necessary significantly more frequently in patients with high compared to patients with low-to-intermediate SYNTAX I score (34% vs.13%; p = 0.003). Nevertheless, overall mortality did not differ between patients with high vs. low-to-intermediate SYNTAX I score (20% vs. 18%). CONCLUSIONS: PCI strategies for the treatment of left main coronary artery stenoses get significantly more complex with increasing SYNTAX I scores. While this translates into a significantly longer procedure duration and contrast load, short-term outcome seems not to be influenced by the SYNTAX I score.

Comparison of invasively measured FFR with FFR derived from coronary CT angiography for detection of lesion-specific ischemia: Results from a PC-based prototype algorithm.

BACKGROUND: We evaluated the diagnostic accuracy of a novel prototype for on-site determination of CT-based FFR (cFFR) on a standard personal computer (PC) compared to invasively measured FFR in patients with suspected coronary artery disease. METHODS: A total of 91 vessels in 71 patients (mean age 65 ±â€¯9 years) in whom coronary CT angiography had been performed due to suspicion of coronary artery disease, and who subsequently underwent invasive coronary angiography with FFR measurement were analyzed. For both cFFR and FFR, a threshold of ≤0.80 was used to indicate a hemodynamically relevant stenosis. The mean time needed to calculate cFFR was 12.4 ±â€¯3.4 min. A very close correlation between cFFR and FFR could be shown (r = 0.85; p < 0.0001) with Bland-Altman analysis showing moderate agreement between FFR and cFFR with mild systematic overestimation of FFR values in CT (mean difference 0.0049, 95% limits of agreement ±2SD -0.007 to 0.008). Compared to FFR, the sensitivity of cFFR to detect hemodynamically significant lesions was 91% (19/21, 95% CI: 70%-99%), specificity was 96% (67/70, 95% CI: 88%-99%), positive predictive value 86% (95% CI: 65%-97%) and negative predictive value was 97% (95% CI: 90%-100%) with an accuracy of 93%. CONCLUSION: cFFR obtained using an on-site algorithm implemented on a standard PC shows high diagnostic accuracy to detect lesions causing ischemia as compared to FFR. Importantly, the time needed for analysis is short which may be useful for improving clinical workflow.

C-reactive protein levels predict systolic heart failure and outcome in patients with first ST-elevation myocardial infarction treated with coronary angioplasty.

INTRODUCTION: There is growing evidence that inflammation plays a pivotal role in the etiology and progression of atherosclerosis. High C-reactive protein (CRP) levels have been associated with high mortality in patients with acute myocardial infarction (AMI). Furthermore, in animal models CRP has been found to significantly increase infarct size. So there is growing evidence that CRP is not only a marker for cardiovascular disease but also might be pathogenic. The aim of our study was to test the hypothesis that peak CRP levels could predict heart failure (HF) in ST-elevation myocardial infarction (STEMI) patients. MATERIAL AND METHODS: Eighty-one consecutive patients with STEMI were prospectively enrolled in the study. C-reactive protein concentrations were measured on admission and after 6, 12, 24, 30, 48, 72 and 96 h. We assessed the association between the elevation of CRP, heart failure and cardiovascular mortality following the first 12 months after STEMI. RESULTS: C-reactive protein levels reached a peak after 48 h. Patients with STEMI and signs of HF showed significantly higher peak CRP levels. We found a positive correlation between maximum CK levels and peak CRP and a negative correlation between left ventricular ejection fraction (EF) and peak CRP. One year total mortality and HF mortality rates were found to be higher in patients with peak CRP > 47.5 mg/l than in those with CRP below that level (p < 0.001). CONCLUSIONS: Peak CRP levels in STEMI patients predict emergence of HF. Peak CRP is also a strong predictor of global and cardiovascular mortality during the following year after STEMI.

Predictors of Technical Failure in Transradial Coronary Angiography and Intervention.

Transradial access for coronary angiography and intervention is preferred over the femoral approach but can be technically challenging. Identification of predictors of transradial access failure is important, especially in the context of acute coronary syndromes. We therefore retrospectively analyzed 13,095 consecutive patients (66 ± 12 years, 64% male) in whom transradial access was attempted for coronary angiography or intervention to identify predictors of transradial access failure. Angiograms and patient files were systematically reviewed to analyze patient characteristics associated with failure. Transradial access failure rate was 6.8% (909 of 13,095). Patients with transradial access failure were more frequently female (9.5% vs 5.5%; p <0.001), significantly older (68 ± 12 vs 66 ± 12 years, p <0.001), and had a smaller body surface area (1.89 ± 0.21 vs 1.94 ± 0.2 m2; p <0.001). Transradial failure was not significantly more frequent in ST-elevation myocardial infarction versus other patients (8.1% vs 6.9%, p = 0.195). After multivariable adjustment, only female sex (odds ratio [OR] 1.44, p <0.001), higher patient age (OR 1.01/year, p = 0.002), and lower height (OR 0.98/cm, p = 0.004) independently predicted transradial access failure. In conclusion, female sex, higher age, and smaller height independently predict transradial access failure in coronary angiography and intervention. Failure rate in ST-elevation myocardial infarction is not significantly increased.

Applicability and procedural success rate of bioresorbable -vascular scaffolds for percutaneous coronary intervention in an all-comer cohort of 383 consecutive patients.

Objectives The purpose of this study was to determine applicability and procedural success of bioresorbable vascular scaffolds (BVS) for percutaneous coronary intervention (PCI) in an all-comer cohort. Background BVS use in bifurcations and severely calcified lesions is not recommended, and a relatively large crossing profile may cause limitations. It is has never been studied how widely BVS can be applied in all-comer cohorts. Methods In 383 consecutive patients (acute coronary syndrome: 124, stable coronary disease 259), a BVS (Absorb) was used as first-line device unless any of the following contraindications were present: bifurcation with side branch >2.0 mm, reference diameter <2.5 mm or >4.0 mm, required device length <12 mm, in-stent stenosis, or contraindications to 6 months of DAPT. Patients and lesions were evaluated regarding suitability for BVS treatment, procedural success (successful BVS placement and residual stenosis <30%), and outcome. Results Of 588 lesions, 303 (52%) were unsuitable for BVS placement due to presence of a bifurcation (30% of unsuitable lesions), reference -diameter >4.0 mm (13%) or <2.5 mm (12%), contraindication to 6 months DAPT (13%), in-stent stenosis (14%), and desired device length <12 mm (4%). If BVS use was attempted, procedural success with a scaffold was 95% (271/285). Crossing failure occurred in 14 cases (5%), affected lesions were significantly more calcified. After a mean follow-up period of 259 days, definite/probable scaffold thrombosis occurred in 1.1% of patients. Conclusions Approximately one-half of lesions in an all-comer population can successfully be treated with BVS. Crossing failure is rare.

Long-term clinical outcome after implantation of the self-expandable STENTYS stent in a large, multicenter cohort.

OBJECTIVE: The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort. BACKGROUND: Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis. PATIENTS AND METHODS: Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4-3.3) years. RESULTS: TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF. CONCLUSION: Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.

3D printing for sizing left atrial appendage closure device: head-to-head comparison with computed tomography and transoesophageal echocardiography.

AIMS: Device sizing for LAA closure using transoesophageal echocardiography (TEE) can be challenging due to complex LAA anatomy. We investigated whether the use of 3D-printed left atrial appendage (LAA) models based on preprocedural computed tomography (CT) permits accurate device sizing. METHODS AND RESULTS: Twenty-two (22) patients (73±8 years, 55% male) with atrial fibrillation requiring anticoagulation at high bleeding risk underwent LAA closure (WATCHMAN device). Preprocedurally, LAA was sized by TEE and third-generation dual-source CT. Based on CT, 3D printing models of LAA anatomy were created for simulation of device implantation. Device compression was assessed in a CT scan of the 3D model with the implanted device. Implantation was successful in all patients. Mean LAA ostium diameter based on TEE was 22±4 mm and based on CT 25±3 mm (p=0.014). Predicted device size based on simulated implantation in the 3D model was equal to the device finally implanted in 21/22 patients (95%). TEE would have undersized the device in 10/22 patients (45%). Device compression determined in the 3D-CT model corresponded closely with compression upon implantation (16±3% vs. 18±5%, r=0.622, p=0.003). CONCLUSIONS: Patient-specific CT-based 3D printing models may assist device selection and prediction of device compression in the context of interventional LAA closure.

Plasma levels of sRANKL and OPG are associated with atherogenic cytokines in patients with intermediate cardiovascular risk.

Osteoprotegerin (OPG) and receptor activator of nuclear factor-κB ligand (RANKL) are regulators of bone remodeling, but are also considered to play important roles in coronary artery disease (CAD). This study evaluated potential associations of soluble (s) RANKL and OPG with atherosclerosis-relevant cytokines. Blood was collected from 414 individuals who presented to our hospital with intermediate likelihood for CAD for further examination. Plasma concentrations of total sRANKL, OPG, and 20 cytokines were measured using sandwich-type enzyme-linked immunoassays (ELISAs; OPG and sRANKL) and Luminex laser-based fluorescence analysis and correlated with each other. The plasma levels of interferon-γ (IFN-γ) and the T-helper cell 2 cytokines interleukin-4 (IL-4) and IL-13 showed a positive correlation with sRANKL. The association with sRANKL levels was negative for IFN-γ-induced protein-10 (IP-10) and monocyte chemotactic protein-1 (MCP-1). The strongest independent association with sRANKL in multivariable analyses was found for IFN-γ (positive) and IP-10 (negative), while IL-13 showed a positive and independent association with OPG plasma levels. OPG and sRANKL plasma levels correlate strongly and independently with specific circulating atherosclerosis-related cytokines in patients with intermediate cardiovascular risk.

Overlapping implantation of bioresorbable novolimus-eluting scaffolds: an observational optical coherence tomography study.

Overlapping implantation of bioresorbable vascular scaffolds is frequently necessary, but its influence on vessel and scaffold structure has not been thoroughly analyzed previously. The aim of this study was to analyze the acute effects of overlapping implantation on BRS as determined by optical coherence tomography (OCT). A total of 38 patients with de novo coronary artery stenoses who underwent OCT in the context of implantation of novolimus-eluting BRS (DESolve, Elixir Medical Corporation, Sunnyvale, California, USA) were investigated. In 15 patients, overlapping implantation of two BRS was performed, while 23 patients with implantation of one single BRS served as the control group. OCT data were retrospectively analyzed regarding acute scaffold implantation results. There were no significant differences between the overlap and control group in terms of residual in-scaffold area stenosis, scaffold area, mean or minimal lumen area, eccentricity index, incomplete scaffold apposition area or malapposition. While strut fracture was slightly more frequent in BRS with overlap its incidence was low overall. In patients with overlapping BRS, overlap segments did not display smaller lumen areas than segments without overlap (mean lumen area overlap: 8.16 ± 2.97 mm2 vs. no overlap: 7.70 ± 2.55 mm2; p = 0.71; minimal lumen area overlap: 6.83 ± 2.71 mm2 vs. no overlap: 6.17 ± 2.58 mm2; p = 0.37). Acute mechanical performance of novolimus-eluting BRS is not impaired by overlapping implantation. It can be assumed that vessel expansion compensates for the double scaffold layer in the overlap area resulting in a similar lumen area in overlap areas and in those with a single strut layer.

Optical coherence tomography: influence of contrast concentration on image quality and diagnostic confidence.

OCT requires intracoronary injection of contrast agent to remove blood from the coronary lumen during data acquisition, which is a possible limitation of this method. Aim of this study was to analyze the influence of iodine concentration on image quality and diagnostic certainty of optical coherence tomography (OCT). OCT sequences acquired using contrast agent with a reduced concentration of 150 mg iodine/ml and a standard concentration of 350 mg iodine/ml were analyzed. Cross-sectional images with a spacing of 10 mm were evaluated regarding image quality and diagnostic confidence. A total of 67 OCT sequences acquired in 24 patients were analyzed. 31 sequences were acquired using contrast agent with a concentration of 150 mg iodine/ml and 36 sequences with a concentration of 350 mg iodine/ml. The percentage of remaining blood streaks in the cross sections was significantly lower for 350 mg iodine/ml compared to 150 mg iodine/ml (19 ± 21 vs. 34 ± 26%, p = 0.013). Contrast with 350 mg iodine/ml showed a significantly higher percentage of completely flushed pullback length as compared to 150 mg iodine/ml (78 ± 24 vs. 58 ± 27%, p = 0.004). Diagnostic certainty was significantly higher for 350 mg iodine/ml than for 150 mg iodine/ml (Likert scale average 1.4 ± 0.7 vs. 2.1 ± 1.2, p < 0.001; Likert scale: 1 = absolutely confident, 2 = confident with slight doubts, 3 = doubtful/not confident, 4 = non-diagnostic). Regarding image quality and diagnostic certainty, contrast agent with a concentration of 350 mg iodine/ml is superior to 150 mg iodine/ml.

Post-dilatation after implantation of bioresorbable everolimus- and novolimus-eluting scaffolds: an observational optical coherence tomography study of acute mechanical effects.

OBJECTIVES: The objective was to investigate the acute mechanical effects of post-dilatation on bioresorbable scaffolds (BRS) as determined by optical coherence tomography (OCT). BACKGROUND: Post-dilatation with high-pressure balloons is regarded as a key component of BRS implantation for treatment of coronary artery stenoses. However, the impact of post-dilatation on BRS in vivo has not been thoroughly investigated. METHODS: OCT was performed after the implantation procedure of 51 everolimus-eluting or novolimus-eluting polylactic acid-based BRS with (n = 27) or without non-compliant balloon post-dilatation (n = 24). The number of malapposed struts, strut fractures, edge dissections, residual in-scaffold area stenosis, and incomplete scaffold apposition area was analyzed over the complete length of each BRS with a spacing of 1 mm. RESULTS: OCT revealed a significantly lower incomplete scaffold apposition area if post-dilatation was performed (0.16 ± 0.49 mm2 with post-dilatation vs. 2.65 ± 2.78 mm2 without post-dilatation, p < 0.001), as well as a significantly lower absolute number of malapposed struts (1 ± 2 with post-dilatation vs. 13 ± 13 without post-dilatation, p < 0.001). No significant differences regarding residual in-scaffold area stenosis, strut fracture, edge dissection, symmetry index, or eccentricity index were observed in patients with vs. without post-dilatation. CONCLUSION: Post-dilatation of BRS with non-compliant balloons significantly reduces the number of malapposed struts and incomplete scaffold apposition area without inducing higher rates of edge dissection or strut fracture.