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Background: Fractional flow reserve (FFR) is the current gold standard to determine hemodynamic severity of angiographically intermediate coronary lesions. Much less is known about the prognostic effects of FFR measured directly after percutaneous coronary intervention (PCI). The aims of this study were to evaluate post-PCI FFR values, identify predictors for a low post-PCI FFR, and to investigate whether a relationship between postprocedural FFR and outcome during 30-day follow-up exists., Methods and Results: The FFR-SEARCH (Fractional Flow Reserve-Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective registry in which FFR measurements were performed after PCI in 1000 consecutive patients. All FFR measurements were performed under maximum hyperemia with intravenous adenosine with the Navvus RXi system (ACIST Medical Systems, Eden Prairie, MN). The clinical end point was defined as a composite of death, target vessel revascularization, or nonfatal myocardial infarction at 30-day follow-up. Measurement of post-PCI FFR was successful in 959 patients (96%), and a total of 1165 lesions were assessed. There were no complications related to the microcatheter. A total of 322 ST-segment-elevation myocardial infarction patients with 371 measured lesions were excluded leaving 637 patients with 794 measured lesions for the final analysis. Overall post-PCI FFR was 0.90±0.07. In 396 lesions (50%), post-PCI FFR was >0.90. A total of 357 patients (56%) had ≥1 lesion(s) with a post-PCI FFR ≤0.90, and 73 patients (11%) had ≥1 lesion(s) with a post-PCI FFR ≤0.80 with post-PCI FFR ≤0.80 in 78 lesions (9.8%). Complex lesion characteristics, use of multiple stents and smaller reference vessel diameter was associated with post-PCI FFR ≤0.90. During follow-up, 11 patients (1.8%) reached the clinical end point. There was no significant relationship between post-PCI FFR and the clinical end point at 30-day follow-up ( P=0.636)., Conclusions: Routine measurement of post-PCI FFR using a monorail microcatheter is safe and feasible. Several lesion and patient characteristics were associated with a low post-PCI FFR. Post-PCI FFR did not correlate with clinical events at 30 days.

Background: Angiographic assessment of left main coronary artery (LMCA) lesions remains challenging and limited data is available on reference diameters and length of nonobstructive LMCA dimensions. Our aim was to provide insights in the dimensions of nonobstructive LMCA and to find a possible correlation with gender and patient habitus., Methods: This retrospective single center study was performed in a consecutive cohort of patients who underwent Intravascular Ultrasound (IVUS) guided percutaneous coronary interventions of the left coronary system including complete pullbacks of a non-obstructive LMCA (n = 254)., Results: Mean LMCA length as measured with IVUS was 7.37 ± 4.2 mm and mean lumen area (LA) was 15.63 ± 4.76 mm 2 corresponding to a mean lumen diameter (LD) of 4.41 ± 0.67 mm. An IVUS derived mean LD of >4 mm was present in 71.7%, >4.5 mm in 43% and > 5 mm in 19% of patients. LMCA mean LA was significantly smaller in women as compared to men (14.1 ± 4.1 mm 2 and 16.2 ± 4.8 mm 2 , P < 0.01). Multivariable analysis identified weight of the patient as the sole significant predictor for LMCA length while height of the patient and LMCA length were predictors of LMCA mean LA. Correlation coefficients of determination for all independent predictors were low (R 2 < 0.1 for all)., Conclusion: This study demonstrated that the mean LD of a non-obstructive LMCA is 4 mm or greater in the majority of patients, with a mean LMCA length of 7.4 mm. Women have smaller luminal dimension than men. No clinically relevant predictors were found for both LMCA length and mean LA., (© 2018 Wiley Periodicals, Inc.)

Background: Fractional flow reserve (FFR) after percutaneous coronary intervention is a predictor of adverse cardiovascular events during follow-up. However, the rationale for low post procedural FFR values remains often elusive based on angiographic findings alone., Methods and Results: FFR SEARCH (Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective single-center registry in which post-percutaneous coronary intervention FFR was assessed in 1000 consecutive all-comer patients. FFR measurements were performed with a microcatheter ±20 mm distal to the most distal stent edge. In 100 vessels with a post procedural FFR ≤0.85, and 20 vessels >0.85 high definition intravascular ultrasound analysis was performed. In 100 vessels with a post-percutaneous coronary intervention FFR ≤0.85, mean post procedural FFR was 0.79±0.05. Minimal lumen area was 2.19 (1.81-3.19) mm 2 , mean lumen area was 5.95 (5.01-7.03) mm 2 , and minimal stent area was 4.01 (3.09-5.21) mm 2 . Significant residual focal proximal lesions were found in 29% of the assessed vessels whereas, focal distal lesions were found in 30% of the vessels. Stent underexpansion and malapposition were found in 74% and 22% of vessels, respectively. Clear focal signs of luminal narrowing were found in 54% of the vessels analyzed. Although incidences of focal lesions, underexpansion, and malapposition were similar between both cohorts, minimal stent area was significantly smaller in vessels with a post-percutaneous coronary intervention FFR ≤0.85 as compared with those with an FFR >0.85., Conclusions: In patients with a post procedural FFR ≤0.85, intravascular ultrasound revealed focal signs of luminal narrowing in a significant number of cases.

Background: Despite successful restoration of epicardial vessel patency with primary percutaneous coronary intervention, coronary microvascular injury occurs in a large proportion of patients with ST-segment-elevation myocardial infarction, adversely affecting clinical and functional outcome. Ticagrelor has been reported to increase plasma adenosine levels, which might have a protective effect on the microcirculation. We investigated whether ticagrelor maintenance therapy after revascularized ST-segment-elevation myocardial infarction is associated with less coronary microvascular injury compared to prasugrel maintenance therapy., Methods: A total of 110 patients with ST-segment-elevation myocardial infarction received a loading dose of ticagrelor and were randomized to maintenance therapy of ticagrelor (n=56) or prasugrel (n=54) after primary percutaneous coronary intervention. The primary outcome was coronary microvascular injury at 1 month, as determined with the index of microcirculatory resistance in the infarct-related artery. Cardiovascular magnetic resonance imaging was performed during the acute phase and at 1 month., Results: The primary outcome of index of microcirculatory resistance was not superior in ticagrelor- or prasugrel-treated patients (ticagrelor, 21 [interquartile range, 15-39] U; prasugrel, 18 [interquartile range, 11-29] U; P=0.08). Recovery of microcirculatory resistance over time was not better in patients with ticagrelor versus prasugrel (ticagrelor, -13.9 U; prasugrel, -13.5 U; P=0.96). Intramyocardial hemorrhage was observed less frequently in patients receiving ticagrelor (23% versus 43%; P=0.04). At 1 month, no difference in infarct size was observed (ticagrelor, 7.6 [interquartile range, 3.7-14.4] g, prasugrel 9.9 [interquartile range, 5.7-16.6] g; P=0.17). The occurrence of microvascular obstruction was not different in patients on ticagrelor (28%) or prasugrel (41%; P=0.35). Plasma adenosine concentrations were not different during the index procedure and during maintenance therapy with ticagrelor or prasugrel., Conclusions: In patients with ST-segment-elevation myocardial infarction, ticagrelor maintenance therapy was not superior to prasugrel in preventing coronary microvascular injury in the infarct-related territory as assessed by the index of microcirculatory resistance, and this resulted in a comparable infarct size at 1 month., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02422888.

Background: Instantaneous wave-free ratio (iFR) offers a reliable non-hyperemic assessment of coronary physiology but requires dedicated proprietary software with a fully automated algorithm. We hypothesized that dPR (diastolic pressure ratio), calculated with novel universal software, has a strong correlation with iFR, similar diagnostic accuracy relative to resting distal coronary artery pressure/aortic pressure and fractional flow reserve (FFR)., Methods and Results: The dPR study is an observational, retrospective, single-center cohort study including patients who underwent iFR or FFR. Dedicated software was used to calculate the dPR from Digital Imaging and Communications in Medicine (DICOM) pressure waveforms. The flat period on the pressure difference between sample (dP) to the time difference between the same sample points (dt) signal was used to detect automatically the period, where the resistance is low and constant, and to calculate the dPR, which is an average over 5 consecutive heartbeats. The software was validated by correlating iFR results with dPR. Software validation was done by comparing 78 iFR measurements in 44 patients who underwent iFR. Mean iFR and dPR were 0.91±0.10 and 0.92±0.10, respectively, with a significant linear correlation ( R=0.997; P<0.001). Diagnostic accuracy was tested in 100 patients who underwent FFR. Mean FFR, resting distal coronary artery pressure/aortic pressure, and dPR were 0.85±0.09, 0.94±0.05, and 0.93±0.07, respectively. There was a significant linear correlation between dPR and FFR ( R=0.77; P<0.001). Both distal coronary artery pressure/aortic pressure and dPR had good diagnostic accuracy in the identification of lesions with an FFR ≤0.80 (area under the curve, 0.84; 95% CI, 0.76-0.92 and 0.86; 95% CI, 0.78-0.93, respectively)., Conclusions: dPR, calculated by a novel validated software tool, showed a strong linear correlation with iFR. dPR correlated well with FFR with a good diagnostic accuracy to identify positive FFR.

Objectives: This study aimed to evaluate whether polarimetry, performed using a modified optical frequency domain imaging (OFDI) system, can improve the assessment of histological features relevant to characterizing human coronary atherosclerosis., Background: The microscopic structure and organization of the arterial wall influence the polarization of the infrared light used by OFDI. Modification of the OFDI apparatus, along with recently developed image reconstruction methods, permits polarimetric measurements simultaneously with conventional OFDI cross-sectional imaging through standard intravascular imaging catheters., Methods: The main coronary arteries of 5 cadaveric human hearts were imaged with an OFDI system capable of providing polarimetric assessment. Cross-sectional views of tissue birefringence, measured in refractive index units, and depolarization, expressed as the ratio of depolarized signal to total intensity, were reconstructed, together with conventional OFDI images. Following imaging, the vessels underwent histological evaluation to enable interpretation of the observed polarization features of individual tissue components., Results: Birefringence in fibrous tissue was significantly higher than in intimal tissue with minimal abnormality (0.44 × 10 -3 vs. 0.33 × 10 -3 ; p < 0.0001). Birefringence was highest in the tunica media (p < 0.0001), consistent with its high smooth muscle cell content, cells known to associate with birefringence. In fibrous areas, birefringence showed fine spatial features and close correspondence with the histological appearance of collagen. In contrast, necrotic cores and regions rich in lipid elicited significant depolarization (p < 0.0001). Depolarization was also evident in locations of cholesterol crystals and macrophages., Conclusions: Intravascular measurements of birefringence and depolarization can be obtained using conventional OFDI catheters in conjunction with a modified console and signal processing algorithms. Polarimetric measurements enhance conventional OFDI by providing additional information related to the tissue composition and offer quantitative metrics enabling characterization of plaque features., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Significant left main (LM) stem disease is potentially life-threatening and mandates revascularization. This study aimed to assess how patients rate the importance of particular features of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), how this determines their preference for a particular treatment strategy, and whether particular personality characteristics influence this preference., Methods and Results: In total, 1145 patients who visited the outpatient clinic of the Erasmus Medical Center for stable coronary artery disease were asked to complete a case vignette-questionnaire on a hypothetical significant LM stenosis amenable to PCI or CABG. To assess the individual's personality disposition and general distress level, each patient had to complete a set of 3 standardized, validated questionnaires with satisfactory psychometric properties. Overall 89% of patients preferred PCI to CABG. PCI was the preferred strategy despite a higher risk for repeat revascularization and need for more medication. Remarkably, the fact that a risk for repeat revascularization is more common in the PCI group is less important for the patients who opt for PCI. Risk for stroke and bleeding were the most important arguments to opt for PCI over CABG. Type D personality, depression, and anxiety were all associated with a relatively higher preference for CABG as revascularization strategy., Conclusion: Overall, when given the choice patients seem to have a clear preference for PCI over CABG and consider stroke and bleeding important procedure-related complications. Patients with Type D personality, depression, or anxiety favor CABG., (Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Intravascular polarimetry with polarization sensitive optical frequency domain imaging (PS-OFDI) measures polarization properties of the vessel wall and offers characterization of coronary atherosclerotic lesions beyond the cross-sectional image of arterial microstructure available to conventional OFDI. A previous study of intravascular polarimetry in cadaveric human coronary arteries found that tissue birefringence and depolarization provide valuable insight into key features of atherosclerotic plaques. In addition to various tissue components, catheter and sample motion can also influence the polarization of near infrared light as used by PS-OFDI. This paper aimed to evaluate the robustness and repeatability of imaging tissue birefringence and depolarization in a clinical setting. 30 patients scheduled for percutaneous coronary intervention at the Erasmus Medical Center underwent repeated PS-OFDI pullback imaging, using commercial imaging catheters in combination with a custom-built PS-OFDI console. We identified 274 matching cross sections among the repeat pullbacks to evaluate the reproducibility of the conventional backscatter intensity, the birefringence, and the depolarization signals at each spatial location across the vessel wall. Bland-Altman analysis revealed best agreement for the birefringence measurements, followed by backscatter intensity, and depolarization, when limiting the analysis to areas of meaningful birefringence. Pearson correlation analysis confirmed highest correlation for birefringence (0.86), preceding backscatter intensity (0.83), and depolarization (0.78). Our results demonstrate that intravascular polarimetry generates robust maps of tissue birefringence and depolarization in a clinical setting. This outcome motivates the use of intravascular polarimetry for future clinical studies that investigate polarization properties of arterial atherosclerosis.

Introduction and Objectives: There is little evidence on the optimal strategy for bifurcation lesions in the context of a coronary chronic total occlusion (CTO). This study compared the procedural and mid-term outcomes of patients with bifurcation lesions in CTO treated with provisional stenting vs 2-stent techniques in a multicenter registry., Methods: Between January 2012 and June 2016, 922 CTO were recanalized at the 4 participating centers. Of these, 238 (25.8%) with a bifurcation lesion (side branch ≥ 2mm located proximally, distally, or within the occluded segment) were treated by a simple approach (n=201) or complex strategy (n=37). Propensity score matching was performed to account for selection bias between the 2 groups. Major adverse cardiac events (MACE) consisted of a composite of cardiac death, myocardial infarction, and clinically-driven target lesion revascularization., Results: Angiographic and procedural success were similar in the simple and complex groups (94.5% vs 97.3%; P=.48 and 85.6% vs 81.1%; P=.49). However, contrast volume, radiation dose, and fluoroscopy time were lower with the simple approach. At follow-up (25 months), the MACE rate was 8% in the simple and 10.8% in the complex group (P=.58). There was a trend toward a lower MACE-free survival in the complex group (80.1% vs 69.8%; P=.08). After propensity analysis, there were no differences between the groups regarding immediate and follow-up results., Conclusions: Bifurcation lesions in CTO can be approached similarly to regular bifurcation lesions, for which provisional stenting is considered the technique of choice. After propensity score matching, there were no differences in procedural or mid-term clinical outcomes between the simple and complex strategies., (Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Aims: There is limited in vivo evidence regarding the temporal evolution of non-culprit coronary plaque morphology. We aimed to evaluate changes in non-culprit plaque morphology over time by optical coherence tomography (OCT)., Methods and Results: Seventy-two (72) patients with 257 non-culprit segments with serial OCT studies were analysed. Non-culprit 5 mm-long coronary segments from the same imaged region were matched between baseline and follow-up. OCT plaque characterisation including automated attenuation analysis was performed, and changes over a median follow-up of 6.2 months were evaluated. On segment level, lumen area decreased from baseline to follow-up, whereas fibrous cap thickness increased. Similarly, plaque attenuation indices at follow-up were significantly decreased. Minimal cap thickness per patient did not change. In 68.5% of segments, plaque morphology did not change. Favourable change was observed in 18.4% of segments and unfavourable in 12.9%. There were no robust clinical predictors of change in plaque morphology. Attenuation analysis supported the qualitative characterisation, showing significantly different attenuation between different plaque types., Conclusions: In non-culprit coronary segments of patients with coronary artery disease under standard medical therapy, segment-level but not patient-level minimum fibrous cap thickness increases over time, with observations of both favourable and unfavourable changes in individual segments.

Background: Chronic total occlusion (CTO) is common in out-of-hospital cardiac arrest (OHCA) survivors with coronary artery disease. It is unclear whether CTO contributes to ventricular arrhythmias in this population., Objective: This study sought to evaluate the impact of unrevascularized CTOs on the occurrence of appropriate implantable cardioverter-defibrillator (ICD) therapy and all-cause mortality in OHCA survivors with coronary artery disease., Methods: This was a retrospective study that included all consecutive OHCA survivors with coronary artery disease who received an ICD from December 1999 until June 2015. Study end points were appropriate ICD therapy and all-cause mortality., Results: We identified 217 OHCA survivors (mean age 63 ± 10 years; 187 men (86%)) with coronary artery disease. Unrevascularized CTO was present in 71 of 217 patients (33%) at the time of ICD implantation. During a median follow-up of 61 months (interquartile range, 28-97 months), 57 of 217 patients (26%) experienced an appropriate ICD therapy. Patients with CTO had a higher incidence of appropriate ICD therapy in comparison to patients without CTO (log-rank, P = .002). Multivariate Cox regression analysis identified CTO (hazard ratio 2.07; 95% confidence interval 1.23-3.50; P = .007) as an independent predictor of appropriate ICD therapy. The presence of CTO was not associated with a higher mortality rate (log-rank, P = .18)., Conclusions: In OHCA survivors with coronary artery disease receiving an ICD for secondary prevention, CTO was an independent predictor for the occurrence of ventricular arrhythmias but not for mortality., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: There is limited data on the impact of calcium (Ca) on acute procedural and clinical outcomes in patients with lesions treated with bioresorbable vascular scaffolds (BRS). We sought to evaluate the effect of calcium on procedural and clinical outcomes in a 'real world' population., Methods: Clinical outcomes were compared between patients with at least 1 moderately or heavily calcified lesion (Ca) and patients with no/mild calcified lesions (non-Ca) enrolled in our institutional BRS registry., Results: 455 patients (N) with 548 lesions (L) treated with 735 BRS were studied. Patients in the Ca group (N=160, L=200) had more complex (AHA B2/C lesion: 69.0% in Ca vs 14.9% in non-Ca, p<0.001) and significantly longer lesions (27.80±15.27 vs 19.48±9.92mm, p<0.001). Overall device success rate was 99.1% with no significant differences between the groups. Despite more aggressive lesion preparation and postdilation compared to non Ca, acute lumen gain was significantly less in Ca lesions (1.50±0.66 vs 1.62±0.69mm, p=0.040) with lower final MLD (2.28±0.41 vs 2.36±0.43, p=0.046). There were no significant differences in all-cause mortality, total definite scaffold thrombosis (ST), target lesion revascularization and myocardial infarction between the 2 groups. Late ST was more frequent in the Ca group compared to non Ca group (late ST: 2.1 vs 0%, p=0.02)., Conclusions: Clinical outcomes after BRS implantation in calcified and non-calcified lesions were similar. A remarkable difference in timing of thrombosis was observed, with an increased rate of late thrombosis in calcified lesions., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm -1 , p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (median diastolic curvature from 0.305 to 0.283 cm -1 , p = 0.056). Median Percentage relative change in diastolic curvature was lower in the BRS group compared with the MPS group (BRS vs. MPS: 7.48 vs. 29.4%, p = 0.013). By univariate analysis, use of MPS was an independent predictor of change in diastolic curvature (p = 0.022). In the deployment of long coronary scaffolds/stents (28 mm in length), BRS provides better conformability compared with MPS.

Background: Coronary artery perforation (CAP) is a potentially lethal complication of percutaneous coronary intervention. We report on the incidence, clinical characteristics, and management of iatrogenic coronary perforations based on an 11-year single-center experience., Methods and Results: From February 9, 2005, through November 20, 2016, 150 CAP cases were identified from our percutaneous coronary intervention database of 21 212 procedures (0.71%). Mean age of CAP patients was 66±11 years, and 62.7% were male. Treated lesion type was B2/C in 94.6%, and 31.3% were chronic total occlusions. Nonworkhorse guidewires were applied in 74.3%. CAP types were Ellis type I in 2.9%, Ellis type II in 40.4%, Ellis type III in 54.8%, and Ellis type III cavity spilling in 1.9%. CAP treatment was conservative (including prolonged balloon inflation) in 73.3%. Covered stents, coiling, and fat embolization were used in 24.0%, 0.7%, and 2.0%, respectively. Pericardiocentesis for tamponade was required for 72 patients (48.0%), of whom 28 were initially unrecognized. Twelve patients (12.7%) required emergency cardiac surgery to alleviate tamponade. Periprocedural myocardial infarction occurred in 34.0%, and in-hospital all-cause mortality was 8.0%. All-cause mortality accrued to 10.7% at 30 days and 17.8% at 1 year., Conclusions: CAP is a rare complication of percutaneous coronary intervention, but morbidity and mortality are considerable. Early recognition and adequate management are of paramount importance., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Aims: The aim of the study was to investigate whether bivalirudin versus unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous coronary intervention (PPCI) in large acute myocardial infarction (AMI)., Methods and Results: This multicentre open-label trial randomised 78 patients undergoing PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints included index of microcirculatory resistance (IMR), CMR-assessed microvascular obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and cell injury. No difference was observed in mean IS at five days (25.0±19.7 g for bivalirudin vs. 27.1±20.7 g for UFH; p=0.75). Early MVO was numerically lower with bivalirudin (5.3±5.8 g vs. 7.7±6.3 g; p=0.17), with no significant difference in ejection fraction at 90 days (54.6±12.0% vs. 49.1±12.1%; p=0.11). In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm (p=0.0003). Acute IMR was lower (43.5±21.6 vs. 68.7±35.8 mmHg×s, respectively; p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was observed with bivalirudin; the trial was discontinued for futility., Conclusions: This study did not achieve its primary endpoint of significant infarct size reduction in PPCI by prolonged bivalirudin infusion compared to UFH, even though complete thrombin inhibition was achieved in the acute phase, with a lower myocardial microcirculation resistance at the end of the procedure.

Background: A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort., Methods: A total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year., Results: Mean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77-1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively., Conclusions: In all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice., Methods: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported., Results: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%., Conclusions: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Aims: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO)., Methods and Results: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation., Conclusions: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Aims: The aim of this study was to investigate the impact of dual antiplatelet therapy (DAPT) termination on late and very late scaffold thrombosis (ScT) in patients treated with the Absorb bioresorbable vascular scaffold (BVS)., Methods and Results: Data from the registries of three centres were pooled (808 patients). To investigate the effect of DAPT termination on ScT after a minimum of six months, we selected a subgroup ("DAPT study cohort" with 685 patients) with known DAPT status >6 months and excluded the use of oral anticoagulants and early ScT. In this cohort, definite/probable ScT incidence for the period on DAPT was compared to ScT incidence after DAPT termination. ScT incidence was 0.83 ScT/100 py with 95% confidence interval (CI): 0.34-1.98. After DAPT termination, the incidence was higher (1.77/100 py; 95% CI: 0.66-4.72), compared to the incidence on DAPT (0.26/100 py, 95% CI: 0.04-1.86; p=0.12) and increased within the month after DAPT termination (6.57/100 py, 95% CI: 2.12-20.38; p=0.01). No very late ScT occurred in patients who continued on DAPT for a minimum of 18 months., Conclusions: The incidence of late and very late definite/probable ScT was acceptable. The incidence was low while on DAPT but potentially higher when DAPT was terminated before 18 months.

Objectives: To assess whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention., Background: FFR is the mainstay of functional hemodynamic assessment of coronary artery lesions. The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN) is a monorail microcatheter with FFR-measurement capability through optical pressure sensor technology., Methods: This is an investigator-initiated, prospective, single-center, observational cohort study. A total of 238 patients were enrolled, 97 patients with Navvus and 141 with conventional pressure-wire based FFR (PW-FFR). Final analyses were performed on the cohort in which only 1 device was used (82 Navvus procedures vs. 136 PW-FFR procedures)., Results: No significant differences were found in the total amount of contrast used (150±77 vs 147±79ml; p=0.81), radiation use (6200±4601 vs. 5076±4655 centiG∗cm 2 ; p=0.09) or costs (€1994,- vs. €1930,-; p=0.32) in the Navvus vs. PW-FFR groups respectively., Conclusions: No significant differences were found in the amount of contrast used, total procedural costs or radiation when the Navvus system was used as compared to conventional FFR wires., Condensed Abstract: CONTRACT is an investigator-initiated, prospective, single-center, observational cohort study that evaluated whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. Use of the RXi Navvus system was associated with comparable procedural costs, amount of radiation and contrast used as compared to PW-FFR systems., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Aims: Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre., Methods and Results: This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed., Conclusion: FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Chest pain units are defined as organizational short stay units with specific management protocols designed to facilitate and optimize the diagnosis of patients presenting with chest pain in the emergency department. The present document is intended to standardize and facilitate the installation of chest pain units nearby to the emergency department or as an integral part of the emergency department. Recommendations on organizational structure, physical and technical requirements and on disease management are presented. More standardized installation and implementation of chest pain units will enhance the quality of chest pain units and improve the quality of care of our chest pain patients.

Objectives: The acute expansion of bioresorbable vascular scaffolds (BRS) and drug-eluting stents (DES) in lesions with different extent of calcification was compared by Optical Coherence Tomography (OCT)., Background: The acute mechanical performance of polymeric BRS in calcified lesions is poorly understood., Methods: Acute device performance in lesions treated with either BRS(N = 50) or DES (N = 50) was compared using Optical Coherence Tomography (OCT). According to angiographic degree of calcification the lesions were divided in three groups: no/mild, moderate and heavy calcification. Device performance was assessed with the following parameters by OCT: mean scaffold area, eccentricity index (EI), symmetry index (SI) and percentage incomplete strut apposition (ISA)., Results: One hundred lesions from 85 patients (BRS/DES; 37/48) were analyzed. Scaffold area and SI were similar between BRS and DES groups in the three calcification subgroups. Compared to DES, EI in BRS was marginally lower in the no/mild calcification group (0.86 ± 0.03 versus 0.88 ± 0.03, p = 0.018) but was similar in the moderate and heavy calcification groups. Compared to DES, percentage ISA struts in BRS was similar in the no/mild calcification group and was significantly lower in the moderate and heavy calcification groups (2.96 ± 2.36 versus 6.78 ± 4.61%, p = 0.002 and 1.82 ± 2.40 versus 8.89 ± 8.25%, p = 0.025 respectively)., Conclusions: With adequate lesion preparation, implantation of BRS in a population reflective of clinical practice, resulted in a similar luminal gain compared to DES as measured by OCT, regardless of the degree of angiographic calcification, while acute malapposition is lower with BRS in moderately and heavily calcified lesions. The clinical significance of our findings warrants further evaluation in future studies. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Accuracy of high sensitive troponin (hs-cTn) to detect coronary artery disease (CAD) in patients with renal insufficiency is not established. The aim of this study was to evaluate the prognostic role of hs-cTn T and I in patients with chronic kidney disease (CKD)., Methods: All consecutive patients with chest pain, renal insufficiency (eGFR < 60 mL/min/1.73 m2) and high sensitive troponin level were included. The predictive value of baseline and interval troponin (hs-cTnT and hs-cTnI) for the presence of CAD was assessed., Results: One hundred and thirteen patients with troponin I and 534 with troponin T were included, with 95 (84%) and 463 (87%) diagnosis of CAD respectively. There were no differences in clinical, procedural and outcomes between the two assays. For both, baseline hs-cTn values did not differ be-tween patients with/without CAD showing low area under the curve (AUC). For interval levels, hs-cTnI was significantly higher for patients with CAD (0.2 ± 0.8 vs. 8.9 ± 4.6 ng/mL; p = 0.04) and AUC was more accurate for troponin I than hs-cTnT (AUC 0.85 vs. 0.69). Peak level was greater for hs-cTnI in patients with CAD or thrombus (0.4 ± 0.6 vs. 15 ± 20 ng/mL; p = 0.02; AUC 0.87: 0.79-0.93); no differences were found for troponin T assays (0.8 ± 1.5 vs. 2.2 ± 3.6 ng/mL; p = 1.7), with lower AUC (0.73: 0.69-0.77). Peak troponin levels (both T and I) independently predicted all cause death at 30 days., Conclusions: Patients with CKD presenting with altered troponin are at high risk of coronary disease. Peak level of both troponin assays predicts events at 30 days, with troponin I being more accurate than troponin T. (Cardiol J 2017; 24, 2: 139-150).

Background: Limited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment., Methods: Patients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported., Results: A total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm(2) vs Final: 2.17±1.09mm(2), p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11., Conclusions: The results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Background: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated., Methods: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed., Results: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group., Conclusions: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Whether ischemic postconditioning (IPOC) immediately after routine thrombus aspiration (TA) reduces infarct size (IS) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) has not been established., Study Design: The POstconditioning Rotterdam Trial (PORT) is a dual-center, prospective, open-label, randomized trial with blinded endpoint evaluation enrolling 72 subjects with first-time STEMI, and an occluded infarct-related artery (IRA) without collaterals undergoing PPCI. Subjects are randomized 1:1 to a strategy of IPOC immediately after TA followed by stenting of the IRA or to conventional percutaneous coronary intervention (PCI), including TA followed by stenting of the IRA (controls). Cardiac magnetic resonance imaging (MRI) is performed at 3-5 days after STEMI and at 3 months. The primary endpoint is IS at 3 months measured by delayed enhancement MRI. Other secondary endpoints include MRI-derived microvascular obstruction (MVO), left ventricular ejection fraction, myocardial salvage index, enzymatic IS, ST-segment resolution, myocardial blush grade, microcirculatory resistance, inflammation markers, and clinical events through 3-month follow-up., Conclusions: PORT is testing the hypothesis that adding IPOC (against lethal reperfusion injury) to TA (against distal embolization and MVO) is cardioprotective and reduces ultimate IS in STEMI patients undergoing PPCI (Dutch Trial Register identifier: NTR4040). © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Bioresorbable vascular scaffolds have been recently introduced as a novel paradigm for coronary artery disease treatment allowing temporary vessel support and drug delivery without indefinite coronary caging, potentially reducing the long-term limitation of metallic stents. The scientific community has rapidly embraced this concept and bioresorbable devices have been introduced in clinical practice. However, despite the fact that bifurcation lesions represent a large and challenging subset in the field of interventional cardiology, this subgroup of lesions have been avoided in the initial experience with bioresorbable scaffolds and clear recommendations on methodological approaches are lacking. In the present report, we describe the various techniques for bifurcation treatment with bioresorbable scaffolds and the theoretical advantages and disadvantages of this technology in different scenarios, with a glimpse to challenging subsets and possible complications. Therefore, we aim to provide experience based insights and practical guidance for bioresorbable scaffold implantation in bifurcation lesions. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: This study sought to report on clinical outcomes beyond 1 year of the BVS Expand registry., Background: Multiple studies have proven feasibility and safety of the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California). However, data on medium- to long-term outcomes are limited and available only for simpler lesions., Methods: This is an investigator-initiated, prospective, single-center, single-arm study evaluating performance of the BVS in a lesion subset representative of daily clinical practice, including calcified lesions, total occlusions, long lesions, and small vessels. Inclusion criteria were patients presenting with non-ST-segment elevation myocardial infarction, stable/unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native previously untreated coronary artery. Procedural and medium- to long-term clinical outcomes were assessed. Primary endpoint was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization., Results: From September 2012 to January 2015, 249 patients with 335 lesions were enrolled. Mean number of scaffolds per patient was 1.79 ± 1.15. Invasive imaging was used in 39%. In 38.1% there were American College of Cardiology/American Heart Association classification type B2/C lesions. Mean lesion length was 22.16 ± 13.79 mm. Post-procedural acute lumen gain was 1.39 ± 0.59 mm. Median follow-up period was 622 (interquartile range: 376 to 734) days. Using Kaplan-Meier methods, the MACE rate at 18 months was 6.8%. Rates of cardiac mortality, myocardial infarction, and target lesion revascularization at 18 months were 1.8%, 5.2%, and 4.0%, respectively. Definite scaffold thrombosis rate was 1.9%., Conclusions: In our study, BVS implantation in a complex patient and lesion subset was associated with an acceptable rate of adverse events in the longer term, whereas no cases of early thrombosis were observed., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The everolimus eluting bioresorbable vascular scaffold (BVS) represents a novel technology and a novel paradigm for treatment of coronary artery disease, with the potential of improving the long-term clinical outcomes after complete bioresorption. The increasing amount of clinical data is adding in a gradual understanding of the appropriate implantation technique, but long-term results after BVS implantation are sparse. In addition, concern related to a possible increased rate of scaffold thrombosis has recently risen. The present article reviews the current status of knowledge on bioresorbable vascular scaffold from the preclinical phase and the first-in-man experience to the recently reported large randomized trials. Challenging subsets are discussed as well as possible factors impacting on the occurrence of thrombotic events, particularly focusing on clinical outcomes reported in the longest follow-ups currently available.

Introduction: Primary percutaneous coronary intervention (PCI) represents the gold-standard treatment for patients presenting with an ST-elevation myocardial infarction (STEMI). Acute myocardial infarction is a complex clinical scenario, and an appropriate therapeutic approach could be represented by a balanced integration between healthcare system and medical competence., Areas Covered: In this review we discuss how a primary PCI network, and the new therapeutic options could be coupled in order to obtain improved clinical outcomes. The present report will focus on three main issues related to STEMI patients, namely, out of hospital management, primary PCI and pharmacological treatment. Expert commentary: A possible correct approach to a patient presenting a STEMI could be considered as a stepwise process, given by 5 steps: reducing the time to reperfusion; dual antiplatelet administration; radial access; new generation drug eluting stent implantation; long term management.

Microvascular injury is present in a large proportion of patients with ST-elevation myocardial infarction (STEMI) despite successful revascularization. Ticagrelor potentially mitigates this process by exerting additional adenosine-mediated effects. This study aims to determine whether ticagrelor is associated with a better microvascular function compared to prasugrel as maintenance therapy after STEMI. A total of 110 patients presenting with STEMI and additional intermediate stenosis in another coronary artery will be studied after successful percutaneous coronary intervention (PCI) of the infarct-related artery. Patients will be randomized to treatment with ticagrelor or prasugrel for 1 year. FFR-guided PCI of the non-infarct-related artery will be performed at 1 month. Microvascular function will be assessed by measurement of the index of microcirculatory resistance (IMR) in the infarct-related artery and non-infarct-related artery, immediately after primary PCI and after 1 month. The REDUCE-MVI study will establish whether ticagrelor as a maintenance therapy may improve microvascular function in patients after revascularized STEMI.

Aims: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI)., Methods and Results: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure., Conclusions: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes.

Background: Radial artery wall might be damaged after cannulation for cardiac catheterization. We investigated structural changes of the radial artery wall after catheterization to understand whether these might predict radial pulsation loss or occlusion and local pain or functional impairment of the upper extremity., Methods and Results: Ninety patients underwent transradial coronary angiography or intervention and were scanned with a high-resolution 40-MHz ultrasound before cannulation and at 3 hours and 30 days after procedure. Acute injuries of the radial artery occurred in all patients: dissection and intramural hematoma were the most common. However, these phenomena did not predict loss of radial pulsation or occlusion, local pain, or functional impairment at 30 days. Overall, the radial artery lumen was significantly reduced distal to the puncture site. Radial artery intima and total wall thickness increased 3 hours after puncture and persisted at 30 days. Radial occlusion and pulsation loss were observed in 3.9% and 9.2% of patients, respectively, at 30 days. Smaller radial artery lumen at baseline increased the risk of radial pulsation loss at 30 days (odds ratio, 1.23; P=0.049). The number of radial puncture attempts predicted pulsation loss (odds ratio, 2.64; P=0.027), occlusion (odds ratio, 3.49; P=0.022), and symptoms (odds ratio, 2.24; P=0.05) at 30-day follow-up., Conclusions: After catheterization, radial artery puncture site is associated with increased intima and total wall thickness and with modest decrease of inner lumen diameter. Acute injuries of the vessel wall were ubiquitous, but contrary to repeated puncture attempts, did not seem to affect postprocedural radial occlusion or loss of pulsation., (© 2016 American Heart Association, Inc.)

Background: The purpose of this registry is to report the immediate and long-term safety and efficacy of the Biotronik Orsiro stent in an unselected population during everyday practice., Methods: Between May 2012 and June 2013, 246 consecutive coronary angioplasty procedures were performed using at least one Orsiro drug-eluting stent, in 225 patients and 303 lesions., Results: Diabetes was present in 34.7% of patients. Procedures were non-elective percutaneous coronary intervention (PCI) in 17.1% of cases and acute coronary syndromes were 55.1%. Radial vascular access was used in 78% of cases, multivessel PCI was performed in 19.5% of the procedures. In 81.6% of cases lesions were B2/C type, 20.7% of procedures had bifurcation lesions. Procedural success was 99.6%. No acute thrombosis occurred. Clinical follow-up median period was 24.3 (±8.28) months and FU was available in 93.7% of patients. Death for any cause occurred in 11 patients (5.2%), 6 of them were non cardiac-related. Cardiac-related death rate was 2.4%. Two patients had in-stent restenosis. The overall target lesion failure rate was 3.3%., Conclusions: This observational data regards our experience with Biotronik Orsiro stent in an unselected population. This initial data, although limited by a mainly clinical follow-up and restricted number of patients, confirms the good clinical performance of this sirolimus-eluting stent with a biodegradable polymer in everyday practice, including complex lesions, according to current larger studies in the literature.

Aims: To evaluate the implications of an Absorb bioresorbable vascular scaffold (Absorb BVS) on the morphology of the superficial plaques., Methods and Results: Forty-six patients who underwent Absorb BVS implantation and 20 patients implanted with bare metal stents (BMS) who had serial optical coherence tomographic examination at baseline and follow-up were included in this analysis. The thin-capped fibroatheromas (TCFA) were identified in the device implantation regions and in the adjacent native coronary segments. Within all regions, circumferential locations of TCFA and calcific tissues were identified, and the neointimal thickness was measured at follow-up. At six to 12-month follow-up, only 8% of the TCFA detected at baseline were still present in the Absorb BVS and 27% in the BMS implantation segment (p=0.231). Sixty percent of the TCFA in native segments did not change their phenotype at follow-up. At short-term follow-up, significant reduction in the lumen area of the BMS was noted, which was higher compared to that reported in the Absorb BVS group (-2.11±1.97 mm2 vs. -1.34±0.99 mm2, p=0.026). In Absorb BVS, neointima tissue continued to develop at midterm follow-up (2.17±0.48 mm2 vs. 1.38±0.52 mm2, p<0.0001) and covered the underlying tissues without compromising the luminal dimensions (5.93±1.49 mm2 vs. 6.14±1.49 mm2, p=0.571) as it was accommodated by the expanded scaffold (8.28±1.74 mm2 vs. 7.67±1.28 mm2, p<0.0001)., Conclusions: Neointimal tissue develops following either Absorb BVS or BMS implantation and shields lipid tissues. The neointimal response in the BMS causes a higher reduction of luminal dimensions compared to the Absorb BVS. Thus, Absorb BVS may have a value in the invasive re-capping of high-risk plaques.

Aims: The present report describes a novel coronary fractional flow reserve (FFR) system which allows FFR assessment using a rapid exchange microcatheter (RXi)., Methods and Results: The RXi microcatheter is compatible with standard 0.014" coronary guidewires facilitating lesion negotiation and FFR assessment in a wide range of coronary anatomies. In case of serial lesions, a microcatheter would have the important advantage of allowing multiple pullbacks while maintaining wire access to the vessel. The RXi is a fibre-optic sensor technology-based device. This technology might allow reduction in signal drift. The RXi microcatheter's fibre-optic sensor is located 5 mm from the distal tip. The microcatheter profile at the sensor site is 0.027"0.036". The segment of the catheter which is intended to reside within the target lesion is proximal to the sensor and has dimensions decreased to 0.020"0.025"; these dimensions are comparable to a 0.022" circular-shaped wire., Conclusions: The RXi microcatheter FFR system represents a novel technology that could allow easier lesion negotiation, maintaining guidewire position, facilitating pullbacks for assessment of serial lesions and simplifying the obtainment of post-intervention FFR measurements. The optical sensing technology could additionally result in less signal drift. Further investigations are required to evaluate the clinical value of this technology fully.

Background: An increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents., Methods: Individual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up., Results: Data from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile (≤ 25.95 kg/m(2) -Low or normal weight) 1,727 patients; II tertile (>25.95 ≤ 29.74 kg/m(2) -overweight) 1,695 patients, and III tertile (>29.74 kg/m(2) -obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI] = 0.89 [0.69, 1.14], P = 0.341; major adverse cardiac events (I-III tertile, HR [95% CI] = 0.90 [0.72, 1.14], P = 0.389; cardiac death (I-III tertile, HR [95% CI] = 1.20 [0.73, 1.99], P = 0.476); myocardial infarction (I-III tertile, HR [95% CI] = 0.86 [0.55, 1.35], P = 0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI] = 0.75 [0.53, 1.08], P = 0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI] = 0.98 [0.49, 1.99], P = 0.964., Conclusions: In the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions., (© 2015 Wiley Periodicals, Inc.)

Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios., Methods and Results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted., Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.

Background: As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been reported. We present angiographic and optical coherence tomography (OCT) findings in a series of patients treated in our center for definite bioresorbable scaffold thrombosis., Methods and Results: Up to June 2014, 14 patients presented with definite BVS thrombosis in our center. OCT was performed in 9 patients at the operator's discretion. Angiographic and OCT findings were compared with a control group comprising 15 patients with definite metallic stent thrombosis. In the BVS group, time interval from index procedure to scaffold thrombosis ranged from 0 to 675 days. Incomplete lesion coverage by angiography was identified in 4 of 14 cases, malapposition by OCT in 5 of 9 cases, strut discontinuity in 2 of 9 cases, and underexpansion in 2 of 9 cases. Five patients had discontinued dual antiplatelet therapy, and in 3 of them discontinued dual antiplatelet therapy discontinuation had occurred the week preceding the event. There were no significant differences in angiographic or OCT findings between BVS and metallic stent thrombosis., Conclusions: Suboptimal implantation with incomplete lesion coverage, underexpansion, and malapposition comprises the main pathomechanism for both early and late BVS thrombosis, similar to metallic stent thrombosis. Dual antiplatelet therapy discontinuation seems to also be a secondary contributor in several late events. Our observations suggest that several potential triggers for BVS thrombosis could be avoided., (© 2015 American Heart Association, Inc.)

Percutaneous coronary interventions (PCI) have become a reliable revascularisation option to treat ischaemic coronary artery disease. Drug-eluting stents (DES) are widely used as first choice devices in many procedures due to their established good medium to long term outcomes. These permanent implants, however, do not have any residual function after vascular healing following the PCI. Beyond this initial healing period, metallic stents may induce new problems, resulting in an average rate of 2 % reinterventions per year. To eliminate this potential late limitation of permanent metallic DES, bioresorbable coronary stents or 'vascular scaffolds' (BVS) have been developed. In a parallel publication in this journal, an overview of the current clinical performance of these scaffolds is presented. As these scaffolds are currently CE marked and commercially available in many countries and as clinical evidence is still limited, recommendations for their general usage are needed to allow successful clinical introduction.

Drug-eluting stents (DES) are widely used as first choice devices in percutaneous coronary interventions. However, certain concerns are associated with the use of DES, i.e. delayed arterial healing with a subsequent risk of neo-atherosclerosis, late stent thrombosis and hypersensitivity reactions to the DES polymer. Bioresorbable vascular scaffolds are the next step in percutaneous coronary interventions introducing the concept of supporting the natural healing process following initial intervention without leaving any foreign body materials resulting in late adverse events. The first-generation devices have shown encouraging results in multiple studies of selected patients up to the point of full bioresorption, supporting the introduction in regular patient care. During its introduction in daily clinical practice outside the previously selected patient groups, a careful approach should be followed in which outcome is continuously monitored.

Introduction: Although bioresorbable vascular scaffolds (BVS) have been used with promising results in patients with stable and unstable angina, little is known about the acute vascular response following BVS implantation in myocardial infarction. We present angiographic and OCT findings from the first patients undergoing bioresorbable vascular scaffold (BVS) implantation for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) in our institution., Methods: The first 5 patients with NSTEMI and the first 5 patients with STEMI who underwent BVS implantation in our institution, followed by optical coherence tomography (OCT) imaging of the treated culprit vessel, were included in this series. All patients underwent angiographic analysis pre- and post- BVS implantation, as well as OCT analysis, including qualitative and quantitative assessment., Results: Implantation was successful in all cases, as assessed by angiography and OCT. There were no cases with coronary spasm, distal embolization or no-reflow. No adverse clinical events were recorded in any patient at the 6-month follow up. Specific illustrative cases demonstrating the challenges of BVS implantation in myocardial infarction are presented., Conclusions: BVS implantation can potentially be used in the setting of thrombotic lesions encountered in myocardial infarction; however, the role of this treatment approach warrants systematic evaluation in prospective studies.