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Rationale and Objectives: A new postprocessing algorithm named adaptive statistical iterative reconstruction (ASIR)-V has been recently introduced. The aim of this article was to analyze the impact of ASIR-V algorithm on signal, noise, and image quality of coronary computed tomography angiography., Materials and Methods: Fifty consecutive patients underwent clinically indicated coronary computed tomography angiography (Revolution CT; GE Healthcare, Milwaukee, WI). Images were reconstructed using filtered back projection and ASIR-V 0%, and a combination of filtered back projection and ASIR-V 20%-80% and ASIR-V 100%. Image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were calculated for left main coronary artery (LM), left anterior descending artery (LAD), left circumflex artery (LCX), and right coronary artery (RCA) and were compared between the different postprocessing algorithms used. Similarly a four-point Likert image quality score of coronary segments was graded for each dataset and compared. A cutoff value of P < .05 was considered statistically significant., Results: Compared to ASIR-V 0%, ASIR-V 100% demonstrated a significant reduction of image noise in all coronaries (P < .01). Compared to ASIR-V 0%, SNR was significantly higher with ASIR-V 60% in LM (P < .01), LAD (P < .05), LCX (P < .05), and RCA (P < .01). Compared to ASIR-V 0%, CNR for ASIR-V ≥60% was significantly improved in LM (P < .01), LAD (P < .05), and RCA (P < .01), whereas LCX demonstrated a significant improvement with ASIR-V ≥80%. ASIR-V 60% had significantly better Likert image quality scores compared to ASIR-V 0% in segment-, vessel-, and patient-based analyses (P < .01)., Conclusions: Reconstruction with ASIR-V 60% provides the optimal balance between image noise, SNR, CNR, and image quality., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

MitraClip is a validated treatment for significant mitral regurgitation (MR) in high-risk patients. Aims of the study were to evaluate immediate changes in mitral valve (MV) geometry induced by MitraClip and correlations between baseline geometry and cardiac remodeling. Eighty patients who underwent MitraClip for primary (48%) or secondary (52%) MR were enrolled. Intraoperative transesophageal echocardiographic 3D images were acquired immediately before and after the procedure for MV annulus (MVA) morphology analysis. Transthoracic 3D echocardiography was performed preoperatively and at 6 months follow-up (6MFU). Patients were classified on the basis of MR reduction (ΔMR) at 6MFU as Optimal (ΔMR ≥ 2) or Suboptimal (ΔMR < 2). An optimal result was reached in 60 (75%) patients, whereas 20 subjects showed a ΔMR< 2 at 6MFU. The Optimal showed significantly smaller baseline MVA (antero-posterior diameter 4.05 ± 0.59 vs 4.43 ± 0.68 cm; anterolateral-posteromedial diameter 4.38 ± 0.56 vs 4.70 ± 0.73 cm; MVA circumference 14.1 ± 1.7 vs 15.1 ± 2.3 cm; and 3D area 14.8 ± 3.9 vs 17.4 ± 5.3 cm 2 ), lower sphericity index and nonplanar angle compared with Suboptimal. A value of antero-posterior diameter ≥4.44cm was identified (receiver-operating characteristic curve) as a possible cut-off for preoperative identification of Suboptimal patients. Postoperatively, MitraClip induced reduction of MVA flattening (nonplanar angle), sphericity index, and size (as expressed by antero-posterior diameter, MVA circumference and area). At 6MFU, the Optimal showed significant decrease in left ventricular volumes and pulmonary artery systolic pressure. In conclusion, MitraClip induces remarkable changes in MVA geometry and favorable left ventricular remodeling is detected in patients with optimal mid-term outcome; a preprocedural antero-posterior diameter <4.44cm seems to be a potential predictor of mid-term optimal result., (Copyright © 2018. Published by Elsevier Inc.)

Background: Patients hospitalized with acute myocardial infarction (AMI) are often on prior single antiplatelet therapy (SAPT) or a dual antiplatelet therapy (DAPT). Whether chronic SAPT or DAPT is beneficial or associated with an increased risk in AMI is still controversial., Methods and Results: We prospectively enrolled 1718 consecutive patients with AMI (798 ST-segment elevation myocardial infarction and 920 non-ST-segment elevation myocardial infarction) who were divided according to their chronic APT (no APT, SAPT, or DAPT). The study primary end point was the infarct size, as estimated by troponin I peak. Incidence of major bleeding was also evaluated. Five hundred thirty-six (31%) patients were on chronic SAPT and 215 (13%) on DAPT. A graded increase in Global Registry of Acute Coronary Events (GRACE) and Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) risk scores was found going from patients without APT to those with DAPT, while a progressive smaller troponin I peak was observed with the increasing number of chronic antiplatelet agents (11.2 [interquartile range: 2-45] ng/mL, 6.6 [1-33] ng/mL, and 4.1 [1-24] ng/mL; P < .001 for trend). This result was maintained after adjustment for baseline ischemic risk profile (GRACE score) and other major confounders ( P < .001). The incidence of bleeding was higher in patients on chronic APT than in those without APT (5.2% vs 2.4%; P = .002). However, when the bleeding risk was adjusted for the CRUSADE risk score, chronic SAPT (odds ratio [OR]: 1.40, 95% confidence interval [CI]: 0.77-2.53) and DAPT (OR: 0.70, 95% CI: 0.29-1.70) were not associated with an increased bleeding risk., Conclusion: In patients with AMI, chronic APT is associated with higher baseline ischemic and bleeding risks. Despite this and unexpectedly, they have a smaller infarct size and similar adjusted bleeding risk.

Background: Recent studies demonstrated a significant improvement in the diagnostic performance of coronary CT angiography (CCTA) for the evaluation of in-stent restenosis (ISR). However, coronary stent assessment is still challenging, especially because of beam-hardening artifacts due to metallic stent struts and high atherosclerotic burden of non-stented segments. Adenosine-stress myocardial perfusion assessed by CT (CTP) recently demonstrated to be a feasible and accurate tool for evaluating the functional significance of coronary stenoses in patients with suspected coronary artery disease (CAD). Yet, scarce data are available on the performance of CTP in patients with previous stent implantation., Aim of the Study: We aim to assess the diagnostic performance of CCTA alone, CTP alone and CCTA plus CTP performed with a new scanner generation using quantitative invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR) as standard of reference., Methods: We will enroll 300 consecutive patients with previous stent implantation, referred for non-emergent and clinically indicated invasive coronary angiography (ICA) due to suspected ISR or progression of CAD in native coronary segments. All patients will be subjected to stress myocardial CTP and a rest CCTA. The first 150 subjects will undergo static CTP scan, while the following 150 patients will undergo dynamic CTP scan. Measurement of invasive FFR will be performed during ICA when clinically indicated., Results: The primary study end points will be: 1) assessment of the diagnostic performance (diagnostic rate, sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy) of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. ICA as standard of reference in a territory-based and patient-based analysis; 2) assessment of sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. invasive FFR as standard of reference in a territory-based analysis., Conclusions: The ADVANTAGE study aims to provide an answer to the intriguing question whether the combined anatomical and functional assessment with CCTA plus CTP may have higher diagnostic performance as compared to CCTA alone in identifying stented patients with significant ISR or CAD progression., (Copyright © 2018. Published by Elsevier Inc.)

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Objective: To compare the main outcomes of radial versus femoral access at long-term follow-up., Background: Little is known about the long-term major cardiovascular events and bleeding complications of patients undergoing percutaneous coronary intervention (PCI) with radial vs femoral approach., Methods: A total of 1107 patients from the CENTURY II trial were included. To minimize baseline differences between radial and femoral groups, we applied propensity-score matching for this comparison., Results: In this multicenter study, the radial approach was used in 73.4% of patients. After propensity-score matching, baseline and procedural characteristics were comparable between both groups. Procedural success was high and similar in radial and femoral approaches (98.2% vs 97.5%; P=.47) while radial access was associated with a shorter hospital stay (1.69 ± 1.92 days vs 2.08 ± 1.98 days; P<.01). The short-term bleeding and vascular complication rates were significantly lower in the radial group (1.7% vs 6.2% [P<.001 in-hospital] and 2.7% vs 9.6% [P<.001 at 1-month follow-up]). At 3-year follow-up, radial access was associated with lower rates of all-cause mortality (3.9 vs 6.9%; P=.04) and cardiovascular death (2.1 vs 4.9%; P=.02). The composite of all-cause mortality, myocardial infarction, and revascularization showed no differences between groups (18.2 vs 21.1%; P=.29)., Conclusions: Compared to the femoral approach, the radial approach is associated with significantly lower long-term all-cause mortality rate as well as lower in-hospital and short-term bleeding rates. These results suggest additional long-term benefits of radial access for PCI, but should be interpreted within the context of the current study and further verified in future studies.

Purpose: Recently, a new intracycle motion correction algorithm (MCA) was introduced to reduce motion artifacts from heart rate (HR) in coronary computed tomography angiography (cCTA). The aim of the study was to evaluate the image quality, overall evaluability, and effective radiation dose (ED) of cCTA with prospective electrocardiographic (ECG) triggering plus MCA as compared with standard protocol with retrospective ECG triggering in patients with HR≥65 bpm., Materials and Methods: One hundred consecutive patients (67±10 y) scheduled for cCTA with 65

Background: Preclinical data showed that overlapping (OVP) scaffolds might result in delayed healing and strut coverage compared to nonOVP scaffold segments. Furthermore, OVP in patients could result in increased periprocedure myocardial infarction (MI) rate secondary to side branch occlusion; however, little is known whether this may have an impact on long-term clinical outcomes., Methods: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. In this study, we compared the immediate and 2-year clinical outcomes of patients with OVP scaffolds (n = 115) to those of patients with nonOVP scaffolds (n = 697). The primary objective was the comparison of major adverse cardiac event (MACE) (cardiac death, MI and ischemic-driven target lesion revascularization [TLR]) and scaffold thrombosis (ST) rates up to 2 years., Results: Baseline clinical and angiographic characteristics were comparable between cohorts except for longer lesions in the OVP patients as expected (16.7 ± 7.3 vs. 11.6 ± 4.4 mm, P < 0.0001), higher lesion complexity (B2) and numerically smaller vessel size. In-hospital, there was a marked increase in MACE in the OVP cohort (7.0 vs. 0.9%, P = 0.002), exclusively driven by a higher rate of periprocedure MI (7.0 vs. 0.9%, P = 0.002). Long-term MACE did not significantly differ between groups (10.4% in the OVP cohort vs. 6.6% in the no-OVP group, P = 0.1) with comparable rates of cardiac death (0.9 vs. 1.2%, P = 1.0) and ischemia-driven TLR (1.7 vs. 2.5%, P = 1.0). Cumulative incidence of MI was higher in the OVP cohort (7.8 vs. 3.0%, P = 0.02). Of note, the rate of MI between hospital discharge and 2-year follow-up was lower in the OVP cohort (0.8 vs. 2.1%, P = 0.04). Cumulative incidence of definite/probable ST was relatively low and comparable between groups (1.8 vs. 1.5%, P = 0.7)., Conclusions: In this low-to-moderate complex population treated with the ABSORB scaffold the OVP group showed a higher incidence of periprocedure MI with no immediate or long-term increase in cardiac death, TLR or ST., (© 2017 Wiley Periodicals, Inc.)

Objective: Motion artifact can reduce the diagnostic accuracy of coronary CT angiography (CCTA) for coronary artery disease (CAD). The purpose of this study was to compare the diagnostic performance of an algorithm dedicated to correcting coronary motion artifact with the performance of standard reconstruction methods in a prospective international multicenter study., Subjects and Methods: Patients referred for clinically indicated invasive coronary angiography (ICA) for suspected CAD prospectively underwent an investigational CCTA examination free from heart rate-lowering medications before they underwent ICA. Blinded core laboratory interpretations of motion-corrected and standard reconstructions for obstructive CAD (≥ 50% stenosis) were compared with ICA findings. Segments unevaluable owing to artifact were considered obstructive. The primary endpoint was per-subject diagnostic accuracy of the intracycle motion correction algorithm for obstructive CAD found at ICA., Results: Among 230 patients who underwent CCTA with the motion correction algorithm and standard reconstruction, 92 (40.0%) had obstructive CAD on the basis of ICA findings. At a mean heart rate of 68.0 ± 11.7 beats/min, the motion correction algorithm reduced the number of nondiagnostic scans compared with standard reconstruction (20.4% vs 34.8%; p < 0.001). Diagnostic accuracy for obstructive CAD with the motion correction algorithm (62%; 95% CI, 56-68%) was not significantly different from that of standard reconstruction on a per-subject basis (59%; 95% CI, 53-66%; p = 0.28) but was superior on a per-vessel basis: 77% (95% CI, 74-80%) versus 72% (95% CI, 69-75%) (p = 0.02). The motion correction algorithm was superior in subgroups of patients with severely obstructive (≥ 70%) stenosis, heart rate ≥ 70 beats/min, and vessels in the atrioventricular groove., Conclusion: The motion correction algorithm studied reduces artifacts and improves diagnostic performance for obstructive CAD on a per-vessel basis and in selected subgroups on a per-subject basis.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Background: We aimed to evaluate the mid-term outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), as compared with durable-polymer everolimus-eluting stents (EES)., Methods: We compiled a multicenter registry of patients undergoing CTO recanalization followed by BP-SES or EES implantation. The primary endpoint was the incidence of target-lesion failure (TLF, a composite of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization) at one year. Propensity score matching (PSM) was used to adjust for case mix., Results: Overall, 413 patients were included (BP-SES n = 242, EES n = 171). PSM resulted in 131 matched pairs, which represented the subject of the main analysis. Antegrade wire escalation was the most successful crossing technique (66% vs. 63%, p = 0.98) in both the BP-SES and EES groups, respectively. Procedural success rates were similar between groups (BP-SES 96% vs. EES 93%, p = 0.24). At one-year follow-up, there were no differences in the primary endpoint of TLF (5.7% vs. 8.3%, p = 0.44), and in cardiac death (0.9% vs. 2.8%, p = 0.32), target-vessel myocardial infarction (0.9% vs 1.9%, p = 0.57), target-lesion revascularization (3.7% vs 3.7%, p = 0.99), or stent thrombosis (0.9% vs. 1.9%, p = 0.57), in BP-SES vs. EES, respectively., Conclusions: Patients undergoing CTO PCI with BP-SES suffer a low rate of TLF at one-year follow-up, which is similar to that of subjects treated with durable-polymer EES., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Aim of the study was to evaluate image quality, radiation exposure and diagnostic accuracy of coronary CT angiography (CCTA) performed with a novel cardiac CT scanner in patients with very high heart rate (HR)., Methods: We prospectively enrolled 202 patients (111 men, mean age 66±8years) with suspected coronary artery disease who underwent CCTA with a whole-organ volumetric CT scanner. The HR during the scan was ≥80bpm in 100 patients (Group 1), while it was ≤65bpm in the remaining 102 patients (Group 2). In all patients, image quality score and coronary interpretability were evaluated and effective dose (ED) was recorded. In 86 of the 202 enrolled patients (40 patients in Group 1, 46 patients in Group 2) who were referred for a clinically indicated invasive coronary angiography (ICA) within 6months, diagnostic accuracy of CCTA vs. ICA was evaluated., Results: Mean image quality and coronary interpretability were very high in both Groups (Likert=3.35 vs. 3.39 and 97.3% [1542/1584 segments] and 98% [1569/1600 segments] in Group 1 and Group 2, respectively). Mean ED was lower in Group 2 (1.1±0.5mSv) compared to Group 1 (2.9±1.6mSv). In Group 1, sensitivity and specificity of CCTA for detection of >50% stenosis vs. ICA were 95.2% and 98.9% in a segment-based analysis and 100% and 81.8% in a patient-based analysis, respectively., Conclusions: The whole organ high-definition CT scanner allows evaluating coronary arteries in patients with high HR with excellent image quality, coronary interpretability and low radiation exposure., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objective: Acute hyperglycemia is a powerful predictor of poor prognosis in acute myocardial infarction (AMI), particularly in patients without diabetes. This emphasizes the importance of an acute glycemic rise rather than glycemia level at admission alone. We investigated in AMI whether the combined evaluation of acute and chronic glycemic levels, as compared with admission glycemia alone, may have a better prognostic value., Research Design and Methods: We prospectively measured admission glycemia and estimated average chronic glucose levels (mg/dL) by the following formula: [(28.7 × glycosylated hemoglobin %) - 46.7], and calculated the acute-to-chronic (A/C) glycemic ratio in 1,553 consecutive AMI patients (mean ± SD age 67 ± 13 years). The primary end point was the combination of in-hospital mortality, acute pulmonary edema, and cardiogenic shock., Results: The primary end point rate increased in parallel with A/C glycemic ratio tertiles (5%, 8%, and 20%, respectively; P for trend <0.0001). A parallel increase was observed in troponin I peak value (15 ± 34 ng/mL, 34 ± 66 ng/mL, and 68 ± 131 ng/mL; P < 0.0001). At multivariable analysis, A/C glycemic ratio remained an independent predictor of the primary end point and of troponin I peak value, even after adjustment for major confounders. At reclassification analyses, A/C glycemic ratio showed the best prognostic power in predicting the primary end point as compared with glycemia at admission in the entire population (net reclassification improvement 12% [95% CI 4-20]; P = 0.003) and, particularly, in patients with diabetes (27% [95% CI 14-40]; P < 0.0001)., Conclusions: In AMI patients with diabetes, A/C glycemic ratio is a better predictor of in-hospital morbidity and mortality than glycemia at admission., (© 2018 by the American Diabetes Association.)

Aims: Scarce data are available on the long-term structural and functional changes of prosthetic valves after transcatheter aortic valve implantation (TAVI). The objective was to evaluate with echocardiography the long-term structural and functional changes of prosthetic valves after TAVI., Methods and Results: Structural valve deterioration (SVD) was defined as leaflet thickening ≥3mm, presence of calcification and abnormal leaflet motion. Five-year echocardiographic follow-up was available in 96 out of 318 patients who underwent TAVI with a balloon-expandable device between April 2008 and December 2011. At 1-year follow-up, no patient showed SVD. At 5-year follow-up, SVD were observed in 29 (30%) patients who showed also a significant reduction of aortic valve area (AVA) together with an increase of mean and peak aortic pressure gradients at the latest echocardiography evaluation. Moreover, rate of central aortic valve regurgitation ≥2 was higher in SVD patients as compared to those without SVD, while there was no difference in terms of paravalvular regurgitation. Despite SVD, one patient only reached the criteria for severe stenosis and no reintervention was needed at 5-year follow-up. Variables independently associated with SVD were female sex, small body surface area, use of a 23 mm valve, and small AVA at pre-discharge echocardiogram., Conclusion: At 5-year follow-up, 30% of patients who underwent TAVI with a balloon-expandable valve showed initial SVD. However, SVD was not associated with severe stenosis in most of the patients and had no significant impact on and clinical outcome.

Objectives: To evaluate image quality, coronary evaluability and radiation exposure of coronary CT angiography (CCTA) performed with whole-heart coverage cardiac-CT in patients with atrial fibrillation (AF)., Materials and Methods: We prospectively enrolled 164 patients with AF who underwent a clinically indicated CCTA with a 16-cm z-axis coverage scanner. In all patients CCTA was performed using prospective ECG-triggering with targeted RR interval. We evaluated image quality, coronary evaluability and effective dose (ED). Patients were divided in two subgroups based on heart rate (HR) during imaging. Group 1: 64 patients with low HR (<75 bpm), group 2: 100 patients with high HR (≥75 bpm). Written informed consent was obtained from all patients and the institutional ethics committee approved the study protocol., Results: In a segment-based analysis, coronary evaluability was 98.4 % (2,577/2,620 segments) in the whole population, without significant differences between groups (1,013/1,024 (98.9 %) and 1,565/1,596 (98.1 %), for groups 1 and 2, respectively, p=0.15). Mean ED was similar in both groups (3.8±1.9 mSv and 3.9±2.1 mSv in groups 1 and 2, respectively, p=0.75) CONCLUSIONS: The whole-heart-coverage scanner could evaluate coronary arteries with high image quality and without increase in radiation exposure in AF patients, even in the high HR group., Key Points: • Last-generation CT scanner improves coronary artery assessment in AF patients. • The new CT scanner enables low radiation exposure in AF patients. • Diagnostic ICA maybe avoided in AF patients with suspected CAD. • Whole-heart coverage CT scanner enables low radiation exposure in AF patients.

Objectives: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon., Methods: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR)., Results: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups., Conclusion: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: Cardiac magnetic resonance (CMR) is a robust tool to evaluate left ventricular ejection fraction (LVEF), myocardial salvage index, microvascular obstruction, and myocardial hemorrhage in patients with ST-segment-elevation myocardial infarction. We evaluated the additional prognostic benefit of a CMR score over standard prognostic stratification with global registry of acute coronary events (GRACE) score and transthoracic echocardiography LVEF measurement., Methods and Results: Two hundred nine consecutive patients with ST-segment-elevation myocardial infarction (age, 61.4±11.4 years; 162 men) underwent transthoracic echocardiography and CMR after succesful primary percutaneous coronary intervention. Major adverse cardiac events (MACE) were assessed at a mean follow-up of 2.5±1.2 years. MACE occurred in 24 (12%) patients who at baseline showed higher GRACE risk score ( P <0.01), lower LVEF with both transthoracic echocardiography and CMR, lower myocardial salvage index, and higher per-patient myocardial hemorrhage and microvascular obstruction prevalence and amount as compared with patients without MACE ( P <0.01). The best cut-off values of transthoracic echocardiography-LVEF, CMR-LVEF, myocardial salvage index, and microvascular obstruction to predict MACE were 46.7%, 37.5%, 0.4, and 2.6% of left ventricular mass, respectively. Accordingly, a weighted CMR score, including the following 4 variables (CMR-LVEF, myocardial salvage index, microvascular obstruction, and myocardial hemorrhage), with a maximum of 17 points was calculated and included in the multivariable analysis showing that only CMR score (hazard ratio, 1.867 per SD increase [1.311-2.658]; P <0.001) was independently associated with MACE with the highest net reclassification improvement as compared to GRACE score and transthoracic echocardiography-LVEF measurement., Conclusions: CMR score provides incremental prognostic stratification as compared with GRACE score and transthoracic echocardiography-LVEF and may impact the management of patients with ST-segment-elevation myocardial infarction., (© 2017 American Heart Association, Inc.)

Aims: Recent studies suggested that even non-obstructive coronary artery disease (CAD) increases major cardiovascular adverse events (MACE) rate. Aim of this study was to evaluate whether coronary computed tomography angiography (CCTA) may detect specific plaque characteristics that may affect prognosis in patients with non-obstructive CAD., Methods: We enrolled 245 patients who underwent CCTA between April 2004 and April 2007 for suspected CAD and were found to have non-obstructive CAD. Positive remodelling index (PRI), low-attenuation plaque (LAP), plaque burden (PB), spotty calcification (SC), and napkin-ring sign (NRS) have been evaluated for each coronary plaque detected. Acute coronary syndrome, all-cause/cardiac death, and very late elective revascularization (vl-ER) were the endpoints of the study., Results: A total of 28 events were recorded (2 STEMI, 4 NSTEMI, 6 UA, 2 cardiac deaths, 4 non-cardiac death, and 10 vl-ERs) at long-term follow-up (98 ± 20 months). When adjusted for significant clinical variables PRI > 1.4 (HR 3.31 CI 95% 1.11-9.91, P = 0.0392), LAP (HR 8.45 CI 95% 2.22-32.21, P = 0.0019), PB > 0.7 (HR 5.25 CI 95% 1.45-19.03, P = 0.0120), and NRS (HR 12.52 CI 95% 1.51-103.90, P = 0.0198) were still significantly associated with higher rate of hard cardiac events at follow-up. The Kaplan-Meyer curves confirmed lower cumulative hard cardiac events-free survival in patients presenting at least one coronary plaque with two or more high-risk characteristics when compared with patients with no lesion with more than one high-risk plaque characteristics (log-rank P < 0.0001)., Conclusions: High-risk plaque characteristics at CCTA (PRI > 1.4, PB > 0.7, LAP, and NRS) seem to be promising for risk stratification of patients with non-obstructive CAD., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Purpose To assess image quality, interpretability, diagnostic accuracy, and radiation exposure of a computed tomography (CT) scanner with 16-cm coverage and 230-µm spatial resolution at coronary artery evaluation in patients with atrial fibrillation (AF) by using invasive coronary angiography (ICA) as the reference method and to compare the results with those obtained in patients with sinus rhythm (SR). Materials and Methods Written informed consent and institutional ethics committee approval were obtained. Between March 2015 and February 2016, 166 consecutive patients were prospectively enrolled (83 with AF, 83 with SR). They underwent ICA and coronary CT angiography performed with a whole-heart CT scanner. Image quality, coronary segment interpretability, effective dose (ED), and diagnostic accuracy were assessed at CT angiography and were compared with those attained with ICA. Diagnostic performance of the groups was compared with the pairwise McNemar test. Results Mean heart rate during scanning was 83 beats per minute ± 21 (standard deviation) in the AF group and 63 beats per minute ± 14 in the SR group (P < .01). Coronary interpretability was 98.5% in the AF group and 98.4% in the SR group (P = .96). In a segment-based analysis, sensitivity and specificity in the detection of coronary stenosis of more than 50% compared with detection of ICA were 96.4% and 98.7%, respectively, in the chronic AF group (P = .98) and 95.6% and 98.1%, respectively, in the SR group (P = .32). In a patient-based analysis, sensitivity and specificity were 95.2% and 97.6%, respectively, in the chronic AF group (P = .95) and 97.8% and 94.7%, respectively, in the SR group (P = .93). Conclusion Whole-heart CT enables evaluation of coronary arteries with high image quality, low radiation exposure, and high diagnostic accuracy in patients with chronic AF, with a diagnostic performance similar to that in patients with SR. © RSNA, 2017 Online supplemental material is available for this article.

Aims: To evaluate the relationship between an incremental model including cardiovascular risk factors, carotid disease, and inflammatory biomarkers to predict the presence of obstructive coronary artery disease (CAD)., Methods and Results: A total of 134 consecutive and asymptomatic intermediate-risk patients (mean age 61 ± 9 years, 52% men) were enrolled. Each subject underwent circulating levels assessment of interleukin (IL)-2r, IL-6, IL-8, IL-10, high-sensitivity C-reactive protein (hs-CRP) and carotid and coronary artery evaluation using carotid ultrasound and coronary computed tomography angiography (CCTA), respectively. Carotid disease was diagnosed in 71 (53%) patients. Obstructive and multi-vessel CAD were found in 50 (37%) and 18 (14%) patients, respectively. Patients in whom CCTA showed multi-vessel CAD had a higher rate of carotid disease (89 vs. 46%, P = 0.001) and increased values of all interleukins when compared with patients without multi-vessel obstructive CAD. The univariate and multivariate analysis showed that male gender, diabetes, carotid disease, and IL-6 were independently associated with obstructive CAD. At receiver operating characteristic curve analysis, the multivariate model (including male gender, carotid disease, IL-6 > 5.9 pg/mL, and diabetes) showed the highest area under the curve for prediction of obstructive CAD, multi-vessel CAD, and high-risk plaque defined as mixed and/or remodelled plaque when compared with all other models (P < 0.001)., Conclusion: Among asymptomatic intermediate-risk patients, the presence of increased IL6 levels in addition to traditional risk factors (male gender with diabetes) and carotid artery disease predicts higher rates of obstructive CAD and it could be of help to identify which subset of asymptomatic patients could be referred to CCTA for screening., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Swan-Ganz catheter entrapment in the heart, vena cava, or pulmonary artery is rare but may lead to life-threatening events. We report a case of severe tricuspid regurgitation resulting from papillary muscle rupture during percutaneous removal of a Swan-Ganz catheter (SCG) caught by a surgical suture. We performed urgent tricuspid valve repair by suturing the ruptured papillary muscle. This report highlights preventive measures to avoid suture-related entrapment and raises a word of caution regarding percutaneous removal of accidentally entrapped SCGs., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study., Methods and Results: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%., Conclusions: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.

Aims: The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices., Methods and Results: Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02)., Conclusions: According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

Background: Non-obstructive coronary artery disease (CAD) identified by coronary computed tomography angiography (CCTA) demonstrated prognostic value. CT-adapted Leaman score (CT-LeSc) showed to improve the prognostic stratification. Aim of the study was to evaluate the capability of CT-LeSc to assess long-term prognosis of patients with non-obstructive (CAD)., Methods: From 17 centers, we enrolled 2402 patients without prior CAD history who underwent CCTA that showed non-obstructive CAD and provided complete information on plaque composition. Patients were divided into a group without CAD and a group with non-obstructive CAD (<50% stenosis). Segment-involvement score (SIS) and CT-LeSc were calculated. Outcomes were non-fatal myocardial infarction (MI) and the combined end-point of MI and all-cause mortality., Results: Patient mean age was 56±12years. At follow-up (mean 59.8±13.9months), 183 events occurred (53 MI, 99 all-cause deaths and 31 late revascularizations). CT-LeSc was the only multivariate predictor of MI (HRs 2.84 and 2.98 in two models with Framingham and risk factors, respectively) and of MI plus all-cause mortality (HR 2.48 and 1.94 in two models with Framingham and risk factors, respectively). This was confirmed by a net reclassification analysis confirming that the CT-LeSc was able to correctly reclassify a significant proportion of patients (cNRI 0.28 and 0.23 for MI and MI plus all-cause mortality, respectively) vs. baseline model, whereas SIS did not., Conclusion: CT-LeSc is an independent predictor of major acute cardiac events, improving prognostic stratification of patients with non-obstructive CAD., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objectives: We evaluated the rate of use, clinical predictors, and in-hospital outcome of renal replacement therapy (RRT) in acute myocardial infarction (AMI) patients., Methods: All consecutive AMI patients admitted to the Coronary Care Unit between January 1st, 2005 and December 31st, 2015 were identified through a search of our prospectively collected clinical database. Patients were grouped according to whether they required RRT or not., Results: Two-thousand-eight-hundred-thirty-nine AMI patients were included. Eighty-three (3%) AMI patients underwent RRT. Variables confirmed at cross validation analysis to be associated with RRT were: admission creatinine >1.5mg/dl (OR 16.9, 95% CI 10.4-27.3), cardiogenic shock (OR 23.0, 95% CI 14.4-36.8), atrial fibrillation (OR 8.6, 95% CI 5.5-13.4), mechanical ventilation (OR 22.6, 95% CI 14.2-36.0), diabetes mellitus (OR 4.8, 95% CI 3.1-7.4), and left ventricular ejection fraction <40% (OR 9.1, 95% CI 5.6-14.7). The AUC for RRT with the combination of these predictors was 0.96 (95% CI 0.94-0.97; P<0.001). In-hospital mortality was significantly higher in RRT patients (41% vs. 2.1%, P<0.001). Oligoanuria as indication for RRT (OR 5.1, 95% CI 1.7-15.4), atrial fibrillation (OR 4.3, 95% CI 1.6-11.5), mechanical ventilation (OR 20.8, 95% CI 6.1-70.4), and cardiogenic shock (OR 12.9, 95% CI 4.4-38.3) independently predicted mortality in RRT-treated patients. The AUC for in-hospital mortality prediction with the combination of these variables was 0.92 (95% CI 0.87-0.98; P<0.001)., Conclusions: Patients with AMI undergoing RRT had strikingly high in-hospital mortality. Use of RRT and its associated mortality were accurately predicted by easily obtainable clinical variables., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Clinical trials have shown that transcatheter aortic valve implantation for aortic stenosis compares favorably to surgical replacement in high-risk patients and is superior to medical therapy in those at prohibitive risk. There is uncertainty however on patterns and trends in transcatheter aortic valve implantation, especially focusing on Italy., Methods: The RISPEVA study is a prospective Italian registry including 21 institutions. Patients have been enrolled since late 2012, and data collection includes several baseline, procedural, in-hospital, and follow-up details. For the present analysis on patterns and trends, we focused on patients enrolled between 2012 and 2015, and as primary variable on the prevalence of high versus prohibitive surgical risk, limiting our scope to procedural outcomes., Results: A total of 1157 patients were included. The temporal breakdown was 376 (33%) patients enrolled in 2013, 408 (35%) in 2014, and 373 (32%) in 2015. Several patient features differed over time, including risk score, peripheral artery disease, end-stage pulmonary disease, and prior valvuloplasty (all P < 0.05). Several procedural features differed significantly over time, including sheath size, use of general anesthesia, Prostar closure device, predilation, antiembolic device, new TAVI device, and multiple prostheses (all P < 0.05). No significant temporal differences were found for major clinical outcomes, whereas the occurrence of moderate or severe postprocedural regurgitation and pacemaker dependency decreased over the years (both P < 0.05)., Conclusion: According to the RISPEVA results, the Italian uptake of TAVI is steady, with evident trends toward less invasive approaches and fitter patients.

Background: The outcome of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) has improved thanks to left atrium (LA) anatomy reconstruction by cardiac computed tomography (CCT). A new model-based iterative reconstruction algorithm (MBIR) provides image noise reduction achieving effective radiation dose (ED) close to chest X-ray exposure. Aim of this study was comparing RFCA procedural characteristics, AF recurrence and radiation exposure between patients in whom RFCA was guided by CCT image integration with MBIR versus a CCT standard protocol., Methods: Three-hundred consecutive patients with drug-refractory AF were studied with CCT using MBIR (Group 1; N:150) or CCT with standard protocol (Group 2; N:150) for LA evaluation and treated by image integration-supported RFCA. Image noise, signal to noise ratio (SNR), contrast to noise ratio (CNR), RFCA procedural characteristics, rate of AF recurrence and radiation exposure were compared., Results: Group 1 showed higher SNR (25.9±7.1 vs. 16.2±4.8, p<0.001) and CNR (23.3±7.1 vs. 12.2±4.2, p<0.001) and lower image noise (22.3±5.2 vs. 32.6±8.1 HU, p<0.001), fluoroscopy time (21±12 vs. 29±15min, p<0.01) and procedural duration (135±89 vs. 172±55, p<0.001). Group 1 showed a 94% reduction of ED as compared to Group 2 (CCT-ED related: 0.41±0.04 vs. 6.17±4.11mSv, p<0.001; cumulative CCT+RFCA-ED related: 21.9±17.9 vs. 36.0±24.1mSv, p<0.001) with similar rate of AF recurrence (25% vs. 29%, p=0.437)., Conclusions: CCT with MBIR allows accurate reconstruction of LA anatomy in AF patients undergoing RFCA with a sub-millisievert ED and comparable success rate of RFCA as compared to a standard CCT scan protocol., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Rationale: In contrast to cardiomyocyte necrosis, which can be quantified by cardiac troponin, functional cardiomyocyte impairment, including mitochondrial dysfunction, has escaped clinical recognition in acute myocardial infarction (AMI) patients., Objective: To investigate the diagnostic accuracy for AMI and prognostic prediction of in-hospital mortality of cytochrome c., Methods and Results: We prospectively assessed cytochrome c serum levels at hospital presentation in 2 cohorts: a diagnostic cohort of patients presenting with suspected AMI and a prognostic cohort of definite AMI patients. Diagnostic accuracy for AMI was the primary diagnostic end point, and prognostic prediction of in-hospital mortality was the primary prognostic end point. Serum cytochrome c had no diagnostic utility for AMI (area under the receiver-operating characteristics curve 0.51; 95% confidence intervals 0.44-0.58; P=0.76). Among 753 AMI patients in the prognostic cohort, cytochrome c was detectable in 280 (37%) patients. These patients had higher in-hospital mortality than patients with nondetectable cytochrome c (6% versus 1%; P<0.001). This result was mainly driven by the high mortality rate observed in ST-segment-elevation AMI patients with detectable cytochrome c, as compared with those with nondetectable cytochrome c (11% versus 1%; P<0.001). At multivariable analysis, cytochrome c remained a significant independent predictor of in-hospital mortality (odds ratio 3.0; 95% confidence interval 1.9-5.7; P<0.001), even after adjustment for major clinical confounders (odds ratio 4.01; 95% confidence interval 1.20-13.38; P=0.02)., Conclusions: Cytochrome c serum concentrations do not have diagnostic but substantial prognostic utility in AMI., (© 2016 The Authors.)

Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial., Methods and Results: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation., Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Background: Cardiac magnetic resonance (CMR) is useful for the diagnosis of left ventricular noncompaction (LVNC). However, there are limited data regarding its prognostic value., Objectives: The goal of this study was to evaluate the prognostic relevance of CMR findings in patients with LVNC., Methods: A total of 113 patients with an echocardiographic diagnosis of LVNC underwent CMR at 5 referral centers. CMR diagnostic criterion of LVNC (noncompacted/compacted ratio >2.3 in end-diastole) was confirmed in all patients. We performed left ventricular (LV) and right ventricular quantitative analysis and late gadolinium enhancement (LGE) assessments and analyzed the following LVNC diagnostic criteria: left ventricular noncompacted myocardial mass (LV-ncMM) >20% and >25%, total LV-ncMM index >15 g/m 2 , noncompacted/compacted ratio ≥3:1 ≥1 of segments 1 to 3 and 7 to 16 or ≥2:1 in at least 1 of segments 4 to 6 of the American Heart Association model. Outcome was a composite of thromboembolic events, heart failure hospitalizations, ventricular arrhythmias, and cardiac death., Results: At a mean follow-up of 48 ± 24 months, cardiac events (CEs) occurred in 36 patients (16 heart failure hospitalizations, 10 ventricular arrhythmias, 5 cardiac deaths, and 5 thromboembolic events). LV dilation, impaired LV ejection fraction, and LV-ncMM >20% was significantly more frequent in patients with CEs. LV fibrosis was detected by using LGE in 11 cases. CMR predictors of CEs were LV dilation and LGE. LGE was associated with improved prediction of CEs, compared with clinical data and CMR functional parameters in all 3 models. No CEs occurred in patients without dilated cardiomyopathy and/or LGE., Conclusions: In patients with LVNC evaluated by using CMR, the degree of LV trabeculation seems to have no prognostic impact over and above LV dilation, LV systolic dysfunction, and presence of LGE., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Despite expected improvement in left ventricular (LV) systolic and diastolic function after transcatheter aortic valve implantation (TAVI), the complex relationship between pre-existent LV systolic and diastolic function and changes in LV haemodynamics and clinical symptoms have been scarcely investigated. This study investigated the presence of pre-operative LV diastolic dysfunction and its improvement over time after TAVI alongside improvement in New York Heart Association (NYHA) class in high-risk patients with severe aortic stenosis., Methods and Results: The study population (n = 358) was divided into two groups according to baseline LV ejection fraction (LVEF): LVEF < 50% (n = 96) and LVEF ≥ 50% (n = 262). We compared clinical and echocardiographic parameters between groups before TAVI, at 6 and 12 months follow-up. Grade III LV diastolic dysfunction was more frequent in patients with LVEF < 50% compared with patients with LVEF ≥ 50% (50.0 vs. 16.3%, P < 0.001). Systolic and diastolic echocardiographic parameters improved after TAVI together with improvement in NYHA class both in patients with LVEF < 50% (diastolic dysfunction grade ≥2: baseline 100% of patients; 12 months 58.8%, P < 0.001; NYHA III/IV: baseline, 93.8%; 12 months, 9.7%, P < 0.001) and with LVEF ≥ 50% (diastolic dysfunction grade ≥2: baseline, 87.1%; 12 months, 61.2%; NYHA III/IV: baseline, 74.5%; 12 months, 2.6%, P < 0.001). All-cause mortality was comparable between groups., Conclusion: TAVI exerts favourable effects on LV systolic and diastolic function with a remarkable improvement in LV diastolic function associated with improvement in NYHA functional class at follow-up. Prognosis at 1 year after TAVI was not influenced by baseline LV diastolic dysfunction both in patients with and without LV systolic dysfunction., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Spontaneous coronary artery dissection (SCAD) accounts approximately for 0.2% of cases of acute coronary syndrome. It is defined "spontaneous" in absence of any coronary wall damage. This disease affects primarily young women in good health, with no risk factors for coronary artery disease, especially during the postpartum period. Since the clinical presentation varies widely from no symptoms to typical angina and sudden cardiac death, SCAD incidence is underestimated.A 40-year-old woman, in the 8th week after delivery, was admitted to our emergency department because of acute chest pain, and a diagnosis of inferior and posterior non-ST-elevation myocardial infarction was made. Emergency coronary angiography showed a small SCAD of the distal segment of a little marginal branch. Because of the small dimension of the dissection, optimal medical therapy was started. However, two days later, symptoms recurred and the ECG showed an anterior ST-elevation myocardial infarction. The patient was therefore transferred to the cath lab and coronary angiography showed extensive dissection of the left anterior descending coronary artery with good angiographic result. Percutaneous coronary intervention was performed and three drug-eluting stents were implanted.No retrospective studies or randomized clinical trials are available to guide the best treatment option in patients with SCAD, because of the wide variety of clinical presentation and the rarity of the pathology. Early and correct diagnosis of SCAD is key for adequate management. First, the site and precise quantification of lesion severity should be assessed with multiple angiographic projections. Intravascular ultrasound and optical coherence tomography can provide additional information about the entry point of the lesion. Hemodynamic status and extension of the myocardium at risk should be also evaluated to determine the best therapeutic strategy. Since the presence of SCAD may be associated with aneurysm formation and dissections of other arteries, screening of the arterial tree may be useful, especially of the supra-aortic trunks and splanchnic circulation.

Background: Computed tomography coronary angiography (cTCA) and stress cardiac magnetic resonance (stress-CMR) are suitable tools for diagnosing obstructive coronary artery disease in symptomatic patients with previous history of revascularization. However, performance appraisal of noninvasive tests must take in account the consequent diagnostic testing, invasive procedures, clinical outcomes, radiation exposure, and cumulative costs rather than their diagnostic accuracy only. We aimed to compare an anatomic (cTCA) versus a functional (stress-CMR) strategy in symptomatic patients with previous myocardial revascularization procedures., Methods and Results: Six hundred patients with chest pain and previous revascularization included in a prospective observational registry and evaluated by clinically indicated cTCA (n=300, mean age 68.2±9.7 years, male 255) or stress-CMR (n=300, mean age 67.6±9.7 years, male 263) were enrolled and followed-up in terms of subsequent noninvasive tests, invasive coronary angiography, revascularization procedures, cumulative effective radiation dose, major adverse cardiac events, defined as a composite end point of nonfatal myocardial infarction and cardiac death, and medical costs. The mean follow-up for cTCA and stress-CMR groups was similar (773.6±345 versus 752.8±291 days; P=0.21). Compared with stress-CMR, cTCA was associated with a higher rate of subsequent noninvasive tests (28% versus 17%; P=0.0009), invasive coronary angiography (31% versus 20%; P=0.0009), and revascularization procedures (24% versus 16%; P=0.007). Stress-CMR strategy was associated with a significant reduction of radiation exposure and cumulative costs (59% and 24%, respectively; P<0.001). Finally, patients undergoing stress-CMR showed a lower rate of major adverse cardiac events (5% versus 10%; P<0.010) and cost-effectiveness ratio (119.98±250.92 versus 218.12±298.45 Euro/y; P<0.001)., Conclusions: Compared with cTCA, stress-CMR is more cost-effective in symptomatic revascularized patients., (© 2016 American Heart Association, Inc.)

Background: Percutaneous mitral valve repair (PMVR) is an alternative treatment in patients with significant mitral regurgitation (MR) who are denied surgery. Although in surgical patients, outcomes have been related both to acute hemodynamic favorable results and to positive cardiac remodeling in the midterm, in the case of PMVR the effect on cardiac chamber remodeling has never been extensively studied. The aims of this study were (1) to evaluate the short- and mid-term remodeling induced by PMVR on cardiac chamber volume using two- and three-dimensional (3D) transthoracic echocardiographic (TTE) imaging and (2) to assess changes in left ventricular (LV) shape on the basis of 3D TTE data., Methods: Patients undergoing PMVR were prospectively enrolled. Two-dimensional and 3D TTE data sets acquired at baseline, and at 30 days and 6 months after PMVR were analyzed to assess LV and right ventricular (RV) volumes and ejection fraction and left atrial and right atrial volumes. Moreover, 3D endocardial surfaces were extracted to compute 3D shape indexes of LV sphericity and conicity at end-diastole and end-systole., Results: Six of the 64 enrolled patients did not reach follow-up and were excluded. The analysis was feasible in all 58 patients considered (26 with functional MR and 32 [55%] with degenerative MR). PMVR resulted in significant reduction of MR and in favorable remodeling: (1) effective PMVR was mainly associated with decreased LV loading, (2) PMVR-related reverse remodeling was observed in patients with degenerative MR and those with functional MR at 30 days and continued at 6-month follow-up, (3) favorable remodeling in LV shape from abnormally spherical to more normal conical took place in both groups after PMVR, and (4) RV volumes and systolic function were preserved after PMVR., Conclusions: A comprehensive two-dimensional and 3D TTE analysis allows investigation from a double perspective (volume and morphology) of the entity and modality of changes following PMVR. In high-risk patients undergoing PMVR, postprocedural heart remodeling involves all cardiac chambers, occurs in the short term, and further improves at midterm follow-up., (Copyright © 2016 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to determine the prognostic benefit of cardiac magnetic resonance (CMR) over transthoracic echocardiography (TTE) in ischemic cardiomyopathy and nonischemic dilated cardiomyopathy patients evaluated for primary prevention implantable cardioverter-defibrillator therapy., Methods and Results: We enrolled 409 consecutive ischemic and dilated cardiomyopathy patients (mean age: 64±12 years; 331 men). All patients underwent TTE and CMR, and left ventricle end-diastolic volume, left ventricle end-systolic volume, and left ventricle ejection fraction (LVEF) were evaluated. In addition, late gadolinium enhancement was also assessed. All patients were followed up for major adverse cardiac events (MACE) defined as a composite end point of long runs of nonsustained ventricular tachycardia, sustained ventricular tachycardia, aborted sudden cardiac death, or sudden cardiac death. The median follow-up was 545 days. CMR showed higher left ventricle end-diastolic volume (mean difference: 43±22.5 mL), higher left ventricle end-systolic volume (mean difference: 34±20.5 mL), and lower LVEF (mean difference: -4.9±10%) as compared to TTE (P<0.01). MACE occurred in 103 (25%) patients. Patients experiencing MACE showed higher left ventricle end-diastolic volume, higher left ventricle end-systolic volume, and lower LVEF with both imaging modalities and higher late gadolinium enhancement per-patient prevalence as compared to patients without MACE. At multivariable analysis, CMR-LVEF ≤35% (hazard ratio=2.18 [1.3-3.8]) and the presence of late gadolinium enhancement (hazard ratio=2.2 [1.4-3.6]) were independently associated with MACE (P<0.01). A model based on CMR-LVEF ≤35% or CMR-LVEF ≤35% plus late gadolinium enhancement detection showed a higher performance in the prediction of MACE as compared to TTE-LVEF resulting in net reclassification improvement of 0.468 (95% confidence interval, 0.283-0.654; P<0.001) and 0.413 (95% confidence interval, 0.23-0.63; P<0.001), respectively., Conclusions: CMR provides additional prognostic stratification as compared to TTE, which may have direct impact on the indication of implantable cardioverter-defibrillator implantation., (© 2016 American Heart Association, Inc.)

Importance: Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR)., Objective: To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR., Design, Setting, and Participants: The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015., Exposure: Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality., Main Outcomes and Measures: Infective endocarditis and in-hospital mortality after infective endocarditis., Results: A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients. Enterococci species and Staphylococcus aureus were the most frequently isolated microorganisms (24.6%; 95% CI, 19.1%-30.1% and 23.3%; 95% CI, 17.9%-28.7%, respectively). The in-hospital mortality rate was 36% (95% CI, 30.0%-41.9%; 90 deaths; 160 survivors), and surgery was performed in 14.8% (95% CI, 10.4%-19.2%) of patients during the infective endocarditis episode. In-hospital mortality was associated with a higher logistic EuroSCORE (23.1% vs 18.6%; odds ratio [OR], 1.03 per 1% increase; 95% CI, 1.00-1.05), heart failure (59.3% vs 23.7%; OR, 3.36; 95% CI, 1.74-6.45), and acute kidney injury (67.4% vs 31.6%; OR, 2.70; 95% CI, 1.42-5.11). The 2-year mortality rate was 66.7% (95% CI, 59.0%-74.2%; 132 deaths; 115 survivors)., Conclusions and Relevance: Among patients undergoing TAVR, younger age, male sex, history of diabetes mellitus, and moderate to severe residual aortic regurgitation were significantly associated with an increased risk of infective endocarditis. Patients who developed endocarditis had high rates of in-hospital mortality and 2-year mortality.

Purpose: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach., Methods: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups., Results: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up., Conclusion: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications., (© The Author(s) 2016.)

Background: It is still unclear how to exploit information made available by coronary computed tomography angiography (CCTA) on coronary artery disease (CAD) features in order to better predicting major adverse cardiac events (MACEs). Aim of this study was to validate the prognostic role of a comprehensive and simplified CT-derived score in patients evaluated for suspected CAD., Methods: A prospective registry included 477 consecutive symptomatic patients without known CAD who underwent clinically-indicated CCTA. All patients were followed-up for MACE occurrence for a period of 49±15-month., Results: The mean CT Score was 10.5±10.8, with a MACE rate of 11.3%. There was a stepwise relationship between MACE rate during follow-up and CT Score values. MACEs were 1.9% in patients with CT Score<10 (reference group), 16.6% in those with CT Score 10-20 (OR 9.9, 95% C.I. 3.5-27.8 vs. reference group, p<0.001), 24.5% in those with CT Score 21-30 (OR 16.6, 95% C.I. 6.1-45.0 vs. reference group, p<0.001), and 47.4% in those with CT Score>30 (OR 46.1, 95% C.I. 13.0-162.9 vs. reference group, p<0.001) (p for trend <0.001). At ROC curve analysis, CT Score was the best predictor of MACE (AUC: 0.81, CI 95%: 0.78-0.84) as compared to Diamond and Forrester score (p<0.001), segment stenosis score (p<0.05) and segment involved score (p<.0.01)., Conclusions: The use of an integrated score obtained with CCTA and based on the presence of remodeled and mixed atherosclerotic coronary plaques may improve MACE prediction in symptomatic patients at intermediate risk outweighing that provided by standard clinical and CCTA scores., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objectives: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs)., Background: The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled., Methods: The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT., Results: Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint., Conclusions: The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Acute kidney injury (AKI) has been associated with increased mortality in ST-segment elevation myocardial infarction. We compared the mortality predictive accuracy of the 3 AKI definitions used most widely for patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention., Methods and Results: We included 3771 patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention at 2 Italian hospitals. AKI incidence was evaluated according to creatinine increases of ≥25% (AKI-25), ≥0.3 mg/dL (AKI-0.3), and ≥0.5 mg/dL (AKI-0.5). The primary end point was in-hospital mortality. Overall, 557 (15%), 522 (14%), and 270 (7%) patients developed AKI-25, AKI-0.3, and AKI-0.5, respectively (P<0.01). All AKI definitions independently predicted in-hospital mortality (adjusted odds ratio 4.9 [95% CI 3.1-7.8], 5.4 [95% CI 3.3-8.6], and 8.3 [95% CI 5.1-13.3], respectively; P<0.01 for all). At receiver operating characteristic analysis, the addition of each AKI definition to combined clinical predictors of mortality (age, sex, left ventricular ejection fraction, admission creatinine, creatine kinase-MB peak) found at stepwise analysis significantly improved mortality prognostication (area under the curve increased from 0.89 for clinical predictor combination alone to 0.92 for AKI-25, 0.92 for AKI-0.3, and 0.93 for AKI-0.5; P<0.01 for all). At reclassification analysis, AKI-0.5 added to clinical predictors, provided the highest score in mortality (net reclassification improvement +10% versus AKI-0.3 [P=0.01] and +8% versus AKI-25 [P=0.05])., Conclusions: Each AKI definition significantly improved the mortality prediction beyond major clinical variables. AKI-0.5 showed a mortality discrimination advantage, suggesting it should be the preferred definition in studies addressing ST-segment elevation myocardial infarction and focusing on short-term mortality., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objectives: Dipyridamole stress cardiac magnetic resonance (CMR) evaluates the key phases (perfusion and wall motion) of the ischemic cascade. We sought to determine the prognostic value of dipyridamole stress-CMR in consecutive patients symptomatic for chest pain., Methods: Seven hundred and ninety-three consecutive patients symptomatic for chest pain underwent dipyridamole stress-CMR and were followed up for 810 ± 665 days. Patients were classified in group 1 (no- reversible ischemia), group 2 (stress perfusion defect alone), and group 3 [stress perfusion defect plus abnormal wall motion (AWM)]. End points were "all cardiac events" (myocardial infarction, cardiac death and revascularization) and "hard cardiac events" (all cardiac events excluding revascularization)., Results: One hundred and ninety-five (24 %) all cardiac events and 53 (7 %) hard cardiac events were observed. All and hard cardiac event rates in groups 1, 2, and 3 were 11 %, 49 %, 69 % and 4 %, 8 %, 21 %, respectively, with a higher rate in group 2 vs. group 1 (p<0.01) and group 3 vs. groups 1 and 2 (p<0.01). Multivariate analysis showed the presence of late gadolinium enhancement and stress perfusion defect plus AWM as independent predictors of all and hard cardiac events., Conclusions: Dipyridamole stress-CMR improves prognostic stratification of patients through differentiation between the different components of the ischemic cascade., Key Points: • Dipyridamole stress cardiac magnetic resonance helps to assess coronary artery disease. • Novel technique to study the key phases of myocardial ischemia. • Combined assessment of perfusion and motion defects. • Dipyridamole stress imaging has additional value for predicting cardiac events.

Background: Non-invasive stress tests are commonly used as gatekeepers to invasive coronary angiography (ICA) in patients with suspected coronary artery disease (CAD). New computed tomography angiography (CTA) techniques such as fractional flow reserve calculated by CTA (FFRCT) and stress myocardial computed tomography perfusion (CTP) have emerged as potential strategies to combine anatomical and functional evaluation of CAD in one technique. The aim of this study is to compare per-vessel diagnostic accuracy of FFRCT versus stress myocardial CTP for the detection of functionally significant coronary artery disease (CAD), using invasive FFR as the reference standard., Methods: Subjects with suspected CAD due to chest pain who have no contra-indications to FFRCT or stress myocardial CTP and who are referred for non-emergent, clinically indicated invasive coronary angiography (ICA), will be enrolled. A total of 300 subjects will be enrolled within 24 months., Results: The primary study endpoint will be the comparison of per-vessel diagnostic accuracy of CTA versus FFRCT versus stress myocardial CTP for the diagnosis of hemodynamically significant stenosis as defined by invasive FFR ≤0.80., Conclusions: In the PERFECTION study, the comparison between FFRCT and stress myocardial CTP will provide understanding about which technology is more accurate for the diagnosis of functionally significant CAD., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: Coronary CT angiography (CTA) is gaining widespread acceptance for the non-invasive evaluation of coronary arteries. However, radiation exposure and administration of iodinated contrast agents are still reasons of some concern. The 80 kV tube voltage increases the attenuation of iodine, allowing to use lower iodine concentration contrast agents for coronary CTA., Objective: We evaluated the diagnostic accuracy of coronary CTA performed with 64-slice scanner, 80 kV tube voltage, iterative reconstruction algorithm and ultra-low concentration contrast medium to reduce iodine load and radiation dose., Methods: We enrolled 45 patients with low body weight and indication for elective invasive coronary angiography (ICA). All patients received an 80 ml bolus of Iodixanol-270 at an infusion rate of 5 mL/s and underwent coronary CTA (80 kV and 500-550 mA) with prospective ECG-triggering. Image quality score, type of artifacts, coronary CTA evaluability, diagnostic accuracy and radiation exposure were assessed., Results: Pre-test probability of CAD was low-to-intermediate (48%). Accordingly, the prevalence of obstructive CAD was 47% (21 out of 45 patients). Most (93%) of the patients were pre-treated with intravenous metoprolol before scanning and achieved a heart rate suitable for prospective ECG-triggering coronary CTA (53 ± 3 bpm). The mean effective dose and iodine load were 1.1 ± 0.4 mSv and 21.6 gI, respectively. We rated 443 out of 720 coronary segments as being of excellent image quality. In a segment-based model, coronary evaluability (number of coronary segments evaluable/total number of coronary segments), was 97% (699/720 segments). In a segment-based analysis, sensitivity, specificity, positive predictive value, negative predictive value and accuracy for >50% coronary stenosis identification vs. ICA were 89%, 99%, 89%, 99% and 99%, respectively. In a patient-based analysis, sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 94%, 89%, 83%, 96% and 91%, respectively., Conclusions: In patients with low body weight, image quality and diagnostic accuracy of ultra-low radiation dose and low-iodine load coronary CTA are good and similar to values reported in the literature for standard tube voltage and iodine load protocols., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices., Background: It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb., Methods: Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks., Results: Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm(2) vs. 4.27 mm(2), respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation., Conclusions: At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs., Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs)., Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA., Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004)., Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)