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BACKGROUND: Intravascular ultrasound (IVUS) was only rarely used in landmark trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel disease. OBJECTIVES: The authors aimed to evaluate clinical outcomes after optimal IVUS-guided PCI in patients undergoing multivessel PCI. METHODS: The OPTIVUS (OPTimal IntraVascular UltraSound)-Complex PCI study multivessel cohort was a prospective multicenter single-arm study enrolling 1, 021 patients undergoing multivessel PCI, including left anterior descending coronary artery using IVUS, aiming to meet the prespecified criteria (OPTIVUS criteria: minimum stent area > distal reference lumen area [stent length≥28mm], and minimum stent area >0.8× average reference lumen area [stent length

Recent retrospective investigations have suggested that optical coherence tomography (OCT) enables the diagnosis of underlying acute coronary syndrome (ACS) causes such as plaque rupture, plaque erosion, and calcified nodule. The relationships of these etiologies with clinical outcomes, and the clinical utility of OCT-guided primary percutaneous coronary intervention (PCI) are not systematically studied in real-world ACS treatment settings.The TACTICS registry is an investigator-initiated, prospective, multicenter, observational study to be conducted at 21 hospitals in Japan. A total of 700 patients with ACS (symptom onset within 24 h) undergoing OCT-guided primary PCI will be enrolled. The primary endpoint of the study is to identify the underlying causes of ACS using OCT-defined morphological assessment of the culprit lesion. The key secondary clinical endpoints are hazard ratios of the composite of cardiovascular death, non-fatal myocardial infarction, heart failure, or ischemia-driven revascularization in patients with underlying etiologies at the 12- and 24-month follow-ups. The feasibility of OCT-guided primary PCI for ACS will be assessed by the achievement rates of optimal post-procedural results and safety endpoints.The TACTICS registry will provide an overview of the underlying causes of ACS using OCT, and will reveal any difference in clinical outcomes depending on the underlying causes. The registry will also inform on the feasibility of OCT-guided primary PCI for patients with ACS.

Although the simple single stenting rather than complex double stenting is recommended on percutaneous coronary intervention (PCI) for bifurcation lesions, double stenting cannot always be avoided. We investigated the impact of directional coronary atherectomy (DCA), followed by drug-coated balloon (DCB) treatment to reduce the number of stents and avoid complex stenting in PCI for bifurcation lesions and short-term patency. DCA treatment without stents was attempted for 27 bifurcation lesions in 25 patients, of those, 26 bifurcation lesions in 24 patients were successfully treated and 3-month follow-up angiography and optical coherence tomography (OCT) were performed. Sixteen lesions (59.3%) were related to left main trunk distal bifurcations, and 7 (25.9%) were true bifurcation lesions. Among the true bifurcation lesions, 4 lesions (57.1%) needed 1 stent, and the other 3 lesions (42.9%) needed no stents. Among the non-true bifurcation lesions, 1 lesion (5.0%) needed bailout stent and other lesions (95.0%) needed no stents. According to DCA followed by DCB treatment, the angiographic mean diameter stenosis improved from 65.5 ± 15.0% to 7.8 ± 9.8%, and the mean plaque area in intravascular ultrasound improved from 80.4 ± 10.5% to 39.0 ± 11.5%, respectively. Angiographic and OCT late lumen loss values were 0.2 ± 0.6 mm and 1.4 ± 1.9 mm, respectively. No patient had in-hospital major adverse cardiac events (MACE) and 3-month MACE. In conclusion, compared with standard provisional side branch stenting strategy, DCA followed by DCB treatment might reduce the number of stents, avoid complex stenting for major bifurcation lesions and provide good short-term outcomes.

Purpose Optical coherence tomography (OCT) is recommended to be the most appropriate modality in assessing calcium thickness, however, it has limitations associated with infrared attenuation. Although coronary computed tomography angiography (CCTA) detects calcification, it has low resolution and hence not recommended to measure the calcium size. The aim of this study was to devise a simple algorithm to estimate calcium thickness based on the CCTA image. Methods Consecutive patient who had CCTA for suspected coronary artery disease and subsequently went on to have OCT were included in the study. Calcium CT density was collected from CT profile curve. The method to estimate calcium thickness was devised from maximum CT density within the calcification and compared to the measured calcium thickness by OCT. The accuracy of this method was compared to full width at half maximum (FWHM) or inflection point (IP) method. Results A total of 68-patients (238-lesions) divided into derivation and validation dataset at 2:1 ratio (47 patients with 159 lesions and 21 with 79, respectively) were analyzed. Maximum Calcium density and measured calcium-border CT density had a good correlation with a linear equation of y = 0.58x + 201 (r = 0.892, 95% CI: 0.855–0.919, p 2 = 0.481 and 0.527, 95% CI: 0.609–0.842 and 0.497–0.782, p

OBJECTIVE Dobutamine stress echocardiography (DSE) is not always feasible in patients with low-gradient severe aortic stenosis (LG-SAS), and there are limited data available on the resting echocardiographic predictors for true-severe aortic stenosis (TSAS). This study investigated resting echocardiographic predictors for TSAS. METHODS Clinical data of 106 LG-SAS patients who underwent DSE were retrospectively analyzed. LG-SAS was defined as an aortic valve area index (AVAi)

Vascular inflammation, lipid metabolism, and thrombogenicity play a key role not only in atherogenesis but also in the development of acute coronary syndromes. Biomarkers associated with coronary high-risk plaques defined according to intravascular imaging have not been systematically studied. A total of 69 patients with coronary artery disease who underwent both optical coherence tomography and intravascular ultrasound imaging, and who provided blood specimens were included. Comprehensive biomarkers for inflammation, lipid, and coagulation were analyzed. Composite models sought biomarker patterns associated with thin-cap fibroatheroma (TCFA) and "high-risk plaques" (TCFA and large plaque burden). Two different composite models were developed for TCFA, based on the finding that high sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor-1, fibrinogen, IL-6, homocysteine and amyloid A levels were elevated, and high-density lipoprotein cholesterol (HDL) and bile acid levels were decreased in these patients. Both composite models were highly accurate for detecting patients with TCFA (area under curve [AUC]: 0.883 in model-A and 0.875 in model-B, both p 0.001). In addition, creatinine, hsCRP, fibrinogen, tumor necrosis factor-α, IL-6, homocysteine, amyloid A, HDL, prothrombin, and bile acid were useful for detecting patients with "high-risk plaques". Two composite models were highly accurate for detection of patients with "high-risk plaques" (AUC: 0.925 in model-A and 0.947 in model-B, both p 0.001). Biomarkers useful for detection of patients with high-risk coronary plaques defined according to intravascular imaging have been identified. These biomarkers may be useful to risk stratify patients and to develop targeted therapy.Clinical Trial Registration https://www.umin.ac.jp/ctr/ , UMIN000041692. Biomarkers and high-risk plaques hsCRP, PAI-1, fibrinogen, IL-6, homocysteine, amyloid A, HDL, and bile acid were useful for detecting patients with TCFA. hsCRP, fibrinogen, IL-6, homocysteine, amyloid A, creatinine, TNFα, HDL, prothrombin, and bile acid were useful for detecting patients with "high-risk plaques" (plaque which has both TCFA and large plaque burden). White arrowhead denotes TCFA. Red and green dashed lines denote lumen area and external elastic membrane area, respectively.

There are scarce data about the incidence and impact on clinical outcomes of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) in current generation drug eluting stent (cDES) era.We evaluated the incidence and impact on clinical outcomes of TLR after PCI using cDES for ULMD.We identified 720 patients treated with cDES for ULMD at New Tokyo Hospital (Matsudo, Japan), San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus (Milan, Italy) between January 2005 and December 2015. We divided those patients in 2 groups; TLR group (n = 107), no TLR group (n = 613). The TLR group was comprised patients undergoing a repeat revascularization by PCI or coronary artery bypass grafting of the target lesion. Analysis using propensity score adjustment was also performed. The primary endpoint was cardiac mortality. Additionally, we analyzed the impact of TLR for each main branch (MB) or side branch on cardiac mortality using multivariate Cox regression analysis.Cardiac mortality was significantly higher in TLR group than in no TLR group (adjusted HR 1.96; 95 % CI, 1.50-3.62; p = 0.032). Cardiac mortality was also significantly higher in TLR group after propensity score adjustment. TLR for MB was identified as an independent predictor of cardiac death on multivariate Cox regression analysis.The TLR, especially the TLR for MB, after PCI even with cDES for ULMD, was strongly associated with worse cardiac mortality.

Background. Moderate aortic stenosis (AS) increases left ventricular afterload and results in unfavorable outcomes in patients with reduced left ventricular ejection fraction (LVEF). Velocity ratio...

Nonagenarians represent only a small proportion of patients included in large transcatheter aortic valve replacement (TAVR) trials, but will become a relevant future population in need of treatment due to demographic change. Thus, this study sought to evaluate outcomes of TAVR for the treatment of severe aortic stenosis (AS) in nonagenarian patients.We screened Medline/Pubmed for studies that stated specific outcomes for nonagenarians undergoing TAVR. A weighted meta-analysis was conducted, calculating pooled estimate rates using a binary random-effects model for dichotomous variables, and comparing non-dichotomous outcomes with a continuous random-effects model.Data from 23 studies including 16,094 nonagenarians were merged; 53.4% were women. Despite reasonable rates of comorbidities, Society of Thoracic Surgeons mortality risk score was 10.2 ± 5.4. Pooled estimate rate of procedural success was 94.1% (95% confidence interval [CI], 91.7-96.6), with major vascular complications occurring in 6.3% (95% CI, 2.7-9.8) and at least moderate postprocedural paravalvular leak in 7.5% (95% CI, 4.4-10.6). The rate of periprocedural stroke or transient ischemic attack was 2.6% (95% CI, 2.0-3.2). At 30 days, the pooled estimate of mortality was 6.1% (95% CI, 4.7-7.4) and a permanent pacemaker was implanted in 12.6% (95% CI, 7.6-17.6). After 1 year, the mortality rate was 20.5% (95% CI, 15.9-25.1).TAVR in nonagenarians is an effective and safe procedure, with encouraging outcomes given the general life expectancy of these patients. Currently, only selected nonagenarians are undergoing TAVR, but their number will grow as life expectancy continues to increase in the developed world. Specific research to identify ideal candidates and techniques in this cohort is needed.

Objectives The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO). Background CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication. Methods In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR. Results To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p Conclusions Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.

Refractory angina is a growing problem, predominantly due to advanced coronary artery disease, associated with a reduced quality of life and an increased hospitalisation rate with a corresponding impact on healthcare resources. There is an unmet clinical need to be addressed by novel therapeutic approaches. Over the last few years, a treatment approach causing a controlled coronary sinus narrowing by implantation of a balloon-expandable, hourglass-shaped, stainless steel mesh (i.e., the coronary sinus Reducer) has arisen with promising initial short-term and midterm results, in terms of reducing angina and ischaemia burden and improving quality of life. Guidance with proper implantation algorithms and knowledge on how to address potential complications will improve interventional outcomes and foster a wider application of this novel therapeutic approach. In this review, we summarise the implantation technique, the causes of potential complications, and algorithms focusing upon their practical management, based on the experience of the authors.

We systematically categorized the longer-term (>= 3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 +/- 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised insegment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p

Limited data are available about the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after percutaneous coronary intervention (PCI). This study aimed to assess the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after PCI. We identified 1,391 patients treated with drug-eluting stent for unprotected left main distal bifurcation lesions (ULMD), including 604 without calcified lesions (noncalcified left main group) and 787 with calcified ULMD (calcified left main group) in Japan and Italy. We divided the calcified group into the following 2 groups: estimated glomerular filtration rate (eGFR) ≥30 (n = 687) and30 (n = 100) and compared the clinical outcomes. The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. TLF occurred more frequently in the calcified group (adjusted hazard ratio 1.36, 95% confidence interval 1.08 to 1.71, p = 0.01), especially in calcified ULMD with eGFR30 (adjusted hazard ratio relative to the other 2 groups 2.59, 95% confidence interval 1.60 to 4.18, p0.001). In conclusion, the calcified ULMD treated with PCI was associated with poorer clinical outcomes than noncalcified ULMD, especially in those with eGFR30.

Background Ventricular‐arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end‐systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular‐arterial coupling. We aimed to determine the prognostic value of ventricular‐arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN‐TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: 0.666) during the midterm follow‐up after transcatheter aortic valve replacement. During a median follow‐up period of 736 days (interquartile range, 414–956), there were 247 (17.9%) all‐cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08–2.87 [ P =0.024]), group 3 (HR, 2.43; 95% CI, 1.53–3.86 [ P P P =0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow‐up. Registration URL: https://www.upload.umin.ac.jp/ . Unique identifier: UMIN000020423.

Objectives This study evaluated the 5-years outcomes of intracoronary imaging-guided proximal optimization technique (POT) for percutaneous coronary intervention (PCI) in patients with unprotected left main distal bifurcation lesions (ULMD). Background The long-term effects of POT with intracoronary imaging guide in PCI for ULMD have been unclear. Methods Between January 2005 and December 2015, we identified 1832 consecutive patients who underwent DES implantation for ULM distal bifurcation lesions. Of them, 780 (56.1%) patients underwent POT with intravascular imaging guidance (optimal expansion group). Residual 611 (43.9%) patients did not undergo either POT or intravascular imaging or both (suboptimal expansion group). Analysis using propensity score adjustment was performed. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. Results TLF rate at 5 years was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004]. Cardiac mortality was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.46, 95% CI (0.27-0.79), p = 0.004]. The multivariable analysis identified POT with intravascular imaging guide [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004] as an independent predictor of TLF. Conclusions Intravascular imaging guided POT was strongly associated with the reduced risk of TLF at 5 years after PCI for ULMD, mainly driven by reducing cardiac mortality.

Background There are no available data about clinical outcomes of simple stenting for ostial left circumflex (LCX) lesions using current generation drug-eluting stents (cDES). Objective We assessed clinical outcomes after simple stenting using cDES for ostial LCX lesions. Methods We identified 81 consecutive patients who underwent PCI using cDES for ostial LCX lesions at New Tokyo Hospital, Matsudo, Japan between January 2010 and December 2016. An ostial LCX lesion was defined as a lesion with more than 75% stenosis by visual assessment and within 3 mm of the left main (LM) stem. The primary endpoint was target lesion failure (TLF). TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Additionally, we also assessed the revascularization for LM to left anterior descending artery (LAD) after ostial LCX stenting. Results The TLF rate at 3 years after PCI was 24.5%. Furthermore, the rate of TLR and revascularization for LM-LAD after ostial LCX stenting were significantly higher in patients who were previously undergone stent implantation in ostial segment of LAD. Conclusion Clinical outcomes after cDES implantation for ostial LCX lesion could be acceptable. However, it could have better to be avoided in patients who previously received stent implantation in ostial segment of LAD.

Objectives The aims of this study were to evaluate the long-term clinical outcomes after coronary covered stent (CS) implantation and to compare the results according to the indications. Background To date, data on the long-term follow-up of coronary CS are limited, and no studies have been conducted to compare outcomes on the basis of specific lesions treated. Methods A total of 190 consecutive patients (212 lesions) implanted with CS and surviving until discharge between May 1997 and February 2017 were enrolled in this retrospective study. Clinical outcomes were evaluated and compared using the Gehan-Breslow-Wilcoxon test. Results CS was mainly used for the treatment of a saphenous vein graft (SVG) (51.4%), followed by coronary artery perforation (CAP) (25.0%) and coronary artery aneurysm (CAA) (11.8%). The median follow-up duration was 6.0 (interquartile range: 1.6-13.5) years. Target vessel myocardial infarction (MI), target vessel occlusion, target lesion revascularization, and stent thrombosis, frequently occurred in the early follow-up period (7.3%, 16.6%, 21.5%, and 8.9% at 1 year, respectively) and continued to increase throughout the long-term follow-up (14.8%, 38.6%, 38.7%, and 17.8% at 10 years, respectively). Target vessel occlusion, target vessel MI, and ST were not identified in CAA with superiority to CAP (Gehan-Breslow-Wilcoxon p-value = 0.010, 0.047, and 0.046, respectively). SVG had a higher rate of target vessel occlusion than CAA (p = 0.004). Conclusions Clinical events after CS implantation frequently occurred in the early period and steadily increased in the long-term period. CS implantation in CAA was associated with fewer adverse cardiac events and may lead to safe and acceptable outcomes. However, CS implanted in CAP and SVG are associated with a high risk of long-term cardiac events.

Highlights • Limited data on intra-stent CTO. • We explored the long-term outcomes in patients undergoing PCI to intra-stent CTO. • Acceptable rates of hard endpoints (cardiac death; 5.8%, TVMI; 4%). • High rates of TLR (45.6%). • PCI should only be undertaken if symptomatic or if there is inducible ischaemia. • If PCI is undertaken, DCB and DES should be considered over POBA., Background Angioplasty for ISR remains a challenge with relatively high rates of recurrence. Although there is a plethora of data on ISR, there is relatively less data on intra-stent-CTO. In this study, we explore the long-term clinical outcomes following angioplasty to intra-stent CTO and study the differences in clinical outcomes between three treatment-arms: POBA vs. DES vs. DCB. Methods and results We evaluated all patients who underwent PCI to intra-stent CTO between 2011 and 2017. The endpoints used were: cardiac-death, TVMI, TLR, TVR, and MACE. During the study period, 403-patients with a mean age of 69.2 years had successful PCI to intra-stent CTO. 50% were diabetic, 38% had CKD and 32% had left ventricular dysfunction. 93% of cases were stable angina. 22% (n = 88) received only POBA, 28% (n = 113) received DCB and 50% (n = 202) received DES. During the median follow-up of 48-months, cardiac-death occurred in 5.8% (n = 23), TVMI in 4% (n = 16), TLR in 45.6% (n = 182), TVR in 48.7% (n = 194) and MACE of 46%. There were no differences in the hard endpoints between the 3treatment arms. However, the TLR and overall MACE were better in DCB and DES-groups as compared to POBA (TLR: 33%vs.42%vs.49%; p = 0.06); MACE (34% vs. 45% vs. 52%; p = 0.05). Conclusion This is the first study that has focussed on the outcomes following angioplasty to intra-stent CTOs with a very long-term follow-up. The hard endpoints were low, although the TLR rates were high. In regards to treatment strategy, the DCB and DES provide relatively better outcomes than POBA.

International audience; Background: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed.Methods: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents.Results: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI.Conclusions: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.

Background The clinical impact of stent strut thickness in coronary bifurcation lesions in small vessels has not been assessed in a real-world population. Methods and results All 506 patients enrolled in the RAIN study, undergoing PCI in a vessel with a diameter 2.5 mm or less were retrospectively evaluated and divided into two groups according to stent strut thickness: 74 μm (n = 206) versus 81 μm (n = 300); 87.1% of the lesions involved bifurcations. TLF [defined as a composite of myocardial infarction (MI) and target lesion revascularization (TLR)] was the primary endpoint, with MACE (a composite of death, MI and TLR), its components and stent thrombosis the secondary endpoint. After 16 (14-18) months, a lower incidence of TLF (4.3 vs. 9.8%, P = 0.026) and ST (1.0 vs. 3.0%, P = 0.042) was seen in the 74 μm group, whereas MACE occurred in 60 of 506 patients, with no statistical difference between the two groups (9.7 vs. 13.3%, P = 0.070). At multivariate analysis, chronic renal failure increased the risk of TLF while thinner strut was an independent protective factor (hazard ratio 0.51, CI 0.17-0.85, P = 0.005). Conclusion In this real-world population, patients being treated for small vessels lesions with thinner strut stents had lower rates of TLF, MI and ST.

Objectives. To investigate the relationship between the eccentric calcification of aortic valve and transcatheter heart valve (THV) distortion and the impact of THV distortion on echo parameters and clinical outcomes. Background. The effects of eccentric calcification of the aortic valve on the THV distortion and the relationship between THV distortion and clinical impact were not fully understood. Methods. Patients with symptomatic severe aortic stenosis who were undergoing THV implantation were enrolled. Patients underwent preprocedural, postprocedural multislice computed tomography (MSCT), and follow-up transthoracic echocardiogram (TTE). Delta calcium score (ΔCS) is defined as the difference between the maximum and minimal calcium scores of the three cusps, while valve distortion score (VDS) is defined as the difference between the longest and shortest stent frame, as obtained using MSCT. Patients were divided into two groups according to ΔCS: “noneccentric calcification group” and “eccentric calcification group.” Results. A total of 118 patients were enrolled (59 patients in noneccentric and 59 in eccentric calcification groups). VDS was significantly lower in the noneccentric calcification group than in the eccentric calcification group (1.31 ± 0.82 mm vs. 1.73 ± 0.76 mm, p = 0.004 ). VDS was not associated with the degree of paravalvular leak (PVL) and aortic valvular mean pressure gradient (AVPG) at 30-day and 1-year follow-up TTE and the cumulative rates of all-cause death and rehospitalization at 2-year clinical follow-up. Conclusions. Eccentric valvular calcification was associated with longitudinal THV distortion. However, THV distortion was not associated with PVL, AVPG, and adverse clinical events during midterm follow-up.

OBJECTIVES We assessed the impact of pre-percutaneous coronary intervention (PCI) bifurcation angle change (BAC) on clinical outcomes. BACKGROUND There are little available data about the impact of BAC in unprotected left main distal bifurcation lesions (ULMD) PCI. METHODS We identified consecutive 300 patients with ULMD underwent complex stenting using drug-eluting stent in three high-volume centers (Tokyo and Milan). We measured the widest BA of ULMD at both end-diastole and end-systole before stenting with two-dimensional quantitative coronary angiographic assessment and calculated the BAC value as a difference of two BA value in each lesion. We divided them into small and large BAC group according to the median BAC value (7.2°). The primary endpoint was target lesion failure (TLF), which was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction. RESULTS TLF rate at 3-year was significantly higher in the large BAC group than in the small BAC group (adjusted hazard ratio [HR] 5.85; 95% confidence interval [CI], 3.40-10.1; p

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention for unprotected left main distal bifurcation lesions in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent era. We identified 512 consecutive DM patients who underwent percutaneous coronary intervention for unprotected left main distal bifurcation lesions at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR60), moderate CKD (30 ≤ eGFR45), and severe CKD (15 ≤ eGFR30). The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. The rate of TLF was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 3.64, [1.86 to 7.11], p0.001). Cardiac mortality was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 6.43, [2.19 to 18.9], p = 0.001). Target lesion revascularization rate was comparable in 4 groups (Adjusted HR of severe CKD relative to the others 1.71, [0.60 to 4.82], p = 0.31). In conclusions, in DM patients, those with severe CKD was extremely associated with worse clinical outcomes.

Background There are only little data available on the comparison of clinical outcomes between a early generation drug eluting stent (eDES) and a current generation drug eluting stent (cDES) for percutaneous coronary intervention (PCI) with double stent strategy (DSS) for unprotected distal left main disease (ULMD). Methods Between April 2005 and December 2015, we recruited 452 consecutive ULMD patients treated with DSS (eDES, 236 patients; cDES, 216 patients). In this study, eDES included Cipher, Taxus, and Endeavor and cDES included Ultimaster, Resolute family, Xience family, Promus family, Synergy, and Nobori. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI) during the median follow-up period of 1,809(IQR: 1,190-2,510) days. Results In entire population, the rate of overall TLR was significantly lower in cDES group than that in eDES group (adjusted HR 0.62, 95% CI 0.40-0.96, p = .032). The rate of TLR for the ostium of LCX was significantly lower in cDES group than that in eDES group (adjusted HR 0.63, 95% CI 0.39-0.99, p = .047). Cardiac mortality, the rate of TLR for LM-LAD, MI and definite/probable ST did not significantly differ between both groups. The results were preserved in the propensity adjusted population. Conclusions cDES significantly improved the clinical outcomes in population treated with DSS mainly driven by the reduction of TLR for the ostium of LCX.

Aims: We assessed clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) distal bifurcation lesions using drug-eluting stents (DES) in hemodialysis (HD) patients compared to non-HD patients. Methods and Results: We identified 1,858 consecutive patients who underwent PCI for ULMCA distal bifurcation lesions at 4 high-volume centers in Japan, Italy, and Taiwan between January 2005 and December 2015. Of them, 1,416 patients were treated with DES including 113 HD patients and 1,303 non-HD patients. The primary end point was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. HD patients were more likely to be younger and have diabetes mellitus, dyslipidemia, peripheral artery disease, lower ejection fraction, and higher EuroSCORE. TLF rate at 3 years was significantly higher in HD group than in non-HD group (adjusted hazard ratio [HR] 2.43 [1.75–3.38], p < 0.001). Cardiac mortality and TLR rate were also significantly higher in HD group than in non-HD group (adjusted HR 3.85 [2.34–6.34], p < 0.001, and HR 2.10 [1.41–3.14], p < 0.001, respectively). Conclusions: HD was strongly associated with adverse cardiac events after PCI for ULMCA distal bifurcation lesions with DES.

Background: The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). Objective: We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. Methods: We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. Results: Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06–2.13; p = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63–1.95; p = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12–2.54; p = 0.012). Conclusion: DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (

International audience; Objectives: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents.Background: Clinical impact of structural features of contemporary stents remains to be defined.Methods: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (

Objectives This study aimed to predict the displacement of self-expanding transcatheter heart valves (THV) during final deployment. Background Accurate device positioning during transcatheter aortic valve implantation (TAVI) is crucial for optimal results. Methods At our institution, 103 patients who underwent transfemoral TAVI with Evolut R were retrospectively identified. Multiple linear regression models were created, and a predictor equation was built to quantify the factors that may affect THV behavior. Results Multiple linear regression analysis for THV displacement on the left coronary cusp (LCC) identified the angle between the THV and the ascending aorta (ATA), predilation, and less operator experience as independent predictors of upward displacement, whereas estimated glomerular filtration rate (eGFR) was inversely related with THV behavior (95% confidence interval: 0.219 to 0.340, 0.447 to 2.092, 0.165 to 1.757, and -0.053 to -0.011, respectively). Predictors of THV displacement on the noncoronary cusp side could not be identified using this model. Conclusions The ATA at the point of recapture, predilation, and less operator experience were independent predictors of upward displacement of THV on the LCC side. eGFR was an independent predictor of THV downward displacement on the LCC side. Of them, the ATA was the strongest predictor. Physicians may need to adjust this angle adequately before deployment to achieve the appropriate position.

A 52-year-old male underwent percutaneous coronary intervention (PCI) using rotational atherectomy (RA: 1.5-mm burr) for a severely calcified lesion in the proximal to mid obtuse marginal (OM) branch. Even with 7 Fr extra back-up guiding catheter via femoral access, the burr could not cross the lesion due to insufficient back-up support. In order to achieve stronger back-up support, we kept the burr at the position in the OM branch and placed a supportive wire in left anterior descending artery through the side of drive-shaft sheath of the Rotablator, which sufficiently stabilized the guiding catheter during the ablation and the burr crossed the lesion. This case demonstrates that a simple technique of placing additional supportive wire in the other vessel during RA could be an effective and safe solution to facilitate improved back-up support without necessity to change the PCI system used already.

Percutaneous coronary intervention relieves symptoms in patients with chronic ischemic heart disease resistant to optimal medical therapy and alters the natural history of acute coronary syndromes. However, adverse procedural outcomes may occur during the intervention. Knowledge of possible complications and their timely management are essential for the practicing cardiologist and can be life-saving for the patient. In this review, the authors summarize potential complications of percutaneous coronary intervention focusing on their practical management.

Candidates for percutaneous coronary revascularization are becoming progressively older and more complex. A combination of factors related to the patient, lesion, and/or hemodynamic conditions may increase the risk of adverse events. Therefore, when a high-risk procedure is identified, it is crucial to provide the patient with adequate support in order to safely perform percutaneous coronary intervention (PCI). We report the case of a 77-year-old man with moderate left ventricular dysfunction and stage IV chronic kidney disease who underwent successful recanalization of a chronically occluded left anterior descending artery. The procedure was performed with a micro-axial percutaneous left ventricular assist device (Impella 2.5) in order to provide stable hemodynamics, and with minimal contrast medium administration (14 ml) to minimize the risk of acute kidney injury. Despite the use of aggressive techniques (including rotational atherectomy), the patients remained stable throughout the procedure and did not experience contrast-induced nephropathy or periprocedural myocardial infarction, and was discharged two days later. Moreover, we provide recommendations to assist interventional cardiologist safely perform complex and high-risk PCI, with particular attention to renal function preservation.

Objective To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes. Background The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain. Methods Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention. Results Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57). Conclusions Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure.

Objectives This study sought to determine predictors of advanced conduction disturbances requiring late (≥48 h) permanent pacemaker replacement (PPM) after transcatheter aortic valve replacement (TAVR). Methods Data of consecutive patients were identified by retrospective review of a TAVR database of a single center in Milan, Italy, between October 2007 and July 2015. We defined delta PR (ΔPR) and delta QRS (ΔQRS) interval as the difference between the last PR and QRS length available 48 h after TAVR and the baseline PR and QRS length. Results Overall population included 740 patients. We excluded 78 patients who already had a PPM and 51 patients who received a PPM Conclusions This analysis showed that baseline right bundle branch block and the amount of increase of PR length after TAVR are independent predictors of late (≥48 h) advanced conduction disturbances requiring PPM replacement after TAVR in this cohort. A simple ECG analysis could help in detecting potentially lethal advanced conduction disturbances that could occur more than 48 h after TAVR.

Chronic total occlusion (CTO) accounts for 10-20% of lesions identified in coronary artery disease (CAD) patients. CTO percutaneous coronary intervention (PCI) is one of the most challenging of lesion subsets due to its technical difficulty, requiring specific operator expertise and equipment. There has been increased interest on CTO PCI evolving with the development of novel techniques and dedicated devices. Furthermore, in order to effectively and systematically utilize these techniques and devices, CTO PCI algorithms have been established. All of these developments have resulted in procedural success rates increasing to approximately 90%. In this review, we outline the evidence base for CTO PCI, conventional and contemporary CTO PCI techniques, CTO algorithms and outline integrated management strategies between cardiac surgeons and interventional cardiologists.

The impact of chronic kidney disease (CKD) and potential pharmacologic intervention on clinical outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) remains unknown. A total of 1,463 patients underwent successful CTO-PCI between August 2004 and December 2014. Major adverse cardiovascular events (MACE) defined as the composite of all-cause death, myocardial infarction and target lesion revascularization, cardiac death, and stent thrombosis were compared between patients with and without CKD (555 and 908 patients, respectively). The results demonstrated higher risks of MACE (log-rank p = 0.015), all-cause death (log-rank p

A 55-year-old male underwent percutaneous coronary intervention (PCI) for left anterior descending artery chronic total occlusion. After lesion preparation with non-compliant (NC) balloon, two bioresorbable vascular scaffolds (2.5/28 mm, 3.0/28 mm, Absorb BVS, Abbott Vascular, Santa Clara, CA, USA) were implanted followed by 1:1 sized NC balloon post-dilatation at 20 atm. Final intravascular ultrasound (IVUS) showed acceptable BVS expansion in diffusely calcified lesions. Twenty-one months’ follow-up coronary angiography revealed severe restenosis with reocclusion at the distal edge of the distal BVS. After recanalization with a 1.0 mm balloon, optical coherence tomography (OCT) was performed. Quantitative analysis comparing OCT and IVUS at the index procedure demonstrated that minimum scaffold area at follow-up became significantly smaller and with higher eccentricity, suggesting severe recoil at the lesions with thick calcium spot, whereas these changes were not observed at the lesion with relatively thin calcification. The lesions were successfully revascularized with drug-eluting stents and final OCT showed symmetric expansion of metallic stents. Our case demonstrates that different types of calcification can have an impact on BVS expansion and recoil. In calcified lesions, an optimal implantation technique is mandatory to achieve the best possible results, and characterization of calcified lesions with intravascular imaging may be helpful to decide PCI strategy with BVS.

Objectives The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. Background The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Methods Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy. Results Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p Conclusions In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization.

Background There are only a limited number of studies comparing clinical outcomes after treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with early (E-) and new (N-) generation drug-eluting stents (DES). Methods From January 2005 to December 2013, 334 de novo RCA AO lesions treated with DES (E-:142 lesions, N-:192 lesions) at 2 high-volume centers (Italy and Japan) were included in this study. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction, and target lesion revascularization (TLR). Results Baseline and lesion characteristics were well balanced between the 2 groups. The size of the stents deployed (3.35±0.37mm vs 3.39±0.33mm, p=0.29) and non-compliant balloons used for post-dilatation (3.55±0.38mm vs 3.62±0.47mm, p=0.21) were similar between the two groups. The median follow-up period was 1432 (IQR: 703-2197) days in total population. The cumulative rate of TLF at 3years was significantly higher in E-DES group when compared with N-DES group (37.7% vs 14.2%, p Conclusion For the treatment of RCA AO lesions, N-DES were associated with a lower incidence of TLF at 3years when compared with E-DES. N-DES use and suboptimal implantation characteristics were independent predictors of TLF.

Coronary sinus Reducer represents a novel therapeutic option for refractory angina. As emerging evidence of both reduction in angina symptoms and reduction of myocardial ischemia burden might lead to increased Reducer implantations, knowledge on how to manage potential complications is of clinical importance. We report a successful management of scaffold migration in right atrium.