Isolated Coronary Arteritis Treated With FDG-PET/CT-Guided Immunosuppressant to Break the Vicious Cycle of In-Stent Restenosis.

Recurrent in-stent restenosis of the coronary artery is a rare but intractable problem. In this situation, coronary arteritis should be considered as an etiology. This case highlights the use of immunosuppressive drugs, including tocilizumab, and follow-up F-18-fluorodeoxyglucose positron emission tomography/computed tomography to break the vicious circle of recurrent stenosis caused by isolated coronary arteritis of unknown cause.

The Effect of Aggressive Wire Recanalization in Calcified Atheroma and Dilatation (ARCADIA) Technique in Eccentric Calcified Lesion of No-stenting Zone.

PURPOSE: The endovascular approach for eccentric calcified lesions of the no-stenting zone is challenging. This study aimed to investigate the effect of a novel technique for these lesions. METHODS: We performed EVT for severe and eccentric calcified lesions using the technique, which is presented previously and named aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA). In brief, a guidewire is passed to the residual lumen firstly. Next, another guidewire is advanced into and cross through the calcified plaque and returned to the distal original lumen with intravascular ultrasound (IVUS) guided. The calcified plaque is dilated by using a scoring-balloon or non-compliant balloon. RESULTS: Consecutive 14 peripheral artery disease patients with isolated and eccentric calcification in a no-stenting zone were treated using ARCADIA technique between January 2018 and March 2020. In IVUS data, lumen cross-section area was significantly increased from 5.2 ± 2.0 mm2 to 18.1 ± 6.9 mm2 (p < 0.01), lumen area was expanded roundly evaluating as symmetry index from 0.45 ± 0.09 to 0.81 ± 0.12 (p < 0.01). There were no distal embolization and perforation after ARCADIA technique. One-year target lesion revascularization occurred in only 2 cases. The primary patency of 1 year was 85.7%. CONCLUSION: ARCADIA technique is safe and appropriate, and can be 1 option to treat for eccentric calcified lesions of the no-stenting zone as an optimal wire crossing method.

Impact of Optimal Preparation Before Drug-Coated Balloon Dilatation for De Novo Lesion in Patients With Coronary Artery Disease.

BACKGROUND: Drug eluting stent (DES) remain several problems, including stent thrombosis, stent fracture and neoatherosclerosis. Stent-less Percutaneous coronary intervention (PCI) using a drug coated balloon (DCB) is a stent-less strategy, and several trials have supported the efficacy of DCB. However, the optimal preparation before using DCB was uncertain. The aim of this study was to investigate the optimal preparation for plaque oppression/debulking before DCB dilatation for de novo coronary artery lesion. METHODS: A total 936 patients were treated using DCB from 2014 to 2017 at our institution. Among them, we analyzed 247 patients who underwent PCI using DCB alone for de novo lesion. The primary end point of this study was target lesion failure (TLF). RESULTS: The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the optimal cutoff value of % plaque area to predict TLF. ROC curve analysis revealed plaque area ≥ 58.5% (AUC, 0.81) were associated with TLF. Eligible 188 patients were divided into 2 groups (plaque area ≥ 58.5% [n = 38] and <58.5% [n = 150]) according to IVUS data before using DCB. TLF was significantly higher in plaque area ≥ 58.5% group than in <58.5% group (P < 0.01). Multivariable analysis selected plaque area ≥ 58.5% as an independent predictor of TLF (hazard ratio 7.59, P < 0.01). CONCLUSIONS: Lesion preparation achieving plaque area < 58.5% was important in stent-less PCI using DCB.

Incidence and Predictive Factors of Chronic Vessel Enlargement After Percutaneous Coronary Intervention for Severely Stenotic and Occluded Lesions.

BACKGROUND: Chronic vessel enlargement (CVE) of the coronary artery is observed in patients who undergo percutaneous coronary intervention (PCI) for severely stenotic or occluded lesions. Recently, the presence of a peri-medial high-echoic band (PHB) identified by intravascular ultrasound (IVUS) has been reported to correlate with this phenomenon. We sought to assess the incidence, predictive factors of CVE, and association between CVE and PHB. METHODS: From January 2017 to December 2018, 97 patients, with 101 severely stenotic and occluded lesions, who underwent IVUS-guided PCI and a 9-month follow-up angiography were enrolled. CVE was defined as more than a 10% increase of distal lumen gain at follow-up angiography. All lesions were stratified into 2 groups: CVE group and non-CVE group. Clinical outcomes were compared and predictive factors for CVE were assessed. Relationships between PHB angle and CVE were also assessed. RESULTS: At follow-up angiography, CVE was observed in 27 lesions (26.7%, 27/101). PHBs were frequently observed in the CVE group (88.9%), which was significantly higher than that in the non-CVE group (40.5%). The multivariate logistic regression analysis revealed that the presence of PHB was the only predictive factor for CVE (odds ratio, 11.3; 95% confidence interval, 2.95-43.0; p < 0.001). In addition, a linear relationship was observed between the incidence of CVE and PHB angle. The number of patients with CVE significantly increased in cases with a PHB angle more than 180 degrees. CONCLUSIONS: The presence of PHB strongly predicts CVE after PCI for severely stenotic or occluded lesions.

Current status of hybrid intravascular ultrasound and optical coherence tomography catheter for coronary imaging and percutaneous coronary intervention.

Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) play a crucial role in elucidating the pathophysiology of coronary artery disease (CAD) with the goal to improve patient outcomes of medical and/or interventional CAD management. However, no single intravascular imaging technique has been proven to provide complete and detailed evaluation of all CAD lesions due to some limitations. Although sequential use of multiple modalities may sometimes be performed, there may be issues related to risk, time, and cost. To overcome these problems, several hybrids involving dual-probe combined IVUS-OCT catheters have been developed. The aim of this review article is to demonstrate some limitations of stand-alone imaging devices for evaluation of CAD, summarize the advances in hybrid IVUS-OCT imaging devices, discuss the technical challenges, and present the potential value in the clinical setting, especially in patients receiving medical or interventional CAD management.

Comparisons of Nonhyperemic Pressure Ratios: Predicting Functional Results of Coronary Revascularization Using Longitudinal Vessel Interrogation.

OBJECTIVES: The aim of this study was to investigate the accuracy of pre-percutaneous coronary intervention (PCI) predicted nonhyperemic pressure ratios (NHPRs) with actual post-PCI NHPRs and to assess the efficacy of PCI strategy using pre-PCI NHPR pullback. BACKGROUND: Predicting the functional results of PCI is feasible using pre-PCI longitudinal vessel interrogation with the instantaneous wave-free ratio (iFR), a pressure-based, adenosine-free NHPR. However, the reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR]) for this purpose remains uncertain. METHODS: In this prospective, multicenter, randomized controlled trial, vessels were randomly assigned to receive pre-PCI iFR, RFR, or dPR pullback (50 vessels each). The pre-PCI predicted NHPRs were compared with actual NHPRs after contemporary PCI using intravascular imaging. The number and the total length of treated lesions were compared between NHPR pullback-guided and angiography-guided strategies. RESULTS: The predicted NHPRs were strongly correlated with actual NHPRs: iFR, r = 0.83 (95% confidence interval: 0.72 to 0.90; p < 0.001); RFR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001), and dPR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001). The number and the total length of treated lesions were lower with the NHPR pullback strategy than with the angiography-guided strategy, leading to physiological improvement. CONCLUSIONS: Predicting functional PCI results on the basis of pre-procedural RFR and dPR pullbacks yields similar results to iFR. Compared with an angiography-guided strategy, a pullback-guided PCI strategy with any of the 3 NHPRs reduced the number and the total length of treated lesions. (Study to Examine Correlation Between Predictive Value and Post PCI Value of iFR, RFR and dPR; UMIN000033534).

Effect of Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve on Physicians' Clinical Behavior　- Differences Between Sites With and Without Appropriate Use Criteria as Designated by the Japanese Reimbursement System.

Background: Coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFRCT) is an established tool for identifying lesion-specific ischemia that is now approved for use by the Japanese insurance system. However, current clinical reimbursement is strictly limited to institutions with designated appropriate use criteria (AUC). This study assessed differences in physicians' behavior (e.g., use and interpretation of FFRCT, final management) according to Japanese AUC and non-AUC site designation. Methods and Results: Of 5,083 patients in the ADVANCE Registry, 1,829 from Japan were enrolled in this study. Physicians' behavior after interrogating CCTA and FFRCT was analyzed separately according to AUC and non-AUC site designation. Compared with AUC sites, patients referred for FFRCT from non-AUC sites had a higher rate of negative FFRCT, less severe anatomic stenosis, and a slightly lower rate of management plan reclassification (51.2% vs. 61.3%), with near-identical utility in both groups. Actual care corresponded equally well to post-FFRCT plans in both groups. The likelihood of revascularization for positive or negative FFRCT was similar between the 2 groups. Importantly, AUC and non-AUC sites were equally unlikely to revascularize patients with negative FFRCT and stenosis >50% or patients with positive FFRCT and stenosis <50%. Conclusions: Compared with AUC sites, non-AUC sites had lower disease burden and reclassification of management plans, but nearly identical clinical integration. Actual care corresponded equally well to post-FFRCT recommendations at both sites.

Clinical Impact of Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve on Japanese Population in the ADVANCE Registry.

BACKGROUND: Coronary computed tomography angiography (cCTA)-derived fractional flow reserve (FFRCT) is a promising diagnostic method for the evaluation of coronary artery disease (CAD). However, clinical data regarding FFRCTin Japan are scarce, so we assessed the clinical impact of using FFRCTin a Japanese population.Methods and Results:The ADVANCE registry is an international prospective FFRCTregistry of patients suspected of CAD. Of 5,083 patients, 1,829 subjects enrolled from Japan were analyzed. Demographics, symptoms, cCTA, FFRCT, treatment strategy, and 90-day major cardiovascular events (MACE) were assessed. Reclassification of treatment strategy between cCTA alone and cCTA+FFRCToccurred in 55.8% of site investigations and in 56.9% in the core laboratory analysis. Patients with positive FFR (FFRCT≤0.80) were less likely to have non-obstructive disease on invasive coronary angiography than patients with negative FFR (FFRCT>0.80) (20.5% vs. 46.1%, P=0.0001). After FFRCT, 67.0% of patients with positive results underwent revascularization, whereas 96.1% of patients with negative FFRCTwere medically treated. MACE occurred in 5 patients with positive FFRCT, but none occurred in patients with negative FFRCTwithin 90 days. CONCLUSIONS: In this Japanese population, FFRCTmodified the treatment strategy in more than half of the patients. FFRCTshowed potential for stratifying patients suspected of CAD properly into invasive or non-invasive management pathways.

In-stent restenosis assessed with frequency domain optical coherence tomography shows smooth coronary arterial healing process in second-generation drug-eluting stents.

INTRODUCTION: The pathophysiology and mechanism of in-stent restenosis (ISR) after implantation of second-generation drug-eluting stents (DESs) are not fully clear. We compared the morphological characteristics of ISR between first- and second-generation DESs using frequency domain optical coherence tomography (OCT). METHODS: Patients who underwent follow-up coronary angiography (CAG) after first-generation (CYPHER™ and TAXUS™) and second-generation (Nobori®, PROMUS Element™, Resolute Integrity and XIENCE) DES implantations were examined. ISR was defined as lesions of over 50% diameter stenosis at follow-up CAG. Frequency domain OCT was performed at the time of revascularisation of ISR. Tissue morphology was assessed at minimum lumen area. OCT images of DESs at both early (≤ 1 year) and late (> 1 year) phase follow-up were compared. RESULTS: On qualitative OCT assessment, the ratios of homogeneous, layered, heterogeneous without-attenuation and heterogeneous with-attenuation morphologies were 57.1%, 17.1%, 20.0% and 5.7%, respectively, for second-generation DES ISR (n = 35), and 16.7%, 25.0%, 25.0% and 33.3%, respectively, for first-generation DES ISR (n = 36). At late phase follow-up, homogeneous morphology was significantly more common for second-generation DES ISR compared to first-generation DES ISR (first-generation: 8.0% vs. second-generation: 50.0%; p < 0.01) while heterogeneous with-attenuation morphology was significantly more common for first-generation DES ISR (first-generation: 44.0% vs. second-generation: 5.6%; p < 0.01). CONCLUSION: Homogeneous tissue morphology was more frequently found for second-generation than first-generation DES ISR, especially in the late phase. This suggested that neointimal hyperplasia was the main mechanism in second-generation DES ISR, and that the neointima was stabilised, much like in bare metal stent implantation.

In vivo tissue characterization of human atherosclerotic plaques by optical coherence tomography: A directional coronary atherectomy study with histopathologic confirmation.

BACKGROUND: The histopathological validation of optical coherence tomography (OCT) in visualizing atherosclerotic plaques has been reported only in ex vivo studies. We sought to evaluate the accuracy of OCT in tissue characterization in vivo. METHODS AND RESULTS: A total of 25 patients with stable angina pectoris who underwent directional coronary atherectomy (DCA) were included in the investigation, whereby OCT was performed before and after a single debulking. The debulked region was determined on OCT and classified into fibrous tissue, lipid, calcification, thrombus, and macrophage accumulation, which were compared with histology. Changes in OCT signal intensity in the deeper intimal region after DCA were also visually evaluated. Fibrous tissues were detected in all cases, while thrombus was identified only in 1 case, by both OCT and histology. The sensitivity, specificity, positive and negative predictive values, and predictive accuracy for lipid detection by OCT were 88.9%, 75.0%, 66.7%, 92.3%, and 80.0%; those for calcification were 50.0%, 100%, 100%, 91.3%, and 92.0%; and those for macrophage accumulation were 85.7%, 88.9%, 75.0%, 94.1%, and 88.0%, respectively. The false positive diagnoses for lipid were mostly attributed to the extracellular matrix accumulation containing less collagen. The false negative diagnoses for calcification were explained by the presence of lipid around the calcification. The OCT signal intensity in the deeper intimal region substantially increased after DCA in all cases. CONCLUSIONS: The current study showed excellent predictive accuracy of in vivo OCT in tissue characterization, whereas the limitations of OCT were highlighted by an over-detection of lipid, under-detection of calcification, and underestimation of the deeper intimal matrix.

Novel proctorship effectively teaches interventionists coronary artery chronic total occlusion lesions.

BACKGROUND: Interventionists' experience and skills are essential factors for successful chronic total occlusion-percutaneous coronary intervention (CTO-PCI). However, the construction of theoretical strategy independent from interventionists' procedure may also improve it. We sought to assess the feasibility of CTO-PCI using an educational system supported by a single expert proctor. METHODS: A total of 160 patients underwent CTO-PCI between 2009 and 2016 at 92 Japanese centers in the Hands-on proctorship project. The CTO-PCI strategy was discussed with all participants and their specialists, before and during the procedure. We divided patients into 2 groups based on the CTO-PCI experience of their interventionist: (1) the less experienced group (CTO-PCI ≤50 cases, n=65) and (2) the more experienced group (CTO-PCI >50 cases, n=95). Baseline characteristics, procedural complications, and clinical outcomes were compared between groups. RESULTS: No significant differences in patient age, sex, prevalence for coronary risk factors, and lesion complexity was observed between groups. The retrograde approach was used equivalently between groups (55.4% vs. 60.0%, p=0.56), and procedural success rates were similar (96.9% vs. 90.5%, p=0.12). The rate of proctor's bailout for recanalization were not frequent between groups (4.6% vs. 5.3%, p=0.85). No procedure-related mortality was noted in either group. In addition, no significant differences in procedural cardiac complications, including coronary dissection, perforation, or tamponade, were observed between groups (10.8% vs. 14.7%, p=0.47). CONCLUSIONS: The expert-supported CTO-PCI maintained high success rates regardless of interventionists' experience. This highlights the importance of theoretical strategy for the management patients undergoing CTO-PCI.

Successful revascularization improves long-term clinical outcome in patients with chronic coronary total occlusion.

BACKGROUND: Following the development of breakthrough techniques for percutaneous coronary intervention (PCI) in the treatment of chronic total occlusions (CTO), the initial success rate of PCI in CTO lesions (CTO-PCI) has improved; however, there are few reports regarding the effects of successful CTO revascularization on long-term mortality in Japan. The aim of this study was to compare the long-term clinical outcomes of patients with successful versus failed CTO recanalization and to identify related factors. METHODS AND RESULTS: From all PCI procedures performed in our hospital between 2006 and 2013, CTO-PCIs were extracted and classified into two groups: PCI success (n = 656 patients) and PCI failure (n = 82 patients). Patients with successful procedures only on a second attempt, CTO-PCI in small branches, or CTOs in more than one vessel were excluded. Survival was determined from a telephone interview or the consultation history in the outpatient clinic. Initial angiographic success was achieved in 88.9% of the patients. A Kaplan-Meier plot with log-rank analysis showed that cumulative all-cause death was significantly lower in the success group than in the failure group (p = 0.0003; average follow-up duration in success group vs. failure group was 1531.3 ± 33.5 vs. 1565.3 ± 97.5 days, p = 0.7). Moreover, the rate of evident cardiac death was significantly lower in the success group than in the failure group (3.5% [23/656] vs. 15.9% [13/82], p < 0.0001). CONCLUSIONS: This study suggests that successful revascularization in patients with CTO improves their long-term clinical outcomes.

The first clinical experience with a novel directional coronary atherectomy catheter: Preliminary Japanese multicenter experience.

AIMS: Despite development of drug eluting stents (DES), percutaneous coronary intervention (PCI) for bifurcation lesions using DES alone remains challenging. The aim of this study was to report on the initial clinical experience with a novel directional coronary atherectomy (DCA) catheter. METHODS AND RESULTS: Patients with de novo bifurcation lesions were entered into a prospective registry and a novel DCA catheter was used. Device, procedural success and in-hospital outcomes were evaluated. A total of 14 patients with bifurcation lesions were enrolled. DCA was performed successfully in all cases without any major procedure-related events (device success rate: 100%, procedural success rate: 100%). Four patients (29%) were treated without stent implantation and simple stenting was achieved in the other 10 patients. No in-hospital major adverse cardiac event was observed. CONCLUSIONS: PCI with a novel DCA catheter for bifurcation lesions may be safe and effective. The clinical significance of these findings needs to be determined in future studies. This study was performed to evaluate the safety and efficacy of a novel directional coronary atherectomy catheter for bifurcation lesions. Both the device and procedural success rates were 100%. Complex stenting could be avoided in all cases. No inhospital major adverse cardiac event was observed. The novel directional coronary atherectomy catheter may be safe and effective for bifurcation lesions, even in this drug eluting stent era. © 2016 Wiley Periodicals, Inc.

Efficient distal tip size of primary guidewire for antegrade percutaneous coronary intervention in chronic total occlusion: The G-FORCE study.

BACKGROUND: Although several new techniques have been introduced for CTO such as the retrograde approach, the fundamental question of what type of guidewire is the most appropriate as a primary guidewire in the antegrade approach has not been answered. METHODS: The G-FORCE study was designed as a prospective multicenter randomized controlled trial to determine the efficient primary guidewire in antegrade approach for chronic total occlusion (CTO). The first guidewire was randomly assigned to a regular size distal tip group (0.014in. size) or tapered tip group (0.010in. or less). The primary endpoint was defined as successful lesion penetration by the first guidewire into distal true lumen. This study was registered at ClinicalTrials.gov with identifier NCT00987610. RESULTS: A total of 260 patients were enrolled, with an average age of 66±11years and 16% were female. The average J-CTO score was 1.8±1.1. The primary endpoint was achieved in 38% and 32% of patients using tapered and regular distal tip guidewires, respectively (P=0.80). The final PCI success rate was 81% vs. 85%, respectively (P=0.57). Easy CTO lesions with a J-CTO score=0 exhibited a primary endpoint significantly different between tapered and regular distal tip primary guidewires (79% vs. 40%; P=0.046). Guidewire distal coating or distal tip load did not relate with primary guidewire success rate. CONCLUSION: Tapered and regular distal tip guidewires are equivalent as a first choice for CTO. Tapered guidewires are superior for CTO lesions with a J-CTO score=0.

Safety of Live Case Demonstrations in Patients Undergoing Percutaneous Coronary Intervention for Chronic Total Occlusion.

The data regarding the risk and benefits associated with live demonstrations at interventional cardiology congresses are scarce and controversial. We aimed to assess the clinical safety of chronic total occlusion percutaneous coronary intervention (CTO-PCI) procedures during live demonstrations. From January 2008 to December 2013, 739 consecutive patients underwent CTO-PCI at our center, and 199 patients were scheduled to undergo live CTO-PCI demonstrations at cardiology congresses that were globally transmitted to international meetings. The baseline characteristics, procedural complications, and clinical outcomes were compared between the live demonstration group and nonlive demonstration group. The procedural success rates were similar in the live demonstration group than in the nonlive demonstration group (91.5% vs 86.7%, p = 0.076), although the CTO lesions were longer and more tortuous in the live demonstration group (p = 0.029, p = 0.022, respectively). No cases of 30-day mortality were noted in the live demonstration group (0% vs 0.7%, p = 0.28), and no significant differences in procedural complications, such as coronary dissection, coronary perforation, and cardiac tamponade, were observed between the groups (p = 0.53, p = 0.12, and p = 0.40, respectively). The survival rates were similar in the 2 groups at a median follow-up duration of 51.2 ± 28.9 months (log-rank test: p = 0.45). Compared with cases of unsuccessful CTO-PCI, the cases of successful CTO-PCI exhibited improved all-cause survival in both the live and nonlive demonstration groups (log-rank test: p = 0.045, p = 0.0056, respectively). In conclusion, we found that procedural and clinical outcomes of live demonstration CTO-PCI were not significantly different compared with cases undergoing routine CTO-PCI procedures.

Rates of future hemodialysis risk and beneficial outcomes for patients with chronic kidney disease undergoing recanalization of chronic total occlusion.

BACKGROUND: This study aimed to assess the prognosis and deleterious effects of chronic kidney disease (CKD) on future renal function, in patients who had undergone chronic total occlusion-percutaneous coronary intervention (CTO-PCI). METHODS: The treatment effects were studied in 739 patients who underwent CTO-PCI. The patients were divided into 3 groups according to estimated glomerular filtration rate (eGFR): non-CKD (eGFR≥60ml/min/1.73m(2), n=562), CKD-1 (45≤eGFR<60ml/min/1.73m(2), n=90), and CKD-2 (eGFR<45ml/min/1.73m(2), n=87). Future hemodialysis (HD) rates and the prevalence of acute kidney injury (AKI) except for 45 patients undergoing regular HD, and other clinical and prognostic outcomes were compared between the 3 groups. RESULTS: Procedural success rates showed trends toward lower prevalence across the 3 groups (89.5%, 84.4%, and 81.6%, p=0.060). The prevalence of AKI significantly differed between the 3 groups (4.6%, 8.9%, and 16.7%, p=0.001), whereas no patients were introduced to regular HD at discharge. During a median follow-up period of 51.2±28.9months, newly required HD significantly differed between the 3 groups (0.7%, 0%, and 7.1%, p<0.001). When compared with unsuccessful CTO-PCI, successful CTO-PCI was found to improve cardiovascular mortality in the non-CKD and CKD-1 (Log-rank test: p=0.025, p=0.024, respectively) and to improve both cardiovascular and all-cause mortality in the CKD-2 (Log-rank test: p=0.027, p=0.0022, respectively). CONCLUSIONS: Although CTO-PCI for patients with advanced CKD was associated with a high risk of future HD introduction, not directly owing to CTO-PCI and AKI, successful treatment of CTO might contribute to better survival benefit regardless of the presence or absence of CKD.