Operator experience and clinical outcomes of percutaneous coronary intervention for chronic total occlusion: insights from a pooled analysis of the Japanese CTO PCI Expert Registry and the Retrograde Summit General Registry.

There have not been enough studies to examine the association between difference in operator experience and technical success rate in contemporary percutaneous coronary intervention for chronic total occlusion (CTO-PCI). The present study sought to provide insights into the impact of operator experience on clinical outcomes of CTO-PCI through a comparison of two largest Japanese CTO-PCI registries consisting of operators with different CTO-PCI experience. After combining clinical data from the Japanese CTO-PCI Expert Registry (ER) 2014-2016 (N = 4316) including CTO-PCI performed by highly experienced operators and the Retrograde Summit General Registry (RSGR) 2014-2016 (N = 2230) including CTO-PCI performed by less experienced operators, a pooled analysis was performed to compare clinical outcomes of CTO-PCI in 2 registries. The overall technical success rate and the incidence of in-hospital major adverse events were comparable between ER and RSGR (90.1% vs 88.9%, p = 0.133, 1.7% vs 1.5%, p = 0.606, respectively). Technical success rate in ER was significantly higher among the patients treated with primary antegrade approach (91.8% vs 89.5%, p = 0.009), whereas there was no significant difference among the patients treated with the primary retrograde approach (85.7% vs 85.3%, p = 0.857). Multivariate analysis suggested ER operator could not be an independent predictor for technical success. CTO-PCI performed by less experienced but appropriately trained operators could achieve similarly high technical success rate with comparable safety compared with those performed by highly experienced specialists in contemporary Japanese context.

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.

Japanese multicenter registry evaluating the antegrade dissection reentry with cardiac computerized tomography for chronic coronary total occlusion.

Recently, antegrade dissection re-entry (ADR) with re-entry device for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has evolved to become one of the pillar techniques of the hybrid algorithm. Although the success rate of the device is high, it could be improved. We sought to evaluate the current trends and issues associated with ADR in Japan and evaluate the potential of cardiac computed tomography angiography (CCTA) for ADR procedure. A total 48 patients with CTO suitable for ADR evaluated by baseline conventional angiography and CCTA were enrolled. Procedural success and technical success were evaluated as the primary and secondary observations. Furthermore, all puncture points were analyzed by CCTA. CT score at each punctured site depended on the location of plaque deposition (none; + 0, at isolated myocardial site; + 1, at epicardial site; + 2) and the presence of calcification (none; + 0, presence; + 1) was analyzed and calculated (score 0-3). Overall procedure success rate was 95.8%. Thirty-two cases were attempted with the ADR procedure and 25 cases of them were successful. The technical success rate was 78.1% and myocardial infarction or other major complications were not observed in any cases. CT score at 60 puncture sites in 32 cases were analyzed and the score at technical success points was significantly smaller compared to that at technical failure points (0.68 ± 1.09 vs 1.77 ± 1.09, p < 0.0001). CTO-PCI with Stingray device in Japan could achieve a high procedure success and technical success rate. Pre procedure cardiac CT evaluation might support ADR procedure for appropriate patient selection or puncture site selection.

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.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment.

Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm2 versus 0.68 ± 1.07 mm2, p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454.

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.

Efficacy of drug-coated balloon angioplasty after directional coronary atherectomy for coronary bifurcation lesions (DCA/DCB registry).

OBJECTIVES: To evaluate the efficacy and safety of additional drug-coated balloon (DCB) angioplasty after directional coronary atherectomy (DCA) for coronary bifurcation lesions. BACKGROUND: The optimal therapy for bifurcation lesions has not been established, even in the drug-eluting stent era. DCA possibly prevents plaque and carina shift in bifurcation lesions by plaque debulking; however, the efficacy of combined DCA and DCB (DCA/DCB) for bifurcation lesions remains unclear. METHODS: This multicenter registry retrospectively recruited patients with bifurcation lesions who underwent DCA/DCB and follow-up angiogram at 6-15 months. The primary endpoint was the 12-month target vessel failure (TVF) rate. The secondary endpoints were procedure-related major complications, major cardiovascular events at 12 months, restenosis at 12 months, target lesion revascularization (TLR) at 12 months, and target vessel revascularization (TVR) at 12 months. RESULTS: We enrolled 129 patients from 16 Japanese centers. One hundred and four lesions (80.6%) were located around the left main trunk bifurcations. No side branch compromise was found intraoperatively. Restenosis was observed in three patients (2.3%) at 12 months. TLR occurred in four patients (3.1%): 3 (2.3%) in the main vessel and 1 (0.8%) in the ostium of the side branch at 12 months. TVF incidence at 12 months was slightly higher in 14 patients (10.9%), and only two patients (1.6%) had symptomatic TVR. One patient (0.8%) had non-target vessel-related myocardial infarction. CONCLUSIONS: Our data suggested that DCA/DCB provided good clinical outcomes and minimal side branch damage and could be an optimal non-stent percutaneous coronary intervention strategy for bifurcation lesions.

Safety of Percutaneous Coronary Intervention for Chronic Total Occlusion in Patients With Multi-Vesel Disease: Sub-Analysis of the Japanese Retrograde Summit Registry.

BACKGROUND: The success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has gradually increased thanks to the continuous development of devices and techniques. However, the impact of multi-vessel disease (MVD) on its success rate and safety is not well known. METHODS: The clinical records of 5009 patients enrolled in the Japanese Retrograde Summit Registry and who had undergone PCI for CTO at 65 centers between 2012 and 2015 were reviewed. We compared the outcome for patients with and without MVD. RESULTS: Two thousand nine hundred and seventy-eight patients (59%) had MVD. Although there was no significant difference in the J-CTO score between the two groups [MVD group 1.51 ± 1.07 vs. SVD group 1.48 ± 1.07, p = 0.48], the procedural success rate of CTO-PCI in the MVD group was significantly lower than that in the SVD group (87.2% vs. 90.2%, p = 0.001). However, occurrence of procedure-related adverse events (4% vs. 5%, p = 0.11), total fluoroscopy (70 ± 45 min vs. 69 ± 50 min, p = 0.75) and procedural time (154 ± 86 min vs. 151 ± 89 min, p = 0.36), and total amount of contrast media (219 ± 102 mL vs. 222 ± 105 mL, p = 0.33) did not differ between the two groups. CONCLUSIONS: Although MVD had an impact on the success rate of CTO-PCI, it did not affect procedure-related adverse events.

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.

Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions.

We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72). The AUC of the derivation model was 0.650. The model's performance was similar in the validation cohort (AUC, 0.610). When assigned a point for each associated factor (HD = 3, LVEF <35%, ISO = 2, and DM = 1 point), the average predicted versus the observed MACCE probability using the Japan-CTO extension score for the low, moderate, high, and very high risk groups was 8.1% vs. 7.3%, 16.9% vs. 15.9%, 22.0% vs. 26.1%, and 56.2% vs. 44.4%, respectively. This novel risk model may allow for the estimation of long-term risk and be useful in disseminating appropriate revascularization procedures.

Scoring System for Identification of "Survival Advantage" after Successful Percutaneous Coronary Intervention in Patients with Chronic Total Occlusion.

BACKGROUND: Percutaneous coronary intervention (PCI) is widely used in patients with chronic total occlusion (CTO), but its benefit in improving long-term outcomes is controversial. We aimed to develop a prediction score for grading "survival advantage" conferred by successful results of CTO-PCI and a scoring system for prediction of the influence of CTO-PCI results on major adverse cardiac and cerebrovascular events (MACCEs). METHODS: Follow-up data of 2625 patients who underwent CTO-PCI at 65 Japanese centers were analyzed. An integer scoring system was developed by including statistical effect modifiers on the association between successful CTO-PCI and one-year mortality. RESULTS: Follow-up at 12 months was completed in 2034 patients. During follow-up, 76 deaths (3.7%) occurred. Patients with successful CTO-PCI had a better one-year survival than patients with failed CTO-PCI (log rank P = 0.016). Effect modifiers for the association between successful procedure and one-year mortality included diabetes (P interaction = 0.043), multivessel disease (P interaction = 0.175), Canadian Cardiovascular Society class ≥2 (P interaction = 0.088), and prior myocardial infarction (MI) (P interaction = 0.117). Each component was assigned a single point and summed to develop the scoring system. The patients were then categorized to specify the prediction of survival advantage by successful PCI: ≤2 (normal) and ≥3 (distinct). The differences in one-year mortality between patients with successful and failed treatment were -0.7% and 11.3% for normal and distinct score categories, respectively. In the scoring system for MACCE, score components were prior MI (P interaction = 0.19), left anterior descending artery (LAD)-CTO (P interaction = 0.079), and reattempt of CTO-PCI (P interaction = 0.18). The differences in one-year MACCEs between successful and failed patients for each score category (0, 1, and ≥2) were -1.7%, 7.5%, and 15.1%, respectively. CONCLUSIONS: The novel scoring system assessing the advantage of successful PCI can be easily applied in patients with CTO. It is a valid instrument for clinical decision-making while assessing the survival advantage of CTO-PCI and the influence of procedural results on MACCEs.

Efficacy of plaque debulking for bifurcated or ostial lesions by directional coronary atherectomy prior to second-generation drug eluting stenting.

OBJECTIVES: We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) prior to second-generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting is used. METHODS: Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-second-generation DES plaque debulking with a novel DCA catheter (ATHEROCUT®, Nipro Co., Osaka, Japan) was conducted. All patients were scheduled to perform a follow up angiography (9-12 month coronary angiography or coronary computed tomography). The primary end point was target vessel failure (TVF) at follow up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. RESULTS: A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all cases without any major procedure-related event and only one case required complex stenting. The TVF rate at 9-12 month follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at the ostium of the main-branch in three cases. No death, coronary artery bypass grafting, or myocardial infarction were reported for any patients within the first year. CONCLUSION: DCA before second-generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions.

Effect of combination of non-slip element balloon and drug-coating balloon for in-stent restenosis lesions (ELEGANT study).

BACKGROUND: In-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT). METHODS: Patients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD)-follow-up MLD] at 8 months. RESULTS: One hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p=0.002) and geographical miss (6.9% versus 21.9%, p=0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17±0.42mm versus 1.06±0.35mm, p=0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85±1.67mm2 versus 3.81±1.93mm2, p=0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78±3.26mm versus 6.97±4.59mm, p=0.04), but average in-segment late loss was similar between the two groups (0.28±0.45mm versus 0.27±0.38mm, p=0.75). CONCLUSION: Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.

The antegrade dissection and re-entry technique as preparation of intravascular ultrasound guided re-wiring.

Although the antegrade dissection and re-entry technique (ADR) with Stingray system is one of the procedures for percutaneous coronary intervention (PCI) of chronic total occlusion (CTO), it has some risk of side-branch occlusion. This article reports a CTO case in the left circumflex artery successfully treated with combination use of ADR subintimal tracking and intravascular ultrasound (IVUS)-guided re-wiring without side-branch occlusion. Antegrade approach with single-wire and parallel-wire technique was failed. Retrograde approach through ipsilateral collateral was also failed. Therefore, the ADR was attempted and Stingray wire crossed through at the distal site of posterolateral (PL) branch. To avoid PL branch occlusion, IVUS-guided re-wiring to the true lumen was attempted. Finally, the CTO lesion was recanalized without any complication and 1 year follow-up angiography had good result. ADR as preparation of IVUS-guided re-wiring might be one of the useful procedures for those complex CTO cases.

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.

Efficacy of biolimus A9-eluting stent for treatment of right coronary ostial lesion with intravascular ultrasound guidance: a multi-center registry.

The aim of this study was to assess the efficacy of a biolimus A9-eluting stent in patients with a right coronary artery (RCA) ostial lesion. Ostial lesions of the RCA have been a limitation of percutaneous coronary intervention even in the drug-eluting stent (DES) era. However, clinical outcomes after the deployment of a second generation DES to an RCA ostial lesion with intravascular ultrasound (IVUS) guidance have not been fully elucidated. From September 2011 to March 2013, 74 patients were enrolled in 17 centers from Japan. RCA ostial lesion was defined as de novo significant stenotic lesion located within 15 mm from ostium. IVUS was used for all cases to confirm the location of ostium and evaluate stent coverage of ostium. Patients with hemodialysis were excluded. The primary endpoint is a major adverse cardiac event (MACE) at 1 year. Forty two percent of patients had multi-vessel disease. Angiographically severe calcification was observed in 26% of the lesions. The mean stent diameter was 3.3 ± 0.3 mm (3.5 mm, 72%, 3.0 mm, 25%, and 2.75 and 2.5 mm, 3%), stent length was 17.5 ± 5.8 mm, and dilatation pressure of stenting was 15.6 ± 4.1 atm. RCA ostium was covered by stent in all lesions in IVUS findings. Post dilatation was performed for 64% of lesions (balloon size 3.7 ± 0.6 mm). MACE rate at 1 year was 5.4% (target lesion revascularization 5.4%, myocardial infarction 1.2%, and no cardiac death). The biolimus A9-eluting stent for RCA ostial lesions with IVUS guidance showed favorable results at 1-year follow-up.

Impact of Hemodialysis on Procedural Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusion: Insights From the Japanese Multicenter Registry.

BACKGROUND: Among patients treated with percutaneous coronary intervention for chronic total occlusion (CTO-PCI), patients on long-term hemodialysis are at significantly high risk for cardiovascular mortality and morbidity. However, clinical or angiographic predictors that might aid in better patient selection remain unclear. We aimed to assess the acute impact of hemodialysis in patients who underwent CTO-PCI. METHODS AND RESULTS: The Retrograde Summit registry is a multicenter, prospective registry of patients undergoing CTO-PCI at 65 Japanese centers. Patient characteristics and procedural outcomes of 4749 patients were analyzed, according to the presence (n=313) or absence (n=4436) of baseline hemodialysis. A prediction model for technical failure among hemodialysis patients was also developed. The technical success rate of CTO-PCI was significantly lower in hemodialysis than in nonhemodialysis patients (78.0% versus 89.1%, P<0.001). The rates of in-hospital major adverse cardiac and cerebrovascular events were similar between the 2 groups (1.6% versus 0.9%, P=0.24). Irrespective of clinical/angiographic characteristics or previously developed scoring systems, hemodialysis independently predicted technical failure for CTO-PCI. Among hemodialysis patients, predictors of technical failure were blunt stump (odds ratio 2.45, 95% confidence interval, 1.15-5.21, P=0.021), severe lesion calcification (odds ratio 2.50, 95% confidence interval, 1.19-5.24, P=0.015), and absence of diabetes mellitus (odds ratio 3.15, 95% confidence interval, 1.49-6.64, P=0.003). In hemodialysis patients without these predictors, the technical success rate was 96.2%. CONCLUSIONS: Hemodialysis is significantly associated with technical failure. Contemporary CTO-PCI seems feasible and safe in selected hemodialysis patients.