Transformation of the Cardiovascular Clinics in Japan　- How to Overcome Crisis Due to Changes in the External Environment.

The first percutaneous coronary intervention (PCI) was performed in September 1977, and after 1980 this minimally invasive treatment was established in Japan. To deliver this treatment to a larger population, a number of cardiovascular clinics emerged across the country in the 2000s, and the number of PCI cases performed has been steadily increasing, to >250,000 cases per year. In the early 2000s, a single catheterization unit was profitable, if it performed a certain number of treatments and was adequately staffed without excessive capital investment. In the late 1990s, the price of a balloon catheter medical device used for PCI was approximately JPY300,000, although the price was reduced to JPY32,000, almost one-tenth in price, in the April 2022 revision of the National Health Insurance. The reimbursement of the mainstream drug-eluting stent has also decreased from JPY421,000, when it was first introduced, to JPY136,000 currently. In addition, the consumption tax and reforms in working hours will have a major impact on clinic management. We present a history of cardiovascular clinics in Japan and their present and future positions under the variable external environment.

Diagnostic Accuracy of Artificial Intelligence-Based Angiography-Derived Fractional Flow Reserve Using Pressure Wire-Based Fractional Flow Reserve as a Reference.

BACKGROUND: Angiographic fractional flow reserve (angioFFR) is a novel artificial intelligence (AI)-based angiography-derived fractional flow reserve (FFR) application. We investigated the diagnostic accuracy of angioFFR to detect hemodynamically relevant coronary artery disease.Methods and Results: Consecutive patients with 30-90% angiographic stenoses and invasive FFR measurements were included in this prospective, single-center study conducted between November 2018 and February 2020. Diagnostic accuracy was assessed using invasive FFR as the reference standard. In patients undergoing percutaneous coronary intervention, gradients of invasive FFR and angioFFR in the pre-senting segments were compared. We assessed 253 vessels (200 patients). The accuracy of angioFFR was 87.7% (95% confidence interval [CI] 83.1-91.5%), with a sensitivity of 76.8% (95% CI 67.1-84.9%), specificity of 94.3% (95% CI 89.5-97.4%), and area under the curve of 0.90 (95% CI 0.86-0.93%). AngioFFR was well correlated with invasive FFR (r=0.76; 95% CI 0.71-0.81; P<0.001). The agreement was 0.003 (limits of agreement: -0.13, 0.14). The FFR gradients of angioFFR and invasive FFR were comparable (n=51; mean [±SD] 0.22±0.10 vs. 0.22±0.11, respectively; P=0.87). CONCLUSIONS: AI-based angioFFR showed good diagnostic accuracy for detecting hemodynamically relevant stenosis using invasive FFR as the reference standard. The gradients of invasive FFR and angioFFR in the pre-stenting segments were comparable.

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.

Determination of the Optimal Measurement Point for Fractional Flow Reserve Derived From CTA Using Pressure Wire Assessment as Reference.

BACKGROUND. For clinical decision making, it was recently recommended that values of fractional flow reserve (FFR) derived from coronary CTA (FFRCT) be measured 1-2 cm distal to the stenosis, given the potential for overestimation of ischemia when FFRCT values at far distal segments are used. Supporting data are, however, lacking. OBJECTIVE. The purpose of the present study was to evaluate the diagnostic performance of FFRCT values measured 1-2 cm distal to the stenosis and at more distal locations relative to invasive FFR values. METHODS. FFRCT and invasive FFR values for 365 vessels in 253 patients identified from the Assessing Diagnostic Value of Noninvasive FFRCT in Coronary Care (ADVANCE) registry were prospectively assessed. FFRCT values were measured 1-2 cm distal to the stenosis and at the pressure wire position and far distal segments. The diagnostic accuracy of FFRCT was assessed on the basis of the ROC AUC. The AUC of FFRCT was calculated using FFRCT as an explanatory variable and an invasive FFR of 0.80 or less as the dichotomous dependent variable. RESULTS. The AUC of FFRCT values measured 1-2 cm distal to the stenosis (0.85; 95% CI, 0.80-0.88) was higher (p = .002) than that of FFRCT values measured at far distal segments (0.80; 95% CI, 0.76-0.84) and similar (p = .16) to that of FFRCT values measured at the pressure wire position (0.86; 95% CI, 0.81-0.89). FFRCT values measured 1-2 cm distal to the stenosis and at far distal segments had sensitivity of 87% versus 92% (p = .003), specificity of 73% versus 42% (p < .001), PPV of 75% versus 59% (p < .001), and NPV of 86% versus 85% (p = .72), respectively. Subgroup analyses of lesions of the left anterior descending coronary artery, left circumflex coronary artery, and right coronary artery all showed improved specificity and PPV (all p < .005) for FFRCT values measured 1-2 cm distal to the stenosis compared with values measured at the pressure wire position. However, the AUC was higher for measurements obtained 1-2 cm distal to the stenosis versus those obtained at far distal segments, for left anterior descending coronary artery lesions (p < .001) but not for left circumflex coronary artery lesions (p = .27) or right coronary artery lesions (p = .91). CONCLUSION. The diagnostic performance of FFRCT values measured 1-2 cm distal to the stenosis was higher than that of FFRCT values measured at far distal segments and was similar to that of FFRCT values measured at the pressure wire position in evaluating ischemic status, particularly for left anterior descending coronary artery lesions. CLINICAL IMPACT. The present study supports recent recommendations from experts to use FFRCT measured 1-2 cm distal to the stenosis, rather than measurements obtained at far distal segments, in clinical decision making.

Stress Myocardial Perfusion Imaging Interpretation From the Viewpoint of Fractional Flow Reserve.

BACKGROUND: Myocardial perfusion imaging (MPI) and fractional flow reserve (FFR) are established approaches to the assessment of myocardial ischemia. Recently, various FFR cutoff values were proposed, but the diagnostic accuracy of MPI in identifying positive FFR using various cutoff values is not well established.Methods and Results:We retrospectively studied 273 patients who underwent stress MPI and FFR within a 3-month period. Results for FFR were obtained from 218 left anterior descending artery (LAD) lesions and 207 non-LAD lesions. Stress MPI and FFR demonstrated a good correlation in the detection of myocardial ischemia. However, the positive predictive value (PPV) of FFR for detecting MPI-positive lesions at the optimal FFR thresholds was insufficient (44% for LAD and 65% for non-LAD lesions). This was caused by a sharp drop in PPV at an FFR threshold of 0.7 or more. Notably, 41% of the lesions with normal MPI demonstrated FFRs <0.80. However, MPI-negative lesions had an extremely low lesion rate with FFR <0.65 (6%). Conversely, 78% and 41% of MPI-positive lesions had FFR <0.80 and <0.65, respectively. CONCLUSIONS: The data confirmed that decisions based on MPI are reasonable because MPI-negative patients have an extremely low rate of lesions with a FFR below the cutoff point for a hard event, and MPI-positive lesions include many lesions with FFR <0.65.

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.

Feasibility and safety of jailed-pressure wire technique using durable optical fiber pressure wire for intervention of coronary bifurcation lesions.

OBJECTIVES: The objective was to evaluate the safety, feasibility, and accuracy of the jailed-pressure wire technique using a durable optical fiber-based pressure wire with high-pressure dilatation using a non-compliant balloon after main vessel stenting. BACKGROUND: Fractional flow reserve (FFR) information can help interventionists determine whether they should treat a jailed-side branch (SB). However, re-crossing a pressure wire into a jailed-SB is sometimes technically difficult. METHODS: Fifty-one consecutive lesions from 48 patients who underwent the jailed-pressure wire technique were retrospectively investigated. The primary endpoint was complication rate and secondary endpoints included success rate of FFR measurement, incidence of wire disruption, and final drift rate. The usability of FFR for percutaneous coronary intervention of coronary bifurcation lesion was also evaluated. RESULTS: Median age of the patients was 69 years and 80.4% were men. The most frequent underlying disease was stable angina (70.6%) and 68.6% were type B2 lesions. Our main findings were: the procedure was performed successfully in all cases without any complications or wire disruption, FFR could be measured without significant final drift in 95.9% of cases, and FFR measurements helped interventionists determine whether to perform a final kissing balloon dilatation in 49.0% cases. CONCLUSIONS: The jailed-pressure wire technique using a durable optical fiber-based pressure wire with high-pressure post-dilatation maneuver was safe, feasible, and accurate.

Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: The semiquantitative Clinical Frailty Scale (CFS) is a simple tool to assess patients' frailty and has been shown to correlate with mortality in elderly patients even when evaluated by nongeriatricians. The aim of the current study was to determine the prognostic value of CFS in patients who underwent transcatheter aortic valve replacement. METHODS: We utilized the OCEAN (Optimized Catheter Valvular Intervention) Japanese multicenter registry to review data of 1215 patients who underwent transcatheter aortic valve replacement. Patients were categorized into 5 groups based on the CFS stages: CFS 1-3, CFS 4, CFS 5, CFS 6, and CFS ≥7. We subsequently evaluated the relationship between CFS grading and other indicators of frailty, including body mass index, serum albumin, gait speed, and mean hand grip. We also assessed differences in baseline characteristics, procedural outcomes, and early and midterm mortality among the 5 groups. RESULTS: Patient distribution into the 5 CFS groups was as follows: 38.0% (CFS 1-3), 32.9% (CFS4), 15.1% (CFS 5), 10.0% (CFS 6), and 4.0% (CFS ≥7). The CFS grade showed significant correlation with body mass index (Spearman's ρ=-0.077, P=0.007), albumin (ρ=-0.22, P<0.001), gait speed (ρ=-0.28, P<0.001), and grip strength (ρ=-0.26, P<0.001). Cumulative 1-year mortality increased with increasing CFS stage (7.2%, 8.6%. 15.7%, 16.9%, 44.1%, P<0.001). In a Cox regression multivariate analysis, the CFS (per 1 category increase) was an independent predictive factor of increased late cumulative mortality risk (hazard ratio, 1.28; 95% confidence interval, 1.10-1.49; P<0.001). CONCLUSIONS: In addition to reflecting the degree of frailty, the CFS was a useful marker for predicting late mortality in an elderly transcatheter aortic valve replacement cohort.

Initial results of a first-in-human study on the PlasmaWire™ System, a new radiofrequency wire for recanalization of chronic total occlusions.

OBJECTIVES: To examine the safety, efficacy, and efficiency of the PlasmaWireTM System to recanalize coronary chronic total occlusions (CTO) using controlled ablation inside the CTO. BACKGROUND: The PlasmaWireTM System is a new bipolar radiofrequency (RF) wire system utilizing plasma-mediated ablation to facilitate wire crossing in CTOs. Two independent PlasmaWireTM wires are used in tandem for channel creation by applying RF energy between the tips so as to localize the ablation. METHODS: Prospective, nonrandomized, single-arm, multicenter study in seven patients with CTOs indicated for percutaneous coronary intervention (PCI). RESULTS: In this study, both wires were antegradely delivered to the distal end of CTO for antegrade re-entry in two cases and bidirectionally (antegrade and retrograde) delivered to the CTO for retrograde re-entry in five cases. In all cases, channel creation was achieved within a few seconds and was confirmed on angiogram or intravascular ultrasound (IVUS) and CTO recanalization was successfully achieved without any major adverse cardiac and cerebrovascular events (MACCE) or other minor complications. The clinical follow-up showed no clinical event at 1 month. CONCLUSIONS: The PlasmaWireTM System was shown to be safe and effective in obtaining CTO recanalization through a re-entry channel utilizing plasma-mediated ablation while reducing procedure time. The PlasmaWire™ System is a new bi-polar RF wire system utilizing plasma-mediated ablation for channel creation to facilitate CTO recanalization. This first-in-human study in which seven patients were enrolled was conducted to demonstrate the safety, efficacy, and efficiency of this system for CTO recanalization. Channels through the CTOs were successfully created within a few seconds by applying RF energy between the tips of two independent PlasmaWireTM wires and recanalization was achieved in all cases without any complication. The PlasmaWireTM System may safely facilitate CTO recanalization with less vessel injury and improve initial results of CTO PCI while reducing procedure time.

Diagnostic Performance of the Simultaneous Acquisition Rest 99 mTc-Tetrofosmin/Stress 201Tl Dual-Isotope Protocol With a Semiconductor Camera　- Comparison With the Rest-Stress 99 mTc-Tetrofosmin Protocol.

BACKGROUND: This study compared the diagnostic value of myocardial perfusion imaging (MPI) between the rest-stress 99 mTc-tetrofosmin protocol (Tc/Tc protocol) and simultaneous acquisition rest 99 mTc-tetrofosmin/stress 201Tl dual-isotope protocol (SDI protocol) with a semiconductor camera.Methods and Results: We retrospectively studied 147 patients who underwent stress MPI using a cadmium-zinc-telluride camera and invasive coronary angiography within a 3-month interval. The Tc/Tc and SDI protocols were used in 59 and 88 patients, respectively. The sensitivity, specificity, and accuracy of the summed difference score in per-patient analysis were 56%, 85%, and 69%, respectively, for the Tc/Tc protocol and 89%, 82%, and 85%, respectively, for the SDI protocol. The area under the receiver operating characteristic curve was significantly better for the SDI than Tc/Tc protocol for the left anterior descending artery (0.836 vs. 0.674; P=0.0380), the left circumflex artery (0.754 vs. 0.599; P=0.0441), and in per-patient analysis (0.875 vs. 0.707; P=0.0135). There was no significant difference in the diagnostic accuracy of the summed stress score for any vessel or in per-patient analysis between the 2 protocols. CONCLUSIONS: The SDI protocol had a higher diagnostic accuracy for the detection of coronary ischemia than the Tc/Tc protocol.

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.

Safety and utility of total percutaneous endovascular aortic repair with a single Perclose ProGlide closure device.

OBJECTIVE: This study evaluated the safety and efficacy of total percutaneous endovascular aortic aneurysm repair (PEVAR) with a single Perclose ProGlide device (Abbot Vascular, Santa Clara, Calif) compared with endovascular aortic repair with surgical cutdown (SEVAR). METHODS: The study included 50 abdominal aortic aneurysm patients who were treated with PEVAR with a single Perclose ProGlide device and 96 patients treated with SEVAR. Technical success was defined as successful arterial closure of the common femoral artery without the need for adjunctive surgical or endovascular procedures. The rates of complications, including bleeding requiring transfusion, infection, pseudoaneurysm, paresthesia, and lymphocele, as well as the operating room time and hospital duration were compared between the PEVAR and SEVAR groups. RESULTS: Technical success was obtained in all patients in the PEVAR group. One patient in the SEVAR group needed surgical repair due to access site bleeding. Complication rates were similar between the groups (4% in the PEVAR vs 8% in the SEVAR; P = .495). The PEVAR group had significantly shorter operating room times (153 ± 47 minutes vs 211 ± 88 minutes, P < .001) and hospital lengths of stay (6.7 ± 6.8 days vs 9.3 ± 4.5 days, P < .001). CONCLUSIONS: Compared with SEVAR, PEVAR with a single ProGlide device is a safe procedure with a shorter operating room time and hospital stay, without increasing access site complications.

Mechanism of Residual Lumen Stenosis at the Side Branch Ostium After Final Kissing Balloon Inflation: A Volumetric Intracoronary Ultrasound Study of Coronary Bifurcation Lesions.

OBJECTIVES: To investigate the mechanisms of residual stenosis (RS) at side branch ostium (SBO) after final kissing balloon inflation (FKI) and clarify the impact of carina- and plaque-shifts on RS. BACKGROUND: Carina- and plaque-shift induce SBO compromise. FKI is an effective technique to treat this complication; however, RS often persist, and are associated with restenosis at SBO. METHODS: We performed serial volumetric analysis of 91 bifurcations in which crossover-stenting with FKI and pre-/post-intravascular ultrasounds (IVUS) were completed in both branches. The plaque- and carina-shifts were defined as an increase in the plaque-volume and a decrease in the vessel-volume at the SBO, respectively. RS at the SBO, defined as area stenosis >50% on IVUS, was identified in 19 lesions. RESULTS: After FKI, the plaque volume- significantly increased at the SBO, with its reduction in the proximal main vessel (MV). However, at the SBO, the volumetric lumen change correlated with vessel change (ρ = 0.690, P < 0.001), but not plaque change (P = 0.390), suggesting that RS at SBO was more likely associated with inadequate vessel stretch, not plaque increase after FKI. Carina-shift was more frequently found in cases with RS, compared to those without RS (37% vs. 11%, P = 0.013). Pre-procedure IVUS findings to predict RS at SBO after FKI were negative-remodeling at distal MV, plaque -burden at distal MV, and plaque-burden at the SBO. CONCLUSIONS: Carina-shift has a greater contribution to the formation of RS at SBO after FKI. The pre-procedure IVUS provides helpful information for predicting the RS after FKI.

Impending rupture of saphenous vein graft aneurysm with floating fractured bare metal stent treated by coil embolization and covered stent implantation.

Aneurysmal degeneration of a saphenous vein graft (SVG) is a rare, but potentially fatal complication of coronary artery bypass graft (CABG) surgery. In this case report, a patient that had undergone prior CABG surgery and bare metal stent (BMS) implantation at the site of a stenotic SVG lesion presented at our hospital with chest pain, and an SVG aneurysm was detected at the previous BMS implantation site. In addition, the implanted BMS was fractured and floating in the SVG aneurysm. The SVG aneurysm was successfully occluded by percutaneous intervention, using a combination of distal covered stent deployment at the site of the anastomosis between the native coronary artery and the SVG and proximal coil embolization of the aneurysm.

Impact of lesion morphology on angiographic and clinical outcomes in patients with chronic total occlusion after recanalization with drug-eluting stents: a multislice computed tomography study.

OBJECTIVES: The aim of this study was to investigate the multislice computed tomography (MSCT) parameters associated with adverse outcomes after chronic total occlusion percutaneous coronary intervention (CTO-PCI) with drug-eluting stents. METHODS: A total of 285 patients who underwent MSCT before CTO-PCI were analyzed. Lesion morphology was assessed with MSCT. Angiographic restenosis, reocclusion, and MACE (a composite of cardiac death, myocardial infarction, stent thrombosis, and target lesion revascularization) were analyzed. RESULTS: MACE was observed in 36 patients (13.6%). Occlusion length was greater (39.5 ± 19.9 mm vs. 22.3 ± 13.7 mm, p < 0.01), minimal vessel area smaller (11.2 ± 5.7 mm(2) vs. 14.5 ± 5.6 mm(2), p < 0.01), and severe calcification more common (36% vs. 12 %, p < 0.01) in the MACE group compared to the non-MACE group. We defined occluded length >25.4 mm, minimal vessel area <11.9 mm(2), which were identified by receiver operating characteristic analysis, and severe calcification as CT-derived risk factors. Angiographic restenosis (60% vs. 12% vs. 7%, p < 0.01), reocclusion (29% vs. 2% vs. 2%, p < 0.01), and MACE (43% vs. 6% vs. 3%, p < 0.01) were more common in patients with 2 or more risk factors than in those with 1 or 0. CONCLUSIONS: MSCT characteristics associated with adverse outcomes after CTO-PCI were occlusion length, minimal vessel area, and severe calcification. KEY POINTS: • Percutaneous coronary intervention of chronic total occlusion remains a challenge. • The parameters related to adverse outcomes after CTO-PCI have not been clarified. • MSCT can provide useful information associated with adverse outcomes after CTO-PCI.

Impact of sirolimus-eluting stent fractures without early cardiac events on long-term clinical outcomes: a multislice computed tomography study.

OBJECTIVES: This study sought to evaluate the impact of sirolimus-eluting stent (SES) fractures on long-term clinical outcomes using multislice computed tomography (MSCT). METHODS: In this study, 528 patients undergoing 6- to 18-month follow-up 64-slice MSCT after SES implantation without early clinical events were followed clinically (the median follow-up interval was 4.6 years). A CT-detected stent fracture was defined as a complete gap with Hounsfield units (HU) <300 at the site of separation. The major adverse cardiac events (MACEs), including cardiac death, stent thrombosis, and target lesion revascularisation, were compared according to the presence of stent fracture. RESULTS: Stent fractures were observed in 39 patients (7.4 %). MACEs were more common in patients with CT-detected stent fractures than in those without (46 % vs. 7 %, p < 0.01). Univariate Cox regression analysis indicated a significant relationship between MACE and stent fracture [hazard ratio (HR) 7.65; p < 0.01], age (HR 1.03; p = 0.04), stent length (HR 1.03; p < 0.01), diabetes mellitus (HR 1.77; p = 0.04), and chronic total occlusion (HR 2.54; p = 0.01). In the multivariate model, stent fracture (HR 5.36; p < 0.01) and age (HR 1.03; p = 0.04) remained significant predictors of MACE. CONCLUSIONS: An SES fracture detected by MSCT without early clinical events was associated with long-term clinical adverse events. KEY POINTS: • Long-term outcomes of sirolimus-eluting stent fracture have not been fully clarified. • MSCT could detect stent fracture with high accuracy. • Sirolimus-eluting stent fracture detected by MSCT was associated with long-term adverse events.

Wire bias modification with reverse orbital atherectomy for safer rotational atherectomy in calcified bifurcation.

Although debulking devices are very useful in modifying calcified plaques, their effectiveness is highly dependent on wire bias. In particular, in eccentric calcified bifurcation lesions, wire bias tends to be poor and needs to be corrected for adequate lesion preparation. A 67-year-old man was diagnosed with exertional angina pectoris. Coronary angiography showed a highly calcified eccentric lesion from the left main trunk to the left anterior descending artery. The patient refused coronary artery bypass surgery, therefore we decided to treat this complex bifurcation lesion with percutaneous coronary intervention. Initially, we performed reverse orbital atherectomy (OA) and sifted the guide wire position into the calcified plaque successfully. We continued with rotational atherectomy (RA) using a 2.0 mm burr and were able to obtain sufficient lumen without complications. Finally, the lesion was dilated with a cutting balloon and a drug-coated balloon to obtain a stent-like result. This case demonstrates that wire bias modification with reverse OA enables us to perform more aggressive and effective RA safely in eccentric calcified bifurcation lesions. This combination atherectomy can become an attractive approach in eccentric calcified bifurcation lesions. Learning objective: Atherectomy devices are helpful for lesion modification in calcified lesions but their effectiveness is highly dependent on wire bias. If the wire bias can be intentionally moved to an optimal position, it can be a very effective procedure in the treatment of calcified lesions. Wire bias modification by reverse ablation with orbital atherectomy that we have demonstrated enables subsequent aggressive rotational atherectomy and this combination atherectomy can be an attractive approach in eccentric calcified lesions.

Long-term serial angiographic outcomes after sirolimus-eluting stent implantation.

OBJECTIVE: We evaluated, using quantitative coronary angiography, the natural history of change that occurred in target lesions after successful sirolimus-eluting stent (SES) implantation. BACKGROUND: Percutaneous coronary intervention with drug-eluting stents (DES) has significantly reduced the rate of repeated target lesion revascularization. However, early studies have raised concerns regarding the "late catch-up" phenomenon of DES. METHODS: Between June 2004 and March 2007, consecutive 217 patients with 306 lesions without restenosis at early angiographic follow-up underwent late angiographic follow-up (early follow-up: 11.2 ± 2.1 months and late follow-up: 29.4 ± 5.2 months). Predictors of late catch-up were identified with univariate and multivariate regression analyses. RESULTS: Although reference vessel diameter did not significantly change during follow-up [3.15 mm (interquartile range (IQR): 2.81-3.49 mm), 3.12 mm (IQR: 2.79-3.47 mm), and 3.08 mm (IQR: 2.76-3.46 mm) at postprocedure, and early and late angiographic follow-up, respectively; P = 0.2653], late loss (LL) significantly increased during follow-up [0.05 mm (IQR: 0.00-0.13 mm) and 0.08 mm (IQR: 0.01-0.19 mm) at early and late follow-up, respectively; P < 0.0001]. Univariate analysis showed previous intervention, adjunctive use of cutting balloon, lesion length, and progression of MLD, LL, %DS at early follow-up as predictors of late catch-up. Multivariate regression analysis identified %DS at early follow-up as a predictor of late catch-up (OR 1.076, CI 1.039-1.114, P < 0.0001). CONCLUSION: Significant and continuous progression of neointima after SES implantation was observed in the present study. Larger LL may be a sign of late catch-up phenomenon.

Effects of Long-Term Carvedilol Therapy in Patients With ST-Segment Elevation Myocardial Infarction and Mildly Reduced Left Ventricular Ejection Fraction.

The benefits of long-term oral ß-blocker therapy in patients with ST-segment elevation myocardial infarction (STEMI) with mildly reduced left ventricular ejection fraction (LVEF; ≥40%) are still unknown. We sought to evaluate the efficacy of ß-blocker therapy in patients with STEMI with mildly reduced LVEF. In the CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-Scale Randomized Controlled Trial), patients with STEMI with successful percutaneous coronary intervention with an LVEF of ≥40% were randomly assigned to carvedilol or no ß-blocker therapy. Among 794 patients, 280 patients had an LVEF of <55% at baseline (mildly reduced LVEF stratum), whereas 514 patients had an LVEF of ≥55% at baseline (normal LVEF stratum). The primary end point was a composite of all-cause death, myocardial infarction, hospitalization for acute coronary syndrome, and hospitalization for heart failure, and the secondary end point was a cardiac composite outcome: a composite of cardiac death, myocardial infarction, and hospitalization for heart failure. The median follow-up period was 3.7 years. The lower risk of carvedilol therapy relative to no ß-blocker therapy was not significant for the primary end point in either the mildly reduced or normal LVEF strata. However, it was significant for the cardiac composite end point in the mildly reduced LVEF stratum (0.82/100 person-years vs 2.59/100 person-years, hazard ratio 0.32 [0.10 to 0.99], p = 0.047) but not in the normal LVEF stratum (1.48/100 person-years vs 1.06/100 person-years, hazard ratio 1.39 [0.62 to 3.13], p = 0.43, p for interaction = 0.04). In conclusion, long-term carvedilol therapy in patients with STEMI with primary percutaneous coronary intervention might be beneficial for preventing cardiac-related events in those with a mildly reduced LVEF.

Rewiring to the dissected branch along the jailed balloon (Real JAB technique)-A novel rewiring technique for the dissected branch in bifurcation lesion-case report.

Guidewire recrossing into the branch through the stent strut is difficult when that branch was injured or occluded after stenting in the true bifurcation lesion. A 72-year-old man with chronic total occlusion in both mid-left anterior descending coronary artery (LAD) and 2nd diagonal branch (D) was admitted to our hospital. We put a 2.25 × 38 mm drug-eluting stent from the LAD to the D with culotte stenting. However, the LAD occluded after stenting. Although we tried to recross, it was impossible because the guidewire migrated subintimal space which was caused by guidewire manipulation. So, we advanced a 2.25 mm balloon catheter on the 1st guidewire which had already been placed outside of the stent in the LAD, and inflated it at bifurcation to compress the subintimal space. Subsequently, we advanced another guidewire through the strut along the surface of the balloon catheter. Immediately after the deflation of the balloon, the guidewire slipped into the distal LAD without resistance. Large branch occlusion after stenting is a serious complication in true bifurcation treatment. Our new bailout technique is effective for recrossing a guidewire into the dissected branch to preserve it. .