Transition from WATCHMAN generation-2.5 device to WATCHMAN FLX device for percutaneous left atrial appendage closure: Incidence and predictors of device-related thrombosis and short- to mid-term outcomes.

BACKGROUND: Patients with nonvalvular atrial fibrillation (AF) not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC) using the WATCHMAN device. The safety and efficacy of WATCHMAN-FLX (WM-FLX) compared with WATCHMAN-2.5 (WM-2.5), particularly in Asian populations, is unknown. METHODS: We evaluated the background, procedure, and clinical outcomes of 199 patients who underwent LAAC between September 2019 and December 2022 and compared WM-2.5 (72 patients) with WM-FLX (127 patients). RESULTS: The mean age was 76 years, with 128 men, and 100 had nonparoxysmal AF (non-PAF). The mean CHA2DS2-VASc, and HAS-BLED were 5.1, and 3.2 points, respectively. WM-FLX group demonstrated a shorter procedure time than WM-2.5 group (50 vs. 42 min, p = 0.001). The WM-FLX group demonstrated no procedural-related acute cardiac tamponade, which was significantly low (5.6% vs. 0%, p = 0.02), and a significantly higher rate of complete seal at 45-day (63% vs. 80%, p = 0.04). WM-FLX group had a significantly higher cumulative 1-year incidence of device-related thrombosis (DRT) than WM-2.5 group (3.4% vs. 7.0%, Log-rank p = 0.01). Univariate analysis identified two DRT risk factors in the WM-FLX group: non-PAF (odds ratio [OR] 7.72; 95% confidence interval [CI] 1.20-48.7; p = 0.04), and 35-mm device (OR 5.13; 95% CI 1.31-19.8; p = 0.02). CONCLUSIONS: WM-FLX significantly improved the procedural quality and safety of LAAC. However, DRT remains an important issue even in the novel LAAC device, being a hazard for patients with high DRT risk, such as having non-PAF and using 35-mm devices.

Fifteen-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation.

BACKGROUND: Clinical outcomes after percutaneous coronary intervention have improved with the use of drug-eluting stents, but data beyond 10 years are limited. The purpose of this study was to evaluate the clinical outcomes of patients undergoing sirolimus-eluting stent implantation with follow-up beyond 10 years and to determine the impact of clinical and angiographic characteristics on long-term prognosis. METHODS AND RESULTS: The clinical outcomes of 885 patients who had undergone sirolimus-eluting stent implantation at a single institution were retrospectively reviewed. Primary endpoints included in the analysis were clinically driven target lesion revascularization (cTLR) and target lesion revascularization (TLR). Univariate and multivariate nominal logistic regression was used for data analysis. The incidence rates of cTLR and TLR beyond 10 years after sirolimus-eluting stent implantation were 16.4% and 36.8%, respectively, with cTLR tending to decrease beyond 10 years. Acute coronary syndrome was a predominant trigger for cTLR. Age, statin use, and stent restenosis emerged as predictors of cTLR within 10 years, but no significant predictors other than age were identified beyond 10 years. CONCLUSIONS: Events continue to occur beyond 10 years after sirolimus-eluting stent implantation, with a trend toward an increase in acute coronary syndromes. It is important to be vigilant about the occurrence of acute coronary syndromes during long-term follow-up.

Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices　- Insight From the OCEAN-LAAC Registry.

BACKGROUND: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients. METHODS AND RESULTS: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). CONCLUSIONS: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

Comparison of left atrial appendage measurements between conventional transesophageal echocardiography and "Virtual TEE" reconstructed from computed tomography for pre-procedural planning of device closure.

For pre-procedural planning of left atrial appendage (LAA) closure, sizing is crucial. Although transesophageal echocardiography (TEE) is a standard modality, cardiac computed tomography (CT) is also widely used. The virtual TEE (V-TEE) that our group developed enables us to reconstruct images similar to TEE images from CT images. The software should be helpful to understand and plan the procedure strategy. Accordingly, we investigated the utility of V-TEE. Sixty-six patients at 4 participating sites who completed both CT and TEE prior to LAA closure were included. The LAA diameter at the landing zone (LZ) for WATCHMAN™ device implantation was statistically compared at 0°, 45°, 90°, and 135° between V-TEE and TEE. Among 66 cases, only 3 cases were excluded due to poor imaging quality, and 63 cases were analyzed. The device LZ diameters based on V-TEE were strongly correlated with those based on TEE, despite the significantly greater diameter based on V-TEE with mean differences of 2.4 to 3.0 mm (all of them: P < 0.001). The discordances (V-TEE/TEE ratio) at most angles were significantly larger in the elliptical LAAs. V-TEE provides a valuable method for the evaluation of the LAA diameters. V-TEE-based measurements were larger than conventional TEE-based measurements, especially in cases of elliptical LAAs. The assessment by V-TEE has the potential benefit of ensuring proper device sizing regardless of the LAA morphology.

Association between preprocedural thromboembolic and bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure.

Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC) with preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy. We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into three groups based on preprocedural thromboembolic or bleeding events under OAC therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3 year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32-15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45-58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with the conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.

Long-Term Clinical Outcome After Alcohol Septal Ablation and Its Periprocedural Predictive Factors in Japan　- A Retrospective Observational Study.

BACKGROUND: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.Methods and Results: This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34-57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively. CONCLUSIONS: This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure.

Predictors of success and puncture site complications in the distal radial approach.

The distal radial approach (DRA) has been proposed as an alternative approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI); however, the predictors of DRA failure and puncture site complications are unclear. Among 7153 consecutive patients undergoing CAG or PCI between November 2018 and January 2021, 3610 patients undergoing CAG or PCI with DRA were analyzed. The primary endpoint of this study was the procedural success, and the secondary endpoint of this study was puncture site complications during procedure. Puncture site complications during procedure were defined as a composite of major bleeding, minor bleeding, arteriovenous fistula, pseudoaneurysm, and neuropathy. The DRA success rate and the puncture site complication rate were 90.4% and 7.7%, respectively. The predictors of DRA failure were low body weight and dual antiplatelet therapy; those of DRA success were PCI and ultrasonography-guided DRA; those of puncture site complications during procedure were low body weight, peripheral arterial disease, dual antiplatelet therapy, anticoagulant therapy, and PCI; and that of no puncture site complications were previous PCI and ultrasonography-guided DRA. The negative predictors of DRA success with no puncture site complication during procedure were low body weight and dual antiplatelet therapy. The positive predictor of DRA success with no puncture site complication during procedure was ultrasonography-guided DRA. We identified the predictors of DRA failure and puncture site complications during procedure in patients undergoing CAG and PCI with DRA. Ultrasonography-guided DRA was associated with a high DRA success rate and a low puncture site complication rate in patients undergoing CAG or PCI with DRA.

MitraClip Treatment of Moderate-to-Severe and Severe Mitral Regurgitation in High Surgical Risk Patients　- Real-World 1-Year Outcomes From Japan.

BACKGROUND: The MitraClip NT System was approved for marketing in Japan on October 31, 2017, and a prospective, multi-center, single-arm Post-Marketing use Surveillance (PMS) study was launched in 2018. This is the first report of the Japan PMS study with 1-year subject outcomes.Methods and Results:A total of 500 patients were registered between April 2018 and January 2019. Patients with symptomatic chronic moderate-to-severe (3+) or severe mitral regurgitation (MR; 4+), MR with a Society of Thoracic Surgery (STS) replacement score of ≥8%, or presence of 1 pre-defined risk factor were enrolled. Primary outcome measures included acute procedural success (APS), and rate of Single Leaflet Device Attachment (SLDA) at 30 days. The overall cohort was elderly (77.9±9.48 years) with functional MR etiology in 71.6% of the subjects. The majority of subjects were New York Heart Association (NYHA) class III/IV (68.9%), with mean STS replacement score of 11.95±9.66%. The APS rate was 91.13% and the 30-day SLDA rate was 1.21%. Durable MR reduction was achieved with 88.1% of subjects at MR ≤2+ at 1 year. Significant improvement in the functional capacity was observed, with 93% of subjects at NYHA class I/II at 1 year. CONCLUSIONS: In the Japan PMS experience, the MitraClip procedure resulted in improvements in MR severity, with significantly improved functional outcomes. These results demonstrate safety and efficacy of MitraClip therapy in the eligible Japanese population.

Comparison and Validation of Long-Term Bleeding Events for Academic Bleeding Risk (ARC-HBR) Criteria and Contemporary Risk Scores for Percutaneous Coronary Intervention With a Second-Generation Drug Eluting Stent.

BACKGROUND: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined a consensus clinical criterion for patients at HBR undergoing percutaneous coronary intervention (PCI). This study aimed to validate and compare the ARC-HBR criteria and the contemporary risk score for long-term bleeding outcomes using a cohort of patients undergoing PCI.Methods and Results: This study analyzed 3,410 patients who underwent PCI between 2010 and 2013. The endpoint was defined as incidence of The Bleeding Academic Research Consortium 3 or 5 bleeding events. In addition to ARC-HBR, this study validated the predictability of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score, Patterns of non-adherence to Anti-platelet Regimens In Stented patients (PARIS) bleeding score, and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) bleeding scores for bleeding events. There was a trend toward an increase in bleeding events, as the risk score increased for all bleeding risk scores used in this study. The ARC-HBR criteria had higher diagnostic sensitivity for bleeding events than other bleeding risk scores. CONCLUSIONS: Patients with a higher number of risk factors in each of the four bleeding risk scores had a higher risk of long-term bleeding events. In comparison to other contemporary risk scores, the ARC-HBR criteria were more sensitive in the identification of patients with bleeding events in the long-term.

Gastrointestinal and Intracranial Bleeding Events After Second-Generation Drug-Eluting Stent Implantation　- Their Association With High Bleeding Risk, Predictors, and Clinical Outcomes.

BACKGROUND: Gastrointestinal bleeding (GIB) and intracranial bleeding (ICB) are frequently observed as major bleeding events after percutaneous coronary intervention (PCI); however, there are few reports on these predictors and their association with the Academic Research Consortium for High Bleeding Risk (ARC-HBR).Methods and Results: The study included 3,453 patients who underwent PCI with second-generation drug-eluting stents between 2010 and 2013. Mean follow up was 2,663±596 days. The cumulative incidences of GIB and ICB were significantly higher in the HBR group than in the non-HBR group (6.3% vs. 1.9%, P<0.001, 5.5% vs. 2.3%, P<0.001). Older age, oral anticoagulant (OAC), and severe chronic kidney disease were independent predictors of GIB (hazard ratios [HR], 1.64; 95% confidence intervals [CI], 1.11-2.41; P=0.012; HR, 1.94; 95% CI, 1.23-3.05; P=0.004; HR, 1.80; 95% CI, 1.02-3.19, P=0.043 respectively), and low body weight, OAC, and left main coronary artery stenting were independent predictors of ICB by multivariate logistic regression analysis (HR, 1.83; 95% CI, 1.20-2.80; P=0.005; HR, 2.04; 95% CI, 1.31-3.19; P=0.002; HR, 1.79; 95% CI, 1.18-2.70; P=0.006 respectively). CONCLUSIONS: ARC-HBR was consistently associated with GIB and ICB within a 7-year period. GIB and ICB had three predictors each. Of these, only OAC administration was common, and the other two were different.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events.

BACKGROUND: The validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definitions of early (<1 year), late (1-4 years), and very late (>4 years) bleeding events is unknown.Methods and Results:This study was performed on patients (n=3,453) implanted with second-generation drug-eluting stents (DES) between 2010 and 2013. Data on all criteria of the ARC-HBR definition were collected retrospectively. The primary endpoint was Bleeding Academic Research Consortium Type 3 or 5 bleeding events; the ischemic endpoint was a composite of cardiac death, myocardial infarction, and ischemic stroke. The mean follow-up period was 7.5 years. Compared with non-high bleeding risk (HBR) patients, HBR patients (n=1,840; 53.3%) had an increased risk of the primary endpoint (early events, 3.6% vs. 0.5% [P<0.0001]; late events, 5.3% vs. 2.5% [P<0.0001]; very late events, 5.5% vs. 2.1% [P<0.0001]) and of ischemic events during follow-up. The discrimination ability of the ARC-HBR definition for late and very late bleeding events was comparable to that of early bleeding events (C statistics 0.679, 0.621, and 0.620, respectively) with high negative predictive value (96.6%, 95.1%, and 93.1%, respectively). Multivariate analysis revealed the different effects of individual criteria on bleeding events in each follow-up period. CONCLUSIONS: The ARC-HBR definition consistently identified patients at risk of long-term bleeding and ischemic events after second-generation DES implantation.

Outcomes at 1 Year of Non-Left Main Trunk Bifurcation Lesions Treated With a 2-Stent Strategy Using Newer-Generation Everolimus-Eluting Stents.

BACKGROUND: Percutaneous coronary intervention (PCI) for coronary bifurcation lesions using the 2-stent strategy remains a challenging procedure for interventionalists because of the higher incidence of in-stent restenosis (ISR) and adverse events. ISR predictors in patients treated with newer-generation everolimus-eluting stents (EES) and the 2-stent strategy remain unknown. Hence, we aimed to evaluate the 1-year clinical and angiographic outcomes of non-left main trunk (LMT) bifurcation lesions treated with the 2-stent strategy using newer-generation EES.Methods and Results:The study sample consisted of 262 non-LMT bifurcation lesions treated using culotte or T-stenting with EES between 2010 and 2018. One-year post-procedural angiographic and clinical examinations were conducted in 208 (79.4%) and 260 (99.2%) lesions, respectively. The primary outcome measure was the 1-year post-procedural ISR rate, which was found to be 15.9%. Independent predictors of 1-year post-procedural ISR were long side branch lesions (adjusted odds ratio [aOR] 2.31; 95% confidence interval [CI] 1.02-5.23; P=0.04) and 3-link EES implantation (aOR 2.45; 95% CI 1.07-5.61; P=0.03). The 1-year cumulative incidence of target lesion revascularization was 3.5%. CONCLUSIONS: The 1-year clinical outcomes of non-LMT bifurcation lesions treated with the 2-stent strategy using EES were acceptable. Long side branch lesions and lesions treated with 3-link EES were independent predictors of 1-year post-procedural ISR.

Left atrial appendage size in patients with atrial fibrillation in Japan and the United States.

Left atrial appendage (LAA) evaluation is important to select the optimal LAA closure device for patients with atrial fibrillation (AF). The LAA characteristics of Japanese patients remain uninvestigated. We compared the LAA size and morphology between 212 Japanese AF patients before catheter ablation and 119 AF patients undergoing LAA closure in the United States (US). We measured the LAA ostial dimension and depth by transesophageal echocardiography in all patients and determined the LAA morphology types of Japanese patients by multidetector cardiac computed tomography and those of US patients by LAA angiography. The maximum LAA ostial dimension was significantly larger in Japanese patients than in US patients (22.6 ± 4.1 mm vs. 21.5 ± 3.5 mm, P = 0.02). Also, Japanese patients had larger maximum dimension and depth corrected by body surface area than US patients in both paroxysmal and nonparoxysmal AF groups. The angle showing the maximum dimension was 0° or 135° in approximately 75% of patients in both groups. The common LAA morphology types were "cauliflower" and "chicken wing" in Japanese patients and "cactus" and "windsock" in US patients. In this study, Japanese patients had a larger LAA size than US patients. Because the maximum LAA dimension was obtained at the same angles, the LAA measurement method for US patients can be applicable to Japanese patients.

Three-dimensional optical coherence tomography versus intravascular ultrasound in percutaneous coronary intervention for the left main coronary artery.

We aimed to compare the intravascular imaging findings, and clinical outcomes between three-dimensional optical coherence tomography (OCT)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for the left main coronary artery (LMCA). We enrolled 331 patients underwent OCT- or IVUS-guide single crossover stenting across the side branch (SB) and subsequent kissing balloon inflation (KBT) for LMCA bifurcation. Primary endpoint was defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization. Of 331 patients, 58 patients (17.5%) underwent OCT-guide PCI. OCT-guide PCI associated with higher frequency of proximal optimization technique (POT) (98.3% vs 85.3%, P = 0.013) and smaller balloon size of POT (4.29 ± 0.44 mm vs 4.43 ± 0.42, P = 0.02) than IVUS-guide PCI. Although maximal stent area at LMCA and minimal stent area at main vessel were significantly smaller in OCT-guide PCI in intravascular imaging (P = 0.01, and P = 0.002, respectively), the restenosis rate at follow-up angiography was comparable in both groups (15.2% vs. 9.4%, P = 0.387). Cumulative rate of primary endpoint was not significantly different between 2 groups both before and after propensity score adjustment (7.0% vs. 7.4%, P = 0.98 and 2.6% vs. 7.3%, P = 0.18). In conclusion, the clinical outcomes at 1 year were comparable, suggesting OCT- and IVUS-guided PCI for LMCA were similarly feasible. The balloon size of POT in OCT-guide PCI might be influenced by the limited visibility in the proximal LMCA.

Impact of high-dose statin on cardiovascular outcomes in real-world patients with ST-elevation acute myocardial infarction.

Little is known about the impact of a high-dose statin on cardiovascular outcomes after ST-elevation acute myocardial infarction (STEMI) in real-world Japanese patients. Between July 2011 and June 2017, 1110 consecutive STEMI patients underwent primary percutaneous coronary intervention at our hospital and were discharged. A high-dose statin was administered in 117 patients (10.5%) and non-high-dose statin was administered in 947 patients (85.3%). The low-density lipoprotein cholesterol level was significantly higher in the high-dose statin group at admission (129.8 ± 44.9 vs. 110.4 ± 32.7, p < 0.0001), but the levels were not significantly different at follow-up (86.7 ± 25.7 vs. 85.0 ± 25.0, p = 0.52). The cumulative 2-year incidence of a composite of cardiac death, myocardial infarction, ischemic stroke, and any unplanned coronary revascularization was significantly lower in the high-dose statin group (6.2% vs. 16.9%, log-rank p = 0.004). Propensity score matched analysis indicated similar results. Among the types of coronary revascularization, a high-dose statin was significantly correlated with a lower rate of de novo lesion revascularization (hazard ratio 0.31; 95% confidence interval 0.08-0.83; p = 0.02). The results of our analyses indicate that administration of a high-dose statin may result in better cardiovascular outcomes after STEMI mainly by reducing the rate of revascularization for de novo lesions regardless of the achieved low-density lipoprotein cholesterol level in real-world patients.

Clinical Outcomes and Angiographic Results of Bailout Stenting for Guide Catheter-Induced Iatrogenic Coronary Artery Dissection　- Impact of Stent Type.

BACKGROUND: Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear.Methods and Results:The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. CONCLUSIONS: The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.

Prevalence of the Academic Research Consortium for High Bleeding Risk Criteria and Prognostic Value of a Simplified Definition.

BACKGROUND: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria have been suggested as the standard definition of HBR. However, the prevalence of individual criteria and their prognostic value for long-term bleeding events after percutaneous coronary intervention are scarcely studied.Methods and Results:The study population comprised 1,193 patients treated with everolimus-eluting stents between 2010 and 2011. Data on all 17 major and minor criteria of the ARC-HBR definition were retrospectively collected, and applied to this study population. Major bleeding was defined as the occurrence of a BARC type 3 or 5 bleeding event. A simplified definition was developed by excluding the low-frequency criterion, and the prognostic value was assessed by a receiver-operating characteristic curve. Mean follow-up was 2,996±433 days and there were 656 HBR patients (55.0%). The cumulative incidence of major bleeding was significantly higher in the HBR group than in the non-HBR group (16.2% vs. 5.7% at 8 years, P<0.001). The frequencies of 6 of the 17 criteria were less than 1%. The prognostic value of the simplified definition made by excluding these 6 criteria for major bleeding was comparable to that of the original (c-statistic=0.598 and 0.600, P=0.08). CONCLUSIONS: Some risk criteria of the ARC-HBR definition are observed infrequently. Our simplified definition identified patients with long-term bleeding risk as successfully as the original definition.

Clinical and angiographic outcomes of true vs. false lumen stenting of coronary chronic total occlusions: Insights from intravascular ultrasound.

OBJECTIVES: The clinical implications of subintimal stenting (SS) of the recanalized chronic total occlusion (CTO) segment have not been characterized. We evaluated the in-hospital and the long-term clinical and angiographic outcomes of drug-eluting stents (DESs) deployed in true vs. false lumen of successfully recanalized CTO. METHODS AND RESULTS: Two independent reviewers analyzed the intravascular ultrasound (IVUS) images of 173 successfully recanalized CTO lesions (157 patients), between August 2011 and October 2012. After successful guidewire (GW) crossing, lesions were classified according to IVUS evaluation into two groups: (1) true lumen (TL) stenting group and (2) SS group; and compared with regards to in-hospital and long-term clinical outcomes. In 154 lesions, DESs were deployed in the TL; and in 19 (11%) lesions, DESs were deployed in the subintimal space (95% confidence interval: 6.3-15.6%). False GW tracking in the SS group resulted in increased rates of IVUS-detected dissection flaps (84% vs. 42.6%, P ≤ 0.001), intramural hematoma (32 vs. 11%, P = 0.01), and minor perforations 6/19 (31.6% vs. 8.4%, P = 0.002). At 1-year follow-up, both groups had similar cumulative rates of binary restenosis and target lesion revascularization (P = 0.73 and P = 0.97, respectively). Six patients (4.6%, 6/129 patients) in the TL group and none in the subintimal group died at 1 year. CONCLUSIONS: Acknowledging some limitations, our observations may suggest that, subintimal stent deployment in a recanalized CTO segments, using second generation DES and IVUS guidance, might have a comparable success rate and long-term angiographic and clinical outcomes as TL stenting.