Plaque calcification develops by the inflammation-dependent mechanisms involved in progression and regression of atherosclerosis. Macrophages can undergo two distinct polarization states, that is, ...pro-inflammatory M1 phenotype in progression and anti-inflammatory M2 phenotype in regression. In plaque progression, predominant M1 macrophages promote the initial calcium deposition within the necrotic core of the lesions, called as microcalcification, through not only vesicle-mediated mineralization as the result of apoptosis of macrophages and vascular smooth muscle cells (VSMCs), but also VSMC differentiation into early phase osteoblasts. On the other hand, in plaque regression M2 macrophages are engaged in the healing response to plaque inflammation. In association with the resolution of chronic inflammation, M2 macrophages may facilitate macroscopic calcium deposition, called as macrocalcification, through induction of osteoblastic differentiation and maturation of VSMCs. Oncostatin M, which has been shown to promote osteoblast differentiation in bone, may play a pivotal role in the development of plaque calcification. Clinically, two types of plaque calcification have distinct implications. Macrocalcification leads to plaque stability, while microcalcification is more likely to be associated with plaque rupture. Statin therapy, which reduces cardiovascular mortality, has been shown to exert its dual actions on plaque morphology, that is, regression of atheroma and increment of macroscopic calcium deposits. Statins may facilitate the healing process against plaque inflammation by enhancing M2 polarization of macrophages. Vascular calcification has pleiotropic properties as pro-inflammatory “microcalcification” and anti-inflammatory “macrocalcification”. The molecular mechanisms of this process in relation with plaque progression as well as plaque regression should be intensively elucidated.
Background:This observational study validated Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and the Predicting Bleeding Complication in Patients Undergoing Stent Implantation ...and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention.Methods and Results:Risk clusters of 939 STEMI patients with traceable 1-year outcomes were assessed according to ARC-HBR criteria and PRECISE-DAPT score. The diagnostic accuracy and first-year probability of bleeding events, defined as Bleeding Academic Research Consortium (BARC) 3 or 5, according to risk cluster were assessed. Of all patients, 42.9% and 46.8% were classified as HBR (ARC-HBR criteria) and at high risk (PRECISE-DAPT score), respectively, and bleeding events were observed in 13.7% and 16.2% of these patients. The C-statistic for ARC-HBR criteria and the PRECISEDAPT score was 0.60 and 0.69, respectively (P<0.01). Patients with mechanical hemodynamic support devices had high bleeding rates, even in the non-HBR group (22.6%), and excluding these patients improved the C-statistics, making them equivalent between the 2 models (0.72 vs. 0.74; P=0.53). Bleeding event probabilities (95% confidence intervals) were equivalent in high-risk patients in the 2 models (0.12 0.09–0.16 vs. 0.12 0.08–0.16).Conclusions:After exclusion of patients with mechanical devices, who had high bleeding event rates regardless of risk cluster, both ARC-HBR criteria and the PRECISE-DAPT score had high predictive ability.
Objective Cancers increase the risk of both arterial thrombosis and bleeding. The present study investigated whether or not comorbid new-onset cancers increase arterial thrombosis and bleeding events ...in patients after ST-elevation myocardial infarction (STEMI). Methods Among 918 consecutive STEMI patients, excluding 300 who used mechanical hemodynamic supportive devices, the 67 with cancer and 851 without cancer were compared with respect to the frequency of thrombotic events, consisting of myocardial infarction (MI) and ischemic stroke, and bleeding events during the trackable observation period in this observational study. The predictive accuracy for bleeding events evaluated by the Academic Research Consortium (ARC) high bleeding risk (HBR) criteria and the patients receiving stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score was assessed by C-statistics. Bleeding events were defined as type 3 or 5 according to the Bleeding Academic Research Consortium criteria. Results During the 1,233.3±1,284.4-day observation period, thrombotic events were observed in 13.4% of patients with cancer and 7.1% of patients without cancer (p=0.06; incidence rates, 2.4 vs. 2.4/100 person-years). MI and ischemic stroke were observed in 6.0% of patients with cancer and 3.5% of patients without cancer (p=0.23; incidence rates, 1.0 vs. 1.2/100 person-years) and 7.5% of patients with cancer and 3.6% of patients without cancer (p=0.18; incidence rates, 1.0 vs. 1.2/100 person-years), respectively. Bleeding events were observed in 26.9% of patients with cancer and 7.6% of patients without cancer (p<0.01; incidence rates, 4.4 vs. 2.4/100 person-years). The C-statistics for predicting bleeding events in patients with and without cancer were 0.65 vs. 0.71 using the ARC-HBR criteria and 0.67 vs. 0.71 using the PRECISE-DAPT scores, respectively. Conclusion Cancers increase unpredictable bleeding but not arterial thrombotic events in patients after STEMI.
Background:Acute coronary syndrome (ACS) hospital survivors experience a wide array of late adverse cardiac events, despite considerable advances in the quality of care. We investigated 30-day and ...1-year outcomes of ACS hospital survivors using a Japanese nationwide cohort.Methods and Results:We studied 20,042 ACS patients who underwent percutaneous coronary intervention (PCI) in 2017: 10,242 (51%) with ST-elevation myocardial infarction (STEMI), 3,027 (15%) with non-ST-elevation myocardial infarction (NSTEMI), and 6,773 (34%) with unstable angina (UA). The mean (±SD) age was 69.6±12.4 years, 77% of the patients were men, and 20% had a previous history of PCI. The overall 30-day all-cause, cardiac, and non-cardiac mortality rates were 3.0%, 2.4%, and 0.6%, respectively. The overall 1-year incidence of all-cause, cardiac, and non-cardiac death was 7.1%, 4.2%, and 2.8%, respectively. Compared with UA patients, STEMI patients had a higher risk of all fatal events, non-fatal ischemic stroke, and acute heart failure, and NSTEMI patients had a higher risk of heart failure.Conclusions:The results from our ACS hospital survivor PCI database suggest the need to improve care for the acute myocardial infarction population to lessen the burden of 30-day mortality due to ACS, heart failure, and sudden cardiac death, as well as 1-year ischemic stroke and heart failure events.
Background:With the rapid spread of COVID-19, hospitals providing percutaneous coronary intervention (PCI) were placed in unique and unfamiliar circumstances. This study evaluated variations in the ...treatment of coronary artery disease according to time course of the COVID-19 pandemic in Japan.Methods and Results:The Japanese Association of Cardiovascular Intervention and Therapeutics performed serial surveys during the pandemic (in mid-April, late-April and mid-May 2020) with queries regarding the implementation of PCI. Hospitals were asked about their treatment strategies for elective PCI and emergency PCI for ST-elevation myocardial infarction (STEMI) and high-risk acute coronary syndrome (ACS) patients. Most hospitals opted to perform primary PCI in the usual manner at the beginning of the pandemic. As the pandemic progressed, hospitals in the 7 populated areas downgraded the performance of PCI for chronic coronary syndrome and high-risk ACS, but not for STEMI patients. After the state of emergency was lifted in most prefectures in mid-May, the rate of PCI gradually normalized. Screening tests, such as polymerase chain reaction and chest computed tomography, in ACS were frequently used.Conclusions:The COVID-19 pandemic greatly affected PCI treatment in Japan. However, even in the most critical situations during the pandemic, most institutions continued to perform primary PCI normally for STEMI patients.
Rotational atherectomy (RA) has been widely used for percutaneous coronary intervention (PCI) to severely calcified lesions. As compared to other countries, RA in Japan has uniquely developed with ...the aid of greater usage of intravascular imaging devices such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT). IVUS has been used to understand the guidewire bias and to decide appropriate burr sizes during RA, whereas OCT can also provide the thickness of calcification. Owing to such abundant experiences, Japanese RA operators modified RA techniques and reported unique evidences regarding RA. The Task Force on Rotational Atherectomy of the J apanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document to summarize the contemporary techniques and evidences regarding RA.
Introduction
The transradial approach is the standard for percutaneous coronary intervention (PCI). Moreover, to lead to the evolution of PCI, a new approach site was developed, namely the distal ...radial approach (dRA).
Anatomy and vessel diameter
The vessel diameter of the distal radial artery is smaller than that of the forearm radial artery; hence, use of 1 Fr size or a sheath with a thinner outer diameter is recommended. Ultrasound examination before the procedure provides useful information on this matter.
Puncture
There are two approaches to puncture: proximal site puncture of the distal radial artery and distal site puncture. Based on anatomical characteristics, the puncture angle is large on the former and small on the latter. Although a learning curve for the dRA puncture is needed, the use of ultrasound facilitates the process.
Hemostasis
Using a hemostatic device dedicated to the dRA simplifies observation after PCI. Hemostatic devices for the conventional radial approach or simple bandage with an elastic band can be useful. Usually, less hemostasis time is needed for the dRA compared with the conventional radial approach.
Success rate
Studies have shown high success rates of the dRA (approximately 88–99.5%).
Advantages and disadvantages
Advantages of the dRA are patient comfort, short hemostasis time, less restraint for the patients after PCI, and easy observation at the ward. Disadvantages are the learning curve required for the puncture and the small diameter of the distal radial artery.
Conclusion
The dRA is a new approach site for PCI. Further research is warranted for the selection of suitable patients to undergo PCI through the dRA.
Background:Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) ...for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction MI, and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.Conclusions:Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).
Background: Fulminant myocarditis (FM) is rare but has an extremely poor prognosis. Impella, a catheter-based heart pump, is a new therapeutic strategy, but reports regarding its health economics are ...lacking.Methods and Results: This retrospective cohort study compared Impella treatment (Group I) with existing treatments (Group E) using medical data collected from October 2017 to September 2021, with a 1-year analysis period. Cost-effectiveness indices were life-years (LY; effect index) and medical fee amount (cost index). Results were validated using probabilistic sensitivity analysis. The incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted LY (QALY) and medical costs. Each group included 7 patients, and more than half (57.1%) received combined Impella plus extracorporeal membrane oxygenation. There was no significant difference between Groups I and E in 1-year mortality rates (28.6% vs. 57.1%, respectively) or LY (mean ±SD 163.1±128.3 vs. 107.8±127.3 days, respectively), but mortality risk was significantly lower in Group I than Group E (95% confidence interval 0.02–0.96; P<0.05). Compared with Group E, Group I had higher total costs (9,270,597±4,121,875 vs. 6,397,466±3,801,364 JPY/year; P=0.20) and higher cost-effectiveness (32,443,987±14,742,966 vs. 92,637,756±98,225,604 JPY/LY; P=0.74), which was confirmed in the sensitivity analysis. ICER probability distribution showed 23.2% and 51.5% reductions below 5 million and 10 million JPY/QALY, respectively.Conclusions: Impella treatment is more cost-effective than conventional FM treatments. Large-scale studies are needed to validate the added effects and increasing costs.
Background: Transesophageal echocardiography (TEE) has been used for percutaneous atrial septal defect (ASD) closure, with intracardiac echocardiography (ICE) guidance recently being ...introduced.Methods and Results: The Japanese Structural Heart Disease Registry was established by the Japanese Association of Cardiovascular Intervention and Therapeutics. This study analyzed data from the Registry for 2,859 consecutive cases undergoing percutaneous ASD closure between January 2015 and December 2020. ASD closure was performed under ICE guidance (n=519; 18.2%), TEE guidance (n=1,428; 49.9%), or TEE plus ICE guidance (“Both”; n=900 cases; 31.5%). The success rates were similar in the TEE, ICE, and both groups (99.0%, 99.2%, vs. 98.0%, respectively; P=0.054), as were complication rates (1.2%, 0.5%, vs. 2.1%, respectively; P=0.24). In the TEE and Both groups, 92.4% and 79.6% of patients required general anesthesia, compared with only 2.9% of patients in the ICE group (P<0.001). Fluoroscopic time was longer in the ICE and Both groups than in the TEE group (median interquartile range 19 14–28 and 21 13–30 vs. 12 8–19 min, respectively; P<0.001). Rim deficiency and larger defect diameter were inversely related, whereas hospital volume was positively related to ICE guidance.Conclusions: Percutaneous transcatheter ASD closure was as feasible under ICE as under TEE guidance. ICE guidance is used for less challenging cases in high-volume centers in Japan.
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