Association of Plasma Cabozantinib Concentration With Treatment Response and Adverse Events in Japanese Patients With Advanced Renal Cell Carcinoma.

BACKGROUND: Cabozantinib is highly effective against advanced renal cell carcinoma (RCC). However, approximately 60% of the patients require a dose reduction due to severe adverse events. Although associations between trough concentrations of cabozantinib and its efficacy and safety have been reported in other countries, reports on Japanese patients are unavailable. Therefore, we investigated the association of cabozantinib trough concentration with therapeutic efficacy and adverse events in Japanese patients with RCC and evaluated the usefulness of therapeutic drug monitoring. METHODS: In this prospective observational study, we measured the trough concentrations of cabozantinib in 10 Japanese patients with RCC enrolled between May 2022 and September 2023. The associations of trough concentration with treatment response, as determined by RECIST 1.1, and the occurrence of grade 2 or higher adverse events were assessed. RESULTS: Trough concentration was higher in patients with controlled cancer than in those with progressive cancer (1024 ± 352 versus 457 ± 216 ng/mL, P = 0.035). In addition, patients with grade 2 or higher adverse events showed a significantly higher trough concentration than those without (1560 ± 513 versus 807 ± 319 ng/mL, P = 0.032). In particular, grade 2 or higher dysgeusia, anorexia, fatigue, and dyspepsia significantly correlated with trough concentrations. CONCLUSIONS: This is the first clinical study to demonstrate a correlation between cabozantinib trough concentration, therapeutic efficacy, and adverse events in Japanese patients with RCC. The therapeutic drug monitoring of cabozantinib could be useful for improving therapeutic efficacy and avoiding serious adverse events.

Effect of Patient's Symptom Interpretation on In-Hospital Mortality in Acute Coronary Syndrome.

BACKGROUND: The association between symptom interpretation and prognosis has not been investigated well among patients with acute coronary syndrome (ACS). As such, the present study evaluated the effect of heart disease awareness among patients with ACS on in-hospital mortality. METHODS AND RESULTS: We performed a post hoc analysis of 1,979 consecutive patients with ASC with confirmed symptom interpretation on admission between 2014 and 2018, focusing on patient characteristics, recanalization time, and clinical outcomes. Upon admission, 1,264 patients interpreted their condition as cardiac disease, whereas 715 did not interpret their condition as cardiac disease. Although no significant difference was observed in door-to-balloon time between the 2 groups, onset-to-balloon time was significantly shorter among those who interpreted their condition as cardiac disease (254 vs. 345 min; P<0.001). Moreover, the hazard ratio (HR) for in-hospital mortality was significantly higher among those who did not interpret their condition as cardiac disease based on the Cox regression model adjusted for established risk factors (HR 1.73; 95% confidence interval 1.08-2.76; P=0.022). CONCLUSIONS: This study demonstrated that prehospital symptom interpretation was significantly associated with in-hospital clinical outcomes among patients with ACS. Moreover, the observed differences in clinical prognosis were not related to door-to-balloon time, but may be related to onset-to-balloon time.

One-Month Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation　- The REIWA Region-Wide Registry.

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain. METHODS AND RESULTS: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.

Importance of Flow Waveform and Flow Volume as Prognostic Indicators for the Patency of Infra-Inguinal Autologous Vein Bypass.

OBJECTIVE: To investigate the association of the intra-operative flow waveform and the flow volume with graft prognosis of the infra-inguinal vein bypass. METHODS: This was a retrospective study of intra-operative flowmetry performed for infra-inguinal autologous vein bypass between 2011 and 2020. Flow waveforms were classified as type 0 - IV according to the Kyushu University (KU) classification. The patients (n = 340) were divided into three groups based on the flow waveform predicting the graft patency: type 0/I (long patency), type II (no early occlusion but late occlusion possible), and type III/IV (early occlusion). The graft occlusion rates of popliteal artery bypass (PAB) and infrapopliteal artery bypass (IPAB) within 30 days of surgery were compared between type 0/I + II and type III/IV groups, while the midterm graft patency rates were compared between type 0/I and type II groups. Additionally, a multivariate analysis was performed to identify independent risk factors for early and late graft occlusion. RESULTS: The early graft occlusion rates of type 0/I + II and type III/IV groups were 3.9% and 0%, respectively, (p = 1.0) for PAB, and 5.3% and 46.2%, respectively, (p < .001) for IPAB. The two year primary patency rates of type 0/I and type II groups were 91% and 75%, respectively, (p = .030) for PAB, and 58% and 63%, respectively, (p = .72) for IPAB. Independent risk factors for early occlusion were none in PAB and flow waveform (type IV) in IPAB. Independent risk factors for patency loss in PAB were flow waveform (type II), end stage renal disease, and dual antiplatelet use, and those in IPAB were older age, women, lower flow volume, and iterative bypass. CONCLUSION: Intra-operative flowmetry is useful for predicting the graft prognosis in infra-inguinal vein bypass and this is dependent on the distal target artery.

Angioscopic Comparison of Early- and Mid-Term Vascular Responses Following Treatment of ST-Elevation Acute Myocardial Infarction With Biodegradable vs. Durable Polymer Everolimus-Eluting Stents　- A Prespecified Subanalysis of the MECHANISM AMI RCT.

BACKGROUND: The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P>0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023). CONCLUSIONS: Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

Comparing In-Hospital Outcomes for Acute Myocardial Infarction Patients in High-Volume Hospitals Performing Primary Percutaneous Coronary Intervention vs. Regional General Hospitals.

BACKGROUND: It has been reported that patients with acute myocardial infarction (AMI) transferred to low-volume primary percutaneous coronary intervention (PCI) hospitals (<115/year) in low population density areas experience higher in-hospital mortality rates. This study compared in-hospital outcomes of patients admitted to high-volume primary PCI hospitals (≥115/year) with those for other regional general hospitals.Methods and Results: Retrospective analysis was conducted on data obtained from 2,453 patients with AMI admitted to hospitals in Iwate Prefecture (2014-2018). Multivariate analysis revealed that the in-hospital mortality rate of AMI among patients in regional general hospitals was significantly higher than among patients in high-volume hospitals. However, no significant difference in mortality rate was observed among patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. Although no significant difference was found in the in-hospital mortality rate of patients with Killip class I STEMI, significantly lower in-hospital mortality rates were observed in patients admitted in high-volume hospitals for Killip classes II, III, and IV. CONCLUSIONS: Although in-hospital outcomes for patients with STEMI undergoing primary PCI were similar, patients with heart failure or cardiogenic shock exhibited better in-hospital outcomes in high-volume primary PCI hospitals than those in regional general hospitals.

Use of the 11-Item Modified Frailty Index to Determine Accurate Prognosis and Revascularization Strategy in Patients Undergoing Vascular Bypass Surgery for Intermittent Claudication.

BACKGROUND: In cases of intermittent claudication (IC) where traditionally noninvasive management yields unsatisfactory results, revascularization strategy in IC patients is generally decided based on anatomical considerations and the availability of a saphenous vein graft. Life expectancy should also be considered. This study aimed to investigate the relationship between the 11-item modified frailty index (mFI-11) and the overall survival (OS) in patients with IC who underwent vascular bypass surgery to facilitate revascularization strategy selection. METHODS: We reviewed the records of 144 consecutive patients (153 lower limbs) who underwent infrainguinal bypass for IC between 2011 and 2020. Patients were divided into 2 groups based on their mFI-11 score: high frailty (H), mFI score >0.3; and low frailty (L), mFI score ≤0.3. The OS was compared among the 2 groups. Rates of graft patency and freedom from major adverse limb event (ffMALE) were also determined and compared. RESULTS: Five-year OS in the L and H groups was 92% and 55% (P < 0.001). Multivariate analysis showed that mFI, age, and end-stage renal disease were independent predictors of OS. Five-year rates of primary and secondary patency and ffMALE for vein grafts were 81%, 91%, and 94%, respectively; those for prosthetic grafts were 65%, 80%, and 84%, respectively; the differences were not significant. CONCLUSIONS: The mFI-11 was a helpful tool in predicting OS for patients with IC who underwent vascular bypass surgery. Those with H should not undergo open revascularization; however, for IC patients who have either not responded to a regimen of exercise and medication, or have specifically requested a more aggressive approach, obtaining a good score in frailty assessment is useful in determining whether or not bypass surgery would be a viable option.

Quantitative determination of plasma cabozantinib concentration using HPLC-UV and its application to patients with renal cell carcinoma.

Cabozantinib is an oral small-molecule tyrosine kinase inhibitor that has become a standard of care for advanced renal cell carcinoma (RCC). However, cabozantinib is associated with a high rate of adverse events. Therefore, individualised cabozantinib administration and monitoring could help maximise its therapeutic efficacy and avoid serious adverse events. This study developed and validated a method to determine cabozantinib concentration in plasma using HPLC-UV. Sorafenib, an internal standard, was added to the plasma sample containing cabozantinib. A calibration curve for cabozantinib showed good linearity (R2 = 1.00), between 25 and 4,000 ng/ml. The recovery rate was above 92.1%, and the intra- and inter-day coefficients of variation were smaller than 5.2 and 6.8%, respectively. Then, we applied the method for monitoring cabozantinib blood levels in three patients with advanced RCC who were taking cabozantinib at a dose of 20, 40 or 60 mg/day. Grade 3 adverse events were more likely to occur in patients with high dosing and blood level of cabozantinib. Owing to its simplicity, the developed method can be used in general hospitals, and is expected to help maximise drug efficacy and minimise serious adverse events in many patients with RCC undergoing cabozantinib treatment.

Impact of cilostazol on prevention of late failure of autologous vein grafts.

OBJECTIVES: The effectiveness of postoperative medication for the prevention of late graft failure is controversial. We conducted the present study to investigate whether cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass for chronic limb-threatening ischemia (CLTI). METHODS: From April 1994 to March 2022, we performed 590 de novo infrainguinal bypass procedures using autologous vein grafts (AVGs) in three hospitals. The bypass grafts were classified according to the postoperative prescription of cilostazol. The loss of graft patency and major adverse limb events (MALEs) were set as endpoints. Patients who died within 30 days and grafts that lost primary patency within 30 days after surgery were excluded. Data up to 3 years were analyzed. The cumulative primary patency (PP), assisted primary patency (AP), secondary patency (SP), and freedom from MALE (ffMALE) rates were calculated by the Kaplan-Meier method and compared between the cilostazol group and the non-cilostazol group. After a propensity score matching, same statistical analyses were performed. In addition, a Cox proportional hazards regression analysis that included preoperative factors, intraoperative factors, and postoperative medications was performed to identify whether cilostazol is an independent predictor for the outcomes. RESULTS: A total of 523 AVGs met inclusion criteria. Kaplan-Meier curves showed that the cilostazol group was superior to the non-cilostazol group in all outcomes, while the cilostazol group was superior to the non-cilostazol group in AP and SP after a propensity score matching. A multivariable analysis showed that non-use of cilostazol was identified as an independent predictor for loss of AP, SP, and ffMALE. CONCLUSIONS: Cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass.

Predictors of Irregular Protrusion After Everolimus-Eluting Stent Implantation in Patients with Stable Coronary Artery Disease.

This study aimed to investigate clinical and preintervention optical coherence tomography (OCT) findings to predict irregular protrusion (IRP) immediately after stent implantation.We evaluated 84 lesions treated with cobalt-chromium everolimus-eluting stent (CoCr-EES) from the MECHANISM Elective study. Patients were divided into two groups according to the presence of IRP [IRP: n = 16, non-IRP: n = 68]. Optical coherence tomography images before intervention and immediately after stenting were evaluated with standard qualitative and quantitative OCT analyses.Total cholesterol and the prevalence of ruptured plaque before intervention were significantly higher in the IRP group than in the non-IRP group [199 ± 37 mg/dL versus 176 ± 41 mg/dL; P = 0.022, 31% versus 7%; P = 0.008]. Total lipid length tended to be longer in the IRP group than in the non-IRP group [19.6 ± 9.2 mm versus 15.5 ± 9.3 mm; P = 0.090]. The prevalence of ruptured plaque, and total cholesterol levels were independent predictors of IRP immediately after stenting by multivariate logistic regression analysis [OR: 4.6, 95% confidence interval: 1.01-21.23, P = 0.048, OR: 1.02, 95% confidence interval: 1.00-1.03, P = 0.046]. IRP post-CoCr-EES implantation was completely resolved at follow-up OCT.The prevalence of ruptured plaque before intervention and total cholesterol levels were independent predictors of IRP after CoCr-EES implantation in patients with stable coronary artery disease.

Left coronary artery calcification patterns after coronary bypass graft surgery: An in-vivo optical coherence tomography study.

OBJECTIVES: We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG). BACKGROUND: CABG may accelerate upstream calcium development. METHODS: OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls. RESULTS: Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2]). CONCLUSIONS: Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls.

Distribution analysis of hydrogel spacer and evaluation of rectal dose reduction in Japanese prostate cancer patients undergoing stereotactic body radiation therapy.

BACKGROUND: To report on our primary experience with the placement of a hydrogel spacer following stereotactic body radiation therapy (SBRT) in low- and intermediate-risk prostate cancer patients and assess its impact on dosimetry as well as acute toxicity. METHODS: A total of 70 patients treated with SBRT (total dose of 36.25 Gy) in 5 fractions were included. Hydrogel spacers were inserted in 53 patients along with gold fiducial markers. For dosimetry, we trisected the rectum on the sagittal image of magnetic resonance imaging and defined it as the upper rectum (UR), middle rectum (MR), and lower rectum (LR). We compared the dose to each part of the rectum with and without hydrogel spacer using dose volume histograms. Genitourinary (GU) and gastrointestinal (GI) toxicity assessments were conducted until 6 months of follow-up visits. RESULTS: The median volume of the hydrogel spacer was 12.3 mL. Overall, the hydrogel spacer could significantly reduce the rectal dose in the middle-to-high-dose region (V20-V35). The rectum doses at the UR and MR were significantly lower in the spacer group in the middle to high dose region (V20-V35); the dose at the LR was significantly lower in the spacer group in the high-dose region (V30-V35). There was no grade ≥ 3 toxicity observed, but grade 2 toxicity of GU and GI occurred in 17.1% and 1.4% of the patients, respectively. CONCLUSION: Hydrogel spacers could contribute to rectal dose reduction, especially in high dose regions, by creating a prostate-rectum distance.

Coronary Flow Disturbance Phenomenon After Percutaneous Coronary Intervention Is Associated with New-Onset Atrial Fibrillation in Patients with Acute Myocardial Infarction.

Atrial fibrillation (AF) is a common complication of acute myocardial infarction (AMI). Although previous studies have investigated mortality rates and the incidences of adverse events associated with new-onset AF (NOAF) in patients with AMI, the effects of emergency percutaneous coronary intervention (PCI) on the incidence of NOAF in patients with AMI remain unclear. The purpose of this study was to investigate the relationship of clinical characteristics, medical history, and the coronary flow disturbance phenomenon (TIMI < 3) following emergency PCI with NOAF in patients with AMI. Between 2012 and 2016, 731 patients with AMI underwent PCI at our facility. Among these, 52 had a history of chronic/paroxysmal AF before admission and were excluded. The remaining 679 patients (mean age 66.4 years, 532 males) were analyzed in this retrospective observational study.New-onset AF was observed in 45 patients (6.6%). In univariate analysis, the hazard ratios (HRs) for patient age (HR 1.04, 95%CI 1.02-1.07), Killip II-IV (HR 2.34, 95%CI 1.29-4.23), elevated D-dimer level (> 1.0 µg/mL; HR 3.32; 95%CI 1.77-6.23), and coronary flow disturbance phenomenon (HR 5.61; 95%CI 2.88-10.9) were significantly higher in the NOAF group. In multivariate analysis, an elevated D-dimer level (> 1.0 µg/mL; HR 2.44; 95%CI 1.17-5.11) and coronary flow disturbance phenomenon (HR 4.61; 95%CI 2.29-9.27) were found to be independent risk factors for NOAF. An elevated D-dimer level at admission and the presence of coronary flow disturbance phenomenon after PCI were risk factors for NOAF following emergency PCI in patients with AMI.

Vascular Response Occurring at 3 Months After Everolimus-Eluting Cobalt-Chromium Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction vs. Stable Coronary Artery Disease.

BACKGROUND: Second-generation drug-eluting stents (DES) reduce the incidence of stent thrombosis, even in patients with ST-segment elevated myocardial infarction (STEMI). However, the early local vascular healing after DES implantation in STEMI lesions, which mainly concerns stent thrombosis, is still unclear.Methods and Results:We attempted to determine early local vascular healing 3 months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in STEMI lesions relative to stable coronary artery disease (CAD) lesions. This prospective, multicenter study analyzed 96 total lesions (STEMI=49, stable CAD=51) by frequency domain-optical coherence tomography (FD-OCT) performed post-procedure and at the 3-month follow-up. Although CoCr-EES implanted in STEMI were almost entirely covered at 3 months, they had a relatively high incidence of uncovered struts compared with stable CAD (5.5% vs. 1.6%, P<0.001). Intrastent thrombus in the 2 groups was primarily resolved at the 3-month follow-up (STEMI: 91.7%→26.5%, stable CAD: 74.5%→11.8%). Regarding irregular protrusion, complete resolution was observed in stable CAD (21.6%→0%), while a few stents remained in STEMI (79.2%→8.2%). Although there were almost no changes for the serial change of average lumen area in STEMI, there were slight but significant decreases in stable CAD [STEMI 0.08 (-0.44, 0.55) mm2, stable CAD -0.35 (-0.55, 0.11) mm2; P=0.009]. CONCLUSIONS: Although strut coverage after CoCr-EES implantation for STEMI lesions was slightly delayed, the healing process appeared to be acceptable in both STEMI and stable CAD.

Preoperative Nutritional Status is an Independent Predictor of the Long-Term Outcome in Patients Undergoing Open Bypass for Critical Limb Ischemia.

INTRODUCTION: The nutritional status before treatment has been reported to be significantly associated with the prognosis of patients with various diseases. The aim of this study was to examine whether or not this applies to patients undergoing open bypass for critical limb ischemia (CLI). METHODS: The preoperative nutritional status of patients who underwent de novo infrainguinal bypass for CLI from January 2000 to December 2017 was retrospectively evaluated using the geriatric nutritional risk index (GNRI) and controlling nutritional status (CONUT) score. Patients were divided into 4 groups based on the GNRI or CONUT score; group I, normal nutrition; group II, mild malnutrition; group III, moderate malnutrition, and group IV, severe malnutrition. The amputation-free survival (AFS), overall survival (OS), and limb salvage (LS) rates up to 5 years were calculated by Kaplan-Meier method and a Cox proportional hazard regression analysis was performed to elucidate whether or not the nutritional indices were independently associated with these outcomes. RESULTS: A total of 373 patients were included. The median observation term was 969 days. There were significant differences in the AFS and OS of the 4 groups divided based on the GNRI and CONUT score. The 2- and 5-year AFS rates of groups I, II, III, and IV, divided based on the GNRI, were 81% and 56%, 72% and 48%, 56% and 27%, and 56% and 12%, respectively (P < 0.001), while those based on the CONUT score were 75% and 55%, 72% and 41%, 50% and 6%, and 30% and 30%, respectively (P < 0.001). The GNRI (groups III + IV) was an independent predictor of AFS (Hazard ratio [HR], 1.85; 95% confidence interval [CI], 1.27-2.69; P < 0.001) and OS (HR, 2.26; 95% CI, 1.50-3.41; P < 0.001), while the CONUT score (groups III + IV) was also an independent predictor of AFS (HR, 1.68; 95% CI, 1.13-2.49; P = 0.011) and OS (HR, 1.64; 95% CI, 1.07-2.49; P = 0.024). However, neither nutritional index was an independent predictor of LS. CONCLUSIONS: The preoperative nutritional status, as measured by the GNRI or CONUT score, was significantly associated with AFS and OS in patients undergoing infrainguinal bypass for CLI.

Comparison of Archival Angiographic Findings in Patients Later Developing Acute Coronary Syndrome or Stable Angina.

Acute coronary syndrome (ACS) can develop in patients with mildly to moderately stenotic lesions. However, the angiographic characteristics of lesions in patients who will later develop ACS have not been systematically investigated. For this reason, we examined the earlier angiographic findings of such patients in a retrospective study.The study population consisted of 45 consecutive ACS and 45 stable angina (SA) patients who require revascularization. All of them had received cardiac catheterization within 5 years prior to onset, for different reasons. The detailed parameters of the earlier coronary angiographies at the culprit site the whole culprit vessel, and all three vessels were compared between the two groups.Mild-to-moderate stenosis was present exclusively at the culprit site in the earlier angiographies, both in ACS and SA patients. Lesions associated with ACS progression were significantly shorter in length than those associated with SA progression (11.5 ± 5.5 versus 16.1 ± 10.5 mm, P = 0.02) and were more eccentric (eccentricity index: 0.5 ± 0.3 versus 0.7 ± 0.3, P = 0.04). Percent diameter stenosis was similar (42.2 ± 14.5 versus 44.0 ± 13.8%, P = 0.5). The mean grading scores for plaque extension and size (1-3) were significantly lower in ACS than in SA (1.4 ± 0.6 versus 1.8 ± 0.6, P = 0.01, and 1.3 ± 0.6 versus 1.7 ± 0.7, P = 0.01, respectively). Residual SYNTAX scores were significantly lower in ACS (12.5 ± 7.4 versus 16.4 ± 8.6, P = 0.03).Despite equivalent degrees of stenosis in previous angiographies, ACS occurred more frequently in patients with more focal and eccentric lesions but with less diseased coronary arteries than SA.

[Reports of 12 Cases of Stanford Type A Acute Aortic Dissection Emergent Surgery for Jehovah's Witnesses patients].

The Jehovah's Witnesses (JW) is well known for declining blood transfusions. Especially, cardiovascular surgery on JW poses unique challenges. We herein report 12 JW emergent cases of Stanford type A acute aortic dissection which underwent graft replacement between 2003 and 2019. Graft replacement of ascending aorta was performed in all cases. Operative time and anesthetic time were 344±100 and 396±109 minutes respectively. The mean intraoperative hemoglobin nadir was 4.9±1.2 g/dl. The postoperative hemoglobin nadir was 6.3 ±2.4 g/dl. There were 2 deaths within 24 hours after surgery. We did not transfuse any packed red blood cells, fresh frozen plasma or platelets for JW patients of Stanford type A acute aortic dissection surgery.

Effect of orbital atherectomy in calcified coronary artery lesions as assessed by optical coherence tomography.

OBJECTIVES: We sought to assess plaque modification and stent expansion following orbital atherectomy (OA) for calcified lesions using optical coherence tomography (OCT). BACKGROUND: The efficacy of OA for treating calcified lesions is not well studied, especially using intravascular imaging in vivo. METHODS: OCT was performed preprocedure, post-OA, and post-stent (n = 58). Calcium modification after OA was defined as a round, concave, polished calcium surface. Calcium fracture was complete discontinuity of calcium. RESULTS: Comparing pre- vs post-OA OCT (n = 29), calcium area was significantly decreased post-OA (from 3.4 mm2 [2.4-4.7] to 2.9 mm2 [1.9-3.9], P < 0.001). Poststent percent calcium fracture (calcium fracture length/calcium length) correlated with post-OA percent calcium modification (calcium modification length/calcium length) (r = 0.31, P = 0.01). Among 75 calcium fractures in 35 lesions, maximum calcium thickness at the fracture site was greater with vs without calcium modification (0.58 mm [0.50-0.66] vs 0.45 mm [0.38-0.52], P = 0.003). Final optimal stent expansion, defined as minimum stent area ≥6.1 mm2 or stent expansion ≥90% (medians of this cohort) at the maximum calcium angle site, was observed in 41 lesions. Larger post-OA lumen area (odds ratio 2.64; 95% CI 1.21-5.76; P = 0.02) and the presence of calcium fracture (odds ratio 6.77; 95% CI 1.25-36.6; P = 0.03) were independent predictors for optimal stent expansion. CONCLUSIONS: Calcium modification by OA facilitates poststent calcium fracture even in thick calcium. Greater calcium modification correlated with greater calcium fracture, in turn resulting in better stent expansion.

Impact of the Geriatric Nutritional Risk Index on the Long-Term Outcomes of Patients Undergoing Open Bypass for Intermittent Claudication.

BACKGROUND: Nutritional status has been reported to be a predictor of the outcomes of critical limb ischemia. However, there have been no reports of the association between nutritional status and the prognosis of patients with intermittent claudication (IC). The aim of this study was to examine whether or not the geriatric nutritional risk index (GNRI) is independently associated with the long-term outcomes of elderly patients following open bypass for IC.Methods and Results:The preoperative nutritional status of patients aged ≥65 years undergoing infrainguinal bypass for IC between 1991 and 2017 was retrospectively evaluated using the GNRI. Patients were divided into 3 groups based on the GNRI: Group I (normal nutritional risk), GNRI >98; Group II (low nutritional risk), GNRI 92 to ≤98; Group III (moderate to high nutritional risk), GNRI <92. The amputation-free survival (AFS), overall survival, and freedom from cardiovascular death up to 5 years were calculated by Kaplan-Meier method and a multivariate analysis was performed to detect independent predictors of each outcome. Group I showed superior outcomes to Group III for each of the 3 outcomes and the multivariate analysis showed that GNRI was an independent predictor of AFS. CONCLUSIONS: The GNRI was independently associated with the AFS of elderly patients who underwent open bypass for IC.

Impact of Low Activity of Daily Living on the Prognosis of Patients with Critical Limb Ischemia and Sarcopenia.

BACKGROUND: We aimed to investigate the impact of low activity of daily living (ADL) on the long-term outcomes after infrainguinal bypass surgery in patients with critical limb ischemia (CLI) and sarcopenia. METHODS: In this multicenter retrospective cohort study, 110 patients with CLI who underwent infrainguinal bypass between April 2011 and September 2016 were divided into 4 groups according to the presence or absence of sarcopenia before surgery and ADL at discharge (Normal group: absence of sarcopenia and normal ADL [Barthel Index ≥60]; Low ADL alone group: absence of sarcopenia and abnormal ADL [Barthel Index <60]; Sarcopenia alone group: presence of sarcopenia and normal ADL; Sarcopenia and low ADL group: presence of sarcopenia and abnormal ADL). Three-year overall survival (OS) and amputation-free survival (AFS) were compared among the 4 groups using the Kaplan-Meier method, and Cox proportional hazards models were used to assess the unadjusted and adjusted associations between patient characteristics and 3-year OS and AFS. RESULTS: The Sarcopenia and low ADL group was significantly inferior to the other 3 groups in 3-year OS (versus Normal group, P < 0.001; versus Low ADL alone group, P = 0.005; versus Sarcopenia alone group, P = 0.022) and was significantly inferior to the Normal group and Sarcopenia alone group in 3-year AFS (P < 0.001 and P = 0.027, respectively). In the multivariable analysis, after adjustment for age, sex, ischemic heart disease, and hemodialysis, the presence of both sarcopenia and low ADL was a significant predictor of 3-year OS (hazard ratio [HR] 5.99, 95% confidence interval [CI] 1.92-18.69, P = 0.002) and AFS (HR 3.63, 95% CI 1.27-10.39, P = 0.016). CONCLUSIONS: Low ADL at discharge was a significant predictor of 3-year OS and AFS in patients with CLI and sarcopenia, while either sarcopenia alone or low ADL alone did not significantly affect outcomes.