Pathological Evaluation of Predictors for Delayed Endothelial Coverage After Currently Available Drug-eluting Stent Implantation in Coronary Arteries: Impact of Lesions With Acute and Chronic Coronary Syndromes.

BACKGROUND: The optimal duration of dual antiplatelet therapy after currently available drug-eluting stent (DES) implantation to prevent stent thrombosis (ST) remains controversial. Delayed healing is frequently identified as a leading cause of ST in the early phase. However, a thorough pathological investigation into strut coverage after currently available DES implantation is lacking-a gap addressed in the current study. METHODS: From our autopsy registry of 199 stented lesions, 4,713 struts from 66 currently available DES-stented lesions with an implant duration ≤370 days were histologically evaluated. Endothelial coverage was defined as the presence of luminal endothelial cells overlying struts and an underlying smooth muscle cell layer. The stented lesions were classified into acute coronary syndrome (ACS) (n = 40) and chronic coronary syndrome (CCS) (n = 26) groups and were compared. Endothelial coverage predictors were identified through logistic analysis. RESULTS: Although ACS and CCS lesions presented comparable clinical characteristics, including age, sex, and cause of death, the latter exhibited a significantly higher prevalence of chronic kidney disease and hemodialysis than the former (33.3% vs. 65.2%; p = 0.02, 7.7% vs. 30.4%; p = 0.02). The poststent implant median duration was significantly shorter in ACS lesions than in CCS lesions (13 [IQR 5-26 days] vs. 40 [IQR 16-233 days]; p < 0.01). The endothelial coverage percentage was 3.5% at 30 days and 27.7% at 90 days after currently available DES implantation. Multivariable logistic regression analysis implicated implant duration of ≤90 days [odds ratio (OR), 0.009; 95% confidence interval (CI), 0.006-0.012; p < 0.01], superficial calcification (OR, 0.11; 95% CI, 0.07-0.17; p < 0.01), ACS culprit site (OR, 0.29; 95% CI, 0.09-0.94; p = 0.039), and circumferentially durable polymer-coated DES (OR, 0.32; 95% CI, 0.24-0.41; p < 0.01) as delayed endothelial coverage predictors. CONCLUSIONS: Endothelial coverage was limited at 90 days after currently available DES implantation, and the ACS culprit site and circumferentially durable polymer-coated DES were identified as independent predictors of delayed endothelial coverage. Our findings suggest the importance of underlying plaque morphology and stent technology for vessel healing after such implantation.

Predictors of Optical Coherence Tomography-Defined Calcified Nodules in Patients With Acute Coronary Syndrome　- A Substudy From the TACTICS Registry.

BACKGROUND: Recent studies suggest that the presence of calcified nodules (CN) is associated with worse prognosis in patients with acute coronary syndrome (ACS). We investigated clinical predictors of optical coherence tomography (OCT)-defined CN in ACS patients in a prospective multicenter registry.Methods and Results: We investigated 695 patients enrolled in the TACTICS registry who underwent OCT assessment of the culprit lesion during primary percutaneous coronary intervention. OCT-CN was defined as calcific nodules erupting into the lumen with disruption of the fibrous cap and an underlying calcified plate. Compared with patients without OCT-CN, patients with OCT-CN (n=28) were older (mean [±SD] age 75.0±11.3 vs. 65.7±12.7 years; P<0.001), had a higher prevalence of diabetes (50.0% vs. 29.4%; P=0.034), hemodialysis (21.4% vs. 1.6%; P<0.001), and Killip Class III/IV heart failure (21.4% vs. 5.7%; P=0.003), and a higher preprocedural SYNTAX score (median [interquartile range] score 15 [11-25] vs. 11 [7-19]; P=0.003). On multivariable analysis, age (odds ratio [OR] 1.072; P<0.001), hemodialysis (OR 16.571; P<0.001), and Killip Class III/IV (OR 4.466; P=0.004) were significantly associated with the presence of OCT-CN. In non-dialysis patients (n=678), age (OR 1.081; P<0.001), diabetes (OR 3.046; P=0.014), and Killip Class III/IV (OR 4.414; P=0.009) were significantly associated with the presence of OCT-CN. CONCLUSIONS: The TACTICS registry shows that OCT-CN is associated with lesion severity and poor clinical background, which may worsen prognosis.

Real-world outcomes of ponatinib treatment in 724 patients with CML and Ph+ ALL: a post-marketing surveillance study with a special interest in arterial occlusive events in Japan.

BACKGROUND: In September 2016, ponatinib was approved in Japan for the treatment of patients with chronic myeloid leukemia with resistance/intolerance to prior tyrosine kinase inhibitors and patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. METHODS: We conducted a post-marketing all-case surveillance to study the safety and efficacy of ponatinib in clinical practice, focusing on arterial occlusive events. RESULTS: Data from 724 patients were collected for 2 years from the initiation of ponatinib. The arterial occlusive events were reported in 6.49% (47/724) with an exposure-adjusted incidence rate of 6.8/100 person-years. The risks associated with arterial occlusive events were age and comorbidities including hypertension and diabetes. At 104 weeks, the cumulative major molecular response rate in patients with chronic-phase chronic myeloid leukemia was 67.2% and the complete cytogenetic response in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia was 80.0%. Furthermore, the estimated 1-year overall survival rate was 98.5% for chronic-phase chronic myeloid leukemia and 68.6% for Philadelphia chromosome-positive acute lymphoblastic leukemia. CONCLUSIONS: This surveillance demonstrated that ponatinib has a favorable safety and efficacy profile in Japanese patients and also showed the necessity of closely monitoring arterial occlusive events in older adults and patients with predisposing factors for atherosclerosis.

Clinical efficacy of tolvaptan in acute decompensated heart failure patients with severe aortic stenosis and atrial fibrillation: a sub-analysis from the LOHAS registry.

BACKGROUND: Severe aortic valve stenosis (AS) and atrial fibrillation (AF) are risk factors of hemodynamic instability in heart failure (HF) management due to low cardiac output, respectively. Therefore, the treatment of HF due to severe AS complicated with AF is anticipated to be difficult. Tolvaptan, a vasopressin V2 receptor inhibitor, is effective in controlling acute decompensated heart failure (ADHF) with hemodynamic stability. However, its clinical efficacy against ADHF caused by AS with AF remains to be determined. METHODS: Clinical information (from September 2014 to December 2017) of 59 patients diagnosed with ADHF due to severe AS (20 patients with AF; 39 patients with sinus rhythm [SR]) was obtained from the LOHAS registry. The registry collected data from seven hospitals and assessed the short-term effects of tolvaptan in patients hospitalized for ADHF with severe AS. We attempted to identify clinical differences from baseline up to 4 days, comparing patients with AF (AF group) versus those with SR (SR group). RESULTS: There were no significant differences between the groups in age (83.7 ± 4.5 vs. 85.8 ± 6.9 years, respectively; p = 0.11) and aortic valve area (0.60 [0.46-0.73] vs. 0.56 [0.37-0.70] cm2, respectively; p = 0.50). However, left atrial volume was larger (104 [85-126] vs. 87 [64-103] mL, respectively; p < 0.01), whereas stroke volume was lower (51.6 ± 14.8 vs. 59.0 ± 18.7 mL, respectively; p = 0.08) in the AF group versus the SR group. Body weight decreased daily from baseline up to day 4 in both groups (from 55.4 to 53.2 kg [p < 0.01] and from 53.5 to 51.0 kg [p < 0.01], respectively) without change in heart rate. Notably, the systolic blood pressure decreased slightly in the AF group after 2 days of treatment with tolvaptan. CONCLUSIONS: Short-term treatment with tolvaptan improved HF in patients hospitalized for severe AS, regardless of the presence of AF or SR. After achieving sufficient diuresis, a slight decrease in blood pressure was observed in the AF group, suggesting an appropriate timeframe for safe and effective use of tolvaptan.

Clinical outcomes in acute coronary syndrome after presentation of unique electrocardiographic findings.

BACKGROUND: Unique electrocardiographic findings are rarely observed in acute coronary syndrome (ACS) with a culprit left anterior coronary artery (LAD). The aim of this study was to assess the epidemiological features and prognostic impact. METHODS: This study was designed as an observational study. A total of 641 patients with a culprit lesion in the left main trunk or LAD were extracted from a cohort of 1776 ACS patients. The primary endpoint was mortality, comparing patients presenting with unique electrocardiogram patterns, specifically the de Winter pattern or Wellens' syndrome (type A or B), upon hospital arrival, with those presenting common electrocardiogram patterns. RESULTS: A unique electrocardiogram was observed in 7.0% (n = 45; 2 with de Winter pattern, 14 with Wellens' type A and 29 with type B). Compared to patients with a common pattern, cardiogenic shock at hospital arrival were rare in patients with a unique pattern (0% vs. 8.4%, P = 0.04), and percutaneous coronary intervention was primary revascularization strategy in all groups (95.6% vs. 98.2%). The mortality rates were similar between the two groups over a median 565 days of observation period (13.3% vs. 15.7%, P = 0.43), with 0% in Wellens' type A, 13.8% in type B, and both patients with the de Winter pattern died. CONCLUSION: The de Winter pattern or the Wellens syndrome was found in 7.0% of cases with ACS. They had similar mortality rates compared to those with a common pattern, although the de Winter pattern was identified in only 2 patients.

Results from a multicenter retrospective study of transradial iliac artery stenting in Japan.

Large-scale multicenter studies demonstrating the safety and effectiveness of transradial iliac artery stenting are lacking. We evaluated the data from a multicenter database in Japan. Transradial iliac artery stenting was performed on 115 lesions in 105 patients. The approach site was determined at the discretion of the operator. Patients with scheduled multiple sheath insertions for the bidirectional approach were excluded. Clinical data were retrospectively analyzed. The average age of this cohort was 71.1 ± 8.3 years. Eighty-six patients (81.9%) were male. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 39 (37.1%), 84 (80.0%), 69 (65.7%), and 78 patients (74.3%), respectively. Rutherford classifications 1, 2, 3, 4, and 5 comprised 40 (34.8%), 42 (36.5%), 28 (24.3%), 3 (2.6%), and 2 (1.7%) lesions, respectively, while Trans-Atlantic Inter-Society Consensus II classifications A, B, C, and D comprised 74 (64.3%), 21 (18.3%), 15 (13.0%), and 5 (4.3%), respectively. Twenty-seven lesions (23.5%) had chronic total occlusion. All lesions were successfully treated with 141 stents. Four patients (3.8%) required additional puncture of the common femoral artery for successful stent implantation. The ankle-brachial index significantly improved from 0.65 ± 0.17 to 0.95 ± 0.15 (P < 0.0001). None of the patients experienced any procedural or access site-related complications. Asymptomatic radial artery occlusion was observed in three cases (2.9%) after the procedure. There were no target lesion revascularizations or complications at 1 month. Compared to the traditional transfemoral approach, transradial iliac artery stenting is safe and feasible without any specific complications in carefully selected patients.

Takotsubo syndrome complicated by cardiogenic shock due to left ventricular outflow tract obstruction, acute mitral regurgitation, and atrial fibrillation: a case report.

Background: Although Takotsubo syndrome (TTS) is generally considered a benign disease, recent reports showed the incidence of cardiogenic shock due to left ventricular outflow tract obstruction (LVOTO), mitral regurgitation (MR), and primary pump failure was estimated to be 6-20%. Case summary: A 78-year-old woman presented with chest pain and cold sweats 2 days after surgery for lung cancer. Acute coronary syndrome was suspected based on her symptoms, electrocardiography, transthoracic echocardiography (TTE), and laboratory data; thus, emergency catheterization was performed. Normal coronaries were observed, with hyperkinesis at the base of the left ventricle and akinesis at its apex, leading to the diagnosis of the apical ballooning type of TTS. Pressure differences between the apex of the left ventricle (168/8/28 mmHg) and aorta (94/50/64 mmHg) indicated the presence of LVOTO. Two days after TTS onset, she developed cardiogenic shock (blood pressure was 54/38 mmHg). Transthoracic echocardiography showed acute MR due to systolic anterior motion of the mitral valve caused by LVOTO, which was further exacerbated by paroxysmal atrial fibrillation. Fluid resuscitation, intravenous ß-blockers, and amiodarone were administered for reduction of the pressure gradient in the left ventricular outflow, rate control, and sinus rhythm maintenance. Her condition improved along with the MR, thereby improving LVOTO and maintaining sinus rhythm. Discussion: Takotsubo syndrome should be kept in mind as a potential cause of acute MR due to LVOTO. Catheterization and multiple follow-up TTE play a major role in early detection for this condition.

Drug intervention as an emerging concept for secondary prevention in patients with coronary disease.

Non-culprit lesion-related coronary events are a significant concern in patients with coronary artery disease (CAD) undergoing coronary intervention. Since several studies using intra-coronary imaging modalities have reported a high prevalence of vulnerable plaques in non-culprit lesions at the initial coronary event, the immediate stabilization of these plaques by intensive pharmacological regimens may contribute to the reduction in the adverse events. Although current treatment guidelines recommend the titration of statin and other drugs to attain the treatment goal of low-density lipoprotein cholesterol (LDL-C) level in patients with CAD, the early prescription of strong LDL-C lowering drugs with more intensive regimen may further reduce the incidence of recurrent cardiovascular events. In fact, several studies with intensive regimen have demonstrated a higher percentage of patients with the attainment of LDL-C treatment goal in the early phase following discharge. In addition to many imaging studies showing plaque stabilization by LDL-C lowering drugs, several recent reports have shown the efficacy of early statin and proprotein convertase subtilisin/kexin type 9 inhibitors on the immediate stabilization of non-culprit coronary plaques. To raise awareness regarding this important concept of immediate plaque stabilization and subsequent reduction in the incidence of recurrent coronary events, the term 'Drug Intervention' has been introduced and gradually applied in the clinical field, although a clear definition is lacking. The main target of this concept is patients with acute coronary syndrome as a higher prevalence of vulnerable plaques in non-culprit lesions in addition to the worse clinical outcomes has been reported in recent imaging studies. In this article, we discuss the backgrounds and the concept of drug intervention.

Correlation between thromboembolic risk and prevalence of coronary artery disease in patients with atrial fibrillation and impaired renal function.

Background: Atrial fibrillation (AF) and coronary artery disease (CAD) often co-occur. The prevalence of coincident AF and CAD, the characteristics of such patients, and the correlation with thromboembolic risk in association with renal function are unclear. Methods and Results: We studied 435 consecutive patients who underwent contrast-enhanced computed tomography (CT) before catheter ablation for AF. Nineteen patients with inconclusive CT underwent coronary angiography for a calcified coronary artery. Overall, 87 of the 435 patients had CAD (20.0 %: paroxysmal AF, 63.9 %; persistent AF, 35.2 %; and longstanding AF, 0.9 %). Of these, 17.9 % were newly diagnosed with CAD. There was a stepwise increase in CAD prevalence according to the CHADS2 score (10.1 % at 0, 20.1 % at 1, 24.7 % at 2, 35.1 % at 3, and 41.7 % at ≥ 4 points). Of note, in patients with low estimated glomerular filtration rate < 50 mL/min/1.73 m2, the CAD prevalence increased for all CHADS2 scores (15.4 % at 0, 40.0 % at 1, 32.4 % at 2, 38.5 % at 3, and 50.0 % at ≥ 4 points). Conclusions: The prevalence of coexisting CAD increases with the CHADS2 score. This underscores the importance of screening for coexisting CAD in patients who are at high risk for thromboembolic events, particularly in patients with impaired renal function.

Left atrial diastasis strain slope is a marker of hemodynamic recovery in post-ST elevation myocardial infarction: the Laser Atherectomy for STemi, Pci Analysis with Scintigraphy Study (LAST-PASS).

Background: Left atrial (LA) mechanics are strongly linked with left ventricular (LV) filling. The LA diastasis strain slope (LADSS), which spans between the passive and active LA emptying phases, may be a key indicator of the LA-LV interplay during diastole. Aim: This study aimed to investigate the LA-LV interdependencies in post-ST elevation myocardial infarction (STEMI), with particular focus on the LADSS. Materials and methods: Patients with post-anterior STEMI who received primary percutaneous coronary intervention underwent contrast cardiac magnetic resonance imaging (MRI) during acute (5-9 days post-STEMI) and chronic (at 6 months) phases. The LADSS was categorized into three groups: Groups 1, 2, and 3 representing positive, flat, and negative slopes, respectively. Cross-sectional correlates of LADSS Group 2 or 3 compared to Group 1 were identified, adjusting for demographics, LA indices, and with or without LV indices. The associations of acute phase LADSS with the recovery of LV ejection fraction (LVEF) and scar amount were investigated. Results: Sixty-six acute phase (86.4% male, 63.1 ± 11.8 years) and 59 chronic phase cardiac MRI images were investigated. The distribution across LADSS Groups 1, 2, and 3 in the acute phase was 24.2%, 28.9%, and 47.0%, respectively, whereas in the chronic phase, it was 33.9%, 22.0%, and 44.1%, respectively. LADSS Group 3 demonstrated a higher heart rate than Group 1 in the acute phase (61.9 ± 8.7 vs. 73.5 ± 11.9 bpm, p < 0.01); lower LVEF (48.7 ± 8.6 vs. 41.8 ± 9.9%, p = 0.041) and weaker LA passive strain rate (SR) (-1.1 ± 0.4 vs. -0.7 [-1.2 to -0.6] s-1, p = 0.037) in the chronic phase. Chronic phase Group 3 exhibited weaker LA passive SR [relative risk ratio (RRR) = 8.8, p = 0.012] than Group 1 after adjusting for demographics and LA indices; lower LVEF (RRR = 0.85, p < 0.01), higher heart rate (RRR = 1.1, p = 0.070), and less likelihood of being male (RRR = 0.08, p = 0.058) after full adjustment. Acute phase LADSS Groups 2 and 3 predicted poor recovery of LVEF when adjusted for demographics and LA indices; LADSS Group 2 remained a predictor in the fully adjusted model (ß = -5.8, p = 0.013). Conclusion: The LADSS serves both as a marker of current LV hemodynamics and its recovery in post-anterior STEMI. The LADSS is an important index of LA-LV interdependency during diastole. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT03950310.

Vericiguat and transcatheter edge-to-edge mitral valve repair for combined post- and pre-capillary pulmonary hypertension due to left ventricular low ejection fraction and functional mitral regurgitation.

A 66-year-old female was diagnosed with combined post- and pre-capillary pulmonary hypertension due to heart failure with reduced ejection fraction (47 %) and functional mitral regurgitation [mean pulmonary arterial wedge pressure: 27 mmHg; pulmonary arterial pressure: 91/30 (56) mmHg; pulmonary vascular resistance: 12.9 Wood units; and cardiac index: 1.77 L/min/m2]. Following treatment with vericiguat (a novel oral soluble guanylate cyclase stimulator), hemodynamics improved [mean pulmonary arterial wedge pressure: 27 mmHg; pulmonary arterial pressure: 54/26 (35) mmHg; pulmonary vascular resistance: 2.2 Wood units; and cardiac index: 2.80 L/min/m2]. Therefore, transcatheter edge-to-edge repair for functional mitral regurgitation was performed. One month later, further improvement in hemodynamics was confirmed. Learning objective: Vericiguat (a novel oral soluble guanylate cyclase stimulator) and transcatheter edge-to-edge mitral valve repair may improve combined post- and pre-capillary pulmonary hypertension due to low ejection fraction of the left ventricle and functional mitral regurgitation.

Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.

BACKGROUND: Drug-coated balloons (DCBs) are important treatment options for coronary artery disease; however, randomised controlled trials comparing various DCB technologies are sparse, and further investigations are needed. AIMS: This preclinical study aimed to histologically and biologically compare the drug effects and safety of a low-dose paclitaxel-coated DCB (PCB; AGENT), a regular-dose PCB (SeQuent Please NEO) and a sirolimus-coated DCB (SCB; MagicTouch). METHODS: The DCBs were inflated in the healthy iliac arteries of 18 rabbits, which were euthanised after 28 days. The treated iliac arteries and distal skeletal muscles were histopathologically evaluated, and drug concentrations were measured. RESULTS: In the histopathological evaluation, the medial smooth muscle cell loss score regarding depth, an indicator of drug efficacy, was significantly higher with AGENT and SeQuent Please NEO than with MagicTouch (4.0 [3.6-4.0] vs 3.7 [3.7-4.0] vs 2.2 [2.0-2.4]), with significant differences in comparisons between AGENT and MagicTouch (p<0.01) and between SeQuent Please NEO and MagicTouch (p<0.01). AGENT and SeQuent Please NEO showed comparable drug concentrations in the treated artery (p=0.61). In contrast, the drug concentrations in distal skeletal muscles were the highest for MagicTouch, followed by SeQuent Please NEO and AGENT (28.07 [13.19-52.46] ng/mg vs 0.66 [0.22-3.76] ng/mg vs 0.25 [0.04-3.23] ng/mg, respectively). CONCLUSIONS: This study demonstrated that PCBs might have higher efficacy and lower drug concentrations in distal skeletal muscles than the MagicTouch SCB. The efficacy of the AGENT low-dose PCB and the SeQuent Please NEO regular-dose PCB was comparable.

Benefit of prehospital electrocardiogram on door-to-device time in ST-segment elevation myocardial infarction with cardiogenic shock: Data from the Kanagawa Acute Cardiovascular Registry.

BACKGROUND: The benefit of prehospital 12­lead electrocardiogram (PH-ECG) performed by emergency medical service personnel at the site of first medical contact (FMC) in patients with ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock (CS-STEMI) remains unclear. This study aimed to investigate the effect of PH-ECG on door-to-device time in patients with CS-STEMI. METHODS: This study enrolled CS-STEMI (Killip class IV) patients who were transferred directly to hospitals by ambulance (n = 517) from the Kanagawa Acute Cardiovascular Registry database. Patients were divided into PH-ECG (+) (n = 270) and PH-ECG (-) (n = 247) groups. Patients who experienced out-of-hospital cardiac arrest, who did not undergo emergent coronary intervention, or whose data were missing were excluded. Patient characteristics, FMC-to-door time, door-to-device time, and in-hospital mortality were compared between the groups. RESULTS: The patient backgrounds of the PH-ECG (+) and PH-ECG (-) groups were comparable. The peak creatinine kinase level was greater in the PH-ECG (+) group than in the PH-ECG (-) group [2756 (1292-6009) IU/ml vs. 2270 (957-5258) IU/ml, p = 0.048]. The FMC-to-door time was similar between the two groups [25 (20-33) min vs. 27 (20-35) min, p = 0.530], while the door-to-device time was significantly shorter in the PH-ECG group [74 (52-103) min vs. 83 (62-111) min, p = 0.007]. In-hospital mortality did not differ between the two groups (18 % vs. 21 %, p = 0.405). Multivariable logistic regression analyses revealed that PH-ECG (+) was independently associated with a door-to-device time < 60 min [odds ratio (95 % confidence intervals): 1.88 (1.24-2.83), p = 0.003]. CONCLUSIONS: PH-ECG was significantly associated with shorter door-to-device times in patients with CS-STEMI. Further studies with larger populations and more defined protocols are required to evaluate the utility of PH-ECG in patients with CS-STEMI.

Feasibility and Outcome of Transjugular Intracardiac Echocardiography-Guided Transcatheter Aortic Valve Replacement.

Background: There are limited data on the impact of intracardiac echocardiography (ICE)-guided transcatheter aortic valve replacement (TAVR) on the new permanent pacemaker implantation (PPMI) rate. Objectives: This study investigated the feasibility and outcome of transjugular ICE (TJ-ICE) -guided TAVR, by visualizing the relationship between the membranous septum (MS) and the transcatheter aortic valve (TAV). Methods: Among patients with severe aortic stenosis who underwent TAVR between February 2017 and June 2020, this study enrolled a total of 163 patients with TJ-ICE-guided TAVR. MS length was measured by ICE. The primary endpoint of this study was the incidence of new PPMI at 30 days. Results: The mean age of the patients in this study was 84.9 ± 4.6 years, and 71.2% of the patients were female. Device success was 96.3% with TJ-ICE guidance. A TJ-ICE-related complication occurred in 1 case (0.6%). The median length of the MS was 5.8 mm (IQR: 5.0-6.9 mm). Excellent intraobserver (intraclass correlation coefficient [ICC]: 0.94; 95% CI:0.79-0.98; P < 0.001) and interobserver (ICC: 0.93; 95% CI: -0.05 to 0.98; P < 0.001) agreements were shown. The new PPMI rate was 6.7% at 30 days without a significant difference between balloon-expandable valves and self-expandable valves (3.4% vs 8.7%; P = 0.226). Patients with a TAV implantation depth less than MS length had a significantly lower incidence of new PPMI compared with patients with a TAV implantation depth greater than MS length (2.1% vs 13.4%; P = 0.005), regardless of baseline right bundle branch block presence (6.7% vs 66.7%; P = 0.004) or absence (1.2% vs 8.2%; P = 0.041). Conclusions: TJ-ICE-guided TAVR demonstrated remarkable feasibility and safety. The TJ-ICE-guided final TAV position had a significant impact on the new PPMI rate. (Tokai Valve Registry; UMIN000036671).

Pathological Analysis of Medial and Intimal Calcification in Lower Extremity Artery Disease: Impact of Hemodialysis.

Background: The prevalence and degree of lower extremity artery disease in hemodialysis (HD) patients is higher than in the general population. However, the pathological features have not yet been evaluated. Objectives: The aim of the study was: 1) to compare lesion characteristics of lower extremity artery disease in HD vs non-HD patients; and 2) to determine factors associated with severe medial calcification. Methods: Seventy-seven lower limb arteries were assessed from 36 patients (median age 77 years; 23 men; 21 HD and 15 non-HD) who underwent autopsy or lower limb amputation. Arteries were serially cut at 3- to 4-mm intervals creating 2,319 histological sections. Morphometric analysis and calcification measurements were performed using ZEN software. Calcification with a circumferential angle (arc) ≥180° was defined as severe calcification. Multivariable logistic regression was used to identify risk factors for severe medial calcification. Results: The degree of the medial calcification arc was significantly higher in the HD group compared to the non-HD group (P < 0.0001). In the multivariable analysis, HD was associated with severe medial calcification in below-the-knee lesions (OR: 17.1; P = 0.02). The degree of intimal calcification in above-the-knee lesions was also significantly higher in HD patients with a higher prevalence of advanced atherosclerotic plaque (P = 0.02). The prevalence of severe bone formation was more common in the HD patients (P = 0.01). Conclusions: Hemodialysis patients demonstrated a higher degree of medial and intimal calcification compared with non-HD patients. The difference was more prominent in the medial calcification of below-the-knee lesions.