Angiographic flow velocity predicts lower limb outcomes after endovascular therapy: Application of the frame count method.

INTRODUCTION: Several factors related to lesion characteristics and endovascular therapy (EVT) procedures have been reported to affect primary patency after EVT. However, it is unknown why these factors were associated with primary patency. We hypothesized patency failure was related to poor blood flow in affected arteries. METHODS: This retrospective study included 131 consecutive patients who had received EVT with bare metal stents for peripheral artery disease caused by femoropopliteal artery lesions. Based on the tertile post-EVT flow velocity of the superficial femoral artery (SFA), patients were divided into high (n = 43), middle (n = 44), and low (n = 44) flow velocity groups. Flow velocity was measured using the frame count method. We measured incidence of major adverse limb events (MALE), composed of target lesion revascularization (TLR), non-TLR, and major amputation. RESULTS: At a median follow-up period of 22.7 months, MALE had occurred in 7 (16.3%), 10 (22.7%), and 29 (65.9%) of patients from the high, middle, and low SFA flow velocity groups, respectively (p < 0.001). Kaplan-Meier analysis showed incidence of MALE was significantly higher in the patients of low SFA flow velocity (log-rank test χ2 = 38.8, p < 0.001). Multivariate analysis found low SFA flow velocity to be an independent predictor for MALE (hazard ratio: 4.42; 95% CI: 2.27 to 8.60; p < 0.001) as was ankle-brachial index. CONCLUSION: Post-EVT SFA flow velocity for femoropopliteal artery lesions treated with bare metal stents is an independent predictor of limb patency. The frame count method for assessing arterial flow velocity is convenient and has potential for wide applications in EVT.

Elevated Remnant Lipoprotein Related to Adverse Events in Patients with Chronic Limb-Threatening Ischemia after Endovascular Therapy for Below-the-Knee Lesions.

BACKGROUND: The prognosis of patients with chronic limb-threatening ischemia (CLTI) is unacceptably poor, and risk factors are unknown. Serum remnant lipoprotein has been associated with cardiovascular events. The aim of our study was to test the hypothesis that remnant lipoprotein is associated with the prognosis of patients with CLTI. METHODS: This retrospective study included 67 patients with CLTI who had received endovascular therapy (EVT) for de novo below-the-knee lesions. Patients were divided into 2 groups using fasting preoperative value of remnant-like particle cholesterol (RLP-C) with a cutoff value of 5.1 mg/dL into LOW RLP-C (n = 46) and HIGH RLP-C (n = 21). We assessed the differences between the 2 groups in the prevalence of major adverse limb events (MALE), composed of target lesion revascularization and major amputation. RESULTS: At a median follow-up period of 12 months, MALE had occurred in 11 LOW RLP-C patients (23.9%) and 11 HIGH RLP-C patients (52.4%; P = 0.03). Kaplan-Meier analysis showed the prevalence of MALE was significantly higher in HIGH RLP-C than LOW RLP-C (log-rank χ2 = 5.2, P = 0.02). Multivariate analysis found HIGH RLP-C to be an independent predictor for MALE (hazard ratio, 2.6; 95% confidence interval, 1.1-6.1; P = 0.02) along with history of coronary artery disease. CONCLUSIONS: Preoperative remnant lipoprotein was associated with the prognosis of patients with CLTI who had received EVT for de novo below-the-knee lesions.

Risk factors and prognostic impact of post-discharge bleeding after endovascular therapy for peripheral artery disease.

This study evaluated the incidence, predictors, and impact of bleeding requiring hospitalization following successful endovascular therapy (EVT) for peripheral artery disease. Platelet inhibition after EVT reduces the risk of major adverse limb events but increases the risk of bleeding. The incidence of post-discharge bleeding after EVT, its independent predictors, and its prognostic importance in clinical practice have not been fully addressed. We evaluated 779 consecutive patients who underwent EVT. We found that 77 patients (9.9%) were hospitalized for major bleeding during follow-up after EVT (median 39 months, range 22-66 months), with almost half (48.1%) of the bleeding categorized as gastrointestinal bleeding. Significant predictors of post-discharge bleeding were hemodialysis (hazard ratio (HR), 3.12; 95% CI: 1.93 to 5.05; p < 0.001) and dual antiplatelet therapy (DAPT) use (HR, 1.87; 95% CI: 1.03 to 3.41; p = 0.041). During follow-up, the all-cause mortality-free survival rate was significantly worse in patients who had experienced major bleeding than in those who had not (log-rank test χ2 = 54.6; p < 0.001). Cox proportional hazards analysis showed that major bleeding (HR, 2.78; 95% CI: 1.90 to 4.06; p < 0.001) was an independent predictor of all-cause death after EVT. Hospitalization for post-discharge bleeding after EVT is associated with a substantially increased risk of death, even after successful EVT. We concluded that patients' predicted bleeding risk should be considered when selecting patients likely to benefit from EVT, and that the risk should be considered especially thoroughly in hemodialysis patients.

Eicosapentaenoic acid levels predict prognosis of peripheral artery disease caused by aortoiliac artery lesions.

BACKGROUND AND AIM: Eicosapentaenoic acid (EPA) has been reported to improve clinical outcome of high-risk atherosclerotic patients. We investigated whether endogenous EPA values predict prognosis of peripheral artery disease (PAD) patients. METHODS AND RESULTS: This retrospective study included 166 consecutive patients who had received endovascular therapy (EVT) for PAD caused by aortoiliac artery lesions. Patients were divided into 2 groups using median preoperative EPA value (57 µg/ml): LOW EPA (n = 83) and HIGH EPA (n = 83). We compared differences between the 2 groups in prevalence of major adverse limb events (MALE) which included target lesion revascularization (TLR), non-TLR, and major amputation, and major adverse events (MAE) which included MALE and all cause death. At a median follow-up period of 20 months, MALE had occurred in 24 LOW EPA patients (28.9%) and in 12 HIGH EPA patients (14.5%) (p = 0.04), and MAE had occurred in 41 LOW EPA patients (49.4%) and in 21 HIGH EPA patients (25.3%) (p < 0.01). Kaplan-Meier analysis showed prevalence of MALE and MAE was significantly higher in LOW EPA than in HIGH EPA (long-rank test χ2 = 8.5, p < 0.01, log-rank test χ2 = 13.2, p < 0.01, respectively). Multivariate Cox regression revealed preoperative EPA value < 57 µg/ml was an independent predictor for MALE (hazard ratio [HR]: 2.70; 95% CI: 1.35 to 5.4; p < 0.01) and MAE (HR: 2.86; 95% CI: 1.67 to 4.91; p < 0.01). CONCLUSIONS: Endogenous EPA value seems to be associated with risk of MALE and MAE after EVT in patients with PAD caused by aortoiliac artery lesions.

Clinical Outcomes after Endovascular Therapy Among Hemodialysis Patients with Peripheral Artery Disease Stratified by the Primary Kidney Disease.

OBJECTIVES: The objective of this study was to investigate the clinical characteristics of hemodialysis patients with peripheral artery disease (PAD) and the outcomes after endovascular therapy (EVT) in such patients stratified by the primary kidney disease. METHODS: This retrospective observational study evaluated 142 consecutive hemodialysis patients with symptomatic PAD who underwent EVT (men: n = 103, age: 74 ± 8 years). Patients were divided into 3 groups in accordance with the reason for hemodialysis: hypertensive nephrosclerosis (HTN [n = 26]), diabetic nephropathy (DN [n = 85]), and chronic glomerulosclerosis (CGN [n = 31]). The primary outcome was major adverse event(s) (MAEs), including target lesion revascularization, major amputation, and all-cause death. Clinical characteristics and outcomes were compared among the 3 groups. RESULTS: Patients with HTN were older (81 ± 6 years vs. 72 ± 8 years vs. 74 ± 8 years; P < 0.001) and had a shorter hemodialysis vintage (2.4 years vs. 6.8 years vs. 11.2 years; P < 0.001) than those with DN and CGN. Critical limb ischemia (CLI) affected 15 (58%) patients in the HTN group, 52 (61%) in the DN group, and 10 (32%) in the CGN group. Target lesion length was longer in patients with HTN than in those in the other groups (155 ± 101 mm vs. 108 ± 77 mm [DN] vs. 98 ± 76 mm [CGN]; P = 0.020). During a median follow-up period of 372 days (interquartile range, 198-730 days), Kaplan-Meier curve analysis revealed that HTN was associated with an increased risk for MAEs (χ2 11.6; P = 0.003). Furthermore, multivariate Cox regression analysis revealed that CLI, HTN, and B-type natriuretic peptide levels were independent predictors of MAE (hazard ratio 3.91, 2.88, and 1.00; P < 0.001, P < 0.001, and P = 0.001, respectively). CONCLUSIONS: Among hemodialysis patients with PAD, HTN was associated with an increased risk for MAEs after EVT.

Clinical investigation of esophageal injury from cryoballoon ablation of persistent atrial fibrillation.

BACKGROUND: The cryoballoon (CB) can be utilized for extra pulmonary vein (PV) ablation such as for a left atrial (LA) posterior wall (LAPW) isolation. However, scrutiny of the esophageal injuries during the LAPW isolation has never been performed. We sought to thoroughly investigate the esophageal lesions (ELs) and gastric hypomotility (GH) caused by an LAPW isolation using a CB. METHODS: A total of 101 persistent atrial fibrillation patients who underwent an LAPW isolation using a CB were enrolled. The CB was applied on the roof and bottom area of the LAPW after a PV isolation. The luminal esophageal temperature (LET) was monitored by a thermistor probe during the CB applications. When the LET reached 15°C, the freezing application was prematurely interrupted. Esophagogastroscopy was performed on the next day following the ablation. RESULTS: All PVs were successfully isolated in all patients. A successful LAPW isolation solely with CB ablation was performed in 72 (71.3%) patients. Cryofreezing applications were prematurely interrupted due to low LETs in 49 (48.5%) patients predominantly during the LA bottom line ablation. ELs and GH were observed in 11 (10.9%) and 16 patients (15.8%), respectively. The nadir LET tended to be lower in patients with ELs and GH than in those without (ELs: 14.8 ± 4.5°C vs 17.4 ± 6.0°C, P = 0.17; GH: 15.5 ± 4.5°C vs 17.5 ± 6.1°C, P = 0.23, respectively). CONCLUSIONS: Esophageal complications such as ELs and GH occur during the LAPW isolation with a CB. There was no reliable predictor of those adverse events.

Clinical assessment of cryoballoon ablation in cases with atrial fibrillation and a left common pulmonary vein.

INTRODUCTION: Pulmonary vein isolation (PVI) using a cryoballoon (CB) is a useful tool for treating atrial fibrillation (AF); however, the clinical efficacy of the CB has never been fully investigated in patients with a left common pulmonary vein (LCPV). METHODS AND RESULTS: Three hundred twenty-four consecutive paroxysmal AF patients underwent PVI with a CB. Three-dimensional computed tomography was performed in all patients before the ablation. The clinical outcomes of the AF ablation between patients with (Group A) and without an LCPV (Group B) were compared. An LCPV was observed in 27 (8%) patients. There were no significant differences in the procedure time (149 ± 45 min vs. 143 ± 40 min, respectively; P = 0.42) and percentage needing touch up ablation between the 2 groups (26% vs. 20%, respectively; P = 0.45). At a mean follow-up of 454 ± 195 days, 282 of 324 (87%) patients were free from any atrial tachyarrhythmias (ATs) after a single procedure. Twenty out of 27 (74%) Group A patients and 262 of 297 (88%) Group B patients were free from ATs (15-month Kaplan-Meier event free rate estimates, 77% and 89%, respectively; P = 0.02). A multivariate analysis identified the presence of an LCPV and the left atrial diameter as reliable predictors of recurrent ATs. CONCLUSIONS: The long-term clinical outcomes of ablation of AF with the CB was worse in patients with an LCPV than in those without. The presence of an LCPV and the LA size seemed to be reliable predictors of a worse outcome.

Impact of the downstream myocardial mass on values of coronary microvascular resistance.

The assessment of hyperemic microvascular resistance (HMR) may be dependent on the assessment location in the coronary artery and the amount of partial myocardial mass (PMM) distal to the assessment locations. The aim of this study was to investigate the differences in HMR values between the distal and proximal sites in the same coronary arteries as well as the relationship between HMR and PMM. Twenty-nine vessels from 26 patients who had undergone intracoronary physiological assessments including Doppler flow velocity at the distal third part and the proximal third part in the same vessels were assessed. The mean values of HMR and PMM at the distal sites were 2.08 ± 0.75 mmHg/cm/sec and 22.2 ± 10.4 g, respectively. At the proximal sites, the values of HMR and PMM were 1.19 ± 0.33 mmHg/cm/sec and 59.9 ± 18.3 g, respectively. All HMR values at the distal sites were significantly higher than those at the proximal sites (p < 0.001). Smaller PMM at the distal sites was significantly associated with higher HMR (r = -0.544, p = 0.002) and was the strongest factor affecting the HMR values (p = 0.009), while this relationship was not observed at the proximal sites (r = -0.262, p = 0.17). The impact of PMM on HMR was diminished at assessment locations where PMM was greater than 35 g. In conclusion, a small amount of downstream myocardial mass could be related to high HMR values. The assessment location around the proximal coronary artery with over 35 g of myocardium would be appropriate to assess HMR because it minimizes the influence of the assessment location.

Impact of Hemodialysis Duration on Coronary Artery Calcification Among Hemodialysis Patients Who Underwent Percutaneous Coronary Intervention.

Our study aimed to evaluate the prevalence and impact of coronary artery calcification (CAC) on hemodialysis (HD) patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). We enrolled 211 HD patients who underwent PCI (men: n = 155, age: 71 ± 1 0 years). Severe CAC was defined as calcification with an arc of 360° on intravascular ultrasound. Multivariate analysis was performed to determine the predictors of severe CAC. The impact of severe CAC on target lesion revascularization (TLR) was evaluated. Patients with severe CAC (46%) had a higher incidence of diabetes mellitus (DM) (79 vs 59%, P = .003) and longer HD duration (7.7 vs 3.4 years, P < .001) than those with non-severe CAC. Multivariate analysis demonstrated that DM, HD duration, and angiographic calcification were significant predictors for severe CAC (odds ratio 4.42, 1.13, and 6.62; P < .001, P < .001, and P < .001, respectively). After the median follow-up period of 580 days (interquartile range, 302-730 days), Kaplan-Meier curve analysis revealed that severe CAC was associated with an increased risk for TLR (χ2 12.7; P = .002). In HD patients with CAD after PCI, DM and HD duration were significant predictors for severe CAC. Furthermore, severe CAC was associated with an increased risk for TLR.

Usefulness of Lipoprotein (a) for Predicting Outcomes After Percutaneous Coronary Intervention for Stable Angina Pectoris in Patients on Hemodialysis.

Serum lipoprotein (a) level is genetically determined and remains consistent during a person's life. Previous studies have reported that people with high lipoprotein (a) level are at a high risk of cardiac events. We investigated the association between lipoprotein (a) levels and clinical outcomes after percutaneous coronary intervention (PCI) for stable angina pectoris (SAP) in hemodialysis (HD) patients. Serum lipoprotein (a) levels were measured on admission in 410 consecutive HD patients who underwent successful PCI for SAP. Patients were divided into 2 groups: low and high group having lipoprotein (a) level <40 mg/dL (n = 297) and ≧40 mg/dL (n = 113) respectively. After PCI, the incidence of major adverse cardiac event (MACE) including cardiac death, nonfatal myocardial infarction, necessity of a new coronary revascularization procedure (coronary bypass surgery, repeat target lesion PCI, PCI for a new non-target lesion) was analyzed. At a median follow-up of 24 months (12 to 37 months), MACE occurred in 188 patients (45.6%). The rate of MACE rate was significantly higher in the high lipoprotein (a) group than in the low lipoprotein (a) group (59.2% vs 40.7%, long-rank test chi-square = 12.3; p < 0.001). Cox analysis showed that high lipoprotein (a) level (Hazard Ratio, 1.62; 95% Confidence Interval, 1.19 to 2.20; p = 0.002) was an independent predictor for MACE after PCI. In conclusion, high lipoprotein (a) level was associated with a higher incidence of MACE after PCI for SAP in HD patients.

Subcutaneous implantable cardioverter-defibrillator implantation for ventricular fibrillation caused by coronary artery spasm: a case report.

BACKGROUND: Coronary artery spasm usually has a good prognosis, except when it induces lethal ventricular arrhythmias. Implantable cardioverter-defibrillator (ICD) implantation in addition to optimal medical therapy including prescription of coronary vasodilators and smoking cessation is a therapeutic option for coronary artery spasm patients who present with lethal ventricular arrhythmia. Subcutaneous ICDs are now available as an alternative to conventional transvenous ICDs. CASE SUMMARY: We report the first case of a 50-year-old Japanese male without any structural heart disease who presented with ventricular fibrillation caused by coronary artery spasm, and underwent subcutaneous ICD implantation for secondary prevention of sudden cardiac death (SCD). We attributed his aborted SCD to coronary artery spasm based on findings of cardiac catheterization including acetylcholine provocation test and cardiac electrophysiological study. During the 1 year of follow-up, the patient discharged on calcium channel blockers and nicorandil has been free of angina, ventricular arrhythmias, and appropriate ICD therapy. DISCUSSION: Coronary artery spasm patients with aborted SCD may be good candidates for implantation of subcutaneous ICDs, because most of them have no need for concomitant bradycardia therapy, cardiac resynchronization therapy, or anti-tachycardia pacing therapy.

"Clinical Impact of the Cryoballoon Temperature and Occlusion Status on the Success of Pulmonary Vein Isolation".

BACKGROUND: Complete occlusion of the pulmonary veins (PVs) with the cryoballoon (CB) is considered to be the crucial factor for a successful PV isolation (PVI). We investigated whether a complete occlusion was indispensable for a successful CB based PVI of every PV. METHODS AND RESULTS: Atrial fibrillation patients (n=123, 97; paroxysmal) undergoing a de novo PVI were enrolled. A total of 477 PVs were analyzed. The occlusion grade (OG) was scored as follows: OG3 (complete occlusion), OG2 (incomplete occlusion with slight leakage), OG1 (poor occlusion with massive leakage). There was no significant difference in the CB temperature (CBT) at all measured time points (from 30 to 120sec after freezing) and nadir CBT between OG2 and OG3 in all PVs except for the right inferior PV (RIPV). The RIPV isolation success rate was significantly lower for the OG2 status than OG3 (97.5 vs. 57.6%; p<0.0001). In contrast, there was not significant difference in the isolation success rate of the other three PVs between OG2 and OG3. In particular, the success rate of the right superior PV (RSPV) isolation was >95% for both OG2 and OG3. Phrenic nerve paralysis (PNP) was provoked during the RSPV isolation in two patients in whom the RSPVs were frozen during OG3. CONCLUSION: An OG3 may not always be required for a successful PVI of all PVs except the RIPV. OG2 could have comparable effects as OG3 in terms of a successful RSPV isolation. Not aiming for OG3 for the RSPV may reduce the risk of PNP.