Deep Learning Models for Predicting Left Heart Abnormalities From Single-Lead Electrocardiogram for the Development of Wearable Devices.

BACKGROUND: Left heart abnormalities are risk factors for heart failure. However, echocardiography is not always available. Electrocardiograms (ECGs), which are now available from wearable devices, have the potential to detect these abnormalities. Nevertheless, whether a model can detect left heart abnormalities from single Lead I ECG data remains unclear.Methods and Results: We developed Lead I ECG models to detect low ejection fraction (EF), wall motion abnormality, left ventricular hypertrophy (LVH), left ventricular dilatation, and left atrial dilatation. We used a dataset comprising 229,439 paired sets of ECG and echocardiography data from 8 facilities, and validated the model using external verification with data from 2 facilities. The area under the receiver operating characteristic curves of our model was 0.913 for low EF, 0.832 for wall motion abnormality, 0.797 for LVH, 0.838 for left ventricular dilatation, and 0.802 for left atrial dilatation. In interpretation tests with 12 cardiologists, the accuracy of the model was 78.3% for low EF and 68.3% for LVH. Compared with cardiologists who read the 12-lead ECGs, the model's performance was superior for LVH and similar for low EF. CONCLUSIONS: From a multicenter study dataset, we developed models to predict left heart abnormalities using Lead I on the ECG. The Lead I ECG models show superior or equivalent performance to cardiologists using 12-lead ECGs.

Efficacy and Safety of Percutaneous Venoarterial Extracorporeal Membrane Oxygenation Decannulation Using Endovascular Balloon Dilation and Perclose ProGlide Closure Device: Results from the Multicenter SKYLINE Study.

BACKGROUND: The venoarterial extracorporeal membrane oxygenation (VA-ECMO) cannula can be surgically removed, but postoperative complications and surgical staffing issues can be problematic. We previously reported a method of percutaneously removing the arterial cannula of VA-ECMO by combining intravascular balloon dilation and the Perclose ProGlide (PP) closure device. In this study, we investigated the efficacy and safety of this percutaneous decannulation of the VA-ECMO. METHODS: This multicenter, retrospective study involved consecutive patients who underwent percutaneous VA-ECMO decannulation at 2 cardiovascular centers from September 2019 to December 2021. We analyzed 37 patients in whom the VA-ECMO cannula was removed by the percutaneous procedure with balloon dilation and the PP. The primary end point was procedural success of hemostasis. The secondary end points were the procedural time, procedure-related complications, and rate of surgical conversion. RESULTS: The patients' mean age was 65.4 years. The approach site of the endovascular therapy (EVT) procedures were the transradial approach (56.8%), transfemoral approach (27.8%), and transbrachial approach (18.9%). The mean balloon diameter was 7.3 ± 0.68 mm, and the mean balloon inflation time was 14.8 ± 7.3 min. The mean procedure time was 58.5 ± 27.0 min. The procedure success rate was 94.6%, procedure-related complication rate was 10.8%, procedure-related death and postprocedural infection rate was 0.0%, surgical conversion rate was 0.0%, and EVT access site complication rate was 2.7%. CONCLUSIONS: We concluded that percutaneous VA-ECMO decannulation using a combination of intravascular balloon dilation in EVT and the PP appears to be a safe, minimally invasive, and effective procedure.

Clinical outcome of drug-coated balloon versus scaffold device in patients with superficial femoral artery chronic total occlusion.

The demand for endovascular therapy is increasing in an aging society, but the problem of restenosis in the chronic phase has not been resolved in femoropopliteal occlusive disease. Few studies have compared drug-coated balloon (DCB) and scaffold devices in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare DCBs with scaffold in patients with CTO of the SFA. This was a single-center, retrospective study. From June 2018 to December 2019, we compared 31 patients and 33 limbs treated with DCBs and 44 patients and 45 limbs treated with a stent or stent-graft (scaffold) for SFA CTO. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR) and 12-month freedom from re-occlusion. The DCBs were performed using an intravascular ultrasound (IVUS)-guided approach or a non-loop wire technique. Baseline characteristics were similar between the groups. An intraluminal approach was performed to use all DCBs. The bailout stent rate was 0% in the DCB group. Kaplan-Meier analysis showed that rates of 12-month primary patency tended to be higher in the DCB than in the scaffold group (92.7 vs. 76.6%, p = 0.073) and that freedom from CD-TLR also did not differ significantly between the two groups (96.8 vs. 86.3%, p = 0.17). Kaplan-Meier analysis also showed that the 12-month freedom from re-occlusion rate was significantly less in the Scaffold than in the DCB group (96.8 vs. 79.3%, p = 0.045). Therefore, we concluded that in treatment for CTO of the SFA, a DCB with intraluminal angioplasty without bailout stenting was less re-occlusion compared with scaffold.

Efficacy of three-dimensional road mapping by fusion of computed tomography angiography and fluoroscopy in endovascular treatment of aorto-iliac chronic total occlusion.

The efficacy of multimodality image fusion road-mapping technique for endovascular therapy has been reported recently. Our aim was to evaluate the efficacy of endovascular therapy (EVT) with three-dimensional (3D) road mapping by fusing computed tomography (CT) and angiographical volumetric data for aorto-iliac chronic total occlusion (CTO). We retrospectively analyzed 36 patients with aorto-iliac CTO from June 2017 to November 2019 and classified them into two groups: EVT using a CT fused 3D roadmap (CTf3D-RM; 3D group, n = 14) and standard EVT (standard group, n = 22). Primary endpoint was wiring time and secondary endpoints were procedural success rate, number of guidewires, procedure time, radiation dose, contrast medium dose, and complications. Wiring time was significantly shorter in the 3D group than the standard group (3D, 15.6 ± 10.23 min vs. standard, 44.6 ± 35.3 min; p = 0.0052). Both groups had high procedural success rates (3D, 100% vs. standard, 100%) and low complication rates (3D, 0.0% vs. standard, 9.1%; p = 0.51). There were significantly fewer guidewires in the 3D group than the standard group (3D, 2.78 ± 1.31 vs. standard, 4.36 ± 2.01; p = 0.0138). The 3D group trended towards shorter procedural time (3D, 78.8 ± 32.5 min vs. standard, 107.5 ± 52.5 min; p = 0.076), lower radiation dose (3D, 28.6 ± 18.9 Gycm2 vs. standard, 48.9 ± 49.2 Gycm2; p = 0.15), and lower contrast medium dose (3D, 102.2 ± 30.6 vs. standard, 127.5 ± 51.3; p = 0.11) than the standard group. Therefore, we concluded that EVT with CTf3D-RM is effective for aorto-iliac CTO. This method may improve the quality of aorto-iliac CTO interventions.

Efficacy and Safety of Angiography-Guided Retrograde Posterior Popliteal Puncture Technique in the Supine Position.

BACKGROUND: Various techniques are needed for successful treatment of femoropopliteal long chronic total occlusion (CTO). Previous reports have described popliteal puncture by duplex echo guidance, but the safety of angiography-guided popliteal puncture remains unclear. This study was performed to examine the efficacy and safety of angiography-guided retrograde posterior popliteal puncture in the supine position. METHODS: We analyzed 44 consecutive patients treated with retrograde femoropopliteal puncture for femoropopliteal CTO from October 2013 to February 2019. We compared 24 patients who underwent angiography-guided posterior popliteal puncture (posterior group) and 20 patients who underwent frontal superficial femoral artery/popliteal artery puncture (frontal group). The primary end point was successful revascularization. The secondary end points were the puncture time, hemostasis time, and procedure-related complications. RESULTS: The posterior group tended to have a higher procedural success rate than the frontal group (100% vs. 90.0%, respectively; P = 0.20). The hemostasis time was significantly shorter in the posterior than frontal group (527.1 ± 146.5 vs. 710.0 ± 337.8 sec, respectively; P = 0.021). There was no significant difference in the puncture time between the posterior and frontal groups (8.19 ± 9.22 vs. 7.50 ± 9.68 min, respectively; P = 0.81). Both groups had a low complication rate (posterior, 0.0% vs. frontal, 5.0%; P = 0.4). CONCLUSIONS: Angiography-guided posterior popliteal puncture in the supine position can facilitate hemostasis and may improve the success rate of the procedure. This technique may contribute to the treatment of complex femoropopliteal CTO as one option for a retrograde approach.

An Effective Method for Percutaneous Removal of Venoarterial Extracorporeal Membrane Oxygenation by a Combination of Balloon Dilatation in Endovascular Therapy and the Perclose Proglide™ Closure Device.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be undertaken surgically, but there are various problems with this method. METHODS AND CASE REPORT: We removed the arterial cannula of VA-ECMO percutaneously by combining intravascular balloon dilatation and the Perclose ProGlide™ (PP) closure device in a short amount of time and the extent of bleeding was extremely small. Simultaneously, the venous cannula was removed by suturing and manual compression. We report a series of cases of percutaneous removal of VA-ECMO using intravascular balloon dilatation and PP. CONCLUSIONS: By using this method, VA-ECMO removal was possible in a very short amount of time with minimal invasiveness.

Efficacy and safety of endovascular therapy by diluted contrast digital subtraction angiography in patients with chronic kidney disease.

This study was performed to evaluate the efficacy and safety of endovascular therapy (EVT) by diluted contrast digital subtraction angiography (DSA) in patients with chronic kidney disease (CKD). Patients with peripheral artery disease (PAD) often have CKD; thus, EVT carries a risk of contrast-induced nephropathy (CIN). Reducing the amount of contrast medium is, therefore, important in these patients. We developed a novel EVT method using DSA with diluted contrast medium. DSA parameters were adjusted for diluted contrast angiography (1:10 dilution), and we defined this technique as low-concentration DSA (LC-DSA). We retrospectively analyzed 122 patients with CKD [estimated glomerular filtration rate (eGFR), < 45 mL/min/1.73 m2] from June 2012 to November 2017 and classified them into two groups: EVT with diluted contrast (LC-DSA group, n = 63) and conventional EVT (control group, n = 59). Patients with aortoiliac lesions and those undergoing hemodialysis were excluded. The primary endpoint was the incidence of CIN as defined by an absolute increase in serum creatinine of ≥ 0.5 mg/dL or relative increase of ≥ 25% 2-5 days after the procedure. The secondary endpoints were worsening renal function (defined as an eGFR reduction of ≥ 25% compared with that before the procedure), the amount of contrast medium used for EVT, freedom from complications related to LC-DSA, and procedural success. The incidence of CIN was significantly lower in the LC-DSA group than control group (0.0% vs. 11.9%, respectively; P = 0.001). The absolute eGFR increase (4.25 ± 4.7 vs. 1.24 ± 6.9, respectively; P = 0.005) and creatinine decrease ( - 0.16 ± 0.2 vs. 0.007 ± 0.34, respectively; P = 0.0078) were greater in the LC-DSA group than control group. Less contrast medium was used in the LC-DSA group than control group (30.0 ± 14.6 vs. 117.9 ± 52.8 mL, respectively; P < 0.0001). There were no differences in the procedural success rate (100% vs. 96.6%, P = 0.23) or complications related to LC-DSA (0.0% vs. 1.7%, P = 0.48). Therefore, we concluded that EVT with diluted contrast DSA reduced the amount of contrast medium and incidence of CIN. This method is effective and safe for treating patients with CKD who have infrainguinal lesions.

Endovascular Therapy Using Diluted Contrast Medium for Critical Limb Ischemia in a Patient with Chronic Kidney Disease.

A high percentage of patients with critical limb ischemia have concurrent chronic kidney disease (CKD). However, endovascular therapy (EVT) can be problematic in CKD patients. Thus, we developed a method of EVT using digital subtraction angiography (DSA) with diluted contrast medium (low-concentration DSA), wherein DSA parameters were adjusted for diluted contrast angiography (1:10 dilution). Herein, we report the case of an 88-year-old woman with a foot wound and severe CKD. Her estimated glomerular filtration rate was 7.9 mL/minute/1.73 m2. Therefore, EVT was performed with low-concentration DSA. Control angiography revealed total occlusion of the anterotibial and posterotibial arteries as well as severe stenosis of the peroneal artery. EVT with ballooning of the below-the-knee (BTK) lesions resulted in sufficient flow to the wound. Angiographic images of sufficient quality and visible wound blush were obtained with 1:10 diluted contrast medium. Because only 20 mL of contrast medium was required, renal function was preserved. EVT using DSA with diluted contrast medium was shown to be an effective BTK intervention in this CKD patient.

Long-term effects of ipragliflozin on blood pressure in patients with type 2 diabetes: insights from the randomized PROTECT trial.

Although previous reports have shown that sodium-glucose cotransporter-2 (SGLT2) inhibitors have a blood pressure (BP) lowering effect, relevant long-term data is limited. This study aimed to evaluate the effect of the SGLT2 inhibitor ipragliflozin on BP, and associations between BP reduction and changes in cardiometabolic variables in diabetic patients. This was a sub-analysis of the PROTECT trial, a multicenter, randomized, open-label study to assess if ipragliflozin delays carotid atherosclerosis in patients with type 2 diabetes. Participants were randomized to ipragliflozin and control groups. The primary endpoint of the present sub-analysis was the trajectory of systolic BP over 24 months. Correlations between systolic BP changes and cardiometabolic variables were also evaluated. A total of 232 eligible participants with well-balanced baseline characteristics were included in each study group. Throughout the 24-month study period, mean systolic BP was lower in the ipragliflozin group. At 24 months, a between-group difference (ipragliflozin minus control) in mean systolic BP change from baseline was -3.6 mmHg (95% confidence interval, -6.2 to -1.0 mmHg), and the reduction in systolic BP in the ipragliflozin group was consistent across subgroups examined. Changes in systolic BP significantly correlated with those in body mass index in the ipragliflozin group, while no significant correlations with other cardiometabolic variables tested were observed. In conclusion, ipragliflozin treatment was associated with BP reduction throughout the 24-month follow-up period as compared to control treatment. BP reduction correlated with weight loss, which might be one of the mechanisms for the BP lowering effect of SGLT2 inhibitors.

Prognosis of anemic patients with atrial fibrillation undergoing percutaneous coronary intervention.

BACKGROUND: There are limited data regarding whether anemia is associated with adverse clinical outcomes in patients with atrial fibrillation (AF) after percutaneous coronary intervention (PCI). METHODS: Patients with AF undergoing PCI at 15 institutions between January 2015 and March 2021 were included in this analysis. Based on the baseline hemoglobin levels, moderate to severe anemia was defined as hemoglobin levels <11 g/dL, and mild anemia was defined as hemoglobin levels 11-12.9 g/dL for men and 11-11.9 g/dL for women. Clinical outcomes within 1 year, including major adverse cardiovascular events (MACE: all-cause death, myocardial infarction, stent thrombosis, and stroke) and major bleeding events (BARC 3 or 5), were compared among patients with moderate/severe anemia, mild anemia, and no anemia. RESULTS: In a total of 746 enrolled patients, 119 (16.0%) and 168 (22.5%) patients presented with moderate/severe and mild anemia. The incidence of MACE (22.5%, 11.0%, and 9.1%, log-rank p < 0.001), all-cause death (20.0%, 7.2%, and 4.8%, log-rank p < 0.001), and major bleeding events (10.7%, 6.5%, and 2.7%, log-rank p < 0.001) were the highest in the moderate/severe anemia group compared with the mild and no anemia groups. Multivariable Cox regression analyses determined moderate/severe anemia as an independent predictor for MACE (p = 0.008), all-cause death (p = 0.005), and major bleeding events (p = 0.031) at 1 year after PCI. CONCLUSION: Moderate/severe anemia was significantly associated with the higher incidence of MACE and all-cause death as well as major bleeding events compared with mild and no anemia in AF patients undergoing PCI.

Applying masked autoencoder-based self-supervised learning for high-capability vision transformers of electrocardiographies.

The generalization of deep neural network algorithms to a broader population is an important challenge in the medical field. We aimed to apply self-supervised learning using masked autoencoders (MAEs) to improve the performance of the 12-lead electrocardiography (ECG) analysis model using limited ECG data. We pretrained Vision Transformer (ViT) models by reconstructing the masked ECG data with MAE. We fine-tuned this MAE-based ECG pretrained model on ECG-echocardiography data from The University of Tokyo Hospital (UTokyo) for the detection of left ventricular systolic dysfunction (LVSD), and then evaluated it using multi-center external validation data from seven institutions, employing the area under the receiver operating characteristic curve (AUROC) for assessment. We included 38,245 ECG-echocardiography pairs from UTokyo and 229,439 pairs from all institutions. The performances of MAE-based ECG models pretrained using ECG data from UTokyo were significantly higher than that of other Deep Neural Network models across all external validation cohorts (AUROC, 0.913-0.962 for LVSD, p < 0.001). Moreover, we also found improvements for the MAE-based ECG analysis model depending on the model capacity and the amount of training data. Additionally, the MAE-based ECG analysis model maintained high performance even on the ECG benchmark dataset (PTB-XL). Our proposed method developed high performance MAE-based ECG analysis models using limited ECG data.

Dual antithrombotic therapy with oral anticoagulant and P2Y12 inhibitors in patients with atrial fibrillation after percutaneous coronary intervention.

BACKGROUND: The efficacy and safety of dual antithrombotic therapy (DAT) with oral anticoagulant and P2Y12 inhibitors (P2Y12i) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have not been well investigated. The purpose of this study was first to evaluate clinical outcomes of DAT with P2Y12i compared with triple antithrombotic therapy (TAT), and then to compare DAT with low-dose prasugrel and DAT with clopidogrel, in patients with AF undergoing PCI. METHODS: This study was a multicenter, non-interventional, prospective and retrospective registry. A total of 710 patients with AF undergoing PCI between January 2015 and March 2021 at 15 institutions were analyzed. Clinical outcomes within 1 year, including major adverse cardiovascular events (MACE) and major bleeding events (BARC 3 or 5) were compared between patients receiving DAT (n = 239) and TAT (n = 471), and then, compared among prasugrel-DAT (n = 82), clopidogrel-DAT (n = 157), and TAT. RESULTS: The DAT group showed significantly lower incidence of MACE and major bleeding events compared with the TAT group (log-rank p = 0.013 and 0.047). In the multivariable Cox regression analyses, DAT (p = 0.028), acute coronary syndrome (p = 0.025), and anemia (p = 0.015) were independently associated with MACE. In addition, anemia (p = 0.022) was independently associated with, and DAT (p = 0.056) and thrombocytopenia (p = 0.051) tended to be associated with, major bleeding events. When analyzed among the prasugrel-DAT, clopidogrel-DAT, and TAT groups, there were no significant differences in clinical outcomes between the prasugrel-DAT and clopidogrel-DAT groups, and similar trends were observed for both 2 groups in comparison with the TAT group. CONCLUSIONS: In AF patients undergoing PCI, DAT was associated with lower incidence of MACE and major bleeding events compared with TAT. In comparison of P2Y12i, there might be no significant difference in the incidence of MACE and bleeding events between prasugrel-based DAT and clopidogrel-based DAT.

Right versus left coronary artery involvement in patients with type A acute aortic dissection.

BACKGROUND: Type A acute aortic dissection (AAD) complicated by coronary malperfusion is a life-threatening disease. In the present study, we compared the clinical characteristics and prognostic impact of treatment strategies including surgical treatment and percutaneous coronary intervention (PCI) in type A AAD patients with RCA and LCA involvement. METHODS: This multicenter registry included 220 patients with type A AAD and either RCA or LCA involvement. Treatment strategies were left to treating physicians. The primary endpoint was in-hospital death. RESULTS: Of 220 patients, 115 (52.3%) and 105 (47.7%) had RCA and LCA involvement. Patients with LCA involvement were more1 likely to present with Killip class IV on admission than those with RCA involvement. Coronary angiography was performed in 52 of 220 (23.6%) patients, among whom 39 (75.0%) underwent subsequent PCI. During the hospitalization, 93 (42.3%) patients died. Patients with LCA involvement had an increased risk of in-hospital mortality compared to those with RCA involvement (54.3% vs. 31.3%, p < 0.001). In patients with RCA involvement, multivariable analysis identified Killip class IV and no surgical treatment as predictors of in-hospital death, while PCI and surgical treatment were indicated as factors associated with lower in-hospital mortality in patients with LCA involvement. CONCLUSIONS: The rates of RCA and LCA involvement were similar in type A AAD. Immediate PCI as a bridge to subsequent surgical treatment might improve survival in patients with type A AAD complicated by coronary malperfusion, especially in those with LCA involvement.

Combining transradial access and sheathless femoral access for complex iliac artery chronic total occlusions.

BACKGROUND: The transradial approach (TRA) is associated with fewer serious access site-related complications compared with the transfemoral or transbrachial approach. However, TRA has associated problems in complex aortoiliac (AI) lesions, including the procedural difficulty. A bidirectional approach was used combining TRA with a sheathless technique for femoral artery (FA) puncture to treat complex AI lesions, as a minimally-invasive approach. This report describes a representative cases with AI chronic total occlusion in which the combination of TRA and a sheathless technique for FA puncture was useful for guidewire crossing. CASE PRESENTATION: Case 1 was a 71-year-old man with intermittent claudication (IC). Control angiography showed total occlusion of the left common iliac artery (CIA) ostium to the distal external iliac artery (EIA). Guidewire externalization was achieved by combining TRA using a 6Fr guiding sheath and a sheathless technique for the left FA. Two nitinol stents were deployed in the CIA to EIA. Case 2 was a 63-year-old man with IC. Control angiography revealed total occlusion of the right CIA ostium to the common femoral artery (CFA) with severe calcification. The antegrade wire could not pass through the CTO lesion because of the calcified CFA occlusion. A 21-G metal needle was used to penetrate the CFA calcification through the distal true lumen of the CFA, and the wire was inserted into the EIA for wire externalization. Three nitinol stents were deployed in the CIA to EIA, and a drug-coated balloon was dilated in the CFA with hemostasis of the distal puncture site. In both cases, the retrograde puncture site was hemostatic during the procedure and postoperative bed rest was not required. CONCLUSIONS: TRA combined with a sheathless technique from the FA has the potential to treat AI complex lesions in a less invasive manner.

Revisiting where to apply preimplant mapping to improve P-wave sensing of insertable cardiac monitors.

Background: Insertable cardiac monitors (ICMs) are used for long-term cardiac rhythm monitoring. They have proven useful in diagnosing arrhythmias. They are conventionally inserted at the 4th intercostal space without preimplant mapping. Method: We develop a new method, VisP, that finds an optimal insertion position by applying the lightweight preimplant mapping to nine candidate positions beyond the conventional ones. We retrospectively analyze consecutive 60 patients who underwent ICM insertion (Reveal LINQ™) between April 2019 and March 2021 and compare the two groups with and without VisP. Results: After 9 patients were excluded because of ectopic atrial rhythms or atrial fibrillation, 51 patients were analyzed. Thirty-one patients underwent the conventional insertion (non-mapping), whereas 20 patients underwent VisP. VisP achieved large P-wave amplitudes while retaining the R-wave amplitude for all patients; in contrast, P waves were not detected for 11 patients out of the 31 patients in the non-mapping group (35%). On average, the P-wave amplitude was 0.065 mV for VisP, compared to 0.029 mV for the non-mapping group (p-value< .001). The average R-wave amplitude was 0.69 mV for VisP and 0.71 mV for non-mapping (p-value = .88), indicating the R-wave difference is insignificant between the two groups. VisP selected the 4th, 3rd, and 2nd intercostal spaces for 7, 11, and 2 patients, respectively, meaning that 13 out of the 20 cases (65%) fell out of the conventional insertion location of the 4th intercostal space. Conclusions: VisP improves the diagnostic ability of ICMs by finding an optimal position that yields reliable sensing of P waves while keeping high R-wave sensing.

An AnteOwl WR intravascular ultrasound-guided parallel wiring technique for chronic total occlusion of below-the-knee arteries.

BACKGROUND: Although endovascular therapy is used to treat chronic limb-threatening ischemia, long chronic total occlusion (CTO) is still challenging to treat. Especially in patients with poor run-off below-the-knee (BTK) arteries, it is difficult to perform a retrograde approach, and even guidewire passage may be difficult. CASE PRESENTATION: We treated two cases of chronic limb-threatening ischemia using our novel extreme antegrade guidewire crossing technique by AnteOwl WR intravascular ultrasound (IVUS)-guided parallel wiring to a BTK artery (EXCAVATOR technique). Case 1 was a 70-year-old man with ulceration of the right toe. The AnteOwl WR IVUS was intentionally advanced into the subintimal space of the posterior tibial artery, and the totally intraplaque route was advanced by IVUS-guided parallel wiring that was successfully passed from the lateral plantar aspect to the true lumen of the digital artery. Case 2 was a 76-year-old woman with rest pain and cyanosis of the right lower limb. Angiography showed total occlusion from the superficial femoral artery to BTK arteries. AnteOwl WR IVUS-guided parallel wiring was repeatedly performed until the distal true lumen of the peroneal artery was reached, and revascularization was successfully achieved via the antegrade approach alone. CONCLUSIONS: With its excellent crossable performance, good image quality, and high navigational ability within the CTO, the AnteOwl WR can be used to pass parallel wiring into the distal true lumen for BTK CTO.

Optimal Intraluminal Drug-Coated Balloon Versus Drug-Eluting Stent in Patients With Chronic Total Occlusion of the Superficial Femoral Artery: A Retrospective Analysis.

BACKGROUND: Paclitaxel-eluting technologies improve the clinical outcome of femoropopliteal (FP) occlusive disease. Several studies reported efficacy of the high-dose (nominal paclitaxel density of 3.5 µg/mm2) drug-coated balloon (DCB) for complex FP lesions. However, previous studies of DCB have shown a high rate of bailout stents, and few studies have compared the high-dose DCB with successful lesion pre-dilation without bailout stent and drug-eluting stent (DES) in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare the clinical outcome of high-dose DCB with successful lesion preparation and DES in CTO of the SFA. METHODS: This was a single-center, retrospective study. From June 2018 to November 2020, we compared 41 patients (43 lesions) treated with high-dose DCB and 36 patients (37 lesions) treated with DES. The study period was defined as the period after DCB and DES became available simultaneously at our hospital, when all surviving patients had at least 1 year of follow-up. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from: (1) clinically driven target lesion revascularization (CD-TLR), and (2) re-occlusion. RESULTS: Baseline clinical data were comparable between the two groups. Reference vessel diameter was smaller in the DCB group. The mean lesion and occlusion lengths were about the same in both groups. The subintimal angioplasty and bailout stent rate was 0% in the DCB group. The Kaplan-Meier estimate for 12-month primary patency was 92.0% in the DCB group and 87.2% in the DES group (p = 0.47). Freedom from CD-TLR also did not differ significantly between the two groups. The 12-month freedom from re-occlusion rate tended to be higher in the DCB group than in the DES group. CONCLUSIONS: High-dose DCB with successful lesion preparation showed 12-month clinical outcomes comparable with DES for CTO of the SFA, even without bailout stents.

Treatment strategies and in-hospital mortality in patients with type A acute aortic dissection and coronary artery involvement.

OBJECTIVE: Type A acute aortic dissection (AAD), especially that with coronary artery involvement and malperfusion, is a life-threatening disease. In the present study we aimed to investigate the association of surgical treatment and percutaneous coronary intervention (PCI) with in-hospital mortality in patients with type A AAD and coronary artery involvement. METHODS: This retrospective multicenter registry in Japan included 225 patients with type A AAD and coronary artery involvement. Treatment strategies including surgical treatment and/or PCI were left to treating physicians. The primary end point was in-hospital death. RESULTS: Of 225 patients, dissection extended into the right and left coronary arteries and both in 115 (51.1%), 105 (46.7%), and 5 (2.2%), respectively. Overall, 94 (41.8%) patients died during the hospitalization. Coronary angiography was performed in 53 (23.6%) patients, among whom 39 (73.6%) underwent PCI. Surgical repair was performed in 188 (83.6%) patients. In patients who received neither procedure, 33 of 35 (94.3%) died during the hospitalization. PCI was performed as a bridge to surgical repair in 37 of 39 (94.9%) patients, and in-hospital mortality of patients who underwent PCI and surgical procedures was 24.3%. Multivariable analysis identified PCI and surgical procedures as factors associated with lower in-hospital mortality rates. CONCLUSIONS: Coronary artery involvement in type A AAD was associated with high in-hospital mortality of more than 40% in the current era. An early reperfusion strategy with PCI as a bridge to surgical repair might improve clinical outcomes in this fatal condition.

Effective treatment of iatrogenic femoral pseudoaneurysms by combined endovascular balloon inflation and percutaneous thrombin injection.

The increasing number of percutaneous endovascular procedures in highly anticoagulated patients has increased the possibility of iatrogenic femoral artery pseudoaneurysm (IFAP). Ultrasound (US)-guided percutaneous thrombin injection is one of the feasible treatments; however, there are concerns about complications such as peripheral embolization. This study was performed to examine the efficacy and safety of treatment of IFAPs using a combination of percutaneous thrombin injection and intravascular balloon inflation. In this retrospective, single-center study, we analyzed 11 patients who developed and were treated for IFAPs from January 2017 through April 2020. The patients were treated with endovascular therapy (EVT) with percutaneous thrombin injection. The technique utilized fluoroscopic guidance to place a balloon at the neck of the IFAP, and the balloon was then inflated to prevent the inflow of blood to the aneurysm. We then performed US-guided thrombin injection. The mean age was 72.36 ± 10.43 years; mean body mass index (BMI) was 25.25 ± 3.18. All patients had hypertension, 72.7% were undergoing hemodialysis, and 54.5% used oral anticoagulant drugs. The mean aneurysm size was 24.34 ± 13.54 mm. The approach was transfemoral in ten patients and transradial in one patient. All procedures were successful, and there were no complications. The mean thrombin dose was 677.3 ± 410.7 IU; the total hemostatic time was 45.4 ± 24.9 min. In conclusion, the combination of percutaneous thrombin injection and endovascular balloon inflation was feasible and safe for the treatment of IFAPs. This technique may contribute to the treatment of IFAPs.

Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study.

BACKGROUND: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO. MATERIALS AND METHODS: We retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model. RESULTS: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003). CONCLUSIONS: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.