Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Impact of tolvaptan on improvement of tricuspid regurgitation and right ventricular dimension in patients with right-sided heart failure.

Managing right-sided chronic heart failure (CHF) due to tricuspid regurgitation (TR) remains a clinical challenge. Tolvaptan (TLV), a vasopressin V2 receptor inhibitor, is effective in controlling decompensated HF. However, its effects on right-sided CHF caused by TR are unclear. We sought to clarify the effects of TLV in CHF patients complicated with TR. The cohort consisted of 33 CHF patients with moderate or severe TR and permanent atrial fibrillation, who required hospitalization for HF. We observed 19 patients treated with TLV plus conventional therapies (TLV group) and 14 patients with conventional therapies alone (conventional group). Clinical characteristics, echocardiographic parameters, and laboratory data were investigated. Baseline characteristics were similar between groups. In the TLV group, the severity of TR at admission was 73.7% moderate and 26.3% severe. In the conventional group, these percentages were 85.7% and 14.3%, respectively. During the follow-up, the severity of TR improved in the TLV group (trivial-mild: 52.6%; moderate: 36.8%; severe: 10.5%) (p < 0.01). However, it did not improve in the conventional group (trivial-mild: 21.4%; moderate: 50.0%; severe: 28.6%) (p = 0.08). The diameter of the tricuspid annulus (p < 0.01), basal (p = 0.02), and mid right ventricle (p = 0.04) was reduced at follow-up in the TLV group. Nevertheless, these parameters did not change in the conventional group. Serum creatinine levels were maintained (p = 0.74) in the TLV group, but deteriorated in the conventional group (p = 0.03). TLV reduced right ventricular dimensions and improved TR without deterioration of renal function. Thus, TLV may be a new drug for the treatment of CHF patients with TR.

Distal radial artery approach for endovascular therapy.

It has been reported that the distal transradial approach (dTRA) is safe and useful for percutaneous coronary intervention (PCI). In this study we evaluated the safety and efficacy of the dTRA for endovascular therapy (EVT). The dTRA for EVT was performed in 43 lesions from 35 patients. Approach site was determined at the discretion of the operator. Clinical data were analyzed retrospectively. Average patient age was 74.0 ± 6.5 years; 30 (86%) were male; average height was 161.1 ± 8.4 cm. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 19 (54.3%), 31 (88.6%), 29 (82.9%), and 29 (82.9%) patients, respectively. Target lesions were iliac artery in 38 (88.4%) patients, superficial femoral artery in 4 (9.3%) and renal artery in the remaining patient (2.3%). Eight lesions (18.6%) were chronic total occlusions. Thirteen (30.2%), 2 (4.7%), and 28 (65.1%) lesions were treated using 4.5, 6, and 7 French long guiding systems, respectively. All lesions were successfully treated without any procedural or access site-related complications. No additional puncture sites were required. Ankle brachial index significantly improved from 0.62 ± 0.20 to 0.92 ± 0.17 (p < 0.0001) post-treatment for the lower limbs. There were no radial artery occlusions, target lesion revascularization, or complications 1 month later. Similar to PCI, the dTRA for EVT is safe and feasible without any specific complications in carefully selected patients.

Non-enhanced and Non-gated MR Angiography for Robust Visualization of Peripheral Arteries Using Enhanced Acceleration-selective Arterial Spin Labeling (eAccASL).

This study aimed to assess the feasibility for applying enhanced acceleration-selective arterial spin labeling (eAccASL) to non-electrocardiogram-gated and non-enhanced peripheral MRA. We compared eAccASL and background suppressed single shot turbo field echo (TFE)-triggered angiography non-contrast-enhanced sequence (BASS TRANCE) required electrocardiographic-gating in eight volunteers and three patients. In the volunteer study, eAccASL demonstrated a comparable arterial visualization compared with BASS TRANCE. In patient observation, the advantages with eAccASL were found in arterial visualization on the collateral vessels and without artifacts affected by arrhythmia events.

Effect of high-dose strong statin for preventing periprocedural ischemic complications of carotid artery stenting.

Statin therapy has been shown to induce carotid atherosclerotic plaque regression and reduce the periprocedural ischemic complications of carotid artery stenting (CAS). This study assessed the safety and usefulness of pretreatment using a high-dose strong statin (HDSS) to reduce the periprocedural ischemic complications of CAS. We analyzed 117 carotid lesions treated by CAS that were evaluated with magnetic resonance imaging (MRI) within 48 h after the procedure. For 67 lesions, an HDSS (rosuvastatin 20 mg or atorvastatin 40 mg daily) were prescribed from at least 14 days before CAS to at least 14 days after procedure (HDSS group). Clinical and angiographic data, as well as in-hospital outcomes, of the HDSS group were retrospectively compared with 50 lesions with conventional treatment without an HDSS (non-HDSS group). There were no significant differences in the baseline clinical and procedural characteristics between the two groups. There was no side effect related to the HDSS. Stroke rates were similar between the two groups (3.0% in HDSS group vs 8.0% in non-HDSS group, p = 0.22). All were minor strokes. Compared to the non-HDSS group, the HDSS group had a lower frequency of new lesions on diffusion-weighted imaging (DWI) with MRI (25.4% vs 44.0%, p = 0.0345). New ipsilateral DWI-positive rate in the HDSS group was significantly lower than in the non-HDSS group (16.4% vs 34.0%, p = 0.0275). Nonipsilateral (contralateral or posterior circulation) DWI-positive rates were similar between the two groups (13.4% vs 20.0%, p = 0.34). Pretreatment with an HDSS might reduce the periprocedural ischemic complications of CAS.

Superficial femoral artery stenting via radial access using R2P® Misago® stents: First-in-human report of the new R2P® system.

A 73-year-old male with left critical limb ischemia was scheduled to undergo below-the-knee amputation. Prior to the amputation, he was referred to our institute for endovascular treatment. We inserted the new 7-Fr 150-cm-long guiding catheter, SlenGuide®, into the external iliac artery from the right radial artery with the 7-Fr Glidesheath Slender®. We implanted two R2P® Misago® stents with rapid-exchange, 200-cm-long shaft system in the stenosis of the left superficial femoral artery. This new stent system involves rapid-exchange and a long shaft system; furthermore, it is useful in transradial stenting in the superficial femoral artery.

Cardiac function response to stenting in atherosclerotic renal artery disease with and without heart failure: results from the Carmel study.

AIMS: Consensus-derived guidelines recommend renal stenting for patients with atherosclerotic renal artery disease (ARAD) and heart failure (HF). The aim of this prospective multi-centre observational study was to verify our hypothesis that changes in E/e', an echocardiographic correlate of left ventricular (LV) filling pressure, following renal stenting may differ between ARAD patients with and without HF. METHODS AND RESULTS: This study enrolled de novo ARAD patients undergoing renal stenting at 14 institutions. The primary endpoint was the difference in E/e' change between ARAD patients with and without HF. Clinical and echocardiographic data were prospectively collected at baseline, the day following renal stenting, and 1 month and 6 months afterwards. ARAD patients with HF were defined as patients with New York Heart Association (NYHA) Class 2 and more, or a history of HF hospitalization. A total of 76 patients were included, and 39% were ARAD patients with HF. ARAD patients with HF had significantly lower estimated glomerular filtration rate (P = 0.028) and higher NYHA functional class (P < 0.001) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score (P = 0.001) than ARAD patients without HF. Also, ARAD patients with HF had significantly lower LV ejection fraction (P = 0.003) and e'-velocity (P = 0.003) and higher E/e' ratio (P = 0.001), left atrial volume index (LAVI) (P = 0.046), LV end-diastolic volume (LVEDV) (P = 0.001), LV end-systolic volume (LVESV) (P = 0.001), and LV mass index (P = 0.009) than ARAD patients without HF. All procedures were successful. In contrast to blood pressure and renal function, there was a significant interaction in E/e' (Pinteraction  < 0.001) between time and HF, and ARAD patients with HF showed a significant (P < 0.001) decrease in E/e' albeit those without HF. By the same token, there was a significant interaction in NYHA class (Pinteraction  < 0.001), MLHFQ score (Pinteraction  = 0.018), E-velocity (Pinteraction  = 0.002), LAVI (Pinteraction  = 0.001), LVEDV (Pinteraction  = 0.003), and LVESV (Pinteraction  = 0.001) between time and HF with a significant improvement in all these variables in ARAD patients with HF (NYHA class, P = 0.001; MLHFQ score, P = 0.002; E-velocity, P = 0.005; LAVI, P = 0.001; LVEDV, P = 0.017; and LVESV, P = 0.011). CONCLUSIONS: Change in LV filling pressure after renal stenting differed between ARAD patients with and without HF, with a significant improvement in LV filling pressure in patients with HF-ARAD. These unique findings might support clinical cardiac benefits of renal stenting in ARAD patients with HF.

Slender transradial iliac artery stenting using a 4.5 French guiding sheath.

We previously reported safety and usefulness of transradial iliac artery stenting using 6 Fr guiding sheath. However, radial artery occlusion was a major limitation of this procedure. We analyzed the safety and utility of slender transradial iliac artery stenting using a 4.5 Fr guiding sheath to prevent radial artery occlusion. We performed transradial iliac artery stenting in left radial artery, using a 4.5 Fr sheath incorporating a shaft length of 110 cm, for 34 lesions in 29 patients. Transradial intervention was attempted at the discretion of the operator. Clinical data were analyzed retrospectively. Cases with scheduled multiple sheath insertions for a bidirectional approach were excluded. Twenty-three (79.3%) patients were male. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 11 (37.9%), 27 (93.1%), 19 (65.5%), and 24 (82.8%) patients, respectively. Nine lesions (26.5%) were diagnosed as chronic total occlusion. All lesions were successfully treated using a total of 40 stents incorporating a 4.5 Fr radial access system. Ankle-brachial index (ABI) significantly improved from 0.68 ± 0.15 to 0.99 ± 0.17 (p < 0.0001) after the procedure. No patients had procedural or access site-related complications such as hematoma, major bleeding, blood transfusion, stroke, cholesterol embolism, aortic dissection, or arterial perforation. Radial artery occlusion was absent in all cases. ABI value was well maintained at 0.98 ± 0.13 at 1 year, and no target lesion revascularizations were reported. Slender transradial iliac artery stenting using a 4.5 Fr guiding sheath is safe, feasible, and less invasive, and shows no incidence of radial artery occlusion, in carefully selected patient populations.

Prolonged Autonomic Fluctuation Derived from Parasympathetic Hypertonia after Carotid Endarterectomy but not Stenting.

BACKGROUND: Carotid endarterectomy (CEA) is a standard treatment for carotid artery stenosis, but the incidence after periprocedural myocardial infarction (MI) is not negligible. The mechanism for the higher risk of MI following CEA compared with the carotid artery stenting (CAS) is unclear. We hypothesized that it may be explained by different autonomic nervous responses. METHODS: This prospective, nonrandomized, observational study enrolled 50 patients from 2 centers: 25 underwent CEA and 25 CAS. Cardiac autonomic nervous activity was evaluated using 24-hour high-resolution ambulatory electrocardiography with parameters such as deceleration capacity (DC) and heart rate variability before the procedure, and at 1 week and 1-3 months after the procedure. RESULTS: One week after CEA, decreased DC and increased acceleration capacity were recognized. Standard deviation of sequential 5-minute NN interval means and the low-frequency and high-frequency components were all decreased. By the later phase measurement, these changes returned to baseline or beyond. The results suggest that diminished autonomic activity reversed to excessive parasympathetic dominance. In contrast, the patients treated by CAS showed no remarkable autonomic modification in the early or later phases. CONCLUSIONS: Distinct changes of sympathovagal response observed after CEA coincides with the time at which MI onset occurs, suggesting prolonged autonomic fluctuation may be a factor in the MI incidence after CEA.

Clinical outcomes of balloon angioplasty alone versus nitinol stent implantation in patients with small femoropopliteal artery disease: Observations from the Retrospective Multicenter Analysis for Femoropopliteal Stenting (REAL-FP).

OBJECTIVES: We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation. BACKGROUND: The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear. METHODS: We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length. RESULTS: Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001). CONCLUSIONS: Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.

Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan.

Stent placement for treating superficial femoral artery (SFA) lesions has been approved. The Zilver PTX stent, a drug-eluting stent (DES) for treating SFA lesions, has been available in Japan since 2012. However, the penetration rate of this DES has not yet been reported. This prospective multicenter registry study enrolled 314 patients (354 limbs) to be treated by stent placement in 2014 (UMIN000011551). The primary endpoint was the measurement of the penetration rate of the DES. The secondary endpoints were measuring the freedom from restenosis, freedom from target lesion revascularization (TLR), freedom from major adverse limb event (MALE), and the survival rate at 12 months postoperatively. Female patients comprised 28% participants. The mean age was 73.1 ± 9.2 years. A total of 56% patients had diabetes mellitus (DM), 36% patients were receiving hemodialysis, and 30% used cilostazol at baseline. The mean lesion length was 156 ± 101 mm, and the percentage of TASC II C/D lesions was 58%. Critical limb ischemia (CLI) was observed in 32% limbs. The penetration rates of the Zilver PTX stent were only 8%. The primary patency rate was similar between DES and bare-metal stents (BMS) at 12 months postoperatively (77 vs. 84%, p = 0.52). In this study, the rates of freedom from restenosis, freedom from TLR, freedom from MALE, and the survival rate at 12 months postoperatively were 83, 86, 85, and 89%, respectively. The penetration rate of a first-generation DES placement for treating SFA lesions is low in Japan. On the other hand, BMS is well utilized and its primary patency is acceptable.

Collateral filling efficiency of comorbid chronic total occlusion segment on short-term mortality in ST-elevation myocardial infarction.

BACKGROUND: Collateral filling of chronic total occlusion (CTO) segments is considered to affect hemodynamic stability in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) with CTO, however its value as a prognostic indicator for mortality is uncertain. The present study examined the relationship between collateral filling of CTO segments and short-term mortality in patients with STEMI with a comorbid CTO lesion. METHODS: Among 829 STEMI patients who underwent primary PCI, 74 patients with CTO were identified. Collateral filling of their CTO segment was assessed by Rentrop grade (0; n=10, 1; n=13, 2; n=31, 3; n=20) in their initial angiogram and whether the origin of the feeding collateral donor artery was infarct-related artery (IRA) was evaluated using their final angiogram in primary PCI; IRA (n=26) and non-IRA group (n=48). The relationship between these classifications and 30-day all-cause mortality was examined retrospectively. RESULTS: The 30-day mortalities were 4.5% in single-vessel disease, 18.3% in multi-vessel disease (MVD) without CTO and 25.7% in MVD with CTO. Mortality of MVD with CTO reduced with increasing Rentrop grade from 0 to 3 (80.0%, 30.8%, 19.4%, and 5.0%, respectively). IRA was associated with a significant higher mortality than those of non-IRA (50.0% vs. 12.5%, P=0.0004). Low Rentrop grade 0 or 1 was extracted as an independent predictor of 30-day death (HR 3.28, 95% CI 1.20-9.96, P=0.0203). CONCLUSIONS: Poor collateral filling of the CTO segment assessed by Rentrop grade was an independent angiographic predictor for 30-day death in patients with STEMI combined with CTO.

Coronary flow improvement following unsuccessful primary percutaneous coronary intervention in ST-elevation myocardial infarction with diffuse ectatic coronary artery.

BACKGROUND: In ST-elevation myocardial infarction (STEMI) patients with diffuse ectatic coronary artery, extensive thrombi inhibit achievement of final successful revascularization of Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow after primary percutaneous coronary intervention. However, clinical and angiographic outcomes of such patients are uncertain. The present study examined clinical and angiographic outcomes in STEMI incorporating giant coronary artery with diffuse ectasia. METHODS: Seven hundred and forty-four STEMI patients undergoing primary percutaneous coronary intervention were surveyed retrospectively. Culprit lesions in giant coronary artery with diffuse ectasia (Ectatic group, n=39) were investigated. Percutaneous coronary intervention success rate and angiographic or clinical outcomes at 360 days were compared with those of the Non-ectatic group ( n=705). RESULTS: Angiographic percutaneous coronary intervention success rate was significantly lower in the Ectatic group due to lower achievement of final TIMI grade 3 flow (53.8% vs. 92.9%, p<0.0001; 53.8% vs. 93.5%, p<0.0001, respectively). In follow-up angiography, 86% of the Ectatic group showed angiographic improvement from TIMI grade 2 or less immediately after percutaneous coronary intervention to TIMI grade 3 flow at follow-up. In contrast, angiographic improvement was observed in only 25% of cases in the Non-ectatic group. All-cause 360-day mortality was significantly lower in the ectatic group (2.6% vs. 14.5%, p=0.0361, respectively). CONCLUSION: In patients with STEMI in giant coronary artery with diffuse ectasia, achievement of TIMI grade 3 flow was significantly reduced immediately after percutaneous coronary intervention. However, improvement of coronary flow up to TIMI grade 3 was not uncommon at follow-up angiogram. Patients had low mortality despite low TIMI grade 3 achievement immediately after primary percutaneous coronary intervention.

Transradial intervention for chronic total occlusion at the external iliac artery using a bidirectional approach through a single guiding catheter.

A 64-year-old male with intermittent claudication due to long chronic total occlusion of external iliac artery was successfully treated with a bi-directional approach. The retrograde guidewire was inserted into the ipsilateral internal iliac artery to the distal femoral artery through a collateral channel. The procedure was performed with a single guiding catheter through a single puncture of the left radial artery. Avoid puncture of the femoral artery may be less invasive with fewer bleeding complications.

Transcatheter closure of atrial septal defect protects from pulmonary edema: septal occluder device gradually reduces LR shunt.

A 56-year-old woman was diagnosed as atrial septal defect (ASD) with pulmonary hypertension; pulmonary blood flow/systemic blood flow (Qp/Qs) of 2.3, pulmonary artery pressure (PAP) of 71/23(39) mmHg and diastolic dysfunction of left ventricle. PAP was improved after medical therapy; therefore, transcatheter ASD closure was performed. Seven days later, left-sided heart failure occurred, however, the improvement of Qp/Qs (1.7) and PAP of 51/21(32) was confirmed. Diuretic therapy was introduced which led to further decrease of PAP 40/12(25) and Qp/Qs (1.1). Because of gradual decrease of Qp/Qs, this patient appeared to be protected from acute pulmonary edema.

Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions.

BACKGROUND: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions. METHODS: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups. RESULTS: The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. CONCLUSION: The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

Clinical outcomes in patients with acute hemodynamic collapse supported by extracorporeal life support.

Although extracorporeal life support (ECLS) is utilized for acute hemodynamic collapse, clinical outcomes for such patients are uncertain. The present study examined 30-day clinical outcomes in patients treated with ECLS for acute hemodynamic collapse, and determined the factors associated with 30-day mortality in patients who required ECLS for cardiopulmonary arrest (CPA). A total of 200 patients, in whom emergency ECLS was utilized for acute hemodynamic collapse from 2006 to 2015, were analyzed retrospectively. The impact of CPA on all-cause 30-day death in the overall population was examined by multivariable logistic regression analysis; comparisons were made between 30-day survivors (n = 78) and non-survivors (n = 122). In addition, clinical factors associated with 30-day survival for patients in whom ECLS was utilized for CPA (n = 139) were examined. All-cause 30-day mortality in the overall study population was 61 % (122/200). CPA was the most common cause of ECLS requirement (70 %), and the factor associated strongest with death at 30-days (OR 3.31, 95 % CI 1.75-6.36, P < 0.01). Witnessed CPA with bystander cardiopulmonary resuscitation (CPR) (OR 4.33, 95 % CI 1.08-29.1, P = 0.04) and a less than 40 min interval between CPA and ECLS (OR 3.49, 95 % CI 1.39-9.02, P < 0.01) were suggested as factors associated with 30-day survival in CPA patients. CPA as a trigger of ECLS was a strong contributor to 30-day death in patients in whom emergency ECLS was utilized. However, witnessed CPA with bystander CPR and a less than 40 min interval from CPA to start of ECLS were suggested as factors associated with survival in these CPA patients.

Impact of a single universal guiding catheter on door-to-balloon time in primary transradial coronary intervention for ST segment elevation myocardial infarction.

The purpose of this study is to determine reduction of door-to-balloon (D2B) time using a single universal guiding catheter (Ikari-Left catheter) in transradial approach. In this procedure, we can skip a total of five steps compared with a conventional procedure (two catheter insertions, two catheter removals, and one catheter engagement). Reducing total ischemic time is important to achieving a better outcome in primary percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI). We retrospectively compared 30 consecutive STEMI patients who underwent transradial primary PCI with a single guiding catheter (IL group) with 30 consecutive patients with conventional transradial primary PCI. Patients with cardiogenic shock, heart failure, or need for intra-aortic balloon pumping support before primary PCI were excluded. Baseline characteristics were not different between the two groups. The D2B time was significantly shorter in the IL group (55 ± 16 vs. 63 ± 17 min, respectively; p = 0.01). Puncture-to-balloon time was also significantly shorter in the IL group (15 ± 11 min vs. 25 ± 11 min, respectively; p = 0.001). The total number of diagnostic and guiding catheters was significantly less in IL group (1 (IQR 1-1) vs. 3 (IQR 3-3), respectively; p < 0.0001). Primary PCI with a single universal guiding catheter reduced D2B time by skipping several procedural steps, and reduced the total number of catheters needed. This technique could reduce patient mortality as well as total medical cost.