Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism　- First Results From the SALUTE Trial.

BACKGROUND: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up. CONCLUSIONS: The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134).

Anatomical features of the aortic root in aortic stenosis and a novel approach for transcatheter aortic valve implantation.

A narrow and calcified sinotubular junction (STJ) represents a risk for ascending aortic dissection after balloon-expandable transcatheter aortic valve implantation (TAVI). The aim of this study was to assess computed tomography (CT)-based aortic root morphology in patients with aortic stenosis (AS), and to evaluate the feasibility of a two-step inflation technique that we devised for TAVI using the SAPIEN 3 in patients with a narrow and calcified STJ. We retrospectively analyzed the STJ diameter (STJD) as well the as aortic annulus diameter (AAD) and STJ calcification using CT imaging in 412 patients undergoing TAVI. We defined a "narrow STJ" as a minimum STJD that was smaller than the diameter corresponding to a 10% oversized annulus area, and a "calcified STJ" as an STJ calcification angle > 90°. A "narrow and calcified STJ" was identified in 54 patients (13.1%) of patients. Among them, we performed TAVI using the two-step inflation technique with SAPIEN 3 in 20 patients and compared with 11 patients that underwent the conventional inflation procedure. Two-step inflation was successfully performed without ascending aortic dissection in all 20 patients. The effective orifice area index at discharge in these 20 patients was similar to that in 11 patients who underwent the conventional inflation procedure for a "narrow and calcified STJ" [1.40 (1.20-1.51) vs. 1.33 (1.18-1.41) cm2/m2, p = 0.23]. Although further assessment is required, the two-step inflation technique with the SAPIEN 3 is feasible for a narrow and calcified STJ.

AVJ-514 Trial　- Baseline Characteristics and 30-Day Outcomes Following MitraClip® Treatment in a Japanese Cohort.

BACKGROUND: The MitraClip®system is a transcatheter-based therapeutic option for patients with chronic mitral regurgitation (MR) who are at high risk for surgery. A prospective, multicenter, single-arm study was initiated to confirm the transferability of this system to Japan.Methods and Results:Patients with symptomatic chronic moderate-to-severe (3+) or severe (4+) functional or degenerative MR with a Society of Thoracic Surgery (STS) score ≥8%, or the presence of 1 predefined risk factor were enrolled. Patients with left ventricular (LV) ejection fraction (EF) <30% were excluded. MR severity and LV function were assessed by an independent echocardiography core lab. Primary outcome included major adverse events (MAE) at 30 days and acute procedural success (APS). A total of 30 patients (age: 80±7 years; STS score: 10.3%±6.6%) were treated with the MitraClip®. At baseline, all patients had MR 3+/4+ with 53%/47% patients with degenerative/functional etiology with mean LVEF of 50.2±12.8%, and 37% of patients were NYHA class III/IV. APS was achieved in 86.7% with no occurrence of MAE. At 30 days, 86.7% of patients had MR ≤2+ and 96.7% were NYHA class I/II. CONCLUSIONS: The MitraClip®procedure resulted in clinically meaningful improvements in MR severity, function and quality of life measures, and low MAE rates. These early results suggest the transferability of this therapy to appropriately selected Japanese patients. (Trial Registration: clinicaltrials.gov Identifier NCT02520310.).

Apixaban for the treatment of saphenous vein graft thrombosis presenting as unstable angina: a case report.

BACKGROUND: Saphenous vein graft thrombosis can present as unstable angina. However, percutaneous coronary intervention for saphenous vein graft lesions poses a high risk of slow flow related to the procedure. Here we present the utilization of the novel oral anticoagulant, apixaban, in the treatment of unstable angina with extensive saphenous vein graft thrombus, leading to considerable thrombus resolution and eliminating the need of percutaneous coronary intervention. CASE PRESENTATION: A 72-year-old man with 3-vessel coronary artery bypass graft surgery using a saphenous vein graft and a left internal mammary artery, performed 25 years earlier, presented at our hospital with recurrent chest tightness. The echocardiography showed regional hypokinesis of the post-lateral wall with moderate left ventricular dysfunction, which had not been previously confirmed. Coronary angiography showed obstruction of the saphenous vein graft with a large thrombus burden. The left internal mammary artery was patent and other natives were the same as they had been 3 years ago. He was diagnosed with unstable angina due to acute saphenous vein graft thrombosis. Instead of percutaneous coronary intervention, he was treated with apixaban 5 mg twice a day. The angiography 3 weeks after starting apixaban showed considerable resolution of the thrombus and opening of the saphenous vein graft. CONCLUSIONS: Apixaban could become a viable treatment option for acute saphenous vein graft thrombosis.

Interatrial mechanical dyssynchrony shown by tissue doppler imaging during atrial flutter.

Although regular supraventricular tachycardia is traditionally classified on the basis of P-wave morphology, diagnostic accuracy is limited to information obtained from surface electrocardiography. Intracardiac electrophysiology is a conclusive although invasive diagnostic method. We report a case of regular supraventricular tachycardia with a heart rate of 162 bpm. M-mode echocardiography of the interatrial septum clarified both the atrial rate and the ventricular response ratio. Tissue Doppler M-mode imaging demonstrated the delay between the posterior wall motion of the left and right atrium. Although it deserves further study, transthoracic echocardiography may provide useful information in addition to electrocardiography.

Access-site complications of transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: a prospective cohort study with radial ultrasound follow-up.

The advantages of sheathless guiding catheters over the conventional approach using sheaths in percutaneous coronary intervention (PCI) regarding access-site complications, particularly ultrasound-diagnosed radial artery occlusion (RAO), remain unknown. The present study investigated the incidence of access-site complications of transradial primary PCI using sheathless guiding catheters in acute coronary syndrome (ACS). This prospective study evaluated access-site complications in 500 patients with ACS undergoing sheathless transradial primary PCI. Doppler ultrasound evaluation of the radial arteries was performed 2 and 30 days after the procedure. Sheathless guiding catheters (7.5-Fr) were used in 91.0% of the patients. The procedural success rate was 98.4%. Ultrasound-diagnosed RAO rates were 2.0% and 3.8% at 2- and 30-day follow-ups, respectively. Logistic regression analysis identified that the sheath-to-artery ratio (per 0.1) (odds ratio [OR] 5.71; 95% confidence interval [CI] 1.18-27.71; p = 0.001) was associated with more frequent RAO and that hypertension (OR 0.22; 95% CI 0.06-0.81; p = 0.023) was associated with less frequent RAO. Receiver operating characteristic curve analysis revealed that a sheath-to-artery ratio of 1.47 was the cutoff for 30-day post-procedural RAO (sensitivity 72%, specificity 81%). Sheathless transradial primary PCI for ACS was associated with a low incidence of access-site complications and a higher sheath-to-artery ratio cutoff for RAO than that expected from conventional PCI using sheaths based on historical data, demonstrating the access-site safety of sheathless guiding catheters and their benefit in PCI for ACS (University Hospital Medical Information Network-Clinical Trial Registry Number UMIN000019931).

A prospective interventional registry of short-term dual-antiplatelet treatment after implantation of drug-eluting stents in patients with atrial fibrillation requiring oral anticoagulation therapy.

There are limited data regarding the use of antithrombotic therapy in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES). In this prospective interventional study, we evaluated the feasibility of short-term dual-antiplatelet therapy (DAPT) after DES implantation in AF patients treated with oral anticoagulation (OAC). The antithrombotic regimen in the present study was 1-month DAPT, followed by single-antiplatelet therapy with OAC. A total of 285 consecutive patients were enrolled between 2015 and 2017. The mean CHA2DS2-VASc score was 3.91 ± 1.51. The duration of DAPT was 28.5 ± 11.5 days. At 1-year follow-up, serious bleeding complications, defined as Bleeding Academic Research Consortium type ≥ 2, were observed in 27 patients (9.5%). Multivariate analysis showed that previous history of bleeding episodes (P = 0.009) and continuation of aspirin (P = 0.003) were independent predictors for the serious bleeding complications. High ORBIT (P = 0.008) and PRECISE-DAPT (P = 0.002) scores were associated with the bleeding complications, and the cut-off values were 5.00 and 49.0, respectively. No definite stent thrombosis occurred in any of the patients. Short-term DAPT is feasible in AF patients treated with OAC after undergoing PCI with DES. The previous history of bleeding episodes and long-term aspirin use were associated with their 1-year serious bleeding events.

Three-dimensional relationship between the conus branch and the precordial leads confirmed by 64-multidetector-row computed tomography.

A 65-year-old man with effort angina pectoris underwent percutaneous coronary intervention of the proximal right coronary artery. The lesion was dilated with a bare-metal stent under wire protection of the conus branch (CB). However, the jailed CB was occluded. Electrocardiogram with conventional precordial leads (V(1) through V(6)) accompanied with the supplementary leads (V(1) through V(6)) positioned 1 intercostal space higher showed marked ST elevation in V(1) through V(3) that was more prominent in V(1) through V(3). The 64-multidetector-row computed tomographic coronary angiography showed recanalization of the CB located just in the center of the V(1), V(2), V(1), and V(2) electrodes.

Spontaneous Resolution of Residual Shunting in 2 Compromised Patients after Amplatzer Occlusion of Postinfarction Ventricular Septal Defects.

Ventricular septal defect (VSD) is a rare, potentially fatal complication of acute myocardial infarction. When surgical closure is contraindicated, transcatheter closure may be an alternative. Residual shunting after transcatheter closure of postinfarction VSDs has been reported; however, we found few cases of this in patients who also had severe heart failure or hemolysis. We report 2 closures of postinfarction VSDs with use of the Amplatzer Septal Occluder. Both elderly patients-one with severe heart failure, one with persistent hemolysis, and neither a surgical candidate-had high-velocity residual shunting through the occluders. We intensively managed the patients' conditions and used angiography and transthoracic echocardiography to record the gradual disappearance of each shunt over 4 months-the first such serial monitoring of which we are aware. We think that even substantial shunting in the presence of severe heart failure or hemolysis can eventually resolve spontaneously, assuming effective management of the concomitant medical conditions.

Utility of preprocedural multidetector computed tomography in alcohol septal ablation for hypertrophic obstructive cardiomyopathy.

Preprocedural computed tomography (CT) imaging appears to provide an advantage in localization of the appropriate septal branch targeted for alcohol septal ablation (ASA). The objective of this study was to compare the clinical backgrounds, procedural characteristics, and outcomes of patients who underwent ASA with preprocedural CT assessment against those without CT assessment. Thirty consecutive patients with obstructive hypertrophic cardiomyopathy who underwent ASA were retrospectively included. Patients who underwent preprocedural CT (CT-guided ASA group, n = 11) were compared with patients who underwent ASA without CT (traditional ASA group, n = 19). The CT-guided ASA group had a significantly lower number of approached target vessels (1 [interquartile range {IQR}, 1-2] vs. 2 [IQR, 2-3], P = 0.036) and non-ablated target vessels (0 [IQR, 0-1] vs. 1 [IQR, 0-2], P = 0.031) than the traditional ASA group. There were no differences between the two groups in total fluoroscopy time, the amount of delivered radiation dose, and the volume of contrast medium used during the procedures. There were also no differences between the two groups in procedural success rate and improvement of left ventricular outflow tract gradient and New York Heart Association functional class at 1 month follow-up. CT had a significant impact on the ASA procedure diminishing the number of target vessels, and could be a reliable assessment modality to build its procedural strategy.

Transradial Intervention in Patients With Non-ST Elevation Acute Coronary Syndrome Using One 4.0 Fr Sheath and One Sheathless Guide Catheter Via a Single Puncture Site: The 1-1-1 Strategy.

OBJECTIVES: The optimal primary transradial intervention (TRI) technique has not been established in non-ST segment elevation acute coronary syndrome (NSTEACS) patients, because they often, but not always, undergo immediate revascularization after coronary angiography (CAG). Moreover, TRI failure has been reported in 5%-10% of cases. We investigated whether a newly designed strategy of immediate TRI using one sheathless hydrophilic-coated guiding catheter (SH-GC) after diagnostic CAG with one 4.0 Fr sheath via a single access site (the 1-1-1 strategy) could be beneficial for NSTEACS patients. METHODS: We performed immediate TRI prospectively using SH-GC in consecutive NSTEACS patients in our hospital and compared the procedural success rate with that of conventional TRI performed before this study. RESULTS: Between 2015 and 2017, immediate TRI using SH-GC was performed in 330 consecutive NSTEACS patients after CAG using a 4.0 Fr sheath. Compared with the conventional TRI group (n = 330), the procedural success rate was significantly higher in the SH-GC group (P<.01), as SH-GC prevented TRI failure due to radial spasm (P<.01). SH-GC use was also significantly associated with completion of both diagnostic CAG and immediate TRI using only one sheath (P<.001) and one guiding catheter (P=.02). Multivariate analysis revealed that SH-GC use was an independent predictor of successful TRI (P<.01). The rates of major adverse cardiac events were comparable; however, rates of major access-site bleeding (P<.01) and blood transfusion (P=.02) were significantly lower in the SH-GC group. CONCLUSIONS: The 1-1-1 strategy using SH-GC may offer better TRI treatment than conventional systems for NSTEACS patients and simultaneously prevent access-site bleeding.

Complete Atrioventricular Block Associated with Pembrolizumab-induced Acute Myocarditis: The Need for Close Cardiac Monitoring.

Pembrolizumab, a humanized monoclonal IgG4 antibody directed against programmed death-1, is an immune checkpoint inhibitor that has been introduced for the treatment of non-small-cell lung cancer. However, immune checkpoint inhibitors may cause severe immune-related adverse events. We herein present a case of lung cancer with complete atrioventricular block associated with acute myocarditis, which developed 16 days after the administration of pembrolizumab. The clinical course of this case suggested a strong need for close cardiac monitoring when pembrolizumab is administered on an outpatient basis.

A randomised comparison of incidence of radial artery occlusion and symptomatic radial artery spasm associated with elective transradial coronary intervention using 6.5 Fr SheathLess Eaucath Guiding Catheter vs. 6.0 Fr Glidesheath Slender.

AIMS: The aim of this study was to compare incidences of radial artery occlusion (RAO) and spasm (RAS) associated with transradial coronary intervention (TRI) using a 6.5 Fr SheathLess hydrophilic-coated guide catheter (SH-GC) vs. a 6.0 Fr Glidesheath Slender (GSS). METHODS AND RESULTS: We conducted an open-label, single-centre, randomised study to compare radial complications in 600 consecutive patients undergoing elective TRI using 6.5 Fr SH-GC (n=300) or 6.0 Fr GSS (n=300) between 2015 and 2016. The primary endpoint was a composite of RAO evaluated by sonography and symptomatic RAS. The mean diameter of radial arteries was 2.20 mm in both groups; however, the sheath/radial artery diameter (S/RA) ratio was significantly smaller in the SH-GC group (1.03 vs. 1.17, p<0.001). SH-GC was associated with a higher rate of system crossover (1.7% vs. 0.7%, p=0.450) and coronary ostial dissection (1.0% vs. 0.3%, p=0.624), although there were no statistically significant differences. The incidence of major adverse cardiac events was comparable. A lower incidence of RAO and access-site crossover owing to RAS was significantly associated with SH-GC (0.0% vs. 2.0%, p=0.031). Multivariate analysis revealed that a larger S/RA ratio predicted RAO and RAS independently (p=0.007). CONCLUSIONS: The 6.5 Fr SH-GC offers a promising alternative to conventional TRI and is associated with fewer radial complications than the 6.0 Fr GSS.

A case of double stent implantation for left main coronary artery occlusion in transcatheter aortic valve implantation using SAPIEN XT device.

Transcatheter aortic valve implantation is an established alternative and less invasive procedure to replace heart valves in symptomatic aortic stenosis patients; however, severe, life-threatening complications still exist. Coronary artery occlusion is a primary complication. We report a case of left main coronary artery occlusion after transcatheter aortic valve replacement, which was ameliorated using a double stent implantation technique.

A Novel, Modified Reverse Controlled Antegrade and Retrograde Subintimal Tracking Technique for Bypassing the Calcified Proximal Cap of Coronary Total Occlusions.

Antegrade crossing is the most common approach to chronic total occlusions (CTOs). However, it is sometimes difficult to penetrate the proximal hard cap with guidewires, especially in the case of CTOs of anomalous coronary arteries because of a lack of support. Herein, we describe a novel, modified reverse controlled antegrade and retrograde subintimal tracking (CART) technique in which the dissection reentry was intentionally created in the proximal segment of the vessel, not within the occluded segment, using retrograde guidewire and the aid of an antegrade balloon. This technique facilitated retrograde crossing of CTOs by avoiding the proximal hard cap and may provide a viable option for patients in which conventional reverse CART is not possible.

A "tetra-axial" system in transfemoral lead extraction.

Pacemaker lead extractors must become familiar with transfemoral approaches for lead extraction as a bail-out procedure for a failed superior approach. We presented a "tetra-axial" system for transfemoral lead extraction. This system would be more widely applicable in cases with difficulties in extraction, resulting in more procedural success.

Transcatheter valve-in-valve implantation for failed mitral prosthesis: the first experience in Japan.

An 82-year-old woman had a history of mitral valve replacement with a 25-mm MOSAIC (Medtronic, USA) for severe mitral regurgitation (MR) 8 years previously. Recently, she developed heart failure due to MR secondary to prosthetic valve failure. She underwent transcatheter valve-in-valve implantation with a 23-mm SAPIEN XT (Edwards Lifesciences, USA) to the prosthetic mitral valve by transapical approach. To our knowledge, this is the first reported case of transcatheter valve implantation for failed mitral prosthetic valve using valve-in-valve technique in Japan.

Transcatheter closure of an atrial septal defect with high risk of erosion using a Figulla Flex II atrial septal defect occluder.

An 85-year-old man with a high risk for open heart surgery underwent a percutaneous closure of an atrial septal defect that lacked adequate aortic and superior rims. To avoid the risk for erosion, a Figulla Flex II ASD occluder was selected for the procedure. Implantation was successful, and no complications were observed during the 6 months of follow-up.

"Spaghetti twisting" technique: a novel method of catching pacemaker leads using a needle's eye snare.

The needle's eye snare has become an indispensable tool in contemporary pacemaker lead extraction techniques. Here, we present a modified method of using the needle's eye snare, named "spaghetti twisting" technique, to catch and secure pacemaker leads, which would help operators catch and secure leads much easily.

Delayed-Onset Left Main Coronary Artery Obstruction More than 24 Hours after Balloon-Expandable Transcatheter Aortic Valve Replacement.

Coronary obstruction during or after transcatheter aortic valve replacement is a rare and catastrophic sequela that occurs most frequently just after valve implantation. Even rarer is the delayed clinical presentation, in some few patients, of coronary obstruction on the day after self-expandable valve implantation. Here we describe a case of balloon-expandable (not self-expandable) transcatheter aortic valve replacement, followed by partial obstruction of the left main coronary artery on the day after that procedure in a 93-year-old man, despite normal left ventricular contraction just after valve implantation. Visual evaluation of the echocardiogram for left ventricular wall motion was not sufficient, by itself, to achieve early diagnosis of the obstruction. We performed emergency percutaneous coronary intervention. Ninety days after the procedure, the patient was in New York Heart Association functional class I.