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Radiofrequency hotballoon (RHB) is an ablation device used for atrial fibrillation (AF) treatment. The efficacy and safety of RHB-based pulmonary vein isolation (PVI) in real-world practice are unknown.Methods and Results: A multicenter, prospective registry study (UMIN000029567) enrolled AF patients who underwent RHB-PVI. The primary endpoint was the AF recurrence-free survival rate at 12 months after PVI. Of the 679 patients enrolled, 613 (90.3%; paroxysmal AF, n=370; persistent AF, n=136; long-standing AF, n=107) underwent initial RHB-PVI. Acute isolation using only the RHB was successful for 55.6% of patients and 83.5% of pulmonary veins (PVs). The acute isolation rate was higher for patients with paroxysmal AF and more experienced centers. Antiarrhythmic drugs were prescribed after 3 months for 47.5% of patients. The AF recurrence-free survival rate at 12 months was 83.7%. Procedure-related complications including atrio-esophageal fistula (n=1) and phrenic nerve injury (persistent; n=4, permanent; n=2) were observed in 19 (3.1%) patients. Five (1.7%) of the 302 patients who underwent pre-procedural and post-procedural multidetector computed tomography had severe PV stenosis.The size-adjustable RHB has been used for the treatment of various AF types. The arrhythmia recurrence-free rate at 12 months, with the use of antiarrhythmic drugs in approximately half of the patients, was acceptable, but the acute isolation rate using the RHB requires further improvement.

Background SATAKE HotBalloon®catheter (HBC) is a radiofrequency balloon catheter for the treatment of atrial fibrillation (AF), and was approved for use in Japan to treat drug-resistant paroxysmal AF in 2015. Post-marketing surveillance study was conducted by Toray Industries, Inc. to evaluate the efficacy and safety of HBC treatment in patients with paroxysmal AF in a real-world setting. This study is the first nation-wide survey of HBC treatment for paroxysmal AF in clinical practice in Japan.Methods and Results:This was a single-arm, multicenter observational study with an observation period of 48 weeks after ablation. Pulmonary vein isolation and AF non-recurrence rates were evaluated and adverse events (AEs) were observed at 46 sites in Japan. An AF event was defined as recurrence of AF or re-ablation from 12 to 48 weeks after ablation. The success rate of pulmonary vein isolation was 99.0% (486/491) for patients with AF. The cumulative AF non-recurrence rate was 94.1% at 24 weeks and 87.8% at 48 weeks. AEs were found to occur 21.5% (114/530), and ablation-related AEs were found to occur 2.6% (14/530) during the study period, with the most common being pericardial effusion (0.8%, 4/530). Conclusions This study demonstrates the efficacy and safety of HBC ablation in Japanese patients with recurrent symptomatic paroxysmal AF refractory to antiarrhythmic therapy.

Increased variety and use of chemicals and the number of chemical disasters have changed chemical management. Europe and the United States have adopted self-regulation in chemical management; furthermore, countries worldwide must comply with the relevant United Nations recommendations and international standards for chemical management. Japan has experienced numerous pollution incidents and occupational disasters, resulting in the development of laws and regulations on chemical management; however, these policies are inconsistent with international trends. In particular, the shift from a compliance approach to self-regulation and measures for small businesses remain as challenges. This paper discusses the current situation and issues in chemical management in Japan, focusing on international trends.

SATAKE HotBalloonThis study demonstrates the efficacy and safety of HBC ablation in Japanese patients with recurrent symptomatic paroxysmal AF refractory to antiarrhythmic therapy.

Background Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete pulmonary vein (PV) isolation, and is associated with severe complications. Objectives The purpose of this study was to evaluate the safety and effectiveness of a HotBalloon ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF. Methods A prospective multicenter randomized controlled study was conducted in Japan. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period. Results A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n = 100) and 4.7% in the ADT group (n = 43; p 70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively. The mean fluoroscopy time was 49.4 ± 26.6 min (n = 134), and the mean procedure duration was 113.9 ± 31.9 min (n = 133). Conclusions This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile.

Long-Term Outcomes Following Hot Balloon AblationIntroduction Isolation of pulmonary veins (PVs) and the posterior left atrium (LA) can be safely performed by radiofrequency hot balloon (RHB)-based box isolation. However, data on long-term effects for the treatment of atrial fibrillation (AF) by the use of this method remain limited. Methods and Results We treated 238 patients with paroxysmal AF (194 male; age. 62.6 ± 9.4 years) by RHB ablation. During 6.2-year (75 months) follow-up, 154 (64.7%) patients were free from atrial tachyarrhythmias (ATAs) without antiarrhythmic-drugs (AADs). We performed re-ablation in 69 of 84 patients with ATA recurrence (average 1.3 ± 0.6; median 1, total 91 procedures) using a 3D-mapping system and a conventional catheter. The sites of reconnection were observed at the PV in 61 of 69 (88.4%) patients and at the posterior LA in 58 of 69 (84.1%) patients. Finally, during mean follow-up of 4.6 ± 1.6 years, no-ATA episodes were detected in 201 (84.5%) patients without AADs. Independent predictors of ATA recurrence following a single procedure were heart failure with preserved ejection fraction (HR: 2.67, 95%CI: 1.40–5.10, P = 0.003) and low estimated glomerular filtration rate (HR: 1.81, 95%CI: 1.11–2.93, P = 0.03; cut-off of 62.0 mL/min/1.73 m2). During the follow-up period, there were 4 (1.7%) patients with PV stenosis (>70% reduction in PV diameter); however, none of these cases required intervention. Phrenic nerve palsy was detected in 8 patients (3.4%), but resolved during 3 months in all cases. Conclusion RHB ablation can be effective during a long-term follow-up for patients with paroxysmal AF. Safety outcomes were within an acceptable range.

Background— Atrial fibrillation originates mostly from the pulmonary vein (PV) foci or non-PV foci in the posterior left atrium (LA). The present study was designed to evaluate the feasibility and safety of a novel radiofrequency hot balloon catheter for the treatment of patients with atrial fibrillation by electrically isolating the posterior LA, including all PVs. Methods and Results— One hundred consecutive patients with drug-resistant atrial fibrillation (63 paroxysmal, 37 persistent) were enrolled. The isolation of the PVs was performed by wedging the balloon at each PV antrum to create circumferential lesions in each case. Contiguous linear lesions were also created at the roof between the superior PVs and at the bottom of the posterior LA between the inferior PVs by dragging the balloon along the endocardium. Complete elimination of the posterior LA and PV potentials was achieved in all 100 cases, confirmed by either conventional or electro-anatomic mapping system. The total procedure time was 129�26 minutes, inclusive of 29.9�7.3 minutes of fluoroscopy time. Follow-up during 11.0�4.8 months confirmed that 92 patients (60 paroxysmal, 32 persistent) were free from atrial fibrillation without antiarrhythmic drugs, and in the remaining patients except for 2 with LA tachycardia, sinus rhythm was maintained with antiarrhythmic drugs. With precautions of esophageal cooling by irrigation dictated by temperature monitoring and monitoring phrenic nerve pacing, no LA-esophageal fistula or permanent phrenic nerve injury occurred. Conclusion— This feasibility study supports the safety and efficacy of radiofrequency hot balloon catheter for complete isolation of the posterior LA and PVs.

Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete pulmonary vein (PV) isolation, and is associated with severe complications.The purpose of this study was to evaluate the safety and effectiveness of a HotBalloon ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF.A prospective multicenter randomized controlled study was conducted in Japan. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period.A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n = 100) and 4.7% in the ADT group (n = 43; p 0.001). The incidence of major complications was 11.2% (15 of 134 patients). The incidences of PV stenosis (70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively. The mean fluoroscopy time was 49.4 ± 26.6 min (n = 134), and the mean procedure duration was 113.9 ± 31.9 min (n = 133).This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile.

Objective: The purpose of this study was to provide detailed information as to the modification of electrophysiological properties of pulmonary veins (PVs) and adjacent left atrial (LA) tissue caused by circumferential ablation (ABL) of superior and inferior pulmonary vein ostia using a novel radio-frequency balloon catheter (RBC), and to correlate such changes with recurrence or non-recurrence of atrial fibrillation (AF). Background: Although isolation of the triggering foci in PVs using conventional ABL techniques is useful in the treatment of AF, ABL of PVs per se is time consuming and tends to be associated with high AF recurrence rate. Methods and Results: Forty-nine patients with AF refractory to antiarrhythmic medication underwent circumferential ablation of PV-LA junction by RBC. Post ablation changes in electrophysiological properties around the PV ostia were studied with a basket catheter and were correlated with AF recurrence in 34 (1st study) early cases (ablating 68 superior PVs) and 15 (2nd study) later cases (53 superior and inferior PVs). Total elimination of PV potentials or PV-LA dissociation was achieved in 93% (63/68 PVs) and 93% (49/53 PVs), respectively. During mean follow-up periods of 24.1 ± 4.1 and 13.3 ± 1.7 months, AF recurred in 38% (13/34 cases) and 13% (2/15) in early and later groups, respectively, but no case developed severe PV stenosis. Although the amplitude of PV and periostial LA potentials were decreased (p < 0.0001) in all patients, the remaining PV potentials in 34 non-recurrence cases were definitely smaller than those in 15 recurrence cases (p

We treated a case of ventricular septal perforation (VSP) who survived for 14 years after myocardial infarction. Nine years after the onset of myocardial infarction, an apparent cardiac murmur was discovered by chance, and following further examination, the patient was diagnosed as having VSP. The patient is still in the NYHA functional class I, and requiring no surgical treatment. In general, the prognosis of myocardial infarction complicated with VSP is so poor that there have only been 14 reported cases of long survival without surgical treatment. Among these patients, only 2 survived for more than 10 years. The present case is extremely rare, and evidently is the longest living survivor with this condition yet reported.

We evaluated a 68-year-old male patient with isolated levocardia without intracardiac anomaly. The patient's condition was complicated by the absence of the inferior vena cava, a lobulated spleen and sick sinus syndrome. Isolated levocardia without intracardiac anomaly is very rare and only 25 cases of this disease have been reported, to our knowledge. In general, it is accepted that cardiac rhythm disorder is frequently observed in cases of isolated levocardia and/or absence of inferior vena cava. However, there are few cases of isolated levocardia without intracardiac anomaly complicated by the absence of the inferior vena cava, a lobulated spleen and apparent sick sinus syndrome.

Three months after implantation of endocardial pacing leads in 10 mongrel dogs, the tensile forces needed to remove 5 tined type and 5 screw-in type leads were compared experimentally. Mean maximum tensile force was 291 +/- 174 g with the screw-in type and 1174 +/- 369 g with the tined type (p < 0.01). Histopathologically, no changes suggesting any myocardial damage due to lead extraction were recognized in cases where screw-in type leads were used. These results support the clinical feasibility of safe and easy manual retraction of infected pacing leads of the screw-in type.

A case of infective endocarditis (IE) caused by a rare pathogen, Gemella morbillorum, is presented. Because of persistent low-grade fever after dental treatment, the patient was given oral antibiotics. Whereas he was diagnosed as having aortic regurgitation by a cardiologist, and IE was not suggested unfortunately. After long-term chemotherapy over five months, he was aware of nocturnal dyspnea and Gemella morbillorum was detected by blood culture. Then, he was treated with intravenous administration of Penicillin-G, and underwent surgical operation for valve replacement. No cases of IE due to this organism have been reported in Japan.

Atrial fibrillation (AF) is originated from mostly from pulmonary vein (PV) foci or non-PV foci in the posterior left atrium (PLA). The present study was designed to evaluate the usefulness of a radiofrequency HOT balloon catheter (RBC) for isolation of the PLA including all PVs en masse in the patients with AF. In a total of 96 patients (75 men and 21 women; mean age 64±8 years old) with drug-resistant paroxysmal (n=63) and persistent AF(n=33), PLA including all PVs were ablated and isolated using RBC. Dragging the balloon, contiguous lesions at the roof between the superior PVs were first created, then each antrum of all PVs were ablated, and finally, contiguous lesions at the PLA between the both inferior PVs were made, while we performed monitoring esophagus temperature and phrenic nerve pacing. Electro-anatomical bipolar voltage amplitude mapping (CARTO) of the LA-PVs was performed to determine the extent of this electrical isolation after all procedure. Successful isolation of the PLA including all PVs was achieved in all of 96 cases with elimination of all the PLA and PV potentials. The mean total procedure time 133 ± 31 minutes including 32±9 minutes fluoroscopy time. Recurrences of AF were diagnosed by Holter monitoring, mobile electrocardiogram. After first session, eighty- seven (59 paroxysmal, 28 persistent) of 96 patients were free from AF without anti-arrhythmic drugs and the remaining patients could maintain sinus rhythm with anti-arrhythmic drugs except two cases with LA flutter during 11.0±4.1 months follow-up. No major complications such as cerebral embolism, PV stenosis, or phrenic nerve palsy, and LA-esophageal fistula were observed. Complete isolation of the PLA including all PVs using a RBC, is useful for the treatment of both paroxysmal and persistent AF without severe complication.

We report an interesting case of aortic regurgitation. Phonocardiographically, the shape of the diastolic musical murmur in this case changed in each cardiac cycle despite being in sinus rhythm, in the same posture and in the same breathing phase. Experimentally, we were able to obtain a similar noise pattern using an artificial respirator and a hemispherical silicone membrane. We concluded that the irregular and chaotic change in the shape of the diastolic musical murmur in the present case occurred due to irregular swaying of the non-coronary cusp under the influence of the Venturi effect owing to a regurgitant jet stream. (Jpn Circ J 1996; 60: 993 - 997)

We report a case of sudden death due to variant angina during Holter electrocardiogram (ECG) monitoring. The patient, a 60-year-old man, had been aware of chest discomfort lasting less than one minute at midnight 2 days earlier. Because variant angina or arrhythmia was suspected, Holter ECG monitoring was performed. The patient spent a whole day without a recurrence of chest pain before going to bed, but at midnight he developed sudden chest pain, and died immediately after taking a sublingual tablet of isosorbide-dinitrite. Analysis of the Holter ECG revealed ventricular fibrillation after several ventricular premature beats following ST-segment elevation in both the CM5 and NASA leads. This case shows that sudden death from variant angina may occur within a few days after the first onset, and also highlights whether priority should be given to making a definite diagnosis or giving treatment when variant angina is strongly suspected.

We examined histologically whether the severity of arterial stretch injury is related to the degree of subsequent intimal hyperplasia. In six male New Zealand White rabbits, the common carotid artery was hyperextended with a 3F Fogarty balloon catheter. Two weeks later, no proliferative change was evident in the intima in the most hyperextended portion. Paradoxically, however, intimal hyperplasia due to smooth muscle cell proliferation was observed in the moderately extended portions. The intimal hyperplasia appeared to be exacerbated where the arterial stretching was more severe. It is concluded that the severity of arterial stretch injury is closely related to the intimal proliferation of smooth muscle cells.

We observed a case of acute myocardial infarction induced by second diagonal branch occlusion. Electrocardiogram (ECG) on admission showed ST elevation in leads I, aVL and V2-6. Since emergency coronary angiography disclosed complete occlusion of the second diagonal branch, intra-coronary thrombolysis (ICT) was performed, superselectively. Transient coronary reperfusion was obtained, however, reocclusion occurred after several minutes. Rescue percutaneous transluminal coronary angioplasty (PTCA) was then performed immediately and blood flow was improved to TIMI grade 2. During these processes, the ST-segment on the ECG changed in leads I, aVL and V2-6 always corresponding to the blood flow of the second diagonal branch. We have not seen a report hitherto in which occlusion of only the second diagonal branch could be a cause of extensive anterior infarction-like ECG changes. Although the mechanism of ECG changes in this patient cannot be clearly explained by conventional concepts, we report this case because it is considered to be very rare.

Background: Non-uniform heating of the tissue due to direct resistive heating by radiofrequency current under regional cooling was changed blood flow or irrigation, resulting in thrombus formation. To avoid non-uniform heating, we have developed a radiofrequency hot balloon catheter system (RFHBS). Methods and Results: We treated 446 patients with atrial fibrillation (AF) (paroxysmal AF (PAF), n=269; persistent AF (Per-AF), n=78; long persistent AF (Long-AF), n=99) by pulmonary vein (PV) antral isolation or box isolation using RFHBS and performed MRI of brains after procedure. There were no complications such as cardiac tamponade, cerebral embolism, atrio-esophageal fistula, symptomatic PV stenosis or phrenic palsy, associated with the ablation procedure. During 12 months follow up, no AF episodes were detected without anti-arrhythmic drugs in 346 patients (PAF, n=230 (86%); Per-AF, n=53 (68%); Long-AF, n=55 (56%)). During 3.6±1.2 years follow-up period, no AF episodes were detected without anti-arrhythmic drugs in 279 patients (PAF, n=188 (70%); Per-AF, n=43 (55%); Long-AF, n=48 (48%)). Conclusion: PV antral isolation or box isolation using a RFHBS could be performed without serious complication and long-term effective for the patients with AF.

Background: We evaluate the safety and efficacy of a radiofrequency hot balloon catheter (Toray-Satake Balloon; TSB) for the treatment of the patients with AF. Methods and Results: A total of thirty patients (26 men, 60±9 years) with drug-resistant AF (paroxysmal n=26, persistent n=4) were enrolled in this study. Under general anesthesia (n=12) or deep sedation (n=18), we performed isolation of all PVs including PV antrum, only by use of TSB. The center temperature of the balloon (60–70C) and the delivery time of RF energy (90–240 seconds) were determined by the wall thickness of each PV, measured by intra-cardiac echo. Complete PV isolation was observed in 110 of 121 PVs (91%), and decreased PV potentials were left in 4/31 (13%) at right superior PV, 4/30 (13%) at left superior PV, and 3/30 (10%) at left inferior PV. Total procedure times were (102±27 min). Total fluoroscopic times and total application times were (31±14 min) and (12±2 times), respectively. After a single procedure, twenty-seven of 30 patients (87%) were free from AF without anti-arrhythmic drugs during 6 months follow-up period. There were no complications such as stroke, esophageal fistula, symptomatic PV stenosis, phrenic nerve palsy, pyloric spasm. Conclusion: Ablation by TSB might be time-saving, safety and quite promising therapy for the patients with AF.