Therapeutic Research

Eighty years old female who was diagnosed as an advanced atrioventricular conduction block implanted the implantable pacing generator. Although, the atrial pacing lead was screwed in a right atrial appendage, sensing value of atrium was unstable by the lead shape in the right atrium. The pacing system analyzer revealed as pacing threshold 1.5 V / 0.4 ms, 2.5 mV of atrial sensing, and 792Ω of lead impedance at end of the implantation. After two days, the slight towed of the atrial lead was confirmed by chest X–ray, and the fluctuation of an atrial sensing which was 1.0 mV at sitting position, and 6.0 mV at the spine position was observed. She was discharged because of no change of the pacing threshold and pacing lead impedance and the remote monitoring system was introduced to follow up the data of the pacing generator. Seven days after discharge, the atrial pacing threshold increased over 2.5 V which found by the remote monitoring system. The fluoroscopy showed that the atrial pacing lead was dropped in the right atrium, and we performed re –implantation. The remote monitoring system was useful to detect abnormalities of pacing system earlier.

The patient was a 65–year –old woman diagnosed with cardiac sarcoidosis treated with CRT–D for a complete atrioventricular block and ventricular arrhythmias. A generator exchange was performed under continuing anticoagulation because of the high risk of thromboembolism. After the procedure, the uncontrollable bleeding continued, and increased hematoma resulted a right ventricular pacing failure.

The cardiac pacemaker sold by Sorin CRM （Reply200, KORA100, KORA250） has a thoracic impedance monitoring function （SAM） reflecting breathing. The amplitude of the minute ventilation signal based on the thoracic impedance reflects respiration, detects the amplitude pause or decrease, and is recorded as the respiratory disturbance index （RDI）. The relationship between RDI of SAM and RDI of simplified poly for the 10 patients who were implanted with these devices and were also able to wear simple polysomnography （simple poly） and had the result of SAM were evaluated. In this evaluation, the judgment of severe SAS （RDI ≧30） was consistent among all patients, and the RDI of SAM and the RDI of simplified poly had a high correlation. Analysis of the detailed apnea events for the difference between two RDIs and their causes for each patient showed that the more patients with central apnea predominate, the less the RDI error, the lower the respiratory/obstructive apnea dominance resulting in a large error. SAM is useful information for the diagnosis of severe SAS and it was considered that SAS can be detected early by continuous monitoring. There are many reports on the association between SAS and arrhythmia, and SAS is said to increase the risk of developing atrial fibrillation. It was suggested that device follow –up including prevention of new arrhythmia episodes is possible by effectively utilizing the functions of the device.

Among tricuspid surgical cases, there has been a histor y of cardiac device implantation and it has been reported that the right ventricular lead leads to tricuspid valve closure failure（TR）. We report a case of severe TR due to shock lead which was detained 13 years ago. At the age of 53, cardiac catheterization was performed to examine palpitations, diagnosed with advanced atrioventricular block and sustained ventricular tachycardia, and an implantable cardioverter defibrillator（ICD: DDD type） was detained. Dyspnea appeared at the age of 65, so diuretic treatment was performed but weight gain, orthopedic respiration appeared, it became emergency hospitalization to the previous doctor, transferred to our hospital for the purpose of examinations for heart failure. The chest X–ray showed an enlargement of the cardiothoracic ratio, which was high as BNP 281 pg/mL by blood test. Echocardiographic examination showed high TR. Tricuspid valve replacement, Shock Reed reconstruction surgery, ICD exclusion surgery were performed, diagnosed as severe TR associated with Shock Reed. We experienced a case of severe TR due to shock lead which we detained 13 years ago.

ジエノゲスト（ディナゲスト錠1 mg）は，新規の19‒ノルテストステロン誘導体で，選択的プロゲステロン受容体アゴニスト活性に基づき卵巣機能抑制作用および子宮内膜細胞の増殖抑制作用を示すプロゲスチンである。日本においては2007 年10 月に「子宮内膜症」，2016 年12月に「子宮腺筋症に伴う疼痛の改善」の治療薬として製造販売承認を取得した。発売後，子宮内膜症に対するジエノゲストの日常診療下における12 ヵ月間を超えた長期投与時（最長60 ヵ月間）の安全性および有効性を検討することを目的とした製造販売後調査を実施し，安全性および有効性解析対象症例として3132 例の調査票を収集した。副作用発現率は46.2％（1446/3132 例）で，承認時までの臨床試験成績における副作用発現率（77.5％）に比較して低かった。主な副作用は，不正子宮出血1147 例（36.6％），ほてり87例（2.8％）， 頭痛76 例（2.4％）， 悪心52 例（1.7％），抑うつ症状35 例（1.1％），貧血31 例（1.0％）であり，いずれも承認時までに認められた副作用であった。重篤な副作用は34 例（1.1％）54 件で，承認時までの臨床試験成績における重篤な副作用発現率（0.4％）に比較して高値であったが，約半数が不正子宮出血，貧血であり，それ以外の副作用の発現率は低く，いずれの事象についてもほとんどの転帰が回復または軽快であった。骨密度の推移および長期投与時の副作用の発現状況については，特筆すべき事項はなかったことから，本剤を最長60ヵ月長期投与した際の安全性に問題はないことが示された。有効性においては，最終評価時の「全般改善度の改善率」は75.0％（956/1274 例）であった。また，評価時期別の「全般改善度の改善率」は，投与12ヵ月までは投与期間の延長に伴い上昇傾向を示し，12 ヵ月以降も改善率は大きく異ならなかった。以上より，本剤の12ヵ月間を超えた長期投与時（最長60 ヵ月間）の安全性および有効性が確認された。