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Silber S.,Heart Center at the Isar | Serruys P.W.,Erasmus Medical Center | Leon M.B.,Columbia University | Meredith I.T.,Monash University | And 9 more authors.
JACC: Cardiovascular Interventions | Year: 2013

Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). Conclusions: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. © 2013 American College of Cardiology Foundation. Source

Nomura T.,Shonan Kamakura General Hospital
Japanese Journal of Anesthesiology | Year: 2014

Ultrasound guidance for regional anesthesia has gained enormous popularity in the past decade. The usage of ultrasound guidance has reawaken many block techniques in daily clinical practice. In this review, the author described how the ultrasound guidance has changed the manner of intraoperative and postoperative analgesic methods. Here, interscalene block, transversus abdominis plane (TAP) block, paravertebral block and femoral nerve block were discussed. Those success rates increased using sonography, whereas the complications decreased. Advanced sonography shows the clear images of the detailed nerve tissues, so that we can perform the more pinpointed nerve block considering postoperative benefits of patients. However, it must never be forgotten that both the pre-scan examination before a needle insertion and the continuous watching of an advancing needle tip are essential to perform safer regional anesthesia techniques. Source

Toyota K.,Shonan Kamakura General Hospital
Japanese Journal of Anesthesiology | Year: 2014

Surgery is known to be a major risk factor of vein thrombosis. Progression from lower extremity deep vein thrombosis (DVT) to pulmonary embolism can lead to catastrophic outcome, although the incidence ratio is low. The ability to rule in or rule out DVT is becoming essential for anesthesiologists. Non-invasive technique of ultrasonography is a sensitive and specific tool for the assessment of lower extremity DVT. This article introduces the basics and practical methods of ultrasound examination for lower extremity DVT. Source

Tsuburaya A.,Shonan Kamakura General Hospital | Mizusawa J.,Clinical Data | Tanaka Y.,Saitama Cancer Center | Fukushima N.,Yamagata Prefectural Central Hospital | And 2 more authors.
British Journal of Surgery | Year: 2014

Background Locally advanced gastric cancer with extensive regional and/or para-aortic lymph node (PAN) metastases is typically unresectable and associated with poor outcomes. This study investigated the safety and efficacy of S-1 plus cisplatin followed by extended surgery with PAN dissection for gastric cancer with extensive lymph node metastasis. Methods Patients with gastric cancer with bulky lymph node metastasis along the coeliac artery and its branches and/or PAN metastasis received two or three 28-day cycles of S-1 plus cisplatin, followed by gastrectomy with D2 plus PAN dissection. The primary endpoint was the percentage of complete resections with clear margins in the primary tumour (R0 resection). A target sample size of 50 with one-sided α of 0·105 and β of approximately 0·2 corresponded to an expected R0 rate of 65 per cent and a threshold of 50 per cent. Results Between February 2005 and June 2007, 53 patients were enrolled, of whom 51 were eligible. The R0 resection rate was 82 per cent. Clinical and pathological response rates were 65 and 51 per cent respectively. The 3- and 5-year overall survival rates were 59 and 53 per cent respectively. During chemotherapy, grade 3/4 neutropenia occurred in 19 per cent and grade 3/4 non-haematological adverse events in 15·4 per cent. The incidence of grade 3/4 adverse events related to surgery was 12 per cent. There were no reoperations or treatment-related deaths. Conclusion For locally advanced gastric cancer with extensive lymph node metastasis, 4-weekly S-1 plus cisplatin followed by surgery including PAN dissection was safe and effective for some patients. Further investigation of this treatment strategy is warranted. Merits confirmation in a Western population © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd. Source

Wajima Z.,International University of Health and Welfare | Shiga T.,International University of Health and Welfare | Imanaga K.,Shonan Kamakura General Hospital
Journal of Anesthesia | Year: 2015

Purpose: Stroke volume variation (SVV) is affected by many factors. Although elevated intra-abdominal pressure and a pneumoperitoneum have been shown to increase SVV in animals, a recent human study showed that SVV did not change as a pneumoperitoneum was established. However, we considered the results of this study questionable, and we therefore attempted to study whether SVV changes both before and after pneumoperitoneums in humans. Methods: We performed a prospective observational study in 19 patients undergoing cholecystectomy or colectomy while on mechanical ventilation. Immediately before pneumoperitoneum, baseline registrations of variables were obtained (baseline I), which were measured every min for 5 min after the pneumoperitoneum was initiated. Immediately before the pneumoperitoneum was released, another baseline registration of variables was obtained (baseline II); these variables were then measured every min for 5 min. Results: After the pneumoperitoneum was initiated, there were significant increases in SVV at the 2- to 5-min time points. After release of the pneumoperitoneum, there were significant decreases in SVV at the 1- to 5-min time points. Conclusion: A pneumoperitoneum increased SVV, which is similar to the findings of previous animal studies but is different from a previous clinical study. Upon release of the pneumoperitoneum, SVV decreased significantly, which is new information. SVV values must be estimated cautiously during a pneumoperitoneum. © 2014, Japanese Society of Anesthesiologists. Source

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