Peak Endocardial Acceleration-Based Clinical Testing of the "BEST" DDDR Pacemaker

The peak endocardial acceleration (PEA, unit g) shows a near correlation with myocardial contractility during the isometric systolic contraction of the heart (dP/dtmax), with sympathetic activity and, thus, with physiological heart rate modulation. The (Biomechanical Endocardial Sorin Transducer (BEST) sensor is incorporated in the tip of a pacing lead and measures PEA directly near the myocardium. In an international study, the lead was implanted with the dual chamber pacemaker Living-1 (Sorin) in 105 patients. The behavior of the PEA signal was tested under conditions of physical and mental stress and during daily life activities by 24-hour recordings of PEA (PEA Holter) at 1 to 2 months and approximately 1 year after implantation. Implantation of the BEST lead was performed without complications in all patients. The sensor functioned properly in the short- and long-term in 98% of patients. Although PEA values differed from patient to patient, the values closely reflected the variations in sympathetic activity due to physical and mental stress in each patient. During exercise and during daily life activities a close correlation between PEA and heart rate was observed among patients with normal sinus rhythm. Peak endocardial acceleration allows a nearly physiological control of the pacing rate.     

Automatic Sensor Adjustment in a Rate Modulated Pacemaker

A new feature (AutoSlope) has been introduced that can automatically adjust the sensor slope based on the chronic activity level of the patient. The algorithm adjusts the slope once per week so that 99% of the sensor response is maintained between the base rate and 23% of the difference between the programmed Base Rate and the Max Sensor Rate. Offsets are available for fine titration of sensor response in individual patients. The AutoSlope feature was evaluated in 93 patients with DDDR pacemakers (Trilogy DR+, Pacesetter). Patients were seen at 1, 3, and 6 months for a total of 178 evaluations. At each evaluation, the AutoSlope value was recorded. Patients then performed a brisk walk at sensor values equivalent to the AutoSlope value. Desired sensor rate was compared to the rate achieved by AutoSlope for the exercise period. Long-term sensor performance was evaluated by analyzing the sensor histogram. AutoSlope provided the desired sensor rate in most patients. Use of AutoSlope offsets allows fine titration of rate modulation in individual patients. Ongoing changes in sensor performance provided by AutoSlope allow patients to achieve a desired sensor rate from one evaluation to another without changes in permanent programmed settings. Programming a low maximum sensor rate may limit sensor response in some patients.     

Rapid symptom relief in reflux oesophagitis: a comparison of lansoprazole and omeprazole

Background: Lansoprazole, a substituted benzimidazole, is a proton pump inhibitor which is highly effective in the control of 24-h intragastric acidity. The aim of this multicentre, randomized, double-blind study was to compare lansoprazole 30 mg once daily and omeprazole 20 mg once daily in the symptom relief and healing of patients with reflux oesophagitis. Methods: Six hundred and four patients with endoscopically proven oesophagitis and a recent history of heartburn were randomly assigned to receive lansoprazole 30 mg or omeprazole 20 mg daily for 4–8 weeks. Daily assessment of symptoms was made by the patient using a 100-mm Visual Analogue Scale. Clinical symptoms were evaluated at weeks 0, 1, 4 and 8. Endoscopic assessment of healing, defined by normalization of the oesophageal mucosal appearance, was made at weeks 4 and 8. Results: Two hundred and eighty-two patients in the lansoprazole group and 283 patients in the omeprazole group were eligible for inclusion in the per protocol analysis. At 3 days, there was a significant improvement in daytime symptoms of heartburn for patients in the lansoprazole group compared with the omeprazole group (P=0.05). A similar but non-significant trend was seen at 7 days (P=0.18). Clinical assessment at 7 days demonstrated significant improvement in daytime epigastric pain in the lansoprazole group compared with the omeprazole group (P=0.03), with a similar but non-significant trend in night-time epigastric pain (P=0.07). Healing rates of oesophagitis at 4 and 8 weeks were 70 and 87%, respectively, with lansoprazole, and 63 and 82%, respectively, with omeprazole. Logistic regression analysis of the cumulative healing rates, which included baseline factors affecting outcome, resulted in an odds ratio of 1.46 (95% CI=0.87–2.45), suggesting a higher chance of being healed with lansoprazole treatment compared with omeprazole treatment. A total of 615 adverse events were reported by 308 (51%) patients during the study period. The majority of events were mild in nature and the incidence was similar in both treatment groups. The most frequently reported events were headache, diarrhoea and nausea. Conclusion: Lansoprazole provides greater symptom relief compared with omeprazole during the first week of treatment. Both treatments were effective in healing oesophagitis.     

Preliminary Report on Multidisciplinary Treatment for Esophageal Carcinoma

A cooperative study was conducted to examine the effect of bleomycin(BLM) or FT-207 which was combined with preoperative radiotherapy.To both groups of patients a solid form of BLM was administeredduring surgery and FT-207 after surgery. From July 1978 to June1980, 267 cases of esophageal carcinoma were treated accordingto this protocol. Resective surgery was performed on 199 patients,and in 171 of these, six months had passed after the operation.These 171 cases were studied. There were 79 patients in theBLM group and 92 in the FT-207 group. There was no disparityin fluoroscopic findings, age distribution or sex ratio. TheBLM group had a slightly higher operative mortality. There wasno significant difference in survival or in histological effectin the resected specimen. A total dose of 12,500 mg of suppositoryFT-207 had the same effect as a total dose of 45 mg of BLM.FT-207 is easier to administer to patients with esophageal carcinoma. The members of this group are: Toshifumi lizuka, M.D. (NationalCancer Center Hospital, Mitsuo Endo, M.D. (Tokyo Women's MedicalCollege), Koichi Sasaki, M.D. (Niigata University), Kazuo Karasawa,M.D. (Aichi Cancer Center Hospital), Teruo Kakegawa, M.D. (KeioUniversity), Masaki Arimori, M.D. (The 2nd Tokyo National Hospital)and Tetsuji Sasaki, M.D. (Nagoya Hoken Eisei University).     

Infections with Nonthoracotomy Implantable Cardioverter Defibrillators: Can These Be Prevented?

Nonthoracotomy ICDs are believed to be the best therapeutic modality for treatment of life-threatening ventricular arrhythmias. Little is known about the risk of infection with initial implantation of these devices. We studied the incidence, clinical characteristics, and risk factors associated with infections in 1,831 patients with nonthoracotomy ICD from the Endotak-C nonthoracotomy lead registry of Cardiac Pacemakers, Inc. A transvenous lead was implanted in 950 patients (51.9%) and a combination transvenous plus subcutaneous patch was used in 881 patients (48.1%). Nine preselected data variables were studied, and all investigators identified as having patients with infections were personally contacted. Infections occurred in 22 (1.2%) of 1,831 patients receiving this nonthoracotomy ICD system. The mean time to infection was 5.7 ± 6.5 months (range 1–25 months). Staphylococci were isolated in 58% of patients with reported infection. The presence of a subcutaneous defibrillator patch system was associated with the development of infection. Six of 950 patients (0.63%) with a totally transvenous lead system developed infection versus 16 of 838 (1.9%) patients with a transvenous lead plus subcutaneous patch system configuration (P = 0.015, Chi-square test), with an unadjusted estimated odds ratio of 3.06 (CI 1.19–7.86). The risk of infection encountered with the nonthoracotomy ICD is low, estimated from our data to be 1.2%. Placement of a subcutaneous defibrillator patch appears to be an independent risk factor for development of infection.     

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

AIM: Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. METHODS: This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). RESULTS: All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. CONCLUSION: Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.     

Uncertainty,lack of control and emotional functioning in women with metastatic breast cancer: a review and secondary analysis of the literature using the critical appraisal technique

WARREN M. (2010) European Journal of Cancer Care 19 , 564–574 Uncertainty, lack of control and emotional functioning in women with metastatic breast cancer: a review and secondary analysis of the literature using the critical appraisal technique A diagnosis of metastatic (or secondary) breast cancer is frequently more distressing than the diagnosis of a primary tumour since it indicates that the cancer is no longer curable. Relatively little is known, however, about women's experiences of this condition in comparison with those diagnosed with primary breast cancer. This paper therefore reports findings from a secondary analysis of the published literature on the topic using tools from the critical appraisal skills programme to identify and analyse appropriate papers, and the constant comparative method as a means of identifying any overarching or dominant themes emerging from the literature. Uncertainty, lack of control and poor emotional functioning emerged as the main themes affecting women with metastatic breast cancer. These are discussed in relation to their antecedents in the original studies and their implications for nursing care. The themes demonstrate that living with metastatic (or secondary) breast cancer is a multifaceted experience that is influenced by a large number of factors, many of which are under‐researched in comparison with those affecting women diagnosed with primary disease. It is clear, however, that women affected by the condition need a great deal more support than they currently receive, and new services may be required to meet these needs.     

Patient factors,health care factors and survival from lung cancer according to ethnic group in the south of London,UK

NIMAKO K., GUNAPALA R., POPAT S. & O'BRIEN M.E.R. (2013) European Journal of Cancer Care 22 , 79–87 Patient factors, health care factors and survival from lung cancer according to ethnic group in the south of London, UK International and UK data suggest that there are ethnic differences in survival for some malignancies. The aim of the present study was to identify any health inequalities related to lung cancer and ethnicity. Data on 423 patients with a diagnosis of lung cancer treated at a large specialist cancer hospital in London UK were analysed. Data on stage of disease at diagnosis, co-morbidities, socio-economic status, treatments received and survival were collected and examined for differences by ethnic group. There was a significant difference between black and minority ethnic (BME) patients and White-European patients in socio-economic status (Chi-square test P-value < 0.001). BME patients were over-represented in the most deprived socio-economic groups and under-represented in the most affluent. There were no significant differences in histology, stage of disease, co-morbidities and performance status or treatments received between the different ethnic groups. Ethnicity was not associated with survival. Significant prognostic factors for overall survival were performance status (P < 0.001), stage of disease (P= 0.001) and gender (P= 0.003). Our findings suggest that patients from BME groups are over-represented in more deprived socio-economic groups; however, this did not impact on significant prognostic factors or the treatments that they received. Importantly ethnicity did not influence survival.