First interventional exchange of a left transvenous phrenic nerve stimulation lead from the novel remedē system.

The remedē system is a novel fully implantable transvenous phrenic nerve stimulation (TPNS) device developed to treat central sleep apnea. No information is published on how to explant or replace its leads. An eighty-one year-old had a fractured lead and we removed it over a wire.

Phrenic nerve stimulation in patients with central sleep apnea: a single‑center experience from pilot and pivotal trials evaluating the remedē System.

Background: Patients with central sleep apnea (CSA) have recently been shown to have improved sleep metrics and quality of life (QoL) with phrenic nerve stimulation (PNS).

Aims: The aim of this study was to report the results of a partnership between cardiology, sleep medicine, and electrophysiology in a single clinical center as well as the enrollment, implantation, and follow‑up experience demonstrating both the safety and efficacy of PNS.

Methods: This analysis included data from the pilot and pivotal trials investigating the effect of PNS using an implantable transvenous system in patients with CSA.

How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

Background: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA.

Objective: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).

Suitability of the pericardiophrenic veins for phrenic nerve stimulation: an anatomic study.

Objective: The objective of this study was to assess the potential of the pericardiophrenic veins (PPVs) as conduits for transvenous stimulation of the phrenic nerves. Modulating respiration with transvenous phrenic nerve stimulation via the PPVs might reduce or eliminate the adverse effects of central sleep apnea in heart failure.

Methods: Forty-eight fixed cadavers were dissected to study the anatomic characteristics of the PPVs and related neurovascular structures.

Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy.

Background: Changes in serum human epidermal growth factor receptor 2 (HER2) levels associated with clinical outcomes, including objective response rate, progression-free survival (PFS), and overall survival have been reported in patients with metastatic breast cancer (MBC) receiving trastuzumab and chemotherapy. This study investigated whether baseline or changes in serum HER2 correlated with overall response rate (ORR) and/or PFS in patients with MBC receiving first-line lapatinib monotherapy.

Methods: The EGF20009 study investigated lapatinib monotherapy in 138 HER2-positive patients with MBC previously untreated for their metastatic disease.

Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a phase II study.

Background: Inflammatory breast cancer is an aggressive and biologically distinct form with a higher frequency of HER2 overexpression than other breast cancers. For patients with resistance to conventional anthracycline or taxane and trastuzumab treatment, options are limited. Lapatinib, an oral reversible inhibitor of epidermal growth factor receptor tyrosine kinases, previously had a 50% response rate in a cohort of 30 patients with HER2-overexpressing (HER2+) recurrent or anthracycline-refractory inflammatory breast cancer.

Phase II study of predictive biomarker profiles for response targeting human epidermal growth factor receptor 2 (HER-2) in advanced inflammatory breast cancer with lapatinib monotherapy.

Purpose: Inflammatory breast cancer (IBC) is one of the most aggressive forms of breast cancer. Lapatinib, an oral reversible inhibitor of epidermal growth factor receptor (EGFR) and human EGFR 2 (HER-2), demonstrated clinical activity in four of five IBC patients in phase I trials. We conducted a phase II trial to confirm the sensitivity of IBC to lapatinib, to determine whether response is HER-2 or EGFR dependent, and to elucidate a molecular signature predictive of lapatinib sensitivity.

Grafting liquid crystalline polymers from cellulose substrates using atom transfer radical polymerization.

Immobilizing liquid crystalline polymers on cellulose generates new possibilities of accomplishing addressable/responsive bio-based substrates. In this paper we report on our first steps to combine the electro-optic properties of liquid crystals with the versatility of paper as a displaying substrate. Electric current or magnetic fields can be used to manipulate the orientation of liquid crystals and thereby change the appearance and the properties of the material.

Lapatinib antitumor activity is not dependent upon phosphatase and tensin homologue deleted on chromosome 10 in ErbB2-overexpressing breast cancers.

Trastuzumab antitumor activity in ErbB2-overexpressing breast cancers seems to be dependent upon the presence of phosphatase and tensin homologue deleted on chromosome 10 (PTEN), a phosphatase that dampens phosphatidylinositol 3-kinase-Akt signaling. Consequently, PTEN deficiency, which occurs in 50% of breast cancers, predicts for resistance to trastuzumab monotherapy. Here, we show that lapatinib, a small-molecule inhibitor of ErbB1 and ErbB2 tyrosine kinases, exerts its antitumor activity in a PTEN-independent manner.

Adjunctive treatment for mood stabilization of patients with bipolar I disorder treated with lamotrigine.

Objective: To describe the effect of supplemental psychotropic medications, specifically anxiolytics with sedative/hypnotics (ASH) combined with lamotrigine (LTG) on stabilization of symptoms in patients with bipolar I disorder.

Method: Symptomatic patients participating in two LTG maintenance trials were classified post-hoc as those initiating LTG as monotherapy (n=313) or as adjunctive therapy (n=814) and further characterized by supplemental add-on therapies received during an open-label treatment phase. Patients were considered stabilized if they reached a stable dose of LTG monotherapy (100-200 mg/day) and had a Clinical Global Impressions-Severity scale score <3 for at least 4 weeks.

Regulation of survivin by ErbB2 signaling: therapeutic implications for ErbB2-overexpressing breast cancers.

In breast cancer, overexpression of ErbB2 or aberrant regulation of survivin, a member of the inhibitor of apoptosis family, is associated with resistance to chemo/hormone therapy and predicts for a poor clinical outcome. A functional link between the two predictive factors has not been previously shown. Here, using genetic and pharmacologic approaches to block ErbB2 signaling, we show that ErbB2 regulates survivin protein expression in ErbB2-overexpressing breast cancer cells.

Improved extraction of ePTFE and medical adhesive modified defibrillation leads from the coronary sinus and great cardiac vein.

Background: Permanent leads with shocking coils for defibrillation therapy are sometimes implanted in the coronary sinus (CS) and great cardiac vein (GCV). These shocking coils, as documented by pathologic examination of animal investigations, often become tightly encapsulated by fibrosis and can be very difficult to remove.

Methods: One of three configurations of the Guidant model 7109 Perimeter coronary sinus shocking lead was implanted into the distal portion of the GCV of 24 sheep for up to 14 months.

The efficacy of intranasal fluticasone propionate in the relief of ocular symptoms associated with seasonal allergic rhinitis.

Intranasal corticosteroids have been shown to decrease ocular symptoms associated with allergic rhinitis as well as nasal symptoms. The primary objective of this retrospective analysis was to evaluate the efficacy of fluticasone propionate (FP) aqueous nasal spray in the treatment of ocular symptoms in patients with seasonal allergic rhinitis (SAR). We pooled efficacy data from seven multicenter, randomized, double-blind, placebo-controlled studies of similar design.

Intranasal fluticasone propionate is effective for perennial nonallergic rhinitis with or without eosinophilia.

Background: Although response to intranasal corticosteroid therapy has been reported in patients with nonallergic rhinitis with eosinophilic syndrome (NARES), efficacy specifically in non-NARES patients has not been fully characterized.

Objective: To evaluate the efficacy of intranasal fluticasone propionate (FP) in the treatment of patients with perennial nonallergic rhinitis, with and without nasal eosinophilia.

Methods: Data from 983 patients in three randomized, double-blind, placebo-controlled PNAR trials were integrated.

Onset of therapeutic effect of fluticasone propionate aqueous nasal spray.

Background: The effectiveness of fluticasone propionate (FP) aqueous nasal spray in the treatment of rhinitis has been demonstrated in multiple controlled clinical studies. The onset of therapeutic effect of FP in these clinical trials appears to occur within 12 hours after administration of the initial dose.

Objective: This article presents an analysis from previous clinical trials that examined the efficacy of intranasal FP in patients with rhinitis to ascertain whether the time to onset of the therapeutic effect of this medication could be determined.

Absence of nasal mucosal atrophy with fluticasone aqueous nasal spray.

Objective: To evaluate whether 1 year of continuous treatment with intranasal fluticasone propionate would lead to atrophy in the nasal mucosa compared with an active control, oral terfenadine.

Design: Prospective, randomized, multicenter, open-label, parallel-group study.

Setting: Two tertiary care academic institutions.

A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis.

Background: Intranasal corticosteroids and oral antihistamines are both effective in the treatment of seasonal allergic rhinitis, although the therapeutic value of administering the two types of agents concurrently has rarely been evaluated. This study was designed to compared the efficacy, safety, and impact on quality of life of fluticasone propionate aqueous nasal spray (FP ANS), loratadine, FP ANS plus loratadine, and placebo (an aqueous nasal spray plus tablet) in the treatment of seasonal allergic rhinitis during the mountain cedar allergy season in south central Texas.

Methods: Six hundred patients with seasonal allergic rhinitis were treated for 2 weeks with either FP ANS 200 microgram once daily, loratadine 10 mg once daily, the FP ANS and loratadine regimens combined, or placebo in a multicenter, randomized, double-blind, double-dummy, parallel-group study.

Functional status in depressed patients: the relationship to disease severity and disease resolution.

Background: We set out to measure the impact of depression and its clinical resolution on patients' functional status.

Method: The Work and Social Disability Scale (WSDS), a five-category investigator-rated scale measuring patient functional status, was completed at baseline and study discontinuation in a 56-day, open, uncontrolled study evaluating the safety of a sustained release (SR) formulation of bupropion in 3167 patients at 105 sites. To be included in the study, patients had to be 18 years or older, have a diagnosis of depression, and be considered appropriate for treatment with bupropion SR.

Do racial differences in hypertension persist in successful agers? Findings from the MacArthur Study of Successful Aging.

The objective of this study was to determine whether racial differences in hypertension in a random sample of community-dwelling older adults also remained significant in a sample of successful agers. Data for the random sample of community-dwelling older adults came from the Duke University Established Populations for Epidemiologic Studies of the Elderly (4,162 community-dwelling adults age 65 and older) and showed strong racial differences in hypertension. Data for successful agers came from the Duke MacArthur (428 of EPESE respondents in the top 30% in terms of physical, cognitive, and psychosocial performance).

Medication taking behaviors in the high- and low-functioning elderly: MacArthur field studies of successful aging.

Objective: To describe and compare medication-taking behaviors in the high- and low-functioning elderly living in the community.

Design: A cross-sectional design with data collected by interview.

Setting: The study included 5 counties in the southern Piedmont area of North Carolina.

Community dwelling elderly are appropriate subjects for intensive dietary choice restriction studies.

There is a traditional belief that the elderly have difficulty coping with dietary change, and therefore have a diminished likelihood of successfully responding to nutritional interventions or restrictions. Using a controlled mild zinc-deficiency feeding study as a model for strict dietary intervention, we assessed psychological responses to severe dietary choice restriction in 15 Caucasian, elderly (66.12 +/- 4.

Rehabilitation in the nursing home: how much, why, and with what results.

Although rehabilitation is considered an important component of long-term care, few studies have looked at the factors associated with the provision of rehabilitation in this setting. The authors examined one State's skilled nursing homes to gain information on their rehabilitation practices. Data for this study came from a mail survey and from the licensing applications filed with the State Division of Facility Services.

Use of spectacle mounted telescope systems by the visually impaired.

Background: Spectacle mounted telescope low vision aids are designed to magnify objects Spectacle telescopes are often rejected by the visually impaired because of their unusual cosmetic appearance which may call attention to their disability.

Methods: Fifty-six subjects were recruited at four independent low vision clinics and divided into two categories: 24 were current wearers of expanded field spectacle mounted telescope systems, and 32 were new wearers. New wearers underwent a randomized cross-over trial, comparing the experimental device (Ocutech VES) to one of two controls (DFV Expanded Field or Walter's Keplarian Close-focus Telescope).

Abbreviating the Duke Social Support Index for use in chronically ill elderly individuals.

The 35-item Duke Social Support Index (DSSI) measures multiple dimensions of social support and has been used extensively in cross-sectional and longitudinal studies of aging. Epidemiological studies of chronically ill, frail elderly individuals often wish to include a measure of social support. However, most multidimensional measures (including the DSSI) are long and may exhaust the patient, especially when included in an often already congested interview schedule.

A brief depression scale for use in the medically ill.

Objective: Using items from two existing depression scales, we have sought to develop a brief self-rated instrument for detecting major depressive disorder (M.D.D.