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Biomedical subjects

Michael Gold

Publications and source records attributed to Michael Gold.

At least 19 recordsLinked to original sources

Is a broadly based surgical residency program more likely to place graduates in rural practice?

BACKGROUND: There is a shortage of general surgeons practicing in rural America. Rural surgical practices differ from those in urban settings encompassing a broader case mix with a larger percentage of time spent performing abdominal, alimentary, gynecological, genitourinary, and orthopedic procedures. Present graduates of many general surgical residencies do not obtain the range of experience necessary to practice effectively in this environment. We hypothesize that general surgical residents undergoing broadly based training are more likely to practice in a rural location. METHODS AND MATERIALS: We conducted a survey of graduates from the Mary Imogene Bassett Hospital's (MIBH) broadly based surgical residency program in 2004. Additionally, the surgical resident logs from the Accreditation Council for Graduate Medical Education (ACGME) and the residency program were reviewed for years 2001-2004. RESULTS: Of the 56 surveys sent out, 42 (75%) were completed and used in the analysis. A majority of the general surgeons who were raised in a rural environment reported that they are residing and practicing in a rural setting. Graduates of the MIBH residency program, on average, performed more cases as residents in the following subspecialty areas: genitourinary, plastics/hand, gynecology, neurosurgery, and orthopedics than national residency graduates. CONCLUSIONS: Based on our findings, surgical residents graduating from a broadly based training program appear more likely to practice in a rural setting.

Female↗

Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure--the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms, reduces heart failure (HF)-related hospitalizations, and reverses left ventricular remodeling in some patients with moderate to severe HF and ventricular dyssynchrony defined by a prolonged QRS duration. The effects of CRT on HF outcomes in patients with asymptomatic left ventricular dysfunction (ALVD) or mild HF remain to be determined. METHODS: The REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study is a prospective, multicenter, randomized, double-blind, parallel, controlled clinical trial designed to establish whether CRT combined with optimal medical treatment can attenuate HF disease progression compared with optimal medical treatment alone in patients with ALVD +/- New York Heart Association class I American College of Cardiology/American Heart Association stage C or New York Heart Association class II HF, QRS duration > or =120 milliseconds, left ventricular ejection fraction < or =0.40, and left ventricular end-diastolic diameter > or =55 mm. The primary end point is the HF clinical composite response and left ventricular end-systolic volume index is the first-order secondary end point. Approximately 500 patients from 100 centers in the United States, Canada, and Europe will be randomized to CRT versus no CRT. The follow-up is 5 years in total with the primary and first secondary end points reported at 12 months. Enrollment began in September 2004 and is expected to be completed in 2006. CONCLUSION: REVERSE will assess the safety and efficacy of CRT in patients with ALVD or mild HF and electrocardiographic evidence of ventricular dyssynchrony.

Cardiac Output, Low↗

General surgery programs in small rural New York State hospitals: a pilot survey of hospital administrators.

CONTEXT: Hospitals play a central role in small rural communities and are frequently one of the major contributors to the local economy. Surgical services often account for a substantial proportion of hospital revenues. The current shortage of general surgeons practicing in rural communities may further threaten the financial viability of rural hospitals and communities. PURPOSE: To describe hospital administrators' perceptions regarding the current state of general surgery programs at small rural hospitals in New York State, including the impact that surgical services have on hospital financial viability. METHODS: A list of hospitals belonging to the rural hospitals group of the Healthcare Association of New York State was obtained to determine prospective survey recipients. Sixty-eight administrators at each of the identified hospitals were subsequently surveyed and 38 respondents met all inclusion criteria. FINDINGS: Approximately 87% of hospital administrators perceive that the general surgery program is critical to the hospital's financial viability. Forty percent of respondents report that they would be forced to close the hospital if the surgical program was lost. Among the 42% of administrators trying to recruit a general surgeon, almost two thirds have been searching for more than 1 year. CONCLUSIONS: According to the perceptions of hospital administrators, the financial viability of rural hospitals in New York State depends in large part on their ability to provide surgical services. Additionally, general surgeons appear to be in high demand at a significant number of the surveyed institutions.

Health Care Surveys↗

Prospective clinical evaluation of 1440-nm laser delivered by microarray for treatment of photoaging and scars.

BACKGROUND AND OBJECTIVES: The use of thermal heating in microscopic zones is generically termed "microrejuvenation." The objective of this study was to evaluate the benefits of using a novel 1440-nm Nd:YAG laser (Affirm, Cynosure, Westford, MA) with a novel approach for microscopic heating. This device utilizes a microarray of lenses delivering a 10-mm beam as hundreds of high-fluence beamlets interspersed with a relatively uniform low-fluence background irradiation. STUDY DESIGN: Forty subjects (N = 40) at 2 study sites presenting with superficial rhytides and other symptoms of photoaging or scars received 3 treatments at 4-week intervals using a T-250 lens array. Total fluence ranged from 3.0 to 7.0 J/cm2. Zimmer air cooling was used for all treatments. No topical anesthetic was required. RESULTS: The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treatments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2) to 3 weeks (n = 1) was also reported. RESULTS: In all, 92% of the patients completed 3 treatments. Of these, 85% completed the 1-month follow-up. At the follow-up, 94% of subjects exhibited improvement in one or more categories, 82% exhibited mild to moderate improvement, and 12% exhibited good improvement. Side effects were minimal and included mild posttreatment erythema and edema resolving within 24 hours. Pain during treatment was judged minimal to moderate. Postauricular histology showed areas of thermal injury up to 250 microm deep and 150 microm wide. CONCLUSIONS: A 1440-nm beam split by a microlens array is a promising new approach for inducing nonablative neocollagenesis in the remodeling of scars and rhytids. Histologic evidence confirms the microcolumnar nature of collagen heating using this microarray.

Adult↗

Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease.

The primary objective of this study was to evaluate the efficacy and tolerability of a flexible dosing regimen (16 or 24 mg/day) of galantamine prolonged-release capsule (PRC) compared with placebo in subjects with mild to moderate Alzheimer's disease (AD). This phase III, double-blind, placebo- and active-controlled, parallel-group trial randomized 971 patients to treatment for 6 months. Efficacy endpoints included change in the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog/11), Clinician's Interview-Based Impression of Change plus caregiver input (CIBIC-plus), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), and Neuropsychiatric Inventory (NPI) scores. Galantamine was associated with significant improvements in the ADAS-cog/11 score but not in the CIBIC-plus or NPI scores. Galantamine PRC was associated with significant improvement in ADCS-ADL scores. Galantamine PRC had similar tolerability and safety profiles compared with twice-daily galantamine, and when administered as a once-daily flexible dosing regimen of 16 or 24 mg/day, was demonstrated to be as safe and effective for the treatment of mild to moderate AD.

Activities of Daily Living↗

Serial evaluation of atrial tachyarrhythmia burden and frequency after implantation of a dual-chamber cardioverter-defibrillator.

UNLABELLED: Serial evaluation of AT burden and frequency after implantation of D-ICD. BACKGROUND: We sought to characterize atrial tachyarrhythmia (AT) burden and frequency after implantation of a dual-chamber implantable cardioverter-defibrillator (D-ICD). METHODS AND RESULTS: A total of 149 subjects underwent implantation of a D-ICD (Jewel AF model 7250, Medtronic, Inc.) for the primary indication of drug-resistant AT, and were followed for at least 12 months during which device programming was constant. The device employed atrial overdrive pacing as well as shocks to terminate episodes of AT. Arrhythmia burden and frequency were evaluated during the 0- to 6-month follow-up and and 6- to 12-month follow-up intervals. A majority of subjects (62%) received a type I/III antiarrhythmic drug during follow-up. The median arrhythmia burden decreased from 8.2 hours/month during 0-6 months to 3.3 hours/month during 6-12 months (P=0.004); this result was driven primarily by the subgroup with persistent AT prior to device implantation. There was no significant change in the median AT frequency (2.2 vs 1.0 episodes/month). There was a significant decrease in the median shock frequency (0.32 vs 0.00 shocks/month, P=0.003) and an increase in shock efficacy (85.5% vs 94.9%, P=0.01). CONCLUSIONS: Device-based treatment of AT, in association with antiarrhythmic drugs, yields a significant time-dependent decrease in AT burden but not frequency.

Aged↗

Steady-state pharmacokinetics of galantamine are not affected by addition of memantine in healthy subjects.

To evaluate the effect of multiple doses of memantine on the pharmacokinetics of galantamine and to assess the safety and tolerability of galantamine with adjunctive memantine treatment, an open-label, single-center, drug interaction study was conducted in 16 healthy adults. Subjects received an 8-mg dose of galantamine extended release once daily during week 1 and a 16-mg dose of galantamine extended release once daily during week 2. During weeks 3 and 4, they received a 16-mg dose of galantamine extended release once daily and a 10-mg dose of memantine twice daily, except on days 1 and 2 of week 3, when memantine was given as 10 mg once daily. The pharmacokinetic profile and parameters of galantamine at steady state were similar after administration of a 16-mg dose of galantamine once daily alone and after administration with a 10-mg dose of memantine twice daily. Galantamine 16 mg once daily with adjunctive memantine 10 mg twice daily was well tolerated and safe in healthy subjects.

Adult↗

Electrocardiogram and clinical characteristics of patients referred for cardiac transplantation: implications for pacing in heart failure.

BACKGROUND: Permanent pacing for the treatment of heart failure (HF) has been the subject of intense research over the past decade. Those with conduction abnormalities may benefit most from pacing. The incidence of these conduction abnormalities in patients referred for cardiac transplantation and its relationship to outcome has not been well described. HYPOTHESIS: This study sought to determine the incidence of these abnormalities and to correlate these findings to outcome in this patient population. METHODS: A review of 100 patients referred for transplantation was performed. Data were analyzed in two groups: those with QRS duration < 120 ms and those with a QRS duration > 120 ms. Times to transplantation or death were analyzed in these two groups. RESULTS: Of these patients, 34% had QRS duration > or = 120 ms and survival was inversely associated with QRS duration. Of those with QRS duration < 120 ms, 24% (16) went on to cardiac transplantation or died. Of those with a QRS duration > or = 120 ms, 55% (17) went on to transplantation or died (p = 0.0134). CONCLUSIONS: This suggests that in addition to a multi-drug regimen for heart failure, 34% of patients referred for transplantation may benefit from additional therapy with biventricular pacing.

Cardiac Pacing, Artificial↗

Timing isn't everything: an analysis of when to start salvage chemotherapy in ovarian cancer.

OBJECTIVE: Results from GOG 178 showed a prolongation of progression-free survival (PFS) with the immediate use of chemotherapy (CT) following a complete clinical response (CR) in patients with stage III-IV ovarian cancer. We wanted to evaluate our strategy of reserving second line (2nd line) chemotherapy to the time of clinical recurrence by determining PFS intervals following first, second, and third line agents and to compare these finding to results of GOG 178. METHODS: We conducted a retrospective parallel study to GOG 178 using identical criteria for PFS definitions. Patients (pts) with stage III-IV cancer achieving a CR following surgery and five to eight cycles of platinum-based CT were identified. Patients not obtaining a CR and those with a CR who underwent second look surgery were excluded. Rather than immediately beginning consolidation CT after CR, second line agents were started at recurrence and were followed by a third line when pts progressed. Clinical-pathologic characteristics were abstracted, and time intervals including time to recurrence, time to use of second line CT, time to use of third line (3rd line) CT, and survival were recorded. Time intervals were studied by Kaplan-Meier method. RESULTS: Of 217 reviewed pts (1991-2001), 59 eligible pts were identified. Forty-nine patients had stage III disease and ten had stage IV. At completion of surgery, 44 were optimally debulked. With a median follow-up of 51 months, the median PFS (from CR) of all patients was 20 months. At 5 years, 36% of pts remain disease-free, and 66% of pts are alive. Twenty-three pts have not received second line agents, and thirty-six have received them. For all pts, the median time from CR to start of second line chemotherapy was 21 months, and the median time to start of third line agents was 43 months. Recurrences occurred after 6 months from completion of first line (1st line) therapy in 87% of cases and after 12 months in 50%. CONCLUSIONS: Nearly 70% of pts achieving a CR after primary therapy eventually recurred. Most recurrences occurred greater than 6 months from completion of primary chemotherapy, and the use of second line agents at the time of recurrence was effective. In this study, the median time from CR to start of third line agent at 43 months compares favorably with the median PFS of 28 months following 12 months of Taxol reported in GOG 178 and challenges the concept of consolidation chemotherapy in ovarian cancer. A randomized trial to evaluate when to institute second line agents should be performed.

Adult↗

Termination of paroxysmal supraventricular tachycardia by tecadenoson (CVT-510), a novel A1-adenosine receptor agonist.

OBJECTIVES: The aim of this study was to evaluate tecadenoson safety and efficacy during conversion of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm. BACKGROUND: Tecadenoson (CVT-510), a novel adenosine receptor (Ado R) agonist, selectively activates the A1 Ado R and prolongs atrioventricular (AV) nodal conduction at doses lower than those required to cause A2 Ado R-mediated coronary and peripheral vasodilation. Unlike adenosine, which non-selectively activates all four Ado R subtypes and produces unwanted effects, tecadenoson appears to terminate AV node-dependent supraventricular tachycardias without hypotension and bronchoconstriction. METHODS: In this open-label, multicenter, dose escalation study, tecadenoson was administered to 37 patients (AV node re-entrant tachycardia, n = 29; AV re-entrant tachycardia, n = 8) with inducible PSVT sustained for > or =1 min during an electrophysiology study. Seven regimens (0.3 to 15 microg/kg) of up to two identical tecadenoson intravenous bolus doses were administered. RESULTS: After the first or second bolus, PSVT converted to sustained sinus rhythm for > or =5 min in 86.5% (32/37) of the patients, with 91% (29/32) of the conversions occurring after the first bolus (most within 30 s), coincident with anterograde conduction block in the AV node. No effects on sinus cycle length (SCL) or systolic blood pressure were observed. The atrial-His (AH), but not the His-ventricular (HV) interval was prolonged up to 5 min after the final tecadenoson bolus, returning to baseline by 10 min. Tecadenoson was generally well tolerated. CONCLUSIONS: In this study, tecadenoson rapidly terminated sustained PSVT by depressing AV nodal conduction without causing hypotension. After sinus rhythm restoration, there was minimal AH interval prolongation without HV interval or SCL prolongation.

Adenosine↗

A new pacemaker algorithm for the treatment of atrial fibrillation: results of the Atrial Dynamic Overdrive Pacing Trial (ADOPT).

OBJECTIVES: The Atrial Dynamic Overdrive Pacing Trial (ADOPT) was a single blind, randomized, controlled study to evaluate the efficacy and safety of the atrial fibrillation (AF) Suppression Algorithm (St. Jude Medical Cardiac Rhythm Management Division, Sylmar, California) in patients with sick sinus syndrome and AF. BACKGROUND: This algorithm increases the pacing rate when the native rhythm emerges and periodically reduces the rate to search for intrinsic atrial activity. METHODS: Symptomatic AF burden (percentage of days during which symptomatic AF occurred) was the primary end point. Patients underwent pacemaker implantation, were randomized to DDDR with the algorithm on (treatment) or off (control), and were followed for six months. RESULTS: Baseline characteristics and antiarrhythmic drugs used were similar in both groups. The percentage of atrial pacing was higher in the treatment group (92.9% vs. 67.9%, p < 0.0001). The AF Suppression Algorithm reduced symptomatic AF burden by 25% (2.50% control vs. 1.87% treatment). Atrial fibrillation burden decreased progressively in both groups but was lower in the treatment group at each follow-up visit (one, three, and six months) (p = 0.005). Quality of life scores improved in both groups. The mean number of AF episodes (4.3 +/- 11.5 control vs. 3.2 +/- 8.6 treatment); total hospitalizations (17 control vs. 15 treatment); and incidence of complications, adverse events, and deaths were not statistically different between groups. CONCLUSIONS: The ADOPT demonstrated that overdrive atrial pacing with the AF Suppression Algorithm decreased symptomatic AF burden significantly in patients with sick sinus syndrome and AF. The decrease in relative AF burden was substantial (25%), although the absolute difference was small (2.50% control vs. 1.87% treatment).

Aged↗

Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation.

INTRODUCTION: Prior studies suggest that right ventricular apical (RVA) pacing has deleterious effects. Whether the right ventricular outflow tract (RVOT) is a more optimal site for permanent pacing in patients with congestive heart failure (CHF) has not been established. METHODS AND RESULTS: We conducted a randomized, cross-over trial to determine whether quality of life (QOL) is better after 3 months of RVOT than RVA pacing in 103 pacemaker recipients with CHF, left ventricular (LV) systolic dysfunction (LV ejection fraction < or = 40%), and chronic atrial fibrillation (AF). An additional aim was to compare dual-site (RVOT + RVA, 31-ms delay) with single-site RVA and RVOT pacing. QRS duration was shorter during RVOT (167 +/- 45 ms) and dual-site (149 +/- 19 ms) than RVA pacing (180 +/- 58 ms, P < 0.0001). At 6 months, the RVOT group had higher (P = 0.01) role-emotional QOL subscale scores than the RVA group. At 9 months, there were no significant differences in QOL scores between RVOT and RVA groups. Comparing RVOT to RVA pacing within the same patient, mental health subscale scores were better (P = 0.03) during RVOT pacing. After 9 months of follow-up, LVEF was higher (P = 0.04) in those assigned to RVA rather than RVOT pacing between months 6 and 9. After 3 months of dual-site RV pacing, physical functioning was worse (P = 0.04) than during RVA pacing, mental health was worse (P = 0.02) than during RVOT pacing, and New York Heart Association (NYHA) functional class was slightly better (P = 0.03) than during RVOT pacing. There were no other significant differences between RVA, RVOT and dual-site RV pacing in QOL scores, NYHA class, distance walked in 6 minutes, LV ejection fraction, or mitral regurgitation. CONCLUSION: In patients with CHF, LV dysfunction, and chronic AF, RVOT and dual-site RV pacing shorten QRS duration but after 3 months do not consistently improve QOL or other clinical outcomes compared with RVA pacing.

Aged↗

Prevalence of sensing abnormalities in dual chamber implantable cardioverter defibrillators.

BACKGROUND: The clinical efficacy of ICD therapy depends on accurate sensing of intracardiac signals and sensing algorithms. We investigated the occurrence of sensing abnormalities in patients with dual chamber ICDs. METHODS: The study group consisted of all patients with dual chamber ICDs enrolled in the LESS trial and patients implanted with dual chamber ICDs at a single center between January 1997 and July 2000. Electrograms of spontaneous ventricular arrhythmias requiring device intervention were analyzed. RESULTS: A total of 48 patients met the criteria for enrollment. Among the 244 episodes, 215 (88%) were due to ventricular tachycardia and 29 (12%) were due to ventricular fibrillation. Overall undersensing was infrequent with 12 (20%) patients exhibiting on average 2.2 undersensed beats during 26 episodes of ventricular arrhythmias. There was no delay in therapy due to undersensing. Oversensing occurred in 5 (10%) patients resulting in 13 (2.7%) episodes of inappropriate therapy. None of the patients had any lead abnormalities and oversensing resolved after device reprogramming in 4 patients while 1 patient required a separate rate sensing lead. Among patients with oversensing, 4 out of 5 were pacing before the index event while among patients with no oversensing only 5 out of 42 were pacing (P<0.001). CONCLUSIONS: Dual chamber ICDs demonstrate outstanding accuracy of sensing. However, because of the selection of patient population requiring more frequent pacing, oversensing occurs with a significant frequency. Meticulous evaluation in such patients is necessary to minimize the likelihood of oversensing and inappropriate shocks.

Aged↗

Overview of the Alliance for Cellular Signaling.

The Alliance for Cellular Signaling is a large-scale collaboration designed to answer global questions about signalling networks. Pathways will be studied intensively in two cells--B lymphocytes (the cells of the immune system) and cardiac myocytes--to facilitate quantitative modelling. One goal is to catalyse complementary research in individual laboratories; to facilitate this, all alliance data are freely available for use by the entire research community.

B-Lymphocytes↗

Progressive dementia and hypersomnolence with dream-enacting behavior: oneiric dementia.

BACKGROUND: Sleep disorders are associated with several types of degenerative dementias, including Alzheimer and prion diseases. Animal models have demonstrated abolition of rapid eye movement atonia, resulting in dream-enacting complex movements termed oneiric behavior, and patients with fatal familial insomnia may have vivid dreams that intrude on wakefulness. OBJECTIVE: To describe a new form of progressive dementia with hypersomnia and oneiric behavior. METHODS: Neuropsychological and polysomnographic studies of a middle-aged woman with a progressive dementia, excessive daytime sleepiness, and a vertical gaze palsy. RESULTS: Neuropsychological testing revealed decreased verbal fluency, impaired attention and working memory, amnesia, poor recall, and bradyphrenia with hypersomnia. Polysomnography revealed a rapid eye movement behavioral disorder with complete absence of slow wave sleep. Prion protein analysis did not reveal the mutation associated with fatal familial insomnia, and other diagnostic test findings were unrevealing. CONCLUSION: Our patient had a previously unreported syndrome of progressive dementia associated with rapid eye movement behavioral disorder and the absence of slow wave sleep.

Dementia↗