Outcomes after cardiac transplantation: a new tertiary centre experience

Abstract Funding Acknowledgements Type of funding sources: None. Background Our hospital is one of the most remote transplant centres in the world. We evaluated the short- and long-term outcomes after cardiac transplantation at a new Tertiary Centre hospital in Western Australia. Methods A retrospective study of all patients undergoing cardiac transplantation since February 2015 until November 2020 was conducted. De-identified data was collected using hospital medical records and the ANZSCTS database. Primary outcome measure was mortality at any time point and acute rejection. Secondary outcome measures included new renal failure, post-operative blood product use and readmission rate. Results A total of 59 cardiac transplantations were conducted, with the mean age of recipients being 52 (±15) years and the majority being male (64.4%). Ischaemic cardiomyopathy and dilated cardiomyopathy were the most common indications for transplantation, accounting for 71.2% of all transplants. The mean age of donors was 35.29 (±11.11) years with the majority being male (69.5%). There were no mortalities and acute rejection within 3 months of transplant occurred in 16 (27.1%) patients. New renal failure was the most common complication occurring in 16 (27.1%) patients. After multivariate analysis, donor ischaemia time >200minutes was associated with an increased risk of renal failure (OR 1.2, P = 0.044). Conclusions Over a five-year period at a new cardiac transplant centre in one of the most remote locations of the world, we report no mortalities.

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Success of trabeculectomy surgery in relation to cataract surgery: 5-year outcomes

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2018-312972 ◽

2018 ◽

Vol 103 (10) ◽

pp. 1395-1400 ◽

Cited By ~ 2

Author(s):

Rashmi G Mathew ◽

Sahar Parvizi ◽

Ian E Murdoch

Keyword(s):

Cataract Surgery ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Risk Of Failure ◽

Increased Risk ◽

Significant Difference ◽

Measure Change ◽

Group 2

AimsTo compare success proportions at 5 years in three surgical groups: group 1, trabeculectomy alone; group 2, trabeculectomy followed by cataract surgery within 2 years; and group 3, trabeculectomy performed on a pseudophakic eye.MethodsA retrospective cohort study. 194 eyes of 194 patients were identified with at least 5 years’ follow-up post trabeculectomy (N=85, 60 and 49 in groups 1, 2 and 3, respectively).Main outcome measures1. Primary outcome measure: intraocular pressure (IOP) at 5 years post-trabeculectomy surgery, 2.Secondary outcome measure: change in visual acuity at 5 years.ResultsAt 5 years, the mean IOP (SD) was 12.9 (3.5), 12.5 (4.8) and 12.7 (4.8) mm Hg in groups 1, 2 and 3, respectively. Overall success was almost identical, 58%, 57% and 59% in groups 1, 2 and 3, respectively. There was no significant difference between the groups in terms of percentage IOP reduction, number of medications, proportion restarting medication and reoperation rates at 5 years. Logistic regression for an outcome of failure showed men to be at increased risk of failure OR 1.97 (95% CI 1.10 to 3.52, p=0.02). Nearly 80% of patients retained or improved their vision following their initial trabeculectomy.ConclusionsThe sequence in which surgery is carried out does not appear to affect trabeculectomy function at 5 years, success being similar to trabeculectomy alone. In our study, men may be at increased risk of failure.

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A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

Multiple Sclerosis Journal ◽

10.1177/135245859500100210 ◽

1995 ◽

Vol 1 (2) ◽

pp. 118-135 ◽

Cited By ~ 64

Author(s):

LD Jacobs ◽

DL Cookfair ◽

RA Rudick ◽

RM Herndon ◽

J R Richert ◽

...

Keyword(s):

Primary Outcome ◽

Interferon Beta ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Phase Iii ◽

Secondary Outcome ◽

Recombinant Interferon ◽

Study Population ◽

The Mean ◽

Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

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A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

Asian Spine Journal ◽

10.4184/asj.2017.11.1.50 ◽

2017 ◽

Vol 11 (1) ◽

pp. 50-56

Author(s):

Gun Woo Lee ◽

Myun-Whan Ahn ◽

Ji-Hoon Shin ◽

Jae Woo Park ◽

Jae-Hyung Uh ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Kappa Coefficient ◽

Anterior Cervical Discectomy ◽

Secondary Outcome ◽

Distance Method ◽

Cervical Discectomy ◽

Observer Reliability ◽

The Mean

<sec><title>Study Design</title>A retrospective review of prospectively collected data.</sec><sec><title>Purpose</title>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</sec><sec><title>Overview of Literature</title>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</sec><sec><title>Methods</title>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</sec><sec><title>Results</title>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</sec><sec><title>Conclusions</title>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</sec>

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REiNS: Recommendations for Measurement of Attention Outcomes in Preschoolers With Neurofibromatosis

Neurology ◽

10.1212/wnl.0000000000012423 ◽

2021 ◽

pp. 10.1212/WNL.0000000000012423

Author(s):

Bonita P. Klein-Tasman ◽

Kristin Lee ◽

Heather L. Thompson ◽

Jennifer Janusz ◽

Jonathan M. Payne ◽

...

Keyword(s):

Clinical Trials ◽

Rating Scale ◽

Dimensional Change ◽

Neurofibromatosis Type ◽

Primary Outcome Measure ◽

Attention Problems ◽

Developmental Trajectory ◽

Secondary Outcome ◽

Increased Risk ◽

Preschool Aged Children

Children with neurofibromatosis type 1 (NF1) are at increased risk for attention problems. While most research has been conducted with school-aged cohorts, preschool-aged children offer a novel developmental window for clinical studies, with the promise that treatments implemented earlier in the developmental trajectory may most effectively modify risk for later difficulties. Designing research studies around the youngest children with NF1 can result in intervention earlier in the developmental cascade associated with NF1 gene abnormalities. Furthermore, clinical trials for medications targeting physical and psychological aspects of NF1 often include individuals spanning a wide age range, including preschool-aged children. In a prior paper, the REiNS Neurocognitive Subcommittee made recommendations regarding performance-based and observer-rated measures of attention for use in clinical trials and highlighted the need for separate consideration of assessment methods for young children. The observer-rated ADHD Rating Scale – Preschool version is recommended as a primary outcome measure. The NIH Toolbox Flanker, Dimensional Change Card Sort, and List Sort Working Memory tasks and Digits Forward from the Differential Ability Scales – Second Edition (performance-based measures) are recommended as secondary outcome measures. Specific methodological recommendations for inclusion of preschoolers in clinical trials research are also offered.

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A Randomized Controlled Trial of Four Precolonoscopy Bowel Cleansing Regimens

Canadian Journal of Gastroenterology ◽

10.1155/2011/486084 ◽

2011 ◽

Vol 25 (12) ◽

pp. 657-662 ◽

Cited By ~ 27

Author(s):

Dina Kao ◽

Eoin Lalor ◽

Gurpal Sandha ◽

Richard N Fedorak ◽

Bloeme van der Knoop ◽

...

Keyword(s):

Bowel Preparation ◽

Primary Outcome ◽

Controlled Trial ◽

Short Interval ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Bowel Cleansing ◽

The Mean ◽

Clinically Significant ◽

The Ideal

BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined.OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

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Abstract P017: Serum N-Carboxymethyl-Lysine and Risk of Mortality in Older Adults

Circulation ◽

10.1161/circ.129.suppl_1.p017 ◽

2014 ◽

Vol 129 (suppl_1) ◽

Author(s):

Mary Lou Biggs ◽

David Benkeser ◽

Joachim Ix ◽

Jorge Kizer ◽

Luc Djousse ◽

...

Keyword(s):

Renal Failure ◽

Mortality Risk ◽

Community Dwelling ◽

Cardiovascular Health Study ◽

Risk Of Death ◽

Risk Of Mortality ◽

Organ Systems ◽

Increased Risk ◽

Carboxymethyl Lysine ◽

The Mean

Advanced glycation end products (AGEs) are compounds formed by the non-enzymatic glycation of proteins, lipids, and nucleic acids, and are thought to play a role in the pathogenesis of diseases across multiple organ systems. Carboxymethyl-lysine (CML) is a dominant AGE found in tissue proteins and in the circulation, and a commonly used AGE biomarker. Only a few epidemiological studies have evaluated the association between circulating CML and mortality risk, and none have evaluated the association between CML and cause-specific non-CVD mortality. We measured CML by ELISA on serum specimens collected from 3,373 Cardiovascular Health Study participants in 1996. Participants were followed for death through 2010, and cause of death was classified using death certificates, medical records, and proxy interview. We used Cox regression to estimate the relative risk of total and cause-specific mortality associated with circulating CML, adjusting for confounders (Models 1 & 2) and estimated glomerular filtration rate (eGFR) as a potential mediator (Model 3). We tested whether sex or diabetes modified the association between CML and mortality. The mean age among participants was 78 years and 60% were women. The mean CML level among participants was 629 ng/mL. Over median follow-up of 10 years, 2,322 deaths occurred (73.4 per 1,000 person-years). After adjustment for confounders (Models 1 & 2), CML was associated with an increased risk of death from CVD, dementia, infection, fracture/trauma, and renal failure (Table). Aside from renal failure, adjustment for eGFR attenuated the HR estimates modestly. There was no evidence for effect modification of the association of CML and all-cause mortality risk by sex or diabetes. In a cohort of community-dwelling older individuals, elevated circulating CML was associated with increased risk of mortality from cardiovascular causes, dementia, infection, fracture/trauma, and renal failure. A portion of the increased risk may be mediated through decreased renal function.

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Can a tool developed for industry be used to assess fatigue risk in medical rotas? A pilot study of foundation doctors’ rotas in a tertiary centre

BMJ Open ◽

10.1136/bmjopen-2018-023470 ◽

2019 ◽

Vol 9 (2) ◽

pp. e023470 ◽

Cited By ~ 1

Author(s):

Elspeth Cumber ◽

Paul Robert Greig

Keyword(s):

Relative Risk ◽

Risk Index ◽

Health And Safety ◽

General Medicine ◽

Secondary Outcome ◽

Tertiary Centre ◽

Increased Risk ◽

Shift Pattern ◽

Preliminary Study ◽

The Uk

ObjectivesTo determine the feasibility and ease of using a pre-existing health and safety executive fatigue risk calculator to assess doctors’ rotas.DesignObservational.SettingA large tertiary-referral teaching hospital in the UK.Participants95 anonymised foundation years 1 and 2 rotas in General Medicine, General Surgery and Emergency Medicine covering a 4-month period. All rotas provided by rota coordinators were included and assessed.InterventionsRotas were assessed for two indices: relative risk of fatigue-related errors compared with a ‘2-day, two-night, four-off’ shift pattern and percentage chance of a high score on a standardised sleepiness scale.Primary and secondary outcome measuresFatigue index (percentage chance of a high score on a standardised sleepiness scale) and risk index (relative risk of fatigue-related errors compared with a ‘2-day, two-night, four-off’ shift pattern) of all shifts on all rotas.ResultsNearly half of all shifts demonstrated increased risk of fatigue-related errors and increased probability of high levels of sleepiness. There was significant interspeciality variation in both indices. These results are based on rotas as opposed to ‘work as done’ and are therefore likely to slightly universally underestimate actual fatigue risks.ConclusionsThis preliminary study demonstrates that this tool can be used to compare rotas and guide rota design to minimise risk wherever possible. The calculator guidance clearly states there is no ‘ideal risk’ but that values should be minimised, and a maximum fatigue risk agreed which is deemed acceptable given the nature of work undertaken. This study is intended to demonstrate that fatigue can and should be considered during rota design. We do not suggest that it is used to hold either individuals or organisations to account as there is no evidence for it being used in this way. Further work should assess the practicality of designing medical rotas using this tool to minimise fatigue risk.

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Thiamine deficiency mimicking acute rejection following cardiac transplantation

Cardiology in the Young ◽

10.1017/s104795110000473x ◽

1998 ◽

Vol 8 (1) ◽

pp. 113-115 ◽

Cited By ~ 2

Author(s):

Andrew R. Gennery ◽

Kim Bartlett ◽

Asif Hasan

Keyword(s):

Acute Rejection ◽

Cardiac Failure ◽

Thiamine Deficiency ◽

Cardiac Transplantation ◽

Ventricular Dysfunction ◽

Cardiac Transplant

AbstractWe describe a recipient of an orthotopic cardiac transplant who developed severe ventricular dysfunction following an episode of sepsis. He had normal cardiac biopsies and responded to treatment with thiamine. Causes other than rejection should be considered in patients who have received a cardiac transplant and who present in cardiac failure.

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Pulmonary thromboembolism in hospitalised patients with COVID-19: a retrospective national study of patients managed in critical care and ward environments in Scotland

BMJ Open ◽

10.1136/bmjopen-2021-050281 ◽

2021 ◽

Vol 11 (8) ◽

pp. e050281

Author(s):

Michael McGettrick ◽

Alexander MacLellan ◽

Paul McCaughey ◽

Catherine Bagot ◽

Melanie J Brewis ◽

...

Keyword(s):

Critical Care ◽

Hospital Admissions ◽

Pulmonary Thromboembolism ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

National Study ◽

Right Heart ◽

Risk Of Death ◽

Hospitalised Patients ◽

Increased Risk

ObjectivesTo assess for increase in pulmonary thromboembolism (PTE) in hospitalised patients with COVID-19, in both critical care and ward environments.SettingWe reviewed all CT pulmonary angiograms (CTPA) performed in Scotland between 23 March 2020 and 31 May 2020 and identified those with COVID-19 using either classical radiological appearances or positive COVID-19 PCR swab.ParticipantsAll hospitalised patients in Scotland with COVID-19 between 23 March 2020 and 31 May 2020 who underwent a CTPA.Primary outcome measureTo assess if the rate of PTE was increased in those with COVID-19 compared with previously published figures of hospitalised patients.Secondary outcome measuresTo assess the effect of right heart strain or requirement for critical care on mortality.Results3401 CTPAs were reviewed. 192 were positive for PTE in patients with evidence of COVID-19 either real-time PCR swab positive for SARS-CoV-2 (n=104) or having radiological changes consistent with COVID-19 (n=88). The total number of hospital admissions in Scotland between 23rd March 2020 and 31st May 2020 with COVID-19 was 5195. The incidence of PTE during this time was 3.7% in all patients admitted to all hospitals in Scotland with COVID-19 during this period. 475 hospitalised patients were managed in critical care (both level 2 and level 3 care), in whom the incidence of PTE was 6% (n=29). 4720 patients did not require admission to critical care, in whom the incidence of PTE was 3.5% (n=163). There was increased risk of death with right heart strain (25/52 vs 128/140 (p<0.01)) and in critical care (15/29 vs 146/163 (p<0.01)).ConclusionsWe have demonstrated an increased risk of PTE in critical care and ward-based environments. Further studies are required to establish effective prophylactic anticoagulation in this group.

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Factors Contributing to Renal Failure in Patients Undergoing Stem Cell Transplant for Multiple Myeloma and Amyloidosis.

Blood ◽

10.1182/blood.v108.11.5464.5464 ◽

2006 ◽

Vol 108 (11) ◽

pp. 5464-5464

Author(s):

Elie M. Richa ◽

Jeffrey L. Winters ◽

Douglas J. Padley ◽

Robert E. Stowers ◽

Sandra C. Bryant ◽

...

Keyword(s):

Stem Cells ◽

Multiple Myeloma ◽

Renal Failure ◽

Stem Cell ◽

Creatinine Clearance ◽

Stem Cell Transplant ◽

Cell Transplant ◽

Increased Risk ◽

The Mean ◽

Chi Square Analysis

Abstract Autologous stem cells transplant in tandem is considered the standard therapy for patients with Multiple Myeloma (MM) and Primary Amyloidosis. The collection as well as the infusion of stem cells, which are preserved in dimethyl sulfoxide (DMSO), may cause serious side effects including renal failure. We reviewed the charts of MM patients undergoing stem cell transplant from 2001 through the end of 2005. Patients were grouped into one of 3 categories: Amylodosis, MM with Immunoglobulin G (IgG) and MM with non IgG. Creatinine and creatinine clearance values were collected 14 days prior to, the day of, 3 days post, and 28 days post infusion. The volume of the transplant as well as the number of CD 34+ stem cells reflect the dose of DMSO infused since all the cryopreservation of cells were done with 105 DMSO solution. We also collected data about the administration of nephrotoxic agents such as Aminoglycoside antibiotics, Vancomycin and Amphotercin B because these patients are at increased risk of developing infections. We also reviewed the dose of consolidation chemotherapy (Melphalen) as a potential nephrotoxic agent. Chi-square analysis was used. 645 patients were included [380 (58.82%) males and 265 females (41.18%)]. 384 received Vancomycin, 7 received Gentamycin and 8 received Amphotericin B with total of 146 missing data. 191 (29.57%) had Amyloidosis, 285 (44.12%) IgG MM and 169 (26.32%) non IgG MM. Only 6 transplants were allogeneic. The dose of Melphalen ranged between 0–200 mg/m2 over 2 days at the discretion of the physician. The mean weight was 82.25 Kg and median weight was 81.8 Kg. The mean age 57.12 years and median age was 58 years. 608 patients (94.12%) had one transplant, 35 (5.42%) had 2 transplants and 3 (0.46%) had 3 transplants. The mean volume was 289.20 ml and median volume was 245 ml. The mean number of CD34+ cells was 5.39 × 10(6)/kg with a median of 4.74 × 10(6). The mean and median Creatinine levels were 1.26 mg/dl and 1 mg/dl respectively at 2 weeks prior to transplant, 1.23mg/dl and 1mg/dl on the day of transplant, 1.18 mg/dl and 1mg/dl at 3 days after transplant and finally 1.16mg/dl and 0.9mg/dl at 4 weeks interval. 67 males as well 50 females had renal failure prior to transplant but there was no statistical difference due to gender (p 0.001). Creatinine clearance levels were 83.96 ml/min at 2 weeks prior, 83.84 ml/min at day zero, 88.57 ml/min and 91.89 ml/min respectively. The median were 83.37 ml/min, 82.77 ml/min, 86.43 ml/min and 91.29 ml/min respectively. Even though 35 creatinine values were missing within the first 3 days period, there was no acute renal failure (ARF) (0.5 mg/dl increase) noted with a 95% C.I. 95% in 494 patients with normal creatinine. The creatinine level improved in 93 patients with an abnormal level and only 24 were left with abnormal levels. This might represent a dilutional effect due to fluid administration during the transplant. Concerning the incidence of chronic renal failure (CRF) at 4 weeks interval, considering that only 47 laboratory values were missing the results was as follows: 4 patients had > 0.5 mg/dl creatinine increase from the 485 normal patients with C.I. 95%. CRF was still observed in 38 patients of the 72 patients with baseline renal failure. Even though 9 had very poor creatinine clearance <10ml/min (p 0.01) only 5 were left with severe creatinine clearance after transplant (p 0.05) We found that DMSO does not induce ARF or an exacerbation of CRF in transplants patients for Amyloidosis and Multiple Myeloma.

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