Utility of the Stanford Integrated Psychosocial Assessment for Transplant in predicting outcomes before and after lung transplantation.

BACKGROUND: Optimizing donor use and achieving maximal survival following lung transplantation (LTx) require a pretransplant assessment that identifies clinical, physiological, and psychosocial patient factors associated with both poor and optimal post-LTx survival. We examined the utility of a psychosocial tool, the Stanford Integrated Psychosocial Assessment for Transplant (SIPAT), to identify patient suitability for LTx, as well as its association with clinical outcomes before and after LTx. METHODS: This was a retrospective single-center study analyzing LTx assessment clinical variables (age, gender, diagnosis, functional capacity, nutrition, renal function), with a particular focus on the utility of the SIPAT score, to predict patient suitability for LTx. The same variables were analyzed against LTx waitlist mortality, as well as post-LTx survival. RESULTS: Over an 8-year period dating from December 2012, 914 patients (male 54.4%, mean age 55.2 years) underwent LTx assessment. Patients declined for LTx (n = 152, 16.6%) were older and had reduced functional capacity, nutritional markers, and renal function but had a higher SIPAT score. Once listed for LTx, a higher SIPAT score was not associated with waitlist mortality or reduced post-LTx survival. CONCLUSIONS: The SIPAT tool measures psychosocial suitability for transplantation that can be incorporated into a standardized assessment of LTx suitability. While patients with higher SIPAT score were more likely to be declined for LTx, the SIPAT score did not predict outcome in transplanted patients. A subgroup of patients with high SIPAT scores were successfully transplanted, suggesting that unfavorable psychosocial variables are potentially modifiable with a well-resourced multidisciplinary LTx team.

Post-operative, inpatient rehabilitation after lung transplant evaluation (PIRATE): A feasibility randomized controlled trial.

BACKGROUND: Postoperative rehabilitation is crucial following lung transplantation (LTx); however, it is unclear whether intensive rehabilitation is feasible to deliver in the acute setting. We aimed to establish the feasibility and safety of intensive acute physiotherapy post-LTx. METHODS: This feasibility trial randomized 40 adults following bilateral sequential LTx to either standard (once-daily) or intensive (twice-daily) physiotherapy. Primary outcomes were feasibility (recruitment and delivery of intensive intervention) and safety. Secondary outcomes included six-minute walk test; 60-second sit-to-stand; grip strength; physical activity; pain; EQ-5D-5L; length of stay; and readmissions. Data were collected at baseline, week 3, and week 10 post-LTx. ClinicalTrials.gov #NCT03095859. RESULTS: Of 83 LTx completed during the trial, 49% were eligible and 48% provided consent. Median age was 61 years {range 18-70}; waitlist time 85 days [IQR 35-187]. Median time to first mobilization was 2 days [2-3]. Both groups received a median of 10 [7-14] standard interventions post-randomization. A median of 9 [6-18] individual intensive interventions were attempted (86% successful), the most common barrier being medical procedures/investigations (67%). No intervention-related adverse events or between-group differences in secondary outcomes were observed. CONCLUSIONS: Acute, intensive physiotherapy was feasible and safe post-LTx. This trial provides data to underpin definitive trials to establish efficacy.

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention.

INTRODUCTION: Unintentional weight gain, overweight and obesity following solid organ transplantation (SOT) are well-established and linked to morbidity and mortality risk factors. No interventional studies aimed at prevention have been undertaken among lung transplant (LTx) recipients. The combination of group education and telephone coaching is effective in the general population but is untested among SOT cohorts. METHODS: A non-randomized, interventional pilot study was conducted among new LTx recipients. The control group received standard care. In addition to standard care, the intervention involved four group education and four individual, telephone coaching sessions over 12-months. Data collection occurred at 2 weeks, 3- and 12 months post-LTx. Measurements included weight, BMI, fat mass (FM), fat mass index (FMI), fat-free mass (FFM), fat-free mass index (FFMI), waist circumference (WC), visceral adipose tissue (VAT), nutrition knowledge, diet, physical activity, lipid profile, HbA1C , FEV1 , six-minute walk distance and patient satisfaction. RESULTS: Fifteen LTx recipients were recruited into each group. One control participant died 120 days post-LTx, unrelated to the study. There were trends towards lower increases in weight (6.7±7.2 kg vs. 9.8±11.3 kg), BMI (9.6% of baseline vs. 13%), FM (19.7% vs. 40%), FMI, VAT (7.1% vs. 30.8%) and WC (5.5% vs. 9.5%), and greater increases in FFM and FFMI (all P > .05), among the intervention group by 12 months. The intervention was well-accepted by participants. CONCLUSION: This feasible intervention demonstrated non-significant, but clinically meaningful, favorable weight and body composition trends among LTx recipients over 12 months compared to standard care.

High-intensity interval training in patients with left ventricular assist devices: A pilot randomized controlled trial.

BACKGROUND: Left ventricular assist device (LVAD) implantation is an established treatment for patients with advanced heart failure. To date, studies evaluating the impact of aerobic training in patients with LVADs have focused on moderate-intensity exercise. METHODS: This pilot randomized controlled trial compared the effects of high-intensity interval training (HIIT) with those of moderate-intensity continuous training (MICT) on peak oxygen consumption (V̇O2 peak) in patients with LVADs. Secondary outcomes included 6-minute walk test distance, flow-mediated dilation, and anthropometry. Assessments were conducted at baseline and after 12 weeks of supervised training performed 3 times weekly. Participants were randomized to HIIT (4 sets of 4 minutes at 80%-90% V̇O2 reserve, alternating with 3 minutes at 50%-60% V̇O2 reserve) or MICT groups (28 minutes continuously at 50%-60% V̇O2 reserve). Within and between-group differences were analyzed using linear mixed models. Data are expressed as marginal means with 95% confidence intervals or as mean ± SD. RESULTS: A total of 21 participants were randomized (HIIT: age 57.7 ± 13.1 years; n = 11 and MICT: age 55.6 ± 14.2 years; n = 10) (mean ± SD). No major adverse events occurred in response to training in either group. HIIT significantly improved V̇O2 peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups). No significant group differences were detected in secondary outcomes. CONCLUSION: In patients with LVADs, HIIT was well tolerated and increased aerobic capacity more than MICT. These preliminary findings support the prescription of high-intensity exercise in clinically stable patients with LVADs but warrant validation in a larger sample and across a broader range of physiologic and clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au, unique identifier: ACTRN12616001596493.

Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

OBJECTIVE: Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. METHODS: A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. RESULTS: Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. CONCLUSIONS: ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy.

Reliability of sternal instability scale (SIS) for transverse sternotomy in lung transplantation (LTX).

A surgical incision for bilateral sequential lung transplantation (BSLTX) is the "clam shell" (CSI) approach via bilateral anterior thoracotomies and a transverse sternotomy to allow for sequential replacement of the lungs. This can be associated with significant post-operative pain, bony overriding or sternal instability. The sternal instability scale (SIS) is a non-invasive manual assessment tool that can be used to detect early bony non-union or instability following CSI; however, its reliability is unknown. OBJECTIVE: This prospective blinded reliability study aimed to assess intra-rater and inter-rater reliability of the SIS following lung transplantation. METHOD: Participants post BSLTX aged older than 18 years underwent sternal assessment utilizing the SIS. Two assessors examined the sternum using a standardized protocol at two separate time points with a test-re-test time of 48 hours. The outcome measure was SIS tool using four categories from 0 (clinically stable) to 3 (separated sternum with overriding). RESULTS: In total, 20 participants (75% female) with a mean age of 48 years (SD 17) and mean pain score of 3 out of 10 were included, 60% having well healed wounds and 25% reporting symptoms of sternal clicking. The most painful self-reported painful activity was coughing. The SIS demonstrated excellent reliability with a kappa = 0.91 by different assessors on the same day, and kappa = 0.83 for assessments by the same assessor on different days. CONCLUSION: The SIS is a reliable manual assessment tool for evaluation of sternal instability after CSI following BSLTX and may facilitate the timely detection and management of sternal instability.

Effect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effect of a supervised upper limb (UL) program (SULP) compared to no supervised UL program (NULP) after lung transplantation (LTx). DESIGN: Randomized controlled trial. SETTING: Physiotherapy gym. PARTICIPANTS: Participants (N=80; mean age, 56±11y; 37 [46%] men) were recruited after LTx. INTERVENTIONS: All participants underwent lower limb strength thrice weekly and endurance training. Participants randomized to SULP completed progressive UL strength training program using handheld weights and adjustable pulley equipment. MAIN OUTCOME MEASURES: Overall bodily pain was rated on the visual analog scale. Shoulder flexion and abduction muscle strength were measured on a hand held dynamometer. Health related quality of life was measured with Medical Outcomes Study 36-item Short Form health Survey and the Quick Dash. Measurements were made at baseline, 6 weeks, 12 weeks, and 6 months by blinded assessors. RESULTS: After 6 weeks of training, participants in the SULP (n=41) had less overall bodily pain on the visual analog scale than did participants in the NULP (n=36) (mean VAS bodily pain score, 2.1±1.3cm vs 3.8±1.7cm; P<.001) as well as greater UL strength than did participants in the NULP (mean peak force, 8.4±4.0Nm vs 6.7±2.8Nm; P=.037). At 12 weeks, participants in the SULP better quality of life related to bodily pain (76±17 vs 66±26; P=.05), but at 6 months there were no differences between the groups in any outcome measures. No serious adverse events were reported. CONCLUSIONS: UL rehabilitation results in short-term improvements in pain and muscle strength after LTx, but no longer-term effects were evident.

Physical Function in Subjects Requiring Extracorporeal Membrane Oxygenation Before or After Lung Transplantation.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is used as a rescue therapy before and after lung transplantation, but little is known about functional recovery or complications after ECMO in this cohort. This study aimed to describe early physical function and leg complications in subjects who received ECMO before or after lung transplantation, and to compare functional outcomes to a matched cohort of subjects who did not require ECMO. METHODS: A retrospective study was conducted over 2 years. Highest mobility level was assessed, in both the ECMO and non-ECMO groups, prior to ICU admission, at ICU discharge, and at hospital discharge, while 6-min walk distance was measured at hospital discharge and at 3 months. Strength was assessed at ICU discharge and at hospital discharge in the ECMO subjects only, and leg complications were recorded up until hospital discharge. RESULTS: 17 subjects (mean age 43 ± 13 y; 65% (11 of 17 subjects) female) required ECMO before or after lung transplant. Survival to hospital discharge was 82% (14 of 17 subjects). At ICU discharge, strength and mobility levels were poor, but both improved by hospital discharge (P < .001). Leg complications were reported in 50% of survivors (7 of 14 subjects). ECMO survivors spent longer in the ICU (P < .001) and hospital (P = .002) and had worse physical function (ie, lower mobility level at ICU discharge, mean difference -1, P = .02; 6-min walk distance at hospital discharge: mean difference -99 m, P = .004) than lung transplant recipients not requiring ECMO (n = 28). CONCLUSIONS: In subjects requiring ECMO before or after lung transplantation, 82% survived to hospital discharge, but leg complications were common and physical function was poor at ICU discharge. Physical function improved over time, however subjects who required ECMO had a longer period of hospitalization and worse physical function at ICU and hospital discharge than those who did not require ECMO.

Longer Versus Shorter Duration of Supervised Rehabilitation After Lung Transplantation: A Randomized Trial.

OBJECTIVE: To investigate the effects of a supervised longer- (14wk) versus shorter-duration (7wk) rehabilitation program after lung transplantation (LTX). DESIGN: Randomized controlled trial. SETTING: Outpatient rehabilitation gym setting. PARTICIPANTS: Post-LTX patients aged ≥18 years (N=66; 33 women; mean age, 51±13y) who had undergone either single LTX or bilateral LTX. INTERVENTION: Outpatient rehabilitation program consisting of thrice-weekly sessions with cardiovascular training on bike ergometer and treadmill plus upper and lower limb strength training. MAIN OUTCOME MEASURES: Measures were taken at baseline, 7 weeks, 14 weeks, and 6 months by assessors who were blinded to group allocation. Functional exercise capacity was measured by the 6-minute walk test (6MWT). Strength of quadriceps and hamstrings was measured on an isokinetic dynamometer and recorded as average peak torque of 6 repetitions for both muscles. Quality of life (QOL) was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey. RESULTS: Of the participants, 86% had bilateral LTX and 41% had primary diagnosis of chronic obstructive pulmonary disease. The 6MWT increased in both groups with no significant difference between groups at any time point (mean 6mo 6MWD: short, 590±85m vs long, 568±127m; P=0.5). Similarly, at 6 months, there was no difference between groups in quadriceps average peak torque (mean, 115±38Nm vs 114±40Nm, respectively; P=.59), hamstring average peak torque (57±18Nm vs 52±19Nm, respectively; P=.36), or mental or physical health domains of quality of life. CONCLUSIONS: Shorter duration (7wk) of rehabilitation achieves comparable outcomes with 14 weeks of supervised rehabilitation for functional exercise capacity, lower limb strength, and quality of life at 6 months after LTX.

Physical function after extracorporeal membrane oxygenation in patients pre or post heart transplantation - An observational study.

OBJECTIVE: To describe physical function, leg complications and health-related quality of life (HRQOL) in the three months following extracorporeal membrane oxygenation (ECMO) pre- or post-heart transplantation (HTx). BACKGROUND: Little is known about functional recovery following ECMO before or after HTx. METHODS: A 2-year retrospective study in patients who received ECMO pre or post HTx. Strength, mobility, leg complications and HRQOL were recorded to hospital discharge. Six-minute walk distance (6MWD) was assessed at hospital discharge and 3 months. RESULTS: 25 patients were included, with 80% (20/25) survival to hospital discharge. At ICU discharge, strength and mobility were poor but improved by hospital discharge (p < 0.001) despite leg complications in 44% (11/25) of patients. The 6MWD improved over time (mean 203 m, 95% confidence interval 140-265). HRQOL scores were lower than Australian norms (p < 0.05). CONCLUSION: Patients requiring ECMO pre or post HTx had impaired physical function at ICU discharge and leg complications were common.

Physiotherapy for cystic fibrosis in Australia and New Zealand: A clinical practice guideline.

Physiotherapy management is a key element of care for people with cystic fibrosis (CF) throughout the lifespan. Although considerable evidence exists to support physiotherapy management of CF, there is documented variation in practice. The aim of this guideline is to optimize the physiotherapy management of people with CF in Australia and New Zealand. A systematic review of the literature in key areas of physiotherapy practice for CF was undertaken. Recommendations were formulated based on National Health and Medical Research Council (Australia) guidelines and considered the quality, quantity and level of the evidence; the consistency of the body of evidence; the likely clinical impact; and applicability to physiotherapy practice in Australia and New Zealand. A total of 30 recommendations were made for airway clearance therapy, inhalation therapy, exercise assessment and training, musculoskeletal management, management of urinary incontinence, managing the newly diagnosed patient with CF, delivery of non-invasive ventilation, and physiotherapy management before and after lung transplantation. These recommendations can be used to underpin the provision of evidence-based physiotherapy care to people with CF in Australia and New Zealand.

Successful treatment of a patient with severe atopic dermatitis and severe asthma by centrifugal therapeutic plasma exchange.

This is a case of a 42-year-old atopic man with severe atopic dermatitis and asthma who despite long-term immunosuppression was not well controlled. He had a very high IgE at 7897 Iu/mL prior to treatment. He underwent two therapeutic plasma exchanges (TPEs) through two peripheral lines in our outpatient department, which led to an absolute decrease of 44.1% and 37% in his plasma IgE for each exchange, and immediate sustained improvement in shortness of breath, and atopic dermatitis, and hence led to a vast improvement in his quality of life. TPE offers a new exciting adjunctive treatment option for severe atopic individuals, where it may provide a novel role to reduce health burden and improve clinical symptoms. Further studies need to be performed to establish an optimal protocol and potential maintenance with recently available targeted anti-IgE biologics.