Abstract Background Mechanical circulatory support (MCS) is an option for the treatment of medically intractable end-stage heart failure. MCS therapy, however, is resource intensive. Objective The ...purpose of this report was to systematically review the MCS cost-effectiveness literature as it pertains to the treatment of adult patients in end-stage heart failure. Methods We conducted a systematic search and narrative review of available cost- effectiveness and cost-utility analyses of MCS in adult patients with end-stage heart failure. Results Eleven studies analyzing the cost-effectiveness or cost-utility of MCS were identified. Seven studies focused on bridge to transplantation, three studies focused on destination therapy, and one study presented analyses of both strategies. Two articles evaluated the cost-effectiveness of the HeartMate II (Thoratec Corp., Pleasanton, CA). Incremental cost-effectiveness ratios between MCS and medical management ranged between $85,025 and $200,166 for bridge to transplantation and between $87,622 and $1,257,946 for destination therapy (2012 Canadian dollars per quality-adjusted life-year). Sensitivity analyses indicated that improvements in survival and quality of life and reductions in device and initial hospital-stay costs may improve the cost-effectiveness of MCS. Conclusions Current studies suggest that MCS is likely not cost-effective with reference to generally accepted or explicitly stated thresholds. Refined patient selection, complication rates, achieved quality of life, and device/surgical costs, however, could modify the cost-effectiveness of MCS.
Summary Background Rotavirus gastroenteritis causes many deaths in infants in sub-Saharan Africa. Because rotavirus vaccines have proven effective in developed countries but had not been tested in ...developing countries, we assessed efficacy of a pentavalent rotavirus vaccine against severe disease in Ghana, Kenya, and Mali between April, 2007, and March, 2009. Methods In our multicentre, double-blind, placebo-controlled trial, undertaken in rural areas of Ghana and Kenya and an urban area of Mali, we randomly assigned infants aged 4–12 weeks without symptoms of gastrointestinal disorders in a 1:1 ratio to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age. Infants with HIV infection were not excluded. Randomisation was done by computer-generated randomisation sequence in blocks of six. We obtained data for gastrointestinal symptoms from parents on presentation to health-care facilities and clinical data were obtained prospectively by clinicians. The primary endpoint was severe rotavirus gastroenteritis (Vesikari score ≥11), detected by enzyme immunoassay, arising 14 days or more after the third dose of placebo or vaccine to end of study (March 31, 2009; around 21 months of age). Analysis was per protocol; infants who received scheduled doses of vaccine or placebo without intervening laboratory-confirmed naturally occurring rotavirus disease earlier than 14 days after the third dose and had complete clinical and laboratory results were included in the analysis. This study is registered with ClinicalTrials.gov , number NCT00362648. Findings 5468 infants were randomly assigned to receive pentavalent rotavirus vaccine (n=2733) or placebo (n=2735). 2357 infants assigned to vaccine and 2348 assigned to placebo were included in the per-protocol analysis. 79 cases of severe rotavirus gastroenteritis were reported in 2610·6 person-years in the vaccine group, compared with 129 cases in 2585·9 person-years in the placebo group, resulting in a vaccine efficacy against severe rotavirus gastroenteritis of 39·3% (95% CI 19·1–54·7, p=0·0003 for efficacy >0%). Median follow-up in both groups was 527 days starting 14 days after the third dose of vaccine or placebo was given. 42 (1·5%) of 2723 infants assigned to receive vaccine and 45 (1·7%) of 2724 infants assigned to receive placebo had a serious adverse event within 14 days of any dose. The most frequent serious adverse event was gastroenteritis (vaccine 17 0·6%; placebo 17 0·6%). Interpretation Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. We support WHO's recommendation for adoption of rotavirus vaccine into national expanded programmes on immunisation in Africa. Funding PATH (GAVI Alliance grant) and Merck.
Rationale Adoptive immunotherapy using virus-specific T-lymphocytes (VSTs) has been successful in preventing or treating viral infections after hematopoietic stem cell transplantation (HSCT), and has ...also been safe and effective in a limited number of patients with primary immunodeficiency disorders (PID).
Summary Primary immunodeficiencies comprise many diseases caused by genetic defects primarily affecting the immune system. About 150 such diseases have been identified with more than 120 associated ...genetic defects. Although primary immunodeficiencies are quite rare in incidence, the prevalence can range from one in 500 to one in 500 000 in the general population, depending on the diagnostic skills and medical resources available in different countries. Common variable immunodeficiency (CVID) is the primary immunodeficiency most commonly encountered in clinical practice, and appropriate diagnosis and management of patients will have a significant effect on morbidity and mortality as well as financial aspects of health care. Advances in diagnostic laboratory methods, including B-cell subset analysis and genetic testing, coupled with new insights into the molecular basis of immune dysfunction in some patients with CVID, have enabled advances in the clinical classification of this heterogeneous disease.
Arrhythmogenic right ventricular dysplasia (ARVD) is a heritable cardiomyopathy characterized by the fibrofatty replacement of right ventricular (RV) myocardium leading to RV failure and arrhythmias. ...This study evaluated the potential utility of tissue Doppler echocardiography (TDE) and strain echocardiography (SE) to quantitatively assess RV function and their potential role in diagnosing ARVD. Images of 30 patients with ARVD (diagnosed by task force criteria) and 36 healthy controls were obtained. Peak systolic velocity, early diastolic velocity, displacement, strain rate, strain, outflow tract diameter, and fractional RV area change were measured in all subjects. Peak RV systolic velocity (6.4 ± 2.2 vs 9 ± 1.6 cm/s, p <0.0001), early diastolic velocity (−6.7 ± 2.7 vs −9.4 ± 2 cm/s, p <0.0001), displacement (13.7 ± 5.8 vs 18.7 ± 3.5 mm, p <0.0003), strain rate (−1 ± 0.7 vs −2 ± 1 s−1 , p = 0.002), and strain (−10 ± 6% vs −28 ± 11%, p = 0.001) were significantly lower in patients with ARVD compared with controls, respectively. Sensitivity and specificity, respectively, were 67% and 89% for systolic velocity, 77% and 71% for displacement, 73% and 87% for strain, 50% and 96% for strain rate, 53% and 93% for outflow tract diameter, and 47% and 83% for fractional area change. RV systolic velocity and displacement were significantly lower than in controls, even in the subset of patients with ARVD with apparently normal right ventricles by conventional echocardiography. Inter- and intraobserver agreement was high. In conclusion, TDE and SE enable the detection of ARVD via the quantification of RV function and may have potential clinical value in the assessment of patients with suspected ARVD. Peak RV systolic velocity <7.5 cm/s and peak RV strain <18% best identify patients with ARVD.
We previously reported our technique for delivering intensity modulated radiation therapy (IMRT) to the entire pleura while attempting to spare the lung in patients with malignant pleural ...mesothelioma (MPM). Herein, we report a detailed pattern-of-failure analysis in patients with MPM who were unresectable or underwent pleurectomy/decortication (P/D), uniformly treated with hemithoracic pleural IMRT.
Sixty-seven patients with MPM were treated with definitive or adjuvant hemithoracic pleural IMRT between November 2004 and May 2013. Pretreatment imaging, treatment plans, and posttreatment imaging were retrospectively reviewed to determine failure location(s). Failures were categorized as in-field (within the 90% isodose line), marginal (<90% and ≥50% isodose lines), out-of-field (outside the 50% isodose line), or distant.
The median follow-up was 24 months from diagnosis and the median time to in-field local failure from the end of RT was 10 months. Forty-three in-field local failures (64%) were found with a 1- and 2-year actuarial failure rate of 56% and 74%, respectively. For patients who underwent P/D versus those who received a partial pleurectomy or were deemed unresectable, the median time to in-field local failure was 14 months versus 6 months, respectively, with 1- and 2-year actuarial in-field local failure rates of 43% and 60% versus 66% and 83%, respectively (P=.03). There were 13 marginal failures (19%). Five of the marginal failures (38%) were located within the costomediastinal recess. Marginal failures decreased with increasing institutional experience (P=.04). Twenty-five patients (37%) had out-of-field failures. Distant failures occurred in 32 patients (48%).
After hemithoracic pleural IMRT, local failure remains the dominant form of failure pattern. Patients treated with adjuvant hemithoracic pleural IMRT after P/D experience a significantly longer time to local and distant failure than patients treated with definitive pleural IMRT. Increasing experience and improvement in target delineation minimize the incidence of avoidable marginal failures.
Long-Term Efficacy of Catheter Ablation of Ventricular Tachycardia in Patients With Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy Darshan Dalal, Rahul Jain, Harikrishna Tandri, Jun Dong, ...Shaker M. Eid, Kalpana Prakasa, Crystal Tichnell, Cynthia James, Theodore Abraham, Stuart D. Russell, Sunil Sinha, Daniel P. Judge, David A. Bluemke, Joseph E. Marine, Hugh Calkins Prior studies have reported conflicting results concerning the efficacy of radiofrequency catheter ablation (RFA) of ventricular tachycardia (VT) in arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) patients. We sought to evaluate the efficacy of RFA procedures in ARVD/C. Among 48 RFA procedures performed in 24 patients, 46%, 31%, and 23% resulted in elimination of all inducible VTs, the clinical VT but not all, and none of the inducible VTs, respectively. The cumulative recurrence-free survival was 75%, 50%, and 25% after 1.5, 5, and 14 months, respectively. Long-term VT recurrence did not differ by procedural success, mapping technique, or repetition of the procedure. Our study shows a high rate of VT recurrence in ARVD/C patients undergoing RFA of VT.
Complex aortic aneurysms are now being repaired by endovascular techniques, albeit with a potentially increased risk of lower limb ischemia-reperfusion injury. We report a simple technique to ...maintain perfusion to the lower limb during endovascular repair, using one additional introducer sheath placed antegrade, distal to the stent graft introduction site, and connected to the side arm of the working sheath in the contralateral artery. This allows continuous perfusion of the limb distal to the main stent graft introduction site. In our initial experience with 12 cases, with confirmed occlusion of the native arterial system by the stent graft introducer sheath, arterial occlusion time was 165 ± 84 minutes. Use of the sheath-shunt technique resulted in pulsatile flow in all cases, with an average flow of 42.2 ± 13.2 mL/min, and actual ischemia time was reduced to 14 ± 11 minutes. There were no complications related to the use of this technique. Given the limited risk of this technique coupled with a potential benefit, we propose its consideration in patients undergoing complex endovascular repair.
In the largest assembled cohort of ARVD/C patients receiving cardiac transplantation, we found that patients often presented at a relatively young age, significantly younger than the average age of ...onset among our ARVD/C registry participants (3), and most commonly with VT or HF symptoms. The most common indication for cardiac transplantation was HF, with less than one-third of patients receiving transplants for control of ventricular arrhythmias.
To review the current status and rationale of the updated ACR practice guidelines for CT colonography (CTC).
Clinical validation trials in both the United States and Europe are reviewed. Key ...technical aspects of the CTC examination are emphasized, including low-dose protocols, proper insufflation, and bowel preparation. Important issues of implementation are discussed, including training and certification, definition of the target lesion, reporting of colonic and extracolonic findings, quality metrics, reimbursement, and cost-effectiveness.
Successful validation trials in screening cohorts both in the United States with ACRIN and in Germany demonstrated sensitivity > or = 90% for patients with polyps >10 mm. Proper technique is critical, including low-dose techniques in screening cohorts, with an upper limit of the CT dose index by volume of 12.5 mGy per examination. Training new readers includes the requirement of interactive workstation training with 2-D and 3-D image display techniques. The target lesion is defined as a polyp > or = 6 mm, consistent with the American Cancer Society joint guidelines. Five quality metrics have been defined for CTC, with pilot data entered. Although the CMS national noncoverage decision in May 2009 was a disappointment, multiple third-party payers are reimbursing for screening CTC. Cost-effective modeling has shown CTC to be a dominant strategy, including in a Medicare cohort.
Supported by third-party payer reimbursement for screening, CTC will continue to further transition into community practice and can provide an important adjunctive examination for colorectal screening.
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