Similar Improvements In Clinical Outcomes Research Articles

AUGMENTATION OF A TRANSOSSEOSUS EQUIVALENT REPAIR IN POSTEROSUPERIOR NON-ACUTE ROTATOR CUFF TEARS WITH A BIOINDUCTIVE COLLAGEN IMPLANT DECREASE THE RE-TEAR RATE AT ONE YEAR.

To determine whether the addition of a bioinductive collagen implant (BCI) over a transosseous equivalent (TOE) repair of medium-to-large posterosuperior rotator cuff tears improves the healing rate determined by magnetic resonance imaging (MRI) at 12-month follow-up. A Level I randomized controlled trial was performed in 124 subjects with isolated, symptomatic, reparable, full-thickness, medium-to-large posterosuperior nonacute rotator cuff tears, with fatty infiltration ≤2. These were randomized to 2 groups in which an arthroscopic posterosuperior rotator cuff tear TOE repair was performed alone (Control group) or with BCI applied over the TOE repair (BCI group). The primary outcome was the retear rate (defined as Sugaya 4-5) determined by MRI at 12 months of follow-up. Secondary outcomes were characteristics of the tendon (Sugaya grade and thickness of the healed tendon) and clinical outcomes (pain levels, EQ-5D-5L, American Shoulder and Elbow Surgeons, and Constant-Murley scores) at 12 months of follow-up. Of the 124 randomized patients, 122 (60 in the BCI group and 62 in the Control group) were available for MRI evaluation 12.2 ± 1.02 months after the intervention. There were no relevant differences in preoperative characteristics. Adding the BCI reduced the retear rate (8.3% [5/60] in the BCI group vs 25.8% [16/62] in the Control group, P= .010; relative risk of retear of 0.32 [95% confidence interval 0.13-0.83]). Sugaya grade was also better in the BCI group (P=.030). There were no differences between groups in the percentage of subjects who reached the MCID for CMS (76.7% vs 81.7%, P= .654) or American Shoulder and Elbow Surgeons (75% vs 80%, P= .829), in other clinical outcomes or in complication rates at 12.4 ± 0.73 (range 11.5-17) months of follow-up. Augmentation with a BCI of a TOE repair in a medium-to-large posterosuperior rotator cuff tear reduces the retear rate at 12-month follow-up by two-thirds, yielding similar improvements in clinical outcomes and without increased complication rates. Level I, randomized controlled trial.

Mental Health Outcomes for Youths With Public Versus Private Health Insurance Attending a Telehealth Intensive Outpatient Program: Quality Improvement Analysis.

COVID-19 exacerbated a growing mental health crisis among youths and young adults, worsened by a lack of existing in-person options for high-acuity care. The emergence and growth of remote intensive outpatient programs (IOPs) is a solution to overcome geographic limitations to care. However, it remains unclear whether remote IOPs engender equivalent clinical outcomes among youths with public insurance (eg, Medicaid) versus private insurance (eg, commercial) given the disparities found in previous research on place-based treatment in both clinical and engagement outcomes. This analysis sought to establish, as part of ongoing quality improvement efforts, whether engagement and clinical outcomes among adolescents and young adults attending remote IOP treatment differed between youths with public and those with private insurance. The identification of disparities by payer type was used to inform programmatic decisions within the remote IOP system for which this quality improvement analysis was conducted. Pearson chi-square analyses and independent 2-tailed t tests were used to establish that the 2 groups defined by insurance type were equivalent on clinical outcomes (depression, suicidal ideation, and nonsuicidal self-injury [NSSI]) at intake and compare changes in clinical outcomes. McNemar chi-square analyses and repeated-measure 2-tailed t tests were used to assess changes in clinical outcomes between intake and discharge in the sample overall. In total, 495 clients who attended the remote IOP for youths and young adults in 14 states participated in ≥7 treatment sessions, and completed intake and discharge surveys between July 2021 and April 2022 were included in the analysis. Overall, the youths and young adults in the remote IOP attended a median of 91% of their scheduled group sessions (mean 85.9%, SD 16.48%) and reported significantly fewer depressive symptoms at discharge (t447=12.51; P<.001). McNemar chi-square tests of change indicated significant reductions from intake to discharge in suicidal ideation (N=470, χ21=104.4; P<.001), with nearly three-quarters of youths who reported active suicidal ideation at intake (200/468, 42.7%) no longer reporting it at discharge (142/200, 71%), and in NSSI (N=430, χ21=40.7; P<.001), with more than half of youths who reported NSSI at intake (205/428, 47.9%) reporting lower self-harm at discharge (119/205, 58%). No significant differences emerged by insurance type in attendance (median public 89%, median private 92%; P=.10), length of stay (t416=-0.35; P=.73), or reductions in clinical outcomes (depressive symptom severity: t444=-0.87 and P=.38; active suicidal ideation: N=200, χ21=0.6 and P=.49; NSSI frequency: t426=-0.98 and P=.33). Our findings suggest that youths and young adults who participated in remote IOP had significant reductions in depression, suicidal ideation, and NSSI. Given access to the same remote high-acuity care, youths and young adults on both public and private insurance engaged in programming at comparable rates and achieved similar improvements in clinical outcomes.

Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting.

IntroductionReal-world evidence has demonstrated the effectiveness of secukinumab in the treatment of psoriasis; however, limited data are available on patient profiles of US secukinumab initiators over time and clinical outcomes in biologic-naive patients. This study describes clinical characteristics of secukinumab initiators by year, and the clinical outcomes in patients after 6- and/or 12-month follow-up visits, stratified by prior biologic use.MethodsThis observational study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry. Analyses were conducted in two patient cohorts: (1) all secukinumab initiators, stratified by year, and (2) those who initiated and maintained secukinumab through a 6- and/or 12-month follow-up visit. For all secukinumab initiators, patient characteristics at initiation were described per calendar year; in initiators with follow-up visits, mean (SD) differences in percentage affected body surface area (BSA), five-point Investigator’s Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI) scores between baseline and follow-up visits were calculated. Analyses were conducted separately for biologic-naive and biologic-experienced patients.ResultsBetween 2015 and 2020, the proportion of secukinumab initiators in the registry who were biologic-naive increased each year from 12.5% to 49.7%. Overall, 1518 patients initiated secukinumab at or after enrollment; 980 (64.6%) were biologic experienced, and 538 (35.4%) were biologic naive. At 6 months, biologic-experienced and biologic-naive patients reported mean (SD) decreases in BSA (−9.3 [14.5] versus −11.7 [16.6]), IGA (−1.4 [1.3] versus −1.7 [1.4]), and PASI (−5.2 [6.6] versus −6.7 [7.8]). The proportion of patients with an IGA score of clear/almost clear (0/1) increased over fivefold, irrespective of biologic experience. At 12 months, similar improvements were seen.ConclusionsThe proportion of biologic-naive secukinumab initiators increased over time. Biologic-naive patients demonstrated similar improvements in clinical outcomes compared with biologic-experienced patients, suggesting that secukinumab may be considered as a first-line therapy for psoriasis.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-022-00740-y.

Subpectoral versus suprapectoral biceps tenodesis yields similar clinical outcomes: a systematic review

ImportanceArthroscopic suprapectoral biceps tenodesis (ABT) and open subpectoral biceps tenodesis (OBT) are two surgical treatment options for relief of long head of the biceps tendon (LHBT) pathology and superior labrum anterior to posterior (SLAP) tears. There is insufficient knowledge regarding the clinical superiority of one technique over the other.ObjectiveTo systematically review the literature in order to compare the clinical outcomes and safety of ABT and OBT for treatment of LHBT or SLAP pathology.Evidence reviewA systematic review was performed by searching PubMed, the Cochrane Library and Embase to identify studies that compared the clinical efficacy of ABT versus OBT. The search phrase used was: (bicep OR biceps OR biceps brachii OR long head of biceps brachii OR biceps tendinopathy) AND (tenodesis). Patients were assessed based on the American Shoulder and Elbow Surgeons Score, the visual analogue scale, the Single Assessment Numeric Evaluation, Constant-Murley Score, clinical failure, range of motion, bicipital groove pain and strength. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed, and both the Cochrane Collaboration’s and Risk of Bias in Non-randomised Studies - of Interventions (ROBINS-I) risk of bias tools were used to evaluate risk of bias.FindingsEight studies (one level I, seven level III) met inclusion criteria, including 326 patients undergoing ABT and 381 patients undergoing OBT. No differences were found in treatment failure rates or patient-reported outcome scores between groups in any study. One study found OBT patients to experience significantly increased range of shoulder forward flexion when compared with ABT patients (p=0.049). Two studies found ABT patients to experience significantly more postoperative stiffness when compared with OBT patients (p<0.05).ConclusionsPatients undergoing ABT and OBT can be expected to experience similar improvements in clinical outcomes at latest follow-up without differences treatment failure or functional performance. ABT patients may experience an increased incidence of stiffness in the early postoperative period.Level of evidenceIII.

Simultaneous or Staged Bilateral Arthroscopic Rotator Cuff Repair: An Observational Study of Intraoperative and Postoperative Outcomes.

Background:Bilateral arthroscopic rotator cuff repair (ARCR) is frequently performed in patients with symptomatic bilateral rotator cuff tears.Purpose:To compare patient-reported outcomes and mobility between simultaneous and staged bilateral ARCR.Study Design:Cohort study; Level of evidence, 3.Methods:Included were 51 patients who underwent simultaneous (anesthetized once) and 42 patients who underwent staged (anesthetized twice) bilateral ARCR between January 2014 and January 2018; for the staged group, the interval between procedures was at least 12 months. All operations were performed by the same surgeon, and all patients had minimum 24-month follow up in both shoulders. Patient-reported outcomes and range of motion (ROM) were assessed preoperatively and postoperatively and compared between groups. Outcome measures included the Constant-Murley score (CMS) and American Shoulder and Elbow Surgeons (ASES) score as well as measures of psychological status, health-related quality of life, activities of daily living (ADL), and patient satisfaction with the state of one’s shoulders.Results:The mean follow-up times for the staged and simultaneous ARCR groups were 44.1 months (range, 36-60 months) and 37.5 months (range, 25-59 months), respectively. There were no significant differences in age, tear size, or fatty degeneration of rotator cuff muscles between the groups. The cumulative length of hospital stay in the staged group was significantly longer than in the simultaneous group (P < .001). At the final follow-up, both groups showed significant improvement in ROM, CMS, and ASES scores (P < .05). No significant differences between the groups were observed in terms of ROM, CMS, and ASES scores postoperatively. At 24 months postoperatively, psychological status and health-related quality of life in both groups improved significantly (P < .05), and there were no significant between-group differences. Patients were able to perform most essential ADL. Both groups had high patient satisfaction, but patient satisfaction for the second shoulder of the staged group was lower than that of the simultaneous group (P = .039).Conclusion:Simultaneous bilateral ARCR was shown to be effective, resulting in similar improvements in clinical outcomes to staged bilateral ARCR at 2-year follow-up. In addition to higher patient satisfaction, simultaneous bilateral ARCR also had a shorter treatment cycle.

Minimally Invasive Posterior Cervical Foraminotomy as an Alternative to Anterior Cervical Discectomy and Fusion for Unilateral Cervical Radiculopathy: A Systematic Review and Meta-analysis.

Systematic review and meta-analysis. The aim of this study was to evaluate clinical outcomes, complications, and reoperations of minimally invasive posterior cervical foraminotomy (MI-PCF) for unilateral cervical radiculopathy without myelopathy, in comparison to anterior cervical decompression and fusion (ACDF). ACDF is a standard treatment for cervical radiculopathy secondary to lateral disc herniation or foraminal stenosis. Recent studies have suggested MI-PCF to be an effective alternative to ACDF. However, concern for reoperation and whether similar improvements in clinical outcomes can be achieved has led to a debate in the literature. We comprehensively searched PubMed, CINAHL Plus, and SCOPUS utilizing terms related to MI-PCF. Two independent reviewers assessed potential studies and extracted data on clinical outcome scores (neck disability index [NDI], visual analog scale [VAS]-neck, and VAS-arm), reoperation proportion, and complications. Studies included were on noncentral cervical pathology, published in the last 10 years, had a sample size of >10 patients, and reported data on minimally invasive techniques for posterior cervical foraminotomy. Heterogeneity and publication bias analyses were performed. The pooled proportions of each outcome were compared to those of ACDF obtained from two previously published studies. Fourteen studies were included with data of 1216 patients. The study population was 61.8% male, with a mean age of 51.57 years, and a mean follow-up of 30 months. MI-PCF resulted in a significantly greater improvement in VAS-arm scores compared to ACDF, and similar improvements in VAS-neck and NDI scores. Proportions of complications and reoperations were similar between the two cohorts. The most common complications were transient neuropraxia, wound-related, and durotomy. Our findings suggest that MI-PCF may be utilized as a safe and effective alternative to ACDF in patients with unilateral cervical radiculopathy without myelopathy, without concern for increased reoperations or complications. 3.

Angiotensin Receptor Neprilysin Inhibitor in Japanese Patients With Heart Failure and Reduced Ejection Fraction - Baseline Characteristics and Treatment of PARALLEL-HF Trial.

The objective of the present analyses was to describe the baseline characteristics and treatment of the Japanese patients with HFrEF in THE PARALLEL-HF study. Methods and Results: Key demographic, clinical and laboratory findings, along with treatment, were reported and compared with patients enrolled in the PARADIGM-HF trial and other contemporary randomized clinical trials and registries of Japanese patients with HFrEF. In addition, the MAGGIC and EMPHASIS-HF risk scores were calculated. A total of 225 Japanese patients were randomized in PARALLEL-HF with a mean age of 67.9 years and the majority of the patients being male (85.8%) and in NYHA Class II (93.8%). Key baseline characteristics in PARALLEL-HF were generally comparable with PARADIGM-HF, and other contemporary clinical trials and registries of Japanese HFrEF patients. Patients enrolled in PARALLEL-HF were well treated with conventional evidence-based therapy at baseline (angiotensin-converting enzyme inhibitor inhibitor/angiotensin receptor blocker, 62.7%/37.3%; β-blockers, 94.7%; mineralocorticoid receptor antagonist, 59.1%). Despite the evidence-based treatment and most patients being in NYHA Class II, these patients had a low LVEF (mean 28.1%) and were at high risk of cardiovascular mortality and morbidity as assessed by the MAGGIC and EMPHASIS-HF risk scores. Overall, the patients in PARALLEL-HF were largely representative of contemporary ambulatory patients with HFrEF who are well treated with evidence-based therapies. PARALLEL-HF will determine whether sacubitril/valsartan provides similar improvements in clinical outcomes in Japanese HFrEF patients as observed in the PARADIGM-HF study.

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study

BackgroundThe prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. Methods and designThis is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. ConclusionsThe design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients.

Minimally invasive lumbar decompression—the surgical learning curve

Background ContextMinimally invasive spine surgery (MIS) procedures carry an inherently difficult learning curve based upon anecdotal evidence. Few studies have investigated the surgeon's learning curve for MIS lumbar laminectomy or laminotomy with or without discectomy. PurposeTo characterize the learning curve of a 1- or 2-level MIS lumbar decompression (LD) based on perioperative and postoperative parameters . Study Design/SettingRetrospective analysis of a prospectively maintained registry was used for this study. Patient SampleThere were 228 consecutive patients who underwent a primary 1- or 2-level MIS LD by a single surgeon for degenerative spinal pathology from 2009 to 2014. From 2005 to 2006, 50 patients underwent 1- or 2-level open LD consecutively. Outcome MeasuresPerioperative and postoperative outcomes (complications, visual analogue scale [VAS] scores, reoperations) were the outcome measures for this study. MethodsPatients were stratified into first and second groups as determined by the case number at which the procedural time reached a plateau. Demographics, comorbidity, pain scores, and surgical outcomes were compared between the first 50 patients and the subsequent 178 patients. The secondary analysis compared the surgical outcomes between the initial 50 MIS and 50 open LD patients. No funds were received in support of this work. ResultsThe initial cohort was older with a higher comorbidity burden (p<.05). However, body mass index, gender, smoking status, and ethnicity did not differ between cohorts. The initial cohort incurred a greater procedural time (p<.001) and longer length of hospitalization (p<.05) than the second cohort. Estimated blood loss (EBL), pain scores, complication rates, recurrent herniation rates, and reoperation rates were similar between groups. In the secondary analysis, the open LD patients demonstrated greater procedural time, higher EBL, and longer length of hospital stay than the MIS patients. However, the reoperation rate and 30-day readmission rate were not different between the MIS and open patients. ConclusionsContinued surgical experience was associated with a reduced operative time, shorter length of hospitalization, and similar blood loss following an MIS LD. Independent of surgical experience, all patients demonstrated similar improvements in clinical outcomes. These findings appear to suggest that although surgical experience may improve perioperative parameters (operative time, length of hospitalization), an MIS LD may initially be performed safely without prior experience.

Tips and tricks to implant a MitraClip in a patient with previous surgical closure of atrial septal defect

Percutaneous edge-to-edge mitral valve repair using the MitraClipdevicehasevolvedasanewtoolfortreatmentofmitralvalveregurgita-tion (MVR). The first randomized controlled trial (EVEREST II) com-pared the standard surgical repair/replacement of mitral valve versuspercutaneous repair by MitraClip and demonstrated its superior safetycomparedtosurgicalprocedure,withinferiorefficacyinMVRreduction,but similar improvements in clinical outcomes at 4 years follow-up [1].The guidelines [2,3] on the management of valvular heart disease, pub-lished in 2012 and 2014, suggested to consider percutaneous edge-to-edge mitral valve repair in patients with symptomatic severe MR, con-sidered inoperable or at high surgical risk by “heart team” and thathave a reasonable life expectancy (Class IIb). Percutaneous edge-to-edge mitral valve repair by MitraClip device using trans-septal leftheartcatheterization[4] isbecomingafirst-line treatmentfor function-alMR,whenanatomicalfeaturesaresuitable.Infact,thesepatientsusu-ally show a higher surgical risk and hospital mortality and a longerhospital stay than degenerative MR [5].We describea rarecaseof a61-year-oldmanwithsevere functionalMR, idiopathic dilatative cardiomyopathy and low ejection fraction(30%), in which the MitraClip implantation was very demanding. Healso had arterial hypertension, chronic renal failure on dialysis, moder-ate pulmonary hypertension and previous surgical closure of atrialseptum defect with direct suture. He underwent to automatedcardioverter defibrillator implantation in primary prevention and wasreferred to our hospital for a severe MVR in functional Class IV NYHA.The patient's anterior chest wall revealed a well healed sternotomyscar. The results of his laboratory analysis, including metabolic profileand complete blood count, were normal, with the exception of serumcreatinineandpro-BNPlevelsthatwereelevated.TheECGshowednor-mal sinus rhythm at 78 bpm. The trans-thoracic echocardiogramshowedanincreased diameter of theleft atrium and ventricle with dif-fuse hypokinesia and severe reduction of left ventricular systolic func-tion (Simpson ejection fraction 30%); thickening of the mitral valveleaflets, annulus and subvalvular apparatus and increased diameters oftherightsectionswithslightreductionofrightventricularsystolicfunc-tion (TAPSE 14mm). The color-Doppler demonstrated a severe MR (jetarea 11 cm

Subthalamic neurostimulation for Parkinson's disease with early fluctuations: balancing the risks and benefits

Electrical stimulation of the subthalamic nucleus is an established treatment for patients with advanced Parkinson's disease with pharmacologically unresponsive fluctuations. Compared with pharmacological treatment, subthalamic neurostimulation significantly improves motor symptoms, particularly during the phases of poor response to drug treatment, and reduces the severity of dyskinesias. Importantly, it also significantly improves quality of life and other integral measures of disease severity. The treatment response can last for more than 10 years, although there is no evidence that levodopa-resistant symptoms are delayed by subthalamic neurostimulation. At present, the mean disease duration for patients at the time of implantation is 12 years. In a recent study (EARLYSTIM) in patients with a disease duration of 7·5 years and fluctuations for 1·5 years, similar improvements in clinical outcomes were reported. These findings suggest that neurostimulation of the subthalamic nucleus could be used earlier in the disease course for carefully selected patients if the benefits of the treatment are weighed against the surgical risks and the lifelong need for specialised care by an experienced team. As mobility is consistently improved during the times with poor mobility by reducing fluctuations and delaying levodopa-sensitive complications, we propose that this treatment changes the disease course.

Endoscopic mitral valve reconstruction and percutaneous mitral clipping: what is the best solution for our patients?

In this historical period for our profession, we are facing complex and challenging experiences. Being a doctor nowadays is probably more difficult than it was ten years ago and performing cardiac surgery requires different skills, compared to when we started our surgical careers. Firstly, in our daily surgical practice, we are forced to treat an increasingly older population with greater comorbidity. Secondly, the social environment has changed its attitude towards our specialty, such that we are not just surgeons trying to save lives and give years of life to our patients, but we are sometimes considered the cause of damage to our patients. We practice medicine under pressure from a society that considers illness and death to be not merely a normal component of life but the result of errors or omissions by doctors and that, when an adverse event occurs, someone must be found guilty. Public healthcare is a major source of expenditure for a country, absorbing an important part of the Gross National Product. The need to limit costs is therefore urgent and, more often than not, contrasts with the vast scale of investment by major medical companies seeking to increase profits through the introduction of new drugs and medical devices. These profits are essential for investment in new research, but sometimes this profit motive can clash with the safety of the patients in terms of technical challenges, reliability and ability to achieve consistent results. On the other hand, patients’ quest for immortality, avoiding illness and death, encourages us to offer our patients surgical procedures and devices that can be recognized as ‘minimally invasive’. However, ‘minimal invasiveness’ is a very misleading concept that should relate to a more careful consideration of the physiology of body circulation and homeostasis. Practically—and in the majority of cases—it relates only to the extent of the surgical incision. It is a common perception that the relevance and the risk of a surgical procedure is related to the length of the dermal incision or to the number of stitches used to close the skin: the longer the incision, the greater the risk! Some members of the medical community encourage this ‘tribal’ way of approaching the problem, as illustrated by visual displays at meetings, in which a ruler is placed next to a patient’s incision. Except for an aesthetic aspect, no real advantages of minimally invasive procedures over conventional surgery have been demonstrated in large-scale meta-analysis and sometimes the doubt of a suboptimal result can be present [1]. So the definition of ‘small access’ should be preferred to ‘minimally invasive’; a real minimally invasive procedure can be achieved, for example, by optimizing extracorporeal circulation and retaining a ‘physiologic’ haematocrit with low priming, avoiding dangerous haemodilution. More recently, specific percutaneous approaches to mitral valve pathology have been focused either on the leaflet, with the use of edge-to-edge fixation, or the dilated annulus often present in ischaemic and functional mitral regurgitation. In April 2011, the results of the EVEREST II trial were reported in the New England Journal of Medicine. The trial was a randomized comparison of percutaneous repair (using the MitraClip device) with conventional surgery for mitral regurgitation, to evaluate the efficacy and safety of the percutaneous approach [2]. In the abstract the conclusions are clear: ‘Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes’. This conclusion should represent the rationale for introducing the device in the clinical practice. No difference was observed between the two groups in terms of mortality and morbidity: in terms of major adverse events, the only difference was the reduced need for transfusions (8.8 vs. 53.2%, P <0.001) in favour of the percutaneous group. I think we all have to congratulate the authors of EVEREST II who, for the first time in the history of medicine, have considered a treatment as a complication. Indeed, the rate of bleeding (a complication) is not reported and we can surmise that the rate of transfusion might be different from one centre to another, according to different transfusion strategies. Some centres consider a value of haemoglobin less than 10 g/dL as the lower limit for transfusion; others fix the cut-off at 8 g/dL. The conclusion that this procedure was associated with ‘superior safety’ is totally misleading and sounds more like an advertisement than a scientific paper. Furthermore, the cohort of treated patients was exceptionally healthy, with a mean age of 67 years and an EF of 60%; re-do

Comparative Effectiveness of Standard versus Patient‐Centered Collaborative Care Interventions for Depression among African Americans in Primary Care Settings: The BRIDGE Study

To compare the effectiveness of standard and patient-centered, culturally tailored collaborative care (CC) interventions for African American patients with major depressive disorder (MDD) over 12 months of follow-up. Twenty-seven primary care clinicians and 132 African American patients with MDD in urban community-based practices in Maryland and Delaware. Cluster randomized trial with patient-level, intent-to-treat analyses. Patients completed screener and baseline, 6-, 12-, and 18-month interviews to assess depression severity, mental health functioning, health service utilization, and patient ratings of care. Patients in both interventions showed statistically significant improvements over 12 months. Compared with standard, patient-centered CC patients had similar reductions in depression symptom levels (-2.41 points; 95 percent confidence interval (CI), -7.7, 2.9), improvement in mental health functioning scores (+3.0 points; 95 percent CI, -2.2, 8.3), and odds of rating their clinician as participatory (OR, 1.48, 95 percent CI, 0.53, 4.17). Treatment rates increased among standard (OR = 1.8, 95 percent CI 1.0, 3.2), but not patient-centered (OR = 1.0, 95 percent CI 0.6, 1.8) CC patients. However, patient-centered CC patients rated their care manager as more helpful at identifying their concerns (OR, 3.00; 95 percent CI, 1.23, 7.30) and helping them adhere to treatment (OR, 2.60; 95 percent CI, 1.11, 6.08). Patient-centered and standard CC approaches to depression care showed similar improvements in clinical outcomes for African Americans with depression; standard CC resulted in higher rates of treatment, and patient-centered CC resulted in better ratings of care.

Clinical trials update from the American College of Cardiology Meeting 2011: STICH, NorthStar, TARGET, and EVEREST II

This article provides information and a commentary on key trials relevant to the pathophysiology, prevention, and treatment of heart failure (HF) presented at the annual American College of Cardiology meeting held in New Orleans in 2011. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. The STICH trial failed to show a benefit of revascularization on all-cause mortality in patients with HF and coronary artery disease; however, cardiovascular deaths were reduced compared with medical therapy alone. Results from the NorthStar study suggest that patients with clinically stable systolic HF, who are on optimal medical therapy, including those with elevated amino-terminal B-type natriuretic peptide levels, may not benefit from long-term follow-up in an HF clinic. Results from the TARGET study demonstrate that targeted left ventricular lead placement using speckle tracking echocardiography is feasible in patients undergoing implantation of a cardiac resynchronization therapy device and is associated with an enhanced response. Two-year follow-up data from EVEREST II show that although a catheter-based mitral valve repair procedure using the MitraClip(®) system was less effective at reducing mitral regurgitation than conventional surgery, similar improvements in clinical outcomes were observed with fewer short-term adverse events.

Percutaneous Repair or Surgery for Mitral Regurgitation

Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

Clinical and Radiographic Analysis of an Optimized rhBMP-2 Formulation as an Autograft Replacement in Posterolateral Lumbar Spine Arthrodesis

Previous studies have demonstrated the ability of recombinant human bone morphogenetic protein to achieve a solid fusion in anterior lumbar interbody arthrodesis. The purpose of this study was to compare iliac crest bone graft and recombinant human bone morphogenetic protein-2, combined with a carrier consisting of bovine collagen and beta-tricalcium phosphate-hydroxyapatite to create a compression-resistant matrix, for instrumented single-level posterolateral arthrodesis. Four hundred and sixty-three patients with symptomatic single-level lumbosacral degenerative disease with no greater than grade-1 spondylolisthesis were treated with single-level instrumented posterolateral arthrodesis through an open midline approach. Patients were randomly assigned to either the recombinant human bone morphogenetic protein-2 matrix group (239 patients) or the autogenous iliac crest bone-graft group (224 patients). The Oswestry Disability Index, Short Form-36, and back and leg pain scores were determined preoperatively and at 1.5, three, six, twelve, and twenty-four months postoperatively. Radiographs and computed tomography scans were made at six, twelve, and twenty-four months postoperatively to evaluate for fusion. The mean operative time and mean blood loss in the recombinant human bone morphogenetic protein-2 matrix group (2.5 hours and 343.1 mL, respectively) were significantly less than those in the iliac crest bone-graft group (2.9 hours and 448.6 mL). Both groups showed similar improvements in clinical outcomes and reduced pain. At twenty-four months, 60% of the iliac crest bone-graft group reported donor-site pain. At twenty-four months, fusion was evident in 96% of the patients in the recombinant human bone morphogenetic protein-2 matrix group compared with 89% in the iliac crest bone-graft group (p = 0.014). There was a significant difference (p = 0.011) in the rate of failures because of nonunion (eighteen patients with an iliac crest bone graft compared with six patients with the recombinant human bone morphogenetic protein-2 matrix). Also, the number of patients requiring second surgeries was significantly higher in the iliac crest bone-graft group (thirty-six patients) compared with the recombinant human bone morphogenetic protein-2 matrix group (twenty patients) (p = 0.015). The use of recombinant human bone morphogenetic protein-2 in instrumented posterolateral lumbar arthrodesis decreases operative time and blood loss and produces earlier and higher fusion rates than does iliac crest bone graft. Clinical outcomes are similar to those with iliac crest bone graft. Thus, the need for harvesting iliac crest bone is eliminated along with the morbidities associated with the harvest procedure.

Long-term clinical benefits and costs of an integrated rehabilitation programme compared with outpatient physiotherapy for chronic knee pain

Background Chronic knee pain is a major cause of disability in the elderly. Management guidelines recommend exercise and self-management interventions as effective treatments. The authors previously described a rehabilitation programme integrating exercise and self-management [Enabling Self-management and Coping with Arthritic knee Pain through Exercise (ESCAPE-knee pain)] that produced short-term improvements in pain and physical function, but sustaining these improvements is difficult. Moreover, the programme is untried in clinical environments, where it would ultimately be delivered. Objectives To establish the feasibility of ESCAPE-knee pain and compare its clinical effectiveness and costs with outpatient physiotherapy. Design Pragmatic, randomised controlled trial. Setting Outpatient physiotherapy department and community centre. Participants Sixty-four people with chronic knee pain. Interventions Outpatient physiotherapy compared with ESCAPE-knee pain. Outcomes The primary outcome was physical function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. Secondary outcomes included pain, objective functional performance, anxiety, depression, exercise-related health beliefs and healthcare utilisation. All outcomes were assessed at baseline and 12 months after completing the interventions (primary endpoint). ANCOVA investigated between-group differences. Results Both groups demonstrated similar improvements in clinical outcomes. Outpatient physiotherapy cost £130 per person and the healthcare utilisation costs of participants over 1 year were £583. The ESCAPE-knee pain programme cost £64 per person and the healthcare utilisation costs of participants over 1 year were £320. Conclusions ESCAPE-knee pain can be delivered as a community-based integrated rehabilitation programme for people with chronic knee pain. Both ESCAPE-knee pain and outpatient physiotherapy produced sustained physical and psychosocial benefits, but ESCAPE-knee pain cost less and was more cost-effective. Clinical Trial Registration No.: ISRCTN63848242.

Arbitrary-Pressure Continuous Positive Airway Pressure for Obstructive Sleep Apnea Syndrome

Current resources are inadequate to meet the demand for polysomnography, resulting in long waiting lists. This study aimed to evaluate the role of arbitrary-pressure continuous positive airway pressure (CPAP) as a method to reduce delays in commencing treatment. The study was of an open, randomized, parallel design. Ninety-one subjects with obstructive sleep apnea syndrome were randomized to either arbitrary-pressure CPAP based on body mass index before treatment polysomnography or to CPAP at settings determined by polysomnography. Both interventions resulted in similar improvements in clinical outcomes as determined by Epworth Sleepiness Score, Short Form-36 Quality of Life questionnaire, objective compliance, and subjective attitudes to treatment. There was higher sleep efficiency at treatment polysomnography in the group commenced at arbitrary pressure (81.8 +/- 10.1% [mean +/- SD] compared with 72.2 +/- 18.0%, p = 0.01). Subjects unable to tolerate CPAP were identified by the use of arbitrary pressure, leading to a reduction in the proportion of "wasted" treatment polysomnograms (studies performed in subjects not persisting with treatment) relative to commencing therapy after treatment polysomnography (3 of 39 compared with 12 of 35, p = 0.01). This approach to initiating treatment with CPAP appears feasible when there are long waiting lists for polysomnography.