Treatment of right heart thromboemboli

BACKGROUND: The presence of right heart thromboemboli complicating pulmonary thromboemboli carries with it an increased mortality rate compared to pulmonary thromboemboli alone, but little is known about the optimal management of this difficult clinical situation. This fact is highlighted in the case study of a patient with a 19-cm right atrial thrombus complicating bilateral pulmonary thromboemboli. STUDY OBJECTIVES: We sought to determine the effects of anticoagulation therapy, thrombolysis, and surgical embolectomy on mortality rate in patients with right heart thromboemboli. DESIGN: Retrospective analysis of all reported cases in the English language literature (1966 to 2000) of right heart thromboembolism in which age, sex, therapy, and outcome were reported. MEASUREMENTS AND RESULTS: We analyzed 177 cases of right heart thromboembolism. Pulmonary thromboembolism was present in 98% of the cases. The patients were evenly divided by gender with an average age of 59.8 years (SD, 16.6 years) years. Dyspnea (54.2%), chest pain (22.6%), and syncope (17.5%) were the most common presenting symptoms. The treatments administered were none (9%), anticoagulation therapy (35.0%), surgical procedure (35.6%), or thrombolytic therapy (19.8%). The overall mortality rate was 27.1%. The mortality rate associated with no therapy, anticoagulation therapy, surgical embolectomy, and thrombolysis was 100.0%, 28.6%, 23.8%, and 11.3%, respectively. Using multivariate modeling with survival as the primary outcome, age and gender were not associated with mortality rate, but thrombolytic therapy was associated with an improved survival rate (p < 0.05) when compared either to anticoagulation therapy or surgery. CONCLUSION: The presence of right heart thromboemboli may have diagnostic and therapeutic implications in pulmonary thromboembolism patients. A well-designed prospective, randomized trial is needed to determine the optimal treatment of right heart thromboemboli.     

Treatment of histologically mild hepatitis C virus infection with interferon and ribavirin: a multicentre randomized controlled trial

Current guidelines advocate no treatment for patients with histologically mild hepatitis C virus (HCV) infection. This was a UK multicentre randomized controlled trial comparing alpha-interferon (3 MU thrice weekly) + ribavirin (1000-1200 mg/day) for 48 weeks with no treatment in treatment naive, adult patients with histologically mild chronic HCV infection. The aim was to compare benefits, safety and efficacy of combination therapy with alpha-interferon 2b and ribavirin for 48 weeks with no treatment (current standard management) in this patient group. In the treatment group 32 of 98 (33%) patients achieved a sustained virological response (SVR). Patients infected with genotype 1 had a lower SVR than those infected with genotype non-1 (18% vs 49% P = 0.02). No patients who failed to achieve a 2-log drop in viral load at 12 weeks achieved SVR. Improvements in quality of life 24 weeks postcessation of therapy compared with baseline using the SF-36 questionnaire measures were observed in the treated group. For patients with mild HCV infection with viral genotype non-1, the results are sufficiently good to suggest that therapeutic decisions should no longer be biopsy-driven. For patients infected with genotype 1, a liver biopsy is still indicated as the low chance of SVR is outweighed by an unacceptable burden of side-effects. Patients who fail to respond by 12 weeks of therapy should have their treatment curtailed early.     

Prolonged impact of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic,multicentre randomized trial cohort

Objectives

We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure (CHF).

Methods

We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days. Blinded endpoints included event-free survival from all-cause emergency hospitalization or death, all-cause mortality and rate of all-cause hospitalization and stay.

Results

280 patients (73% male, aged 71 ± 14 years and 73% left ventricular systolic dysfunction) were initially randomized to home-based (n = 143) or clinic-based (n = 137) intervention. During extended follow-up (complete for 274 patients), 1139 all-cause hospitalizations (7477 days of hospital stay) and 121 (43.2%) deaths occurred. There was no difference in the primary endpoint; 20 (14.0%) home-based versus 13 (7.4%) clinic-based patients remained event-free (adjusted HR 0.89, 95% CI 0.70 to 1.15; p = 0.378). Significantly fewer home-based (51/143, 35.7%) than clinic-based intervention (71/137, 51.8%) patients died (adjusted HR 0.62, 95% CI 0.42 to 0.90: p = 0.012). Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations (p = 0.087) associated with 3067 (median 4.0, IQR 2.0 to 6.8) versus 4410 (6.0, IQR 3.0 to 12.0) days of hospital stay (p < 0.01 for rate and duration of hospital stay).

Conclusions

Relative to clinic-based intervention, home-based intervention was not associated with prolonged event-free survival. Home-based intervention was, however, associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term.

Trial registration

Australian New Zealand Clinical Trials Registry number 12607000069459 (http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803)     

Pilates in heart failure patients: a randomized controlled pilot trial

Background: Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Purpose: Investigate the effects of Pilates on exercise capacity variables in HF. Methods: Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. Results: At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P= 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P= 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P= 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P= 0.02). Conclusions: The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy.     

Pregnancy and heart disease: Time for a randomized controlled trial

Cardiac disease is the most important cause of maternal mortality and despite considerable efforts by cardiologists and obstetricians alike, the numbers of deaths continue to rise. The literature on the subject is limited and almost entirely made up of case series. In this editorial we consider the need for randomized controlled trials in key areas, some will be harder than others to complete, but all are required to help reverse the growing numbers of women who die from heart disease during pregnancy.     

Treatment of severe,nonfulminant acute hepatitis B with lamivudine vs placebo: a prospective randomized double‐blinded multicentre trial

Acute hepatitis B virus (aHBV) infection can lead to fulminant liver failure, which likely is prevented by early lamivudine therapy. Even nonfulminant but severe acute hepatitis B can lead to significant morbidity and impaired quality of life. Therefore, lamivudine was evaluated in patients with severe aHBV in a placebo‐controlled trial. Patients with severe aHBV infection (ALT >10× ULN, bilirubin >85 μm , prothrombin time >50%) were prospectively treated with lamivudine 100 mg/day or with placebo within 8 days after the diagnosis. The primary end point was time to bilirubin <34.2 μm . Secondary end points were time to clear HBsAg and HBV‐DNA, development of anti‐HBs and normalization of ALT. Eighteen cases were randomized to lamivudine, 17 to placebo. 94% of patients were hospitalized. No individual progressed to hepatic failure; all but one patient achieved the primary end point. Due to smaller than expected patient numbers, all study end points did not become statistically significant between treatment arms. Median time end points [in days] were bilirubin <34.2 μm (26.5 vs 32), ALT normalization (35 vs 48) and HBsAg clearance (48 vs 67) referring to earlier recovery under lamivudine, in contrast to loss of HBV‐DNA (62 vs 54) and development of anti‐HBs (119 vs 109). In all but two patients (one in every group), HBsAg clearance was reached in the study. Adverse events occurred more frequently during lamivudine therapy, but did not reach statistical significance. Lamivudine may ameliorate severe aHBV infection, but limited patient numbers prevented definite conclusions.     

Can anaerobic threshold be used as an end-point for therapeutic trials in heart failure?: Lessons from a multicentre randomized placebo-controlled trial

‘Anaerobic threshold’ (AT), proposed as a non-invasiveindex of exercise tolerance, independent of patient motivation,is considered more reliable than exercise duration in assessingthe effect of drug therapy in chronic heart failure (CHF). However,inter-observer variation in patients may be more difficult thanin normal subjects. In a multicentre study, 85 patients from10 centres performed a total of 331 bicycle maximal tests (rampprotocols, 10 watts. min^–1) with respiratory gas analysisby different systems. A central committee reviewed all the tests.Percentages of AT determination ranged from 34% to 71% dependingon the method used. Apart from the respiratory exchange ratio(RER=1) method, which yielded the lowest rate of determination.and the crossing point (when RER=1), which yielded the highestrate, 71%, other methods of determination, such as carbon dioxide(42%), minute ventilation (52%) or ventilatory equivalents plottedvs time (57%), did not dtffer in the rate of AT determination. Thus, even among trained physicians, AT determination was notreliable. The crossing point may nevertheless be a valuableindex from a pragmatic standpoint, although it occurs afterthe actual AT Peak oxygen uptake should remain the main end-pointin assessment of exercise capacity.     

右心血栓的处理

右心血栓是少见病,如不能及时处理,病死率可达90%。目前,国内外无权威性的右心血栓处理原则可依,故笔者结合自己的临床经验并复习近年国内外文献,认为右心血栓处理前必须与其它心脏肿瘤鉴别,尤其是黏液瘤。右心血栓的处理可根据具体情况采取溶栓、抗凝、手术。     

A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study

OBJECTIVE: To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections (ESI) in patients with sciatica. We performed a 12-month, multicentre, double-blind, randomized, placebo-controlled, parallel-group trial in four secondary pain-care clinics in the Wessex Region. METHODS: Two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of 1-18 months' duration were randomized to either three lumbar ESIs of triamcinolone acetonide or interligamentous saline injections at intervals of 3 weeks. The main outcome measure was the Oswestry low back pain disability questionnaire (ODQ). RESULTS: At 3 weeks, the ESI group demonstrated a transient benefit over the placebo group (patients achieving a 75% improvement in ODQ, 12.5 vs 3.7%; number needed to treat, 11.4). No benefit was demonstrated from 6 to 52 weeks. ESIs did not improve physical function, hasten return to work or reduce the need for surgery. There was no benefit of repeated ESIs over single injection. No clinical predictors of response were found. At the end of the study the majority of patients still had significant pain and disability regardless of intervention. CONCLUSIONS: In this pragmatic study, ESIs offered transient benefit in symptoms at 3 weeks in patients with sciatica, but no sustained benefits in terms of pain, function or need for surgery. Sciatica is a chronic condition requiring a multidisciplinary approach. To fully investigate the value of ESIs, they need to be evaluated as part of a multidisciplinary approach.