Triple-Site Versus Standard Cardiac Resynchronization Therapy Study (TRUST CRT): Clinical Rationale, Design, and Implementation

Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF), lowered LV ejection fraction, and wide QRS. However, many patients (≤40%) do not respond to this form of pacing. TRUST CRT is a prospective, single-center, randomized, single-blind, parallel, and controlled study that has been designed to treat patients with moderate to severe HF (NYHA III-IV), QRS ≥120 ms, sinus rhythm, LV dysfunction (EF ≤ 35%), and signs of mechanical dyssynchrony.
Objective: The primary objective will evaluate the 6-month's combined endpoint of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in peak oxygen consumption, and ≥10% in 6-minute walking distance.
Methods: Patients with HF receiving optimal pharmacotherapy, with LV dysfunction, mechanical dyssynchrony, wide QRS and sinus rhythm will be randomized in a 1: 1 fashion to standard or triple-site CRT-D. Patients will be followed for 1 week, 1, 3, and 6 months during a blind phase, then every 6 months until study completion. One hundred patients will be enrolled by the study center.
Conclusions: TRUST CRT is a randomized, clinical trial in CRT candidates to evaluate the effectiveness of triple-site pacing versus standard resynchronization in patients with HF.     

Ankle brachial index measurement in primary care: are we doing it right?

Background

The reference standard for diagnosing peripheral arterial disease in primary care is the ankle brachial index (ABI). Various methods to measure ankle and brachial blood pressures and to calculate the index are described.

Aim

To compare the ABI measurements performed in primary care with those performed in the vascular laboratory. Furthermore, an inventory was made of methods used to determine the ABI in primary care.

Design of study

Cross-sectional study.

Setting

Primary care practice and outpatient clinic.

Method

Consecutive patients suspected of peripheral arterial disease based on ABI assessment in primary care practices were included. The ABI measurements were repeated in the vascular laboratory. Referring GPs were interviewed about method of measurement and calculation of the index. From each patient the leg with the lower ABI was used for analysis.

Results

Ninety-nine patients of 45 primary care practices with a mean ABI of 0.80 (standard deviation [SD] = 0.27) were included. The mean ABI as measured in the vascular laboratory was 0.82 (SD = 0.26). A Bland–Altman plot demonstrated great variability between ABI measurements in primary care practice and the vascular laboratory. Both method of blood pressure measurements and method of calculating the ABI differed greatly between primary care practices.

Conclusion

This study demonstrates that the ABI is often not correctly determined in primary care practice. This phenomenon seems to be due to inaccurate methods for both blood pressure measurements and calculation of the index. A guideline for determining the ABI with a hand-held Doppler, and a training programme seem necessary.     

The contribution of general practice based research to the development of national policy: case studies from Ireland and Australia

Background

This paper aims to describe the influence of general practice based research on the development of two specific policy initiatives, namely the Heartwatch Programme in Ireland and the Better Outcomes in Mental Health Care (BOiMHC) program in Australia. A case study approach was used to explore the extent to which relevant general practice based research shaped these initiatives.

Results

In both case studies, a range of factors beyond general practice based research shaped the initiative in question, including political will, the involvement of stakeholders (including key opinion leaders), and the historical context. Nonetheless, the research played an important role, and was not merely put to 'symbolic use' to support a position that had already been reached independently. Rather, both case studies provide examples of 'instrumental use': in the case of Heartwatch, the research was considered early in the piece; in the case of the BOiMHC program, it had a specific impact on the detail of the components of the initiative.

Conclusion

General practice based research can influence policy-making and planning processes by strengthening the foundation of evidence upon which they draw. This influence will not occur in a vacuum, however, and general practice researchers can maximise the likelihood of their work being 'picked up' in policy if they consider the principles underpinning knowledge transfer.

     

Effect of Short-term Psychiatric Intervention in Amputees

A total of 40 patients with limb amputations were included in the present study aimed at evaluating the psychological status of amputees. All patients filled a specially designed proforma and the following psychological questionnaires: General Health Questionnaire, Carroll Rating Scale for Depression, State-Trait Anxiety Inventory, Michigan Alcoholism Screening Test and Disability Assessment Questionnaire. Analysis of the results showed that 29 (72.5%) of the amputees had psychiatric disorders and this number had reduced to 20 (50%) after therapy. The difference was statistically significant. Psychiatric treatment also resulted in a statistically significant reduction in level of depression as measured by Carroll Rating scale for Depression. The amputees had the highest score on vocational subscale of Dysfunction Analysis Questionnaire. Short term psychiatric treatment was found to be very useful in treating psychiatric morbidity and depression in amputees.Key Words: Amputees, Depression, Psychiatric morbidity     

Risk factors for sudden infant death syndrome following the prevention campaign in New Zealand: a prospective study

OBJECTIVES: To identify the risk factors for sudden infant death syndrome (SIDS) following a national campaign to prevent SIDS. METHODS: For 2 years (October 1, 1991 through September 30, 1993) data were collected by community child health nurses on all infants born in New Zealand at initial contact and at 2 months. RESULTS: There were 232 SIDS cases in the postneonatal age group (2.0/1000 live births) and these were compared with 1200 randomly selected control subjects. Information was available for 127 cases (54.7%) and 922 (76.8%) of controls. The previously identified modifiable risk factors were examined. The prevalence of prone sleeping position of the infant was very low (0.7% at initial contact and 3. 0% at 2 months), but was still associated with an increased risk of SIDS. In addition, the side sleeping position was also found to have an increased risk of SIDS compared with the supine sleeping position (at 2 months: adjusted odds ratio (OR) = 6.57; 95% confidence interval (CI) = 1.71, 25.23). Maternal smoking was found to be the major risk factor for SIDS. Bed sharing was also associated with an increased risk of SIDS. There was an interaction between maternal smoking and bed sharing on the risk of SIDS. Compared with infants not exposed to either bed sharing or maternal smoking, the adjusted OR for infants of mothers who smoked was 5.01 (95% CI = 2.01, 12.46) for bed sharing at the initial contact and 5.02 (95% CI = 1.05, 24. 05) for bed sharing at 2 months. In this study breastfeeding was not associated with a statistically significant reduction in the risk of SIDS. The other risk factors for SIDS identified were: unmarried mother, leaving school at a younger age, young mother, greater number of previous pregnancies, late attendance for antenatal care, smoking in pregnancy, male infant, Maori ethnicity, low birth weight, and shorter gestation. CONCLUSIONS: After adjustment for potential confounders, prone and side sleeping positions, maternal smoking, and the joint exposure to bed sharing and maternal smoking were associated with statistically significant increased risk of SIDS. A change from the side to the supine sleeping position could result in a substantial reduction in SIDS. Maternal smoking is common in New Zealand and with the reduction in the prevalence of prone sleeping position is now the major risk factor in this country. However, smoking behavior has been difficult to change. Bed sharing is also a major factor but appears only to be a risk to infants of mothers who smoke. Addressing bed sharing among mothers who smoke could reduce SIDS by at least one third. Breastfeeding did not appear to offer a statistically significant reduction in SIDS risk after adjustment of potential confounders, but as breastfeeding rates are comparatively good in New Zealand, this result should be interpreted with caution as the power of this study to detect a benefit is small.     

The role of radiology in extracorporeal shock wave therapy

Extracorporeal shock wave lithotripsy was used for the treatment of 1,252 kidneys and ureters with calculi during a 10-month period at the authors' medical center. Before lithotripsy was performed, excretory urography, radiography, renography, computed tomography, and ultrasound studies were done, when necessary, to locate the calculi. Nine calculi in five kidneys could not be fragmented with lithotripsy. Of 895 patients with calculi less than 2.5 cm in diameter, only 13 (1.5%) required interventional procedures to clear the calculi, whereas of 161 patients with calculi greater than or equal to 2.5 cm, 36 (22.4%) required nephrostomies. A column of calculous debris in the mid and distal portions of the ureter (steinstrasse) was seen in 171 instances (13.6%) after lithotripsy; 62% required interventions. The most common intervention required for successful lithotripsy was retrograde ureteral catheterization. Evaluation and treatment of patients with urolithiasis were largely dependent on radiography and excretory urography.