Beth L. Abramson

A PROSPECTIVE COMPARISON OF CARDIAC REHABILITATION ENROLLMENT FOLLOWING AUTOMATIC VS USUAL REFERRAL

OBJECTIVE Cardiac rehabilitation remains grossly under-utilized despite its proven benefits. This study prospectively compared verified cardiac rehabilitation enrollment following automatic vs usual referral, postulating that automatic referral would result in significantly greater enrollment for cardiac rehabilitation. DESIGN Prospective controlled multi-center study. PATIENTS AND METHODS A consecutive sample of 661 patients with acute coronary syndrome treated at 2 acute care centers (75% response rate) were recruited, one site with automatic referral via a computerized prompt and the other with a usual referral strategy at the physicians discretion. Cardiac rehabilitation referral was discerned in a mailed survey 9 months later (n = 506; 84% retention), and verified with 24 cardiac rehabilitation sites to which participants were referred. RESULTS A total of 124 (52%) participants enrolled in cardiac rehabilitation following automatic referral, vs 84 (32%) following usual referral (p < 0.001). Automatically referred participants were more likely to be referred from an in- patient unit (p < 0.01), and to be referred in a shorter time period (p < 0.001). Logistic regression analyses revealed that, after controlling for sociodemographic characteristics and case-mix, automatically referred participants were significantly more likely to enroll in cardiac rehabilitation (odds ratio = 2.1; 95% confidence interval 1.4-3.3) than controls. CONCLUSION Automatic referral resulted in over 50% verified cardiac rehabilitation enrollment; 2 times more than usual referral. It also significantly reduced utilization delays to less than one month.

Effect of Atrial Natriuretic Peptide on Muscle Sympathetic Activity and Its Reflex Control in Human Heart Failure

BACKGROUND The purpose of this study was to determine if atrial natriuretic peptide (ANP) exerts a relative inhibitory effect on muscle sympathetic nerve activity (MSNA) at rest and during nonhypotensive lower body negative pressure (LBNP) in heart failure, as in healthy subjects. METHODS AND RESULTS Fifteen men (age 39+/-2 years [mean+/-SE]) with dilated cardiomyopathy (ejection fraction 18+/-3%) received intravenous ANP (50 microgram bolus, then 50 ng. kg-1. min-1) and nitroglycerin (NTG, 8 mg/min) as a hemodynamic control. During each infusion MSNA, blood pressure (BP), central venous pressure (CVP), and heart rate (HR) were recorded before and during LBNP at -6 and -12 mm Hg. NTG and ANP caused similar and significant reductions in CVP and diastolic BP, but resting MSNA did not increase with either infusion. LBNP at -6 mm Hg lowered CVP (P<0.05), whereas LBNP at -12 mm Hg caused significant reductions in CVP, systolic BP, and diastolic BP. These effects of nonhypotensive and hypotensive LBNP on CVP and BP were similar during ANP and NTG infusions, yet MSNA was lower both before and with LBNP during ANP (P<0.02). Nonhypotensive LBNP increased MSNA during NTG (+133+/-68 Units; P<0.001) but not during ANP infusion (+24+/-23 Units; P=NS). CONCLUSIONS These observations are consistent with the concept that ANP exerts a sympathoinhibitory action in heart failure. This is most evident in response to reductions in atrial pressures that do not affect systemic BP.

Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial.

BACKGROUND The HARMONY study was a randomized, controlled trial examining the efficacy of an 8-week mindfulness-based stress reduction (MBSR) program for blood pressure (BP) lowering among unmedicated stage 1 hypertensive participants. METHODS Participants diagnosed with stage 1 hypertension based on ambulatory BP were randomized to either immediate treatment of MBSR for 8 weeks or wait-list control. Primary outcome analysis evaluated whether change in awake and 24-hour ambulatory BP from baseline to week 12 was significantly different between the 2 groups. A within-group before and after MBSR analysis was also performed. RESULTS The study enrolled 101 adults (38% male) with baseline average 24-hour ambulatory BP of 135±7.9/82±5.8mm Hg and daytime ambulatory BP of 140±7.7/87±6.3 mmHg. At week 12, the change from baseline in 24-hour ambulatory BP was 0.4±6.7/0.0±4.9mm Hg for the immediate intervention and 0.4±7.8/-0.4±4.6mm Hg for the wait-list control. There were no significant differences between intervention and wait-list control for all ambulatory BP parameters. The secondary within-group analysis found a small reduction in BP after MBSR compared with baseline, a finding limited to female subjects in a sex analysis. CONCLUSIONS MBSR did not lower ambulatory BP by a statistically or clinically significant amount in untreated, stage 1 hypertensive patients when compared with a wait-list control group. It leaves untested whether MBSR might be useful for lowering BP by improving adherence in treated hypertensive participants. CLINICAL TRIALS REGISTRATION NCT00825526.

Hormone replacement therapy for the primary prevention of chronic diseases: recommendation statement from the Canadian Task Force on Preventive Health Care

In the early 1990s the Canadian Task Force on Preventive Health Care issued a grade B recommendation for counselling perimenopausal women regarding the use of estrogen replacement therapy (ERT) for the primary prevention of osteoporotic fractures.[1][1] At that time, the large observational studies

Design and rationale for a randomized, controlled trial of interpersonal psychotherapy and citalopram for depression in coronary artery disease (CREATE).

Objective: Recognition that depression is associated with increased morbidity and mortality in coronary artery disease (CAD) patients has augmented the need for evidence-based treatment guidelines. This article presents the design of a multisite, Canadian trial of the efficacy, safety, and tolerability of interpersonal psychotherapy (IPT), an empirically supported, depression-focused therapy, and the selective serotonin reuptake inhibitor citalopram, alone or in combination, in the treatment of major depression in CAD patients. Methods: Two hundred eighty stable CAD patients with a current major depressive episode of at least 4 weeks’ duration, based on the Structured Clinical Interview for Depression (SCID), and who have a baseline score >19 on a centralized, telephone-administered, 24-item Hamilton Depression Rating Scale (HAM-D) will be randomly assigned to receive 12 weekly IPT sessions or 12 weekly sessions of standardized clinical management (CM). Patients are also randomly assigned to receive 20 to 40 mg per day of citalopram or pill-placebo. This results in a 2-by-2 factorial design with four groups: IPT plus pill-placebo, IPT plus citalopram, CM plus pill-placebo, and CM plus citalopram. This permits the evaluation of both IPT and citalopram. Blinded, centralized, 24-item, HAM-D telephone ratings constitute the primary outcome variable. The self-report Beck Depression Inventory-II is the secondary outcome. Analyses will involve the intent-to-treat principle with last observation carried forward for incomplete assessments. Results: Not applicable. Conclusions: The results of this trial will contribute to the development of evidence-based clinical guidelines for managing depression in the context of CAD. CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy; IPT = interpersonal psychotherapy; CAD = coronary artery disease; SCID = Structured Clinical Interview for Depression; HAM-D = Hamilton Depression Rating Scale; CM = clinical management; SADHART = Sertraline Antidepressant Heart Attack Randomized Trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease; SSRI = selective serotonin reuptake inhibitor; ECG = electrocardiogram; NIMH = National Institute of Mental Health; TDCRP = Treatment of Depression Collaborative Research Program; MMSE = Mini-mental Status Exam; STAR*D = Sequenced Treatment Alternatives to Relieve Depression; IDS = Inventory for Depressive Symptomatology; BDI-II = Beck Depression Inventory-II; IPRI = Interpersonal Relationship Inventory; FPI = Functional Performance Inventory; SAE = serious adverse event; LOCF = last observation carried forward; DSMB = data safety monitoring board.

Neural and Hypotensive Effects of Angiotensin II Receptor Blockade

Angiotensin II participates in the neural regulation of the heart and circulation at both central and peripheral sites. To explore the role of endogenous angiotensin II in blood pressure regulation, we conducted a randomized double-blind crossover trial in nine young healthy men (aged 33+/-3 [mean+/-SE] years) studied in the absence of salt restriction, comparing the effect of 1 week treatment with the angiotensin II receptor antagonist losartan (100 mg daily) against placebo with respect to the following variables, recorded during supine rest: intra-arterial blood pressure (BP), heart rate (HR), forearm vascular resistance and norepinephrine appearance rate, total body norepinephrine spillover, variability of BP and HR (spectral analysis), and baroreflex sensitivity for HR (gain of the transfer function from systolic BP to HR). Blood pressure was 119+/-7/66+/-4 mm Hg (systolic BP/diastolic BP) after 1 week of placebo and 112+/-6/61+/-3 mm Hg after 1 week of losartan (P<.05). Forearm vascular resistance tended to fall, from 42.3+/-6.9 U on placebo to 32.8+/-5.0 U with losartan treatment (P=.07). Losartan had no effect on HR (60+/-3 on placebo versus 59+/-2 beats per minute with losartan), total body norepinephrine spillover (3.0+/-0.8 versus 3.3+/-1.2 nmol/min), forearm norepinephrine appearance rate (3.8+/-1.1 versus 5.3+/-1.1 pmol/100 mL forearm tissue per minute), power in the high- or low-frequency components of the HR variability and BP variability spectra or on baroreflex sensitivity for HR. Endogenous angiotensin II contributes to the maintenance of supine BP in normal subjects, studied in the absence of sodium restriction. The fall in BP caused by losartan is accompanied by a resetting of the baroreflex regulation of HR and sympathetic outflow, but baroreflex sensitivity for heart rate is not altered. Therefore, the reduction in BP observed after short-term angiotensin type 1 receptor antagonism may be achieved through a direct effect on vascular tone rather than through a primary reduction in sympathetic outflow.

A prospective, controlled multisite study of psychosocial and behavioral change following women's cardiac rehabilitation participation.

BACKGROUND Despite its proven benefits and need, women are significantly less likely than men to participate in and complete cardiac rehabilitation (CR). Thus, there are few reports of CR outcomes among women, particularly when compared with women who do not participate in CR. The purpose of this study was to prospectively assess psychosocial and behavioral changes, comparing women who participated in CR with those who did not. METHODS One hundred fifty-seven female cardiac inpatients from three hospitals consented to participate in a prospective study, and 110 (79%) were retained 18 months postdischarge. A mailed survey discerned CR participation 9 months postdischarge. Quality of life (Short-Form Health Survey Physical and Mental Component Summary [SF-12 PCS and MCS]), exercise behavior (Health-Promoting Lifestyle Profile II [HPLPII]), Exercise Benefits and Barriers Scale (EBBS), and anxiety and depressive symptoms (Hospital Anxiety and Depression Scale [HADS]) were assessed in hospital and 18 months postdischarge. RESULTS Fifty-one (45.1%) women self-reported participating in CR at 1 of 18 sites, and site-verified participation was 82.43% +/- 29.97% of prescribed sessions. For CR participants, paired t tests assessing change from hospitalization to 18 months postdischarge revealed significant improvements in physical quality of life (p < 0.001), anxiety (p < 0.05), and exercise behavior (p = 0.01). Women who did not participate in CR experienced significant improvements in physical quality of life (p = 0.02), and depressive symptoms (p = 0.03) but not exercise behavior. CONCLUSIONS Following a cardiac event, female patients improved their physical quality of life and affect, but only patients who participated in CR increased their exercise behavior. Given the cardiac benefits of exercise and that women are often sedentary and given that this exercise behavior was sustained post-CR, these findings are significant. Randomized controlled trials of womens CR outcomes are needed.

Cardiovascular Health and Aromatase Inhibitors

Cardiovascular disease is the most frequent cause of death in North American women, and so death resulting from cardiovascular disease, rather than from malignancy, is not uncommon in breast cancer patients. This may be a consequence of the shared risk factors for developing breast cancer and cardiovascular disease, as well as the difficulty of managing cancer patients at higher risk for developing cardiovascular disease. Recently, much attention has focused on understanding the cardiovascular risk factors associated with breast cancer therapies. Tamoxifen has a lowering effect on serum lipids and is reported to decrease the risk of myocardial infarction but to increase the risk of thromboembolic events. Current data indicate that aromatase inhibitors (AIs) are not associated with an increased risk of thromboembolic or cerebrovascular events. Reports of a greater incidence of hypercholesterolaemia when AIs are compared head-to-head with tamoxifen may be a result of the intrinsic lipid-lowering effects of tamoxifen therapy and may be confounded by differences in data collection among trials. The incidence of cardiovascular events associated with AIs in large trials has been reported to be higher in trials comparing AIs with tamoxifen; comparisons within the MA.17 trial, which evaluated an AI versus placebo, did not show increases in hypercholesterolaemia or in cardiovascular events with the AI.When treating breast cancer patients, oncologists should consider the same positive lifestyle changes that are proposed to lower the risk of cardiovascular disease in patients who do not have breast cancer. Moreover, physicians should assess cardiovascular risk, and monitor and treat patients already diagnosed with or at risk for coronary heart disease, according to established guidelines.

Patient-Provider Communication Regarding Referral to Cardiac Rehabilitation

&NA; This study investigated the dynamics of patient‐provider communication in the cardiac rehabilitation (CR) referral process, to identify which aspects lead to CR participation. Semi‐structured individual interviews were conducted with 31 patients eligible for CR. Questions probed the content and perception of the discussion that patients had with healthcare providers (HCP) regarding CR attendance. The interviews were audiotaped, transcribed, and imported into N6 software for grounded analyses. Key emerging themes were identified: illness perceptions; HCP encouragement; timing of discussion; and ease of referral. CR attenders were apt to self‐advocate to ensure their enrollment in CR, whereas nonattenders were more likely to minimize the seriousness of their disease, and less likely to persevere to overcome obstacles in enrolling in a CR program. Surprisingly, the strength of the HCP referral did not influence the decision to attend CR as strongly when compared to the HCPs ability to facilitate enrollment in a CR program

Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial

Introduction Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives. Methods and analysis Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives. Ethics and dissemination This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012. Trial registration number This study is registered with http://clinicaltrials.gov (NCT00825526).