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Cardiac device deactivation rarely mentioned in advanced directives

13 Apr, 14 | by Alistair Lindsay

The authors retrospectively reviewed medical records of 150 patients who underwent deactivation of a pacemaker or implantable cardioverter-defibrillator in a four-year period at a single tertiary care center. These were older patients (median age 79) and 99% had a poor or terminal prognosis. More than half of the patients had an advance directive, yet only 1 patient explicitly mentioned device deactivation in their advanced directive. Surrogates for the patient made more than half of the requests for device deactivation (51%). Median survival after device deactivation was 2 days (IQR 0-483).

Conclusion

The intersection of implantable cardiac devices and end-of-life care is certain to become more frequent.  The current study highlights an important gap in addressing these devices as part of advance directives and end-of-life planning, leaving surrogates frequently burdened with the decision of device deactivation.

Summarized by Steven M. Bradley and Supriya Shore

  • Buchhalter LC, Ottenberg AL, Webster TL, et al. Features and outcomes of patients who underwent cardiac device deactivation. JAMA Intern Med. 2014 Jan;174(1):80-5.

Coronary artery calcium density is inversely associated with coronary risk

13 Apr, 14 | by Alistair Lindsay

 

Coronary calcium is associated with cardiovascular disease risk.  However, it may not only be the volume, but the density of coronary calcium that influences risk as more dense calcium may reflect stable plaque at lower risk of inciting coronary events.  The traditional Agatson method of scoring coronary calcium burden does not consider coronary calcium volume and density independently. In this prospective cohort study of 3,398 adults without known cardiovascular disease, the authors examined the predictive value of adding coronary calcium density to Agatston volume scores for cardiovascular disease risk. Over a median follow-up of more than 7 years, there were 265 cardiovascular events in the study population and the Agatston volume score of coronary calcium was positively associated with cardiovascular disease risk. However, the density score was inversely associated with cardiovascular disease risk. Furthermore, the addition of the density score improved a risk prediction model for cardiovascular disease.

 Conclusion

Coronary density appears to refine cardiovascular disease risk estimation using coronary calcium scoring, with more dense calcium reflecting stable plaques at lower risk.

  •  Criqui MH, Denenberg JO, Ix JH, et al. Calcium density of coronary artery plaque and risk of incident cardiovascular events. JAMA. 2014 Jan 15;311(3):271-8.

Mesenchymal stem cells may improve quality of life for patients with ischemic cardiomyopathy

13 Apr, 14 | by Alistair Lindsay

In this study, patients with chronic ischemic cardiomyopathy and EF <50% on optimal medical therapy were randomized to autologous culture expanded mesenchymal cells (=22), autologous bone marrow mononuclear cells (n=22) or placebo vehicle (n=21) delivered by transendocardial stem cell injection (TESI). There were no serious adverse events among any patients undergoing a TESI procedure. Rates of major adverse cardiovascular events did not vary between groups. A possible signal of improved quality of life was observed following treatment with either of the cell types.  At one year, a repeated measures model demonstrated the Minnesota Living with Heart Failure score had improved following treatment with mesenchymal (-6.3; 95% CI -15.0 to 2.4, P=.02) or bone marrow cells (-8.2; 95% CI -17.4 to 0.97, P=.005) but not in the placebo group (0.4; 95% CI -9.45 to 10.25, P=.38). Only mesenchymal cells decreased scar size as a percentage of the LV mass (-18.9%; 95% CI  -30.4 to -7.4, P=.004).

Conclusion

Transendocardial injection of both mesenchymal and bone marrow cells for ischemic cardiomyopathy was safe in this small initial trial.  Signals of quality of life improvement with these therapies are encouraging.  However, this enthusiasm must be tempered against a change in quality of life scores that is at the low end of clinical significance and the performance of multiple comparisons in the study analysis.

Summarized by Steven M. Bradley and Supriya Shore

  • Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014;311(1):62-73.

Pre-hospital cooling with saline infusion does not improve cardiac arrest outcomes

13 Apr, 14 | by Alistair Lindsay

Prior randomized trials have established hypothermia as a promising therapy to improve outcomes of cardiac arrest.  It has been suggested that the benefit of hypothermia may be increased through early initiation of cooling in the field prior to hospital arrival.  In this trial, 1,364 patients with out-of-hospital cardiac arrest were randomized to usual care or pre-hospital cooling with infusion of cold normal saline immediately after return of spontaneous circulation. The intervention was associated with a reduction in core temperature, but no change in clinical outcomes. Among patients with arrest in the setting of ventricular fibrillation, there were no differences between patients treated with cold saline vs control in survival to discharge (62.7% vs. 64.3%, P.69) or neurologic recovery (57.5% vs. 61.9%, P=.69). Similarly, among patients without ventricular fibrillation, the proportion of patients surviving to discharge (19.2% vs 16.3%, P=.30) or with neurological recovery (14.4% vs. 13.4%, P=.30) did not differ between the intervention and control groups.

Conclusions

In this randomized trial of pre-hospital cooling of patients with out-of-hospital cardiac arrest, this therapy resulted in no improvements in clinical outcomes despite more rapid reduction of core temperature.  As the method of achieving reductions in core temperature may influence the benefit of this therapy, alternate approaches to cooling that do not result in expansion of patient intravascular volume should be considered.

 Summarized by Steven M. Bradley and Supriya Shore

  • Kim F, Nichol G, Maynard C, et al. Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial. JAMA. 2014 Jan 1;311(1):45-52.

Multivitamins of no benefit for secondary prevention

13 Apr, 14 | by Alistair Lindsay

A healthy diet that includes foods rich in antioxidants and vitamins has consistently been associated with lower risk of atherosclerosis.  Whether secondary risk reduction can be achieved with oral vitamin supplementation is unclear.  The TACT (Trial to Assess Chelation Therapy) study was a 2×2 factorial design randomized trial to assess the impact of chelation therapy or multivitamin supplementation on cardiovascular outcomes among patients with a history of cardiovascular disease.  This study reports the outcomes of the multivitamin supplementation compared with placebo.  The primary endpoint was composite of death from any cause, reinfarction, stroke, coronary revascularization, or hospitalization for angina.  The pre-specified secondary endpoint was the composite of cardiovascular death, reinfarction, or stroke.  Patients were intended to take high dose oral multivitamins or placebo for 5 years, however the study suffered from significant drop out in both arms.  Of the 1708 patients randomized, only about 800 received the assigned treatment for more than 3 years.  The outcomes were assessed using intention-to-treat analysis, and showed no significant differences between groups for the primary or secondary end points. 

Conclusions

While the results of this study must be interpreted with caution due to the high drop-out rate and any signal of benefit (or harm) could be obscured. However, this study agrees with the growing literature that suggests no benefit of vitamin supplementation for secondary cardiovascular risk reduction.

 Summarized by Steven M. Bradley and Preston M. Schneider

  • Lamas GA, Boineau R, Goertz C, et al. Oral High-Dose Multivitamins and Minerals After Myocardial Infarction: A Randomized Trial. Annals of Internal Medicine. 2013;159(12):797–805. doi:10.7326/0003-4819-159-12-201312170-00004.

Stenting of atherosclerotic renal artery disease fails to improve outcomes

13 Apr, 14 | by Alistair Lindsay

Atherosclerotic renal-artery stenosis is common among patients with cardiovascular disease and the condition may contribute to hypertension. The impact of renal artery angioplasty or stenting on the risk of clinical events among patients with atherosclerotic renal disease remains poorly defined. In the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study, 947 patients atherosclerotic renal-artery stenosis and hypertension and/or chronic kidney disease were randomized to medical therapy alone or medical therapy plus renal artery stenting.  The primary composite end-point included cardiovascular and renal death, myocardial infarction, stroke and progressive renal failure.  Over a median follow-up of 43 months, there was no difference in the rate of the composite outcome in patients treated with renal artery stenting compared with medical therapy alone (35.1% vs. 35.8%,; hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58).  Further, individual components of the composite end-point were similar for both treatment groups.

Conclusions

In this large randomized trial, renal artery stenting for atherosclerotic stenosis failed to demonstrate clinical benefit.  These findings call into question a commonly performed, invasive, and costly procedure for patients with renal-artery atherosclerotic stenosis and suggest similar outcomes can be obtained with optimal medical management.

Summarized by Steven M. Bradley and Hussain Contractor

  • Cooper CJ1, Murphy TP, Cutlip DE, Jamerson K, Henrich W, Reid DM, Cohen DJ, Matsumoto AH, Steffes M, Jaff MR, Prince MR, Lewis EF, Tuttle KR, Shapiro JI, Rundback JH, Massaro JM, D’Agostino RB Sr and Dworkin LD.  Stenting and medical therapy for atherosclerotic renal-artery stenosis.  N Engl J Med. 2014 Jan 2;370(1):13-22.

No renal protection with low-dose dopamine or nesiritide in acute heart failure

13 Apr, 14 | by Alistair Lindsay

Diuresis to decongest patients with acute heart failure (AHF) is particularly challenging in the setting of renal dysfunction, as these patients are at risk of worsening renal function.  Small studies have suggested that low-dose dopamine or nesiritide may increase urine output and maintain renal function in such patients. The Renal Optimization Strategies Evaluation (ROSE) trial randomized 360 patients with AHF and renal dysfunction (GFR 15-60ml/min/1.73m2) to nesiritide, low-dose dopamine, or placebo in addition to an intravenous loop diuretic. Primary outcomes included urine volume and change in cystatin C at 72-hours post-randomization. Compared to placebo, patients randomized to low-dose dopamine had similar 72-hour urine volumes (8524mL vs. 8296mL, p=0.59) and cystatin C levels (0.12 vs. 0.11mg/L, p=0.72). In addition, there was no change in weight or creatinine at 72 hours. Similarly, patients randomized to low-dose nesiritide demonstrated no better 72-hour urine volumes (8574 mL vs. 8296 mL, p=0.49), cystatin C levels (0.07 vs. 0.11 mg/L, p=0.36), weight or creatinine.

Conclusion

These findings suggest neither low-dose dopamine nor nesiritide are effective as adjuvant renal therapies in patients with AHF and renal dysfunction. A therapy that allows for diuresis without angering the nephron remains elusive.

Summarized by Steven M. Bradley and Supriya Shore

 

Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, Bart BA, Bull DA, Stehlik J, LeWinter MM, Konstam MA, Huggins GS, Rouleau JL, O’Meara E, Tang WH, Starling RC, Butler J, Deswal A, Felker GM, O’Connor CM, Bonita RE, Margulies KB, Cappola TP, Ofili EO, Mann DL, Dávila-Román VG, McNulty SE, Borlaug BA, Velazquez EJ, Lee KL, Shah MR, Hernandez AF, Braunwald E, Redfield MM; NHLBI Heart Failure Clinical Research Network. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial. JAMA. 2013 Dec 18;310(23):2533-43. doi: 10.1001/jama.2013.282190.

Treatment of obstructive sleep apnea lowers blood pressure

13 Apr, 14 | by Alistair Lindsay

More than 70% of patients with resistant hypertension have obstructive sleep apnea (OSA). However, whether continuous positive airway pressure (CPAP) for OSA improves blood pressure in patients with resistant hypertension is unknown.  This was a randomized controlled trial of CPAP in 194 patients with resistant hypertension in the setting of OSA. The primary outcome was the change in 24-hour ambulatory mean blood pressure (AMBP) from baseline to 12 weeks post-randomization. Medical therapy used for resistant hypertension did not differ between the two groups. Patients treated with CPAP showed a greater decrease in 24-hour AMBP (3.1mmHg, 95% CI 0.6-5.6mmHg, p=.02). In analyses restricted to patients tolerant of CPAP, akin to an on-treatment analysis, the intervention resulted in a larger decrease in AMBP (4.4mmHg, 95% CI 1.8-7mmHg). Furthermore, each hour of CPAP use was associated with a 1.3 mmHg decrease in AMBP.

Conclusion

Among patients with OSA and resistant hypertension, CPAP therapy for 12 weeks resulted in improvements in 24-hour ambulatory blood pressure. The degree of blood pressure change was small, but could have meaningful effects on cardiovascular mortality.

 Summarized by Steven M. Bradley and Supriya Shore

  • Martínez-García MA, Capote F, Campos-Rodríguez F, Lloberes P, Díaz de Atauri MJ, Somoza M, Masa JF, González M, Sacristán L, Barbé F, Durán-Cantolla J, Aizpuru F, Mañas E, Barreiro B, Mosteiro M, Cebrián JJ, de la Peña M, García-Río F, Maimó A, Zapater J, Hernández C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15.

Pre-hospital Epinephrine for Witnessed Cardiac Arrest: Improved Outcomes?

13 Apr, 14 | by Alistair Lindsay

Epinepherine remains a common part of resuscitation care for cardiac arrest, despite a lack of clinical evidence to suggest it improves patient survival.  This study was a retrospective cohort of patients in Japan with witnessed out-of-hospital cardiac arrest.  From this cohort, 1990 matched pairs of patients with initial rhythm of ventricular tachycardia or ventricular fibrillation (VT/VF) and 9058 pairs with non-VT/VF were created on the basis of the propensity for administration of epinephrine by emergency medical services.  The outcome was survival and neurological status at one month or at discharge.  In the propensity matched analysis, epinephrine was associated with greater survival in patients with VF/VT (17.0% versus 13.4%; adjusted odds ratio [OR] 1.36, 95% confidence interval [CI] 1.13 – 1.63) and in patients with non-VF/VT arrest (4.0% versus 2.4%; adjusted OR 1.78, 95% CI 1.49 – 2.13).  The difference in neurologically intact survival was not significant for VF/VT (6.6% versus 6.6%) or non-VF/VT arrest (0.7% versus 0.4%; adjusted OR 1.55, 95% CI 0.99 – 2.41).

Conclusion

Administration of pre-hospital epinephrine for witnessed cardiac arrest is associated with increased overall survival in this propensity matched observational study.  However, given the lack of association with neurologically intact survival, questions remain as to whether epinephrine improves outcomes that are desired by patients.  Randomized study of this important question is warranted.

 Summarized by Steven M. Bradley and Preston M. Schneider

  • Nakahara S, Tomio J, Takahashi H, et al. Evaluation of pre-hospital administration of adrenaline (epinephrine) by emergency medical services for patients with out of hospital cardiac arrest in Japan: controlled propensity matched retrospective cohort study. BMJ. 2013;347.

Sudden increase in LVAD thrombosis rates

13 Apr, 14 | by Alistair Lindsay

The left ventricular assist device (LVAD) has rapidly been incorporated into the management of patients with advanced heart failure.  In response to an internal audit demonstrating a rapid increase in the incidence of pump thrombosis following implantation of HeartMate II LVADs, the authors pooled data from additional centers to investigate this trend.  The resultant retrospective analysis of 895 HeartMate II LVADs implanted in 837 patients identified 72 confirmed pump thrombosis in 66 patients and an additional 36 suspected thrombosis. Starting in the spring of 2011, the incidence of thrombosis at 3 months from implant rose from 2.2% to 8.4% by early 2013.  Levels of LDH and in particular a doubling in levels in the previous week were highly predictive of thrombosis.  Thrombosis was associated with substantial morbidity and mortality with 11 patients receiving urgent transplantation and a further 20 requiring pump replacement.  Mortality in those not undergoing a surgical procedure was 48.2% in the following 6 months. 

Conclusions

The incidence of thrombosis in the HeartMate II LVAD device has increased dramatically since early 2011 and is associated with substantial morbidity and mortality.  Of note, anticoagulation protocols changed during the course of this analysis, but continued inquiry is required to understand the underlying cause of these findings.  This study speaks to the importance of real-world surveillance of device therapies to continually ensure their optimal use and safety for patient benefit.

 Summarized by Steven M. Bradley and Hussain Contractor

  •  Starling RC, Moazami N, Silvestry SC, Ewald G, Rogers JG, Milano CA, Rame JE, Acker MA, Blackstone EH, Ehrlinger J, Thuita L, Mountis MM, Soltesz EG, Lytle BW, Smedira NG. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014 Jan 2;370(1):33-40.

 

 

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