Wednesday, November 7, 2012

Ultrafiltration vs. Diuretics for Cardiorenal Syndrome

Ultrafiltration in Decompensated Heart Failure with Cardiorenal Syndrome
Bradley Bart et al. NEJM Online (Nov 7, 2012)
Editorial on this article NEJM Online (Nov 7, 2012)

Background
Ultrafiltration is an alternative strategy to diuretic therapy for the treatment of patients with acute decompensated heart failure. Little is known about the efficacy and safety of ultrafiltration in patients with acute decompensated heart failure complicated by persistent congestion and worsened renal function.

Methods
We randomly assigned a total of 188 patients with acute decompensated heart failure, worsened renal function, and persistent congestion to a strategy of stepped pharmacologic therapy (94 patients) or ultrafiltration (94 patients). The primary end point was the bivariate change from baseline in the serum creatinine level and body weight, as assessed 96 hours after random assignment. Patients were followed for 60 days.

Results

Ultrafiltration was inferior to pharmacologic therapy with respect to the bivariate end point of the change in the serum creatinine level and body weight 96 hours after enrollment (P=0.003), owing primarily to an increase in the creatinine level in the ultrafiltration group. At 96 hours, the mean change in the creatinine level was −0.04±0.53 mg per deciliter (−3.5±46.9 μmol per liter) in the pharmacologic-therapy group, as compared with +0.23±0.70 mg per deciliter (20.3±61.9 μmol per liter) in the ultrafiltration group (P=0.003). There was no significant difference in weight loss 96 hours after enrollment between patients in the pharmacologic-therapy group and those in the ultrafiltration group (a loss of 5.5±5.1 kg [12.1±11.3 lb] and 5.7±3.9 kg [12.6±8.5 lb], respectively; P=0.58). A higher percentage of patients in the ultrafiltration group than in the pharmacologic-therapy group had a serious adverse event (72% vs. 57%, P=0.03).

Conclusions
In a randomized trial involving patients hospitalized for acute decompensated heart failure, worsened renal function, and persistent congestion, the use of a stepped pharmacologic-therapy algorithm was superior to a strategy of ultrafiltration for the preservation of renal function at 96 hours, with a similar amount of weight loss with the two approaches. Ultrafiltration was associated with a higher rate of adverse events. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00608491.)

Tuesday, November 6, 2012

Obesity: Role of Government & Policy

Circulation 2012;126:2345

Obesity : Role of Policy and Government in the Obesity Epidemic

Nicole L. Novak, MSc; Kelly D. Brownell, PhD


From the Rudd Center for Food Policy and Obesity, Department of Psychology, Department of Epidemiology and Public Health, Yale University, New Haven, CT.

(Click on image to enlarge)


Correspondence to Nicole L. Novak, Rudd Center for Food Policy and Obesity, 309 Edwards St, New Haven, CT 06511. E-mail nicole.l.novak@gmail.com.

In 2001, the Surgeon General's “Call to Action to Prevent and Decrease Overweight and Obesity”1 identified obesity as a key public health priority for the United States. Obesity rates were higher than ever, with 61% of adults nationwide overweight or obese. In the intervening years, several administrations have declared a commitment to deal with the problem, and the food industry has issued numerous pledges for change, yet the prevalence of overweight and obesity has risen further, to 68%.2 Children have been particularly affected; >19% of school-aged children were obese in 2007 to 2008 compared with just 6% in the late 1970s.3 Disease rates join high healthcare costs, so everyone is affected personally, economically, or both.4,5


A wide range of government policies and programs have been implemented, including the development of national clinical guidelines, nutrition labeling on packaged foods, education and social marketing efforts, and more recently, calorie labeling on restaurant menus and federal efforts to increase access and financing for fresh fruits and vegetables. However, most of these efforts focus on clinical and educational factors or on community interventions and, until recently, have rarely addressed environmental drivers of obesity. There is growing theoretical and scientific support for policies that intervene on environmental determinants of overeating. The implementation of some policies is facing resistance from the food and beverage industries.

Saturday, October 20, 2012

SVT prophylaxis in infants: Digoxin vs. Propranolol

Circ Arrhythm Electrophysiol. 2012 Oct 1;5(5):984-91. doi: 10.1161/CIRCEP.112.972620. Epub 2012 Sep 8.


The Study of Antiarrhythmic Medications in Infancy (SAMIS): A Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Digoxin Versus Propranolol for Prophylaxis of Supraventricular Tachycardia in Infants.

Sanatani S, Potts JE, Reed JH, Saul JP, Stephenson EA, Gibbs KA, Anderson CC, Mackie AS, Ro PS, Tisma-Dupanovic S, Kanter RJ, Batra AS, Fournier A, Blaufox AD, Singh HR, Ross BA, Wong KK, Bar-Cohen Y, McCrindle BW, Etheridge SP.

Background- Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.

Methods and Results- A randomized, double-blind, multicenter study of infants <4 atrioventricular="atrioventricular" comparing="comparing" digoxin="digoxin" excluding="excluding" months="months" nodal="nodal" or="or" propranolol.="propranolol." reciprocating="reciprocating" reentrant="reentrant" svt="svt" tachycardia="tachycardia" with="with" wolff-parkinson-white="wolff-parkinson-white">The primary end point was recurrence of SVT requiring medical intervention.
Time to recurrence and adverse events were secondary outcomes.
Sixty-one patients completed the study, 27 randomized to digoxin and 34 to propranolol.
SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25).
No first recurrence occurred after 110 days of treatment.
The 6-month recurrence-free status was 79% for patients on digoxin and 67% for patients on propranolol (P=0.34), and there were no first recurrences in either group between 6 and 12 months. There were no deaths and no serious adverse events related to study medication.

Conclusions- There was no difference in SVT recurrence in infants treated with digoxin versus propranolol. The current standard practice may be treating infants longer than required and indicates the need for a placebo-controlled trial.
Clinical Trial Registration Information- http://clinicaltrials.gov; NCT-00390546.



Sunday, October 14, 2012

Balloon Pulmonary Valvuloplasty - Safety & Efficacy

Catheter Cardiovasc Interv. 2012 Oct 1;80(4):663-72.

Safety and efficacy of balloon pulmonary valvuloplasty: A Multicenter Experience.

Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L.

METHODS: Prospective data collection. C3PO Registry. Cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV.


RESULTS:
211 cases were included (45%, Less than 1 month old).

Procedural success was achieved in 91% procedures, being defined as one of the following:
   (i) post-BPV peak systolic valvar gradient to < 25 mm Hg (88%),
   (ii) decrease in gradient by 50% (79%), or
   (iii) reduction of RV/systemic pressure ratio by 50% (45%).

Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03).

Procedure failure - Risk factors included (i) moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and (ii) presence of supravalve PS (OR 9.6, CI 2.7-33.8).

Adverse events:
Low severity AEs (levels 1-2) occurred in 9% of patients.
Higher severity AEs (levels 3-5) occurred in 3% of patient.
No deaths.
Risk factors for any AE (levels 1-5) were (i) age below 1 month (OR 3.5, CI 1.3-8.9) and (ii) operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).

CONCLUSIONS: Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.

© 2012 Wiley Periodicals Inc.

Tuesday, September 25, 2012

Articles on Single Ventricle Reconstruction Surgery from October 2012 issue of JTCVS


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Congenital Heart Disease

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Introduction to the Single Ventricle Reconstruction trial

Emile Bacha and Pedro del Nido

J Thorac Cardiovasc Surg 2012;144 880-881

http://jtcs.ctsnetjournals.org/cgi/content/extract/144/4/880?etoc





Risk factors for hospital morbidity and mortality after the Norwood

procedure: A report from the Pediatric Heart Network Single Ventricle

Reconstruction trial

Sarah Tabbutt, Nancy Ghanayem, Chitra Ravishankar, Lynn A. Sleeper, David

S. Cooper, Deborah U. Frank, Minmin Lu, Christian Pizarro, Peter Frommelt,

Caren S. Goldberg, Eric M. Graham, Catherine Dent Krawczeski, Wyman W. Lai,

Alan Lewis, Joel A. Kirsh, Lynn Mahony, Richard G. Ohye, Janet Simsic,

Andrew J. Lodge, Ellen Spurrier, Mario Stylianou, Peter Laussen Pediatric

Heart Network Investigators

J Thorac Cardiovasc Surg 2012;144 882-895

http://jtcs.ctsnetjournals.org/cgi/content/abstract/144/4/882?etoc





Interstage mortality after the Norwood procedure: Results of the

multicenter Single Ventricle Reconstruction trial

Nancy S. Ghanayem, Kerstin R. Allen, Sarah Tabbutt, Andrew M. Atz, Martha

L. Clabby, David S. Cooper, Pirooz Eghtesady, Peter C. Frommelt, Peter J.

Gruber, Kevin D. Hill, Jonathan R. Kaltman, Peter C. Laussen, Alan B.

Lewis, Karen J. Lurito, L. LuAnn Minich, Richard G. Ohye, Julie V.

Schonbeck, Steven M. Schwartz, Rakesh K. Singh, Caren S. Goldberg

Pediatric Heart Network Investigators

J Thorac Cardiovasc Surg 2012;144 896-906

http://jtcs.ctsnetjournals.org/cgi/content/abstract/144/4/896?etoc





Cause, timing, and location of death in the Single Ventricle Reconstruction

trial

Richard G. Ohye, Julie V. Schonbeck, Pirooz Eghtesady, Peter C. Laussen,

Christian Pizarro, Peter Shrader, Deborah U. Frank, Eric M. Graham, Kevin

D. Hill, Jeffrey P. Jacobs, Kirk R. Kanter, Joel A. Kirsh, Linda M.

Lambert, Alan B. Lewis, Chitra Ravishankar, James S. Tweddell, Ismee A.

Williams, Gail D. Pearson Pediatric Heart Network Investigators

J Thorac Cardiovasc Surg 2012;144 907-914

http://jtcs.ctsnetjournals.org/cgi/content/abstract/144/4/907?etoc





Variation in perioperative care across centers for infants undergoing the

Norwood procedure

Sara K. Pasquali, Richard G. Ohye, Minmin Lu, Jonathan Kaltman, Christopher

A. Caldarone, Christian Pizarro, Carolyn Dunbar-Masterson, J. William

Gaynor, Jeffrey P. Jacobs, Aditya K. Kaza, Jane Newburger, John F. Rhodes,

Mark Scheurer, Eric Silver, Lynn A. Sleeper, Sarah Tabbutt, James Tweddell,

Karen Uzark, Winfield Wells, William T. Mahle, Gail D. Pearson Pediatric

Heart Network Investigators

J Thorac Cardiovasc Surg 2012;144 915-921

http://jtcs.ctsnetjournals.org/cgi/content/abstract/144/4/915?etoc

Wednesday, August 8, 2012

Guidelines: Cardiovascular Risk Reduction in Children

Link to free full text (Pediatrics 2011;128(Suppl 5):S213-S256).

Extensive data on evidence of risk and comprehensive review of current treatment options for children.