Month: March 2014

Antibiotics Linked to Increased Risks for Arrhythmia and Mortality

Azithromycin use has been associated with increased risk of death among patients at high baseline risk, but not for younger and middle-aged adults. The Food and Drug Administration issued a public warning on azithromycin, including a statement that the risks were similar for levofloxacin. Researchers conducted a retrospective cohort study among US veterans to test the hypothesis that taking azithromycin or levofloxacin would increase the risk of cardiovascular death and cardiac arrhythmia compared with persons taking amoxicillin.

Azithromycin and levofloxacin carry higher arrhythmia and mortality risks than amoxicillin, according to an observational study in the Annals of Family Medicine. The FDA issued a cardiac warning on azithromycin in March 2013.  Researchers studied nearly 1.8 million U.S. veterans (mean age, 57) who received outpatient prescriptions for one of the three antibiotics from 1999 to 2012.    On weighted analysis, the numbers of deaths by day 5 of treatment per million antibiotics dispensed were 154 for amoxicillin, 228 for azithromycin, and 384 for levofloxacin.  Patients receiving azithromycin had roughly a 50% increased risk for death and an 80% increased risk for serious arrhythmia, compared with those on amoxicillin. Risk increases were even greater for levofloxacin.

The researchers conclude: “There are usually multiple antibiotic choices available for older patients, especially those with cardiac comorbidities; physicians may consider prescribing medications other than azithromycin and levofloxacin.”

New (2014) AHA/ACC Guideline for Management of Valvular Heart Disease

New, 2014 AHA/ACC, Guideline   for the Management of Patients With Valvular Heart Disease: has been   released.  This document is   a major revision of the 2006 and 2008 American College of Cardiology   (ACC)/American Heart Association (AHA) guidelines on the management of   patients with valvular heart disease. There are substantial changes in   multiple areas, and practitioners who are involved in the care of patients   with heart valve disease should read at least the executive summary, if not   the full guideline document.

The following are 10 areas with important changes to remember:

1. Stages of heart valve disease. The revised guidelines include a new classification of heart valve diseases with four progressive stages: A, at risk; B, progressive; C, asymptomatic severe; and D, symptomatic severe. For each valve lesion, stages are based on valve anatomy, valve hemodynamics, hemodynamic consequences, and symptoms.

2. The heart valve team. The guidelines recommend (Class I) that the management of patients with severe heart valve disease is best achieved by a heart valve team, composed minimally of a cardiologist and a cardiac surgeon; but potentially including cardiologists, structural valve interventionalists, cardiovascular imaging specialists, cardiovascular surgeons, anesthesiologists, and nurses, all of whom have expertise in the management and outcome of patients with severe heart valve disease.

3. Heart valve centers of excellence. The guidelines recommend (Class IIa) that consultation with or referral to a heart valve center of excellence is reasonable for asymptomatic patients with severe valve disease, patients with disease that could be best treated with valve repair rather than replacement, and patients with multiple comorbidities in whom valve intervention is considered. Specific criteria for a heart valve center of excellence include experienced providers from multiple disciplines, an ability to offer all available options for diagnosis and management, participation in regional or national outcome registries, demonstrated adherence to guidelines, ongoing quality improvement processes, and public reporting of intervention mortality and success rates.

4. Evaluation of surgical and interventional risk. The guidelines provide specific recommendations for the assessment of surgical and interventional risks that include the Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) calculator, patient frailty (e.g., Katz Activities of Daily Living and independence), the number of compromised major organ systems, and procedure-specific impediments.

5. Exercise testing. The guidelines place increased emphasis (Class IIa) on the use of exercise testing in the evaluation of asymptomatic patients with severe heart valve disease (notably including asymptomatic severe aortic stenosis [AS] and asymptomatic severe primary mitral regurgitation [MR]); aimed at confirmation of the absence of symptoms, assessment of the hemodynamic response to exercise, and assessment of prognosis.

6. Aortic stenosis. Changes were made in the characterization of and indications for intervention for AS:

  • Two important changes were made in the characterization of AS:

i)    ‘very severe’ AS is defined as aortic Vmax ≥5 m/s or mean gradient ≥60 mm Hg; and

ii)   symptomatic severe AS is subdivided into high gradient (Vmax ≥4 m/s or mean gradient ≥40 mm Hg), low-flow low-gradient (LFLG) with reduced left ventricular ejection fraction (LVEF) (severe leaflet calcification with severely reduced motion, effective orifice area [EOA] ≤1.0 cm2, and Vmax <4 m/s or gradient <40 mm Hg with LVEF <50%, and EOA remaining ≤1.0 cm2, but Vmax ≥4 m/s at any flow rate during dobutamine echocardiography), and LFLG with normal LVEF (or paradoxical LFLG severe AS; severe leaflet calcification with severely reduced motion, EOA ≤1.0 cm2 and Vmax <4 m/s or gradient <40 mm Hg with LVEF ≥50%).

  • Indications for intervention are expanded from previous to include patients with very severe AS (above) and low surgical risk (Class IIa); asymptomatic severe AS and decreased exercise tolerance or exercise-related decrease in blood pressure (Class IIa); and symptomatic  patients with LFLG severe AS and normal LVEF if clinical, hemodynamic, and  anatomic data support valve obstruction as the likely cause of symptoms      (Class IIa).

7. Transcatheter aortic valve replacement. Surgical aortic valve replacement (AVR) remains the intervention of choice for patients with an indication for AVR and low or intermediate operative risk (Class I). Transcatheter AVR (TAVR) is recommended for patients with an indication for AVR, but a prohibitive surgical risk (Class I). TAVR is a reasonable alternative to surgical AVR in patients with an indication for AVR and high surgical risk (Class IIa). Notably, members of a heart valve team should collaborate in order to optimize patient care for patients in whom TAVR or high-risk surgical AVR are being considered (Class I).

8. Management of primary MR. A clear distinction is drawn between chronic primary (degenerative) MR, with pathology of one or more components of the valve (leaflets, annulus, chordae, papillary muscles); and chronic secondary (functional) MR. Intervention for severe chronic primary MR remains indicated (all Class I) for symptoms, LV dysfunction (LVEF ≤60% and/or systolic diameter ≥40 mm), and at the time of other cardiac surgical intervention. Changes in the recommendations for mitral valve repair (MVr) include the following:

  • MVr is recommended over mitral valve replacement (MVR) when pathology  is limited to the posterior leaflet (Class I);
  • MVr is recommended over MVR when pathology involves the anterior or both leaflets and a successful and durable repair can be accomplished (Class I);
  • ‘Prophylactic’ MVr (repair in an asymptomatic patient with preserved LV function) is reasonable when performed at a heart valve center of excellence and the likelihood of successful and durable repair without      residual MR is >95% and operative mortality risk is <1% (Class IIa);
  • MVr is reasonable in an asymptomatic patient with severe nonrheumatic MR and preserved LV function in the setting of new-onset atrial fibrillation or resting pulmonary artery systolic pressure >50 mm Hg (Class IIa); and
  • MVr may be considered in the setting of rheumatic mitral valve disease when surgery is indicated and either successful repair is likely or when long-term anticoagulation management appears unreliable (Class IIb). There      is a Class III (harm) indication for MVR in the setting of isolated disease involving less than half of the posterior mitral leaflet unless repair was attempted and was unsuccessful.
  • Finally, transcatheter MVr may be considered in severely symptomatic patients who have favorable anatomy and a reasonable life expectancy and a prohibitive surgical risk due to comorbidities, and remain severely      symptomatic despite optimal medical therapy (Class IIb).

9. Management of secondary MR. Chronic secondary (functional) MR occurs as a result of abnormalities of the LV, and has more differences than similarities with chronic primary MR (above). The treatment of chronic secondary MR involves treatment of the underlying cardiomyopathy (Class I) and cardiac resynchronization therapy if indicated (Class I). Intervention for chronic secondary MR is reasonable at the time of coronary artery bypass grafting or other cardiac surgery if MR is severe (Class IIa) and not unreasonable if MR is moderate (Class IIb). Surgical intervention performed primarily for chronic secondary MR remains limited to severely (New York Heart Association class III-IV) symptomatic patients with persistent symptoms despite optimal medical therapy for heart failure (Class IIb); new in these guidelines is acceptance of equivalence among these patients between MVR and MVr.

10. Low molecular weight heparin (LMWH) ‘bridging’ of patients with a mechanical heart valve prosthesis. Low LMWH ‘bridging’ is now considered to be appropriate (Class I) among patients with a mechanical valve at high risk of thrombosis when warfarin needs to be interrupted in the context of an invasive or surgical procedure (previously Class IIb).

 

Source: D.S. Bach, MD (Cardiosource)

 

Vitamin D deficiency Linked to Inflammation

An observational study published online on February 25, 2014 in the Journal of Clinical Endocrinology and Metabolism found that older, healthy individuals who were deficient in 25-hydroxy vitamin D (vitamin D) tended to have higher levels of biomarkers linked with CVD and inflammatory conditions such as multiple sclerosis and rheumatoid arthritis, in an observational study.

To investigate the link between vitamin-D status and markers of inflammation, the researchers analyzed data from 957 hypertensive participants in TUDA. The participants, with roughly equal numbers of men and women, had a mean age of 70.5 years.

Compared with individuals with sufficient serum levels of vitamin D (>75 nmol/L), those who were deficient (<25 nmol/L) had significantly higher levels of the inflammatory biomarkers IL-6 and CRP, and they were more likely to have CRP:IL-10 and IL-6:IL-10 ratios above 2, where IL-10 is an anti-inflammatory biomarker.

The results suggest that older adults with a deficiency in vitamin D may be at risk of having a more proinflammatory immune profile, which in itself may be a risk factor for development of acute or chronic cardiovascular disease, osteoporosis, and cognitive dysfunction.

This is the first study to demonstrate that vitamin-D status is linked with markers of inflammation in a population of independently living, older adults.

However, this is an observational study which may not provide much insight into the relationship between deficiency of vitamin D and chronic inflammation. The authors of this study expressed the urgent need for further studies to prove with certainty the serum level of vitamin-D that is optimal for immune function and the potential implications of increasing dietary recommendations for vitamin-D intake within the population.

The Vitamin D and Omega-3 Trial (VITAL), a randomized clinical trial of 20 000 men and women, which is looking at hard outcomes and expected to be completed in June 2016, should provide a clearer picture of the role for vitamin D and omega-3 supplements in reducing risk for development of cancer, heart disease and stroke.

 

Source: Laird E, McNulty H, Ward M. Vitamin D deficiency is associated with inflammation in older Irish adults. J Clin Endocrinol Metab 2014.

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