Cardiology

Harmon, D. M., K. M. Tecson, B. Lima, J. D. G. Collier, A. F. Shaikh, S. Still, R. D. Baxter, N. Lew, R. Thakur, J. Felius, S. A. Hall, G. V. Gonzalez-Stawinski and S. M. Joseph (2019). “Outcomes of Moderate-to-Severe Acute Kidney Injury following Left Ventricular Assist Device Implantation.” Cardiorenal Med 9(2): 100-107.

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BACKGROUND: Although acute kidney injury (AKI) is a common complication following cardiac surgery, less is known about the occurrence and consequences of moderate/severe AKI following left ventricular assist device (LVAD) implantation. METHODS: All patients who had an LVAD implanted at our center from 2008 to 2016 were reviewed to determine the incidence of, and risk factors for, moderate/severe (stage 2/3) AKI and to compare postoperative complications and mortality rates between those with and those without moderate/severe AKI. RESULTS: Of 246 patients, 68 (28%) developed moderate/severe AKI. A multivariable logistic regression comprising body mass index and prior sternotomy had fair predictive ability (area under the curve = 0.71). A 1-unit increase in body mass index increased the risk of moderate/severe AKI by 7% (odds ratio = 1.07; 95% confidence interval: 1.03-1.11); a prior sternotomy increased the risk more than 3-fold (odds ratio = 3.4; 95% confidence interval: 1.84-6.43). The group of patients with moderate/severe AKI had higher rates of respiratory failure and death than the group of patients with mild/no AKI. Patients with moderate/severe AKI were at 3.2 (95% confidence interval: 1.2-8.2) times the risk of 30-day mortality compared to those without. Even after adjusting for age and Interagency Registry for Mechanically Assisted Circulatory Support profile, those with moderate/severe AKI had 1.75 (95% confidence interval: 1.03-3.0) times the risk of 1-year mortality compared to those without. DISCUSSION: Risk-stratifying patients prior to LVAD placement in regard to AKI development may be a step toward improving surgical outcomes.

Dewan, P., R. Rorth, P. S. Jhund, L. Shen, V. Raparelli, M. C. Petrie, W. T. Abraham, A. S. Desai, K. Dickstein, L. Kober, U. M. Mogensen, M. Packer, J. L. Rouleau, S. D. Solomon, K. Swedberg, M. R. Zile and J. J. V. McMurray (2019). “Differential Impact of Heart Failure With Reduced Ejection Fraction on Men and Women.” J Am Coll Cardiol 73(1): 29-40.

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BACKGROUND: Heart failure (HF) trials initiated in the last century highlighted many differences between men and women. Of particular concern was undertreatment of women compared with men, but much has changed during the past 20 years. OBJECTIVES: This study sought to identify these changes, which may give a new perspective on the management of, and outcomes in, women with HF. METHODS: The study analyzed 12,058 men and 3,357 women enrolled in 2 large HF with reduced ejection fraction (HFrEF) trials with near identical inclusion and exclusion criteria and the same principal outcomes. Outcomes were adjusted for other prognostic variables including N-terminal pro-B-type natriuretic peptide. RESULTS: Women were older and more often obese than men were, had slightly higher systolic blood pressure and heart rate, and were less likely to have most comorbidities, except hypertension. Women had more symptoms and signs (e.g., pedal edema 23.4% vs 19.9%; p < 0.0001) and worse quality of life-median Kansas City Cardiomyopathy Questionnaire Clinical Summary Score 71.3 (interquartile range: 53.4 to 86.5) versus 81.3 (interquartile range: 65.1 to 92.7; p < 0.0001)-despite similar left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide. However, women had lower mortality (adjusted hazard ratio: 0.68; 95% confidence interval: 0.62 to 0.74; p < 0.001) and risk of HF hospitalization (hazard ratio: 0.80; 95% confidence interval: 0.72 to 0.89; p < 0.001). Diuretics and anticoagulants were underutilized in women. Device therapy was underused in both men and women, but more so in women (e.g., defibrillator 8.6% vs. 16.6%; p < 0.0001). CONCLUSIONS: Although women with HFrEF live longer than men, their additional years of life are of poorer quality, with greater self-reported psychological and physical disability. The explanation for this different sex-related experience of HFrEF is unknown as is whether physicians recognize it. Women continue to receive suboptimal treatment, compared with men, with no obvious explanation for this shortfall.

Dehmer, G. J., R. G. Brindis, D. M. Shahian and M. J. Mack (2019). “Challenges of Measuring and Assuring Quality for Transcatheter Aortic Valve Replacement.” J Am Coll Cardiol 73(3): 336-339.

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On July 25, 2018, the U.S. Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine whether there is sufficient scientific evidence to support specific procedure volume requirements for hospitals and heart team members to begin or maintain transcatheter aortic valve replacement (TAVR) programs. The meeting was organized for experts to make recommendations to CMS in anticipation of a new National Coverage Determination for TAVR to replace the original determination published in May 2012. MEDCAC panels do not make coverage determinations because that authority rests solely with CMS, but CMS considers their advice and the total body of information collected at the meeting. Three topics were common in many of the presentations, public comments, and deliberations of the committee: 1) the benefits, challenges and unintended consequences resulting from procedural volume requirements; 2) understanding the relationship between procedure volume and outcome; and 3) the challenge of measuring outcome when procedural volumes (sample sizes) are small. Assessing the overall ability of a center to treat aortic valve disease optimally involves not only TAVR but also surgical aortic valve replacement (SAVR) and, to a lesser extent, percutaneous coronary intervention (PCI). SAVR is the surgical alternative to TAVR and is occasionally required to deal with life-threatening TAVR complications. PCI is sometimes performed before TAVR or may be required on an emergency basis to correct a serious complication developing during TAVR. The relationship between TAVR and SAVR procedure volume, outcome, and quality is a specific example of the broader issue facing the U.S. health care system. As our health care system moves from one based on quantity and fee-for-service to one based more on quality and accountability for patients’ outcomes, determining what constitutes quality medical care and how to measure it will continue to increase in importance. (Excerpt from text, p. 337; abstract not available.)

Stone, G. W., J. Lindenfeld, W. T. Abraham, S. Kar, D. S. Lim, J. M. Mishell, B. Whisenant, P. A. Grayburn, M. Rinaldi, S. R. Kapadia, V. Rajagopal, I. J. Sarembock, A. Brieke, S. O. Marx, D. J. Cohen, N. J. Weissman and M. J. Mack (2018). “Transcatheter Mitral-Valve Repair in Patients with Heart Failure.” N Engl J Med 379(24): 2307-2318.

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BACKGROUND: Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes. METHODS: At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy. Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up. The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%. RESULTS: Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001). CONCLUSIONS: Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079 .).

Tran, H. V., N. A. Erskine, H. L. Nguyen, D. D. McManus, H. H. Awad, C. I. Kiefe and R. J. Goldberg (2019). “Increase in white blood cell count is associated with the development of atrial fibrillation after an acute coronary syndrome.” Int J Cardiol 274: 138-143.

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BACKGROUND: Evidence linking an elevated white blood cell count (WBCC), a marker of inflammation, to the development of atrial fibrillation (AF) after an acute coronary syndrome (ACS) is limited. We examined the association between WBCC at hospital admission, and changes in WBCC during hospitalization, with the development of new-onset AF during hospitalization for an ACS. METHODS: Development of AF was based on typical ECG changes in a systematic review of hospital medical records. Increase in WBCC was calculated as the difference between maximal WBCC during hospitalization and WBCC at hospital admission. Multiple logistic regression analysis was used to adjust for several potentially confounding demographic and clinical variables in examining the association between WBCC, and changes over time therein, with the occurrence of AF. RESULTS: The median age of study patients (n=1325) was 60years, 31.8% were women, and 80.1% were non-Hispanic whites. AF developed in 7.3% of patients with an ACS. Patients who developed AF, as compared with those who did not, had a similar WBCC at admission, but a greater increase in WBCC during hospitalization (6.0×10(9)cell/L vs. 2.7×10(9) cell/L, p<0.001). After adjusting for several potentially confounding factors, an increase in WBCC was associated with the development of AF. This association was observed in patients with different ACS subtypes, types of treatment received, and according to time of acute symptom onset. CONCLUSION: Increase in the WBCC during hospitalization for an ACS should be further studied as a potentially simple predictor for new-onset AF in these patients.