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By Michael H. Crawford, MD, Editor
SYNOPSIS: In the PARADIGM-HF trial, signs of congestion during physical exam were related to outcomes and the improved outcomes observed with valsartan/sacubitril vs. enalapril.
SOURCES: Selvaraj S, Claggett B, Pozzi A, et al. Prognostic implications of congestion on physical examination among contemporary patients with heart failure and reduced ejection fraction: PARADIGM-HF. Circulation 2019;140:1369-1379.
Drazner MH, Stevenson LW. Relief and prevention of congestion in heart failure enhance quality and length of life. Circulation 2019;140:1380-1382.
In the modern bedside ultrasound and cardiac biomarker era, the value of the physical exam is unclear. Investigators from the PARADIGM-HF study of an angiotensin receptor-neprilysin inhibitor vs. an angiotensin-converting enzyme inhibitor for systolic heart failure assessed whether drug therapy influenced the physical exam and if changes in the physical exam were associated with quality of life and prognosis.
This was a study of patients with symptomatic heart failure (HF), a left ventricular ejection fraction (LVEF) < 40%, and a brain natriuretic peptide (BNP) level > 150 pg/mL (or > 100 pg/mL if they had been hospitalized for heart failure in the last 12 months). Exclusion criteria included hypotension, significant renal dysfunction, and elevated serum potassium. The physical exam parameters assessed at each visit were jugular venous distention (JVD), third heart sound (S3), rales, and edema. The primary outcome was a composite of cardiovascular death or first hospitalization for HF.
At baseline among the 8,380 patients randomized, 10% exhibited JVD, 14% edema, 10% S3, 8% rales, and 70% showed no signs of congestion. During follow-up, there was a significant graded relation between the number of signs of congestion and incidence rates for all outcomes. After multivariate adjustments, the hazard ratios for the primary endpoint for one, two, three, or four signs of congestion vs. no signs were 1.48, 1.74, 2.35, and 5.96, respectively (P < 0.001 for all).
Valsartan/sacubitril reduced the risk for the primary outcome regardless of the baseline physical exam, but signs of congestion decreased compared to enalapril during treatment (P = 0.011). Also, decreases in the number of signs of congestion was associated with improvement in the patients’ quality of life (QOL) score and changes in congestion-predicted outcomes after adjusting for baseline congestion (P < 0.001).
The authors concluded that in HF with reduced EF patients, the physical exam for congestion is an independent predictor of outcome, even when adjusted for symptoms and BNP levels. Also, improvements in congestion signs are independently associated with fewer cardiovascular events and improved QOL.
For many of us who frequently manage patients with HF, these results are not surprising, but I suspect they may be for trainees who seem enamored by biomarkers, bedside ultrasound, and implantable pulmonary artery pressure (PAP) monitors. However, studies of natriuretic peptides for management decisions in HF have not shown better outcomes, but increase the cost of care.
Also, in this study, the value of the physical exam was independent of BNP levels. PAP monitors have been shown to be useful, but higher costs, the need for a staffed central monitoring site, and the small but potentially serious risks of these devices has created limited enthusiasm for their use. Bedside ultrasound to examine the JV, the inferior vena cava, and lung water is gaining in popularity, but requires special training, equipment, and more time than the usual outpatient setting allows. On the other hand, trainees’ skills at performing a physical exam are waning.
Edema was the most common exam finding in this study, and I have found that trainees are fairly good at assessing edema. Pulmonary rales were least common, but I have found that trainees also are good at detecting rales. One could argue that the routine chest X-ray also is a good pulmonary venous congestion detection tool. However, it is not viable to use X-rays for every outpatient visit. JVD and S3 were equally prevalent findings and are the most challenging for trainees. Hearing an S3 often requires positioning the patient in the left lateral decubitus position and a stethoscope with a true bell. Most of the internal medicine trainees and medical students I encounter do not own stethoscopes with bells. Detecting JVD can be challenging in obese subjects, and bedside ultrasound may be especially useful in such patients.
This study did not standardize the exam, but still found it to be an independent predictor of outcomes and QOL, the accuracy of which was not related to body mass index. In this study, no confirmatory tests for congestion were performed. Also, physical exam findings could have influenced the decision to admit a patient, but when this was corrected, the relationship to outcomes persisted. Finally, in the TOPCAT trial of patients with HF and preserved EF treated with an aldosterone antagonist, the robust value of the physical exam also was demonstrated.1 Although the term “congestive heart failure” has fallen out of favor, the importance of congestion has not. In the current patient-centered care era, it is worth noting that a reduction in congestion improves QOL. In fact, eliminating just one sign of congestion in this study significantly improved QOL. Also, reducing congestion improves outcomes. Thus, we should all maintain our physical exam skills and teach them to our trainees. They are an inexpensive and effective way to evaluate the effect of therapy on inpatients and outpatients with HF of all types.
Financial Disclosure: Clinical Cardiology Alert’s Physician Editor Michael H. Crawford, MD, Peer Reviewer Susan Zhao, MD, Nurse Planner Aurelia Macabasco-O’Connell, PhD, ACNP-BC, RN, PHN, FAHA, Editor Jonathan Springston, Editor Jason Schneider, Editorial Group Manager Leslie Coplin, and Accreditations Manager Amy M. Johnson, MSN, RN, CPN, report no financial relationships relevant to this field of study.