Patients at Heightened Risk for Early Demise Following CRT
Prediction Rule to Identify Patients at High Risk for Early Demise Following CRT
Background In patients with advanced heart failure, the decision of whether to pursue cardiac resynchronization therapy (CRT) or to proceed directly to advanced heart failure therapies can be challenging. We sought to create a prediction rule to identify patients with advanced systolic heart failure at heightened risk of rapid deterioration despite receiving CRT.
Methods Clinical data were collected on consecutive patients with advanced heart failure presenting for a new CRT device at the Cleveland Clinic between February 12, 2002 and July 8, 2008. Early demise was defined as death, left ventricular assist device, or heart transplant within 6 months following CRT implant. Using a multivariate model, variables associated with early demise were identified and a prediction rule created.
Results A total of 879 patients were included of whom 47 met criteria for early demise. Using forward stepwise regression followed by a bootstrapping analysis, the final model included: left ventricular end-diastolic diameter ≥6.5 cm (OR 3.23 [1.72–6.06 g], P < 0.001), the presence of a non-left bundle branch block (non-LBBB) morphology (OR 2.18 [1.18–4.04, P = 0.013]), creatinine ≥1.5 mg/dL (OR 2.98 [1.52–5.49], P < 0.001), and lack of or intolerance to β-blocker use (OR 2.80 [1.46–5.39], P = 0.002). The specificity for ≥2 and ≥3 risk factors was 72.6% and 94.6%, respectively.
Conclusions Left ventricular dilatation, the presence of a non-LBBB morphology, renal dysfunction, and lack of or intolerance to β-blockers are associated with early demise following CRT. In patients with at least 3 of these factors, bypassing CRT with early adoption of advanced heart failure therapies may be considered given the high specificity for rapid decline.
Heart failure remains a significant cause of morbidity and mortality in the Western world affecting nearly 6 million people in the United States alone. Over the last 15 years, invasive therapies including cardiac resynchronization therapy (CRT), heart transplantation, and the left ventricular assist device (LVAD) have revolutionized the treatment of advanced heart failure. According to current guidelines, candidates for heart transplantation or destination LVAD support should have progressive heart failure despite optimal medical and surgical therapies including CRT in appropriate candidates. Despite current appropriate use guidelines, however, nonresponse to CRT remains a significant problem with rates as high as 40–50%. Given this rate, it remains uncertain whether certain patients on optimal therapies with progressive advanced heart failure should bypass CRT and be directly listed for more advanced therapies. How to select patients in whom this may be the most optimal strategy is unclear. We sought to determine factors associated with rapid deterioration following CRT implant in patients with advanced heart failure in order to create a clinical prediction rule to aid physicians in determining the utility of a trial of CRT versus a strategy of bypassing CRT and listing for advanced heart failure therapies directly.
Abstract and Introduction
Abstract
Prediction Rule to Identify Patients at High Risk for Early Demise Following CRT
Background In patients with advanced heart failure, the decision of whether to pursue cardiac resynchronization therapy (CRT) or to proceed directly to advanced heart failure therapies can be challenging. We sought to create a prediction rule to identify patients with advanced systolic heart failure at heightened risk of rapid deterioration despite receiving CRT.
Methods Clinical data were collected on consecutive patients with advanced heart failure presenting for a new CRT device at the Cleveland Clinic between February 12, 2002 and July 8, 2008. Early demise was defined as death, left ventricular assist device, or heart transplant within 6 months following CRT implant. Using a multivariate model, variables associated with early demise were identified and a prediction rule created.
Results A total of 879 patients were included of whom 47 met criteria for early demise. Using forward stepwise regression followed by a bootstrapping analysis, the final model included: left ventricular end-diastolic diameter ≥6.5 cm (OR 3.23 [1.72–6.06 g], P < 0.001), the presence of a non-left bundle branch block (non-LBBB) morphology (OR 2.18 [1.18–4.04, P = 0.013]), creatinine ≥1.5 mg/dL (OR 2.98 [1.52–5.49], P < 0.001), and lack of or intolerance to β-blocker use (OR 2.80 [1.46–5.39], P = 0.002). The specificity for ≥2 and ≥3 risk factors was 72.6% and 94.6%, respectively.
Conclusions Left ventricular dilatation, the presence of a non-LBBB morphology, renal dysfunction, and lack of or intolerance to β-blockers are associated with early demise following CRT. In patients with at least 3 of these factors, bypassing CRT with early adoption of advanced heart failure therapies may be considered given the high specificity for rapid decline.
Introduction
Heart failure remains a significant cause of morbidity and mortality in the Western world affecting nearly 6 million people in the United States alone. Over the last 15 years, invasive therapies including cardiac resynchronization therapy (CRT), heart transplantation, and the left ventricular assist device (LVAD) have revolutionized the treatment of advanced heart failure. According to current guidelines, candidates for heart transplantation or destination LVAD support should have progressive heart failure despite optimal medical and surgical therapies including CRT in appropriate candidates. Despite current appropriate use guidelines, however, nonresponse to CRT remains a significant problem with rates as high as 40–50%. Given this rate, it remains uncertain whether certain patients on optimal therapies with progressive advanced heart failure should bypass CRT and be directly listed for more advanced therapies. How to select patients in whom this may be the most optimal strategy is unclear. We sought to determine factors associated with rapid deterioration following CRT implant in patients with advanced heart failure in order to create a clinical prediction rule to aid physicians in determining the utility of a trial of CRT versus a strategy of bypassing CRT and listing for advanced heart failure therapies directly.