Cardiac Resynchronization Therapy For Advanced Chronic...

Proposal Title: Cardiac Resynchronization Therapy in Advanced Chronic Kidney Disease: Impact on Patient Centered Outcomes Background In the United States, over 5 million patients have heart failure (HF) and approximately 20 million patients have chronic kidney disease (CKD). Both conditions are linked by multiple risk factors including obesity, hypertension, diabetes mellitus, tobacco abuse, and increasing age. The presence of HF increases the risk of CKD and vice versa. Nearly one third of all patients with HF and 70% of Medicare patients with HF have Stage III CKD or greater and approximately 50% of dialysis dependent end stage renal disease (ESRD) patients will develop HF. Patients with medication refractory HF and CKD and their†¦show more content†¦Cardiac resynchronization therapy (CRT) emerged as an important treatment for HF patients with systolic dysfunction and a prolonged QRS duration. Although findings from landmark trials have led to widespread use of CRT in many patient cohorts, there has been considerable controversy surrounding its use in patients with advanced CKD because these patients are poorly represented in these trials. The few published studies exploring the use of CRT in advanced CKD have shown modest reduction in HF hospitalization or death, but those studies have been limited by their small size, retrospective nature, and lack of data on patient centered outcomes (e.g. functional status and quality of life). The lack of data regarding how CRT impacts outcomes among patients with advanced CKD is a major problem especially in light of the results of an unpublished analysis of the National Cardiovascular Data Registry (NCDR) Implantable Cadioverter Defibrillator (ICD) Database (which captures data on most patients who receive a CRT-D device in the United States) demonstrating that 37% of patients receiving a CRT device had advanced CKD (defined as CKD Stage III-V). There are no prospective studies that have evaluated, or are in the process of evaluating, CRT in patients with advanced CKD. This issue is further compounded by the potentially higher risk of procedural complications in such patients. Physicians