Present Guidelines for Device Implantation
Clinical Considerations and Clinical Challenges From Pacing, Implantable Cardiac Defibrillator, and Cardiac Resynchronization Therapy
Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) have become mainstays of clinical cardiology practice for high-risk patients supported by persuasive clinical trial data. Yet, areas of certainty are offset by considerable uncertainty about the criteria for implantation and for reimbursement. This article reviews selected elements of the clinical trial data and reconciles, when possible, guideline recommendations with the Center for Medicare & Medicaid Services (CMS) national coverage determination (NCD).
The Basis for Guidelines Recommendations and CMS Reimbursement Criteria
Medical practice guidelines represent the cumulative effort of patients, clinicians, scientists, and statisticians striving to guide patient care on the basis of the best clinical trial science available.1–6 Expert consensus dates back centuries, but the modern era of clinical guidelines is founded on the concept of evidence-based medicine, introduced in the 1980s. Having its origin in the discipline of clinical epidemiology and public health, evidence-based medicine incorporates both best science and best clinical practice. The most commonly used definition by Sackett et al7 states, “Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” Guidelines rank the strength of evidence by class: Class I represents the highest recommendation, Class II requires further physician consideration, and Class III discourages the use of the therapy considered. A complementary grading system considers the relative benefit versus risk as a statement of certainty of treatment effect from A, indicating strongest certainty, to C, indicating lowest certainty.8 Guidelines provide the practicing physician an exhaustive summary of the available literature, including areas of conflict and differences in study protocols and patient cohorts. Without such guidelines, physician and hospital performance metrics would be adrift, and payers would have no objective footprint to assess reasonable standards of care.
Although medical practice guidelines are an important tool for physicians faced with clinical …