The centerpiece of the integrated model is a certification process that would designate appropriate hospitals as “Comprehensive (Level I)” or “Primary (Level II)” valve centers to serve as the designated U.S. sites for performing repair or replacement of aortic and mitral valves by transcatheter or open-surgery procedures.
The consensus document, written by a panel of mostly interventional cardiologists or heart surgeons and published in Journal of the American College of Cardiology, cited the success of similar accreditation and tiered systems that have become fixtures in United States for the delivery of care for trauma, stroke, cancer, bariatric surgery, and percutaneous coronary intervention for acute ST-segment elevation MI.
The focus of the consensus document is to “initiate a discussion regarding whether a regionalized, tiered system of care for patients with [valvular heart disease (VHD)] that accounts for the differences in valve center expertise, experience, and resources constitutes a more rational delivery model than one left to expand continuously without direction,” the panel wrote.
Under the proposal, a key component of every designated valve center would be a multidisciplinary clinical team, staffed at minimum with an interventional cardiologist, a cardiac surgeon, echocardiographic and radiographic imaging specialists, a specialist in heart failure, a person with valve expertise, nurse practitioners, a cardiovascular anesthesiologist, a program navigator, and a data manager. Valve centers also would need to enroll patients in registries, perform research, education, and training, and collect data using carefully selected performance metrics.
The document addresses case-volume minimums, a topic that’s been tricky for leaders in the heart-valve field to reconcile as they try to balance volume thresholds against having valve procedures readily available and convenient for rural or remote patients.
“The primary motivation behind volume recommendations is not to exclude centers but rather to serve as one metric in the identification of centers that are most capable of providing certain services,” the consensus statement explained. “Volumes alone are not necessarily the best surrogate for quality, but a volume-outcome association does exist for many cardiac procedures.”
Recent proof of this relationship for transcatheter aortic valve replacement appeared in an article published earlier in April; the article reviewed 30-day mortality outcomes for more than 113,000 U.S. patients who underwent this procedure and showed that centers with the lowest procedure volumes also had the highest mortality rate (New Engl J Med. 2019 April 3. doi: 10.1056/NEJMsa1901109).
But the document also qualified its support of and the role for volume minimums, highlighting that case volume is an inadequate surrogate for program quality, especially when considered in isolation. “The proposed concept of system care for VHD patients is not conceived to deny individuals and institutions the opportunity to provide services, nor should it be perceived to impede the ability of a committed center to achieve its strategic goals. Rather, it is intended to focus more on outcomes and not simply on procedural volumes.”
The launch by the Joint Commission of a Comprehensive Cardiac Advanced Certification program in January 2017, which included VHD care, is a step toward that goal, but “there is a great deal of detailed work ahead to realize the goal of this proposal,” according to the consensus document.
The consensus statement was issued by the American Association for Thoracic Surgery, the American College of Cardiology, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.
SOURCE: Nishimura RA et al. J Amer Coll Cardiol. 2019 April 19. doi: 10.1016/j.jacc.2018.10.007.