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Clinical Innovation

Catheter-based treatment for structural heart conditions is growing and a key component of a comprehensive heart program.

Sorting through treatment options – such as TAVR, EVAR, mitral valves, etc. – to determine what to offer at your hospital is daunting. CFA’s experts can guide you through initial evaluation to implementation and startup.



Service Delivery

Revenue Growth

The Challenges of Developing Comprehensive Structural Heart Services

Until recently, most structural abnormalities in the heart required open surgery to repair.  Offering the potential benefits of less scarring, less blood loss, less pain, and a quicker recovery, catheter-based treatment is a rapidly growing approach to structural heart conditions and is considered by many to be a key component of a comprehensive heart program in the future.

While the most prominent technique currently in structural heart repair is Transcatheter Aortic Valve Replacement (TAVR), these techniques are rapidly evolving and include (among many others):  abdominal aortic aneurysm repair by Endovascular Aneurysm Repair (EVAR) devices; Percutaneous Mitral Valve repair, MitraClip; Cardioseal (SJM), Transcatheter closure of ASDs, VSDs and PFOs; carotid stenting; repair of Chronic Total Occlusions (CTO); Atrial Appendage Occlusion (Watchman device, Boston Scientific), Amplatzer Cardiac Plug (St. Jude Medical), Lariat Suture Delivery Device (SentreHeart);  Percutaneous Ventricular Restoration Therapy (PVRT); Percutaneous Transluminal Septal Myocardial Ablation/Alcohol Septal Ablation; Renal Artery Ablation/Denervation.  

Hospitals seeking to expand their structural heart capabilities must consider the following:

  • The integration of interventional and surgical techniques is driving a new working environment for an interdisciplinary cardiovascular team:  the HYBRID operating room, where angiographic imaging capabilities are integrated into an operating suite.  The hybrid OR can be a costly retrofit, or require new construction.  Total costs can easily approach $4-5 million.
  • While originally intended for high risk patients, TAVR for intermediate-risk patients is now being performed and TAVR for low-risk patients is on the horizon.  CMS currently has strict volume and outcome requirements.  Growth of this technique is substantial.  Two devices are FDA approved (Edwards Sapien, approved 11/2011 and Medtronic CoreValve System, approved 3/2015.  There are several companies currently developing additional improved devices.

How to Succeed in the Structural Heart Market

The structural heart market is growing and reimbursement is reasonably strong.  For those hospitals not yet performing TAVR and other structural heart repair techniques, it is prudent, as a first step, to incorporate this issue into their mid and longer range strategic planning.

Given the types of procedures considered under this umbrella, it is important to include cardiologists, cardiac surgeons, vascular surgeons, interventional radiologists, interventional neurologists, and potentially other specialists in the planning discussions.  In concert with these clinicians, the planning team must sort through the various types of structural heart procedures for appropriateness at the facility (typically on the basis of potential volume, acceptance by payers, outcome predictions based on clinical trials and studies, medical staff desires and skill sets, etc.).  If a hybrid OR is the focus, it is important to include as many types of procedures as appropriate to ensure efficient utilization of the suite; however, it is equally important not to fill the hybrid OR with procedures that can (and should) be performed in a cath lab or traditional OR..

Once the general direction of development is outlined, specific and detailed operational analysis and planning can begin.   

CFA’s Structural Heart Program Development Services

CFA provides experienced assistance to address issues of:

  • Strategy – potential impact on overall program positioning and long term growth/success; relationship to the organization’s strategic plan; and implications related to population health management, bundling, and episode-of-care management
  • Clinical trends – current predictions in the medical community for ultimate efficacy of new techniques and devices; professional organizations’ stances on specific clinical approaches
  • Market positioning – competitor analysis; market trends, and impact on other services
  • Financial implications – evolving CMS guidelines; financial feasibility, including volume projections, capital investment, operational budgeting, potential spin-off volume, ROI, NPV, cash flow, IRR
  • Facility development – architectural and design/development assistance pertaining to hybrid OR (including location, functionality, layout) and facility impact on other cardiac services

Medical Staff implications – physician leadership, participation and support; internal politics; assessment of needed specialists, recruitment needs, and recruiting assistance

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