The CFA Perspective

Amidst the constant barrage of clinical diagnosis and treatment news impacting coronary artery disease (CAD), and the delivery of related services, it is always instructive to be aware of the epidemiological news as well. Several news articles recently came to my attention that I wanted to pass on.

 These items are particularly relevant from a broad population health perspective, as proactively addressing CAD (as well as the social determinants of health) will continue to be a significant issue for all hospitals, physicians and payer organizations. Everyone should be cognizant of these underlying trends, as they will impact all providers, directly or indirectly, and their overall strategy and resource allocation decisions, for many years to come.

CAD Trends are Changing

CAD is the single leading cause of death in the U.S., accounting for about one of every three deaths. It is estimated that more than 17.6 million Americans have diagnosed CAD. It is slightly more prevalent in men than women and increases with age. However, despite these significant facts, the risk of death from CAD declined by 29.2 percent from 1996 to 2006. The risk of death and number of people dying from aged 40 to 60 has been declining. The risk of deaths among people in their 30’s has been stable. CAD used to be an older person’s disease. But it is changing! CAD used to be rare in the young. In the U.S., the average age for a first heart attack in men is 65. That is why CAD is thought of as a disease of senior citizens. But as many as 4 percent to 10 percent of all heart attacks occur before age 45, and most of these strike men.

Heart Disease Increasing in the Middle-Aged Populations

A recent article in the Wall Street Journal documents the fact that even in historically healthy communities, there is an increasing trend towards rising rates of CAD among 45 to 64 year old’s. The WSJ documents that death rates in three Colorado metro areas (Colorado Springs, Fort Collins, and Greeley) rose 25%. Similar reports of increasing death rates among these younger age cohorts are widespread. Their analysis of the changes in Cardiac-disease death rates among middle-aged people in metro areas concluded that:

“The underlying causes of CA disease are universal and difficult to address, public-health officials and doctors say. While the South and some other parts of the nation have perpetually high rates of death from heart disease and strokes, middle-aged CA deaths rates are rising even in places where these rates have been historically low.”

Causal factors include rising rates of obesity and diabetes, high blood pressure, drug and alcohol abuse, stress, and lack of physical activity (plus underlying genetic disposition to CAD).

…And in the Younger Populations as well

As reported by Harvard (refer to https://www.health.harvard.edu/heart-health/premature-heart-disease), premature deaths from CAD among young adults is also on the rise. The historical disease of senior citizens is trending downward.

In older men, nearly all heart attacks are caused by atherosclerotic blockages in coronary arteries. Conventional CAD also predominates in young adults, accounting for about 80% of heart attacks. About 60% of these young patients have disease of just one coronary artery, while older patients are more likely to have disease in two or three arteries.

The lion's share of heart disease in young adults is caused by the same risk factors that cause coronary artery disease in older men. The culprits include a family history of heart disease, smoking, high cholesterol, hypertension, abdominal obesity, diabetes, the metabolic syndrome[1], lack of exercise, hostility, and elevated levels of C-reactive protein. The opioid epidemic has also been singled out as a major underlying cause in both young and middle age.

Implications

In summary, CAD is no longer a disease of seniors, but is increasing among the young and middle aged. Overall trends in healthcare, and CAD in particular, are important reflections on goals, priorities and resource allocation. While the prevention, diagnosis and treatment of CAD has always been the triple aim of all healthcare practitioners, prevention and early diagnosis has historically been the greatest challenge. As hospitals and physicians continually assess their approach to prevention in particular, (the earlier in life the better since atherosclerosis can — and does — start in youth) they will need to be ever more cognizant of trends that impact their efforts, inclusive of epidemiological shifts and the social determinants of health, inclusive of multiple factors, including income levels.

Prescription

Every hospital will need to assess its approach to prevention, from early screening and education of (ever changing) targeted groups, through new and evolving screening and diagnostic programs, services and technologies. Tools such as CT Calcium Scoring programs have been highly successful in many communities. Early screening and detection programs are attempting to rule-out congenital issues in high school athletes. Church and other civic groups have formed weight control support groups, provide periodic blood pressure monitoring, stress management classes, smoking cessation and other relevant services with support from healthcare professionals. Traditional health fairs and community screenings continue to reveal at-risk people within larger populations. As population health approaches and digital health technologies continue to develop, additional targeted opportunities will likely be identified and healthcare providers will need to step-up.

If you are interested in learning more about any of this important issue or in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.

[1] Metabolic syndrome is a cluster of conditions that occur together, increasing the risk of heart disease, stroke and type 2 diabetes. These conditions include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels.

FFR-CT Aims for Real-World Application

Fractional flow reserve-computed tomography (FFR-CT), in the still early stages of clinical implementation, is beginning to make inroads into how some hospitals and physician groups diagnose chest pain patients noninvasively.  Some cardiologists have described it as a “paradigm shift.” Early adapters have seen declines in cath lab admissions and changes in the way they approach the diagnosis of obstructive coronary artery disease. FFR-CT accomplishes something that no other methodology has been able to – noninvasively; providing both an anatomical and a functional assessment (e.g., actual blood flow).  It could potentially replace catheter-based, invasive FFR pressure wire measurements in many patients. It could save money and time by reducing the need for additional tests, facilitate early discharge of chest pain patients without coronary occlusions, and reduce/eliminate coronary angiograms. As with the roll-out of virtually all new technologies, there remains many questions about its optimal clinical use and concomitant organizational implications

Current Practice

Currently, there are various alternative methods used to diagnose suspected coronary artery disease – none of them perfect – all with limitations.  Invariably, regardless of diagnostic method, many patients end up in the cath lab for invasive angiography and potentially a catheter-based FFR procedure.  Various studies have documented the fact that too many patients go to the cath lab and are diagnosed with clinically insignificant coronary artery disease, leading to overutilization, clinical risk and high cost.  Cardiac CT provided a significant anatomical view of the coronary vessels, but falls short on evaluating “intermediate” lesions – those that are truly dangerous (typically with blood flow capacity limited to 40 to 70 percent).  Dealing with the intermediate lesions (particularly when multiple intermediate lesions are present) is the primary niche of FFR-CT.  

The New Technology   

FFR-CT is the exclusive domain of HeartFlow® which provides proprietary software that collects data sent from the user, analyses the data and calculates the results, and transmits the results back to the user.  The technology is extensive, including the use of proprietary algorithms, artificial intelligence, supercomputers, and highly trained staff. The delay in results (currently a matter of hours), is a primary disadvantage to its use, particularly for emergency department cases.  Although, it should be noted, that anecdotal information says that some hospitals are using HeartFlow® analysis for chest pain patients in the ED. (For a full description of the product, go to www.heartflow.com).  The U.S. Food and Drug Administration (FDA) cleared FFR-CT in November 2014, and it is currently reimbursed through Category III CPT codes for Medicare and many commercial payers.  It is currently approved in the U.S., Canada, Europe and Japan.

The technology has been validated through a number of clinical trials, most prominently the PLATFORM trial and RIPCHORD study in Europe.  It has been presented at the annual American College of Cardiology and Society of Cardiovascular Computed Tomography meetings.  PLATFORM revealed that 61 percent of patients did not need invasive coronary angiography, resulting in a 32 percent lower cost. In RIPCHORD, three experienced cardiologists reviewed coronary CT angiography images of 200 patients with stable chest pain and agreed on one of three treatment options:  optimal medical therapy, PCI or bypass surgery. The physicians were then shown FFR-CT analysis for each patient and asked to make a second treatment decision. In total, viewing the FFR-CT analyses resulted in a change in treatment plan for 36 percent of patients. Also, in 18 percent of cases initially decided for PCI, one or more target lesions were changed following FFR-CT analysis.  

Currently FFR-CT is available to only a fraction of potential patients in U.S. hospitals, free-standing CT centers and/or radiology or cardiology medical groups.  In a review of the HeartFlow® website for example, in California, there were three hospitals, one radiology group location, one cardiology group, and a research institute listed as available providers.

Patient Selection

Patient selection remains the single biggest issue with implementation of FFR-CT.  As referenced above, intermediate lesions remain the target for further evaluation.  If CT angiography identifies clearly high-level, multi-vessel disease, or the opposite, smaller lesions unlikely to have a significant impact on blood flow, treatment decisions are relatively clear cut.  FFR-CT can help to identify intermediate (particularly multiple) lesion severity and prioritize the most significant. Another issue is that, unlike clinical practice in many European countries, cardiac CT is not the typical first line of diagnosis for chest pain patients (in comparison to, for example nuclear myocardial perfusion imaging) – largely due to insurance issues.  In some European settings, virtually all chest patients are referred for CCT, and FFR-CT analysis is used for all patients with intermediate lesions of 40 to 70 percent stenosis. American cardiologists continue to develop FFR-CT and its application to patients. Limitations are currently few, including the inherent delay in receiving the analysis from HeartFlow®, and limitations based on the precision of the CT images (false positives are still a risk).  

Experience at California Pacific Medical Center

One early adapter has been California Pacific Medical Center in San Francisco, a large, urban full-service cardiovascular provider.  Opening new facilities with 256-slice CT capability and support from a radiology champion served as their incentive to partner with HeartFlow™.  According to W. Michael Barber, R.N., Manager of Cardiac Cath Labs, Interventional Radiology and Electrophysiology, early results are very promising.  “It’s hard to find anything negative about this technology,” he says.  FFR-CT’s utilization at this hospital is increasing rapidly as more cardiologists accept its clinical utility under specific (albeit still evolving) circumstances.  While the technology is designed to produce definitive results to prevent further testing, from nuclear stress testing to diagnostic (or potential therapeutic) catheterization, he believes that broad adoption could actually lead to increased cath lab utilization, as patients that truly need revascularization through PCI are definitively identified.  CPMC has a high volume of emergency department presentations, as well as critical care transfers from outlying hospitals, which complicates the decision-making surrounding the use of FFR-CT. Optimization of results analyses turnaround times from HeartFlow™ remains a key goal, given that application to specific patients (and results turnaround times) is highly variable and active roll-out of the methodology continues.  A consensus-based treatment protocol is currently being developed to identify appropriate candidates, standardize both the process and the treatment required to optimize usage and mitigate delays. The additional fact that the technology is well reimbursed is also a positive in its adaption.

Outstanding Issues Going-Forward

As with the roll-out of virtually all new technologies, there remains many questions about its optimal clinical use and concomitant organizational implications.  Among these questions are the following:

• What patients are optimally appropriate for FFR-CT?
• How is FFR-CT best implemented to serve both inpatients and outpatients, especially chest-pain patients presenting in the ED?
• How will radiology and cardiology work together to best optimize and promote its use?
• Will FFR-CT actually decrease cath lab utilization over time, or identify additional patients that would benefit from revascularization?
• What organizational and clinical barriers are present to prevent optimal roll-out and utilization?
• Is a physician champion required?  How is FFR-CT best promoted amongst potential physician users?
• How can consensus-based standardized treatment protocols be developed and implemented to optimally utilize FFR-CT?
• What organizational, clinical utilization and related issues must be mitigated to optimize results turn-around times from HeartFlow™?
• Would an FFR-CT strategy make clinical sense as a service enhancement for a hospital without a cath lab?

Conclusion

Like many developing technologies, FFR-CT has a tremendous upside potential in diagnosing the significance of a patient’s coronary artery disease.  This potential can only be reached through broad, universal adaption and the mitigation of existing barriers and limitations (perceived or real). Significant barriers still exist that will slow adaption and prevent its potential from being reached.  It is incumbent on all hospitals with cardiovascular programs to critically evaluate this technology and objectively determine its place in the unique program and service offerings for each hospital and each unique marketplace.

If you are interested in learning more about any of this important issue or in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.   

[1] Douglas, PS, et al.  One-Year Outcomes of FFR-CT-Guided Care in Patients with Suspected Coronary Disease:  The PLATFORM Study. J. American College of Cardiology, 2016; 68(5): 435-45.

[2] Douglas, PS, et al.  Clinical outcomes of fractional flow reserve by computed tomography angiographic-guided diagnostic strategies versus usual care in patients with suspected coronary artery disease; the prospective longitudinal trial of FFR (CT); outcomes and resource impacts study. European Heart Journal 2015; 36(47):  3359-67.

[3] Believed to be helpful, but not mandatory.

Occasionally, CFA will highlight a few significant news articles on cardiovascular topics -- clinical or organizational.  Reprinted below are four interesting news items we feel worthy to highlight.  For full information, the links to the original news sources are included.  We have included our interpretation of the organizational implications of each item.

• ISCHEMIA and ISCHEMIA-CKD Trial Results Presented at AHA

The results of the ISCHEMIA and ISCHEMIA-CKD studies were presented at the American Heart Association Scientific sessions on Saturday, November 16, 2019.  The multicenter, international randomized trial was designed to determine the differences between a conservative medical therapy approach to treating stable ischemia heart disease (SIHD) and an interventional/surgical approach to SIHD patients.

ISCHEMIA Study Design from the ischemiatrial.org website:

Approximately 400 research centers worldwide will participate in ISCHEMIA enrolling 5,000-6,000 patients.

Eligible participants were recruited following clinically indicated stress imaging testing, but before catheterization, and randomized in a 1:1 fashion to one of two groups:

• Invasive (INV) Management: Study participants in this group will undergo a cardiac catheterization within 30 days of randomization; if significant coronary artery disease is present, coronary revascularization will be performed. In addition, study participants in this group will receive optimal medical therapy (OMT).
• Conservative (CON) Management: Study participants in this group will receive optimal medical therapy (OMT) alone with catheterization and possibly revascularization if the participant is not responding to therapy.

Quoting from the ISCHEMIA Study results summary:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not reduce the overall rate of heart attack or death compared with medicines and lifestyle changes alone. However, for people with chest pain symptoms, heart procedures improved symptoms better than medicines and lifestyle changes alone. The more chest pain to begin with, the more symptoms improved after getting a stent or bypass surgery.

These results apply to people with stable symptoms. They do not apply to people having a heart attack, when emergency stent procedures save lives.”

You will find a summary of the ISCHEMIA Study on the American College of Cardiology website.

The ISCHEMIA-CKD Trial results were summarized on the ischemiatrial.org website:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not result in a reduced rate of heart attack or death compared with medicines and lifestyle changes alone. The trial also showed that heart procedures did not reduce symptoms appreciably or improve the quality of life compared with medicines and lifestyle changes alone. These results do not apply to people having a heart attack or those with severe chest pain symptoms.”

Implications – The results of the ISCHEMIA Trial will assuredly be questioned, dissected and in some quarters possibly argued as flawed in study design.  The study endpoint time period of 3.3 years will potentially be stated by some as not long enough to more fully illuminate the differences in the two distinct forms of treatment.  But with more than 5,000 patients in a two-track, international randomized trial, the ISCHEMIA Study brings forward new information that will generate discussion, reflection and review of protocols that may prospectively identify patient sub-sets that will clearly benefit from one approach or the other.

• CMS to Reimburse Select Outpatient PCI Procedures in ASC’s in 2020

According to newly finalized rule, CMS will pay for certain angioplasty and stenting procedures performed outside the hospital outpatient setting starting in calendar year 2020.

CMS initially estimated that moving 5% of coronary interventions from the hospital outpatient setting to ASCs would reduce Medicare payments by about $15 million and total beneficiary copays by about $3 million in calendar year 2020.  The agency updated those figures to estimated savings of $20 million and $5 million, respectively, in its final rule.  Reimbursement in ASCs will be available for six specific current procedural terminology (CPT) codes covering percutaneous transluminal coronary angioplasty with or without placement of stents in a single major coronary artery or branch, as well as in each additional branch of a major coronary artery.  The inclusion of these interventions on the CPL comes despite the fact they may involve major blood vessels, which has been considered an exclusion for CMS coverage at ASCs.

“Although the proposed coronary intervention procedures may involve blood vessels that could be considered major, . . . we believe the involvement of major blood vessels is best considered in the context of the clinical characteristics of individual procedures, and we do not believe that it is logically or clinically consistent to exclude certain cardiac procedures from the list of ASC covered surgical procedures on the basis of the involvement of major blood vessels, yet continue to provide ASC payment for similar procedures involving major blood vessels that have a history of safe performance in ASCs,” CMS said.  In support of their decision, CMS cites CPT codes for “mechanochemical destruction of insufficient vein of arm or leg, accessed through the skin using imaging guidance” and “insertion of stents into groin artery, endovascular, accessed through the skin or open procedure.”

Implications – There has been a longstanding interest on the part of some interventional cardiologists in adding invasive and interventional cath lab capabilities to ASC’s in which they have (or could acquire) an ownership interest.  Federal reimbursement policies, as well as state law (for example, it is prohibited in California, among other states) has prevented the proliferation of such services.  This may now change.  Hospitals in markets with competing ASCs should monitor this situation and prepare for potential proliferation of this important service capability.

• Association Between Aging and Heart Disease Mortality from 2011 to 2017

Was the rapid increase in the number of adults aged 65 years and older from 2011 to 2017 associated with mortality related to heart disease?  A new study published in JAMA online finds the answer to be “yes.”  A deceleration in the rate of decrease of heart disease (HD) mortality between 2011 and 2014 has been reported.  In the context of the rapid increase in the population of adults aged 65 years and older, extending the examination of HD mortality through 2017 has potentially important implications for public health and medical care.  The total size of this population of US adults aged 65 years and older increased 22.9% from 41.4 million to 50.9 million between January 1, 2011, and December 31, 2017, while the population of adults younger than 65 years increased by only 1.7%.  During this period, the age-adjusted mortality rate decreased 5.0% for HD and 14.9% for CHD while increasing 20.7% for heart failure and 8.4% for other HDs.  The number of deaths increased 8.5% for HD, 38.0% for heart failure, and 23.4% for other HDs while decreasing 2.5% for CHD.  A total of 80% of HD deaths occurred in the group of adults aged 65 years and older.  The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population.

Implications – The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population. With the number of adults aged 65 years and older projected to increase an additional 44% from 2017 to 2030, innovative and effective approaches to prevent and treat HD, particularly the substantially increasing rates of heart failure, are needed.

For your review, you can find this important study in full here.

CMS Confirms Substantial Cuts to Cardiac CT Reimbursement in 2020

The Centers for Medicare & Medicaid Services (CMS) has rendered its final rule regarding 2020 reimbursement rates associated with cardiac computed tomography performed in hospitals, and imagers are not happy.  In July, the agency announced proposed cuts of nearly 30% compared with 2018 rates for the three main billing codes as part of the Hospital Outpatient Prospective Payment System (OPPS). In an addendum to its final rule, CMS cut the reimbursement for all three of the following codes to $182.20, a drop of $19.54 compared with 2019 rates:

• 75572: Heart CT with contrast for evaluation of cardiac structure and morphology
• 75573: Heart CT with contrast for evaluation of cardiac structure and morphology in the setting of congenital heart disease
• 75574: CT angiography of the heart, coronary arteries, and bypass grafts with contrast

The full document has been posted to the federal register, with a formal publication date of November 12, 2019.  The Society of Cardiac CT along with the American College of Cardiology (ACC) and the American College of Radiology (ACR) mounted a concerted effort over the past several months to convince CMS to rethink its suggested cuts, sending letters and encouraging members to submit comments on the proposal as well as establish how much their institutions bill for cardiac CT, but to no avail.

Implications -- SCCT President Ron Blankstein, MD (Brigham and Women’s Hospital, Boston, MA), states that “This is a very big deal for the field of cardiac CT,” he told TCTMD, adding, “The current methodology that CMS is using is vastly underestimating the cost of cardiac CT and therefore the payment rate.” Any negative change in reimbursement for important tests such as cardiac CT could ultimately have a negative impact on overall usage and thus the early diagnosis of CHD.

If you are interested in learning more about any of these important issues or in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.  

EFFECTIVE IMMEDIATELY:  CMS Publishes New National Coverage Determination for TAVR Reimbursement

Posted by John W. Meyer, LFACHE

CMS announced its long-awaited updated transcatheter aortic valve replacement (TAVR) national coverage determination (NCD) final rules on June 21, 2019.  Based upon the proposed changes from its original 2012 coverage determination, the updates, as formally adapted, could be a gift to low-volume cardiac surgery programs — and lower-volume cardiology programs in general — nationwide!  The pressure was on CMS to increase access to and availability of TAVR for more hospitals from the hospital industry by lowering the existing volume requirements.  The counter was the professional societies that believed keeping, or even strengthening the current requirements would help ensure a quality product (the classic volume = quality issue).  It appears the hospital industry has won this debate over balancing access and outcomes.  After a comment period following the release of the proposed changes, CMS adopted the final regulations with no material changes from the proposal published on March 26, 2019.

The final decision specifies hospital infrastructure requirements, such as needing on-site heart valve surgery and interventional cardiology programs, along with a post-procedural intensive care unit experienced in managing patients following open-heart valve procedures.

The heart of the final NCD are the proposed volume requirements, which requires the following for hospitals to begin a program and receive reimbursement for the procedures:

• ≥ 50 open-heart surgeries in the year prior to starting a TAVR program, and;
• ≥ 20 aortic valve-related procedures in the two years before program initiation, and;
• ≥ Two cardiac surgeons, and;
• ≥ One or more interventional cardiologists, and;
• ≥ 300 percutaneous coronary interventions (PCIs) per year.

 In order to maintain reimbursement for a TAVR program, the proposal requires centers to have:

• At least 50 AVRs (TAVR or SAVR) per year annually, including ≥ 20 TAVRs in the prior year, or;
• ≥ 100 AVRs (TAVR or SAVR) every two years; including ≥ 40 TAVR procedures in the two years prior, and;
• Two physicians with cardiac surgery privileges, and;
• One physician with interventional cardiology privileges, and;
• 300 PCIs per year.

The CT surgeon on the team is required to have completed 100 or more open-heart surgeries, of which 25 or more are related to the aortic valve, while the interventional cardiologist must have done 100 or more structural heart disease procedures (or 30 left-sided structural procedures per year), as well as device-specific training by the valve manufacturers.

Requirements for the heart team’s composition and for independent evaluation by both a surgeon and an interventional cardiologist for either a surgical or transcatheter procedure, are included in the final NCD. The prior NCD rule that requires a two-surgeon signoff HAS BEEN REMOVED.

Low-volume cardiac surgery programs could benefit from the decreases in required volumes for combined SAVR, catheterization, PCIs and going-forward TAVRs under the final NCD, effective immediately.  These changes will significantly impact entry into this new market. CFA has several client hospitals that are following these developments closely, on the cusp of making a decision to move forward – unable to meet the strict current requirements, but probably able to meet the proposed changes.  We have blogged extensively about the TAVR question – whether or not to proceed with TAVR under the best of circumstances.  Structural heart services[i] including TAVR (and also transcatheter mitral valve repair/replacement) are complex and demanding services.  Beyond the question of “can we meet the current and/or proposed standards,” comes the larger, more complex question of “should we enter this market?”  With the latter question, each hospital will have to assess its own corporate strategy, internal existing/potential volumes, referral patterns and practices, operational capabilities, competition within the marketplace, physician leadership and capabilities, and other pertinent questions.    

The official NCD can be accessed by clicking here.

If you are interested in learning more about structural heart programs, and/or low-volume cardiac surgery programs strategies, please download our updated and expanded 2019 white paper (see Low-Volume Cardiac Surgery Programs:  Grow, Consolidate or Divest:  Self-Preservation Strategies and Excellence Expectations, our expanded and updated White Paper).  If you are interested in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.

[i] See also Valve Surgery Trends and Implications, posted June 28, 2018, and Mitral Valve Surgery Trends and Implications, posted March 14, 2019.

Over the last few years, we have continued to blog to keep readers up to date on the evolving state of cardiac valve surgery and the development of transcatheter aortic valve replacement (TAVR) specifically.  As both clinical research results and regulatory changes push TAVR for all into the forefront, hospitals on the cusp of entering this market will need to reevaluate their positions before deciding to move forward. 

On March 16, 2019, the NEJM published online the results of two TAVR versus surgical AVR (SAVR) trials in low-risk patients, which effectively ended the debate.  At the ACC meeting in March 2019, one of the principal investigators stated that “TAVR is no longer just an alternative therapy, it is the preferred therapy.” [i]

On the heels of these and other similar results, everyone is waiting for CMS to issue its final, updated national coverage determination (NCD), proposed on March 26, 2019.  The pending updated TAVR NCD is predicted to reset minimum volume requirements and effectively lower the threshold for entering into and maintaining a TAVR program (see the proposed CMS decision memo).  These changes alone, will induce many more hospitals to enter this market.  CFA has a number of clients on the verge of making their decision to move forward.  Should the volume threshold be lowered by CMS, as proposed, we offer the following summary of critical considerations for implementing TAVR as Part One of a two-part blog post

• Organizational commitment – Expanding the hospital’s structural heart program capabilities to include TAVR will require a commitment on the part of both the organization and its medical staff. This is a significant undertaking in terms of infrastructure, organization and management, physician leadership, staffing and training, and ultimately, financial investment and hopefully, a return-on-investment.  While this new service should expand its cardiovascular capabilities, enhance the hospital’s reputation and potentially increase market share (for both TAVR and SAVR), these are never givens, but have to be earned in a competitive marketplace.
  
  
• Know your numbers – It is vital that any hospital contemplating TAVR know its current volumes of both SAVR patients and those referred elsewhere for potential TAVR procedures in order to achieve the required minimum volumes. (Refer to CMS New TAVR Coverage Decision Memo:  A Gift to Low-Volume Cardiac Surgery Programs? posted 3/29/19 for volume requirements).  Going forward must include a breakdown of current SAVR, as well as potential TAVR, factoring in patients deemed “inoperable” due to adverse risk and/or physiological considerations.
  
  
• Infrastructure requirements – While the hybrid OR procedure room is the “optimal” site for TAVR, many hospitals will enter the market by using existing cath labs with upgraded levels of imaging equipment. This approach obviates the multi-million-dollar investment required to plan, develop and build out a hybrid OR.
  • Staffing assessment will need to be made to match expected volume with existing staffing patterns to ascertain both need and TAVR training requirements. At program initiation, some hospitals will tend to “overstaff’ the procedure, which can be refined over time.
  • Valves, delivery systems and related inventory will need to be purchased. Vendors typically require hospitals to purchase the valves up front, adding overhead costs.
  • Mandatory participation in the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry is required by CMS and has both a participation/licensing fee and ongoing staffing cost.
    
    
• Multidisciplinary approach – Ultimately, any structural heart program should optimize its efficiency and effectiveness through multidisciplinary decision-making processes involving both cardiology and cardiac surgery. Input from all disciplines in evaluating candidates for therapies and interventions can be institutionalized into a cardiac valve clinic situation, or less formally through close communication between referring cardiologist, cardiac surgeon and other team members.  Realistically, referring cardiologists will tend to “pre-select” TAVR candidates and send them on to the preferred interventionalist.  In larger volume programs with formalized cardiac valve clinics and programs, dedicated nurse practitioners are often charged with coordinating the multidisciplinary meetings, clinics and processes necessary to achieve the desired clinical outcome.  Newer, smaller volume programs will be challenged to have existing staff multitasking with various targeted groups to achieve the same ends.
  
  
• Trained operator(s) – While both interventional cardiology and cardiac surgeons can be trained to performed percutaneous valve procedures, it is the cardiologist that controls the patient and ultimately controls the procedure. The primary operator will need to be trained in the new procedure and achieve a certain level of proficiency and experience before initiating a new program.  Specific roles, and any turf issues will need to be addressed before the program can proceed.  Obviously, the skill of the individual operator will be critical to building a high-quality program over time.
  
  
• Clinical philosophy and approach – Whenever clinicians initiate a new procedure, they tend to take a conservative approach in both patient selection and clinical protocols. As patient selection criteria, risk assessment and clinical application is further refined through clinical trial results, a focus on the treatment protocols seems logical.  Initially, when these procedures were new (and riskier), the use of general anesthesia or transesophageal echocardiography was used.  As experience progressed, many hospitals began using a so-called “minimalist” approach with protocols that call for conscious sedation and local anesthesia, eliminating sternotomy, cardiopulmonary bypass, and tracheal intubation. Thus, conscious sedation dramatically reduces procedure time, time in the ICU post-procedure, and patients’ hospital stay, resulting in lower costs, better health outcomes, and greater patient satisfaction.  Ultimately (and at the appropriate time) focusing on reducing overall procedure cost is a critical factor, as these are expensive procedures where reimbursement levels may not cover costs, particularly at low volume levels.

It is important to recognize that while AVR represents about 75% of all cardiac valve surgeries, transcatheter mitral valve procedures are now in active clinical trials and, if ultimately proven successful, will have similar impact (and generate the same issues) as those found with TAVR; further increasing the importance of transcatheter technologies on cardiac programs in general, and the overall importance of this market segment.

Some lower-volume cardiac surgery programs can be expected to benefit from the decreases in required volumes for combined SAVR, overall catheterization procedures, PCIs and going-forward TAVRs under the proposed NCD.  If adapted, these changes will significantly impact entry into this new market.  

Structural heart services[ii] including TAVR (and also transcatheter mitral valve repair and replacement) are complex and demanding services.  Beyond the question of “can we meet the current and/or proposed standards,” comes the larger, more complex question of “should we enter this market?”  With the latter question, each hospital will have to assess its own corporate strategy, internal existing/potential volumes, referral patterns and practices, payer mix/procedural cost/reimbursement, capital investment, operational capabilities, competition within the marketplace, physician leadership and capabilities, and other pertinent questions similar to those raised above. 

In Part Two of this blog post, we will address in more detail many of the issues raised above, including program planning, development and implementation needs; assessing prospective financial performance, physician and staff training, infrastructure needs and other related topics.

If you are interested in learning more about low-volume cardiac surgery programs strategies, please download our updated and expanded white paper (please see Low-Volume Cardiac Surgery Programs:  Grow, Consolidate or Divest:  Self-Preservation Strategies and Excellence Expectations).  If you are interested in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.

Footnotes

[i] Allar, Daniel, Cardiovascular Business, May/June 2019, page 32, quoting Michael J. Reardon, MD, Houston Methodist Hospital, ACC19.

[ii] See also Valve Surgery Trends and Implications, posted June 28, 2018, and Mitral Valve Surgery Trends and Implications, posted March 14, 2019.