The CFA Perspective

Has Consolidation’s Time Come?  80% of Surveyed Health System Execs Think So

Posted by John W. Meyer, LFACHE, and Charles W. Franc

5/20/21 11:26 AM

Service-line consolidation has always been a challenge – theoretically feasible, strategically supportable, even desirable (particularly from a health system perspective), yet fraught with practical and political roadblocks.  Has the pandemic and the financial stress it has placed on the American health care system made consolidation more likely in the years to come?  Eighty percent of system execs have said so in a new poll.  Nearly 80% of 79 health system, hospital and physician group administrators surveyed in early February said they are more likely to accelerate service rationalization over the next year, according to a poll by Optum’s Advisory Board.  While this opinion focuses on money-losing services and programs, it can apply to whole service lines and its components.  Thus, it would be an oversimplification to say that this opinion is largely driven by financial performance; it goes beyond mere money.

It is demonstrable fact that the overall volume of cardiac surgery has decreased, thus the number of low-volume cardiac surgery programs has concomitantly increased.  Remarkably,  the number of hospitals offering cardiac surgery has continued to increase until recently.  Go figure!

Our Own Experience

Cardiac surgery program consolidation is a hot topic.  In our own consulting practice, we are currently working with two Western U.S. hospitals, both part of larger regional systems, with thriving cardiovascular service lines, that are debating the issue of consolidating their cardiac surgery programs into larger system hospitals.  It would be easier to address the issue of consolidation if both these hospitals (one low volume, one moderate volume) were losing money on cardiac surgery, but even at low volume, that is not the major issue or precipitating event that launched the discussion.  Both hospitals, in different markets, are facing unique challenges (primarily, but not exclusively physician staffing) and subject to corporate pressure to seriously study the issue. 

Why Consider Consolidation?

While consolidation considerations are often triggered by low volume, there are a myriad of other interrelated issues that are often present.  These can include the need for greater efficiency, better clinical outcomes, lower costs-per-case, physician and other staffing-related issues, reduction in unnecessary variation, better overall patient experience, appropriate distribution of specialty services within regions, the need to optimize resource management, a leadership or physician staffing crisis, value creation, and overriding corporate strategy.  Increasingly, systems are trying to create optimized “system-ness” and well-integrated service lines to appeal to value-driven payers and referring organizations.  Service line integration and rational distribution can also integrate hospital strategy with physician group strategy for a more coordinated system-wide marketing position.  Many systems with regional hospital assets have adopted a “hub-and-spoke” approach to specialty service lines, with full-service cardiovascular programs based in larger, regional referral facilities with community hospitals relegated to a less-comprehensive array of services.  Physician referral patterns are difficult to shift, and attitudes will often reflect “winners’ and “losers” among hospitals and clinical staff.  Optimizing hub-and-spoke service lines is often particularly challenging without sound leadership and strong centralized program direction and overall development.

The continuing development of both interventional cardiology and electrophysiology as cardiac subspecialties at the community hospital level, have implications when considering divesting lower-volume cardiac surgery programs.  “Complex” PCI is routinely performed in community hospitals and the percentage of complex cases as a percent of total cases continues to rise as the population ages.  While the emergency conversion of all PCIs to surgery remains extremely low, most interventional cardiologists are biased towards performing such procedures in facilities with on-site access to cardiac surgery.  The same holds true for many electrophysiologists performing complex EP ablation procedures, again, an increasing percentage of their work.  Divesting cardiac surgery can have serious consequences and the attitudes, opinions and clinical patient and procedural mix of cardiologists must be seriously considered in any divestiture project.  In one specific low-volume divestiture project we are aware of, corporates’ attitude was that divesting cardiac surgery would have an unacceptably negative impact on both the hospital’s existing and continuing growth of cardiology and electrophysiology business, and was therefore “discouraged” for this sole reason. 

It is important to note that any consideration of consolidation has broader impacts than simply on the program or the service line itself.  Cardiac surgery, for example, impacts many other clinical areas of the hospital, its physician staff and clinical team.  Additionally, it reflects directly in the hospital (and health system) market positioning, value-based managed care considerations, public perception, EMS interface and even philanthropy.  All of these constituent bodies need to be considered when contemplating the addition, and particularly the deletion, of any special program.

Strategizing the Consolidation Decision

Strategizing the consolidation decision is consequential and thus must be thorough, market-driven and fact-based.  With that in mind, it is realized that such decisions go  beyond clinical considerations and can be very political.  Involving all stakeholders, both inside and outside the hospital, will be critical.  Corporate pressure to consolidate is commonplace, as is local system hospitals reluctance to forfeit any service line program or service that it has built, promoted and resourced over long periods.  Alternatives to cardiac surgery such as providing PCI without surgery on site, available in many (but not all) states can be considered a viable alternative in some circumstances.  

The Importance of Process

If a decision is reached to divest, it is critical that the effort be process-driven, all-inclusive, and thoroughly planned through a comprehensive team implementation approach.  A good case study describing the process involving two hospitals consolidating their cardiac surgery programs is featured in (NEJM Catalyst, Cardiac Surgery Consolidation – Improving Value in Care Delivery, Volume 1, Number 2, February 19, 2020).  They emphasize the need to include all affected constituents, including those beyond the institution’s walls, the need for a comprehensive process involving multiple work teams, and the critical need for administrative and physician champions to support a significant change such as this.  Additionally, they strongly emphasize one point – “don’t rush discernment.”  Consolidation issues are rarely time-critical and thus should be given the thoroughness required to mitigate unexpected issues or areas of resistance that will often appear.

Summary

In summary, changing markets and continuing financial stress will force hospitals and health care systems to evaluate the optimal, market-based, service line provision of individual services and programs.  Cardiac surgery, in particular, should be strongly considered a potential candidate for divestiture or consolidation under specific/unique circumstances, but will require serious study and understanding of the pros and cons of such a decision.  These decisions can have wide-ranging community repercussions beyond the more obvious inside-the-walls hospital consequences.  Thorough analyses and well-planned implementation of subsequent decisions will be critical.

 If you are interested in learning more about rationalizing and consolidating cardiac service lines or other areas of 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.

Periodic Cardiovascular News Update and Implications August 2020

Posted by John W. Meyer, LFACHE, and Charles W. Franc

8/26/20 3:01 PM

Periodic News Update and Implications

Periodically, CFA will highlight a few significant news articles on cardiovascular topics -- clinical or organizational.  Reprinted below are four news items we found interesting and 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.

Springboard’s Back to Work Survey Results

Springboard, a healthcare staffing and education firm, conducted a Back to Work Survey, between June 18, 2020 and July 6, 2020, to analyze the current state of the Cath/EP/IR industry and the impact the COVID-19 pandemic has had on it.  The national survey, distributed by e-mail to facility managers across a diverse cross-section of rural and urban facilities, was developed in cooperation with managers and director-level professionals who were looking for answers to twelve specific questions related to the current and changing landscape of an industry being shaped by the pandemic.

The survey received 135 responses and provided key insights on these and other critical topics:

  • Methods of disinfection for PPE
  • Factors contributing to operational capacity
  • Caseloads
  • Planning.

See the full, detailed survey results here.

Implications – Without question, hospital CV programs have been adversely impacted by the COVID-19 pandemic – directly and indirectly through the hospitals overall financial health and substantially decreased patient volumes.  This survey documents that fact.  On a going-forward basis, much will have to change to convince many CV patients that have deferred hospital visits and procedures that they will be safe and treated appropriately.  (Also, refer to the following paragraph).  Additionally, assuring availability to timely COVID-19 testing was also an issue raised by a significant number of those surveyed.  Many of those surveyed are unclear on when operations and patient volumes will return to normal.

American Heart Association “Don’t Die of Doubt” Campaign

The American Heart Association has launched a public communication campaign targeting hospital patient safety during the coronavirus pandemic.  Aimed at cardiac and potential stroke patients, the information provided focuses on urging patients to not delay needed or urgent medical care because of fear of going to the hospital.  The program stresses the measures that hospitals utilize to assure patient safety. The Don’t Die of Doubt campaign information can be found here.

Implications – As highlighted in the Springboard Back to Work survey described above, patient fears and concerns regarding visiting the hospital for testing or needed procedures during the coronavirus pandemic continue to suppress cardiac care activity.  It will benefit patients and hospitals throughout the country if hospitals can effectively communicate the patient safety measures they consistently employ during the pandemic and educate their community on the risks of delaying diagnosis and treatment.

SCAI Issues Position Paper on PCI in ASC’s

The Society for Cardiovascular Angiography and Interventions (SCAI) issued a position paper on May 14, 2020 concerning PCI in ambulatory surgical centers (ASCs).  The Centers for Medicare & Medicaid Services began reimbursing for PCI in ASCs in 2020 after data were published supporting same-day discharge after PCI.

ASCs can appropriately perform diagnostic procedures, such as left and right heart catheterization and coronary angiography, as well as intravascular imaging, physiologic assessment, and coronary angioplasty and stenting, according to the document.

But the statement says that only patients who are candidates for same-day discharge should be treated in ASCs, and not all of these patients would be appropriate for the ASC.

“It is crucial that patients in the ASC receive the same quality of care as those in the hospital setting…This paper is a ‘must-read’ for anyone involved with PCI in an ASC.” Lyndon C. Box, MD, chair of the writing group that prepared this document and an interventional cardiologist at West Valley Cardiology Services in Idaho, said in a statement at the release of the position paper.

The Position Paper can be accessed here.  Additionally, a companion statement was issued May 11, 2020 on optimal percutaneous coronary interventional therapy for complex coronary artery disease (available here.)

Implications – Hospitals in markets with competing ASC’s (and not otherwise prohibited by State regulation) have reason to be concerned that they will potentially lose PCI business if cardiologists shift selective business to ASC’s, particularly if they have a financial interest in such facilities.  Notably, CMS has specifically excluded PCI for coronary artery bypass grafts, chronic total occlusions (CTO), myocardial infarction or coronary atherectomy from being reimbursed in an ASC site of service. The implication is that only “clinically easy,” elective cases will be performed in ASC’s, leaving the more difficult cases to be done in-hospital.  The SCAI has published a list of “unfavorable patient conditions,” and “complex or high-risk lesion characteristics” that should be deferred to the hospital setting.  In general, the PCI market is changing, with increasingly complex cases.  The shift in procedural volume from hospitals to ASCs will have financial implications for hospitals that could potentially impact their ability to provide other necessary services, as well as adversely impacting cost per case and clinical outcomes.  Hospitals need to monitor this scenario very seriously.

Key Trends in Cardiac CT at SCCT 2020

Hospitals that are planning or are already pursing advanced imaging programs utilizing CT should be encouraged by the multitude of new and evolving advances highlighted in the Society for Cardiovascular CT (SCCT) 2020 virtual meeting.  Hot topics included quantification of low-attenuation coronary plaque as the next big cardiac risk assessment, coronary artery shear stress as a marker for heart attacks, CT for the assessment of non-STEMI patients, the role of CT in COVID-19, CT's role in structural heart assessments, as well as new CT technologies.   The trial that had many people talking was the SCOT-HEART Trial: LAP (low-attenuation plaque) Burden sub-study.  It showed non low attenuation, noncalcified plaque accurately predicts MI.  The study found there was a five-fold increase in MI if LAP was above 4 percent.  Classifying plaque can be tedious to characterize manually and subject to reader variability, so this study used a semi-automated artificial intelligence (AI)-based plaque quantification software to standardize how the plaque was analyzed.

Other key topics covered at the SCCT 2020 virtual sessions included information on the recent incorporation of calcium scoring into guidelines for primary cardiac risk assessment and cardiac CT increases in uses while reimbursement has been decreased.

For a full review, go to the Diagnostic and Interventional Cardiology website here.  A CFA article titled CT Coronary Artery Calcium Scoring Revisited:  One Hospital’s Successful Cardiac Screening Program, can be found here.

Implications – Advanced imaging continues to rapidly evolve the use of cardiac CT as a diagnostic tool.  Many hospitals have been slow to adapt cardiac CT beyond basic coronary artery calcium scoring for risk-assessment and diagnosis, particularly in light of the dearth of cardiologists truly qualified to use CT to its fullest potential.  While most of the reported developments from SCCT 2020 are not in everyday practice, their future is very positive.  However, reimbursement for existing approved scans has been diminished.  Hospitals need to continually explore advanced imaging technologies, particularly CV CT, as these advancements move into accepted practice.  Recruiting and supporting cardiologists with advanced imaging training and certification will be critical to advance these technologies in the future.  Look for a future blog post from CFA on advanced cardiovascular imaging.

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.  

Cardiovascular News Update and Implications

Posted by John W. Meyer, LFACHE, and Charles W. Franc

3/11/20 10:00 AM

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

More Than Half of Heart Patients Nonadherent to Multi-drug Regimens

This topic is an important one and has always fascinated me personally, as I am also on a cardiac multi-drug regimen.  A new study in the American Journal of Cardiology Feb. 6, 2020 edition finds that over half of heart patients on a triple-drug regimen of ACE inhibitors, statins and either calcium channel blockers (CCB) or aspirin are nonadherent to their medications.  Polypharmacy is effective, the authors said, …” but it also complicates a person’s medication regimen, making them less likely to stick to their doctor’s treatment plan. Data from the World Health Organization suggest nonadherence to antihypertensive meds in particular is low, ranging from 30% to 50%.”

The research team found that 52.1% of patients were nonadherent to the ACE inhibitor/CCB/statin regimen, and 50.6% reported nonadherence to the ACE inhibitor/statin/aspirin regimen. Men and patients at a higher CV risk were more likely to be adherent to their pills; those with depression and atrial fibrillation were less likely to adhere.

Implications – The implications of this research are significant.  “These results confirm that nonadherence is one of the most important hurdles to achieve effectiveness in preventing CVD,” the authors said.  Developing ways to enhance compliance, designing mitigations to existing barriers to compliance, and overall strategies to promote compliance through methodologies such as those supported by smart technology (e.g., wearables, smartphones, EHRs), are critical.

Do Anti-Smoking Policies Pay Off?

As reported in the January 3, 2020 edition of WebMD, U-Haul Corporation is stopping the hiring tobacco users in 21 states, but workplace wellness programs efficacy is in doubt.  U-Haul, with 30,000 employees nation-wide, will stop new-hires of tobacco users in the 21 states where such practices are legal (interestingly, California isn’t one of them).  This may sound logical, since it has been documented by the CDC that smoking-related medical expenses add nearly $170 billion dollars per year to employer and government medical expenses.  Employers also suffer $156 billion dollars in lost productivity from smoking-related health issues.  Further, a randomized 4,500 patient study published in JAMA in 2019 found that employees enrolled in wellness programs showed no major improvements in healthcare status or spending after 18 months, compared with employees who didn’t participate.[i]  A Rand study further found that wellness programs generated an average savings of $157 per employee, which was wiped out by the programs cost of $144 per person.[ii] 

Implications – Such programs and policies remain controversial.  Firstly, only 21 states allow discrimination against tobacco-users in employment.  The issues being individual rights and the best way to address tobacco addiction.  Smokers tend to be less educated, make less money and have fewer health benefits than non-smokers.  In practice, it may be better for a smoker to work for a company that has a smoke-free workplace, but provides support to quit.  Comprehensive health and wellness programs still have a place in a broader program of health promotion, including incentives for compliance and meeting health goals, but they are not a panacea for all employers or employees.  It will be instructive to see how the U-Haul policy plays out over time.      

World’s First Transcatheter Mitral Valve Approved in Europe

The Abbott Tendyne Transcatheter Mitral Valve Implantation (TMVI) system received European approval In January 2020.  It is the first transcatheter mitral valve replacement (TMVR) technology to gain commercial clearance in the world. It addresses a critical need to eliminate mitral regurgitation when surgery or mitral repair is not an option in high-risk surgical patients. 

Implications – The Tendyne system is an investigational device in the United States.  In July 2018, Abbott initiated the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) clinical study in the U.S. for the TMVR system (primary completion date 2022). Abbott will use the SUMMIT data for a market clearance submission to the U.S. Food and Drug Administration (FDA). The Tendyne device allows repositioning and retrieval, enabling more accurate device placement during implantation for better outcomes. The trial is enrolling up to 1,010 patients at 80 sites in the U.S., Europe and Canada.  The rapid development of transcatheter approaches to valve surgery will continue to evolve the competitive marketplace in the U.S.  Small or low-volume valve surgery providers will continue to attempt to build their programs with the additional support provided by new research (see item to follow), new products and new techniques. Competition will inevitably increase; and consequently, volume per provider will decrease.

CMS PCI Volume Requirements Questioned for TAVR, MitraClip

Investigators have completed research that found that there was no relationship between a hospital’s percutaneous coronary intervention (PCI) volume and patient outcomes after valve replacement, therefore questioning the relevance of setting minimum PCI volume standards for structural heart programs.  These findings (reported in JAMA online) are timely now that the Centers for Medicare and Medicaid Services (CMS) is updating the National Coverage Determination (NCD) for the TMVr, which currently includes PCI volume requirements, according to the study authors. TAVR had its most recent NCD update in June 2019.  National readmissions data showed hospitals with different PCI volumes had nearly identical median rates of risk-adjusted in-hospital mortality or 30-day readmission after transcatheter aortic valve replacement (TAVR) in 2016.

Implications – Barriers to entry into the TAVR market keep falling.  As regulation and reimbursement guidelines keep changing in favor of smaller volume programs, additional hospital programs will continue to enter this market.  The findings that PCI volume requirements have minimal or no impact on TAVR outcomes will likely further this trend.

FDA Approves New Lipid-Lowering Drug

The U.S. Food and Drug Administration has approved bempedoic acid, an oral, once-daily, non-statin LDL cholesterol (LDL-C)-lowering medicine for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.

Bempedoic acid has been studied four phase III clinical trials representing more than 3,600 patients. The most recent of these was CLEAR Wisdom, presented at the American College of Cardiology (ACC) 2019 Scientific Session, showing that the addition of bempedoic acid to maximally tolerated statin therapy significantly lowered LDL-C by 15.1% at 12 weeks; it also lowered total cholesterol, apolipoprotein B, non-HDL cholesterol, and C-reactive protein levels. While the study wasn’t powered for clinical events, major adverse cardiovascular events were reduced in the patients treated with bempedoic acid.

Implications – This is important news for the subset of patients who continue to struggle with bad cholesterol and have ASCVD or HeFH, even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. This new drug is an important addition to the continuing pharmaceutical approach to preventing and managing CVD.

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.  

 


Footnotes

[i] https://jamanetwork.com/journals/jama/fullarticle/2730614

[ii] http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf

Coronary Artery Disease Epidemiological Update

Posted by John W. Meyer, LFACHE

2/13/20 10:00 AM

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

Posted by John W. Meyer, LFACHE with interview contribution by W. Michael Barber, R.N.

1/9/20 12:58 PM

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.