The CFA Perspective

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.

Quarterly Cardiovascular News Update and Implications

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

11/21/19 4:07 PM

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.