The CFA Perspective

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