Advances in Cardiology: Current and Emerging Procedures
Utilization Management Insights
By Kathryn Kolonic, , DO, MPH, CPHQ
AllMed Vice President & Medical Director
Cardiovascular disease (CVD) claims more than 850,000 lives in the United States each year and is the leading cause of death and disability worldwide.1 Almost half of adults in the U.S. have some form of CVD2, which affects people of all ages, sexes, ethnicities, and socioeconomic levels. Recent advances in treatment offer promise for reducing CVD’s impact on lives. Yet, as with all therapies and technologies, understanding the specific risks, benefits, and appropriate uses of each is essential to realizing positive outcomes.
In a recent AllMed-hosted webinar, we had the opportunity to discuss contemporary procedures and emerging technologies for treating CVD with two specialists in the field. Our guests were cardiologist and internal medicine specialist Dr. David Brill of Northeast Medical Group, a part of Yale New Haven Health, and Dr. Jason Linefsky, cardiologist at Grady Memorial Hospital and Atlanta Veterans Affairs Medical Center and associate professor of cardiology at Emory University School of Medicine. Given the strong interest in this topic, I’ve summarized some of the key takeaways from the discussion below.
Devices Reduce Danger from Blood Clots
Blood clots play a major role in heart attacks and strokes. Researchers are making significant progress in reducing the risks associated with clots.
One relatively new technology receiving a fair amount of attention, partly due to direct-to-consumer marketing, is the WATCHMAN™ endovascular device. Approved by the U.S. Food & Drug Administration (FDA) in 2015, the WATCHMAN was designed to prevent blood clots from forming in the heart’s left atrial appendage (LAA) and then escaping and causing a stroke—a common problem for patients with atrial fibrillation (AFib). The device, which is implanted in the LAA via a minimally invasive procedure, provides a useful alternative to blood-thinning medication or to more invasive surgery for patients whose AFib is not caused by a heart valve problem.
Drs. Brill and Linefsky clarified that the WATCHMAN can be particularly beneficial for patients who should avoid taking blood thinners, which are the standard of care, due to risk factors such as high blood pressure or history of a stroke that increase the risk of severe bleeding. Over the past twenty years, a substantial number of rigorous studies, such as the PREVAIL and PROTECT AF trials, have demonstrated that the WATCHMAN provides stroke prevention in nonvalvular atrial fibrillation comparable to warfarin.3
Similar to the WATCHMAN, the Amplatzer Amulet Left Atrial Appendage Occluder, approved by the FDA in 2021, is a smaller alternative that serves the same purpose. Data analyzed to date indicate that the Amulet’s effectiveness in terms of stroke prevention for nonvalvular atrial fibrillation is comparable to that of the WATCHMAN4, however there is less data available for the newer Amulet.
Many providers are familiar with the Greenfield filter, another useful tool for minimizing danger from blood clots. Drs. Brill and Linefsky emphasized that, unlike the WATCHMAN and the Amulet, which are endovascular devices designed to prevent clots from forming in and escaping from the heart itself, the Greenfield Filter is a screen placed in the inferior vena cava to catch clots coming up from the lower extremities, for example in cases involving trauma. The filters have become a major component of catastrophic pulmonary embolism prevention but have some long-term risks, including caval thrombosis, visceral penetration, and the filter serving as a nidus for infection.5
Implantable and Wearable Devices Help Manage Heart Rhythm
Progress in the design of pacemakers and defibrillators is expanding options available to CVD patients who need assistance managing their heart rhythm.
A leadless pacemaker, which is 90 percent smaller than a transvenous pacemaker, is a battery-operated device inserted into the right ventricle of the heart via a catheter. The device eliminates some of the complications associated with transvenous pacemakers and leads. These include pocket infections, hematoma, lead dislodgment, and lead fracture. In addition, the leadless pacemaker has cosmetic appeal because there is no chest incision or visible pacemaker pocket.6 It is important to note that leadless pacemakers provide only single-chamber ventricular pacing and therefore are not appropriate for patients who require dual-chamber pacing. Currently, there is only one FDA-approved leadless pacemaker, the Medtronic Micra.
The first wearable defibrillator was approved by the FDA in 2001. Its utility has been the subject of some debate since then. Currently, there are three wearable defibrillators commercially available: the LifeVest, the LifeVest for children, and the ASSURE system. Data accumulated to date indicate that this type of device is appropriate only for a very select, high-risk population—people who need an implanted defibrillator but are not eligible yet according to current guidelines (40 to 90 days after an acute event or revascularization) or those who need a cardiac transplant and have an underlying condition such as an active infection that makes it impossible to implant a defibrillator. Studies have shown the device can be an effective method of reducing the risk of sudden cardiac death following an acute myocardial infarction if used properly (i.e., worn continuously, with close attention to the various alarms that may become activated).7 Because the device is cumbersome and uncomfortable, a lack of adherence often limits its benefit, but efforts are underway to improve the patient experience.
Biopharmaceutical Research Yields Innovative Medicines
As with devices, recent pharmaceutical research has yielded new options in medications available for CVD treatment.
Mavacamten is a cardiac myosin inhibitor for patients with hypertrophic cardiomyopathy. A recent study of 251 patients found mavacamten to be extremely effective in reducing hemodynamic outflow tract obstructions with no significant long-term treatment-related adverse events.8 This study, in which patients had a left ventricular outflow tract (LVOT) of at least 50, is the basis for the current guidelines. Drs. Brill and Linefsky emphasized that hypertrophic cardiomyopathy is a very heterogeneous disorder, so the results of the study cannot be extrapolated to patients who don’t have an LVOT of at least 50. Mavacamten is available only under a restricted distribution program. Doctors who prescribe it must monitor patients closely with periodic echocardiographic follow-up.
PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors offer a new alternative to widely prescribed statins for patients for whom other medications have not worked or for those with a genetic predisposition toward high cholesterol. PCSK9 is a protein made by the liver that regulates how many low-density lipoprotein (LDL) receptors a person has. LDL receptors attach to LDL cholesterol to carry it into the liver, which then breaks it down and gets rid of it. PCSK9 inhibitors are a biologic drug, administered by injection, that blocks the PCSK9 from breaking down LDL receptors. The result is that more of a patient’s LDL receptors work, which allows the patient’s liver to reduce LDL cholesterol more efficiently. Currently, there are two types of PCSK9 inhibitors that have been approved by the FDA.
Technology Advances Prevention and Early Detection
While managing lifestyle factors remains the first line of defense to prevent and control CVD, there have been advances in this area as well.
A calcium-score screening test may be helpful for early detection. The test uses computerized tomography (CT) to detect and measure calcium-containing plaque in arteries. A higher coronary calcium score (over 200 on a scale of zero to 400) suggests that a patient has a higher chance of significant narrowing in the coronary arteries and a higher risk of future heart attack. A health provider considers the score combined with other risk factor measurements to determine a patient’s overall risk and whether lipid-lowering therapy is warranted.
Use of myocardial strain imaging, another technology-based advance, has been growing over the past 10-15 years. Because strain abnormalities often develop before overt clinical disease or even mild subclinical abnormalities9, an echocardiogram with strain can be a non-invasive way for a healthcare provider to diagnose some heart conditions earlier in people at risk. Though the relationships between strain rate measurement and abnormalities/diseases are useful, development of focused clinical roles for strain imaging has been slow. This is largely because, while evidence indicating that strain imaging leads to improved outcomes is growing, there have not yet been very large, randomized studies. In addition, a lack of standardization creates uncertainty as to appropriate use. Currently, providers most frequently use myocardial strain imaging to screen people who receive cardio-toxic medications during cancer treatment, those who receive radiation to their chest, and those who have cardiomyopathy, heart failure, or pericardial disease.
Cardiology Expertise from AllMed Helps You Determine the Optimal Treatment for Each Member
As this summary of our webinar highlights, emerging technologies and original research are moving the treatment of CVD forward significantly. Understanding how new therapies work and the risks and benefits of each is key to delivering the right care at the right time to members. At AllMed, the board-certified cardiologists on our review panel are in active practice, gaining experience with innovative, new treatments daily. Rely on our experts for support when your team needs specialized knowledge to ensure optimal care that aligns with plan policies.
- 1 American Heart Association. AHA names top advances in cardiovascular disease research for 2022. 2022 Dec 21. https://www.heart.org/en/around-the-aha/top-cardiovascular-research-advances-of-2022. Accessed March 27, 2023.
- 2 Benjamin E, Muntner P, et al. American Heart Association Heart Disease and Stroke Statistics—2019 Update. Circulation. 2019 Jan 31. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000659. Accessed March 28, 2023.
- 3 Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4. PMID: 29103847. https://pubmed.ncbi.nlm.nih.gov/29103847/ Accessed March 27, 2023.
- 4 Lakkireddy D, Thaler D, et al.; Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation AHA. 2021 Aug 30. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057063. Accessed March 27, 2023.
- 5 Huang J, Bold M, Rajebi MR. Endovascular retrieval of Greenfield IVC filters 13 and 19 years post placement without major complication. J Radiol Case Rep. 2017 Jun 30;11(6):15-25. doi: 10.3941/jrcr.v11i6.3031. PMID: 29299094; PMCID: PMC5743144.
- 6 Groner A, Grippe K. The leadless pacemaker: an innovative design to enhance pacemaking capabilities. Journal of the American Academy of Physician Assistants 32(6):p 48-50, June 2019. | DOI: 10.1097/01.JAA.0000554750.85170.d4. https://journals.lww.com/jaapa/Abstract//2019/06000//The-leadless_pacemaker_An_innovative_design_to.11.aspx. Accessed March 29, 2023.
- 7 Chu, Edward MD. The Wearable Cardioverter Defibrillator: A Life (Vest) of Controversy. American College of Cardiology. 2020 Oct 15. https://www.acc.org/latest-in-cardiology/articles/2020/10/01/01/42/focus-on-ep-the-wearable-cardioverter-defibrillator-a-life-vest-of-controversy. Accessed March 29, 2023. Or Olgin J, Pletcher M, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction. The New England Journal of Medicine. 2018 Sep 27. https://www.nejm.org/doi/full/10.1056/NEJMoa1800781. Accessed March 29, 2023.
- 8 Bavry A. Mavacamten for Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy – EXPLORER-HCM. American College of Cardiology. 2022 Apr 3. https://www.acc.org/latest-in-cardiology/clinical-trials/2020/08/28/16/14/explorer-hcm. Accessed March 29, 2023.
- 9 Reichek, Nathaniel. Myocardial Strain. Circulation: Cardiovascular Imaging. 2017 Nov 14. https://www.ahajournals.org/doi/full/10.1161/CIRCIMAGING.117.007145. Accessed March 28, 2023.