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| The Monthly Pulse |
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| Abbott’s HeartMate LVADs recalled again over screen issues—FDA highlights significant risks
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| The Story |
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| According to the U.S. FDA, Abbott recently issued a Class I recall for the system monitors of their HeartMate left ventricular assist devices (LVADs), citing ongoing safety issues. To be categorized as a Class I recall, devices must present a risk of serious injury or death. In this case, screen issues including freezing, distorted text, missing information, and overlapping or unresponsive buttons could cause clinicians to inadvertently alter pump settings, which could lead to inadequate flow of blood and ultimately, stroke, brain damage, organ failure, or death. |
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| What You Should Know |
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| This latest recall follows a series of separate Class I recalls for Abbott’s LVADs, including one in April and another one in May. The FDA is not asking devices to be returned to the manufacturer; instead, Abbott has provided recommendations for clinicians to follow when using the devices. According to Abbott, there have not been any serious adverse health outcomes, and no devices are being removed from the market.
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| How persistent AFib impacts TAVR survival
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| The Story |
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| New findings published in the American Journal of Cardiology show patients with persistent atrial fibrillation (AFib) who undergo transcatheter aortic valve replacement (TAVR) may face a higher risk of long-term mortality. Yet, this doesn’t appear to be the case for patients presenting with preoperative paroxysmal AFib. These findings were based on a review of data from nearly 3,000 TAVR patients at a single high-volume medical center in the U.S.
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| What You Should Know |
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| A year after TAVR, AFib patients experienced higher rates of all-cause mortality than those without AFib. After a mean follow-up period of four years, however, the study authors noticed a trend: there was no longer an increased risk of all-cause mortality among the group with preoperative paroxysmal AFib, while preoperative persistent AFib was still associated with a greater mortality risk. Researchers suspect the overlap between AFib risk factors and aortic stenosis, including advanced age and heart disease, may be an explanation for their findings.
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| Mechanical valves linked to superior long-term survival after tricuspid valve replacement |
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| The Story |
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| Each type of valve comes with unique benefits and drawbacks. To better determine the differences in long-term outcomes between mechanical and tissue valves, researchers assessed data from more than 7,000 patients across 21 different studies. Their findings showed that mechanical valves were associated with a lower risk of death over time compared to tissue valves, with mean survival times of 12.4 years and 10.2 years, respectively. |
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| What You Should Know |
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| Researchers determined that patients presenting with AFib who received mechanical valves had even better long-term survival odds. The research group believes this is related to the protective anticoagulation against AFib-related events that patients with a mechanical prosthesis and AFib receive. Based on these benefits, they suggest that mechanical valves be considered when clinically reasonable.
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| Leadership Reflections |
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The Age of Noise
If you are a consumer of earnings reports and outlooks, you know that AI is a common topic of discussion by leaders in virtually all industries. AI has applications that directly benefit the customer and use cases that increase productivity on the administrative end of the organization. It also reminds me a bit of the dot com boom. I don’t believe this is some flash in the pan technology, however, we often observe exuberance around new technologies while collectively discerning use cases that are value creating vs. those that are conceptually attractive not delivering yields (CANDY for short).
I have experienced the most interactions with AI, specifically LLMs, in my email inbox. In the early stages, it was fairly easy to identify clunky marketing outreach generated with LLMs. Two primary selling points include the models constantly “learning” and enabling scaling up to reach a larger audience. Conceptually, the technology can deliver almost limitless personalized touch points, vastly exceeding the capabilities of a human creating and initiating each interaction. As these technologies continue to evolve and improve, it becomes increasingly difficult to distinguish AI prepared communication from human communication. Proponents will say that is the power of the technology.
Given that these technologies have virtually limitless scale, at what point does the communication medium like email become so full of noise that the channel becomes worthless? Ironically, one of the other use cases is the idea of a virtual assistant which can include screening and perhaps even responding to the deluge of incoming email. This sets up the scenario where messaging initiated by an AI technology is filtered and responded to by an AI technology. So, bots talking to bots? On the one hand, that sounds crazy. On the other hand, it would be unwise to underestimate the capabilities of these technologies.
Are you observing similar trends in your inbound communication? Are you experiencing the “noise” related to AI-generated content and volume? What strategies are you using to cut through the noise?
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| 2024 AANP Fall Conference |
| Thurs., Sept. 19 - Sun., Sept. 22 |
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AAPA Leadership and Advocacy Summit |
| Thurs., Sept. 12 - Sat., Sept. 14 |
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| American College of Surgeons Clinical Congress 2024 |
| Sat., Oct. 19 - Tues., Oct. 22 |
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| OR Manager Conference |
| Mon., Oct. 28 - Wed., Oct. 30 |
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