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The CMG Voice

New research indicates more patients with faulty heart valves can avoid open-heart surgery

Posted Monday, April 1, 2019 by Tyler Goldberg-Hoss

The New England Journal of Medicine recently published results of a study which found that many more patients with aortic heart valve problems can avoid open-heart surgery and replace the valves through a less invasive procedure.

For years, patients who had damaged heart valves needed major surgery to replace them. This means opening up the chest cavity, putting patients on bypass (a machine pumps blood and breathes for them while the surgery is going on), and replacing the valve surgically.

About 10 years ago, an expandable valve was designed for patients who were too sick to undergo such a major surgery – the valve is placed using a catheter into an artery instead.

Now, researchers apparently have concluded that this method can also be used for patients who are not at high risk – all patients can use this method to avoid the trauma of open heart surgery.

In particular, the study found using this expandable heart valve led to fewer deaths and strokes, and less cost.

More research is being conducted to see whether this catheter-based approach might work for other types of heart valves.

You can read more here:

Tens of Thousands of Heart Patients May Not Need Open-Heart Surgery

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FDA Expresses Concern on Use of Robotic Devices in Cancer Surgeries

Posted Wednesday, March 27, 2019 by Carl-Erich Kruse

The FDA recently issued a safety communication warning against the use of robotically assisted surgical devices in cancer treatments, including mastectomies. The FDA was careful to reiterate that it has never granted marketing authorization of robotically assisted surgical devices for use in cancer treatment, though surgeons continue to use the machines at an increased pace. Patients are cautioned to take a closer look at the surgical options offered by their surgeon.

In fact, a pair of studies published in the fall of 2018 showed that robotic, “minimally invasive hysterectomies” performed on women with cervical cancer result in lower rates of disease-free survival and overall survival than “open” surgeries performed without a robot. One study revealed that four years after surgery nearly twice as many patients died following robotic surgery than those who had open surgery.

It was unclear why the outcomes were significantly different. This lack of clarity contributed to the FDA’s recent communication.

On the one hand, patients and providers are attracted to the faster recovery times of robotic surgeries. But these two studies and the FDA safety communication show that there is far more to consider when evaluating treatment options.

The FDA communication recommends that patients discuss the risks, benefits, and alternatives of all treatment options with health care providers. It specifically recommended patients ask about possible complications and how they happen as well as the surgeon’s training, experience (including number of procedures performed), and patient outcomes with robotic surgery. The FDA in turn recommended “that [surgeons] take training for the specific robotically-assisted surgical device procedures….”

You can read the FDA’s safety communication here.

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Clinical Trial Bots can help sick patients find the right clinical trials

Posted Monday, March 18, 2019 by Tyler Goldberg-Hoss

Roughly, there are 50,000 clinical trials worldwide – trials designed to test new drugs and therapies, often involving sick patients as willing participants.

Unfortunately, for a sick patient it can be very difficult to find a clinical trial that might benefit him or her.

Enter “Clinical Trials Bot”, software created by Microsoft to allow patients to search studies, answer some questions, and hopefully find a list of clinical trials that may be right for them.

Certainly, when someone is sick or dying, finding the right clinical trial may be a matter of life and death. However, there are some possible downsides.

Microsoft is apparently trying to sell this tool to drug and device companies to allow them to better find patient participants. Although the patient and company may have a shared goal of success, the company’s main goal is always profit. As such, patients with little or no hope of success may be coerced into participating in a clinical trial that has little benefit to the patient, but helps the company reach its goal of being able to sell whatever product they are testing.

You can read more here:

Microsoft builds a bot to match patients to clinical trials

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Maternal death rates in US highest among developed nations

Posted Thursday, March 14, 2019 by Tyler Goldberg-Hoss

Developed nations may be defined as those with a more developed economy and advanced infrastructure relative to other, less developed nations. Although exact definitions are up for debate, most agree that countries such as Australia, Germany, Norway, Switzerland, England and, yes, the United States, qualify.

In many such nations, the maternal death and injury rate has been decreasing over time. However, the opposite is true in the United States. These rates of mothers dying or being seriously injured giving birth are going up, and now with 26.4 per 100,000 births, we have the highest rate in the developed world.

There are a number of reasons for this. First, oversight groups have been lax in quantifying these complications relative to others. Medicare, for example, doesn’t require hospitals to report childbirth complications, while they do for hip and knee surgeries. Without data to analyze trends, it’s harder to effect change.

Second, many of these complications are preventative. One leading cause of maternal death is extreme blood loss. With earlier intervention by hospital personnel, many of these lives could be saved. California is an example of a State which has a protocol in place to administer medications in a timely manner. In part as a result of this, maternal deaths in California have been cut by half, even while rates rise in other parts of the US.

Something doesn’t add up when the most prosperous nation in the world still allows more death and injury to mothers in childbirth than every other developed nation. Tracking adverse events and creating protocols are two simple, common sense ways to save lives.

You can read more here:

U.S. Hospitals Do Little to Protect Mothers During Birth

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Research Shows that Overlapping Surgeries are Generally Safe (some exceptions may apply)

Posted Monday, March 11, 2019 by Morgan Cartwright

A series produced by the Seattle Times in 2017 covered the practice of overlapping brain and spine surgeries done without informing patients of the practice. While the articles touched off discussions on the practice, facilities varied in their responses: some banned the practice outright, while others allow the practice after disclosing the possibility of overlapping surgeries to patients as part of the informed consent process.

A report of research studying the issue was issued in early 2019: “Is surgery safe as practiced in academic environments that balance the needs of safe patient care with those required to train the next generation of surgeons? The answer appears to be ‘yes’.” The caveat is that overall, while overlapping surgery is probably a safe practice for most patients, different procedures and high-risk patients see a higher rate of complications and/or death.

Researchers looked at 66,430 operations in patients aged 18-90, undergoing total knee or hip replacements, spine surgery, coronary artery bypass graft surgery, and craniotomies at eight centers over eight years between 2010 and 2018. Of the 66,340 operations, 8,224 (12%) were overlapping.

“Overlapping surgery” was defined as two or more operations performed by the same surgeon in which more than one hour of one case, or, if one case is less than an hour the entire case, occurs when another operation is being performed. The practice is often seen as critical for training surgical residents, who need exposure to parts of surgeries over the course of their fellowships to ultimately perform full surgeries independently. High-risk patients were classified based on age, health, and comorbidities.

The study found overlapping surgery was overall not associated with a significant difference of mortality (1.9% overlapping v. 1.6% non-overlapping) or risk of complications (12.8% v. 11.9%). Overlapping surgeries did result in increased surgery length, which puts patients at greater risk (e.g. longer time under anesthesia), as well as possibly higher bills related to longer surgery times.

Overlapping surgery was found to be significantly worse for high risk patients: with increased rates of mortality (5.8% v. 4.7%) and complications (29.2% v. 27%). And the study found higher rates of complications for specific overlapping procedures, such as coronary artery bypass grafts.

Admittedly, the study was limited in that it did not account for whether overlapping procedures were the result of emergencies, or whether surgeons were more likely to overlap surgeries in low-risk patients. The authors acknowledged that further study is needed to understand the association of overlapping surgery among specific patient subgroups.

Further research should continue to shed light on appropriateness of overlapping surgeries in different patients, and for different circumstances, while benefiting overall patient outcomes.

You can read more here:

Study: High-risk patients may have worse outcomes when surgeons are double-booked

Overlapping Surgery and Perioperative Outcomes

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