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Pioneering heart procedure
CMC first in the world to implant heart device in new population of patients

03/23/17
By Ryan Lessard news@hippopress.com



 In February, Catholic Medical Center in Manchester became the first hospital in the world to implant a stroke-preventing heart implant in a new population of patients. 

CMC spokesperson Lauren Collins-Cline said the device, called a Watchman, was launched in 2015 and invented to serve people diagnosed with non-valvular atrial fibrillation (AFib) who can’t tolerate blood thinners like coumadin. Essentially, it blocks off a pocket in the heart called the left atrial appendage. 
“It looks a little bit like a mesh balloon,” Collins-Cline said.
Non-valvular AFib is a neurological disorder that causes the valve to that pocket to open and close irregularly. That leads to blood pooling in the atrial appendage, which leads to clotting, which leads to a stroke if a blood clot comes loose.
“Traditionally [with] these patients, in order to help prevent stroke, we … still recommend anticoagulants,” said Dr. Jamie Kim at CMC.
The initial clinical study of this device, developed by Boston Scientific, required blood thinners be temporarily prescribed after the surgery, so the first population of patients who could use the device were those who could tolerate using those drugs for a short period of time. 
But that left out the group that could potentially benefit the most from the Watchman: people who, due to various physiological issues, can’t risk using blood thinners at all. 
The reason for that, Kim said, was an abundance of caution. When a foreign body is implanted into an organ, blood has a tendency to clot on the device, at least for the first 45 days, before a layer of human tissue grows around it. So, without blood thinners, the Watchman runs the risk, in the early days, of causing or accelerating the very problem it’s meant to prevent: strokes. 
In the current study, patients are given a less powerful regimen of drugs that are meant to help prevent clotting.
“We know with stents, that risk is mitigated by aspirin and Plavix,” Kim said.
Patients in the new study will use those drugs instead of coumadin for the first three months after surgery, and neurologists will be added to an already diverse team of specialists involved in the procedure to monitor for strokes or minor strokes.
Kim said there was a small study in Europe looking at how the device works without blood thinners and researchers saw positive results. This study involves 100 centers in several countries. CMC is a leader in the project, helping to train other centers in the procedure. Kim performed the first procedure on a female patient in February.
Since then, CMC has stayed ahead of the pack in procedures performed to date. 
Kim says one of the reasons CMC was able to do this is the diverse team required, which includes an implanting physician, imaging specialist, anesthesiologist and back-up cardiac surgeon.
“Not every center is equipped with all those different disciplines to provide this service,” Kim said.
The CMC team has come up with best practices to streamline the process and can perform up to four or five of these procedures in a single day. Most centers can only do two or three in a day.
Ultimately, researchers hope to have at least 888 patients enrolled in the clinical study, which includes a control group of people who will not receive the device. As part of a push to get more female patients involved, since they’re traditionally underrepresented in cardiac device trials, the study stipulated 35 percent of the subjects be female. 





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