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Appendix removal triples Parkinson’s risk but do you really need to worry?

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Recent scary press reports suggest that having your appendix out could triple your risk of getting Parkinson’s disease. Given that there is currently no cure for this neurodegenerative condition, people who have had their appendix out might be quite worried. But worrying, at this point, would be premature. The science is far from settled.


The news reports were based on a new study by researchers at Case Western Reserve University, which analysed data on more than 62m people in the US. It’s true that the new study found that the risk of Parkinson’s was higher in people who’d had an appendectomy than in those who didn’t, but the risk was small in both groups. The researchers found that of those who’d had an appendectomy, 0.92% went on to develop Parkinson’s compared with 0.29% who developed the disease but hadn’t had an appendectomy earlier in life.


The Parkinson’s risk figure is roughly similar to the lifetime risk of dying in a motor vehicle crash if you live in the US (despite many people overestimating their chances of dying in a car crash). In my opinion, the risk of Parkinson’s from having your appendix out is too small to worry about, given all the other risks of life. For example, about half of people born in the UK after 1960 will be diagnosed with some sort of cancer during their lifetime. According to an NHS data tool, for men of my age, height, weight and with a similar medical history to mine, about 15% will have a heart attack or stroke in the next ten years. And I don’t smoke. For men otherwise like me but who smoke 20 or more cigarettes a day, the ten-year risk goes up to 25%. Anyway, as we’ll see, it’s not possible to tell whether the appendix operations caused the difference in risk in the new Parkinson’s study.


Limited information


We know little about this new study. All there is, so far, is a press release and an abstract. The researchers will describe the study in more detail at an upcoming conference. But at this stage, the evidence hasn’t been peer reviewed – that is, other scientists haven’t had a chance to comment on the study’s strengths and weaknesses.


The details are particularly important for this new study because its findings aren’t consistent with some previous studies that looked at appendix operations and Parkinson’s. There have been several such studies. Some chime with the latest study. A study in Denmark, for example, also found that people who had their appendix out had an increased risk of Parkinson’s. However, a study published in 2018, based on data from millions of people in Sweden and the US found the opposite. That is, people who had their appendix removed had a lower risk of Parkinson’s. And another study in 2017 found no association between appendix removal and Parkinson’s.


It might surprise you, if you haven’t come upon this before, that researchers are interested in possible links between appendectomy and Parkinson’s – something that involves changes in the brain. The reason is that abnormal forms of a protein involved in Parkinson’s have been found in the gut, and there are many nerves that link the gut to the brain.


Observational studies


I’m a statistician, so I’m not qualified to comment on the biological aspects of these studies, but I do know about studies based on data from large numbers of people. The studies that I’ve mentioned work in one of two ways. Either you find two comparable groups of people, one group who have had their appendix out and another who haven’t, then see which of them develops Parkinson’s later. Or you find a group that has Parkinson’s and another comparable group that hasn’t and you look back to see how many in the two groups had their appendix out.


These are all called observational studies because they simply observe people and don’t attempt to change what they do. That sounds simple enough. But there’s a snag with observational studies. If you look at Parkinson’s risk in people who have and have not had their appendix out, there will be other differences between the groups apart from whether they have had an appendix operation.


For example, they might be older or younger on average, or they might have had a different experience with other diseases. Any difference in Parkinson’s risk between the groups might be a result of one of these other factors, called “confounders” and have nothing directly to do with the appendix operations at all.


Statisticians can “adjust” for the confounders that they know about and have data on, and that might make what is going on a bit clearer – though it’s still not possible to be sure about what is causing what. And nothing can be done statistically about the confounders that the researchers have no data on or that they don’t know about.


It’s possible that the differences in findings between all these studies are all down to other differences in the populations involved, or to differences in the adjustments for confounders that were made. So I’d say that we still don’t know whether having your appendix out is associated with a reduced risk of Parkinson’s, or an increased risk, or isn’t associated with the risk at all.


We don’t even know yet what the new Cleveland study did about adjustment for confounders. All that is mentioned in the abstract is that they looked at data on age and ethnicity.


Personally, I won’t pay any more attention to the Cleveland study until it’s properly published in a scientific journal, following peer review. Conference abstracts are there mainly to inform other scientists because they usually come too early on in the scientific process to be a good guide for the media on what’s going on.


And the fact that different studies have produced such different findings is a clear demonstration that you shouldn’t read too much into any single research study, particularly when all the studies are observational. However good the Cleveland study turns out to be when it’s published, we can’t just ignore all the others. Scientists still have to go through the process of looking at all this varied research in the round. And, anyway, the picture probably won’t become clear until even more research is done.


 





Kevin McConway
, Emeritus Professor of Applied Statistics, The Open University


This article is republished from The Conversation under a Creative Commons license. Read the original article.

 


The Conversation



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Medtronic says won’t recall pacemakers after drug regulator issues alert

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Medtronic India has said it is not recalling its pacemaker models in the country and is in discussion with relevant stakeholders following an alert issued by drug regulator Central Drugs Standard Control Organisation (CDSCO) over the performance of pacemakers.


CDSCO has alerted patients with implants of three Medtronic pacemaker models to seek immediate medical care if they feel certain symptoms that could be signs of the devices’ sudden battery depletion.


Medtronic sells in India, Astra pacemaker, Solara CRT-P and Serena CRT-P.


“We have and continue to communicate proactively with the doctors and relevant stakeholders in India and have informed them about the performance note. There have been no patient issues reported in India related to this performance note,” the statement by the company said.


Stressing that it was “not a case of product recall”, Medtronic India said, “We are in proactive discussion with CDSCO”.


Medtronic has published a performance note about a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers.


“We have received three complaints out of 266,700 devices distributed worldwide since February 2017. The projected rate of occurrence for this issue is 0.0028 per cent, with the most susceptible period being the first 12 months after a device is implanted,” the statement said.


In consultation with company’s independent physician quality panel, “We do not recommend device replacement, and advise physicians to continue normal patient follow-up in accordance with standard practice and, where possible, to continue with remote monitoring,” it added.


“While the devices continue to perform well within reliability projections, Medtronic has implemented additional process and component enhancements that have been reviewed and approved by Food and Drug Administration,” the statement said.


The CDSCO has asked patients with any of the three models to seek immediate medical care if they feel light-headed, dizzy or experience chest pain and loss of consciousness.


The alert by the regulator came after the US Food and Drug Administration raised alarm over the use of the pacemaker models Astra, Serena and Solara.


In its alert on May 7, the USFDA cited a case in which a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider.


Medtronic’s implantable pacemakers or cardiac resynchronization therapy pacemaker (CRT-Ps) are devices that provide pacing for slow heart rhythms and heart failure pacemakers and CRT-Ps are both implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart.


As per the alert by CDSCO, doctors have been recommended to be alert and consider whether elective device replacement is warranted for a pacemaker patient.


“Be aware of sudden battery level drops during follow-up visits and remote transmissions. Watch for decrease in battery level out of proportion to the life of the device from the time of implant even if the level remains within the normal range,” the alert stated.



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India’s drug regulator warns patients against faulty Medtronic pacemakers

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The Indian drug regulator has alerted patients with implants of three Medtronic pacemaker models to seek immediate medical care if they feel light-headed, dizzy or experience chest pain and loss of consciousness, saying these could be signs of the devices’ sudden battery depletion.


The alert by Central Drug Standards Control Organisation (CDSCO) came after the US Food and Drug Administration (USFDA) raised alarm over the use of the pacemaker models Astra, Serena and Solara.


In its alert on May 7, the USFDA cited a case in which a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider.


If a capacitor in a CRT-P is cracked, it can create an electric short, which can cause the battery to drain earlier than expected.


Medtronic’s implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are devices that provide pacing for slow heart rhythms and heart failure pacemakers and CRT-Ps are both implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart.


India’s CDSCO has advised patients to seek immediate medical assistance if they feel dizzy, light-headed, severe short breath or loss of consciousness.


“These may be signs that your device’s battery has had a sudden drop or has drained,” it said.


Doctors have been recommended to be alert and consider whether elective device replacement is warranted for a pacemaker patient.


“Be aware of sudden battery level drops during follow-up visits and remote transmissions. Watch for decrease in battery level out of proportion to the life of the device from the time of implant even if the level remains within the normal range,” the alert stated.


Medtronic reported that healthcare providers were unable to communicate with the device due to battery depletion resulting in loss of pacemaker function. It also reported these events occurred in the US within one year after the patient was implanted with the pacemaker or CRT-P.


One of the reported events resulted in the death of a pacemaker-dependent patient.


In another reported incident, the patient experienced dizziness during follow-up and the healthcare provider was unable to communicate with the device, which resulted in the patient getting their device replaced.


In the third event, there was no harm to the patient because the device was not implanted when the healthcare provider became aware that a connection with the device could not be established.



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Health

Specialised microscope can diagnose skin cancer, perform surgeries: Study

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Scientists have developed a specialised microscope that has the potential to diagnose diseases like skin cancer as well as perform precise surgery without making any incisions in the skin.


According to the study published in the journal Science Advances, the microscope allows medical professionals to pinpoint the exact location of an abnormality, diagnose it and treat it instantly.



“Our technology allows us to scan tissue quickly, and when we see a suspicious or abnormal cell structure, we can perform ultra-precise surgery and selectively treat the unwanted or diseased structure within the tissue — without cutting into the skin,” said Yimei Huang from the University of British Columbia in Canada.


It could be used to treat any structure of the body that can be reached by light and requires extremely precise treatment, including nerves or blood vessels in the skin, eye, brain or other vital structures, researchers said.


“For diagnosing and scanning diseases like skin cancer, this could be revolutionary,” said Harvey Lui, professor at the University of British Columbia.


The study shows that the device allows imaging of living tissue up to about one millimetre in depth using an ultrafast infrared laser beam.


Researchers said that this microscope, however, is different from previous technology due to its capability to not only digitally scan living tissue, but also treat the tissue by intensifying the heat produced by the laser.


“We can alter the pathway of blood vessels without impacting any of the surrounding vessels or tissues,” said Lui.


The researchers also said that their aim is to make multiphoton microscope technology more versatile while also increasing its precision.


“We wanted to be able to identify what was happening under the skin from many different angles and to have the capability of imaging different body sites,” said Haishan Zeng from the University of British Columbia.


Developments of a miniature version of the telescope that could be used to perform microscopic examinations and treatment during endoscopy are also underway, researchers said.


“We are not only the first to achieve fast video-rate imaging that enables clinical applications, but also the first to develop this technology for therapeutic uses,” said Zeng.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)



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