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FDA approves upadacitinib for ulcerative colitis
The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.
It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.
In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.
In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.
Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”
Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.
Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.
It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.
In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.
In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.
Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”
Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.
Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.
It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.
In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.
In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.
Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”
Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.
Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.
A version of this article first appeared on Medscape.com.
Relax. The dog-tor will see you now
Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
FROM PLOS ONE
FDA clears once-weekly transdermal patch for Alzheimer’s
Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.
Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.
“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.
“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.
The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company expects the donepezil transdermal patch to be available in early Fall 2022.
A version of this article first appeared on Medscape.com.
Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.
Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.
“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.
“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.
The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company expects the donepezil transdermal patch to be available in early Fall 2022.
A version of this article first appeared on Medscape.com.
Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.
Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.
“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.
“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.
The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company expects the donepezil transdermal patch to be available in early Fall 2022.
A version of this article first appeared on Medscape.com.
AI-assisted colonoscopy cuts adenoma miss rate in half
Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.
“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.
The study was published online March 15 in Gastroenterology.
Tandem colonoscopy study
Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.
All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.
The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.
Bowel preparation and quality of the examinations were similar for the study groups.
The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.
Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.
With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.
The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).
The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
More high-quality evidence for AI-assisted colonoscopy
“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.
“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.
Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.
This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.
Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”
Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”
He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.
The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 3/16/22.
Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.
“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.
The study was published online March 15 in Gastroenterology.
Tandem colonoscopy study
Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.
All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.
The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.
Bowel preparation and quality of the examinations were similar for the study groups.
The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.
Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.
With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.
The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).
The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
More high-quality evidence for AI-assisted colonoscopy
“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.
“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.
Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.
This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.
Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”
Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”
He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.
The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 3/16/22.
Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.
“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.
The study was published online March 15 in Gastroenterology.
Tandem colonoscopy study
Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.
All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.
The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.
Bowel preparation and quality of the examinations were similar for the study groups.
The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.
Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.
With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.
The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).
The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
More high-quality evidence for AI-assisted colonoscopy
“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.
“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.
Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.
This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.
Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”
Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”
He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.
The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 3/16/22.
Can green tea extract protect against colorectal adenomas?
Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.
Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.
But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.
However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.
Their study was published online in The American Journal of Gastroenterology.
Largest trial to date
The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.
There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.
After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.
The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.
However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.
In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.
This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.
The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.
The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
Caveats and cautionary notes
Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”
“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.
The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.
Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”
The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.
Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.
But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.
However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.
Their study was published online in The American Journal of Gastroenterology.
Largest trial to date
The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.
There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.
After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.
The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.
However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.
In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.
This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.
The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.
The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
Caveats and cautionary notes
Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”
“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.
The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.
Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”
The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.
Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.
But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.
However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.
Their study was published online in The American Journal of Gastroenterology.
Largest trial to date
The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.
There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.
After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.
The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.
However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.
In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.
This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.
The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.
The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
Caveats and cautionary notes
Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”
“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.
The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.
Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”
The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiologist pleads guilty to abusive sexual contact
John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.
Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.
According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.
The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.
The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.
Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.
“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.
“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.
A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.
Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.
A version of this article first appeared on Medscape.com.
John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.
Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.
According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.
The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.
The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.
Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.
“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.
“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.
A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.
Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.
A version of this article first appeared on Medscape.com.
John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.
Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.
According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.
The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.
The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.
Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.
“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.
“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.
A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.
Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.
A version of this article first appeared on Medscape.com.
‘Overwhelming’ need to study COVID vaccine–associated tinnitus
It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.
As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.
“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.
The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
Molecular mimicry?
The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.
“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.
Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.
“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.
Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.
Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
Jury out on best management
How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.
A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.
“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.
Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.
Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.
Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.
Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.
Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.
“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.
The research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.
As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.
“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.
The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
Molecular mimicry?
The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.
“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.
Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.
“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.
Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.
Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
Jury out on best management
How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.
A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.
“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.
Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.
Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.
Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.
Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.
Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.
“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.
The research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.
As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.
“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.
The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
Molecular mimicry?
The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.
“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.
Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.
“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.
Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.
Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
Jury out on best management
How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.
A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.
“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.
Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.
Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.
Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.
Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.
Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.
“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.
The research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF MEDICINE AND SURGERY
COVID-19 often more severe with congenital heart defects
Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.
“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.
“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.
The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.
The study was published online March 7, 2022, in Circulation.
The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.
Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.
Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).
After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.
When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.
Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.
“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.
The study had no specific funding. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.
“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.
“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.
The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.
The study was published online March 7, 2022, in Circulation.
The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.
Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.
Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).
After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.
When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.
Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.
“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.
The study had no specific funding. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.
“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.
“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.
The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.
The study was published online March 7, 2022, in Circulation.
The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.
Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.
Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).
After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.
When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.
Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.
“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.
The study had no specific funding. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Heavy drinking in your 20s has lasting impact on cancer risk
according to a new study from Australia.
Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”
The study, published online Feb. 19 in the International Journal of Cancer, assessed lifetime drinking trajectories and risk for alcohol-related cancer using data from 22,756 women and 15,701 men recruited to the prospective Melbourne Collaborative Cohort Study from 1990-1994. Heavy drinking was considered an average alcohol intake of at least 60 g/day, which is equivalent to the alcohol content in 6 standard drinks.
During 485,525 person-years of follow-up among women, 2,303 incident alcohol-related cancers were diagnosed, most commonly breast (64%) and colorectal cancer (31%).
During 303,218 person-years of follow-up among men, 789 alcohol-related cancers were found, most commonly colorectal cancer (83%).
The researchers identified three distinct lifetime alcohol intake trajectories for women – lifetime abstainer (39%), stable light (54%), and increasing moderate (7%) – and six for men – lifetime abstainer (14.3%), stable light (51.5%), stable moderate (20.4%), increasing heavy (6.6%), early decreasing heavy (5.1%), and late decreasing heavy (2.2%).
Almost three times more, women were lifetime abstainers (39% vs. 14% of men). And approximately the same percentage of men and women increased their alcohol consumption over time. About 7% of men were classified as increasing heavy drinkers, consuming a moderate amount of alcohol (30-59 g/day) at age 20-39 and increasing their intake markedly from age 40-49 (over 60 g/day) before reducing it by age 60-69. Among women, 7% were classified as increasing moderate, tending to consume around 20 g/day at age 20-29 and gradually increasing their alcohol intake over time to consume close to 40 g/day at age 50-59.
Among men, the early decreasing heavy group started as heavy drinkers at age 20-39 (greater than or equal to 60 g/day) and continued to cut down their intake over time until developing stable light drinking habits by age 60-69, whereas late decreasing heavy drinks continued to drink a lot until age 60-69 before cutting their intake in their 70s.
Impact on cancer risk
For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.
The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).
The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.
Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.
For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.
Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).
The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
‘Striking’ findings
Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.
“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.
Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”
Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”
“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”
The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study from Australia.
Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”
The study, published online Feb. 19 in the International Journal of Cancer, assessed lifetime drinking trajectories and risk for alcohol-related cancer using data from 22,756 women and 15,701 men recruited to the prospective Melbourne Collaborative Cohort Study from 1990-1994. Heavy drinking was considered an average alcohol intake of at least 60 g/day, which is equivalent to the alcohol content in 6 standard drinks.
During 485,525 person-years of follow-up among women, 2,303 incident alcohol-related cancers were diagnosed, most commonly breast (64%) and colorectal cancer (31%).
During 303,218 person-years of follow-up among men, 789 alcohol-related cancers were found, most commonly colorectal cancer (83%).
The researchers identified three distinct lifetime alcohol intake trajectories for women – lifetime abstainer (39%), stable light (54%), and increasing moderate (7%) – and six for men – lifetime abstainer (14.3%), stable light (51.5%), stable moderate (20.4%), increasing heavy (6.6%), early decreasing heavy (5.1%), and late decreasing heavy (2.2%).
Almost three times more, women were lifetime abstainers (39% vs. 14% of men). And approximately the same percentage of men and women increased their alcohol consumption over time. About 7% of men were classified as increasing heavy drinkers, consuming a moderate amount of alcohol (30-59 g/day) at age 20-39 and increasing their intake markedly from age 40-49 (over 60 g/day) before reducing it by age 60-69. Among women, 7% were classified as increasing moderate, tending to consume around 20 g/day at age 20-29 and gradually increasing their alcohol intake over time to consume close to 40 g/day at age 50-59.
Among men, the early decreasing heavy group started as heavy drinkers at age 20-39 (greater than or equal to 60 g/day) and continued to cut down their intake over time until developing stable light drinking habits by age 60-69, whereas late decreasing heavy drinks continued to drink a lot until age 60-69 before cutting their intake in their 70s.
Impact on cancer risk
For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.
The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).
The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.
Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.
For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.
Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).
The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
‘Striking’ findings
Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.
“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.
Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”
Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”
“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”
The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study from Australia.
Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”
The study, published online Feb. 19 in the International Journal of Cancer, assessed lifetime drinking trajectories and risk for alcohol-related cancer using data from 22,756 women and 15,701 men recruited to the prospective Melbourne Collaborative Cohort Study from 1990-1994. Heavy drinking was considered an average alcohol intake of at least 60 g/day, which is equivalent to the alcohol content in 6 standard drinks.
During 485,525 person-years of follow-up among women, 2,303 incident alcohol-related cancers were diagnosed, most commonly breast (64%) and colorectal cancer (31%).
During 303,218 person-years of follow-up among men, 789 alcohol-related cancers were found, most commonly colorectal cancer (83%).
The researchers identified three distinct lifetime alcohol intake trajectories for women – lifetime abstainer (39%), stable light (54%), and increasing moderate (7%) – and six for men – lifetime abstainer (14.3%), stable light (51.5%), stable moderate (20.4%), increasing heavy (6.6%), early decreasing heavy (5.1%), and late decreasing heavy (2.2%).
Almost three times more, women were lifetime abstainers (39% vs. 14% of men). And approximately the same percentage of men and women increased their alcohol consumption over time. About 7% of men were classified as increasing heavy drinkers, consuming a moderate amount of alcohol (30-59 g/day) at age 20-39 and increasing their intake markedly from age 40-49 (over 60 g/day) before reducing it by age 60-69. Among women, 7% were classified as increasing moderate, tending to consume around 20 g/day at age 20-29 and gradually increasing their alcohol intake over time to consume close to 40 g/day at age 50-59.
Among men, the early decreasing heavy group started as heavy drinkers at age 20-39 (greater than or equal to 60 g/day) and continued to cut down their intake over time until developing stable light drinking habits by age 60-69, whereas late decreasing heavy drinks continued to drink a lot until age 60-69 before cutting their intake in their 70s.
Impact on cancer risk
For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.
The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).
The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.
Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.
For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.
Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).
The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
‘Striking’ findings
Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.
“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.
Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”
Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”
“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”
The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF CANCER
Man who received first modified pig heart transplant dies
He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.
Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.
Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.
When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.
“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.
“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.
Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.
Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.
“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.
Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”
The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.
“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.
“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.
A version of this article first appeared on Medscape.com.
He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.
Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.
Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.
When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.
“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.
“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.
Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.
Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.
“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.
Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”
The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.
“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.
“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.
A version of this article first appeared on Medscape.com.
He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.
Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.
Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.
When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.
“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.
“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.
Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.
Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.
“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.
Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”
The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.
“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.
“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.
A version of this article first appeared on Medscape.com.