Endocuff safely cut nearly 1 minute off colonoscopy time

Article Type
Changed
Display Headline
Endocuff safely cut nearly 1 minute off colonoscopy time

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

 

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

 

Amy Karon
Dr. Paul Feuerstadt

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

Meeting/Event
Publications
Topics
Legacy Keywords
colonoscopy, adenoma, colon cancer, Endocuff, colonoscope
Sections
Meeting/Event
Meeting/Event

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

 

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

 

Amy Karon
Dr. Paul Feuerstadt

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

 

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

 

Amy Karon
Dr. Paul Feuerstadt

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

Publications
Publications
Topics
Article Type
Display Headline
Endocuff safely cut nearly 1 minute off colonoscopy time
Display Headline
Endocuff safely cut nearly 1 minute off colonoscopy time
Legacy Keywords
colonoscopy, adenoma, colon cancer, Endocuff, colonoscope
Legacy Keywords
colonoscopy, adenoma, colon cancer, Endocuff, colonoscope
Sections
Article Source

AT DDW® 2016

Disallow All Ads
Alternative CME
Vitals

Key clinical point: Attaching a disposable Endocuff to the tip of a colonoscope enabled endoscopists to cut about 1 minute off withdrawal times and slightly increase their polyp detection rates.

Major finding: The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41). Average withdrawal times were 9.9 minutes with the Endocuff and 11.1 minutes without it (P = .02).

Data source: A prospective, randomized, controlled trial of 562 patients from two endoscopy centers.

Disclosures: Dr. Feuerstadt disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

New Community-Based Palliative Care Certification to Launch

Article Type
Changed
Display Headline
New Community-Based Palliative Care Certification to Launch

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

Image Credit: Shuttershock.com

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

  • A robust interdisciplinary care team
  • Customized, comprehensive care plans
  • After-hours care and services
  • Use of evidence-based clinical practice guidelines
  • A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

Issue
The Hospitalist - 2016(05)
Publications
Topics
Sections

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

Image Credit: Shuttershock.com

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

  • A robust interdisciplinary care team
  • Customized, comprehensive care plans
  • After-hours care and services
  • Use of evidence-based clinical practice guidelines
  • A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

Image Credit: Shuttershock.com

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

  • A robust interdisciplinary care team
  • Customized, comprehensive care plans
  • After-hours care and services
  • Use of evidence-based clinical practice guidelines
  • A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

Issue
The Hospitalist - 2016(05)
Issue
The Hospitalist - 2016(05)
Publications
Publications
Topics
Article Type
Display Headline
New Community-Based Palliative Care Certification to Launch
Display Headline
New Community-Based Palliative Care Certification to Launch
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)

Early Follow-up Can Reduce Readmission Rates

Article Type
Changed
Display Headline
Early Follow-up Can Reduce Readmission Rates

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

  1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.
Issue
The Hospitalist - 2016(05)
Publications
Sections

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

  1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

  1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.
Issue
The Hospitalist - 2016(05)
Issue
The Hospitalist - 2016(05)
Publications
Publications
Article Type
Display Headline
Early Follow-up Can Reduce Readmission Rates
Display Headline
Early Follow-up Can Reduce Readmission Rates
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)

Obesity is diverticula risk factor in women, not men

Article Type
Changed
Display Headline
Obesity is diverticula risk factor in women, not men

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

Dr. Anne Peery

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
diverticula, diverticulitis, obesity
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

Dr. Anne Peery

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

Dr. Anne Peery

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Obesity is diverticula risk factor in women, not men
Display Headline
Obesity is diverticula risk factor in women, not men
Legacy Keywords
diverticula, diverticulitis, obesity
Legacy Keywords
diverticula, diverticulitis, obesity
Sections
Article Source

AT DDW® 2016

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Obesity is associated with diverticula in women, not men, and a low-fiber diet is not a risk factor.

Major finding: Younger than age 50 years, men were more likely to have diverticula, and obese women were twice as likely as men to have six or more diverticula.

Data source: A prospective, cross-sectional study.

Disclosures: The National Institutes of Health sponsored the study.

Chronic HCV boosts hospitalization risk, not just for liver

Article Type
Changed
Display Headline
Chronic HCV boosts hospitalization risk, not just for liver

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

References

Click for Credit Link
Author and Disclosure Information

Publications
Topics
Legacy Keywords
hepatitis C, HCV, hospitalization
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Chronic HCV boosts hospitalization risk, not just for liver
Display Headline
Chronic HCV boosts hospitalization risk, not just for liver
Legacy Keywords
hepatitis C, HCV, hospitalization
Legacy Keywords
hepatitis C, HCV, hospitalization
Click for Credit Status
Active
Article Source

FROM THE JOURNAL OF VIRAL HEPATITIS

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Individuals with chronic hepatitis C infection have significantly greater risk of hospitalization for a range of health issues than other health system patients.

Major finding: The risk of hospitalization was 3.7 times greater in individuals with chronic hepatitis C infection, compared with general health system patients.

Data source: An observational cohort study in 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 other health system patients.

Disclosures: The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

Stevens-Johnson syndrome, TEN not as rare as thought

Article Type
Changed
Display Headline
Stevens-Johnson syndrome, TEN not as rare as thought

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Stevens-Johnson syndrome, toxic epidermal necrolysis
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Stevens-Johnson syndrome, TEN not as rare as thought
Display Headline
Stevens-Johnson syndrome, TEN not as rare as thought
Legacy Keywords
Stevens-Johnson syndrome, toxic epidermal necrolysis
Legacy Keywords
Stevens-Johnson syndrome, toxic epidermal necrolysis
Article Source

AT THE 2016 SID ANNUAL MEETING

PURLs Copyright

Inside the Article

Vitals

Key clinical point: The annual incidence of SJS was 8.6-9.8 cases per million adults per year, with a mean of 9.3 cases.

Major finding: The annual incidence of SJS was 8.6-9.8 cases per million adults per year, with a mean of 9.3. Annual rates of combined SJS/TEN and TEN were substantially lower, averaging 1.6 and 1.9 cases per million individuals per year, respectively.

Data source: An analysis of Nationwide Inpatient Sample data from 2009 through 2012.

Disclosures: The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer

Article Type
Changed
Display Headline
Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer

WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.

A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.

“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”

Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.

Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.

The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.

Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.

A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.

On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).

In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.

Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.

Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”

The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.

Dr. Gotimer had no financial declarations.

[email protected]

On Twitter @Alz_Gal

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
ACOG 2016, ovarian cancer, intraperitoneal chemotherapy
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.

A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.

“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”

Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.

Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.

The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.

Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.

A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.

On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).

In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.

Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.

Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”

The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.

Dr. Gotimer had no financial declarations.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.

A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.

“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”

Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.

Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.

The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.

Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.

A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.

On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).

In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.

Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.

Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”

The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.

Dr. Gotimer had no financial declarations.

[email protected]

On Twitter @Alz_Gal

References

References

Publications
Publications
Topics
Article Type
Display Headline
Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer
Display Headline
Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer
Legacy Keywords
ACOG 2016, ovarian cancer, intraperitoneal chemotherapy
Legacy Keywords
ACOG 2016, ovarian cancer, intraperitoneal chemotherapy
Article Source

AT ACOG 2016

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Despite its challenges, most women who used intraperitoneal chemotherapy for ovarian cancer said it was a good option for them.

Major finding: More than 80% of women said the regimen was “worth it,” and more than 90% said they would recommend it to another woman.

Data source: The retrospective study comprised 98 women, 48 of whom completed a survey about their treatment.

Disclosures: Dr. Gotimer had no financial disclosures.

Ablation tops drug escalation for persistent VT

Article Type
Changed
Display Headline
Ablation tops drug escalation for persistent VT

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

Dr. John Sapp

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

Dr. John Sapp

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

Dr. John Sapp

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Ablation tops drug escalation for persistent VT
Display Headline
Ablation tops drug escalation for persistent VT
Sections
Article Source

AT HEART RHYTHM 2016

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Catheter ablation is a better option than antiarrhythmic drug escalation when ventricular tachycardia patients fail standard first-line medical therapy.

Major finding: During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation in the study, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia storm, or appropriate implantable cardioverter defibrillator shock (HR favoring ablation, 0.72; P = 0.04).

Disclosures: The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. The lead investigator reported research grants from St. Jude, Biosense, Medtronic, and Philips.

Drug-coated stent sets new standard in ACS patients at high bleeding risk

Article Type
Changed
Display Headline
Drug-coated stent sets new standard in ACS patients at high bleeding risk

PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.

Bruce Jancin/Frontline Medical News
Dr. Christoph K. Naber

“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.

“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.

Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).

Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.

The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.

The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.

The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.

It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.

The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.

Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”

He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?

In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.

The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.

Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).

[email protected]

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
LEADER FREE, ACS, high bleeding risk, BioFreedom, drug-coated stent
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.

Bruce Jancin/Frontline Medical News
Dr. Christoph K. Naber

“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.

“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.

Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).

Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.

The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.

The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.

The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.

It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.

The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.

Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”

He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?

In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.

The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.

Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).

[email protected]

PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.

Bruce Jancin/Frontline Medical News
Dr. Christoph K. Naber

“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.

“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.

Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).

Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.

The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.

The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.

The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.

It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.

The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.

Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”

He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?

In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.

The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.

Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Drug-coated stent sets new standard in ACS patients at high bleeding risk
Display Headline
Drug-coated stent sets new standard in ACS patients at high bleeding risk
Legacy Keywords
LEADER FREE, ACS, high bleeding risk, BioFreedom, drug-coated stent
Legacy Keywords
LEADER FREE, ACS, high bleeding risk, BioFreedom, drug-coated stent
Sections
Article Source

AT EUROPCR 2016

PURLs Copyright

Inside the Article

Vitals

Key clinical point: There are no longer any good indications for implanting a bare-metal stent.

Major finding: The cumulative 1-year rate of cardiac death, MI, or definite or probable stent thrombosis in high–bleeding risk patients who underwent PCI for acute coronary syndrome was 9.3% in those randomized to a novel drug-coated stent, compared with 18.5% in those who got a bare-metal stent.

Data source: This was a prespecified subgroup analysis of the Leaders Free trial in which 659 acute coronary syndrome patients with high bleeding risk undergoing PCI for acute coronary syndrome were randomized to a unique drug-coated, polymer-free stent or a bare-metal stent, with 1 month of dual-antiplatelet therapy for all.

Disclosures: The study was funded by Biosensors. The presenter reported receiving consultant fees from that medical device company and several others.

Marijuana may lower death risk after acute MI

Article Type
Changed
Display Headline
Marijuana may lower death risk after acute MI

CHICAGO – Patients who reported using marijuana prior to experiencing an acute MI had significantly lower in-hospital mortality and were less likely to have cardiogenic shock or require an intra-aortic balloon pump than marijuana nonusers with an MI in an eight-state hospital records study, Dr. Cecelia P. Johnson-Sasso reported at the annual meeting of the American College of Cardiology.

“If this observation is confirmed in independent studies, further investigation into the possible therapeutic benefit of cannabinoid receptor agonists in acute MI may be warranted,” declared Dr. Johnson-Sasso of the University of Colorado Denver.

Smithore

She and her coinvestigators obtained hospital records with identity information removed for more than 3 million patients admitted for acute MI during 1994-2013 in eight states: California, Colorado, New Hampshire, New Jersey, New York, Texas, Vermont, and West Virginia.

After excluding concomitant users of cocaine, methamphetamine, or alcohol due to the potential for confounding cardiotoxic effects; MI patients under age 19 because of the likelihood of congenital heart disease; and patients over age 70 because only 0.01% of them admitted to marijuana use, the investigators were left with a study population of 3,854 marijuana users and 1.27 million MI patients who hadn’t used marijuana.

In a multivariate regression analysis adjusted for potential confounders including baseline comorbid conditions, patient demographics, and payer status, the marijuana users prior to MI had a 17% reduction in in-hospital mortality, were 20% less likely to undergo intra-aortic balloon pump placement, and had a 26% reduction in shock. On the other hand, they were also 19% more likely than marijuana nonusers to be placed on mechanical ventilation. And even though they were equally likely to undergo diagnostic coronary angiography, they were 28% less likely than marijuana nonusers to undergo percutaneous coronary intervention. All of these differences were statistically significant and clinically meaningful.

She was quick to note the limitations of her study: No data were available on readmissions or late mortality, and it’s highly likely that marijuana use by patients with acute MI was significantly underreported during the study period, which was largely before the legalization movement took off.

With state marijuana laws rapidly changing and the legal pot industry becoming a big business, the lack of research into the health consequences of marijuana by disinterested parties has become glaringly obvious, according to Dr. Johnson-Sasso. Cannabinoid receptors are found not only in the brain, but in cardiac muscle, the kidney, liver, vascular and visceral muscle, aorta, bladder, and immune cells.

She reported having no financial conflicts of interest regarding this study.

[email protected]

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
marijuana, MI, cannabinoids
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

CHICAGO – Patients who reported using marijuana prior to experiencing an acute MI had significantly lower in-hospital mortality and were less likely to have cardiogenic shock or require an intra-aortic balloon pump than marijuana nonusers with an MI in an eight-state hospital records study, Dr. Cecelia P. Johnson-Sasso reported at the annual meeting of the American College of Cardiology.

“If this observation is confirmed in independent studies, further investigation into the possible therapeutic benefit of cannabinoid receptor agonists in acute MI may be warranted,” declared Dr. Johnson-Sasso of the University of Colorado Denver.

Smithore

She and her coinvestigators obtained hospital records with identity information removed for more than 3 million patients admitted for acute MI during 1994-2013 in eight states: California, Colorado, New Hampshire, New Jersey, New York, Texas, Vermont, and West Virginia.

After excluding concomitant users of cocaine, methamphetamine, or alcohol due to the potential for confounding cardiotoxic effects; MI patients under age 19 because of the likelihood of congenital heart disease; and patients over age 70 because only 0.01% of them admitted to marijuana use, the investigators were left with a study population of 3,854 marijuana users and 1.27 million MI patients who hadn’t used marijuana.

In a multivariate regression analysis adjusted for potential confounders including baseline comorbid conditions, patient demographics, and payer status, the marijuana users prior to MI had a 17% reduction in in-hospital mortality, were 20% less likely to undergo intra-aortic balloon pump placement, and had a 26% reduction in shock. On the other hand, they were also 19% more likely than marijuana nonusers to be placed on mechanical ventilation. And even though they were equally likely to undergo diagnostic coronary angiography, they were 28% less likely than marijuana nonusers to undergo percutaneous coronary intervention. All of these differences were statistically significant and clinically meaningful.

She was quick to note the limitations of her study: No data were available on readmissions or late mortality, and it’s highly likely that marijuana use by patients with acute MI was significantly underreported during the study period, which was largely before the legalization movement took off.

With state marijuana laws rapidly changing and the legal pot industry becoming a big business, the lack of research into the health consequences of marijuana by disinterested parties has become glaringly obvious, according to Dr. Johnson-Sasso. Cannabinoid receptors are found not only in the brain, but in cardiac muscle, the kidney, liver, vascular and visceral muscle, aorta, bladder, and immune cells.

She reported having no financial conflicts of interest regarding this study.

[email protected]

CHICAGO – Patients who reported using marijuana prior to experiencing an acute MI had significantly lower in-hospital mortality and were less likely to have cardiogenic shock or require an intra-aortic balloon pump than marijuana nonusers with an MI in an eight-state hospital records study, Dr. Cecelia P. Johnson-Sasso reported at the annual meeting of the American College of Cardiology.

“If this observation is confirmed in independent studies, further investigation into the possible therapeutic benefit of cannabinoid receptor agonists in acute MI may be warranted,” declared Dr. Johnson-Sasso of the University of Colorado Denver.

Smithore

She and her coinvestigators obtained hospital records with identity information removed for more than 3 million patients admitted for acute MI during 1994-2013 in eight states: California, Colorado, New Hampshire, New Jersey, New York, Texas, Vermont, and West Virginia.

After excluding concomitant users of cocaine, methamphetamine, or alcohol due to the potential for confounding cardiotoxic effects; MI patients under age 19 because of the likelihood of congenital heart disease; and patients over age 70 because only 0.01% of them admitted to marijuana use, the investigators were left with a study population of 3,854 marijuana users and 1.27 million MI patients who hadn’t used marijuana.

In a multivariate regression analysis adjusted for potential confounders including baseline comorbid conditions, patient demographics, and payer status, the marijuana users prior to MI had a 17% reduction in in-hospital mortality, were 20% less likely to undergo intra-aortic balloon pump placement, and had a 26% reduction in shock. On the other hand, they were also 19% more likely than marijuana nonusers to be placed on mechanical ventilation. And even though they were equally likely to undergo diagnostic coronary angiography, they were 28% less likely than marijuana nonusers to undergo percutaneous coronary intervention. All of these differences were statistically significant and clinically meaningful.

She was quick to note the limitations of her study: No data were available on readmissions or late mortality, and it’s highly likely that marijuana use by patients with acute MI was significantly underreported during the study period, which was largely before the legalization movement took off.

With state marijuana laws rapidly changing and the legal pot industry becoming a big business, the lack of research into the health consequences of marijuana by disinterested parties has become glaringly obvious, according to Dr. Johnson-Sasso. Cannabinoid receptors are found not only in the brain, but in cardiac muscle, the kidney, liver, vascular and visceral muscle, aorta, bladder, and immune cells.

She reported having no financial conflicts of interest regarding this study.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Marijuana may lower death risk after acute MI
Display Headline
Marijuana may lower death risk after acute MI
Legacy Keywords
marijuana, MI, cannabinoids
Legacy Keywords
marijuana, MI, cannabinoids
Sections
Article Source

AT ACC 16

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Patients who used marijuana prior to their acute MI had better outcomes.

Major finding: Marijuana use prior to acute MI was associated with a 17% reduction in in-hospital mortality.

Data source: This was a retrospective analysis of hospital records for nearly 1.3 million MI patients in eight states.

Disclosures: The study presenter reported having no financial conflicts of interest.