POP severity not linked to risk of de novo stress urinary incontinence

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– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

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– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

 

– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

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Key clinical point: The severity of pelvic organ prolapse does not seem to be factor in the risk of de novo stress urinary incontinence.

Major finding: Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Data source: A single-center retrospective study of 206 patients who underwent surgical correction of POP and had no objective evidence of SUI at baseline.

Disclosures: The researchers did not report information on funding sources or financial disclosures.

AHA: Midlife hypertension linked with cognitive impairment

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Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association
The experts cited several uncovered questions, including how hypertension affects key factors of neurodegeneration, such as tau and amyloid beta, and whether certain classes of antihypertensive drugs have more robust cognitive benefits than others. “Although antihypertensive therapy in midlife is already supported by evidence of its benefit in reducing clinical events such as stroke, more robust evidence of its role in cognition would have important implications for our understanding of the pathogenesis of dementia,” they added. “The results of the ongoing SPRINT-MIND trial (Interaction With Other Risk Factors, Including Genetics section) may help shed light on this question.”

The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.

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Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association
The experts cited several uncovered questions, including how hypertension affects key factors of neurodegeneration, such as tau and amyloid beta, and whether certain classes of antihypertensive drugs have more robust cognitive benefits than others. “Although antihypertensive therapy in midlife is already supported by evidence of its benefit in reducing clinical events such as stroke, more robust evidence of its role in cognition would have important implications for our understanding of the pathogenesis of dementia,” they added. “The results of the ongoing SPRINT-MIND trial (Interaction With Other Risk Factors, Including Genetics section) may help shed light on this question.”

The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.

 

Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association
The experts cited several uncovered questions, including how hypertension affects key factors of neurodegeneration, such as tau and amyloid beta, and whether certain classes of antihypertensive drugs have more robust cognitive benefits than others. “Although antihypertensive therapy in midlife is already supported by evidence of its benefit in reducing clinical events such as stroke, more robust evidence of its role in cognition would have important implications for our understanding of the pathogenesis of dementia,” they added. “The results of the ongoing SPRINT-MIND trial (Interaction With Other Risk Factors, Including Genetics section) may help shed light on this question.”

The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.

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Patients with stage 1 NSCLC more likely to die of other causes in short term

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Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

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Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

 

Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

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Key clinical point: Patients with resected stage 1 non-small cell lung cancer are more likely to die of other causes in the short term. Major finding: The non–cancer-specific cumulative incidence of death was higher than CID from lung cancer for up to 1.5 years after resection.

Data source: A single-center competing risk analysis of 2,186 patients who underwent curative-intent resection for stage 1 non–small cell lung cancer.

Disclosures: Senior author Prasad Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

Cough harder during stress urinary incontinence testing, study suggests

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– Patients often do not cough hard enough during the cough stress test for it to identify urinary incontinence, Sudhi Trye, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Dr. Sudhi Trye stands in front of a podium, addressing the crowd during PFD Week.
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Dr. Sudhi Trye
There currently is no standard recommendation for minimum coughing effort to diagnose stress urinary incontinence during urodynamic testing, Dr. Trye noted. To explore the question, the researchers retrospectively studied 145 women with stress urinary incontinence who underwent complex urodynamic testing with cough stress tests at multiple bladder volumes. The investigators excluded patients if their urodynamics were negative or their intravesical volume did not exceed 200 mL on filling cystometry.

Patients were asked to cough at least three times with increasing force at volumes of 200 mL, 300 mL, 400 mL, and 500 mL. The median minimum abdominal leak point pressure ranged from 120 to 127 cm H2O, regardless of bladder volume, and did not differ significantly between premenopausal and postmenopausal women, Dr. Trye said. Only 5% had leakage at abdominal pressures of 70 cm of H2O or less. The same was true at the other end of the spectrum – only 5% of women had leakage at abdominal pressures above 200 cm H2O.

A total of 70% of patients were white; mean age was 65 years, with a standard deviation of 13.6 years; and average body mass index was 28.2 kg/m2 with a standard deviation of 5.4 kg/m2.

Although the findings merit replication in a larger and more diverse cohort, they suggest that patients should be encouraged to cough hard enough to achieve abdominal pressures above 120-127 cm H2O, Dr. Trye said. Since many patients have trouble coughing this hard, operators should model it rather than just tell patients to cough, she added.

Dr. Trye reported having no financial disclosures. One coinvestigator reported ties to Kimberly-Clark and Boston Scientific.

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– Patients often do not cough hard enough during the cough stress test for it to identify urinary incontinence, Sudhi Trye, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Dr. Sudhi Trye stands in front of a podium, addressing the crowd during PFD Week.
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Dr. Sudhi Trye
There currently is no standard recommendation for minimum coughing effort to diagnose stress urinary incontinence during urodynamic testing, Dr. Trye noted. To explore the question, the researchers retrospectively studied 145 women with stress urinary incontinence who underwent complex urodynamic testing with cough stress tests at multiple bladder volumes. The investigators excluded patients if their urodynamics were negative or their intravesical volume did not exceed 200 mL on filling cystometry.

Patients were asked to cough at least three times with increasing force at volumes of 200 mL, 300 mL, 400 mL, and 500 mL. The median minimum abdominal leak point pressure ranged from 120 to 127 cm H2O, regardless of bladder volume, and did not differ significantly between premenopausal and postmenopausal women, Dr. Trye said. Only 5% had leakage at abdominal pressures of 70 cm of H2O or less. The same was true at the other end of the spectrum – only 5% of women had leakage at abdominal pressures above 200 cm H2O.

A total of 70% of patients were white; mean age was 65 years, with a standard deviation of 13.6 years; and average body mass index was 28.2 kg/m2 with a standard deviation of 5.4 kg/m2.

Although the findings merit replication in a larger and more diverse cohort, they suggest that patients should be encouraged to cough hard enough to achieve abdominal pressures above 120-127 cm H2O, Dr. Trye said. Since many patients have trouble coughing this hard, operators should model it rather than just tell patients to cough, she added.

Dr. Trye reported having no financial disclosures. One coinvestigator reported ties to Kimberly-Clark and Boston Scientific.

 

– Patients often do not cough hard enough during the cough stress test for it to identify urinary incontinence, Sudhi Trye, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Dr. Sudhi Trye stands in front of a podium, addressing the crowd during PFD Week.
Amy Karon/Frontline Medical News
Dr. Sudhi Trye
There currently is no standard recommendation for minimum coughing effort to diagnose stress urinary incontinence during urodynamic testing, Dr. Trye noted. To explore the question, the researchers retrospectively studied 145 women with stress urinary incontinence who underwent complex urodynamic testing with cough stress tests at multiple bladder volumes. The investigators excluded patients if their urodynamics were negative or their intravesical volume did not exceed 200 mL on filling cystometry.

Patients were asked to cough at least three times with increasing force at volumes of 200 mL, 300 mL, 400 mL, and 500 mL. The median minimum abdominal leak point pressure ranged from 120 to 127 cm H2O, regardless of bladder volume, and did not differ significantly between premenopausal and postmenopausal women, Dr. Trye said. Only 5% had leakage at abdominal pressures of 70 cm of H2O or less. The same was true at the other end of the spectrum – only 5% of women had leakage at abdominal pressures above 200 cm H2O.

A total of 70% of patients were white; mean age was 65 years, with a standard deviation of 13.6 years; and average body mass index was 28.2 kg/m2 with a standard deviation of 5.4 kg/m2.

Although the findings merit replication in a larger and more diverse cohort, they suggest that patients should be encouraged to cough hard enough to achieve abdominal pressures above 120-127 cm H2O, Dr. Trye said. Since many patients have trouble coughing this hard, operators should model it rather than just tell patients to cough, she added.

Dr. Trye reported having no financial disclosures. One coinvestigator reported ties to Kimberly-Clark and Boston Scientific.

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Key clinical point: Urodynamic operators should encourage patients to cough hard enough to exceed about 120-127 cm H2O in abdominal pressure.

Major finding: The median minimum abdominal leak point pressure ranged from 120-127 cm H2O across all bladder volumes.

Data source: A retrospective study of 145 women with stress urinary incontinence based on urodynamic testing.

Disclosures: Dr. Trye reported having no financial disclosures. One coinvestigator reported ties to Kimberly-Clark and Boston Scientific.

Fluorescein, 10% dextrose topped other media for visualizing ureteral patency

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– Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

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– Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

 

– Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

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Key clinical point: Not all modalities for evaluating ureteral patency are equivalent in the post–indigo carmine era.Major finding: Visibility of the ureteral jet was significantly greater with 10% dextrose and oral phenazopyridine than with intravenous fluorescein or saline (P = .001).

Data source: A multicenter, randomized controlled trial of 174 women undergoing intraoperative cystoscopy.

Disclosures: The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

Ombitasvir, paritaprevir, ritonavir, and dasabuvir in CKD patients with HCV

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Twelve weeks of ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak) achieved sustained viral response in 90% of patients with noncirrhotic chronic hepatitis C virus (HCV) genotype 1 infection and comorbid stage 4 or 5 chronic kidney disease, according to a small, single-arm, industry-sponsored trial reported in the November issue of Gastroenterology.

Adverse effects were usually mild or moderate, and serious adverse effects were considered unrelated to treatment, Paul Pockros, MD, at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates reported in Gastroenterology. No patients stopped direct-acting antivirals because of adverse effects, although nearly half had to interrupt or discontinue ribavirin because of worsening anemia. “The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with direct-acting antiviral therapy but who may not yet have seen sufficient data to initiate [it] in patients with end-stage renal disease,” the researchers said. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent end-stage sequelae of HCV.”

Chronic HCV infection was rarely treated in patients with end-stage renal disease during the interferon era because of its toxicities and low tolerability, the researchers noted. Among the new direct-acting antivirals, sofosbuvir is cleared renally and therefore is not recommended in patients with estimated glomerular filtration rates below 30 mL/min per 1.73 m2. Most other direct-acting antiviral agents are metabolized by the liver, but blood levels of simeprevir and daclatasvir can rise in the setting of severe renal impairment. In contrast, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and did not require dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. Thus, the investigators studied this regimen in 20 adults with treatment-naive noncirrhotic HCV genotype 1 infections and stage 4 (estimated glomerular filtration rate [eGFR] 15-30 mL/min per 1.73 m2) or stage 5 (eGFR less than 15 mL/min per 1.73 m2 or requiring hemodialysis) chronic kidney disease. Patients with genotype 1a infections also received ribavirin at a reduced dose of 200 mg once daily (Gastroenterology. 2016 Mar 11. doi: 10.1053/j.gastro.2016.02.078).

All patients completed treatment, and 18 (90%) achieved sustained viral response (95% confidence interval, 70%-97%). The most common adverse events were anemia (45% of patients), fatigue (35%), diarrhea (25%), and nausea (25%). Among the two patients who did not achieve sustained viral response, one relapsed and the other died. The relapse occurred in a 49-year-old black man on hemodialysis who took about 91% of his medication doses, compared with about 97% for the rest of the cohort, the investigators said. This patient also had to interrupt ribavirin after his hemoglobin level dropped below 10 g/dL. The death occurred in a 60-year-old male hemodialysis patient who had hypertensive nephropathy and developed hypertensive urgency and cardiomyopathy soon after finishing treatment. His death, although considered unrelated to HCV treatment, underscores the need for close monitoring and collaboration between physicians treating HCV and nephrologists, the researchers said.

Most patients in this study were in stage 5 chronic kidney disease. However, the median baseline hemoglobin level was relatively high at 12 g/dL, implying that these patients would tolerate ribavirin better than would those with more pronounced anemia, the researchers noted. Nonetheless, 9 of 13 patients had to interrupt discontinue ribavirin because of worsening anemia. “Therefore, this study does not provide guidance for chronic kidney disease patients with much lower baseline hemoglobin levels, who might not tolerate even a small decrease,” the investigators cautioned.

AbbVie makes Viekira Pak and sponsored the study. Dr. Pockros disclosed ties to AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.

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Twelve weeks of ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak) achieved sustained viral response in 90% of patients with noncirrhotic chronic hepatitis C virus (HCV) genotype 1 infection and comorbid stage 4 or 5 chronic kidney disease, according to a small, single-arm, industry-sponsored trial reported in the November issue of Gastroenterology.

Adverse effects were usually mild or moderate, and serious adverse effects were considered unrelated to treatment, Paul Pockros, MD, at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates reported in Gastroenterology. No patients stopped direct-acting antivirals because of adverse effects, although nearly half had to interrupt or discontinue ribavirin because of worsening anemia. “The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with direct-acting antiviral therapy but who may not yet have seen sufficient data to initiate [it] in patients with end-stage renal disease,” the researchers said. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent end-stage sequelae of HCV.”

Chronic HCV infection was rarely treated in patients with end-stage renal disease during the interferon era because of its toxicities and low tolerability, the researchers noted. Among the new direct-acting antivirals, sofosbuvir is cleared renally and therefore is not recommended in patients with estimated glomerular filtration rates below 30 mL/min per 1.73 m2. Most other direct-acting antiviral agents are metabolized by the liver, but blood levels of simeprevir and daclatasvir can rise in the setting of severe renal impairment. In contrast, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and did not require dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. Thus, the investigators studied this regimen in 20 adults with treatment-naive noncirrhotic HCV genotype 1 infections and stage 4 (estimated glomerular filtration rate [eGFR] 15-30 mL/min per 1.73 m2) or stage 5 (eGFR less than 15 mL/min per 1.73 m2 or requiring hemodialysis) chronic kidney disease. Patients with genotype 1a infections also received ribavirin at a reduced dose of 200 mg once daily (Gastroenterology. 2016 Mar 11. doi: 10.1053/j.gastro.2016.02.078).

All patients completed treatment, and 18 (90%) achieved sustained viral response (95% confidence interval, 70%-97%). The most common adverse events were anemia (45% of patients), fatigue (35%), diarrhea (25%), and nausea (25%). Among the two patients who did not achieve sustained viral response, one relapsed and the other died. The relapse occurred in a 49-year-old black man on hemodialysis who took about 91% of his medication doses, compared with about 97% for the rest of the cohort, the investigators said. This patient also had to interrupt ribavirin after his hemoglobin level dropped below 10 g/dL. The death occurred in a 60-year-old male hemodialysis patient who had hypertensive nephropathy and developed hypertensive urgency and cardiomyopathy soon after finishing treatment. His death, although considered unrelated to HCV treatment, underscores the need for close monitoring and collaboration between physicians treating HCV and nephrologists, the researchers said.

Most patients in this study were in stage 5 chronic kidney disease. However, the median baseline hemoglobin level was relatively high at 12 g/dL, implying that these patients would tolerate ribavirin better than would those with more pronounced anemia, the researchers noted. Nonetheless, 9 of 13 patients had to interrupt discontinue ribavirin because of worsening anemia. “Therefore, this study does not provide guidance for chronic kidney disease patients with much lower baseline hemoglobin levels, who might not tolerate even a small decrease,” the investigators cautioned.

AbbVie makes Viekira Pak and sponsored the study. Dr. Pockros disclosed ties to AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.

 

Twelve weeks of ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak) achieved sustained viral response in 90% of patients with noncirrhotic chronic hepatitis C virus (HCV) genotype 1 infection and comorbid stage 4 or 5 chronic kidney disease, according to a small, single-arm, industry-sponsored trial reported in the November issue of Gastroenterology.

Adverse effects were usually mild or moderate, and serious adverse effects were considered unrelated to treatment, Paul Pockros, MD, at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates reported in Gastroenterology. No patients stopped direct-acting antivirals because of adverse effects, although nearly half had to interrupt or discontinue ribavirin because of worsening anemia. “The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with direct-acting antiviral therapy but who may not yet have seen sufficient data to initiate [it] in patients with end-stage renal disease,” the researchers said. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent end-stage sequelae of HCV.”

Chronic HCV infection was rarely treated in patients with end-stage renal disease during the interferon era because of its toxicities and low tolerability, the researchers noted. Among the new direct-acting antivirals, sofosbuvir is cleared renally and therefore is not recommended in patients with estimated glomerular filtration rates below 30 mL/min per 1.73 m2. Most other direct-acting antiviral agents are metabolized by the liver, but blood levels of simeprevir and daclatasvir can rise in the setting of severe renal impairment. In contrast, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and did not require dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. Thus, the investigators studied this regimen in 20 adults with treatment-naive noncirrhotic HCV genotype 1 infections and stage 4 (estimated glomerular filtration rate [eGFR] 15-30 mL/min per 1.73 m2) or stage 5 (eGFR less than 15 mL/min per 1.73 m2 or requiring hemodialysis) chronic kidney disease. Patients with genotype 1a infections also received ribavirin at a reduced dose of 200 mg once daily (Gastroenterology. 2016 Mar 11. doi: 10.1053/j.gastro.2016.02.078).

All patients completed treatment, and 18 (90%) achieved sustained viral response (95% confidence interval, 70%-97%). The most common adverse events were anemia (45% of patients), fatigue (35%), diarrhea (25%), and nausea (25%). Among the two patients who did not achieve sustained viral response, one relapsed and the other died. The relapse occurred in a 49-year-old black man on hemodialysis who took about 91% of his medication doses, compared with about 97% for the rest of the cohort, the investigators said. This patient also had to interrupt ribavirin after his hemoglobin level dropped below 10 g/dL. The death occurred in a 60-year-old male hemodialysis patient who had hypertensive nephropathy and developed hypertensive urgency and cardiomyopathy soon after finishing treatment. His death, although considered unrelated to HCV treatment, underscores the need for close monitoring and collaboration between physicians treating HCV and nephrologists, the researchers said.

Most patients in this study were in stage 5 chronic kidney disease. However, the median baseline hemoglobin level was relatively high at 12 g/dL, implying that these patients would tolerate ribavirin better than would those with more pronounced anemia, the researchers noted. Nonetheless, 9 of 13 patients had to interrupt discontinue ribavirin because of worsening anemia. “Therefore, this study does not provide guidance for chronic kidney disease patients with much lower baseline hemoglobin levels, who might not tolerate even a small decrease,” the investigators cautioned.

AbbVie makes Viekira Pak and sponsored the study. Dr. Pockros disclosed ties to AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.

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Key clinical point: Twelve weeks of ombitasvir, paritaprevir, ritonavir, and dasabuvir with or without ribavirin was relatively well tolerated and cured most genotype 1 chronic hepatitis C virus infections in patients with severe or end-stage renal disease.

Major finding: All patients completed treatment and 18 (90%) achieved sustained viral response. The most common adverse effect was anemia (45% of patients).

Data source: A single-arm, multicenter study of 20 treatment-naive, noncirrhotic adults with HCV genotype 1 infection and stage 4 or 5 chronic kidney disease.

Disclosures: AbbVie makes Viekira Pak and sponsored the study. Dr. Pockros disclosed ties to AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.

Clinicians call for expanded pulmonary palliative care

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Clinicians call for expanded pulmonary palliative care

Patients with chronic obstructive pulmonary disease or interstitial lung disease have longer stays in the intensive care unit, yet are less likely than patients with metastatic cancer to receive comprehensive palliative care.

This finding, reported in Annals of the American Thoracic Society, underscores the need to expand palliative care programs, incorporate elements of palliative care into routine ICU practices, and identify the most effective components of palliative care, said several experts who were not involved in the study.

 

Dr. Michael J. Waxman

“Patients with metastatic cancer are more likely to discuss goals of therapy and code status with their inpatient physician and then receive referrals to palliative care,” said Dr. Michael J. Waxman, medical director of the intensive care unit at Research Medical Center in Kansas City. “I can share many anecdotes over the years where a patient is admitted to my ICU with metastatic cancer, or severe COPD [chronic obstructive pulmonary disease] or IPF [idiopathic pulmonary fibrosis],” he added. “The cognition of these patients in some cases may have been normal, but I learned during my review that they did not receive a good discussion of desires regarding resuscitation or intensity of care. It was regularly assumed that there would be no limits on intensity of care.”

Palliative care historically has focused on patients with cancer, even though mortality rates can be high in noncancer lung disease, Dr. Crystal Brown and her associates at the University of Washington in Seattle wrote in their article (Ann Am Thorac Soc. 2016;13:684-9.). Their secondary analysis of the randomized Integrating Palliative and Critical Care trial examined medical chart data for 592 patients with COPD, 158 patients with metastatic cancer, and 79 patients with interstitial lung disease (ILD) who died in the ICUs of 15 Seattle-area hospitals between 2003 and 2008. The investigators performed regression modeling to test associations between diagnosis and eight elements of palliative care – avoidance of cardiopulmonary resuscitation during the hour before death, pain assessment during the 24 hours before death, the presence of a do-not-resuscitate order at the time of death, discussion of prognosis within 72 hours of ICU admission, withdrawal of life support measures before death, involvement of a spiritual care provider, consultation with a palliative care specialist, and the presence of an advance directive. The statistical models controlled for many potential confounders, including age, sex, race and ethnicity, education level, hospital, and whether patients died before or after hospitals implemented a palliative care quality improvement intervention.

Even though median lengths of ICU stay were significantly longer for ILD patients (4.2 days) and COPD patients (2.9 days) than for metastatic cancer patients (2.3 days), patients with COPD were significantly less likely to avoid CPR in the hour before death (adjusted odds ratio, 0.43; 95% confidence interval, 0.20-0.90), while ILD patients were less likely to have a documented pain assessment in the 24 hours before death (OR, 0.43; 95% CI, 0.19-0.97), compared with metastatic cancer patients. Patients with ILD or COPD also were significantly less likely to have a do-not-resuscitate order in place or documentation of a discussion of their prognosis, Dr. Brown and her associates reported.

 

Dr. Vera De Palo

The findings raise several concerns. “Clearly, this points to both intensivists and palliative care consultants needing to do more to target patients with nonmalignant end-stage chronic lung diseases, such as some patients with COPD and ILD,” said Dr. Robert Hyzy, director of the critical care medicine unit at the University of Michigan Hospital, Ann Arbor. The difference in length of stay also suggests a need to recognize earlier when critically ill patients have not responded to an appropriate time period of treatment (sometimes called a “time-limited trial”), “which signals the transition from cure to comfort,” he added.

Vera De Palo, MD, MBA, FCCP, who is chief of medicine at Signature Healthcare Brockton (Mass.) Hospital, agreed. “While treatment plans for patients with end-stage ILD and COPD do at times include palliative care, the study points out what is often the experience for most patients,” she said. “Our oncology colleagues have better understood the time line of transition between curative care and palliative care than those of us who also manage noncancer chronic diseases. They are more likely to participate in the development of palliative care programs, ensuring that this avenue of care is also available to their patients.”

This is not the only study to reveal gaps in palliative care for advanced nonmalignant lung disease. In a recent analysis of the Nationwide Inpatient Sample, only 2.6% of COPD patients who were home on oxygen and then were hospitalized with an exacerbation received a palliative care referral (CHEST. 2016 Jul 4. doi:10.1016/j.chest.2016.06.023). Such findings belie the most recent palliative care guidelines from the American Thoracic Society for patients with respiratory diseases and critical illnesses, which not only emphasize most of the same palliative care elements as the study by Dr. Brown and her colleagues, but also recommend “early consultation” with palliative care experts to help manage difficult end-of-life discussions (Am J Respir Crit Care Med. 2008;177:912-27).

 

 

Oncology palliative care includes both primary and secondary (specialty-level) services, Dr. Arif Kamal of Duke Cancer Institute at Duke University Medical Center, Durham, N.C., and his associates wrote in a viewpoint published in JAMA. Primary services, such as assessing and managing symptoms, discussing priorities and what to expect, and ensuring continuity of care, are usually left to the oncology team. Secondary services are reserved for more complex or time-consuming cases and are provided by palliative care consultants. “This ‘manage first, refer second’ practice reflects the ethos of the oncology profession – the notion that ‘this is our job’ – while also reflecting a practical humility – ‘It’s hard to be everything to everyone all the time,’ ” Dr. Kamal and his associates wrote.

When it comes to palliative care for advanced nonmalignant lung disease, Dr. De Palo said, patients and families may not feel ready to discuss end-of-life issues, and providers may find it difficult to initiate these conversations. “From the moment of diagnosis, the focus of a patient’s care for providers is curative care.” Including a palliative focus can be difficult.

 

Dr. David Bowton

Nonmalignant pulmonary diseases often carry an “uncertain short-term prognosis,” the ATS guidelines stated, and experts echoed that point. “I believe our confidence in determination of prognosis is a key factor in hesitation or delay in engaging palliative care,” said David Bowton, MD, a professor specializing in critical care at Wake Forest School of Medicine, Winston-Salem, N.C. Oncology patients needing ICU care usually have “considerably higher” mortality than the rates of 20%-45% and 15%-30% that are cited for ILD and COPD patients, respectively, he said. Furthermore, there are seemingly accurate scoring systems for predicting short-term mortality in critically ill cancer patients, which is not the case for ILD or COPD, he added.

Such factors point to differences in disease trajectory. “In this study, it is likely that the patients with cancer diagnoses more often received the elements of palliative care in the ICU because it was clearly communicated to the intensive care providers that the opportunities for curative care were exhausted,” Dr. De Palo said. “With care for end-stage chronic respiratory diseases, ICU care can usually optimize breathing enough to get the patient off the vent and stabilized at their previous functional plateau or, more often, at a lower functional plateau, until the next shortness of breath episode.”

Given these challenges and uncertainties, how can clinicians improve palliative care for patients with advanced nonmalignant lung diseases? “Simple. Have a discussion with everyone about what their expectations are,” said Dr. Waxman. “Find out what is important to them and what their goals of therapy are. Help them understand the reality of what actually will be possible to accomplish in a hospitalization, a surgery, or a therapy.”

Dr. De Palo agreed. “For my patients with end-stage respiratory disease, we often discuss whether a sustaining therapy of mechanical ventilation would offer any benefit, and what role cardiopulmonary resuscitation should play in the context of their wishes for care as their disease progresses,” she said. “I believe that providers and health care organizations should offer patients the spectrum of curative and palliative care, and work together to develop a palliative care program where one does not exist,” she stressed. Access to “the full spectrum of care – from curative to palliative – will provide the compassion and quality of life at each stage of their chronic disease.”

Intensivists should also ensure that all ICU patients receive consultations with providers “who can look more at the big picture of their health care, not just at their admission diagnosis and the specific treatment they are receiving,” Dr. Waxman said. And Dr. Bowton offered a final caveat. “While it appears obvious that providing palliative care consultation or integrating elements of palliative care into our routine ICU care will improve the experience for our patients and their families, this has been difficult to demonstrate in well-designed studies,” he said. “Thus, rather than focusing solely on our apparent shortcomings in providing palliative care to our ICU patients with ILD and COPD, we should vigorously support efforts to ascertain what components of palliative care and what ‘dose’ are most effective in alleviating physical and emotional distress.”

The National Institute of Nursing Research funded the study by Dr. Brown and her associates, who reported no relevant financial conflicts of interest.

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Patients with chronic obstructive pulmonary disease or interstitial lung disease have longer stays in the intensive care unit, yet are less likely than patients with metastatic cancer to receive comprehensive palliative care.

This finding, reported in Annals of the American Thoracic Society, underscores the need to expand palliative care programs, incorporate elements of palliative care into routine ICU practices, and identify the most effective components of palliative care, said several experts who were not involved in the study.

 

Dr. Michael J. Waxman

“Patients with metastatic cancer are more likely to discuss goals of therapy and code status with their inpatient physician and then receive referrals to palliative care,” said Dr. Michael J. Waxman, medical director of the intensive care unit at Research Medical Center in Kansas City. “I can share many anecdotes over the years where a patient is admitted to my ICU with metastatic cancer, or severe COPD [chronic obstructive pulmonary disease] or IPF [idiopathic pulmonary fibrosis],” he added. “The cognition of these patients in some cases may have been normal, but I learned during my review that they did not receive a good discussion of desires regarding resuscitation or intensity of care. It was regularly assumed that there would be no limits on intensity of care.”

Palliative care historically has focused on patients with cancer, even though mortality rates can be high in noncancer lung disease, Dr. Crystal Brown and her associates at the University of Washington in Seattle wrote in their article (Ann Am Thorac Soc. 2016;13:684-9.). Their secondary analysis of the randomized Integrating Palliative and Critical Care trial examined medical chart data for 592 patients with COPD, 158 patients with metastatic cancer, and 79 patients with interstitial lung disease (ILD) who died in the ICUs of 15 Seattle-area hospitals between 2003 and 2008. The investigators performed regression modeling to test associations between diagnosis and eight elements of palliative care – avoidance of cardiopulmonary resuscitation during the hour before death, pain assessment during the 24 hours before death, the presence of a do-not-resuscitate order at the time of death, discussion of prognosis within 72 hours of ICU admission, withdrawal of life support measures before death, involvement of a spiritual care provider, consultation with a palliative care specialist, and the presence of an advance directive. The statistical models controlled for many potential confounders, including age, sex, race and ethnicity, education level, hospital, and whether patients died before or after hospitals implemented a palliative care quality improvement intervention.

Even though median lengths of ICU stay were significantly longer for ILD patients (4.2 days) and COPD patients (2.9 days) than for metastatic cancer patients (2.3 days), patients with COPD were significantly less likely to avoid CPR in the hour before death (adjusted odds ratio, 0.43; 95% confidence interval, 0.20-0.90), while ILD patients were less likely to have a documented pain assessment in the 24 hours before death (OR, 0.43; 95% CI, 0.19-0.97), compared with metastatic cancer patients. Patients with ILD or COPD also were significantly less likely to have a do-not-resuscitate order in place or documentation of a discussion of their prognosis, Dr. Brown and her associates reported.

 

Dr. Vera De Palo

The findings raise several concerns. “Clearly, this points to both intensivists and palliative care consultants needing to do more to target patients with nonmalignant end-stage chronic lung diseases, such as some patients with COPD and ILD,” said Dr. Robert Hyzy, director of the critical care medicine unit at the University of Michigan Hospital, Ann Arbor. The difference in length of stay also suggests a need to recognize earlier when critically ill patients have not responded to an appropriate time period of treatment (sometimes called a “time-limited trial”), “which signals the transition from cure to comfort,” he added.

Vera De Palo, MD, MBA, FCCP, who is chief of medicine at Signature Healthcare Brockton (Mass.) Hospital, agreed. “While treatment plans for patients with end-stage ILD and COPD do at times include palliative care, the study points out what is often the experience for most patients,” she said. “Our oncology colleagues have better understood the time line of transition between curative care and palliative care than those of us who also manage noncancer chronic diseases. They are more likely to participate in the development of palliative care programs, ensuring that this avenue of care is also available to their patients.”

This is not the only study to reveal gaps in palliative care for advanced nonmalignant lung disease. In a recent analysis of the Nationwide Inpatient Sample, only 2.6% of COPD patients who were home on oxygen and then were hospitalized with an exacerbation received a palliative care referral (CHEST. 2016 Jul 4. doi:10.1016/j.chest.2016.06.023). Such findings belie the most recent palliative care guidelines from the American Thoracic Society for patients with respiratory diseases and critical illnesses, which not only emphasize most of the same palliative care elements as the study by Dr. Brown and her colleagues, but also recommend “early consultation” with palliative care experts to help manage difficult end-of-life discussions (Am J Respir Crit Care Med. 2008;177:912-27).

 

 

Oncology palliative care includes both primary and secondary (specialty-level) services, Dr. Arif Kamal of Duke Cancer Institute at Duke University Medical Center, Durham, N.C., and his associates wrote in a viewpoint published in JAMA. Primary services, such as assessing and managing symptoms, discussing priorities and what to expect, and ensuring continuity of care, are usually left to the oncology team. Secondary services are reserved for more complex or time-consuming cases and are provided by palliative care consultants. “This ‘manage first, refer second’ practice reflects the ethos of the oncology profession – the notion that ‘this is our job’ – while also reflecting a practical humility – ‘It’s hard to be everything to everyone all the time,’ ” Dr. Kamal and his associates wrote.

When it comes to palliative care for advanced nonmalignant lung disease, Dr. De Palo said, patients and families may not feel ready to discuss end-of-life issues, and providers may find it difficult to initiate these conversations. “From the moment of diagnosis, the focus of a patient’s care for providers is curative care.” Including a palliative focus can be difficult.

 

Dr. David Bowton

Nonmalignant pulmonary diseases often carry an “uncertain short-term prognosis,” the ATS guidelines stated, and experts echoed that point. “I believe our confidence in determination of prognosis is a key factor in hesitation or delay in engaging palliative care,” said David Bowton, MD, a professor specializing in critical care at Wake Forest School of Medicine, Winston-Salem, N.C. Oncology patients needing ICU care usually have “considerably higher” mortality than the rates of 20%-45% and 15%-30% that are cited for ILD and COPD patients, respectively, he said. Furthermore, there are seemingly accurate scoring systems for predicting short-term mortality in critically ill cancer patients, which is not the case for ILD or COPD, he added.

Such factors point to differences in disease trajectory. “In this study, it is likely that the patients with cancer diagnoses more often received the elements of palliative care in the ICU because it was clearly communicated to the intensive care providers that the opportunities for curative care were exhausted,” Dr. De Palo said. “With care for end-stage chronic respiratory diseases, ICU care can usually optimize breathing enough to get the patient off the vent and stabilized at their previous functional plateau or, more often, at a lower functional plateau, until the next shortness of breath episode.”

Given these challenges and uncertainties, how can clinicians improve palliative care for patients with advanced nonmalignant lung diseases? “Simple. Have a discussion with everyone about what their expectations are,” said Dr. Waxman. “Find out what is important to them and what their goals of therapy are. Help them understand the reality of what actually will be possible to accomplish in a hospitalization, a surgery, or a therapy.”

Dr. De Palo agreed. “For my patients with end-stage respiratory disease, we often discuss whether a sustaining therapy of mechanical ventilation would offer any benefit, and what role cardiopulmonary resuscitation should play in the context of their wishes for care as their disease progresses,” she said. “I believe that providers and health care organizations should offer patients the spectrum of curative and palliative care, and work together to develop a palliative care program where one does not exist,” she stressed. Access to “the full spectrum of care – from curative to palliative – will provide the compassion and quality of life at each stage of their chronic disease.”

Intensivists should also ensure that all ICU patients receive consultations with providers “who can look more at the big picture of their health care, not just at their admission diagnosis and the specific treatment they are receiving,” Dr. Waxman said. And Dr. Bowton offered a final caveat. “While it appears obvious that providing palliative care consultation or integrating elements of palliative care into our routine ICU care will improve the experience for our patients and their families, this has been difficult to demonstrate in well-designed studies,” he said. “Thus, rather than focusing solely on our apparent shortcomings in providing palliative care to our ICU patients with ILD and COPD, we should vigorously support efforts to ascertain what components of palliative care and what ‘dose’ are most effective in alleviating physical and emotional distress.”

The National Institute of Nursing Research funded the study by Dr. Brown and her associates, who reported no relevant financial conflicts of interest.

Patients with chronic obstructive pulmonary disease or interstitial lung disease have longer stays in the intensive care unit, yet are less likely than patients with metastatic cancer to receive comprehensive palliative care.

This finding, reported in Annals of the American Thoracic Society, underscores the need to expand palliative care programs, incorporate elements of palliative care into routine ICU practices, and identify the most effective components of palliative care, said several experts who were not involved in the study.

 

Dr. Michael J. Waxman

“Patients with metastatic cancer are more likely to discuss goals of therapy and code status with their inpatient physician and then receive referrals to palliative care,” said Dr. Michael J. Waxman, medical director of the intensive care unit at Research Medical Center in Kansas City. “I can share many anecdotes over the years where a patient is admitted to my ICU with metastatic cancer, or severe COPD [chronic obstructive pulmonary disease] or IPF [idiopathic pulmonary fibrosis],” he added. “The cognition of these patients in some cases may have been normal, but I learned during my review that they did not receive a good discussion of desires regarding resuscitation or intensity of care. It was regularly assumed that there would be no limits on intensity of care.”

Palliative care historically has focused on patients with cancer, even though mortality rates can be high in noncancer lung disease, Dr. Crystal Brown and her associates at the University of Washington in Seattle wrote in their article (Ann Am Thorac Soc. 2016;13:684-9.). Their secondary analysis of the randomized Integrating Palliative and Critical Care trial examined medical chart data for 592 patients with COPD, 158 patients with metastatic cancer, and 79 patients with interstitial lung disease (ILD) who died in the ICUs of 15 Seattle-area hospitals between 2003 and 2008. The investigators performed regression modeling to test associations between diagnosis and eight elements of palliative care – avoidance of cardiopulmonary resuscitation during the hour before death, pain assessment during the 24 hours before death, the presence of a do-not-resuscitate order at the time of death, discussion of prognosis within 72 hours of ICU admission, withdrawal of life support measures before death, involvement of a spiritual care provider, consultation with a palliative care specialist, and the presence of an advance directive. The statistical models controlled for many potential confounders, including age, sex, race and ethnicity, education level, hospital, and whether patients died before or after hospitals implemented a palliative care quality improvement intervention.

Even though median lengths of ICU stay were significantly longer for ILD patients (4.2 days) and COPD patients (2.9 days) than for metastatic cancer patients (2.3 days), patients with COPD were significantly less likely to avoid CPR in the hour before death (adjusted odds ratio, 0.43; 95% confidence interval, 0.20-0.90), while ILD patients were less likely to have a documented pain assessment in the 24 hours before death (OR, 0.43; 95% CI, 0.19-0.97), compared with metastatic cancer patients. Patients with ILD or COPD also were significantly less likely to have a do-not-resuscitate order in place or documentation of a discussion of their prognosis, Dr. Brown and her associates reported.

 

Dr. Vera De Palo

The findings raise several concerns. “Clearly, this points to both intensivists and palliative care consultants needing to do more to target patients with nonmalignant end-stage chronic lung diseases, such as some patients with COPD and ILD,” said Dr. Robert Hyzy, director of the critical care medicine unit at the University of Michigan Hospital, Ann Arbor. The difference in length of stay also suggests a need to recognize earlier when critically ill patients have not responded to an appropriate time period of treatment (sometimes called a “time-limited trial”), “which signals the transition from cure to comfort,” he added.

Vera De Palo, MD, MBA, FCCP, who is chief of medicine at Signature Healthcare Brockton (Mass.) Hospital, agreed. “While treatment plans for patients with end-stage ILD and COPD do at times include palliative care, the study points out what is often the experience for most patients,” she said. “Our oncology colleagues have better understood the time line of transition between curative care and palliative care than those of us who also manage noncancer chronic diseases. They are more likely to participate in the development of palliative care programs, ensuring that this avenue of care is also available to their patients.”

This is not the only study to reveal gaps in palliative care for advanced nonmalignant lung disease. In a recent analysis of the Nationwide Inpatient Sample, only 2.6% of COPD patients who were home on oxygen and then were hospitalized with an exacerbation received a palliative care referral (CHEST. 2016 Jul 4. doi:10.1016/j.chest.2016.06.023). Such findings belie the most recent palliative care guidelines from the American Thoracic Society for patients with respiratory diseases and critical illnesses, which not only emphasize most of the same palliative care elements as the study by Dr. Brown and her colleagues, but also recommend “early consultation” with palliative care experts to help manage difficult end-of-life discussions (Am J Respir Crit Care Med. 2008;177:912-27).

 

 

Oncology palliative care includes both primary and secondary (specialty-level) services, Dr. Arif Kamal of Duke Cancer Institute at Duke University Medical Center, Durham, N.C., and his associates wrote in a viewpoint published in JAMA. Primary services, such as assessing and managing symptoms, discussing priorities and what to expect, and ensuring continuity of care, are usually left to the oncology team. Secondary services are reserved for more complex or time-consuming cases and are provided by palliative care consultants. “This ‘manage first, refer second’ practice reflects the ethos of the oncology profession – the notion that ‘this is our job’ – while also reflecting a practical humility – ‘It’s hard to be everything to everyone all the time,’ ” Dr. Kamal and his associates wrote.

When it comes to palliative care for advanced nonmalignant lung disease, Dr. De Palo said, patients and families may not feel ready to discuss end-of-life issues, and providers may find it difficult to initiate these conversations. “From the moment of diagnosis, the focus of a patient’s care for providers is curative care.” Including a palliative focus can be difficult.

 

Dr. David Bowton

Nonmalignant pulmonary diseases often carry an “uncertain short-term prognosis,” the ATS guidelines stated, and experts echoed that point. “I believe our confidence in determination of prognosis is a key factor in hesitation or delay in engaging palliative care,” said David Bowton, MD, a professor specializing in critical care at Wake Forest School of Medicine, Winston-Salem, N.C. Oncology patients needing ICU care usually have “considerably higher” mortality than the rates of 20%-45% and 15%-30% that are cited for ILD and COPD patients, respectively, he said. Furthermore, there are seemingly accurate scoring systems for predicting short-term mortality in critically ill cancer patients, which is not the case for ILD or COPD, he added.

Such factors point to differences in disease trajectory. “In this study, it is likely that the patients with cancer diagnoses more often received the elements of palliative care in the ICU because it was clearly communicated to the intensive care providers that the opportunities for curative care were exhausted,” Dr. De Palo said. “With care for end-stage chronic respiratory diseases, ICU care can usually optimize breathing enough to get the patient off the vent and stabilized at their previous functional plateau or, more often, at a lower functional plateau, until the next shortness of breath episode.”

Given these challenges and uncertainties, how can clinicians improve palliative care for patients with advanced nonmalignant lung diseases? “Simple. Have a discussion with everyone about what their expectations are,” said Dr. Waxman. “Find out what is important to them and what their goals of therapy are. Help them understand the reality of what actually will be possible to accomplish in a hospitalization, a surgery, or a therapy.”

Dr. De Palo agreed. “For my patients with end-stage respiratory disease, we often discuss whether a sustaining therapy of mechanical ventilation would offer any benefit, and what role cardiopulmonary resuscitation should play in the context of their wishes for care as their disease progresses,” she said. “I believe that providers and health care organizations should offer patients the spectrum of curative and palliative care, and work together to develop a palliative care program where one does not exist,” she stressed. Access to “the full spectrum of care – from curative to palliative – will provide the compassion and quality of life at each stage of their chronic disease.”

Intensivists should also ensure that all ICU patients receive consultations with providers “who can look more at the big picture of their health care, not just at their admission diagnosis and the specific treatment they are receiving,” Dr. Waxman said. And Dr. Bowton offered a final caveat. “While it appears obvious that providing palliative care consultation or integrating elements of palliative care into our routine ICU care will improve the experience for our patients and their families, this has been difficult to demonstrate in well-designed studies,” he said. “Thus, rather than focusing solely on our apparent shortcomings in providing palliative care to our ICU patients with ILD and COPD, we should vigorously support efforts to ascertain what components of palliative care and what ‘dose’ are most effective in alleviating physical and emotional distress.”

The National Institute of Nursing Research funded the study by Dr. Brown and her associates, who reported no relevant financial conflicts of interest.

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Botox for overactive bladder led to low rate of catheterization

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– Less than 2% of onabotulinumtoxinA injections for idiopathic detrusor overactivity resulted in clean intermittent catheterization, a substantially lower rate than previously found, Juzar Jamnagerwalla, MD, reported at Pelvic Floor Disorders Week.

These included two cases of acute urinary retention and one case in which a patient complained of problems voiding and had a postvoid residual urine volume (PVR) of 353 mL, said Dr. Jamnagerwalla of Cedars-Sinai, Los Angeles. Taken together, the findings suggest that postprocedural PVR can usually be managed safely by observation alone, which may reassure patients who are considering treatment options for overactive bladder, he added.

Amy Karon/Frontline Medical News
Dr. Juzar Jamnagerwalla
In a pivotal phase III trial, intravesical onabotulinumtoxinA (Botox) was shown to be safe and effective in treating overactive bladder associated with idiopathic detrusor overactivity, but up to 7% of patients met criteria for clean intermittent catheterization (CIC), with postprocedural PVRs greater than 350 mL, or subjective voiding complaints and PVRs greater than 200 mL (Eur Urol. 2013 Aug;64[2]:249-56).

But these “strict” criteria contrast with real-world practice, in which patients with postprocedural PVR often are observed without CIC unless they have subjective complaints or other contraindications, Dr. Jamnagerwalla said. The discrepancy is especially relevant because patients with overactive bladder who decline onabotulinumtoxinA often cite the risk of CIC as the reason, he added.

To better understand CIC rates at Cedars-Sinai, Dr. Jamnagerwalla and his colleagues reviewed 27 months of records from patients with idiopathic detrusor overactivity who received injections of 100 U of onabotulinumtoxinA given by female pelvic medicine and reconstructive surgery physicians. The patients were followed up immediately and 2 weeks later, but underwent CIC only if they could not void or had PVRs above 350 mL and subjective voiding complaints.

In all, 99 patients received a total of 187 injections, of which only 3 (1.6%) led to urinary retention requiring CIC. The median postprocedure PVR was 117 mL. About three-quarters of patients had PVRs less than 200 mL, 29 (16%) had PVRs between 200 mL and 350 mL, and 13 (7%) had PVRs greater than 350 mL.

Age, body mass index, and preprocedure PVR did not predict urinary retention in the univariate analysis, Dr. Jamnagerwalla said at the meeting, which was sponsored by the American Urogynecologic Society.

The results support the practice of observing patients with elevated PVRs after Botox, as long as they do not develop obstructive symptoms, he advised.

“While it remains important to counsel patients on the risk of urinary retention after Botox injection for idiopathic detrusor overactivity, patients can be reassured that the true rate of retention requiring CIC is relatively low,” he said.

Dr. Jamnagerwalla reported no funding sources and reported having no financial disclosures. Two coauthors reported ties to Boston Scientific, Astora, and Allergan.

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– Less than 2% of onabotulinumtoxinA injections for idiopathic detrusor overactivity resulted in clean intermittent catheterization, a substantially lower rate than previously found, Juzar Jamnagerwalla, MD, reported at Pelvic Floor Disorders Week.

These included two cases of acute urinary retention and one case in which a patient complained of problems voiding and had a postvoid residual urine volume (PVR) of 353 mL, said Dr. Jamnagerwalla of Cedars-Sinai, Los Angeles. Taken together, the findings suggest that postprocedural PVR can usually be managed safely by observation alone, which may reassure patients who are considering treatment options for overactive bladder, he added.

Amy Karon/Frontline Medical News
Dr. Juzar Jamnagerwalla
In a pivotal phase III trial, intravesical onabotulinumtoxinA (Botox) was shown to be safe and effective in treating overactive bladder associated with idiopathic detrusor overactivity, but up to 7% of patients met criteria for clean intermittent catheterization (CIC), with postprocedural PVRs greater than 350 mL, or subjective voiding complaints and PVRs greater than 200 mL (Eur Urol. 2013 Aug;64[2]:249-56).

But these “strict” criteria contrast with real-world practice, in which patients with postprocedural PVR often are observed without CIC unless they have subjective complaints or other contraindications, Dr. Jamnagerwalla said. The discrepancy is especially relevant because patients with overactive bladder who decline onabotulinumtoxinA often cite the risk of CIC as the reason, he added.

To better understand CIC rates at Cedars-Sinai, Dr. Jamnagerwalla and his colleagues reviewed 27 months of records from patients with idiopathic detrusor overactivity who received injections of 100 U of onabotulinumtoxinA given by female pelvic medicine and reconstructive surgery physicians. The patients were followed up immediately and 2 weeks later, but underwent CIC only if they could not void or had PVRs above 350 mL and subjective voiding complaints.

In all, 99 patients received a total of 187 injections, of which only 3 (1.6%) led to urinary retention requiring CIC. The median postprocedure PVR was 117 mL. About three-quarters of patients had PVRs less than 200 mL, 29 (16%) had PVRs between 200 mL and 350 mL, and 13 (7%) had PVRs greater than 350 mL.

Age, body mass index, and preprocedure PVR did not predict urinary retention in the univariate analysis, Dr. Jamnagerwalla said at the meeting, which was sponsored by the American Urogynecologic Society.

The results support the practice of observing patients with elevated PVRs after Botox, as long as they do not develop obstructive symptoms, he advised.

“While it remains important to counsel patients on the risk of urinary retention after Botox injection for idiopathic detrusor overactivity, patients can be reassured that the true rate of retention requiring CIC is relatively low,” he said.

Dr. Jamnagerwalla reported no funding sources and reported having no financial disclosures. Two coauthors reported ties to Boston Scientific, Astora, and Allergan.

 

– Less than 2% of onabotulinumtoxinA injections for idiopathic detrusor overactivity resulted in clean intermittent catheterization, a substantially lower rate than previously found, Juzar Jamnagerwalla, MD, reported at Pelvic Floor Disorders Week.

These included two cases of acute urinary retention and one case in which a patient complained of problems voiding and had a postvoid residual urine volume (PVR) of 353 mL, said Dr. Jamnagerwalla of Cedars-Sinai, Los Angeles. Taken together, the findings suggest that postprocedural PVR can usually be managed safely by observation alone, which may reassure patients who are considering treatment options for overactive bladder, he added.

Amy Karon/Frontline Medical News
Dr. Juzar Jamnagerwalla
In a pivotal phase III trial, intravesical onabotulinumtoxinA (Botox) was shown to be safe and effective in treating overactive bladder associated with idiopathic detrusor overactivity, but up to 7% of patients met criteria for clean intermittent catheterization (CIC), with postprocedural PVRs greater than 350 mL, or subjective voiding complaints and PVRs greater than 200 mL (Eur Urol. 2013 Aug;64[2]:249-56).

But these “strict” criteria contrast with real-world practice, in which patients with postprocedural PVR often are observed without CIC unless they have subjective complaints or other contraindications, Dr. Jamnagerwalla said. The discrepancy is especially relevant because patients with overactive bladder who decline onabotulinumtoxinA often cite the risk of CIC as the reason, he added.

To better understand CIC rates at Cedars-Sinai, Dr. Jamnagerwalla and his colleagues reviewed 27 months of records from patients with idiopathic detrusor overactivity who received injections of 100 U of onabotulinumtoxinA given by female pelvic medicine and reconstructive surgery physicians. The patients were followed up immediately and 2 weeks later, but underwent CIC only if they could not void or had PVRs above 350 mL and subjective voiding complaints.

In all, 99 patients received a total of 187 injections, of which only 3 (1.6%) led to urinary retention requiring CIC. The median postprocedure PVR was 117 mL. About three-quarters of patients had PVRs less than 200 mL, 29 (16%) had PVRs between 200 mL and 350 mL, and 13 (7%) had PVRs greater than 350 mL.

Age, body mass index, and preprocedure PVR did not predict urinary retention in the univariate analysis, Dr. Jamnagerwalla said at the meeting, which was sponsored by the American Urogynecologic Society.

The results support the practice of observing patients with elevated PVRs after Botox, as long as they do not develop obstructive symptoms, he advised.

“While it remains important to counsel patients on the risk of urinary retention after Botox injection for idiopathic detrusor overactivity, patients can be reassured that the true rate of retention requiring CIC is relatively low,” he said.

Dr. Jamnagerwalla reported no funding sources and reported having no financial disclosures. Two coauthors reported ties to Boston Scientific, Astora, and Allergan.

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Key clinical point: Botox injections for overactive bladder may cause urinary retention requiring clean intermittent catheterization substantially less than previously thought.

Major finding: Of 187 injections, 1.6% of led to acute urinary retention requiring clean intermittent catheterization.

Data source: A single-center, retrospective study of 99 patients receiving 187 onabotulinumtoxinA injections.

Disclosures: Dr. Jamnagerwalla and his colleagues reported no funding sources and had no disclosures.

Absorbable suture performs well in sacrocolpopexy with mesh

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– Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.

That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.

The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.

“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”

Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.

Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.

At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.

At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.

Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).

In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.

Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.

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– Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.

That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.

The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.

“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”

Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.

Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.

At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.

At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.

Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).

In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.

Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.

 

– Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.

That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.

The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.

“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”

Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.

Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.

At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.

At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.

Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).

In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.

Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.

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Key clinical point: Permanent suture may be unnecessary to secure mesh during laparoscopic sacrocolpopexy to repair pelvic organ prolapse.

Major finding: When 90-day delayed absorbable polydioxanone suture was used, the mesh erosion rate was 1.6%. There were no anatomic failures or cases of suture extrusion.

Data source: A single-center prospective case series of 64 patients.

Disclosures: Dr. Taylor reported having no financial disclosures. One coauthor reported ties to Coloplast Corp.

Analysis yields ‘strong evidence’ for benefit of physical activity in NAFLD

Strong evidence for benefit of exercise in NAFLD
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Tue, 12/13/2016 - 10:27

 

Regular physical exercise significantly improved measures of nonalcoholic fatty liver disease independently of dietary changes, according to a meta-analysis of randomized controlled* trials published in the October issue of Clinical Gastroenterology and Hepatology.

“On the basis of the current findings, physical activity should be recommended not only in combination with dietary changes but also independently as an effective approach to manage NAFLD,” wrote Lorenzo Orci, MD, and his associates at the University of Geneva. “We propose that the level of evidence surrounding the specific role of physical activity in the management of NAFLD is now sufficient to be awarded a grade of Ia.”

 


Nonalcoholic fatty liver disease, “the hepatic manifestation of metabolic syndrome,” affects at least one in four U.S. adults and 15%-35% of individuals in Europe, the Middle East, China, and Japan, the researchers noted. Dietary changes are the cornerstone of NAFLD management, and there is less evidence for how physical exercise affects liver fat content. Therefore, the researchers searched MEDLINE, Embase, and the Cochrane databases from inception through October 2015 to find randomized trials of the impact of physical activity on markers of liver steatosis and liver inflammation in patients diagnosed with NAFLD, obesity, type 2 diabetes, or metabolic syndrome. This approach yielded 28 trials with data from more than 1,600 patients. Only two trials were multicenter, 13 required participants to have an NAFLD diagnosis, four focused on type 2 diabetes, and most of the rest included sedentary obese patients without requiring a diagnosis of NAFLD, the researchers said (Clin Gastroenterol Hepatol. 2016 May 4. doi: 10.1016/j.cgh.2016.04.036).

After researchers accounted for dietary changes, physical activity led to a significant drop in intrahepatic lipid content with a standardized mean difference of –0.69 compared with controls (95% confidence interval, –0.90 to –0.48; P less than .0001). “Because effect sizes such as standard mean difference [SMD] are difficult to interpret, the translation of such a statistical measure into a clinically relevant notion has been the focus of research for more than a decade,” the investigators added. “A commonly used interpretation was proposed by Cohen, who suggested that SMDs of 0.2, 0.5, and 0.8 correspond to small, moderate, and large effect sizes, respectively. By using this rule of thumb, our results indicate that physical activity exerts a moderate-to-large impact on the reduction of intrahepatic lipid content.”

Exercise reduced liver fat content even more in pediatric patients (SMD, –0.75; 95% CI, –0.1 to –0.5; P less than .0001) and in patients who had been specifically diagnosed with NAFLD (SMD, –0.86; 95% CI, –1.26 to –0.46; P less than .0001). Patients with the highest baseline body mass index also seemed to benefit more than patients with lower baseline BMI (P = .04). Indeed, exercise reduced BMI itself by a weighted mean difference of 0.8 (95% CI, –1.22 to 0.38; P less than .001), the researchers noted. Exercise intensity did not seem to affect the likelihood of benefit. There was a trend toward a greater effect of aerobic over resistance training (P = .06), and few studies examined the effects of combining both types of exercise.

The multivariable analysis also linked physical activity to an average 3.30 IU/L drop in alanine aminotransferase levels (95% CI, –5.57 to –1.04) and to a 4.9 IU/L decrease in aspartate aminotransferase levels (95% CI, –8.68 to –1.02). The investigators were unable to assess the long-term effects of physical exercise, nor its effects on hepatic fibrosis or inflammation, they noted. Nonetheless, the moderate to large effect size “provides strong evidence for the recommendation of physical activity as an effective intervention in the treatment of NAFLD,” they concluded. “Physical activity is also associated with an improvement in blood levels of aminotransferases and is particularly beneficial in patients presenting with severe obesity at baseline.”

The work was funded by the Ligue Genevoise contre le Cancer and the Dr Henri Dubois-Ferrière/Dinu Lipatti Foundation and by the Swiss National Science Foundation. The investigators had no disclosures.

*Content was updated on 10/25/2016 

 

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There has been tremendous interest in developing pharmacologic treatments for nonalcoholic steatohepatitis, especially in the Western world. There has not been significant enthusiasm for investigating exercise-based lifestyle modification as a primary treatment for NASH. Although the meta-analysis by Orci et al. included 28 studies, there are only 2 studies (combined, fewer than 100 patients) that examined the effect of exercise on liver histology in NASH and they both suggest that lifestyle modification consisting of exercise in addition to dietary modification improves liver histology in NASH. A seminal study was published by Vilar-Gomez et al. (Gastroenterology. 2015;149:367-78) that showed that a lifestyle modification consisting of reduction in caloric intake by 750 kcal/d along with low-intensity exercise (200 minutes of walking each week) led to significant improvement in liver histology, especially in those who lost at least 5% of their body weight.

Dr. Naga P. Chalasani
What do these data mean for practicing clinicians who are seeing an ever growing number of patients with NAFLD? A serious attempt at lifestyle modification should be the first-line treatment option for patients with NAFLD and NASH. Patients should be given a formal target for weight loss and exercise and should be encouraged to seek formal consultation with a nutritionist and perhaps a personal trainer.
 

Naga Chalasani, MD, AGAF, FACG, FAASLD, is the David W. Crabb Professor and director of the division of gastroenterology and hepatology, Indiana University, Purdue. He had no relevant conflicts.

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There has been tremendous interest in developing pharmacologic treatments for nonalcoholic steatohepatitis, especially in the Western world. There has not been significant enthusiasm for investigating exercise-based lifestyle modification as a primary treatment for NASH. Although the meta-analysis by Orci et al. included 28 studies, there are only 2 studies (combined, fewer than 100 patients) that examined the effect of exercise on liver histology in NASH and they both suggest that lifestyle modification consisting of exercise in addition to dietary modification improves liver histology in NASH. A seminal study was published by Vilar-Gomez et al. (Gastroenterology. 2015;149:367-78) that showed that a lifestyle modification consisting of reduction in caloric intake by 750 kcal/d along with low-intensity exercise (200 minutes of walking each week) led to significant improvement in liver histology, especially in those who lost at least 5% of their body weight.

Dr. Naga P. Chalasani
What do these data mean for practicing clinicians who are seeing an ever growing number of patients with NAFLD? A serious attempt at lifestyle modification should be the first-line treatment option for patients with NAFLD and NASH. Patients should be given a formal target for weight loss and exercise and should be encouraged to seek formal consultation with a nutritionist and perhaps a personal trainer.
 

Naga Chalasani, MD, AGAF, FACG, FAASLD, is the David W. Crabb Professor and director of the division of gastroenterology and hepatology, Indiana University, Purdue. He had no relevant conflicts.

Body

 

There has been tremendous interest in developing pharmacologic treatments for nonalcoholic steatohepatitis, especially in the Western world. There has not been significant enthusiasm for investigating exercise-based lifestyle modification as a primary treatment for NASH. Although the meta-analysis by Orci et al. included 28 studies, there are only 2 studies (combined, fewer than 100 patients) that examined the effect of exercise on liver histology in NASH and they both suggest that lifestyle modification consisting of exercise in addition to dietary modification improves liver histology in NASH. A seminal study was published by Vilar-Gomez et al. (Gastroenterology. 2015;149:367-78) that showed that a lifestyle modification consisting of reduction in caloric intake by 750 kcal/d along with low-intensity exercise (200 minutes of walking each week) led to significant improvement in liver histology, especially in those who lost at least 5% of their body weight.

Dr. Naga P. Chalasani
What do these data mean for practicing clinicians who are seeing an ever growing number of patients with NAFLD? A serious attempt at lifestyle modification should be the first-line treatment option for patients with NAFLD and NASH. Patients should be given a formal target for weight loss and exercise and should be encouraged to seek formal consultation with a nutritionist and perhaps a personal trainer.
 

Naga Chalasani, MD, AGAF, FACG, FAASLD, is the David W. Crabb Professor and director of the division of gastroenterology and hepatology, Indiana University, Purdue. He had no relevant conflicts.

Title
Strong evidence for benefit of exercise in NAFLD
Strong evidence for benefit of exercise in NAFLD

 

Regular physical exercise significantly improved measures of nonalcoholic fatty liver disease independently of dietary changes, according to a meta-analysis of randomized controlled* trials published in the October issue of Clinical Gastroenterology and Hepatology.

“On the basis of the current findings, physical activity should be recommended not only in combination with dietary changes but also independently as an effective approach to manage NAFLD,” wrote Lorenzo Orci, MD, and his associates at the University of Geneva. “We propose that the level of evidence surrounding the specific role of physical activity in the management of NAFLD is now sufficient to be awarded a grade of Ia.”

 


Nonalcoholic fatty liver disease, “the hepatic manifestation of metabolic syndrome,” affects at least one in four U.S. adults and 15%-35% of individuals in Europe, the Middle East, China, and Japan, the researchers noted. Dietary changes are the cornerstone of NAFLD management, and there is less evidence for how physical exercise affects liver fat content. Therefore, the researchers searched MEDLINE, Embase, and the Cochrane databases from inception through October 2015 to find randomized trials of the impact of physical activity on markers of liver steatosis and liver inflammation in patients diagnosed with NAFLD, obesity, type 2 diabetes, or metabolic syndrome. This approach yielded 28 trials with data from more than 1,600 patients. Only two trials were multicenter, 13 required participants to have an NAFLD diagnosis, four focused on type 2 diabetes, and most of the rest included sedentary obese patients without requiring a diagnosis of NAFLD, the researchers said (Clin Gastroenterol Hepatol. 2016 May 4. doi: 10.1016/j.cgh.2016.04.036).

After researchers accounted for dietary changes, physical activity led to a significant drop in intrahepatic lipid content with a standardized mean difference of –0.69 compared with controls (95% confidence interval, –0.90 to –0.48; P less than .0001). “Because effect sizes such as standard mean difference [SMD] are difficult to interpret, the translation of such a statistical measure into a clinically relevant notion has been the focus of research for more than a decade,” the investigators added. “A commonly used interpretation was proposed by Cohen, who suggested that SMDs of 0.2, 0.5, and 0.8 correspond to small, moderate, and large effect sizes, respectively. By using this rule of thumb, our results indicate that physical activity exerts a moderate-to-large impact on the reduction of intrahepatic lipid content.”

Exercise reduced liver fat content even more in pediatric patients (SMD, –0.75; 95% CI, –0.1 to –0.5; P less than .0001) and in patients who had been specifically diagnosed with NAFLD (SMD, –0.86; 95% CI, –1.26 to –0.46; P less than .0001). Patients with the highest baseline body mass index also seemed to benefit more than patients with lower baseline BMI (P = .04). Indeed, exercise reduced BMI itself by a weighted mean difference of 0.8 (95% CI, –1.22 to 0.38; P less than .001), the researchers noted. Exercise intensity did not seem to affect the likelihood of benefit. There was a trend toward a greater effect of aerobic over resistance training (P = .06), and few studies examined the effects of combining both types of exercise.

The multivariable analysis also linked physical activity to an average 3.30 IU/L drop in alanine aminotransferase levels (95% CI, –5.57 to –1.04) and to a 4.9 IU/L decrease in aspartate aminotransferase levels (95% CI, –8.68 to –1.02). The investigators were unable to assess the long-term effects of physical exercise, nor its effects on hepatic fibrosis or inflammation, they noted. Nonetheless, the moderate to large effect size “provides strong evidence for the recommendation of physical activity as an effective intervention in the treatment of NAFLD,” they concluded. “Physical activity is also associated with an improvement in blood levels of aminotransferases and is particularly beneficial in patients presenting with severe obesity at baseline.”

The work was funded by the Ligue Genevoise contre le Cancer and the Dr Henri Dubois-Ferrière/Dinu Lipatti Foundation and by the Swiss National Science Foundation. The investigators had no disclosures.

*Content was updated on 10/25/2016 

 

 

Regular physical exercise significantly improved measures of nonalcoholic fatty liver disease independently of dietary changes, according to a meta-analysis of randomized controlled* trials published in the October issue of Clinical Gastroenterology and Hepatology.

“On the basis of the current findings, physical activity should be recommended not only in combination with dietary changes but also independently as an effective approach to manage NAFLD,” wrote Lorenzo Orci, MD, and his associates at the University of Geneva. “We propose that the level of evidence surrounding the specific role of physical activity in the management of NAFLD is now sufficient to be awarded a grade of Ia.”

 


Nonalcoholic fatty liver disease, “the hepatic manifestation of metabolic syndrome,” affects at least one in four U.S. adults and 15%-35% of individuals in Europe, the Middle East, China, and Japan, the researchers noted. Dietary changes are the cornerstone of NAFLD management, and there is less evidence for how physical exercise affects liver fat content. Therefore, the researchers searched MEDLINE, Embase, and the Cochrane databases from inception through October 2015 to find randomized trials of the impact of physical activity on markers of liver steatosis and liver inflammation in patients diagnosed with NAFLD, obesity, type 2 diabetes, or metabolic syndrome. This approach yielded 28 trials with data from more than 1,600 patients. Only two trials were multicenter, 13 required participants to have an NAFLD diagnosis, four focused on type 2 diabetes, and most of the rest included sedentary obese patients without requiring a diagnosis of NAFLD, the researchers said (Clin Gastroenterol Hepatol. 2016 May 4. doi: 10.1016/j.cgh.2016.04.036).

After researchers accounted for dietary changes, physical activity led to a significant drop in intrahepatic lipid content with a standardized mean difference of –0.69 compared with controls (95% confidence interval, –0.90 to –0.48; P less than .0001). “Because effect sizes such as standard mean difference [SMD] are difficult to interpret, the translation of such a statistical measure into a clinically relevant notion has been the focus of research for more than a decade,” the investigators added. “A commonly used interpretation was proposed by Cohen, who suggested that SMDs of 0.2, 0.5, and 0.8 correspond to small, moderate, and large effect sizes, respectively. By using this rule of thumb, our results indicate that physical activity exerts a moderate-to-large impact on the reduction of intrahepatic lipid content.”

Exercise reduced liver fat content even more in pediatric patients (SMD, –0.75; 95% CI, –0.1 to –0.5; P less than .0001) and in patients who had been specifically diagnosed with NAFLD (SMD, –0.86; 95% CI, –1.26 to –0.46; P less than .0001). Patients with the highest baseline body mass index also seemed to benefit more than patients with lower baseline BMI (P = .04). Indeed, exercise reduced BMI itself by a weighted mean difference of 0.8 (95% CI, –1.22 to 0.38; P less than .001), the researchers noted. Exercise intensity did not seem to affect the likelihood of benefit. There was a trend toward a greater effect of aerobic over resistance training (P = .06), and few studies examined the effects of combining both types of exercise.

The multivariable analysis also linked physical activity to an average 3.30 IU/L drop in alanine aminotransferase levels (95% CI, –5.57 to –1.04) and to a 4.9 IU/L decrease in aspartate aminotransferase levels (95% CI, –8.68 to –1.02). The investigators were unable to assess the long-term effects of physical exercise, nor its effects on hepatic fibrosis or inflammation, they noted. Nonetheless, the moderate to large effect size “provides strong evidence for the recommendation of physical activity as an effective intervention in the treatment of NAFLD,” they concluded. “Physical activity is also associated with an improvement in blood levels of aminotransferases and is particularly beneficial in patients presenting with severe obesity at baseline.”

The work was funded by the Ligue Genevoise contre le Cancer and the Dr Henri Dubois-Ferrière/Dinu Lipatti Foundation and by the Swiss National Science Foundation. The investigators had no disclosures.

*Content was updated on 10/25/2016 

 

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Key clinical point: Physical activity benefits measures of nonalcoholic fatty liver disease independently of diet.

Major finding: After researchers accounted for dietary changes, physical activity led to a significant drop in intrahepatic lipid content with a standardized mean difference of –0.69 compared with controls (95% confidence interval, –0.90 to –0.48; P less than .0001).

Data source: A systematic review and meta-analysis of 28 randomized controlled trials comprising more than 16,000 patients.

Disclosures: The work was funded by the Ligue Genevoise contre le Cancer and the Dr Henri Dubois-Ferrière/Dinu Lipatti Foundation and by the Swiss National Science Foundation. The researchers had no disclosures.