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Glimmer of promise for nivolumab in neoadjuvant NSCLC therapy
COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.
Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.
To see whether immunotherapy could be safe and practical in the neoadjuvant setting, the investigators enrolled 18 patients with untreated, resectable disease and performed pretreatment tumor biopsies. Patients then received doses of nivolumab 3 mg/kg delivered at 4 weeks and 2 weeks prior to scheduled surgery. Following surgery, patients received adjuvant chemotherapy at the investigator’s discretion.
Treatment related adverse events included one grade 3 to 4 toxicity and one event leading to discontinuation. There were no adverse events requiring delay of surgery.
The investigators also conducted an exploratory analysis of response to treatment among 17 who had sufficient follow-up data for evaluation of the primary endpoints of safety and feasibility.
As noted, 12 patients had a measurable tumor response, and 7 had a major pathologic response. Of this latter group, three had no radiographic evidence of response, but tumor specimens from all 7 showed evidence of “substantial” T-cell infiltration, indicating an enhanced immune response, Dr. Forde said.
In all, 9 of the 17 patients had tumor regression of more than 50%, and 7 patients had pathologic downstaging from their pretreatment clinical stage.
Four of the seven tumors with the major pathologic response were tested with a programmed death–1 ligand immunohistochemical assay, and three were positive for the ligand.
The investigators also isolated both unique and shared T-cell clones from peripheral blood, and detected new infiltration of T-cell clones that were not seen in the tumor specimens taken prior to nivolumab therapy.
Based on these early results, the investigators plan to expand the study, with one cohort planned to receive a third presurgical dose of nivolumab, and a second cohort scheduled to receive both nivolumab and ipilimumab (Yervoy).
It remains to be seen, he said, whether patients should also receive maintenance therapy, and whether combined checkpoint inhibitors might be more effective.
However, Pieter Postmus, chair of thoracic oncology at the University of Liverpool (England), who was not involved in the study, said that he is reserving judgment on efficacy until further data are available.
“There is a potential for bias when comparing a small biopsy, which might not represent the whole tumor, with the resected tumor,” he said in a statement. “This is not a validated way to measure response to a treatment. It describes a biological effect but whether that has any clinical impact on survival is unproven.”
“Although we do not know for the time being if a major pathological response is correlated with improved survival, this method could first be validated in a cohort of patients with advanced disease by comparing the percentages of viable tumor cells in tumor biopsies taken before and 4 to 8 weeks after immunotherapy,” he added. “If in this way regression – as defined in the preoperative study – correlates with survival in patients with advanced cancer, it is likely to hold true in less advanced or resectable patients. Long-term survival data will be the ultimate test for these neoadjuvant immunotherapy strategies.”
COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.
Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.
To see whether immunotherapy could be safe and practical in the neoadjuvant setting, the investigators enrolled 18 patients with untreated, resectable disease and performed pretreatment tumor biopsies. Patients then received doses of nivolumab 3 mg/kg delivered at 4 weeks and 2 weeks prior to scheduled surgery. Following surgery, patients received adjuvant chemotherapy at the investigator’s discretion.
Treatment related adverse events included one grade 3 to 4 toxicity and one event leading to discontinuation. There were no adverse events requiring delay of surgery.
The investigators also conducted an exploratory analysis of response to treatment among 17 who had sufficient follow-up data for evaluation of the primary endpoints of safety and feasibility.
As noted, 12 patients had a measurable tumor response, and 7 had a major pathologic response. Of this latter group, three had no radiographic evidence of response, but tumor specimens from all 7 showed evidence of “substantial” T-cell infiltration, indicating an enhanced immune response, Dr. Forde said.
In all, 9 of the 17 patients had tumor regression of more than 50%, and 7 patients had pathologic downstaging from their pretreatment clinical stage.
Four of the seven tumors with the major pathologic response were tested with a programmed death–1 ligand immunohistochemical assay, and three were positive for the ligand.
The investigators also isolated both unique and shared T-cell clones from peripheral blood, and detected new infiltration of T-cell clones that were not seen in the tumor specimens taken prior to nivolumab therapy.
Based on these early results, the investigators plan to expand the study, with one cohort planned to receive a third presurgical dose of nivolumab, and a second cohort scheduled to receive both nivolumab and ipilimumab (Yervoy).
It remains to be seen, he said, whether patients should also receive maintenance therapy, and whether combined checkpoint inhibitors might be more effective.
However, Pieter Postmus, chair of thoracic oncology at the University of Liverpool (England), who was not involved in the study, said that he is reserving judgment on efficacy until further data are available.
“There is a potential for bias when comparing a small biopsy, which might not represent the whole tumor, with the resected tumor,” he said in a statement. “This is not a validated way to measure response to a treatment. It describes a biological effect but whether that has any clinical impact on survival is unproven.”
“Although we do not know for the time being if a major pathological response is correlated with improved survival, this method could first be validated in a cohort of patients with advanced disease by comparing the percentages of viable tumor cells in tumor biopsies taken before and 4 to 8 weeks after immunotherapy,” he added. “If in this way regression – as defined in the preoperative study – correlates with survival in patients with advanced cancer, it is likely to hold true in less advanced or resectable patients. Long-term survival data will be the ultimate test for these neoadjuvant immunotherapy strategies.”
COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.
Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.
To see whether immunotherapy could be safe and practical in the neoadjuvant setting, the investigators enrolled 18 patients with untreated, resectable disease and performed pretreatment tumor biopsies. Patients then received doses of nivolumab 3 mg/kg delivered at 4 weeks and 2 weeks prior to scheduled surgery. Following surgery, patients received adjuvant chemotherapy at the investigator’s discretion.
Treatment related adverse events included one grade 3 to 4 toxicity and one event leading to discontinuation. There were no adverse events requiring delay of surgery.
The investigators also conducted an exploratory analysis of response to treatment among 17 who had sufficient follow-up data for evaluation of the primary endpoints of safety and feasibility.
As noted, 12 patients had a measurable tumor response, and 7 had a major pathologic response. Of this latter group, three had no radiographic evidence of response, but tumor specimens from all 7 showed evidence of “substantial” T-cell infiltration, indicating an enhanced immune response, Dr. Forde said.
In all, 9 of the 17 patients had tumor regression of more than 50%, and 7 patients had pathologic downstaging from their pretreatment clinical stage.
Four of the seven tumors with the major pathologic response were tested with a programmed death–1 ligand immunohistochemical assay, and three were positive for the ligand.
The investigators also isolated both unique and shared T-cell clones from peripheral blood, and detected new infiltration of T-cell clones that were not seen in the tumor specimens taken prior to nivolumab therapy.
Based on these early results, the investigators plan to expand the study, with one cohort planned to receive a third presurgical dose of nivolumab, and a second cohort scheduled to receive both nivolumab and ipilimumab (Yervoy).
It remains to be seen, he said, whether patients should also receive maintenance therapy, and whether combined checkpoint inhibitors might be more effective.
However, Pieter Postmus, chair of thoracic oncology at the University of Liverpool (England), who was not involved in the study, said that he is reserving judgment on efficacy until further data are available.
“There is a potential for bias when comparing a small biopsy, which might not represent the whole tumor, with the resected tumor,” he said in a statement. “This is not a validated way to measure response to a treatment. It describes a biological effect but whether that has any clinical impact on survival is unproven.”
“Although we do not know for the time being if a major pathological response is correlated with improved survival, this method could first be validated in a cohort of patients with advanced disease by comparing the percentages of viable tumor cells in tumor biopsies taken before and 4 to 8 weeks after immunotherapy,” he added. “If in this way regression – as defined in the preoperative study – correlates with survival in patients with advanced cancer, it is likely to hold true in less advanced or resectable patients. Long-term survival data will be the ultimate test for these neoadjuvant immunotherapy strategies.”
AT ESMO 2016
Key clinical point: Checkpoint inhibitors have shown good efficacy for treatment of advanced NSCLC, but use in the neoadjuvant setting is still investigational.
Major finding: Seven of 17 patients had a major pathologic response (less than 10% viable tumor remaining).
Data source: Safety and feasibility study in 18 patients with stage I-IIIA non–small cell lung cancer.
Disclosures: The study was supported by the American Association for Cancer Research, the Cancer Research Institute, LUNGevity, and Stand Up to Cancer. Bristol-Myers Squibb donated nivolumab and provided funding for PD-L1 testing. Dr. Forde disclosed institution research grants from Bristol-Myers Squibb, Kyowa, Novartis, and uncompensated consulting for AstraZeneca and Celgene. Dr. Baas disclosed grants and research support from Bristol-Myers Squibb. Dr. Postmus had no disclosures.
Fluorescein, 10% dextrose topped other media for visualizing ureteral patency
DENVER – 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.
DENVER – 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.
DENVER – 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.
Key clinical point: 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.
Laparoscopic sacrocolpopexy offers advantages over abdominal route
BOSTON – Laparoscopic sacrocolpopexy offers some distinct advantages over the abdominal route for treatment of pelvic organ prolapse, including reduced intraoperative blood loss and shorter hospital stays, according to findings from a new research review.
“We wanted to compare the efficiency and safety of abdominal sacral colpopexy and laparoscopic sacral colpopexy for the treatment of pelvic organ collapse,” Juan Liu, MD, of Guangzhou Medical University in China said at the annual Minimally Invasive Surgery Week, held by the Society of Laparoendoscopic Surgeons.
Analyses directly comparing the safety and effectiveness of the two surgical routes are low in number, Dr. Liu added.
The researchers looked at published articles, written in English or Chinese, that were either retrospective analyses or randomized controlled trial studies examining laparoscopic sacrocolpopexy (LSC) or abdominal sacrocolpopexy (ASC), with follow-up times of at least 30 days.
Studies that investigated robot-assisted sacrocolpopexy were excluded, as well as studies for which there were no specific feature data or for which the full text of the study was inaccessible. Of 1,807 articles identified, 10 studies containing 3,816 cases were included for the analysis.
The studies were used to compare laparoscopic and abdominal sacrocolpopexy on the following criteria: operating time; blood loss; hospital length of stay; intraoperative complications such as urinary, bladder, and rectal injury; and postoperative complications such as infection, intestinal obstruction, mesh exposure, new urinary incontinence, and dyspareunia. Weighted mean difference was calculated to account for the different sample sizes across the studies.
The weighted mean difference in intraoperative blood loss in the laparoscopic cohort, compared with the abdominal cohort, was –100.68 mL (P less than .01). Hospital length of stay was also significantly reduced in the laparoscopic cohort, with a weighted mean difference of –1.77 days (P less than .01). The odds ratio for gastrointestinal complications was 0.30 for the laparoscopic route, compared with the abdominal route (P less than .01).
Additionally, pulmonary complications and blood transfusions were also found to be reduced with laparoscopic sacrocolpopexy, compared with abdominal sacrocolpopexy, with an odds ratio of 0.59 (P = .02) and 0.47 (P = .03), respectively.
But the review found little difference in other areas. The weighted mean difference for operating time in the laparoscopic cohort was 0.06 minutes, compared with the abdominal cohort, which was not statistically significant (P= .84). And there was not a statistically significant difference between the two surgical approaches in urinary complications (OR, 0.41; P = .11), cardiovascular complications (OR, 0.31; P = .49), or mesh exposure (OR, 1.60, P = .18).
No funding source for this study was disclosed. Dr. Liu reported having no relevant financial disclosures.
BOSTON – Laparoscopic sacrocolpopexy offers some distinct advantages over the abdominal route for treatment of pelvic organ prolapse, including reduced intraoperative blood loss and shorter hospital stays, according to findings from a new research review.
“We wanted to compare the efficiency and safety of abdominal sacral colpopexy and laparoscopic sacral colpopexy for the treatment of pelvic organ collapse,” Juan Liu, MD, of Guangzhou Medical University in China said at the annual Minimally Invasive Surgery Week, held by the Society of Laparoendoscopic Surgeons.
Analyses directly comparing the safety and effectiveness of the two surgical routes are low in number, Dr. Liu added.
The researchers looked at published articles, written in English or Chinese, that were either retrospective analyses or randomized controlled trial studies examining laparoscopic sacrocolpopexy (LSC) or abdominal sacrocolpopexy (ASC), with follow-up times of at least 30 days.
Studies that investigated robot-assisted sacrocolpopexy were excluded, as well as studies for which there were no specific feature data or for which the full text of the study was inaccessible. Of 1,807 articles identified, 10 studies containing 3,816 cases were included for the analysis.
The studies were used to compare laparoscopic and abdominal sacrocolpopexy on the following criteria: operating time; blood loss; hospital length of stay; intraoperative complications such as urinary, bladder, and rectal injury; and postoperative complications such as infection, intestinal obstruction, mesh exposure, new urinary incontinence, and dyspareunia. Weighted mean difference was calculated to account for the different sample sizes across the studies.
The weighted mean difference in intraoperative blood loss in the laparoscopic cohort, compared with the abdominal cohort, was –100.68 mL (P less than .01). Hospital length of stay was also significantly reduced in the laparoscopic cohort, with a weighted mean difference of –1.77 days (P less than .01). The odds ratio for gastrointestinal complications was 0.30 for the laparoscopic route, compared with the abdominal route (P less than .01).
Additionally, pulmonary complications and blood transfusions were also found to be reduced with laparoscopic sacrocolpopexy, compared with abdominal sacrocolpopexy, with an odds ratio of 0.59 (P = .02) and 0.47 (P = .03), respectively.
But the review found little difference in other areas. The weighted mean difference for operating time in the laparoscopic cohort was 0.06 minutes, compared with the abdominal cohort, which was not statistically significant (P= .84). And there was not a statistically significant difference between the two surgical approaches in urinary complications (OR, 0.41; P = .11), cardiovascular complications (OR, 0.31; P = .49), or mesh exposure (OR, 1.60, P = .18).
No funding source for this study was disclosed. Dr. Liu reported having no relevant financial disclosures.
BOSTON – Laparoscopic sacrocolpopexy offers some distinct advantages over the abdominal route for treatment of pelvic organ prolapse, including reduced intraoperative blood loss and shorter hospital stays, according to findings from a new research review.
“We wanted to compare the efficiency and safety of abdominal sacral colpopexy and laparoscopic sacral colpopexy for the treatment of pelvic organ collapse,” Juan Liu, MD, of Guangzhou Medical University in China said at the annual Minimally Invasive Surgery Week, held by the Society of Laparoendoscopic Surgeons.
Analyses directly comparing the safety and effectiveness of the two surgical routes are low in number, Dr. Liu added.
The researchers looked at published articles, written in English or Chinese, that were either retrospective analyses or randomized controlled trial studies examining laparoscopic sacrocolpopexy (LSC) or abdominal sacrocolpopexy (ASC), with follow-up times of at least 30 days.
Studies that investigated robot-assisted sacrocolpopexy were excluded, as well as studies for which there were no specific feature data or for which the full text of the study was inaccessible. Of 1,807 articles identified, 10 studies containing 3,816 cases were included for the analysis.
The studies were used to compare laparoscopic and abdominal sacrocolpopexy on the following criteria: operating time; blood loss; hospital length of stay; intraoperative complications such as urinary, bladder, and rectal injury; and postoperative complications such as infection, intestinal obstruction, mesh exposure, new urinary incontinence, and dyspareunia. Weighted mean difference was calculated to account for the different sample sizes across the studies.
The weighted mean difference in intraoperative blood loss in the laparoscopic cohort, compared with the abdominal cohort, was –100.68 mL (P less than .01). Hospital length of stay was also significantly reduced in the laparoscopic cohort, with a weighted mean difference of –1.77 days (P less than .01). The odds ratio for gastrointestinal complications was 0.30 for the laparoscopic route, compared with the abdominal route (P less than .01).
Additionally, pulmonary complications and blood transfusions were also found to be reduced with laparoscopic sacrocolpopexy, compared with abdominal sacrocolpopexy, with an odds ratio of 0.59 (P = .02) and 0.47 (P = .03), respectively.
But the review found little difference in other areas. The weighted mean difference for operating time in the laparoscopic cohort was 0.06 minutes, compared with the abdominal cohort, which was not statistically significant (P= .84). And there was not a statistically significant difference between the two surgical approaches in urinary complications (OR, 0.41; P = .11), cardiovascular complications (OR, 0.31; P = .49), or mesh exposure (OR, 1.60, P = .18).
No funding source for this study was disclosed. Dr. Liu reported having no relevant financial disclosures.
AT MINIMALLY INVASIVE SURGERY WEEK
Key clinical point:
Major finding: The weighted mean difference in intraoperative blood loss in the laparoscopic cohort, compared with the abdominal cohort, was –100.68 mL (P less than .01).
Data source: Retrospective review of 10 studies involving 3,816 sacrocolpopexy cases.
Disclosures: Dr. Liu reported having no relevant financial disclosures.
Lung cryobiopsies could reduce need for surgical biopsy
LONDON – The vast majority of surgical lung biopsies currently used to diagnose interstitial lung diseases (ILDs) could be avoided, suggests research presented at the annual congress of the European Respiratory Society.
During an oral presentation, Benjamin Bondue, MD, of Hopital Erasme, Brussels, presented the preliminary results of a Belgian prospective study evaluating the role of transbronchial lung cryobiopsies in 24 patients with undefined ILD treated at three participating centers.
Cryobiopsies were found to have a diagnostic yield of 79%, meaning that patients might be able to avoid undergoing a more invasive surgical removal of tissue in many cases. Compared with surgical biopsy, cryobiopsies offered the potential advantage of lower morbidity and shorter hospitalization time, Dr. Bondue said. He reported that patients needed to stay in hospital just 1.2 days after the procedure in the study.
“Our data also show that there is some benefit of surgical lung biopsy after cryobiopsy if we identify an NSIP [nonspecific interstitial pneumonia] pattern or idiopathic conditions, or if we cannot obtain a clear pathological diagnosis,” he reported. Acknowledging the study was small and conducted in a single center, he said the use of cryobiopsies following surgical biopsy might be worth further study.
Transbronchial lung cryobiopsy is a relatively new technique that uses a cryoprobe inserted down through a bronchoscope about 1-2 cm from the thoracic wall. Once in place, the probe is cooled for between 3 and 6 seconds, lung tissue freezes to the probe, and the probe and bronchoscope are removed together. This method allows for larger samples of tissue to be taken than does traditional transbronchial biopsy, which involves using large forceps to obtain tissue samples (Respirology. 2014;19:645-54).
In the Belgian study, Dr. Bondue noted that a Fogarty balloon was used to control any bleeding and that four transbronchial lung cryobiopsies were obtained from two different segments of the same lobe of a patient’s lungs. All biopsies were then analyzed by an expert pathologist in ILDs, and reviewed by two other expert pathologists when needed. The mean sample size obtained was 16 mm2.
The patients included in the study had undergone chest X-ray and had inconclusive findings in the majority (84%) of cases. They then had the option to undergo cryobiopsy or surgical lung biopsy, with the latter performed following discussion among a multidisciplinary team’s members.
Following cryobiopsy, 16 of the 24 patients – who were a mean age of 62 years, and over half of whom were past (56%) or current (12%) smokers – were diagnosed with a specific pattern of ILD not due to NSIP. Of the 16 cases, 6 were due to hypersensitive pneumonitis, 4 were due to interstitial pulmonary fibrosis, and 2 were due to sarcoidosis. The other four cases included patients with one of the following conditions: adenocarcinoma, desquamative interstitial pneumonia, eosinophilic pneumonia, and amyloidosis.
Six of the 24 cases were defined as NSIP, with 2 reclassified as definite and 1 as probable hypersensitive pneumonitis, after discussion within the multidisciplinary team.
Five patients – three who had been diagnosed with NSIP and two who had been given no pathological diagnosis after cryobiopsy – underwent surgical lung biopsy. Of these, following the surgical biopsies, only one patient was considered to have NSIP and the other four were eventually diagnosed with interstitial pulmonary fibrosis.
In terms of safety, five patients experienced pneumothorax, two patients required chest drainage, two needed simple aspiration and one underwent observation. In the majority of cases, patients experienced mild bleeding, with only one patient having experienced severe bleeding. During this study, none of the participants experienced significant chest pain, acute exacerbations, or infections, and none of them died.
Dr. Bondue has received research grants and fees for consulting from Boehringer Ingelheim and Roche.
LONDON – The vast majority of surgical lung biopsies currently used to diagnose interstitial lung diseases (ILDs) could be avoided, suggests research presented at the annual congress of the European Respiratory Society.
During an oral presentation, Benjamin Bondue, MD, of Hopital Erasme, Brussels, presented the preliminary results of a Belgian prospective study evaluating the role of transbronchial lung cryobiopsies in 24 patients with undefined ILD treated at three participating centers.
Cryobiopsies were found to have a diagnostic yield of 79%, meaning that patients might be able to avoid undergoing a more invasive surgical removal of tissue in many cases. Compared with surgical biopsy, cryobiopsies offered the potential advantage of lower morbidity and shorter hospitalization time, Dr. Bondue said. He reported that patients needed to stay in hospital just 1.2 days after the procedure in the study.
“Our data also show that there is some benefit of surgical lung biopsy after cryobiopsy if we identify an NSIP [nonspecific interstitial pneumonia] pattern or idiopathic conditions, or if we cannot obtain a clear pathological diagnosis,” he reported. Acknowledging the study was small and conducted in a single center, he said the use of cryobiopsies following surgical biopsy might be worth further study.
Transbronchial lung cryobiopsy is a relatively new technique that uses a cryoprobe inserted down through a bronchoscope about 1-2 cm from the thoracic wall. Once in place, the probe is cooled for between 3 and 6 seconds, lung tissue freezes to the probe, and the probe and bronchoscope are removed together. This method allows for larger samples of tissue to be taken than does traditional transbronchial biopsy, which involves using large forceps to obtain tissue samples (Respirology. 2014;19:645-54).
In the Belgian study, Dr. Bondue noted that a Fogarty balloon was used to control any bleeding and that four transbronchial lung cryobiopsies were obtained from two different segments of the same lobe of a patient’s lungs. All biopsies were then analyzed by an expert pathologist in ILDs, and reviewed by two other expert pathologists when needed. The mean sample size obtained was 16 mm2.
The patients included in the study had undergone chest X-ray and had inconclusive findings in the majority (84%) of cases. They then had the option to undergo cryobiopsy or surgical lung biopsy, with the latter performed following discussion among a multidisciplinary team’s members.
Following cryobiopsy, 16 of the 24 patients – who were a mean age of 62 years, and over half of whom were past (56%) or current (12%) smokers – were diagnosed with a specific pattern of ILD not due to NSIP. Of the 16 cases, 6 were due to hypersensitive pneumonitis, 4 were due to interstitial pulmonary fibrosis, and 2 were due to sarcoidosis. The other four cases included patients with one of the following conditions: adenocarcinoma, desquamative interstitial pneumonia, eosinophilic pneumonia, and amyloidosis.
Six of the 24 cases were defined as NSIP, with 2 reclassified as definite and 1 as probable hypersensitive pneumonitis, after discussion within the multidisciplinary team.
Five patients – three who had been diagnosed with NSIP and two who had been given no pathological diagnosis after cryobiopsy – underwent surgical lung biopsy. Of these, following the surgical biopsies, only one patient was considered to have NSIP and the other four were eventually diagnosed with interstitial pulmonary fibrosis.
In terms of safety, five patients experienced pneumothorax, two patients required chest drainage, two needed simple aspiration and one underwent observation. In the majority of cases, patients experienced mild bleeding, with only one patient having experienced severe bleeding. During this study, none of the participants experienced significant chest pain, acute exacerbations, or infections, and none of them died.
Dr. Bondue has received research grants and fees for consulting from Boehringer Ingelheim and Roche.
LONDON – The vast majority of surgical lung biopsies currently used to diagnose interstitial lung diseases (ILDs) could be avoided, suggests research presented at the annual congress of the European Respiratory Society.
During an oral presentation, Benjamin Bondue, MD, of Hopital Erasme, Brussels, presented the preliminary results of a Belgian prospective study evaluating the role of transbronchial lung cryobiopsies in 24 patients with undefined ILD treated at three participating centers.
Cryobiopsies were found to have a diagnostic yield of 79%, meaning that patients might be able to avoid undergoing a more invasive surgical removal of tissue in many cases. Compared with surgical biopsy, cryobiopsies offered the potential advantage of lower morbidity and shorter hospitalization time, Dr. Bondue said. He reported that patients needed to stay in hospital just 1.2 days after the procedure in the study.
“Our data also show that there is some benefit of surgical lung biopsy after cryobiopsy if we identify an NSIP [nonspecific interstitial pneumonia] pattern or idiopathic conditions, or if we cannot obtain a clear pathological diagnosis,” he reported. Acknowledging the study was small and conducted in a single center, he said the use of cryobiopsies following surgical biopsy might be worth further study.
Transbronchial lung cryobiopsy is a relatively new technique that uses a cryoprobe inserted down through a bronchoscope about 1-2 cm from the thoracic wall. Once in place, the probe is cooled for between 3 and 6 seconds, lung tissue freezes to the probe, and the probe and bronchoscope are removed together. This method allows for larger samples of tissue to be taken than does traditional transbronchial biopsy, which involves using large forceps to obtain tissue samples (Respirology. 2014;19:645-54).
In the Belgian study, Dr. Bondue noted that a Fogarty balloon was used to control any bleeding and that four transbronchial lung cryobiopsies were obtained from two different segments of the same lobe of a patient’s lungs. All biopsies were then analyzed by an expert pathologist in ILDs, and reviewed by two other expert pathologists when needed. The mean sample size obtained was 16 mm2.
The patients included in the study had undergone chest X-ray and had inconclusive findings in the majority (84%) of cases. They then had the option to undergo cryobiopsy or surgical lung biopsy, with the latter performed following discussion among a multidisciplinary team’s members.
Following cryobiopsy, 16 of the 24 patients – who were a mean age of 62 years, and over half of whom were past (56%) or current (12%) smokers – were diagnosed with a specific pattern of ILD not due to NSIP. Of the 16 cases, 6 were due to hypersensitive pneumonitis, 4 were due to interstitial pulmonary fibrosis, and 2 were due to sarcoidosis. The other four cases included patients with one of the following conditions: adenocarcinoma, desquamative interstitial pneumonia, eosinophilic pneumonia, and amyloidosis.
Six of the 24 cases were defined as NSIP, with 2 reclassified as definite and 1 as probable hypersensitive pneumonitis, after discussion within the multidisciplinary team.
Five patients – three who had been diagnosed with NSIP and two who had been given no pathological diagnosis after cryobiopsy – underwent surgical lung biopsy. Of these, following the surgical biopsies, only one patient was considered to have NSIP and the other four were eventually diagnosed with interstitial pulmonary fibrosis.
In terms of safety, five patients experienced pneumothorax, two patients required chest drainage, two needed simple aspiration and one underwent observation. In the majority of cases, patients experienced mild bleeding, with only one patient having experienced severe bleeding. During this study, none of the participants experienced significant chest pain, acute exacerbations, or infections, and none of them died.
Dr. Bondue has received research grants and fees for consulting from Boehringer Ingelheim and Roche.
AT THE ERS CONGRESS 2016 LONDON
Key clinical point: Transbronchial lung cryobiopsies are useful for the diagnosis of interstitial lung diseases and could help avoid surgical lung biopsies.
Major finding: Transbronchial lung cryobiopsy had a diagnostic yield of 79%.
Data source: Single-center study of 24 patients with interstitial lung diseases who underwent transbronchial lung cryobiopsies, surgical lung biopsies, or both.
Disclosures: Dr. Bondue has received research grants and fees for consulting from Boehringer Ingelheim and Roche.
Almost half of health providers will see PQRS pay cut
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
[email protected]
On Twitter @legal_med
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
[email protected]
On Twitter @legal_med
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
[email protected]
On Twitter @legal_med
Four of five health care providers get flu shot
Influenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.
Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.
“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.
CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.
Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.
“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”
As a CDC employee, Dr. Black has no financial conflicts.
Influenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.
Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.
“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.
CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.
Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.
“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”
As a CDC employee, Dr. Black has no financial conflicts.
Influenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.
Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.
“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.
CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.
Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.
“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”
As a CDC employee, Dr. Black has no financial conflicts.
Key clinical point:
Major finding: The flu vaccination rate was 79% among health care workers.
Data source: An Internet survey contained data on 2,258 people.
Disclosures: As a CDC employee, Dr. Black has no financial disclosures.
Midterm results of thoracic stenting for acute type B dissection promising
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
AT VIVA16 LAS VEGAS
Key clinical point:
Major finding: Three-year results of the Valiant thoracic stent graft in the treatment of acute type B dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%.
Data source: Midterm results were presented from the multicenter, prospective, nonrandomized Medtronic Dissection US IDE trial.
Disclosures: The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
Boost dose pays off long term after surgery, WBRT for DCIS
BOSTON – Adding a boost dose after surgery and whole-breast radiation therapy (WBRT) for ductal carcinoma in situ offers a small but significant reduction in long-term risk of same-breast recurrence, according to results of a multicenter study.
An analysis of pooled data from 10 institutions showed that after 15 years of follow-up, 91.6% of women who had been treated with breast-conserving surgery, WBRT, and a boost dose remained free of ipsilateral breast tumor recurrence (IBTR), compared with 88% of women who received WBRT alone, reported Meena Savur Moran, MD, director of the breast cancer radiotherapy program at Smilow Cancer Hospital, Yale New Haven, Connecticut.
The absolute differences between the groups – 3% at 10 years, and 4% at 15 years – “don’t seem like a lot, but it is clinically important for patients, because what we’ve learned from the invasive cancer data is that this small, incremental decrease results in about a 40% less mastectomy rate for salvage mastectomies for recurrences,” she said.
It is common practice in many centers to give a radiation boost to the tumor bed of 8-16 Gy in 4-8 additional fractions following breast-conserving surgery and WBRT. This has been shown in invasive cancers to be associated with a statistically significant decrease in risk for IBTR in all age groups of about 4% at 20 years.
Yet because DCIS generally has an excellent prognosis with very few recurrences after whole-breast irradiation, it has been harder to determine whether radiation boosting would offer similar benefit to that seen in invasive cancers,
In an attempt to answer this question, investigators from 10 centers collaborated to create a DCIS database of patients treated with WBRT either with or without boost, and then analyzed the results.
The final cohort included 4,131 patients, far exceeding the minimum sample size the statisticians calculated would be needed to detect a benefit.
The median age of patients at the time of therapy was 56.1 years, median follow-up was 9 years, and the median boost dose was 14 Gy. In all, 4% of patients had positive tumor margins after surgery.
Rates of IBTR-free survival with boost vs. no boost were 97.1% vs. 96.3% at 5 years, 94.1% vs. 92.5% at 10 years, and, as noted before, 91.6% vs. 88% at 15 years (P = .0389).
In both univariate and in multivariate analysis controlling for tumor grade, comedo carcinoma, tamoxifen use, margin status, and age, IBTR was significantly associated with lower risk for recurrence.
The investigators also conducted a boost/no boost analysis stratified by margin status using both the National Surgical Adjuvant Breast and Bowel Project (NSABP) definition of negative margins as no ink on tumor, and the joint Society of Surgical Oncology, ASTRO, and American Society of Clinical Oncology guideline definition as less than 2 mm, and in each case found that among patients with negative margins, boosting offered a significant recurrence-free advantage.
Finally, they found that boosting offered a significant advantage both for patients 50 and older (P = .0073) and those 49 and younger (P = .0166).
“For DCIS, most of who treat breast cancer have used a boost, but we really extrapolated from the treatment from invasive breast cancer. Evidence for this practice until now in specific for DCIS has been lacking,” said Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown. Dr. Jacobson moderated the briefing.
She noted that the large sample size and long follow-up of the study was necessary for the treatment benefit to emerge.
BOSTON – Adding a boost dose after surgery and whole-breast radiation therapy (WBRT) for ductal carcinoma in situ offers a small but significant reduction in long-term risk of same-breast recurrence, according to results of a multicenter study.
An analysis of pooled data from 10 institutions showed that after 15 years of follow-up, 91.6% of women who had been treated with breast-conserving surgery, WBRT, and a boost dose remained free of ipsilateral breast tumor recurrence (IBTR), compared with 88% of women who received WBRT alone, reported Meena Savur Moran, MD, director of the breast cancer radiotherapy program at Smilow Cancer Hospital, Yale New Haven, Connecticut.
The absolute differences between the groups – 3% at 10 years, and 4% at 15 years – “don’t seem like a lot, but it is clinically important for patients, because what we’ve learned from the invasive cancer data is that this small, incremental decrease results in about a 40% less mastectomy rate for salvage mastectomies for recurrences,” she said.
It is common practice in many centers to give a radiation boost to the tumor bed of 8-16 Gy in 4-8 additional fractions following breast-conserving surgery and WBRT. This has been shown in invasive cancers to be associated with a statistically significant decrease in risk for IBTR in all age groups of about 4% at 20 years.
Yet because DCIS generally has an excellent prognosis with very few recurrences after whole-breast irradiation, it has been harder to determine whether radiation boosting would offer similar benefit to that seen in invasive cancers,
In an attempt to answer this question, investigators from 10 centers collaborated to create a DCIS database of patients treated with WBRT either with or without boost, and then analyzed the results.
The final cohort included 4,131 patients, far exceeding the minimum sample size the statisticians calculated would be needed to detect a benefit.
The median age of patients at the time of therapy was 56.1 years, median follow-up was 9 years, and the median boost dose was 14 Gy. In all, 4% of patients had positive tumor margins after surgery.
Rates of IBTR-free survival with boost vs. no boost were 97.1% vs. 96.3% at 5 years, 94.1% vs. 92.5% at 10 years, and, as noted before, 91.6% vs. 88% at 15 years (P = .0389).
In both univariate and in multivariate analysis controlling for tumor grade, comedo carcinoma, tamoxifen use, margin status, and age, IBTR was significantly associated with lower risk for recurrence.
The investigators also conducted a boost/no boost analysis stratified by margin status using both the National Surgical Adjuvant Breast and Bowel Project (NSABP) definition of negative margins as no ink on tumor, and the joint Society of Surgical Oncology, ASTRO, and American Society of Clinical Oncology guideline definition as less than 2 mm, and in each case found that among patients with negative margins, boosting offered a significant recurrence-free advantage.
Finally, they found that boosting offered a significant advantage both for patients 50 and older (P = .0073) and those 49 and younger (P = .0166).
“For DCIS, most of who treat breast cancer have used a boost, but we really extrapolated from the treatment from invasive breast cancer. Evidence for this practice until now in specific for DCIS has been lacking,” said Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown. Dr. Jacobson moderated the briefing.
She noted that the large sample size and long follow-up of the study was necessary for the treatment benefit to emerge.
BOSTON – Adding a boost dose after surgery and whole-breast radiation therapy (WBRT) for ductal carcinoma in situ offers a small but significant reduction in long-term risk of same-breast recurrence, according to results of a multicenter study.
An analysis of pooled data from 10 institutions showed that after 15 years of follow-up, 91.6% of women who had been treated with breast-conserving surgery, WBRT, and a boost dose remained free of ipsilateral breast tumor recurrence (IBTR), compared with 88% of women who received WBRT alone, reported Meena Savur Moran, MD, director of the breast cancer radiotherapy program at Smilow Cancer Hospital, Yale New Haven, Connecticut.
The absolute differences between the groups – 3% at 10 years, and 4% at 15 years – “don’t seem like a lot, but it is clinically important for patients, because what we’ve learned from the invasive cancer data is that this small, incremental decrease results in about a 40% less mastectomy rate for salvage mastectomies for recurrences,” she said.
It is common practice in many centers to give a radiation boost to the tumor bed of 8-16 Gy in 4-8 additional fractions following breast-conserving surgery and WBRT. This has been shown in invasive cancers to be associated with a statistically significant decrease in risk for IBTR in all age groups of about 4% at 20 years.
Yet because DCIS generally has an excellent prognosis with very few recurrences after whole-breast irradiation, it has been harder to determine whether radiation boosting would offer similar benefit to that seen in invasive cancers,
In an attempt to answer this question, investigators from 10 centers collaborated to create a DCIS database of patients treated with WBRT either with or without boost, and then analyzed the results.
The final cohort included 4,131 patients, far exceeding the minimum sample size the statisticians calculated would be needed to detect a benefit.
The median age of patients at the time of therapy was 56.1 years, median follow-up was 9 years, and the median boost dose was 14 Gy. In all, 4% of patients had positive tumor margins after surgery.
Rates of IBTR-free survival with boost vs. no boost were 97.1% vs. 96.3% at 5 years, 94.1% vs. 92.5% at 10 years, and, as noted before, 91.6% vs. 88% at 15 years (P = .0389).
In both univariate and in multivariate analysis controlling for tumor grade, comedo carcinoma, tamoxifen use, margin status, and age, IBTR was significantly associated with lower risk for recurrence.
The investigators also conducted a boost/no boost analysis stratified by margin status using both the National Surgical Adjuvant Breast and Bowel Project (NSABP) definition of negative margins as no ink on tumor, and the joint Society of Surgical Oncology, ASTRO, and American Society of Clinical Oncology guideline definition as less than 2 mm, and in each case found that among patients with negative margins, boosting offered a significant recurrence-free advantage.
Finally, they found that boosting offered a significant advantage both for patients 50 and older (P = .0073) and those 49 and younger (P = .0166).
“For DCIS, most of who treat breast cancer have used a boost, but we really extrapolated from the treatment from invasive breast cancer. Evidence for this practice until now in specific for DCIS has been lacking,” said Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown. Dr. Jacobson moderated the briefing.
She noted that the large sample size and long follow-up of the study was necessary for the treatment benefit to emerge.
AT THE ASTRO ANNUAL MEETING 2016
Key clinical point: This study shows a significant benefit for adding a boost radiation dose following breast-conserving surgery and whole-breast radiation for ductal carcinoma in situ (DCIS).
Major finding: After 15 years of follow-up, 91.6% of women who had received a boost dose were free of ipsilateral breast recurrence, compared with 88% of women who did not have a boost.
Data source: Analysis of pooled data on 4,131 patients with DCIS treated at 10 academic medical centers.
Disclosures: The study was supported by participating institutions. Dr. Moran and Dr. Jacobson reported no conflicts of interest.
Asleep deep brain stimulation placement offers advantages in Parkinson’s
PORTLAND, ORE. – Performing deep brain stimulation surgery for Parkinson’s disease using intraoperative CT imaging while the patient is under general anesthesia had clinical advantages and no disadvantages over surgery using microelectrode recording for lead placement with the patient awake, in a prospective, open-label study of 64 patients.
Regarding motor outcomes after asleep surgery, “We found that it was noninferior, so in other words, the change in scores following surgery were the same for asleep and awake patients,” physician assistant and study coauthor Shannon Anderson said during a poster session at the World Parkinson Congress. “What was surprising to us was that verbal fluency ... the ability to come up with the right word, actually improved in our asleep DBS [deep brain stimulation] group, which is a huge complication for patients [and] has a really negative impact on their life.”
Patients with Parkinson’s disease and motor complications (n = 64) were enrolled prospectively at the Oregon Health & Science University in Portland. Thirty received asleep procedures under general anesthesia with ICT guidance for lead targeting to the globus pallidus pars interna (GPi; n = 21) or to the subthalamic nucleus (STN; n = 9). Thirty-four patients received DBS devices with MER guidance (15 STN; 19 GPi). At baseline, the two groups were similar in age (mean 61.1-62.7 years) and off-medication motor subscale scores of the Unified Parkinson’s Disease Rating Scale (mUPDRS; mean 43.0-43.5). The university investigators optimized the DBS parameters at 1, 2, 3, and 6 months after implantation. The same surgeon performed all the procedures at the same medical center.
Motor improvements were similar between the asleep and awake cohorts. At 6 months, the ICT (asleep) group experienced a mean improvement in motor abilities of 14.3 (plus or minus 10.88) on the mUPDRS off-medication and on DBS, compared with an improvement of 17.6 (plus or minus 12.26) for the MER (awake) group (P = .25).
Better language measures with asleep DBS
Asleep DBS with ICT resulted in improvements in aspects of language, whereas awake patients lost language abilities. The asleep group showed a 0.8-point increase in phonemic fluency and a 1.0-point increase in semantic fluency at 6 months versus a worsening on both language measures (–3.5 points and –4.7 points, respectively; both P less than .001) if DBS was performed via MER on awake patients.
Although both cohorts showed significant improvements on the 39-item Parkinson’s Disease Questionnaire at 6 months, the cohorts did not differ in their degrees of improvement. Similarly, both had improvements on scores of activities of daily living, and both cohorts had a 4-4.5 hours/day increase in “on” time without dyskinesia and a 2.6-3.5 hours/day decrease in “on” time with dyskinesia.
Patients tolerated asleep DBS well, and there were no serious complications.
The sleep surgery is much shorter, “so it’s about 2 hours long as opposed to 4, 5, sometimes 8, 10 hours with the awake. There [are fewer] complications, so less risk of hemorrhage or seizures or things like that,” Ms. Anderson said. “In a separate study, we found that it’s a much more accurate placement of the electrodes so the target is much more accurate. So, all of those things considered, we feel the asleep version is definitely the superior choice between the two.”
Being asleep is much more comfortable for the patient, added study leader Matthew Brodsky, MD. “But the biggest advantage is that it’s a single pass into the brain as opposed to multiple passes.” The average number of passes using MER is two to three per side of the brain, and in some centers, four or more. “Problems such as speech prosody are related to pokes in the brain, if you will, rather than stimulation,” he said.
Ms. Anderson said MER “is a fantastic research tool, and it gives us a lot of information on the electrophysiology, but really, there’s no need for it in the clinical application of DBS.”
Based on the asleep procedure’s accuracy, lower rate of complications, shorter operating room time, and noninferiority in terms of motor outcomes, she said, “Our recommendation is that more centers, more neurosurgeons be trained in this technique ... We’d like to see the clinical field move toward that area and really reserve microelectrode recording for the research side of things.”
“If you talk to folks who are considering brain surgery for their Parkinson’s, for some of them, the idea of being awake in the operating room and undergoing this is a barrier that they can’t quite overcome,” Dr. Brodsky said. “So, having this as an option makes it easier for them to sign up for the process.”
Richard Smeyne, PhD, director of the Jefferson Comprehensive Parkinson’s Center at Thomas Jefferson University in Philadelphia, said that the asleep procedure is the newer one and can target either the GPi or the STN. “The asleep DBS seems to have a little bit better improvement on speech afterwards than the awake DBS, and there could be several causes of this,” he said. “Some might be operative in that you can make smaller holes, you can get really nice guidance, you don’t have to sort of move around as in the awake DBS.”
In addition, CT scanning with the patients asleep in the operating room allows more time in the scanner and greater precision in anatomical placement of the DBS leads.
“If I had to choose, looking at this particular study, it would suggest that the asleep DBS is actually a better overall way to go,” Dr. Smeyne said. However, he had no objection to awake procedures “if the neurosurgeon has a record of good results with it ... But if you have the option ... that becomes an individual choice that you should discuss with the neurosurgeon.”
Some of the work presented in the study was supported by a research grant from Medtronic. Ms. Anderson and Dr. Brodsky reported having no other financial disclosures. Dr. Smeyne reported having no financial disclosures.
PORTLAND, ORE. – Performing deep brain stimulation surgery for Parkinson’s disease using intraoperative CT imaging while the patient is under general anesthesia had clinical advantages and no disadvantages over surgery using microelectrode recording for lead placement with the patient awake, in a prospective, open-label study of 64 patients.
Regarding motor outcomes after asleep surgery, “We found that it was noninferior, so in other words, the change in scores following surgery were the same for asleep and awake patients,” physician assistant and study coauthor Shannon Anderson said during a poster session at the World Parkinson Congress. “What was surprising to us was that verbal fluency ... the ability to come up with the right word, actually improved in our asleep DBS [deep brain stimulation] group, which is a huge complication for patients [and] has a really negative impact on their life.”
Patients with Parkinson’s disease and motor complications (n = 64) were enrolled prospectively at the Oregon Health & Science University in Portland. Thirty received asleep procedures under general anesthesia with ICT guidance for lead targeting to the globus pallidus pars interna (GPi; n = 21) or to the subthalamic nucleus (STN; n = 9). Thirty-four patients received DBS devices with MER guidance (15 STN; 19 GPi). At baseline, the two groups were similar in age (mean 61.1-62.7 years) and off-medication motor subscale scores of the Unified Parkinson’s Disease Rating Scale (mUPDRS; mean 43.0-43.5). The university investigators optimized the DBS parameters at 1, 2, 3, and 6 months after implantation. The same surgeon performed all the procedures at the same medical center.
Motor improvements were similar between the asleep and awake cohorts. At 6 months, the ICT (asleep) group experienced a mean improvement in motor abilities of 14.3 (plus or minus 10.88) on the mUPDRS off-medication and on DBS, compared with an improvement of 17.6 (plus or minus 12.26) for the MER (awake) group (P = .25).
Better language measures with asleep DBS
Asleep DBS with ICT resulted in improvements in aspects of language, whereas awake patients lost language abilities. The asleep group showed a 0.8-point increase in phonemic fluency and a 1.0-point increase in semantic fluency at 6 months versus a worsening on both language measures (–3.5 points and –4.7 points, respectively; both P less than .001) if DBS was performed via MER on awake patients.
Although both cohorts showed significant improvements on the 39-item Parkinson’s Disease Questionnaire at 6 months, the cohorts did not differ in their degrees of improvement. Similarly, both had improvements on scores of activities of daily living, and both cohorts had a 4-4.5 hours/day increase in “on” time without dyskinesia and a 2.6-3.5 hours/day decrease in “on” time with dyskinesia.
Patients tolerated asleep DBS well, and there were no serious complications.
The sleep surgery is much shorter, “so it’s about 2 hours long as opposed to 4, 5, sometimes 8, 10 hours with the awake. There [are fewer] complications, so less risk of hemorrhage or seizures or things like that,” Ms. Anderson said. “In a separate study, we found that it’s a much more accurate placement of the electrodes so the target is much more accurate. So, all of those things considered, we feel the asleep version is definitely the superior choice between the two.”
Being asleep is much more comfortable for the patient, added study leader Matthew Brodsky, MD. “But the biggest advantage is that it’s a single pass into the brain as opposed to multiple passes.” The average number of passes using MER is two to three per side of the brain, and in some centers, four or more. “Problems such as speech prosody are related to pokes in the brain, if you will, rather than stimulation,” he said.
Ms. Anderson said MER “is a fantastic research tool, and it gives us a lot of information on the electrophysiology, but really, there’s no need for it in the clinical application of DBS.”
Based on the asleep procedure’s accuracy, lower rate of complications, shorter operating room time, and noninferiority in terms of motor outcomes, she said, “Our recommendation is that more centers, more neurosurgeons be trained in this technique ... We’d like to see the clinical field move toward that area and really reserve microelectrode recording for the research side of things.”
“If you talk to folks who are considering brain surgery for their Parkinson’s, for some of them, the idea of being awake in the operating room and undergoing this is a barrier that they can’t quite overcome,” Dr. Brodsky said. “So, having this as an option makes it easier for them to sign up for the process.”
Richard Smeyne, PhD, director of the Jefferson Comprehensive Parkinson’s Center at Thomas Jefferson University in Philadelphia, said that the asleep procedure is the newer one and can target either the GPi or the STN. “The asleep DBS seems to have a little bit better improvement on speech afterwards than the awake DBS, and there could be several causes of this,” he said. “Some might be operative in that you can make smaller holes, you can get really nice guidance, you don’t have to sort of move around as in the awake DBS.”
In addition, CT scanning with the patients asleep in the operating room allows more time in the scanner and greater precision in anatomical placement of the DBS leads.
“If I had to choose, looking at this particular study, it would suggest that the asleep DBS is actually a better overall way to go,” Dr. Smeyne said. However, he had no objection to awake procedures “if the neurosurgeon has a record of good results with it ... But if you have the option ... that becomes an individual choice that you should discuss with the neurosurgeon.”
Some of the work presented in the study was supported by a research grant from Medtronic. Ms. Anderson and Dr. Brodsky reported having no other financial disclosures. Dr. Smeyne reported having no financial disclosures.
PORTLAND, ORE. – Performing deep brain stimulation surgery for Parkinson’s disease using intraoperative CT imaging while the patient is under general anesthesia had clinical advantages and no disadvantages over surgery using microelectrode recording for lead placement with the patient awake, in a prospective, open-label study of 64 patients.
Regarding motor outcomes after asleep surgery, “We found that it was noninferior, so in other words, the change in scores following surgery were the same for asleep and awake patients,” physician assistant and study coauthor Shannon Anderson said during a poster session at the World Parkinson Congress. “What was surprising to us was that verbal fluency ... the ability to come up with the right word, actually improved in our asleep DBS [deep brain stimulation] group, which is a huge complication for patients [and] has a really negative impact on their life.”
Patients with Parkinson’s disease and motor complications (n = 64) were enrolled prospectively at the Oregon Health & Science University in Portland. Thirty received asleep procedures under general anesthesia with ICT guidance for lead targeting to the globus pallidus pars interna (GPi; n = 21) or to the subthalamic nucleus (STN; n = 9). Thirty-four patients received DBS devices with MER guidance (15 STN; 19 GPi). At baseline, the two groups were similar in age (mean 61.1-62.7 years) and off-medication motor subscale scores of the Unified Parkinson’s Disease Rating Scale (mUPDRS; mean 43.0-43.5). The university investigators optimized the DBS parameters at 1, 2, 3, and 6 months after implantation. The same surgeon performed all the procedures at the same medical center.
Motor improvements were similar between the asleep and awake cohorts. At 6 months, the ICT (asleep) group experienced a mean improvement in motor abilities of 14.3 (plus or minus 10.88) on the mUPDRS off-medication and on DBS, compared with an improvement of 17.6 (plus or minus 12.26) for the MER (awake) group (P = .25).
Better language measures with asleep DBS
Asleep DBS with ICT resulted in improvements in aspects of language, whereas awake patients lost language abilities. The asleep group showed a 0.8-point increase in phonemic fluency and a 1.0-point increase in semantic fluency at 6 months versus a worsening on both language measures (–3.5 points and –4.7 points, respectively; both P less than .001) if DBS was performed via MER on awake patients.
Although both cohorts showed significant improvements on the 39-item Parkinson’s Disease Questionnaire at 6 months, the cohorts did not differ in their degrees of improvement. Similarly, both had improvements on scores of activities of daily living, and both cohorts had a 4-4.5 hours/day increase in “on” time without dyskinesia and a 2.6-3.5 hours/day decrease in “on” time with dyskinesia.
Patients tolerated asleep DBS well, and there were no serious complications.
The sleep surgery is much shorter, “so it’s about 2 hours long as opposed to 4, 5, sometimes 8, 10 hours with the awake. There [are fewer] complications, so less risk of hemorrhage or seizures or things like that,” Ms. Anderson said. “In a separate study, we found that it’s a much more accurate placement of the electrodes so the target is much more accurate. So, all of those things considered, we feel the asleep version is definitely the superior choice between the two.”
Being asleep is much more comfortable for the patient, added study leader Matthew Brodsky, MD. “But the biggest advantage is that it’s a single pass into the brain as opposed to multiple passes.” The average number of passes using MER is two to three per side of the brain, and in some centers, four or more. “Problems such as speech prosody are related to pokes in the brain, if you will, rather than stimulation,” he said.
Ms. Anderson said MER “is a fantastic research tool, and it gives us a lot of information on the electrophysiology, but really, there’s no need for it in the clinical application of DBS.”
Based on the asleep procedure’s accuracy, lower rate of complications, shorter operating room time, and noninferiority in terms of motor outcomes, she said, “Our recommendation is that more centers, more neurosurgeons be trained in this technique ... We’d like to see the clinical field move toward that area and really reserve microelectrode recording for the research side of things.”
“If you talk to folks who are considering brain surgery for their Parkinson’s, for some of them, the idea of being awake in the operating room and undergoing this is a barrier that they can’t quite overcome,” Dr. Brodsky said. “So, having this as an option makes it easier for them to sign up for the process.”
Richard Smeyne, PhD, director of the Jefferson Comprehensive Parkinson’s Center at Thomas Jefferson University in Philadelphia, said that the asleep procedure is the newer one and can target either the GPi or the STN. “The asleep DBS seems to have a little bit better improvement on speech afterwards than the awake DBS, and there could be several causes of this,” he said. “Some might be operative in that you can make smaller holes, you can get really nice guidance, you don’t have to sort of move around as in the awake DBS.”
In addition, CT scanning with the patients asleep in the operating room allows more time in the scanner and greater precision in anatomical placement of the DBS leads.
“If I had to choose, looking at this particular study, it would suggest that the asleep DBS is actually a better overall way to go,” Dr. Smeyne said. However, he had no objection to awake procedures “if the neurosurgeon has a record of good results with it ... But if you have the option ... that becomes an individual choice that you should discuss with the neurosurgeon.”
Some of the work presented in the study was supported by a research grant from Medtronic. Ms. Anderson and Dr. Brodsky reported having no other financial disclosures. Dr. Smeyne reported having no financial disclosures.
AT WPC 2016
Key clinical point:
Major finding: The asleep group showed a 0.8-point increase in phonemic fluency and a 1.0-point increase in semantic fluency at 6 months versus a worsening on both language measures (–3.5 points and –4.7 points, respectively; both P less than .001) if DBS was performed via MER on awake patients.
Data source: Prospective, open-label study of 64 patients receiving either awake or asleep deep brain stimulation placement.
Disclosures: Some of the work presented in the study was supported by a research grant from Medtronic. Ms. Anderson and Dr. Brodsky reported having no other financial disclosures. Dr. Smeyne reported having no financial disclosures.
Cerebral protection in TAVI reduces ischemic brain lesions
In patients undergoing transcatheter aortic valve implantation, use of a cerebral protection device to entrap and remove embolic debris reduced both the number and the size of ischemic brain lesions, according to a report published in JAMA.
The frequency and severity of postprocedure stroke symptoms were similar with and without the filter; however, the researchers noted that the study included only 100 patients and was not powered to assess differences in stroke rates.
Various cerebral protection devices were invented in response to the finding of a threefold increase in periprocedural stroke mortality following TAVI. Yet “clear evidence of the efficacy of any embolic protection device in TAVI is still missing,” said Stephan Haussig, MD, of the University of Leipzig (Germany) Heart Center, and his associates.
They performed a prospective randomized clinical trial at their center to assess the efficacy of the only cerebral protection device that was available when their study was designed. For the study, 100 patients with severe, symptomatic aortic stenosis were randomly assigned to undergo TAVI either with (50 patients) or without (50 patients) the use of a protective filter to capture embolic debris. The filter device was estimated to fully protect 74% of the brain and partially protect 24%, leaving only 2% unprotected.
The primary endpoint of the study was the number of ischemic brain lesions detected on diffusion-weighted MRI in the filter group, compared with the control group. This imaging was performed at baseline, 2 days after the procedure, and 7 days after the procedure.
In protected brain regions, the median number of new ischemic brain lesions was markedly lower in the filter group than in the control group (4 vs. 10) at 2 days, as well as at 7 days (3 vs. 7, respectively). In addition, the volume of new lesions in protected brain regions also was markedly lower in the filter group at 2 days (242 mm vs. 527 mm) and at 7 days (101 mm vs. 292 mm).
Similar protective effects were evident when the entire brain was evaluated. The median number of new lesions was markedly lower in the filter group than in the control group (8 vs. 16) at 2 days and at 7 days (5 vs. 10, respectively). The median lesion volume also was markedly lower in the filter group at 2 days (466 mm vs. 800 mm) and at 7 days (205 mm vs. 720 mm).
However, this protective effect didn’t translate into a substantive difference in neurologic outcomes between the two study groups, as assessed by the National Institutes of Health Stroke Scale and the modified Rankin scale. Five patients in each group developed symptoms of stroke, and all symptoms were deemed minor and nondisabling, the investigators said (JAMA 2016;316[6]:592-601).
It is important to note that this study wasn’t powered to assess differences in stroke rates. Larger studies will be needed to assess the impact of protective devices on neurological and functional outcomes, Dr. Haussig and his associates wrote.
The two study groups also did not differ with regard to complications. Thirty-day mortality was 0% in the filter group and 2% in the control group, a nonsignificant difference.
The investigators pointed out that protective filter devices can protect the brain only while they are in place during TAVI, “which usually takes less than 1 hour and represents only 2% of the first 48 hours after which the first MRI was performed in this study. Based on the analyzed material captured and removed by the filters – e.g., old and fresh thrombus, endothelium, atheromatous plaque, valve tissue, and calcium – it becomes evident that causes of cerebral injury are multifactorial and that the embolic risk does not resolve immediately at the end of the TAVI procedure,” they said.
Perhaps the study’s most surprising finding was that nearly every patient had new cerebral lesions consistent with infarcts, but most of these were very small and not associated with any neurocognitive or functional impairments.
This study was limited in that it involved a single cardiac team assessing only one brand of filter device at a single hospital, so the results are not necessarily generalizable to a broader patient population or to the many other devices that have since been developed, Dr. Haussig and his associates added.
This study was funded by a grant from Claret Medical and Medtronic. Dr. Haussig reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
These findings are compelling and encouraging, even though we don’t yet know whether the reduction in the number and volume of ischemic brain lesions translates into clinical benefit.
The results also confirm what previous research has suggested: that emboli to the brain are extremely common and do cause small infarctions detectable on MRI. In this trial, virtually every patient demonstrated such acute lesions, though the vast majority were quite small.
Steven R. Messe, MD, is in the department of neurology at the Hospital of the University of Pennsylvania, Philadelphia. Michael J. Mack, MD, is in the department of cardiac surgery at The Heart Hospital Baylor Plano in Plano, Tex. Dr. Messe reported ties to GlaxoSmithKline; Dr. Mack reported having no relevant financial disclosures. Dr. Messe and Dr. Mack made these remarks in an editorial accompanying Dr. Haussig’s report (JAMA 2016;316[6]:587-8).
These findings are compelling and encouraging, even though we don’t yet know whether the reduction in the number and volume of ischemic brain lesions translates into clinical benefit.
The results also confirm what previous research has suggested: that emboli to the brain are extremely common and do cause small infarctions detectable on MRI. In this trial, virtually every patient demonstrated such acute lesions, though the vast majority were quite small.
Steven R. Messe, MD, is in the department of neurology at the Hospital of the University of Pennsylvania, Philadelphia. Michael J. Mack, MD, is in the department of cardiac surgery at The Heart Hospital Baylor Plano in Plano, Tex. Dr. Messe reported ties to GlaxoSmithKline; Dr. Mack reported having no relevant financial disclosures. Dr. Messe and Dr. Mack made these remarks in an editorial accompanying Dr. Haussig’s report (JAMA 2016;316[6]:587-8).
These findings are compelling and encouraging, even though we don’t yet know whether the reduction in the number and volume of ischemic brain lesions translates into clinical benefit.
The results also confirm what previous research has suggested: that emboli to the brain are extremely common and do cause small infarctions detectable on MRI. In this trial, virtually every patient demonstrated such acute lesions, though the vast majority were quite small.
Steven R. Messe, MD, is in the department of neurology at the Hospital of the University of Pennsylvania, Philadelphia. Michael J. Mack, MD, is in the department of cardiac surgery at The Heart Hospital Baylor Plano in Plano, Tex. Dr. Messe reported ties to GlaxoSmithKline; Dr. Mack reported having no relevant financial disclosures. Dr. Messe and Dr. Mack made these remarks in an editorial accompanying Dr. Haussig’s report (JAMA 2016;316[6]:587-8).
In patients undergoing transcatheter aortic valve implantation, use of a cerebral protection device to entrap and remove embolic debris reduced both the number and the size of ischemic brain lesions, according to a report published in JAMA.
The frequency and severity of postprocedure stroke symptoms were similar with and without the filter; however, the researchers noted that the study included only 100 patients and was not powered to assess differences in stroke rates.
Various cerebral protection devices were invented in response to the finding of a threefold increase in periprocedural stroke mortality following TAVI. Yet “clear evidence of the efficacy of any embolic protection device in TAVI is still missing,” said Stephan Haussig, MD, of the University of Leipzig (Germany) Heart Center, and his associates.
They performed a prospective randomized clinical trial at their center to assess the efficacy of the only cerebral protection device that was available when their study was designed. For the study, 100 patients with severe, symptomatic aortic stenosis were randomly assigned to undergo TAVI either with (50 patients) or without (50 patients) the use of a protective filter to capture embolic debris. The filter device was estimated to fully protect 74% of the brain and partially protect 24%, leaving only 2% unprotected.
The primary endpoint of the study was the number of ischemic brain lesions detected on diffusion-weighted MRI in the filter group, compared with the control group. This imaging was performed at baseline, 2 days after the procedure, and 7 days after the procedure.
In protected brain regions, the median number of new ischemic brain lesions was markedly lower in the filter group than in the control group (4 vs. 10) at 2 days, as well as at 7 days (3 vs. 7, respectively). In addition, the volume of new lesions in protected brain regions also was markedly lower in the filter group at 2 days (242 mm vs. 527 mm) and at 7 days (101 mm vs. 292 mm).
Similar protective effects were evident when the entire brain was evaluated. The median number of new lesions was markedly lower in the filter group than in the control group (8 vs. 16) at 2 days and at 7 days (5 vs. 10, respectively). The median lesion volume also was markedly lower in the filter group at 2 days (466 mm vs. 800 mm) and at 7 days (205 mm vs. 720 mm).
However, this protective effect didn’t translate into a substantive difference in neurologic outcomes between the two study groups, as assessed by the National Institutes of Health Stroke Scale and the modified Rankin scale. Five patients in each group developed symptoms of stroke, and all symptoms were deemed minor and nondisabling, the investigators said (JAMA 2016;316[6]:592-601).
It is important to note that this study wasn’t powered to assess differences in stroke rates. Larger studies will be needed to assess the impact of protective devices on neurological and functional outcomes, Dr. Haussig and his associates wrote.
The two study groups also did not differ with regard to complications. Thirty-day mortality was 0% in the filter group and 2% in the control group, a nonsignificant difference.
The investigators pointed out that protective filter devices can protect the brain only while they are in place during TAVI, “which usually takes less than 1 hour and represents only 2% of the first 48 hours after which the first MRI was performed in this study. Based on the analyzed material captured and removed by the filters – e.g., old and fresh thrombus, endothelium, atheromatous plaque, valve tissue, and calcium – it becomes evident that causes of cerebral injury are multifactorial and that the embolic risk does not resolve immediately at the end of the TAVI procedure,” they said.
Perhaps the study’s most surprising finding was that nearly every patient had new cerebral lesions consistent with infarcts, but most of these were very small and not associated with any neurocognitive or functional impairments.
This study was limited in that it involved a single cardiac team assessing only one brand of filter device at a single hospital, so the results are not necessarily generalizable to a broader patient population or to the many other devices that have since been developed, Dr. Haussig and his associates added.
This study was funded by a grant from Claret Medical and Medtronic. Dr. Haussig reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
In patients undergoing transcatheter aortic valve implantation, use of a cerebral protection device to entrap and remove embolic debris reduced both the number and the size of ischemic brain lesions, according to a report published in JAMA.
The frequency and severity of postprocedure stroke symptoms were similar with and without the filter; however, the researchers noted that the study included only 100 patients and was not powered to assess differences in stroke rates.
Various cerebral protection devices were invented in response to the finding of a threefold increase in periprocedural stroke mortality following TAVI. Yet “clear evidence of the efficacy of any embolic protection device in TAVI is still missing,” said Stephan Haussig, MD, of the University of Leipzig (Germany) Heart Center, and his associates.
They performed a prospective randomized clinical trial at their center to assess the efficacy of the only cerebral protection device that was available when their study was designed. For the study, 100 patients with severe, symptomatic aortic stenosis were randomly assigned to undergo TAVI either with (50 patients) or without (50 patients) the use of a protective filter to capture embolic debris. The filter device was estimated to fully protect 74% of the brain and partially protect 24%, leaving only 2% unprotected.
The primary endpoint of the study was the number of ischemic brain lesions detected on diffusion-weighted MRI in the filter group, compared with the control group. This imaging was performed at baseline, 2 days after the procedure, and 7 days after the procedure.
In protected brain regions, the median number of new ischemic brain lesions was markedly lower in the filter group than in the control group (4 vs. 10) at 2 days, as well as at 7 days (3 vs. 7, respectively). In addition, the volume of new lesions in protected brain regions also was markedly lower in the filter group at 2 days (242 mm vs. 527 mm) and at 7 days (101 mm vs. 292 mm).
Similar protective effects were evident when the entire brain was evaluated. The median number of new lesions was markedly lower in the filter group than in the control group (8 vs. 16) at 2 days and at 7 days (5 vs. 10, respectively). The median lesion volume also was markedly lower in the filter group at 2 days (466 mm vs. 800 mm) and at 7 days (205 mm vs. 720 mm).
However, this protective effect didn’t translate into a substantive difference in neurologic outcomes between the two study groups, as assessed by the National Institutes of Health Stroke Scale and the modified Rankin scale. Five patients in each group developed symptoms of stroke, and all symptoms were deemed minor and nondisabling, the investigators said (JAMA 2016;316[6]:592-601).
It is important to note that this study wasn’t powered to assess differences in stroke rates. Larger studies will be needed to assess the impact of protective devices on neurological and functional outcomes, Dr. Haussig and his associates wrote.
The two study groups also did not differ with regard to complications. Thirty-day mortality was 0% in the filter group and 2% in the control group, a nonsignificant difference.
The investigators pointed out that protective filter devices can protect the brain only while they are in place during TAVI, “which usually takes less than 1 hour and represents only 2% of the first 48 hours after which the first MRI was performed in this study. Based on the analyzed material captured and removed by the filters – e.g., old and fresh thrombus, endothelium, atheromatous plaque, valve tissue, and calcium – it becomes evident that causes of cerebral injury are multifactorial and that the embolic risk does not resolve immediately at the end of the TAVI procedure,” they said.
Perhaps the study’s most surprising finding was that nearly every patient had new cerebral lesions consistent with infarcts, but most of these were very small and not associated with any neurocognitive or functional impairments.
This study was limited in that it involved a single cardiac team assessing only one brand of filter device at a single hospital, so the results are not necessarily generalizable to a broader patient population or to the many other devices that have since been developed, Dr. Haussig and his associates added.
This study was funded by a grant from Claret Medical and Medtronic. Dr. Haussig reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
Key clinical point: In patients undergoing transcatheter aortic valve implantation, use of a cerebral protection device to entrap and remove embolic debris reduced both the number and the size of ischemic brain lesions.
Major finding: At 2 days, the number of new brain lesions was markedly lower in the filter group than in the control group (8 vs. 16), as was the lesion volume (466 mm vs. 800 mm).
Data source: A prospective single-center randomized clinical trial involving 100 patients undergoing TAVI for severe aortic stenosis.
Disclosures: This study was funded by a grant from Claret Medical and Medtronic. Dr. Haussig reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.