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FDA approves first duodenoscope with disposable distal cap
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
Roux-en-Y gastric bypass produced durable clinical improvements at 12 years
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
Few prospective studies have tracked long-term outcomes after bariatric surgery. Among 1,156 participants in this study, 418 patients underwent RYGB, 417 individuals sought but did not undergo surgery – mainly for insurance reasons – and 321 individuals did not seek surgery. Participants were mostly females in their 40s or 50s at baseline, and typically weighed 120 kg-130 kg.
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
AGA Resource
Gastroenterologists are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The AGA Obesity Practice Guide was created to provide a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
Few prospective studies have tracked long-term outcomes after bariatric surgery. Among 1,156 participants in this study, 418 patients underwent RYGB, 417 individuals sought but did not undergo surgery – mainly for insurance reasons – and 321 individuals did not seek surgery. Participants were mostly females in their 40s or 50s at baseline, and typically weighed 120 kg-130 kg.
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
AGA Resource
Gastroenterologists are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The AGA Obesity Practice Guide was created to provide a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
Few prospective studies have tracked long-term outcomes after bariatric surgery. Among 1,156 participants in this study, 418 patients underwent RYGB, 417 individuals sought but did not undergo surgery – mainly for insurance reasons – and 321 individuals did not seek surgery. Participants were mostly females in their 40s or 50s at baseline, and typically weighed 120 kg-130 kg.
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
AGA Resource
Gastroenterologists are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The AGA Obesity Practice Guide was created to provide a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Roux-en-Y gastric bypass produced durable results on numerous clinical outcome measures.
Major finding: Twelve years after surgery, RYGB patients averaged a 27% weight loss from baseline, with a 51% rate of diabetes remission and a 3% incidence of type 2 diabetes mellitus.
Data source: A prospective study of 1,156 severely obese individuals, of whom 418 underwent Roux-en-Y gastric bypass.
Disclosures: Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and the quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
Roux-en-Y gastric bypass produced durable clinical improvements at 12 years
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
Severely obese individuals in the United States who underwent Roux-en-Y gastric bypass (RYGB) averaged a 27% weight loss 12 years later, with only a 3% incidence of type 2 diabetes mellitus and a 51% rate of diabetes remission, according to the results of a large multicenter observational prospective study.
In striking contrast, patients who did not undergo bariatric surgery averaged a 1%-2% weight loss at 12 years, a 26% incidence of diabetes, and only a 5%-10% rate of diabetes remission, said Ted D. Adams, PhD, of the University of Utah, Salt Lake City, and his associates. RYGB surgery also conferred substantial and statistically significant improvements long-term improvements in systolic hypertension and lipid levels, the researchers reported in the New England Journal of Medicine (2017 Sep 20. doi: 10.1056/NEJMoa1700459).
“The follow-up rate exceeded 90% at 12 years,” the researchers wrote. Two years after undergoing Roux-en-Y gastric bypass, patients had lost an average of 45 kg (95% confidence interval, 43-47 kg). By postoperative year 6, they had regained an average of 9 kg (average loss from baseline, 36 kg; 95% CI, 34-39 kg). But they typically gained only about 1.3 kg more between years 6 and 12, and they had about a 92% lower odds of developing diabetes mellitus, compared with individuals who did not undergo bariatric surgery (odds ratio, 0.08; P less than .001). “Remission of type 2 diabetes was much more likely if the Roux-en-Y gastric bypass occurred before [patients began] treatment with insulin, presumably owing to the ability of partially viable beta cells to improve their function,” the researchers noted.
Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Roux-en-Y gastric bypass produced durable results on numerous clinical outcome measures.
Major finding: Twelve years after surgery, RYGB patients averaged a 27% weight loss from baseline, with a 51% rate of remission and a 3% incidence of type 2 diabetes mellitus.
Data source: A prospective study of 1,156 severely obese individuals, of whom 418 underwent Roux-en-Y gastric bypass.
Disclosures: Funders included the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, Weill Cornell Medicine, and Intermountain Healthcare. Dr. Adams reported having no relevant conflicts of interest. One coinvestigator disclosed royalties from licensing a questionnaire on weight loss and the quality of life, and another coinvestigator disclosed fees for services rendered during a trial of an intragastric balloon. The remaining researchers had no relevant disclosures.
Readmission rates linked to hospital quality measures
Poorer-performing hospitals have higher readmission rates than better-performing hospitals for patients with similar diagnoses, a study shows.
Lead author Harlan M. Krumholz, MD, of Yale University, New Haven, Conn., and his colleagues analyzed Centers for Medicare and Medicaid Services hospital-wide readmission data and divided data from July 2014 through June 2015 into two random samples. Researchers used the first sample to calculate the risk-standardized readmission rate within 30 days for each hospital and classified hospitals into performance quartiles, with a lower readmission rate indicating better performance. The second study sample included patients who had two admissions for similar diagnoses at different hospitals that occurred more than 1 month and less than 1 year apart. Researchers compared the observed readmission rates among patients who had been admitted to hospitals in different performance quartiles. The analysis included all discharges occurring from July 1, 2014, through June 30, 2015, from short-term acute care or critical access hospitals in the United States involving Medicare patients who were aged 65 years or older.
Results found that among the patients hospitalized more than once for similar diagnoses at different hospitals, the readmission rate was significantly higher among patients admitted to the worst-performing quartile of hospitals than among those admitted to the best-performing quartile (absolute difference in readmission rate, 2.0 percentage points; 95% confidence interval, 0.4-3.5; P = .001) (N Engl J Med. 2017. doi: 10.1056/NEJMsa1702321). The differences in the comparisons of the other quartiles were smaller and not significant, according to the study. 
The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors, study authors concluded.
“This study addresses a persistent concern that national readmission measures may reflect differences in unmeasured factors rather than in hospital performance,” study authors noted in the study. “The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors. By studying patients who were admitted twice within 1 year with similar diagnoses to different hospitals, this study design was able to isolate hospital signals of performance while minimizing differences among the patients. In these cases, because the same patients had similar admissions at two hospitals, the characteristics of the patients, including their level of social disadvantage, level of education, or degree of underlying illness, were broadly the same. The alignment of the differences that we observed with the results of the CMS hospital-wide readmission measure also adds to evidence that the readmission measure classifies true differences in performance.”
Dr. Krumholz and seven coauthors reported receiving support from contracts with the Center for Medicare and Medicaid Services to develop and reevaluate performance measures that are used for public reporting.
[email protected]
On Twitter @legal_med
Poorer-performing hospitals have higher readmission rates than better-performing hospitals for patients with similar diagnoses, a study shows.
Lead author Harlan M. Krumholz, MD, of Yale University, New Haven, Conn., and his colleagues analyzed Centers for Medicare and Medicaid Services hospital-wide readmission data and divided data from July 2014 through June 2015 into two random samples. Researchers used the first sample to calculate the risk-standardized readmission rate within 30 days for each hospital and classified hospitals into performance quartiles, with a lower readmission rate indicating better performance. The second study sample included patients who had two admissions for similar diagnoses at different hospitals that occurred more than 1 month and less than 1 year apart. Researchers compared the observed readmission rates among patients who had been admitted to hospitals in different performance quartiles. The analysis included all discharges occurring from July 1, 2014, through June 30, 2015, from short-term acute care or critical access hospitals in the United States involving Medicare patients who were aged 65 years or older.
Results found that among the patients hospitalized more than once for similar diagnoses at different hospitals, the readmission rate was significantly higher among patients admitted to the worst-performing quartile of hospitals than among those admitted to the best-performing quartile (absolute difference in readmission rate, 2.0 percentage points; 95% confidence interval, 0.4-3.5; P = .001) (N Engl J Med. 2017. doi: 10.1056/NEJMsa1702321). The differences in the comparisons of the other quartiles were smaller and not significant, according to the study.
The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors, study authors concluded.
“This study addresses a persistent concern that national readmission measures may reflect differences in unmeasured factors rather than in hospital performance,” study authors noted in the study. “The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors. By studying patients who were admitted twice within 1 year with similar diagnoses to different hospitals, this study design was able to isolate hospital signals of performance while minimizing differences among the patients. In these cases, because the same patients had similar admissions at two hospitals, the characteristics of the patients, including their level of social disadvantage, level of education, or degree of underlying illness, were broadly the same. The alignment of the differences that we observed with the results of the CMS hospital-wide readmission measure also adds to evidence that the readmission measure classifies true differences in performance.”
Dr. Krumholz and seven coauthors reported receiving support from contracts with the Center for Medicare and Medicaid Services to develop and reevaluate performance measures that are used for public reporting.
[email protected]
On Twitter @legal_med
Poorer-performing hospitals have higher readmission rates than better-performing hospitals for patients with similar diagnoses, a study shows.
Lead author Harlan M. Krumholz, MD, of Yale University, New Haven, Conn., and his colleagues analyzed Centers for Medicare and Medicaid Services hospital-wide readmission data and divided data from July 2014 through June 2015 into two random samples. Researchers used the first sample to calculate the risk-standardized readmission rate within 30 days for each hospital and classified hospitals into performance quartiles, with a lower readmission rate indicating better performance. The second study sample included patients who had two admissions for similar diagnoses at different hospitals that occurred more than 1 month and less than 1 year apart. Researchers compared the observed readmission rates among patients who had been admitted to hospitals in different performance quartiles. The analysis included all discharges occurring from July 1, 2014, through June 30, 2015, from short-term acute care or critical access hospitals in the United States involving Medicare patients who were aged 65 years or older.
Results found that among the patients hospitalized more than once for similar diagnoses at different hospitals, the readmission rate was significantly higher among patients admitted to the worst-performing quartile of hospitals than among those admitted to the best-performing quartile (absolute difference in readmission rate, 2.0 percentage points; 95% confidence interval, 0.4-3.5; P = .001) (N Engl J Med. 2017. doi: 10.1056/NEJMsa1702321). The differences in the comparisons of the other quartiles were smaller and not significant, according to the study.
The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors, study authors concluded.
“This study addresses a persistent concern that national readmission measures may reflect differences in unmeasured factors rather than in hospital performance,” study authors noted in the study. “The findings suggest that hospital quality contributes at least in part to readmission rates, independent of patient factors. By studying patients who were admitted twice within 1 year with similar diagnoses to different hospitals, this study design was able to isolate hospital signals of performance while minimizing differences among the patients. In these cases, because the same patients had similar admissions at two hospitals, the characteristics of the patients, including their level of social disadvantage, level of education, or degree of underlying illness, were broadly the same. The alignment of the differences that we observed with the results of the CMS hospital-wide readmission measure also adds to evidence that the readmission measure classifies true differences in performance.”
Dr. Krumholz and seven coauthors reported receiving support from contracts with the Center for Medicare and Medicaid Services to develop and reevaluate performance measures that are used for public reporting.
[email protected]
On Twitter @legal_med
FROM NEJM
Key clinical point:
Major finding: The readmission rate was significantly higher among patients admitted to the worst-performing quartile of hospitals than among those admitted to the best-performing quartile (absolute difference in readmission rate, 2.0 percentage points).
Data source: Analysis of Centers for Medicare and Medicaid Services hospital-wide readmission data from July 2014 through June 2015.
Disclosures: Dr. Krumholz and seven coauthors reported receiving support from contracts with the Center for Medicare and Medicaid Services to develop and reevaluate performance measures that are used for public reporting.
Assessment of Free Flap Breast Reconstructions
Free flap autologous breast reconstruction is an excellent surgical option for breast reconstruction in select patients. A free flap involves moving skin, fat, and/or muscle from a distant part of the body, based on a named blood supply (pedicle), and attaching it to another blood supply adjacent to the acquired defect. This procedure is particularly useful in areas where local tissue supply is lacking in volume or is damaged due to trauma or radiation. These reconstructions are performed largely in high-volume centers outside the VA because of the required specialized level of surgical training, manpower, and nursing support.1 The Malcom Randall VAMC in Gainesville, Florida, started offering autologous free flap breast reconstruction as an option to select patients in October 2012.
The Malcom Randall VAMC operating room (OR) does not operate 24/7, and the system has limited available OR time and surgical staff compared with the volume of patients requesting care.2 Operative planning for free flap autologous breast reconstruction must occur months ahead of surgery to balance the system limitations with the ability to offer the highest level of care. Planning includes strict patient selection, preoperative imaging, practice runs with OR staff, use of venous couplers, and frequent intensive care unit (ICU) staff in-services. Planning also includes the need to keep surgeries within the allocated OR time to avoid shift changes during critical periods. Frequent and early communication occurs between the surgical scheduler, OR nurses, and the anesthesia and critical care teams.
Studies have found that the best chance of flap salvage in the event of a thrombotic event is a rapid return to the OR.3 It is essential to minimize the risk of emergent returns to the OR because it is not staffed throughout the night. Patient risk factors for perioperative vascular complications include hypercoagulable disorders, peripheral vascular disease, use of the superficial epigastric system, and smoking.4-7
A PubMed search for free flap reconstruction solely within the VA over the past 20 years found 1 article discussing the use of free flaps in head and neck reconstruction which demonstrated an impressive success rate of 93%.8
The object of this study was to assess free flap breast reconstruction results at the Malcolm Randall VAMC to determine whether it is a realistic treatment to offer in the federal system.
Methods
The Malcolm Randall Institutional Review Board approved a retrospective chart review of all autologous free flap breast reconstructions using CPT code 19364, performed from October 2012 to June 2016. Medical records of patients who had a free flap breast reconstruction were queried during that period. Patient age; comorbidities listed on the electronic medical record “problem list;” body mass index (BMI); type of reconstruction (delayed vs immediate); length of surgery; length of stay; and complications over a 30-day period were recorded (Table). The authors looked for documentation of preoperative imaging and unplanned returns to the OR within the 30-day period. 
Of 3 full-time VA plastic surgeons on staff during the study period, 2 surgeons had advanced fellowship training in either microsurgery or hand and microsurgery. Plastic surgery fellows and general surgery interns participated in the surgeries and postoperative care. The service had 1 dedicated advanced practice registered nurse involved in the surgical scheduling and perioperative care.
Results
A total of 11 abdominally based free flap breast reconstructions—6 muscle-sparing transverse rectus abdominus musculocutaneous (TRAM) and 5 deep inferior epigastric perforator (DIEP) flaps—were performed in 8 patients during the study period (Figures 1A, 1B, 1C, and 1D). Patient ages ranged from 31 to 58 years with a mean of 45.6 years. Six patients had preoperative computer tomography angiography (CTA) to define the location of the abdominal wall perforators. One muscle-sparing free flap was performed immediately after mastectomy; the other free flaps were performed as delayed reconstructions. Body mass index ranged from 24 to 35, with a mean of 30. All patients reported no tobacco use during the consultation; however, 1 patient later admitted to chewing tobacco. No urinary cotinine confirmation was requested. Two patients had 1 free flap reconstruction and 1 pedicle TRAM. This bilateral combination has been recently described in the literature and was chosen as a reasonable option to balance limited resources with abdominal wall morbidity.9 Operating room time ranged from 7 hours 50 minutes to 13 hours 3 minutes. All patients went to the ICU for hourly flap monitoring. 
Length of stay ranged from 4 to 7 days, with a mean of 4.5 days. The longest stay was for a patient who had immediate reconstruction using a pedicle TRAM and muscle-sparing free TRAM. She was not a DIEP candidate because poor perforator quality had been noted during preoperative imaging. 
Six patients had documentation of postoperative wound complications. One patient returned to the OR on the elective schedule 3 weeks postoperatively for a partial flap debridement. Her tissue transfer was > 1,000 g, and she required a matching reduction on the other side. There were no complete flap losses or postoperative thrombotic events; no cases went back to the OR emergently.
Discussion
With the number of women veterans steadily increasing, the number of patients in need of breast cancer surgery, including reconstruction, will rise in the VA.10 Fortunately, breast reconstruction is an elective procedure. Immediate breast reconstruction is a popular option because patients can combine surgeries and potentially avoid 2 recovery periods, and a better aesthetic outcome is possible because the skin does not have time to contract. Although immediate reconstruction has been increasing in popularity, it is associated with a higher complication rate.11 Further, reconstruction can be jeopardized if the oncologic plan is changed in the early postoperative period.
Positive margins found after an autologous reconstruction result in a more complicated postoperative course and a higher rate of wound complications.12 Unexpected radiation therapy after autologous reconstruction can severely distort a tissue flap because of fat necrosis, fibrosis, and contraction.13,14 From a practical perspective in the federal system, it is very difficult to coordinate 2 surgeons’ schedules when the system is already struggling to keep up with demand. Splitting the ablative and reconstructive surgery allows the urgent problem (cancer) to be addressed first, ensuring clear margins and allowing the patient to recover and consider all reconstructive options without feeling time pressure.
A large tertiary care center will have staff and equipment redundancy, but this study had to consider limitations in resources. The preoperative lead time allows the ICU to arrange a bed for hourly flap checks and for in-servicing new nursing staff on free flap monitoring. This was well received, and patients gave positive feedback on the staff. The OR schedulers can schedule nurses and techs who are familiar with the microscope and microsurgery instruments. The micro sets were opened, and the microscope powered on for practice runs a week before the procedures to insure no broken or missing instruments.
High-procedure volume would logically improve efficiency. Although the VA is not likely to become a tertiary center for breast reconstruction, the findings of other high-volume microsurgeons can be applied to improve speed and limit complications. Efforts to limit the OR time included use of preoperative imaging and intraoperative venous couplers. Venous couplers can result in shorter OR time, fewer returns to the OR, and excellent patency rates.15,16 One microsurgeon performed his surgery using only loupe-assisted vision (x 3.5), without use of the microscope. Pannucci and colleagues have recommended this as a way to improve access and OR efficiency.17 Use of the CTA has been found to decrease the rate of partial flap necrosis and improve speed of surgery.18-20
Careful patient selection allowed a hospital stay that averaged 4.5 days and minimized risks for return to the OR. Only patients who were nonsmokers were offered the surgery. Average BMI was 30 to prevent the known operative risks in breast surgery patients who are morbidly obese.21-23 No patients had a history of thromboembolic disease. Most patients were discharged home from the ICU. They eventually returned for elective revisions, second stages, and balancing procedures.
Conclusion
Free flap breast reconstruction can be offered as a treatment option with appropriate patient selection and planning. The most efficient way to provide this procedure within the federal system and to minimize the risk of flap loss and complications is by offering delayed reconstruction, obtaining preoperative CTA imaging, utilizing venous couplers, and frequently communicating with all involved practitioners from the OR to the ICU. This small study provides a good starting point to illustrate that tertiary-care reconstructive surgery can be offered to veterans within the federal system.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.
1. Tuggle CT, Patel A, Broer N, Persing JA, Sosa JA, Au AF. Increased hospital volume is associated with improved outcomes following abdominal-based breast reconstruction. J Plast Surg Hand Surg. 2014;48(6):382-388.
2. Shulkin DJ. Beyond the VA crisis — becoming a high-performance network. N Engl J Med. 2016;374(11):1003-1005.
3. Novakovic D, Patel RS, Goldstein DP, Gullane PJ. Salvage of failed free flaps used in head and neck reconstruction. Head Neck Oncol. 2009;1:33.
4. Davison SP, Kessler CM, Al-Attar A. Microvascular free flap failure caused by unrecognized hypercoagulability. Plast Reconstr Surg. 2009;124(2):490-495.
5. Masoomi H, Clark EG, Paydar KZ, et al. Predictive risk factors of free flap thrombosis in breast reconstructive surgery. Microsurgery. 2014;34(8):589-594.
6. O’Neill AC, Haykal S, Bagher S, Zhong T, Hofer S. Predictors and consequences of intraoperative microvascular problems in autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2016;69(10):1349-1355.
7. Sanati-Mehrizy P, Massengburg BB, Rozehnal JM, Ignargiola MJ, Hernandez Rosa J, Taub PJ. Risk factors leading to free flap failure: analysis from the national surgical quality improvement program database. J Craniofac Surg. 2016;27(8):1956-1964.
8. Myers LL, Sumer BD, Defatta RJ, Minhajuddin A. Free tissue transfer reconstruction of the head and neck at a Veterans Affairs hospital. Head Neck. 2008;30(8):1007-1011.
9. Roslan EJ, Kelly EG, Zain MA, Basiron NH, Imran FH. Immediate simultaneous bilateral breast reconstruction with deep inferior epigastric (DIEP) flap and pedicled transverse rectus abdominis musculocutaneous (TRAM) pedicle flap. Med J Malaysia. 2017;72(1):85-87.
10. Leong M, Chike-Obi CJ, Basu CB, Lee EL, Albo D, Netscher DT. Effective breast reconstruction in female veterans. Am J Surg. 2009;198(5):658-663.
11. Kwok AC, Goodwin IA, Ying J, Agarwal JP. National trends and complication rates after bilateral mastectomy and immediate breast reconstruction from 2005 to 2012. Am J Surg. 2015;210(3):512-516.
12. Ochoa O, Theoharis C, Pisano S, et al. Positive margin re-excision following immediate autologous breast reconstruction: morbidity, cosmetic outcome, and oncologic significance. Aesthet Surg J. 2017; [Epub ahead of print.]
13. Garvey PB, Clemens MW, Hoy AE, et al. Muscle-sparing TRAM flap does not protect breast reconstruction from post-mastectomy radiation damage compared to DIEP flap. Plast Reconstr Surg. 2014;133(2):223-233.
14. Kronowitz SJ. Current status of autologous tissue-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012;130(2):282-292.
15. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, et al. The microvascular anastomotic coupler for venous anastomoses in free flap breast reconstruction improves outcomes. Gland Surg. 2016;5(2):88-92.
16. Jandali S, Wu LC, Vega SJ, Kovach SJ, Serletti JM. 1000 consecutive venous anastomoses using the microvascular anastomotic coupler in breast reconstruction. Plast Reconstr Surg. 2010;125(3):792-798.
17. Pannucci CJ, Basta MN, Kovach SJ, Kanchwala SK, Wu LC, Serletti JM. Loupes-only microsurgery is a safe alternative to the operating microscope: an analysis of 1,649 consecutive free flap breast reconstruction. J Reconstr Microsurg. 2015;31(9):636-642.
18. Teunis T, Heerma van Voss MR, Kon M, van Maurik JF. CT-angiography prior to DIEP flap reconstruction: a systemic review and meta-analysis. Microsurgery. 2013;33(6):496-502.
19. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, Band B, Ramakrishnan VV, Griffiths M. Preoperative computed tomography angiography for planning DIEP flap breast reconstruction reduces operative time and overall complications. Gland Surgery. 2016;5(2):93-98.
20. Malhotra A, Chhaya N, Nsiah-Sarbeng P, Mosahebi A. CT-guided deep inferior epigastric perforator (DIEP) flap localization—better for the patient, the surgeon, and the hospital. Clin Radiol. 2013;68(2):131-138.
21. Ilonzo N, Tsang A, Tsantes S, Estabrook A, Thu Ma AM. Breast reconstruction after mastectomy: a ten-year analysis of trends and immediate postoperative outcomes. Breast. 2017;32:7-12.
22. McAllister P, Teo L, Chin K, Makubate B, Alexander Munnoch D. Bilateral breast reconstruction with abdominal free flaps: a single centre, single surgeon retrospective review of 55 consecutive patients. Plast Surg Int. 2016;2016:6085624.
23. Myung Y, Heo CY. Relationship between obesity and surgical complications after reduction mammoplasty: a systemic literature review and meta-analysis. Aesthet Surg J. 2017;37(3):308-315.
Free flap autologous breast reconstruction is an excellent surgical option for breast reconstruction in select patients. A free flap involves moving skin, fat, and/or muscle from a distant part of the body, based on a named blood supply (pedicle), and attaching it to another blood supply adjacent to the acquired defect. This procedure is particularly useful in areas where local tissue supply is lacking in volume or is damaged due to trauma or radiation. These reconstructions are performed largely in high-volume centers outside the VA because of the required specialized level of surgical training, manpower, and nursing support.1 The Malcom Randall VAMC in Gainesville, Florida, started offering autologous free flap breast reconstruction as an option to select patients in October 2012.
The Malcom Randall VAMC operating room (OR) does not operate 24/7, and the system has limited available OR time and surgical staff compared with the volume of patients requesting care.2 Operative planning for free flap autologous breast reconstruction must occur months ahead of surgery to balance the system limitations with the ability to offer the highest level of care. Planning includes strict patient selection, preoperative imaging, practice runs with OR staff, use of venous couplers, and frequent intensive care unit (ICU) staff in-services. Planning also includes the need to keep surgeries within the allocated OR time to avoid shift changes during critical periods. Frequent and early communication occurs between the surgical scheduler, OR nurses, and the anesthesia and critical care teams.
Studies have found that the best chance of flap salvage in the event of a thrombotic event is a rapid return to the OR.3 It is essential to minimize the risk of emergent returns to the OR because it is not staffed throughout the night. Patient risk factors for perioperative vascular complications include hypercoagulable disorders, peripheral vascular disease, use of the superficial epigastric system, and smoking.4-7
A PubMed search for free flap reconstruction solely within the VA over the past 20 years found 1 article discussing the use of free flaps in head and neck reconstruction which demonstrated an impressive success rate of 93%.8
The object of this study was to assess free flap breast reconstruction results at the Malcolm Randall VAMC to determine whether it is a realistic treatment to offer in the federal system.
Methods
The Malcolm Randall Institutional Review Board approved a retrospective chart review of all autologous free flap breast reconstructions using CPT code 19364, performed from October 2012 to June 2016. Medical records of patients who had a free flap breast reconstruction were queried during that period. Patient age; comorbidities listed on the electronic medical record “problem list;” body mass index (BMI); type of reconstruction (delayed vs immediate); length of surgery; length of stay; and complications over a 30-day period were recorded (Table). The authors looked for documentation of preoperative imaging and unplanned returns to the OR within the 30-day period.
Of 3 full-time VA plastic surgeons on staff during the study period, 2 surgeons had advanced fellowship training in either microsurgery or hand and microsurgery. Plastic surgery fellows and general surgery interns participated in the surgeries and postoperative care. The service had 1 dedicated advanced practice registered nurse involved in the surgical scheduling and perioperative care.
Results
A total of 11 abdominally based free flap breast reconstructions—6 muscle-sparing transverse rectus abdominus musculocutaneous (TRAM) and 5 deep inferior epigastric perforator (DIEP) flaps—were performed in 8 patients during the study period (Figures 1A, 1B, 1C, and 1D). Patient ages ranged from 31 to 58 years with a mean of 45.6 years. Six patients had preoperative computer tomography angiography (CTA) to define the location of the abdominal wall perforators. One muscle-sparing free flap was performed immediately after mastectomy; the other free flaps were performed as delayed reconstructions. Body mass index ranged from 24 to 35, with a mean of 30. All patients reported no tobacco use during the consultation; however, 1 patient later admitted to chewing tobacco. No urinary cotinine confirmation was requested. Two patients had 1 free flap reconstruction and 1 pedicle TRAM. This bilateral combination has been recently described in the literature and was chosen as a reasonable option to balance limited resources with abdominal wall morbidity.9 Operating room time ranged from 7 hours 50 minutes to 13 hours 3 minutes. All patients went to the ICU for hourly flap monitoring.
Length of stay ranged from 4 to 7 days, with a mean of 4.5 days. The longest stay was for a patient who had immediate reconstruction using a pedicle TRAM and muscle-sparing free TRAM. She was not a DIEP candidate because poor perforator quality had been noted during preoperative imaging.
Six patients had documentation of postoperative wound complications. One patient returned to the OR on the elective schedule 3 weeks postoperatively for a partial flap debridement. Her tissue transfer was > 1,000 g, and she required a matching reduction on the other side. There were no complete flap losses or postoperative thrombotic events; no cases went back to the OR emergently.
Discussion
With the number of women veterans steadily increasing, the number of patients in need of breast cancer surgery, including reconstruction, will rise in the VA.10 Fortunately, breast reconstruction is an elective procedure. Immediate breast reconstruction is a popular option because patients can combine surgeries and potentially avoid 2 recovery periods, and a better aesthetic outcome is possible because the skin does not have time to contract. Although immediate reconstruction has been increasing in popularity, it is associated with a higher complication rate.11 Further, reconstruction can be jeopardized if the oncologic plan is changed in the early postoperative period.
Positive margins found after an autologous reconstruction result in a more complicated postoperative course and a higher rate of wound complications.12 Unexpected radiation therapy after autologous reconstruction can severely distort a tissue flap because of fat necrosis, fibrosis, and contraction.13,14 From a practical perspective in the federal system, it is very difficult to coordinate 2 surgeons’ schedules when the system is already struggling to keep up with demand. Splitting the ablative and reconstructive surgery allows the urgent problem (cancer) to be addressed first, ensuring clear margins and allowing the patient to recover and consider all reconstructive options without feeling time pressure.
A large tertiary care center will have staff and equipment redundancy, but this study had to consider limitations in resources. The preoperative lead time allows the ICU to arrange a bed for hourly flap checks and for in-servicing new nursing staff on free flap monitoring. This was well received, and patients gave positive feedback on the staff. The OR schedulers can schedule nurses and techs who are familiar with the microscope and microsurgery instruments. The micro sets were opened, and the microscope powered on for practice runs a week before the procedures to insure no broken or missing instruments.
High-procedure volume would logically improve efficiency. Although the VA is not likely to become a tertiary center for breast reconstruction, the findings of other high-volume microsurgeons can be applied to improve speed and limit complications. Efforts to limit the OR time included use of preoperative imaging and intraoperative venous couplers. Venous couplers can result in shorter OR time, fewer returns to the OR, and excellent patency rates.15,16 One microsurgeon performed his surgery using only loupe-assisted vision (x 3.5), without use of the microscope. Pannucci and colleagues have recommended this as a way to improve access and OR efficiency.17 Use of the CTA has been found to decrease the rate of partial flap necrosis and improve speed of surgery.18-20
Careful patient selection allowed a hospital stay that averaged 4.5 days and minimized risks for return to the OR. Only patients who were nonsmokers were offered the surgery. Average BMI was 30 to prevent the known operative risks in breast surgery patients who are morbidly obese.21-23 No patients had a history of thromboembolic disease. Most patients were discharged home from the ICU. They eventually returned for elective revisions, second stages, and balancing procedures.
Conclusion
Free flap breast reconstruction can be offered as a treatment option with appropriate patient selection and planning. The most efficient way to provide this procedure within the federal system and to minimize the risk of flap loss and complications is by offering delayed reconstruction, obtaining preoperative CTA imaging, utilizing venous couplers, and frequently communicating with all involved practitioners from the OR to the ICU. This small study provides a good starting point to illustrate that tertiary-care reconstructive surgery can be offered to veterans within the federal system.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.
Free flap autologous breast reconstruction is an excellent surgical option for breast reconstruction in select patients. A free flap involves moving skin, fat, and/or muscle from a distant part of the body, based on a named blood supply (pedicle), and attaching it to another blood supply adjacent to the acquired defect. This procedure is particularly useful in areas where local tissue supply is lacking in volume or is damaged due to trauma or radiation. These reconstructions are performed largely in high-volume centers outside the VA because of the required specialized level of surgical training, manpower, and nursing support.1 The Malcom Randall VAMC in Gainesville, Florida, started offering autologous free flap breast reconstruction as an option to select patients in October 2012.
The Malcom Randall VAMC operating room (OR) does not operate 24/7, and the system has limited available OR time and surgical staff compared with the volume of patients requesting care.2 Operative planning for free flap autologous breast reconstruction must occur months ahead of surgery to balance the system limitations with the ability to offer the highest level of care. Planning includes strict patient selection, preoperative imaging, practice runs with OR staff, use of venous couplers, and frequent intensive care unit (ICU) staff in-services. Planning also includes the need to keep surgeries within the allocated OR time to avoid shift changes during critical periods. Frequent and early communication occurs between the surgical scheduler, OR nurses, and the anesthesia and critical care teams.
Studies have found that the best chance of flap salvage in the event of a thrombotic event is a rapid return to the OR.3 It is essential to minimize the risk of emergent returns to the OR because it is not staffed throughout the night. Patient risk factors for perioperative vascular complications include hypercoagulable disorders, peripheral vascular disease, use of the superficial epigastric system, and smoking.4-7
A PubMed search for free flap reconstruction solely within the VA over the past 20 years found 1 article discussing the use of free flaps in head and neck reconstruction which demonstrated an impressive success rate of 93%.8
The object of this study was to assess free flap breast reconstruction results at the Malcolm Randall VAMC to determine whether it is a realistic treatment to offer in the federal system.
Methods
The Malcolm Randall Institutional Review Board approved a retrospective chart review of all autologous free flap breast reconstructions using CPT code 19364, performed from October 2012 to June 2016. Medical records of patients who had a free flap breast reconstruction were queried during that period. Patient age; comorbidities listed on the electronic medical record “problem list;” body mass index (BMI); type of reconstruction (delayed vs immediate); length of surgery; length of stay; and complications over a 30-day period were recorded (Table). The authors looked for documentation of preoperative imaging and unplanned returns to the OR within the 30-day period.
Of 3 full-time VA plastic surgeons on staff during the study period, 2 surgeons had advanced fellowship training in either microsurgery or hand and microsurgery. Plastic surgery fellows and general surgery interns participated in the surgeries and postoperative care. The service had 1 dedicated advanced practice registered nurse involved in the surgical scheduling and perioperative care.
Results
A total of 11 abdominally based free flap breast reconstructions—6 muscle-sparing transverse rectus abdominus musculocutaneous (TRAM) and 5 deep inferior epigastric perforator (DIEP) flaps—were performed in 8 patients during the study period (Figures 1A, 1B, 1C, and 1D). Patient ages ranged from 31 to 58 years with a mean of 45.6 years. Six patients had preoperative computer tomography angiography (CTA) to define the location of the abdominal wall perforators. One muscle-sparing free flap was performed immediately after mastectomy; the other free flaps were performed as delayed reconstructions. Body mass index ranged from 24 to 35, with a mean of 30. All patients reported no tobacco use during the consultation; however, 1 patient later admitted to chewing tobacco. No urinary cotinine confirmation was requested. Two patients had 1 free flap reconstruction and 1 pedicle TRAM. This bilateral combination has been recently described in the literature and was chosen as a reasonable option to balance limited resources with abdominal wall morbidity.9 Operating room time ranged from 7 hours 50 minutes to 13 hours 3 minutes. All patients went to the ICU for hourly flap monitoring.
Length of stay ranged from 4 to 7 days, with a mean of 4.5 days. The longest stay was for a patient who had immediate reconstruction using a pedicle TRAM and muscle-sparing free TRAM. She was not a DIEP candidate because poor perforator quality had been noted during preoperative imaging.
Six patients had documentation of postoperative wound complications. One patient returned to the OR on the elective schedule 3 weeks postoperatively for a partial flap debridement. Her tissue transfer was > 1,000 g, and she required a matching reduction on the other side. There were no complete flap losses or postoperative thrombotic events; no cases went back to the OR emergently.
Discussion
With the number of women veterans steadily increasing, the number of patients in need of breast cancer surgery, including reconstruction, will rise in the VA.10 Fortunately, breast reconstruction is an elective procedure. Immediate breast reconstruction is a popular option because patients can combine surgeries and potentially avoid 2 recovery periods, and a better aesthetic outcome is possible because the skin does not have time to contract. Although immediate reconstruction has been increasing in popularity, it is associated with a higher complication rate.11 Further, reconstruction can be jeopardized if the oncologic plan is changed in the early postoperative period.
Positive margins found after an autologous reconstruction result in a more complicated postoperative course and a higher rate of wound complications.12 Unexpected radiation therapy after autologous reconstruction can severely distort a tissue flap because of fat necrosis, fibrosis, and contraction.13,14 From a practical perspective in the federal system, it is very difficult to coordinate 2 surgeons’ schedules when the system is already struggling to keep up with demand. Splitting the ablative and reconstructive surgery allows the urgent problem (cancer) to be addressed first, ensuring clear margins and allowing the patient to recover and consider all reconstructive options without feeling time pressure.
A large tertiary care center will have staff and equipment redundancy, but this study had to consider limitations in resources. The preoperative lead time allows the ICU to arrange a bed for hourly flap checks and for in-servicing new nursing staff on free flap monitoring. This was well received, and patients gave positive feedback on the staff. The OR schedulers can schedule nurses and techs who are familiar with the microscope and microsurgery instruments. The micro sets were opened, and the microscope powered on for practice runs a week before the procedures to insure no broken or missing instruments.
High-procedure volume would logically improve efficiency. Although the VA is not likely to become a tertiary center for breast reconstruction, the findings of other high-volume microsurgeons can be applied to improve speed and limit complications. Efforts to limit the OR time included use of preoperative imaging and intraoperative venous couplers. Venous couplers can result in shorter OR time, fewer returns to the OR, and excellent patency rates.15,16 One microsurgeon performed his surgery using only loupe-assisted vision (x 3.5), without use of the microscope. Pannucci and colleagues have recommended this as a way to improve access and OR efficiency.17 Use of the CTA has been found to decrease the rate of partial flap necrosis and improve speed of surgery.18-20
Careful patient selection allowed a hospital stay that averaged 4.5 days and minimized risks for return to the OR. Only patients who were nonsmokers were offered the surgery. Average BMI was 30 to prevent the known operative risks in breast surgery patients who are morbidly obese.21-23 No patients had a history of thromboembolic disease. Most patients were discharged home from the ICU. They eventually returned for elective revisions, second stages, and balancing procedures.
Conclusion
Free flap breast reconstruction can be offered as a treatment option with appropriate patient selection and planning. The most efficient way to provide this procedure within the federal system and to minimize the risk of flap loss and complications is by offering delayed reconstruction, obtaining preoperative CTA imaging, utilizing venous couplers, and frequently communicating with all involved practitioners from the OR to the ICU. This small study provides a good starting point to illustrate that tertiary-care reconstructive surgery can be offered to veterans within the federal system.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.
1. Tuggle CT, Patel A, Broer N, Persing JA, Sosa JA, Au AF. Increased hospital volume is associated with improved outcomes following abdominal-based breast reconstruction. J Plast Surg Hand Surg. 2014;48(6):382-388.
2. Shulkin DJ. Beyond the VA crisis — becoming a high-performance network. N Engl J Med. 2016;374(11):1003-1005.
3. Novakovic D, Patel RS, Goldstein DP, Gullane PJ. Salvage of failed free flaps used in head and neck reconstruction. Head Neck Oncol. 2009;1:33.
4. Davison SP, Kessler CM, Al-Attar A. Microvascular free flap failure caused by unrecognized hypercoagulability. Plast Reconstr Surg. 2009;124(2):490-495.
5. Masoomi H, Clark EG, Paydar KZ, et al. Predictive risk factors of free flap thrombosis in breast reconstructive surgery. Microsurgery. 2014;34(8):589-594.
6. O’Neill AC, Haykal S, Bagher S, Zhong T, Hofer S. Predictors and consequences of intraoperative microvascular problems in autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2016;69(10):1349-1355.
7. Sanati-Mehrizy P, Massengburg BB, Rozehnal JM, Ignargiola MJ, Hernandez Rosa J, Taub PJ. Risk factors leading to free flap failure: analysis from the national surgical quality improvement program database. J Craniofac Surg. 2016;27(8):1956-1964.
8. Myers LL, Sumer BD, Defatta RJ, Minhajuddin A. Free tissue transfer reconstruction of the head and neck at a Veterans Affairs hospital. Head Neck. 2008;30(8):1007-1011.
9. Roslan EJ, Kelly EG, Zain MA, Basiron NH, Imran FH. Immediate simultaneous bilateral breast reconstruction with deep inferior epigastric (DIEP) flap and pedicled transverse rectus abdominis musculocutaneous (TRAM) pedicle flap. Med J Malaysia. 2017;72(1):85-87.
10. Leong M, Chike-Obi CJ, Basu CB, Lee EL, Albo D, Netscher DT. Effective breast reconstruction in female veterans. Am J Surg. 2009;198(5):658-663.
11. Kwok AC, Goodwin IA, Ying J, Agarwal JP. National trends and complication rates after bilateral mastectomy and immediate breast reconstruction from 2005 to 2012. Am J Surg. 2015;210(3):512-516.
12. Ochoa O, Theoharis C, Pisano S, et al. Positive margin re-excision following immediate autologous breast reconstruction: morbidity, cosmetic outcome, and oncologic significance. Aesthet Surg J. 2017; [Epub ahead of print.]
13. Garvey PB, Clemens MW, Hoy AE, et al. Muscle-sparing TRAM flap does not protect breast reconstruction from post-mastectomy radiation damage compared to DIEP flap. Plast Reconstr Surg. 2014;133(2):223-233.
14. Kronowitz SJ. Current status of autologous tissue-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012;130(2):282-292.
15. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, et al. The microvascular anastomotic coupler for venous anastomoses in free flap breast reconstruction improves outcomes. Gland Surg. 2016;5(2):88-92.
16. Jandali S, Wu LC, Vega SJ, Kovach SJ, Serletti JM. 1000 consecutive venous anastomoses using the microvascular anastomotic coupler in breast reconstruction. Plast Reconstr Surg. 2010;125(3):792-798.
17. Pannucci CJ, Basta MN, Kovach SJ, Kanchwala SK, Wu LC, Serletti JM. Loupes-only microsurgery is a safe alternative to the operating microscope: an analysis of 1,649 consecutive free flap breast reconstruction. J Reconstr Microsurg. 2015;31(9):636-642.
18. Teunis T, Heerma van Voss MR, Kon M, van Maurik JF. CT-angiography prior to DIEP flap reconstruction: a systemic review and meta-analysis. Microsurgery. 2013;33(6):496-502.
19. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, Band B, Ramakrishnan VV, Griffiths M. Preoperative computed tomography angiography for planning DIEP flap breast reconstruction reduces operative time and overall complications. Gland Surgery. 2016;5(2):93-98.
20. Malhotra A, Chhaya N, Nsiah-Sarbeng P, Mosahebi A. CT-guided deep inferior epigastric perforator (DIEP) flap localization—better for the patient, the surgeon, and the hospital. Clin Radiol. 2013;68(2):131-138.
21. Ilonzo N, Tsang A, Tsantes S, Estabrook A, Thu Ma AM. Breast reconstruction after mastectomy: a ten-year analysis of trends and immediate postoperative outcomes. Breast. 2017;32:7-12.
22. McAllister P, Teo L, Chin K, Makubate B, Alexander Munnoch D. Bilateral breast reconstruction with abdominal free flaps: a single centre, single surgeon retrospective review of 55 consecutive patients. Plast Surg Int. 2016;2016:6085624.
23. Myung Y, Heo CY. Relationship between obesity and surgical complications after reduction mammoplasty: a systemic literature review and meta-analysis. Aesthet Surg J. 2017;37(3):308-315.
1. Tuggle CT, Patel A, Broer N, Persing JA, Sosa JA, Au AF. Increased hospital volume is associated with improved outcomes following abdominal-based breast reconstruction. J Plast Surg Hand Surg. 2014;48(6):382-388.
2. Shulkin DJ. Beyond the VA crisis — becoming a high-performance network. N Engl J Med. 2016;374(11):1003-1005.
3. Novakovic D, Patel RS, Goldstein DP, Gullane PJ. Salvage of failed free flaps used in head and neck reconstruction. Head Neck Oncol. 2009;1:33.
4. Davison SP, Kessler CM, Al-Attar A. Microvascular free flap failure caused by unrecognized hypercoagulability. Plast Reconstr Surg. 2009;124(2):490-495.
5. Masoomi H, Clark EG, Paydar KZ, et al. Predictive risk factors of free flap thrombosis in breast reconstructive surgery. Microsurgery. 2014;34(8):589-594.
6. O’Neill AC, Haykal S, Bagher S, Zhong T, Hofer S. Predictors and consequences of intraoperative microvascular problems in autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2016;69(10):1349-1355.
7. Sanati-Mehrizy P, Massengburg BB, Rozehnal JM, Ignargiola MJ, Hernandez Rosa J, Taub PJ. Risk factors leading to free flap failure: analysis from the national surgical quality improvement program database. J Craniofac Surg. 2016;27(8):1956-1964.
8. Myers LL, Sumer BD, Defatta RJ, Minhajuddin A. Free tissue transfer reconstruction of the head and neck at a Veterans Affairs hospital. Head Neck. 2008;30(8):1007-1011.
9. Roslan EJ, Kelly EG, Zain MA, Basiron NH, Imran FH. Immediate simultaneous bilateral breast reconstruction with deep inferior epigastric (DIEP) flap and pedicled transverse rectus abdominis musculocutaneous (TRAM) pedicle flap. Med J Malaysia. 2017;72(1):85-87.
10. Leong M, Chike-Obi CJ, Basu CB, Lee EL, Albo D, Netscher DT. Effective breast reconstruction in female veterans. Am J Surg. 2009;198(5):658-663.
11. Kwok AC, Goodwin IA, Ying J, Agarwal JP. National trends and complication rates after bilateral mastectomy and immediate breast reconstruction from 2005 to 2012. Am J Surg. 2015;210(3):512-516.
12. Ochoa O, Theoharis C, Pisano S, et al. Positive margin re-excision following immediate autologous breast reconstruction: morbidity, cosmetic outcome, and oncologic significance. Aesthet Surg J. 2017; [Epub ahead of print.]
13. Garvey PB, Clemens MW, Hoy AE, et al. Muscle-sparing TRAM flap does not protect breast reconstruction from post-mastectomy radiation damage compared to DIEP flap. Plast Reconstr Surg. 2014;133(2):223-233.
14. Kronowitz SJ. Current status of autologous tissue-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012;130(2):282-292.
15. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, et al. The microvascular anastomotic coupler for venous anastomoses in free flap breast reconstruction improves outcomes. Gland Surg. 2016;5(2):88-92.
16. Jandali S, Wu LC, Vega SJ, Kovach SJ, Serletti JM. 1000 consecutive venous anastomoses using the microvascular anastomotic coupler in breast reconstruction. Plast Reconstr Surg. 2010;125(3):792-798.
17. Pannucci CJ, Basta MN, Kovach SJ, Kanchwala SK, Wu LC, Serletti JM. Loupes-only microsurgery is a safe alternative to the operating microscope: an analysis of 1,649 consecutive free flap breast reconstruction. J Reconstr Microsurg. 2015;31(9):636-642.
18. Teunis T, Heerma van Voss MR, Kon M, van Maurik JF. CT-angiography prior to DIEP flap reconstruction: a systemic review and meta-analysis. Microsurgery. 2013;33(6):496-502.
19. Fitzgerald O’Connor E, Rozen WM, Chowdhry M, Band B, Ramakrishnan VV, Griffiths M. Preoperative computed tomography angiography for planning DIEP flap breast reconstruction reduces operative time and overall complications. Gland Surgery. 2016;5(2):93-98.
20. Malhotra A, Chhaya N, Nsiah-Sarbeng P, Mosahebi A. CT-guided deep inferior epigastric perforator (DIEP) flap localization—better for the patient, the surgeon, and the hospital. Clin Radiol. 2013;68(2):131-138.
21. Ilonzo N, Tsang A, Tsantes S, Estabrook A, Thu Ma AM. Breast reconstruction after mastectomy: a ten-year analysis of trends and immediate postoperative outcomes. Breast. 2017;32:7-12.
22. McAllister P, Teo L, Chin K, Makubate B, Alexander Munnoch D. Bilateral breast reconstruction with abdominal free flaps: a single centre, single surgeon retrospective review of 55 consecutive patients. Plast Surg Int. 2016;2016:6085624.
23. Myung Y, Heo CY. Relationship between obesity and surgical complications after reduction mammoplasty: a systemic literature review and meta-analysis. Aesthet Surg J. 2017;37(3):308-315.
ADRs highest among gastroenterologists, women, early-career physicians
Gastroenterologists, female physicians, and physicians who were less than a decade out of residency had significantly higher adenoma detection rates (ADRs) than their counterparts in a retrospective cohort study of colonoscopists.
“Efforts to target physicians with lower-quality performance are needed,” wrote Ateev Mehrotra, MD, MPH, of Harvard Medical School in Boston, with his associates. The study, one of the first to use natural language processing to compare electronic health data from geographically diverse health care systems, was published online 30 in Gastrointestinal Endoscopy (2017 Aug 30. doi: 10.1016/j.gie.2017.08.023).
These associations persisted among patients who received only screening colonoscopies, who had complete colonoscopies with adequate bowel preparation, or who were younger than 80 years, the researchers said. The findings on sex reflect recent studies in which treatment by female hospitalists slightly decreased the risk of 30-day mortality when compared with treatment by a male hospitalist, they added. “A deliberate and meticulous approach to colonoscopy may facilitate achievement of a high ADR, and this method may be more common among female physicians,” they wrote. “This is supported by research showing that female physicians are more likely to adhere to clinical guidelines and to provide preventive care.” Studies of men in other fields have found them more likely to take risks, which contradicts the methodical approach needed for a high ADR, they emphasized. “Sex differences in color perception [also] may make it easier for female physicians to identify adenomas.”
Likewise, research outside gastroenterology has linked fewer years in practice with better quality of care. Improvements in fellowship training, better access to new equipment, “or simply decay of performance with age” all could explain the findings, the researchers wrote. They also cited five prior studies in which nongastroenterologists had lower ADRs. They called for studies that would further explore the reasons why specific physician traits affect performance.
Physicians in the study tended to have practiced fewer years than gastroenterologists in general in the United States, the investigators noted. “We also could not measure some other physician factors that might explain some of the variation we observed, such as type of endoscopes used.”
The National Cancer Institute provided funding. The researchers did not report having conflicts of interest.
Gastroenterologists, female physicians, and physicians who were less than a decade out of residency had significantly higher adenoma detection rates (ADRs) than their counterparts in a retrospective cohort study of colonoscopists.
“Efforts to target physicians with lower-quality performance are needed,” wrote Ateev Mehrotra, MD, MPH, of Harvard Medical School in Boston, with his associates. The study, one of the first to use natural language processing to compare electronic health data from geographically diverse health care systems, was published online 30 in Gastrointestinal Endoscopy (2017 Aug 30. doi: 10.1016/j.gie.2017.08.023).
These associations persisted among patients who received only screening colonoscopies, who had complete colonoscopies with adequate bowel preparation, or who were younger than 80 years, the researchers said. The findings on sex reflect recent studies in which treatment by female hospitalists slightly decreased the risk of 30-day mortality when compared with treatment by a male hospitalist, they added. “A deliberate and meticulous approach to colonoscopy may facilitate achievement of a high ADR, and this method may be more common among female physicians,” they wrote. “This is supported by research showing that female physicians are more likely to adhere to clinical guidelines and to provide preventive care.” Studies of men in other fields have found them more likely to take risks, which contradicts the methodical approach needed for a high ADR, they emphasized. “Sex differences in color perception [also] may make it easier for female physicians to identify adenomas.”
Likewise, research outside gastroenterology has linked fewer years in practice with better quality of care. Improvements in fellowship training, better access to new equipment, “or simply decay of performance with age” all could explain the findings, the researchers wrote. They also cited five prior studies in which nongastroenterologists had lower ADRs. They called for studies that would further explore the reasons why specific physician traits affect performance.
Physicians in the study tended to have practiced fewer years than gastroenterologists in general in the United States, the investigators noted. “We also could not measure some other physician factors that might explain some of the variation we observed, such as type of endoscopes used.”
The National Cancer Institute provided funding. The researchers did not report having conflicts of interest.
Gastroenterologists, female physicians, and physicians who were less than a decade out of residency had significantly higher adenoma detection rates (ADRs) than their counterparts in a retrospective cohort study of colonoscopists.
“Efforts to target physicians with lower-quality performance are needed,” wrote Ateev Mehrotra, MD, MPH, of Harvard Medical School in Boston, with his associates. The study, one of the first to use natural language processing to compare electronic health data from geographically diverse health care systems, was published online 30 in Gastrointestinal Endoscopy (2017 Aug 30. doi: 10.1016/j.gie.2017.08.023).
These associations persisted among patients who received only screening colonoscopies, who had complete colonoscopies with adequate bowel preparation, or who were younger than 80 years, the researchers said. The findings on sex reflect recent studies in which treatment by female hospitalists slightly decreased the risk of 30-day mortality when compared with treatment by a male hospitalist, they added. “A deliberate and meticulous approach to colonoscopy may facilitate achievement of a high ADR, and this method may be more common among female physicians,” they wrote. “This is supported by research showing that female physicians are more likely to adhere to clinical guidelines and to provide preventive care.” Studies of men in other fields have found them more likely to take risks, which contradicts the methodical approach needed for a high ADR, they emphasized. “Sex differences in color perception [also] may make it easier for female physicians to identify adenomas.”
Likewise, research outside gastroenterology has linked fewer years in practice with better quality of care. Improvements in fellowship training, better access to new equipment, “or simply decay of performance with age” all could explain the findings, the researchers wrote. They also cited five prior studies in which nongastroenterologists had lower ADRs. They called for studies that would further explore the reasons why specific physician traits affect performance.
Physicians in the study tended to have practiced fewer years than gastroenterologists in general in the United States, the investigators noted. “We also could not measure some other physician factors that might explain some of the variation we observed, such as type of endoscopes used.”
The National Cancer Institute provided funding. The researchers did not report having conflicts of interest.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Adenoma detection rates were highest among gastroenterologists, female physicians, and physicians less than a decade out of residency.
Major finding: On average, their ADRs were 9.4, 6.0, and 4.2 percentage points higher than those of their respective comparison groups, and each difference was statistically significant (all P values less than .03).
Data source: A retrospective cohort study of four diverse health systems.
Disclosures: The National Cancer Institute provided funding. The researchers did not report having conflicts of interest.
Endocrine Society updates treatment guidelines for transgender persons
Previous clinical recommendations on caring for transgender individuals have advised that hormone treatment begin no earlier than age 16 years, but
“Sixteen is the typical age cutoff in many areas of the world for some decision-making capacity from a legal perspective, but when you think about hormones and puberty, 16 is pretty late,” Joshua D. Safer, MD, one of the task force members who authored the guideline, said in an interview. “If we’re going to use biology for guidance, then hormone interventions for transgender kids should begin occurring earlier, when puberty really happens, like around age 12, 13, or 14. However, we’re in a situation where we lack a test. We can’t diagnose anybody as transgender with excellent confidence, outside of talking to those kids. When we start talking about hormone therapies, we talk about some things that will be irreversible. That’s a fraught place to go, but we recognize that people are going to treat kids under 16 in many instances.”
Over several years, Dr. Safer and nine other task force members, chaired by Wylie Hembree, MD, of the College of Physicians and Surgeons at Columbia University, New York, worked to establish a framework for the appropriate treatment of transgender individuals. The efforts of the task force were framed around a durable biological underpinning to gender identity. “That’s state of the art right now,” said Dr. Safer, who is the medical director of the Center for Transgender Medicine and Surgery at Boston University Medical Center. “People think there’s debate about whether there’s a substantial biological component. I think that the data are pretty strong, so I don’t think there’s a lot of debate about that in the scientific world. The debate is more about what that biology might be. That’s all over the map.”
That notion of a biological basis for gender identity contributed to a second major change from the Endocrine Society’s 2009 guideline, which recommended that the diagnosis of gender identity disorder be made by a mental health professional. The current guideline states that for the care of peripubertal youths and older adolescents, “we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents.” Meanwhile, for adult gender-dysphoric/gender-incongruent persons, “the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient.” Dr. Safer described this new approach as “a major change in terms of trying to gain access to care by liberalizing the variety of those in the medical community who can be associated with the diagnosis, at least on the adult side.”
A number of associations cosponsored the guideline, including the American Association of Clinical Endocrinologists, American Society of Andrology, European Society for Paediatric Endocrinology, European Society of Endocrinology, Pediatric Endocrine Society, and World Professional Association for Transgender Health. Other key recommendations from the guideline include:
- All individuals seeking gender-affirming medical treatment should receive information and counsel on options for fertility preservation prior to initiating puberty suppression in adolescents and prior to treating with hormonal therapy of the affirmed gender in both adolescents and adults.
- Removal of gonads may be considered when high doses of sex steroids are required to suppress the body’s secretion of hormones and/or to reduce steroid levels in advanced age.
- During sex-steroid treatment, clinicians should monitor, in both transgender males (female to male) and transgender females (male to female), prolactin, metabolic disorders, and bone loss, as well as cancer risks in individuals who have not undergone surgical treatment.
Concurrent with the release of the new guideline, the Endocrine Society issued a position statement that calls on federal and private insurers to cover medical interventions for transgender individuals as prescribed by a physician. “I live in Massachusetts, where our insurance commissioner deemed insurance coverage obligatory for transgender individuals as of 2015,” said Dr. Safer, who is also director of the endocrinology fellowship training program at Boston University. “I’ve spoken to the medical directors of our large insurers, like Blue Cross/Blue Shield. What’s notable is that there has been no push back [on coverage for transgender individuals] from the insurance companies. These services are not expensive: the primary care, the mental health care, and the hormones. Many of the patients are not opting for surgeries. The theme of their concern was to get their [health insurance] policies right as quickly as possible so that they could stop wasting time talking about it, and they could focus their energy on other, more expensive health care concerns.”
In the guideline, Dr. Safer and the other task force members called for more rigorous evaluations of the effectiveness and safety of endocrine and surgical protocols in the future. “Specifically, endocrine treatment protocols for GD/gender incongruence should include the careful assessment of the following: (1) the effects of prolonged delay of puberty in adolescents on bone health, gonadal function, and the brain (including effects on cognitive, emotional, social, and sexual development); (2) the effects of treatment in adults on sex hormone levels; (3) the requirement for and the effects of progestins and other agents used to suppress endogenous sex steroids during treatment; and (4) the risks and benefits of gender-affirming hormone treatment in older transgender people.”
Dr. Safer reported having no financial disclosures.
Previous clinical recommendations on caring for transgender individuals have advised that hormone treatment begin no earlier than age 16 years, but
“Sixteen is the typical age cutoff in many areas of the world for some decision-making capacity from a legal perspective, but when you think about hormones and puberty, 16 is pretty late,” Joshua D. Safer, MD, one of the task force members who authored the guideline, said in an interview. “If we’re going to use biology for guidance, then hormone interventions for transgender kids should begin occurring earlier, when puberty really happens, like around age 12, 13, or 14. However, we’re in a situation where we lack a test. We can’t diagnose anybody as transgender with excellent confidence, outside of talking to those kids. When we start talking about hormone therapies, we talk about some things that will be irreversible. That’s a fraught place to go, but we recognize that people are going to treat kids under 16 in many instances.”
Over several years, Dr. Safer and nine other task force members, chaired by Wylie Hembree, MD, of the College of Physicians and Surgeons at Columbia University, New York, worked to establish a framework for the appropriate treatment of transgender individuals. The efforts of the task force were framed around a durable biological underpinning to gender identity. “That’s state of the art right now,” said Dr. Safer, who is the medical director of the Center for Transgender Medicine and Surgery at Boston University Medical Center. “People think there’s debate about whether there’s a substantial biological component. I think that the data are pretty strong, so I don’t think there’s a lot of debate about that in the scientific world. The debate is more about what that biology might be. That’s all over the map.”
That notion of a biological basis for gender identity contributed to a second major change from the Endocrine Society’s 2009 guideline, which recommended that the diagnosis of gender identity disorder be made by a mental health professional. The current guideline states that for the care of peripubertal youths and older adolescents, “we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents.” Meanwhile, for adult gender-dysphoric/gender-incongruent persons, “the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient.” Dr. Safer described this new approach as “a major change in terms of trying to gain access to care by liberalizing the variety of those in the medical community who can be associated with the diagnosis, at least on the adult side.”
A number of associations cosponsored the guideline, including the American Association of Clinical Endocrinologists, American Society of Andrology, European Society for Paediatric Endocrinology, European Society of Endocrinology, Pediatric Endocrine Society, and World Professional Association for Transgender Health. Other key recommendations from the guideline include:
- All individuals seeking gender-affirming medical treatment should receive information and counsel on options for fertility preservation prior to initiating puberty suppression in adolescents and prior to treating with hormonal therapy of the affirmed gender in both adolescents and adults.
- Removal of gonads may be considered when high doses of sex steroids are required to suppress the body’s secretion of hormones and/or to reduce steroid levels in advanced age.
- During sex-steroid treatment, clinicians should monitor, in both transgender males (female to male) and transgender females (male to female), prolactin, metabolic disorders, and bone loss, as well as cancer risks in individuals who have not undergone surgical treatment.
Concurrent with the release of the new guideline, the Endocrine Society issued a position statement that calls on federal and private insurers to cover medical interventions for transgender individuals as prescribed by a physician. “I live in Massachusetts, where our insurance commissioner deemed insurance coverage obligatory for transgender individuals as of 2015,” said Dr. Safer, who is also director of the endocrinology fellowship training program at Boston University. “I’ve spoken to the medical directors of our large insurers, like Blue Cross/Blue Shield. What’s notable is that there has been no push back [on coverage for transgender individuals] from the insurance companies. These services are not expensive: the primary care, the mental health care, and the hormones. Many of the patients are not opting for surgeries. The theme of their concern was to get their [health insurance] policies right as quickly as possible so that they could stop wasting time talking about it, and they could focus their energy on other, more expensive health care concerns.”
In the guideline, Dr. Safer and the other task force members called for more rigorous evaluations of the effectiveness and safety of endocrine and surgical protocols in the future. “Specifically, endocrine treatment protocols for GD/gender incongruence should include the careful assessment of the following: (1) the effects of prolonged delay of puberty in adolescents on bone health, gonadal function, and the brain (including effects on cognitive, emotional, social, and sexual development); (2) the effects of treatment in adults on sex hormone levels; (3) the requirement for and the effects of progestins and other agents used to suppress endogenous sex steroids during treatment; and (4) the risks and benefits of gender-affirming hormone treatment in older transgender people.”
Dr. Safer reported having no financial disclosures.
Previous clinical recommendations on caring for transgender individuals have advised that hormone treatment begin no earlier than age 16 years, but
“Sixteen is the typical age cutoff in many areas of the world for some decision-making capacity from a legal perspective, but when you think about hormones and puberty, 16 is pretty late,” Joshua D. Safer, MD, one of the task force members who authored the guideline, said in an interview. “If we’re going to use biology for guidance, then hormone interventions for transgender kids should begin occurring earlier, when puberty really happens, like around age 12, 13, or 14. However, we’re in a situation where we lack a test. We can’t diagnose anybody as transgender with excellent confidence, outside of talking to those kids. When we start talking about hormone therapies, we talk about some things that will be irreversible. That’s a fraught place to go, but we recognize that people are going to treat kids under 16 in many instances.”
Over several years, Dr. Safer and nine other task force members, chaired by Wylie Hembree, MD, of the College of Physicians and Surgeons at Columbia University, New York, worked to establish a framework for the appropriate treatment of transgender individuals. The efforts of the task force were framed around a durable biological underpinning to gender identity. “That’s state of the art right now,” said Dr. Safer, who is the medical director of the Center for Transgender Medicine and Surgery at Boston University Medical Center. “People think there’s debate about whether there’s a substantial biological component. I think that the data are pretty strong, so I don’t think there’s a lot of debate about that in the scientific world. The debate is more about what that biology might be. That’s all over the map.”
That notion of a biological basis for gender identity contributed to a second major change from the Endocrine Society’s 2009 guideline, which recommended that the diagnosis of gender identity disorder be made by a mental health professional. The current guideline states that for the care of peripubertal youths and older adolescents, “we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents.” Meanwhile, for adult gender-dysphoric/gender-incongruent persons, “the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient.” Dr. Safer described this new approach as “a major change in terms of trying to gain access to care by liberalizing the variety of those in the medical community who can be associated with the diagnosis, at least on the adult side.”
A number of associations cosponsored the guideline, including the American Association of Clinical Endocrinologists, American Society of Andrology, European Society for Paediatric Endocrinology, European Society of Endocrinology, Pediatric Endocrine Society, and World Professional Association for Transgender Health. Other key recommendations from the guideline include:
- All individuals seeking gender-affirming medical treatment should receive information and counsel on options for fertility preservation prior to initiating puberty suppression in adolescents and prior to treating with hormonal therapy of the affirmed gender in both adolescents and adults.
- Removal of gonads may be considered when high doses of sex steroids are required to suppress the body’s secretion of hormones and/or to reduce steroid levels in advanced age.
- During sex-steroid treatment, clinicians should monitor, in both transgender males (female to male) and transgender females (male to female), prolactin, metabolic disorders, and bone loss, as well as cancer risks in individuals who have not undergone surgical treatment.
Concurrent with the release of the new guideline, the Endocrine Society issued a position statement that calls on federal and private insurers to cover medical interventions for transgender individuals as prescribed by a physician. “I live in Massachusetts, where our insurance commissioner deemed insurance coverage obligatory for transgender individuals as of 2015,” said Dr. Safer, who is also director of the endocrinology fellowship training program at Boston University. “I’ve spoken to the medical directors of our large insurers, like Blue Cross/Blue Shield. What’s notable is that there has been no push back [on coverage for transgender individuals] from the insurance companies. These services are not expensive: the primary care, the mental health care, and the hormones. Many of the patients are not opting for surgeries. The theme of their concern was to get their [health insurance] policies right as quickly as possible so that they could stop wasting time talking about it, and they could focus their energy on other, more expensive health care concerns.”
In the guideline, Dr. Safer and the other task force members called for more rigorous evaluations of the effectiveness and safety of endocrine and surgical protocols in the future. “Specifically, endocrine treatment protocols for GD/gender incongruence should include the careful assessment of the following: (1) the effects of prolonged delay of puberty in adolescents on bone health, gonadal function, and the brain (including effects on cognitive, emotional, social, and sexual development); (2) the effects of treatment in adults on sex hormone levels; (3) the requirement for and the effects of progestins and other agents used to suppress endogenous sex steroids during treatment; and (4) the risks and benefits of gender-affirming hormone treatment in older transgender people.”
Dr. Safer reported having no financial disclosures.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
CRP may predict survival after immunotherapy for lung cancer
CHICAGO – A baseline C-reactive protein (CRP) level above 50 mg/L independently predicted worse overall survival after immunotherapy in patients with advanced non–small cell lung cancer and small cell lung cancer in a retrospective study.
In 99 patients treated with nivolumab after a first-line platinum doublet, the median baseline CRP level was 22 mg/L. After a median follow-up of 8.5 months, 50% of patients were alive, and, based on univariate and multivariate analysis, both liver involvement and having a CRP level greater than 50 mg/L were significantly associated with inferior overall survival after immunotherapy.
The median overall survival after immunotherapy was 9.3 months versus 2.7 months with a CRP level of 50 mg/L or less versus above 50 mg/L, Abdul Rafeh Naqash, MD, of East Carolina University, Greenville, N.C., reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Notably, significant increases in CRP level, compared with baseline, were seen at the time of grade 2 to grade 4 immune-related adverse events, which occurred in 38.4% of patients. This is a hypothesis-generating finding in that it suggests there is dysregulation of the immune system, in the context of immune checkpoint blockade, that leads to a more proinflammatory state, which ultimately leads to immune-related adverse events, Dr. Naqash said.
Study subjects were adults with a median age of 65 years who were treated during April 2015-March 2017. Most were white (64.7%), were male (64.6%), and had non–small cell lung cancer (88%). Most had stage IV disease (70.7%), and the most common site for metastases was the bones (35.4%) and the liver (24.2%). Patients’ CRP levels were measured at anti-PD-1–treatment initiation and serially with subsequent doses.
The findings are important because the identification of predictive biomarkers in patients treated with anti-PD-1 therapy could provide valuable insights into underlying mechanisms regulating patient responses, elucidate resistance mechanisms, and help with optimal selection of patients for treatment with and development of patient-tailored treatment, Dr. Naqash said, noting that identifying such biomarkers has thus far been a challenge.
However, this study is limited by its retrospective design and limited follow-up; the findings require validation in prospective lung cancer trials, he concluded.
Dr. Naqash reported having no disclosures.
CHICAGO – A baseline C-reactive protein (CRP) level above 50 mg/L independently predicted worse overall survival after immunotherapy in patients with advanced non–small cell lung cancer and small cell lung cancer in a retrospective study.
In 99 patients treated with nivolumab after a first-line platinum doublet, the median baseline CRP level was 22 mg/L. After a median follow-up of 8.5 months, 50% of patients were alive, and, based on univariate and multivariate analysis, both liver involvement and having a CRP level greater than 50 mg/L were significantly associated with inferior overall survival after immunotherapy.
The median overall survival after immunotherapy was 9.3 months versus 2.7 months with a CRP level of 50 mg/L or less versus above 50 mg/L, Abdul Rafeh Naqash, MD, of East Carolina University, Greenville, N.C., reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Notably, significant increases in CRP level, compared with baseline, were seen at the time of grade 2 to grade 4 immune-related adverse events, which occurred in 38.4% of patients. This is a hypothesis-generating finding in that it suggests there is dysregulation of the immune system, in the context of immune checkpoint blockade, that leads to a more proinflammatory state, which ultimately leads to immune-related adverse events, Dr. Naqash said.
Study subjects were adults with a median age of 65 years who were treated during April 2015-March 2017. Most were white (64.7%), were male (64.6%), and had non–small cell lung cancer (88%). Most had stage IV disease (70.7%), and the most common site for metastases was the bones (35.4%) and the liver (24.2%). Patients’ CRP levels were measured at anti-PD-1–treatment initiation and serially with subsequent doses.
The findings are important because the identification of predictive biomarkers in patients treated with anti-PD-1 therapy could provide valuable insights into underlying mechanisms regulating patient responses, elucidate resistance mechanisms, and help with optimal selection of patients for treatment with and development of patient-tailored treatment, Dr. Naqash said, noting that identifying such biomarkers has thus far been a challenge.
However, this study is limited by its retrospective design and limited follow-up; the findings require validation in prospective lung cancer trials, he concluded.
Dr. Naqash reported having no disclosures.
CHICAGO – A baseline C-reactive protein (CRP) level above 50 mg/L independently predicted worse overall survival after immunotherapy in patients with advanced non–small cell lung cancer and small cell lung cancer in a retrospective study.
In 99 patients treated with nivolumab after a first-line platinum doublet, the median baseline CRP level was 22 mg/L. After a median follow-up of 8.5 months, 50% of patients were alive, and, based on univariate and multivariate analysis, both liver involvement and having a CRP level greater than 50 mg/L were significantly associated with inferior overall survival after immunotherapy.
The median overall survival after immunotherapy was 9.3 months versus 2.7 months with a CRP level of 50 mg/L or less versus above 50 mg/L, Abdul Rafeh Naqash, MD, of East Carolina University, Greenville, N.C., reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Notably, significant increases in CRP level, compared with baseline, were seen at the time of grade 2 to grade 4 immune-related adverse events, which occurred in 38.4% of patients. This is a hypothesis-generating finding in that it suggests there is dysregulation of the immune system, in the context of immune checkpoint blockade, that leads to a more proinflammatory state, which ultimately leads to immune-related adverse events, Dr. Naqash said.
Study subjects were adults with a median age of 65 years who were treated during April 2015-March 2017. Most were white (64.7%), were male (64.6%), and had non–small cell lung cancer (88%). Most had stage IV disease (70.7%), and the most common site for metastases was the bones (35.4%) and the liver (24.2%). Patients’ CRP levels were measured at anti-PD-1–treatment initiation and serially with subsequent doses.
The findings are important because the identification of predictive biomarkers in patients treated with anti-PD-1 therapy could provide valuable insights into underlying mechanisms regulating patient responses, elucidate resistance mechanisms, and help with optimal selection of patients for treatment with and development of patient-tailored treatment, Dr. Naqash said, noting that identifying such biomarkers has thus far been a challenge.
However, this study is limited by its retrospective design and limited follow-up; the findings require validation in prospective lung cancer trials, he concluded.
Dr. Naqash reported having no disclosures.
AT A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point:
Major finding: Median overall survival after immunotherapy: 9.3 months vs. 2.7 months with CRP of 50 mg/L or less vs. above 50 mg/L.
Data source: A retrospective study of 99 patients.
Disclosures: Dr. Naqash reported having no disclosures.
Postsurgical antibiotics cut infection in obese women after C-section
A 48-hour course of postoperative cephalexin and metronidazole, plus typical preoperative antibiotics, cut surgical site infections by 59% in obese women who had a cesarean delivery.
The benefit of the additional postoperative treatment was driven by a significant, 69% risk reduction among women who had ruptured membranes, Amy M. Valent, DO, and her colleagues reported (JAMA. 2017;318[11]:1026-34). However, the authors noted, “tests for interaction between the intact membranes and [ruptured] subgroups and postpartum cephalexin-metronidazole were not statistically different and should not be interpreted as showing a difference in significance or effect size among the subgroups with and without [rupture].”
The trial comprised 403 obese women who had a cesarean delivery. They were a mean of 28 years old. The mean body mass index was 40 kg/m2, and the mean subcutaneous adipose tissue thickness was about 3.4 cm. About a third of each treatment group was positive for Group B streptococcus; 31% had ruptured membranes at the onset of labor. More than 60% of women in both groups had a scheduled cesarean delivery.
All women had standard preoperative care, including skin prep with a chlorhexidine or povidone-iodine cleansing and an intravenous infusion of 2 g cefazolin. After delivery, they were randomized to placebo or to oral cephalexin 500 mg plus metronidazole 500 mg every 8 hours for 48 hours. The primary outcome was surgical site infection incidence within 30 days.
The overall rate of surgical site infection was 10.9% (44 women). Infections developed in 13 women in the active group and 31 in the placebo group (6.4% vs. 15.4%) – a significant difference, translating to a 59% risk reduction (relative risk, 0.41). Cellulitis was the only secondary outcome that was significantly reduced by prophylactic antibiotics, with infections occurring in 5.9% of the metronidazole-cephalexin group vs. 13.4% of the placebo group (RR, 0.44). The antibiotic regimen didn’t affect the other secondary endpoints, which included rates of incisional morbidity, endometritis, fever of unknown etiology, and wound separation.
The authors conducted a post-hoc analysis to examine the antibiotics’ effects on women who had ruptured and intact membranes at the time of delivery. The benefit was greatest among those with ruptured membranes. There were six infections among the active group and 19 among the placebo group (9.5% vs. 30.2%). This difference translated to a relative risk of 0.31 – a 69% risk reduction.
Among women with intact membranes, there were seven infections in the active group and 12 in the placebo group (5% vs. 8.7%). This translated to a 0.58 relative risk, which was not statistically significant.
“Interaction testing was performed between study groups (cephalexin-metronidazole vs. placebo) and by membrane status (intact vs. ruptured),” the authors noted. “The rate of surgical site infection was highest in those with [ruptured membranes] who received placebo (30.2%) and lowest in those with intact membranes who received antibiotics (5.0%), but the test for interaction did not show statistical significance at P = .30.”
There were no serious adverse events or allergic reactions reported for cephalexin or metronidazole. The authors noted that both drugs are excreted into breast milk in small amounts, but that no study has ever linked them with neonatal harm through breast milk exposure. However, they added, “Long-term childhood or adverse neonatal outcomes specific to cephalexin-metronidazole exposure cannot be determined, as outcome measures were not evaluated for this study protocol. Recognizing the maternal and neonatal benefit of breastfeeding, the lack of known neonatal adverse effects, and maternal reduction in [surgical site infection], the benefit of this antibiotic regimen likely outweighs the theoretical risks of breast milk exposure in the obese population.”
The University of Cincinnati Department of Obstetrics and Gynecology sponsored the trial. None of the authors reported any financial conflicts.
Despite the positive outcomes of this trial, it’s not yet time to tack on yet more antibiotics for every obese woman who undergoes a cesarean delivery, David P. Calfee, MD, and Amos Grünebaum, MD, wrote in an accompanying editorial (JAMA. 2017;318[11]:1012-3).
“When determining if and how the results of this study should alter current clinical practice, it is important to recognize that the results of this study are quite different from those of several previous studies conducted in other surgical patient populations in which no benefit from postoperative antimicrobial prophylaxis was found and on which current clinical guidelines for antimicrobial prophylaxis are based,” they wrote. “The explanation for this difference may be as simple as the identification in the current study of a very specific, high-risk group of patients for which the intervention is effective. However, several questions are worthy of additional consideration and study.”
For instance, the study was conducted over 5 years and may not reflect current practices for managing these patients, such as glycemic control and maintaining normothermia. Additionally, there may be additional risks to women that were not identified in the study, such as infection from antimicrobial-resistant pathogens.
Dr. Calfee and Dr. Grünebaum are at Weill Cornell Medical Center in New York. Dr. Calfee reported receiving grants from Merck, Sharp, and Dohme.
Despite the positive outcomes of this trial, it’s not yet time to tack on yet more antibiotics for every obese woman who undergoes a cesarean delivery, David P. Calfee, MD, and Amos Grünebaum, MD, wrote in an accompanying editorial (JAMA. 2017;318[11]:1012-3).
“When determining if and how the results of this study should alter current clinical practice, it is important to recognize that the results of this study are quite different from those of several previous studies conducted in other surgical patient populations in which no benefit from postoperative antimicrobial prophylaxis was found and on which current clinical guidelines for antimicrobial prophylaxis are based,” they wrote. “The explanation for this difference may be as simple as the identification in the current study of a very specific, high-risk group of patients for which the intervention is effective. However, several questions are worthy of additional consideration and study.”
For instance, the study was conducted over 5 years and may not reflect current practices for managing these patients, such as glycemic control and maintaining normothermia. Additionally, there may be additional risks to women that were not identified in the study, such as infection from antimicrobial-resistant pathogens.
Dr. Calfee and Dr. Grünebaum are at Weill Cornell Medical Center in New York. Dr. Calfee reported receiving grants from Merck, Sharp, and Dohme.
Despite the positive outcomes of this trial, it’s not yet time to tack on yet more antibiotics for every obese woman who undergoes a cesarean delivery, David P. Calfee, MD, and Amos Grünebaum, MD, wrote in an accompanying editorial (JAMA. 2017;318[11]:1012-3).
“When determining if and how the results of this study should alter current clinical practice, it is important to recognize that the results of this study are quite different from those of several previous studies conducted in other surgical patient populations in which no benefit from postoperative antimicrobial prophylaxis was found and on which current clinical guidelines for antimicrobial prophylaxis are based,” they wrote. “The explanation for this difference may be as simple as the identification in the current study of a very specific, high-risk group of patients for which the intervention is effective. However, several questions are worthy of additional consideration and study.”
For instance, the study was conducted over 5 years and may not reflect current practices for managing these patients, such as glycemic control and maintaining normothermia. Additionally, there may be additional risks to women that were not identified in the study, such as infection from antimicrobial-resistant pathogens.
Dr. Calfee and Dr. Grünebaum are at Weill Cornell Medical Center in New York. Dr. Calfee reported receiving grants from Merck, Sharp, and Dohme.
A 48-hour course of postoperative cephalexin and metronidazole, plus typical preoperative antibiotics, cut surgical site infections by 59% in obese women who had a cesarean delivery.
The benefit of the additional postoperative treatment was driven by a significant, 69% risk reduction among women who had ruptured membranes, Amy M. Valent, DO, and her colleagues reported (JAMA. 2017;318[11]:1026-34). However, the authors noted, “tests for interaction between the intact membranes and [ruptured] subgroups and postpartum cephalexin-metronidazole were not statistically different and should not be interpreted as showing a difference in significance or effect size among the subgroups with and without [rupture].”
The trial comprised 403 obese women who had a cesarean delivery. They were a mean of 28 years old. The mean body mass index was 40 kg/m2, and the mean subcutaneous adipose tissue thickness was about 3.4 cm. About a third of each treatment group was positive for Group B streptococcus; 31% had ruptured membranes at the onset of labor. More than 60% of women in both groups had a scheduled cesarean delivery.
All women had standard preoperative care, including skin prep with a chlorhexidine or povidone-iodine cleansing and an intravenous infusion of 2 g cefazolin. After delivery, they were randomized to placebo or to oral cephalexin 500 mg plus metronidazole 500 mg every 8 hours for 48 hours. The primary outcome was surgical site infection incidence within 30 days.
The overall rate of surgical site infection was 10.9% (44 women). Infections developed in 13 women in the active group and 31 in the placebo group (6.4% vs. 15.4%) – a significant difference, translating to a 59% risk reduction (relative risk, 0.41). Cellulitis was the only secondary outcome that was significantly reduced by prophylactic antibiotics, with infections occurring in 5.9% of the metronidazole-cephalexin group vs. 13.4% of the placebo group (RR, 0.44). The antibiotic regimen didn’t affect the other secondary endpoints, which included rates of incisional morbidity, endometritis, fever of unknown etiology, and wound separation.
The authors conducted a post-hoc analysis to examine the antibiotics’ effects on women who had ruptured and intact membranes at the time of delivery. The benefit was greatest among those with ruptured membranes. There were six infections among the active group and 19 among the placebo group (9.5% vs. 30.2%). This difference translated to a relative risk of 0.31 – a 69% risk reduction.
Among women with intact membranes, there were seven infections in the active group and 12 in the placebo group (5% vs. 8.7%). This translated to a 0.58 relative risk, which was not statistically significant.
“Interaction testing was performed between study groups (cephalexin-metronidazole vs. placebo) and by membrane status (intact vs. ruptured),” the authors noted. “The rate of surgical site infection was highest in those with [ruptured membranes] who received placebo (30.2%) and lowest in those with intact membranes who received antibiotics (5.0%), but the test for interaction did not show statistical significance at P = .30.”
There were no serious adverse events or allergic reactions reported for cephalexin or metronidazole. The authors noted that both drugs are excreted into breast milk in small amounts, but that no study has ever linked them with neonatal harm through breast milk exposure. However, they added, “Long-term childhood or adverse neonatal outcomes specific to cephalexin-metronidazole exposure cannot be determined, as outcome measures were not evaluated for this study protocol. Recognizing the maternal and neonatal benefit of breastfeeding, the lack of known neonatal adverse effects, and maternal reduction in [surgical site infection], the benefit of this antibiotic regimen likely outweighs the theoretical risks of breast milk exposure in the obese population.”
The University of Cincinnati Department of Obstetrics and Gynecology sponsored the trial. None of the authors reported any financial conflicts.
A 48-hour course of postoperative cephalexin and metronidazole, plus typical preoperative antibiotics, cut surgical site infections by 59% in obese women who had a cesarean delivery.
The benefit of the additional postoperative treatment was driven by a significant, 69% risk reduction among women who had ruptured membranes, Amy M. Valent, DO, and her colleagues reported (JAMA. 2017;318[11]:1026-34). However, the authors noted, “tests for interaction between the intact membranes and [ruptured] subgroups and postpartum cephalexin-metronidazole were not statistically different and should not be interpreted as showing a difference in significance or effect size among the subgroups with and without [rupture].”
The trial comprised 403 obese women who had a cesarean delivery. They were a mean of 28 years old. The mean body mass index was 40 kg/m2, and the mean subcutaneous adipose tissue thickness was about 3.4 cm. About a third of each treatment group was positive for Group B streptococcus; 31% had ruptured membranes at the onset of labor. More than 60% of women in both groups had a scheduled cesarean delivery.
All women had standard preoperative care, including skin prep with a chlorhexidine or povidone-iodine cleansing and an intravenous infusion of 2 g cefazolin. After delivery, they were randomized to placebo or to oral cephalexin 500 mg plus metronidazole 500 mg every 8 hours for 48 hours. The primary outcome was surgical site infection incidence within 30 days.
The overall rate of surgical site infection was 10.9% (44 women). Infections developed in 13 women in the active group and 31 in the placebo group (6.4% vs. 15.4%) – a significant difference, translating to a 59% risk reduction (relative risk, 0.41). Cellulitis was the only secondary outcome that was significantly reduced by prophylactic antibiotics, with infections occurring in 5.9% of the metronidazole-cephalexin group vs. 13.4% of the placebo group (RR, 0.44). The antibiotic regimen didn’t affect the other secondary endpoints, which included rates of incisional morbidity, endometritis, fever of unknown etiology, and wound separation.
The authors conducted a post-hoc analysis to examine the antibiotics’ effects on women who had ruptured and intact membranes at the time of delivery. The benefit was greatest among those with ruptured membranes. There were six infections among the active group and 19 among the placebo group (9.5% vs. 30.2%). This difference translated to a relative risk of 0.31 – a 69% risk reduction.
Among women with intact membranes, there were seven infections in the active group and 12 in the placebo group (5% vs. 8.7%). This translated to a 0.58 relative risk, which was not statistically significant.
“Interaction testing was performed between study groups (cephalexin-metronidazole vs. placebo) and by membrane status (intact vs. ruptured),” the authors noted. “The rate of surgical site infection was highest in those with [ruptured membranes] who received placebo (30.2%) and lowest in those with intact membranes who received antibiotics (5.0%), but the test for interaction did not show statistical significance at P = .30.”
There were no serious adverse events or allergic reactions reported for cephalexin or metronidazole. The authors noted that both drugs are excreted into breast milk in small amounts, but that no study has ever linked them with neonatal harm through breast milk exposure. However, they added, “Long-term childhood or adverse neonatal outcomes specific to cephalexin-metronidazole exposure cannot be determined, as outcome measures were not evaluated for this study protocol. Recognizing the maternal and neonatal benefit of breastfeeding, the lack of known neonatal adverse effects, and maternal reduction in [surgical site infection], the benefit of this antibiotic regimen likely outweighs the theoretical risks of breast milk exposure in the obese population.”
The University of Cincinnati Department of Obstetrics and Gynecology sponsored the trial. None of the authors reported any financial conflicts.
FROM JAMA
Key clinical point:
Major finding: Infections developed in 13 women in the active group and 31 in the placebo group (6.4% vs. 15.4%) – a significant difference, translating to a 59% risk reduction (relative risk, 0.41).
Data source: The randomized, placebo-controlled study comprised 403 women.
Disclosures: The University of Cincinnati Department of Obstetrics and Gynecology sponsored the study. None of the authors reported any financial conflicts.
PHM17 session summary: Career Development (K Award) grants
Session
Career Development (K Award) grants: What are they, why should I apply, and how do I get funded?
Presenters
Christopher Bonafide, MD, MSCE; Patrick Brady, MD, MS; Kavita Parikh, MD, MSHS; Raj Srivastava, MD, MPH, SFHM; Derek Williams, MD, MPH
Session Summary
Pediatric hospital medicine, in its relative infancy, is attracting a cohort of academicians dedicated to advancing the care of hospitalized children. While other pediatric subspecialties have long reserved a significant proportion of fellowship training for research, pediatric hospitalist research has instead developed from the work of scholarly pioneers in the industry.
More colloquially known as K Awards, NIH Career Development Awards exist to financially support early-career clinical, translational, and basic science investigators through a closely mentored career development and research plan. The result? A mutually beneficial initiative lasting 3-5 years aligning the interests of the early-career investigator, hosting institution, and NIH. The realm of grant funding is confusing and can be intimidating, particularly for early-career investigators in a rapidly growing field of practice. Presenters at this session addressed the stigma of applying for K awards head on.
Who should apply for an NIH Career Development Award?
Competitive applicants for a Career Development Award are ideally interested in embarking on a career dedicated to research of some type, although exactly what that entails can and certainly may change over time.
What does the NIH Career Development Award provide?
The award funds a significant portion of your salary to provide protected time dedicated to your research and career development. Removing this financial barrier allows the investigator to become fully immersed in maturation as an independent investigator. The presenters were quick to caution that applicants (along with department and division chairs) should be aware that the award does not cover your entire salary; early-career investigators truly need dedication from their department and/or division to be successful.
Why apply for an NIH Career Development Award?
Clinical, translational, and basic science research takes time to complete, and the skills needed to be a successful investigator are not intuitive. Rather, they require close mentorship and practice. A career development award organizes and prioritizes an early-career investigator’s approach to obtaining research independence. Applying for an NIH Career Development Award helps identify the applicant’s experiential and knowledge gaps and, more importantly, develops a plan for how these deficits will be addressed over the course of the research project. This formative process ideally allows the early-career investigator to be more competitive in seeking larger grant funding.
Interested in pursuing a career development award? Dr. Bonafide and Dr. Srivastava offered the valuable advice that an applicant’s proposed research is only part of the equation for funding success. Equally important is your ability to identify your weaknesses as they pertain to research (and how you will address these weaknesses) as well as to find your mentorship team. You and your fellow awardees should surround yourselves with mentors who will address specific needs, which, in some circumstances, may require creativity and collaboration to augment the experience gained from others.
Key takeaway for PHM
As we recognize the growing complexities of caring for the hospitalized child, opportunities for clinical, translational, and basic science are expanding rapidly. Embracing the benefits of formalizing your research training early can lead to a successful and satisfying academic career in the long term.
Dr. Morrison is a Pediatric Hospital Medicine Fellow at Johns Hopkins All Children’s Hospital, St. Petersburg, Fla.
Session
Career Development (K Award) grants: What are they, why should I apply, and how do I get funded?
Presenters
Christopher Bonafide, MD, MSCE; Patrick Brady, MD, MS; Kavita Parikh, MD, MSHS; Raj Srivastava, MD, MPH, SFHM; Derek Williams, MD, MPH
Session Summary
Pediatric hospital medicine, in its relative infancy, is attracting a cohort of academicians dedicated to advancing the care of hospitalized children. While other pediatric subspecialties have long reserved a significant proportion of fellowship training for research, pediatric hospitalist research has instead developed from the work of scholarly pioneers in the industry.
More colloquially known as K Awards, NIH Career Development Awards exist to financially support early-career clinical, translational, and basic science investigators through a closely mentored career development and research plan. The result? A mutually beneficial initiative lasting 3-5 years aligning the interests of the early-career investigator, hosting institution, and NIH. The realm of grant funding is confusing and can be intimidating, particularly for early-career investigators in a rapidly growing field of practice. Presenters at this session addressed the stigma of applying for K awards head on.
Who should apply for an NIH Career Development Award?
Competitive applicants for a Career Development Award are ideally interested in embarking on a career dedicated to research of some type, although exactly what that entails can and certainly may change over time.
What does the NIH Career Development Award provide?
The award funds a significant portion of your salary to provide protected time dedicated to your research and career development. Removing this financial barrier allows the investigator to become fully immersed in maturation as an independent investigator. The presenters were quick to caution that applicants (along with department and division chairs) should be aware that the award does not cover your entire salary; early-career investigators truly need dedication from their department and/or division to be successful.
Why apply for an NIH Career Development Award?
Clinical, translational, and basic science research takes time to complete, and the skills needed to be a successful investigator are not intuitive. Rather, they require close mentorship and practice. A career development award organizes and prioritizes an early-career investigator’s approach to obtaining research independence. Applying for an NIH Career Development Award helps identify the applicant’s experiential and knowledge gaps and, more importantly, develops a plan for how these deficits will be addressed over the course of the research project. This formative process ideally allows the early-career investigator to be more competitive in seeking larger grant funding.
Interested in pursuing a career development award? Dr. Bonafide and Dr. Srivastava offered the valuable advice that an applicant’s proposed research is only part of the equation for funding success. Equally important is your ability to identify your weaknesses as they pertain to research (and how you will address these weaknesses) as well as to find your mentorship team. You and your fellow awardees should surround yourselves with mentors who will address specific needs, which, in some circumstances, may require creativity and collaboration to augment the experience gained from others.
Key takeaway for PHM
As we recognize the growing complexities of caring for the hospitalized child, opportunities for clinical, translational, and basic science are expanding rapidly. Embracing the benefits of formalizing your research training early can lead to a successful and satisfying academic career in the long term.
Dr. Morrison is a Pediatric Hospital Medicine Fellow at Johns Hopkins All Children’s Hospital, St. Petersburg, Fla.
Session
Career Development (K Award) grants: What are they, why should I apply, and how do I get funded?
Presenters
Christopher Bonafide, MD, MSCE; Patrick Brady, MD, MS; Kavita Parikh, MD, MSHS; Raj Srivastava, MD, MPH, SFHM; Derek Williams, MD, MPH
Session Summary
Pediatric hospital medicine, in its relative infancy, is attracting a cohort of academicians dedicated to advancing the care of hospitalized children. While other pediatric subspecialties have long reserved a significant proportion of fellowship training for research, pediatric hospitalist research has instead developed from the work of scholarly pioneers in the industry.
More colloquially known as K Awards, NIH Career Development Awards exist to financially support early-career clinical, translational, and basic science investigators through a closely mentored career development and research plan. The result? A mutually beneficial initiative lasting 3-5 years aligning the interests of the early-career investigator, hosting institution, and NIH. The realm of grant funding is confusing and can be intimidating, particularly for early-career investigators in a rapidly growing field of practice. Presenters at this session addressed the stigma of applying for K awards head on.
Who should apply for an NIH Career Development Award?
Competitive applicants for a Career Development Award are ideally interested in embarking on a career dedicated to research of some type, although exactly what that entails can and certainly may change over time.
What does the NIH Career Development Award provide?
The award funds a significant portion of your salary to provide protected time dedicated to your research and career development. Removing this financial barrier allows the investigator to become fully immersed in maturation as an independent investigator. The presenters were quick to caution that applicants (along with department and division chairs) should be aware that the award does not cover your entire salary; early-career investigators truly need dedication from their department and/or division to be successful.
Why apply for an NIH Career Development Award?
Clinical, translational, and basic science research takes time to complete, and the skills needed to be a successful investigator are not intuitive. Rather, they require close mentorship and practice. A career development award organizes and prioritizes an early-career investigator’s approach to obtaining research independence. Applying for an NIH Career Development Award helps identify the applicant’s experiential and knowledge gaps and, more importantly, develops a plan for how these deficits will be addressed over the course of the research project. This formative process ideally allows the early-career investigator to be more competitive in seeking larger grant funding.
Interested in pursuing a career development award? Dr. Bonafide and Dr. Srivastava offered the valuable advice that an applicant’s proposed research is only part of the equation for funding success. Equally important is your ability to identify your weaknesses as they pertain to research (and how you will address these weaknesses) as well as to find your mentorship team. You and your fellow awardees should surround yourselves with mentors who will address specific needs, which, in some circumstances, may require creativity and collaboration to augment the experience gained from others.
Key takeaway for PHM
As we recognize the growing complexities of caring for the hospitalized child, opportunities for clinical, translational, and basic science are expanding rapidly. Embracing the benefits of formalizing your research training early can lead to a successful and satisfying academic career in the long term.
Dr. Morrison is a Pediatric Hospital Medicine Fellow at Johns Hopkins All Children’s Hospital, St. Petersburg, Fla.