Richard Mark Kirkner

FORT LAUDERDALE, FLA. – Hip joint pain and deterioration can be a painful and disabling outcome for patients with sickle cell disease, but femoral head core decompression with the addition of bone marrow aspirate concentrate decreases their pain and may help avoid or delay hip replacement, according to results of a pilot study presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

Eric Fornari, MD, of the Children’s Hospital at Montefiore in Bronx, N.Y., reported on results of core decompression (CD) in 35 hips of 26 sickle cell patients; 17 underwent CD only and 18 had CD with injection of bone marrow aspirate concentrate (CD+BMAC). The average patient age was 24.3 years, with a range from 9.7-50.7 years.

“Compared to patients treated with CD alone, patients treated with CD+BMAC complained of significantly less pain and had significant improvement in their functional scores and patient-related outcomes at short-term follow-up,” Dr. Fornari said.

Among the CD+BMAC patients, pain scores declined two points on average, from 6 preoperatively to 4 postoperatively, he said. This was clinically significant, compared with the CD-only group, Dr. Fornari said.

Patients in the CD+BMAC group also reported consistently superior hip outcome and modified Harris hip scores. With either treatment, more than 90% of patients were pain-free and walked independently at their most recent follow-up, he said.

The objective of CD is to relieve pressure within the head of the femur, stimulate vascularity and target the avascular necrosis (AVN) lesion within the head that is visible on imaging. To get the bone marrow aspirate concentrate, Dr. Fornari extracts 120 cc of bone marrow from the iliac crest, then concentrates it to 12 cc. The same instrument is used to tap into the femoral head and inject the bone marrow aspirate concentrate. The study looked at clinical and radiographic outcomes of treated patients.

Average follow-up for the entire study population was 3.6 years, but that varied widely between the two groups (CD-only at almost 6 years, CD+BMAC at 1.4 years) because CD+BMAC has only been done for the last 3 years, Dr. Fornari said.

Progression to total hip arthroplasty (THA) was similar between both groups: 5 of 17 patients (29%) for CD-only vs. 4 of 18 patients (22%) for CD+BMAC (P = .711).

“When you look at progression, there were a number of hips that got CD or CD+BMAC and were better postoperatively; they went from a Ficat score of stage II to a stage I, or stage III to stage II,” he said.

X-rays were not always a reliable marker of outcome after either CD procedure, Dr. Fornari noted. “I’ve seen patients who’ve had terrible looking X-rays who have no pain, and patients who have totally normal X-rays that are completely debilitated,” he said. “We have to start asking ourselves, ‘What is the marker of success?’ because when we do this patients are feeling better.”

Multivariate analysis was used to identify factors predictive of progression to THA after the procedure, Dr. Fornari said. “Age of diagnosis, age of surgery, female gender, and lower hydroxyurea dose at surgery were predictive of advancing disease, whereas a higher dose of hydroxyurea was predictive against advancement,” he said.

The average age of patients who had no THA after either procedure was 21 years, compared with 33.9 years for those who had THA (P = .003). Average hydroxyurea dose at surgery was 24.7 mg/kg in the no-THA group vs. 12.5 mg/kg in those who had THA (P = .005).

Notably, there were no readmissions, fractures, deep vein thromboses, pulmonary embolisms or infarctions after CD, Dr. Fornari said. Transfusions were required in two CD-only and three CD+BMAC patients. Hospitalization rates for vaso-occlusive crisis were similar between groups (P = .103).

Dr. Fornari said the challenge is to identify suitable patients for these procedures. “These are complicated patients and you don’t want to put them through the process of having surgery, putting them on crutches and restricted weight bearing, if they’re not going to get better,” he said. “This procedure done minimally invasively is not the end all and be all, but we have to figure out who are the right patients for it. Patient selection is key.”

Finding those patients starts with a rigorous history and physical exam, he said. Physicians should have a “low threshold” for MRI in these patients because that will reveal findings, such as pre-collapse disease and characteristic of AVN lesions, that may appear normal on X-ray. Patient education is also important. “To think that an injection into the top of the hip is going to solve all their problems is a little naive, so you have to have an honest conversation with the patient,” he said.

Dr. Fornari reported having no financial disclosures.

SOURCE: Fornari ED et al. FSCDR 2019, Abstract JSCDH-D-19-00004.

FORT LAUDERDALE, FLA. – Hip joint pain and deterioration can be a painful and disabling outcome for patients with sickle cell disease, but femoral head core decompression with the addition of bone marrow aspirate concentrate decreases their pain and may help avoid or delay hip replacement, according to results of a pilot study presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

Eric Fornari, MD, of the Children’s Hospital at Montefiore in Bronx, N.Y., reported on results of core decompression (CD) in 35 hips of 26 sickle cell patients; 17 underwent CD only and 18 had CD with injection of bone marrow aspirate concentrate (CD+BMAC). The average patient age was 24.3 years, with a range from 9.7-50.7 years.

“Compared to patients treated with CD alone, patients treated with CD+BMAC complained of significantly less pain and had significant improvement in their functional scores and patient-related outcomes at short-term follow-up,” Dr. Fornari said.

Among the CD+BMAC patients, pain scores declined two points on average, from 6 preoperatively to 4 postoperatively, he said. This was clinically significant, compared with the CD-only group, Dr. Fornari said.

Patients in the CD+BMAC group also reported consistently superior hip outcome and modified Harris hip scores. With either treatment, more than 90% of patients were pain-free and walked independently at their most recent follow-up, he said.

The objective of CD is to relieve pressure within the head of the femur, stimulate vascularity and target the avascular necrosis (AVN) lesion within the head that is visible on imaging. To get the bone marrow aspirate concentrate, Dr. Fornari extracts 120 cc of bone marrow from the iliac crest, then concentrates it to 12 cc. The same instrument is used to tap into the femoral head and inject the bone marrow aspirate concentrate. The study looked at clinical and radiographic outcomes of treated patients.

Average follow-up for the entire study population was 3.6 years, but that varied widely between the two groups (CD-only at almost 6 years, CD+BMAC at 1.4 years) because CD+BMAC has only been done for the last 3 years, Dr. Fornari said.

Progression to total hip arthroplasty (THA) was similar between both groups: 5 of 17 patients (29%) for CD-only vs. 4 of 18 patients (22%) for CD+BMAC (P = .711).

“When you look at progression, there were a number of hips that got CD or CD+BMAC and were better postoperatively; they went from a Ficat score of stage II to a stage I, or stage III to stage II,” he said.

X-rays were not always a reliable marker of outcome after either CD procedure, Dr. Fornari noted. “I’ve seen patients who’ve had terrible looking X-rays who have no pain, and patients who have totally normal X-rays that are completely debilitated,” he said. “We have to start asking ourselves, ‘What is the marker of success?’ because when we do this patients are feeling better.”

Multivariate analysis was used to identify factors predictive of progression to THA after the procedure, Dr. Fornari said. “Age of diagnosis, age of surgery, female gender, and lower hydroxyurea dose at surgery were predictive of advancing disease, whereas a higher dose of hydroxyurea was predictive against advancement,” he said.

The average age of patients who had no THA after either procedure was 21 years, compared with 33.9 years for those who had THA (P = .003). Average hydroxyurea dose at surgery was 24.7 mg/kg in the no-THA group vs. 12.5 mg/kg in those who had THA (P = .005).

Notably, there were no readmissions, fractures, deep vein thromboses, pulmonary embolisms or infarctions after CD, Dr. Fornari said. Transfusions were required in two CD-only and three CD+BMAC patients. Hospitalization rates for vaso-occlusive crisis were similar between groups (P = .103).

Dr. Fornari said the challenge is to identify suitable patients for these procedures. “These are complicated patients and you don’t want to put them through the process of having surgery, putting them on crutches and restricted weight bearing, if they’re not going to get better,” he said. “This procedure done minimally invasively is not the end all and be all, but we have to figure out who are the right patients for it. Patient selection is key.”

Finding those patients starts with a rigorous history and physical exam, he said. Physicians should have a “low threshold” for MRI in these patients because that will reveal findings, such as pre-collapse disease and characteristic of AVN lesions, that may appear normal on X-ray. Patient education is also important. “To think that an injection into the top of the hip is going to solve all their problems is a little naive, so you have to have an honest conversation with the patient,” he said.

Dr. Fornari reported having no financial disclosures.

SOURCE: Fornari ED et al. FSCDR 2019, Abstract JSCDH-D-19-00004.

FORT LAUDERDALE, FLA. – Hip joint pain and deterioration can be a painful and disabling outcome for patients with sickle cell disease, but femoral head core decompression with the addition of bone marrow aspirate concentrate decreases their pain and may help avoid or delay hip replacement, according to results of a pilot study presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

Eric Fornari, MD, of the Children’s Hospital at Montefiore in Bronx, N.Y., reported on results of core decompression (CD) in 35 hips of 26 sickle cell patients; 17 underwent CD only and 18 had CD with injection of bone marrow aspirate concentrate (CD+BMAC). The average patient age was 24.3 years, with a range from 9.7-50.7 years.

“Compared to patients treated with CD alone, patients treated with CD+BMAC complained of significantly less pain and had significant improvement in their functional scores and patient-related outcomes at short-term follow-up,” Dr. Fornari said.

Among the CD+BMAC patients, pain scores declined two points on average, from 6 preoperatively to 4 postoperatively, he said. This was clinically significant, compared with the CD-only group, Dr. Fornari said.

Patients in the CD+BMAC group also reported consistently superior hip outcome and modified Harris hip scores. With either treatment, more than 90% of patients were pain-free and walked independently at their most recent follow-up, he said.

The objective of CD is to relieve pressure within the head of the femur, stimulate vascularity and target the avascular necrosis (AVN) lesion within the head that is visible on imaging. To get the bone marrow aspirate concentrate, Dr. Fornari extracts 120 cc of bone marrow from the iliac crest, then concentrates it to 12 cc. The same instrument is used to tap into the femoral head and inject the bone marrow aspirate concentrate. The study looked at clinical and radiographic outcomes of treated patients.

Average follow-up for the entire study population was 3.6 years, but that varied widely between the two groups (CD-only at almost 6 years, CD+BMAC at 1.4 years) because CD+BMAC has only been done for the last 3 years, Dr. Fornari said.

Progression to total hip arthroplasty (THA) was similar between both groups: 5 of 17 patients (29%) for CD-only vs. 4 of 18 patients (22%) for CD+BMAC (P = .711).

“When you look at progression, there were a number of hips that got CD or CD+BMAC and were better postoperatively; they went from a Ficat score of stage II to a stage I, or stage III to stage II,” he said.

X-rays were not always a reliable marker of outcome after either CD procedure, Dr. Fornari noted. “I’ve seen patients who’ve had terrible looking X-rays who have no pain, and patients who have totally normal X-rays that are completely debilitated,” he said. “We have to start asking ourselves, ‘What is the marker of success?’ because when we do this patients are feeling better.”

Multivariate analysis was used to identify factors predictive of progression to THA after the procedure, Dr. Fornari said. “Age of diagnosis, age of surgery, female gender, and lower hydroxyurea dose at surgery were predictive of advancing disease, whereas a higher dose of hydroxyurea was predictive against advancement,” he said.

The average age of patients who had no THA after either procedure was 21 years, compared with 33.9 years for those who had THA (P = .003). Average hydroxyurea dose at surgery was 24.7 mg/kg in the no-THA group vs. 12.5 mg/kg in those who had THA (P = .005).

Notably, there were no readmissions, fractures, deep vein thromboses, pulmonary embolisms or infarctions after CD, Dr. Fornari said. Transfusions were required in two CD-only and three CD+BMAC patients. Hospitalization rates for vaso-occlusive crisis were similar between groups (P = .103).

Dr. Fornari said the challenge is to identify suitable patients for these procedures. “These are complicated patients and you don’t want to put them through the process of having surgery, putting them on crutches and restricted weight bearing, if they’re not going to get better,” he said. “This procedure done minimally invasively is not the end all and be all, but we have to figure out who are the right patients for it. Patient selection is key.”

Finding those patients starts with a rigorous history and physical exam, he said. Physicians should have a “low threshold” for MRI in these patients because that will reveal findings, such as pre-collapse disease and characteristic of AVN lesions, that may appear normal on X-ray. Patient education is also important. “To think that an injection into the top of the hip is going to solve all their problems is a little naive, so you have to have an honest conversation with the patient,” he said.

Dr. Fornari reported having no financial disclosures.

SOURCE: Fornari ED et al. FSCDR 2019, Abstract JSCDH-D-19-00004.

FORT LAUDERDALE, FLA. – Orthopedic crises are common in patients with sickle cell disease, ranging from osteonecrosis to bone infarction, and physicians who manage these patients should know how to recognize these crises and not hesitate to consult an orthopedic surgeon early on, according to one expert at the annual meeting of the Foundation for Sickle Cell Disease Research.

Richard Mark Kirkner/MDedge News

“Sickle cell is a common entity in orthopedic surgery, so you shouldn’t hesitate in the hospital or outpatient settings to call for an orthopedic surgeon when you’re dealing with acute pain crises, medullary infarcts, and osteonecrosis,” said Mark W. Bridges, MD, an orthopedic surgeon with Orthopaedic Associates in Southern Florida.

Dr. Bridges noted that the femoral head is the most common location for osteonecrosis, one of the four major orthopedic manifestations of sickle cell disease that he reviewed. The others are septic arthritis, osteomyelitis, and bone infarction.

“Bone infarction is more common than osteomyelitis, and gadolinium-enhanced MRI can help to differentiate the two,” he said.

Osteonecrosis occurs when ischemic cells die, weakening the subchondral bone. Besides the femoral head, osteonecrosis commonly affects the humeral head of the shoulder and the femoral condyles of the knee. Dr. Bridges reviewed the five stages of the Ficat and Arlet classification of osteonecrosis:

• 0 – no pain, normal x-rays.
• I – pain, normal x-rays but abnormal MRI.
• II – pain, abnormal x-ray (sclerosis without collapse).
• III – pain (subchondral collapse without joint degeneration).
• IV – pain (arthritic changes with subchondral collapse).

For osteonecrosis of the shoulder, Dr. Bridges said four surgical options exist: core decompression for stages I and II; humeral head resurfacing for stages II and III; and hemiarthroplasty or total shoulder replacement for stages III and IV.

“No medical therapies are known to slow the progression,” he said.

Total joint replacement can be inevitable in these patients when total collapse of the joint occurs, but Dr. Bridges added a word of caution. “Overall when it comes down to replacing joints, there are more complications in patients that have [sickle cell disease],” he said. “Normally the complication rate is about 1%; that typically goes up to about 10% in SCD patients, but when you have a patient with end-stage disease – shoulder collapse or hip collapse – you have to do something.”

Septic arthritis is an infection within the joint space, most commonly the hip, and it affects 5% of children and 0.3% of adults with sickle cell disease (Clin Orthop Relat Res. 2010;468:1676-81).

“This is very similar to a vaso-occlusive crisis,” Dr. Bridges said.

MRI with gadolinium can help guide treatment, and blood cultures and joint aspiration can identify the infectious microbe. Staphylococcus aureus is the most common, Dr. Bridges said. Treatment consists of IV antibiotics, irrigation, and debridement.

Osteomyelitis is an infection within the bone with symptoms similar to those of septic arthritis, although osteomyelitis patients are typically sicker, he said. MRI with gadolinium is indicated in patients who don’t respond to IV fluid, oxygenation, and nonsteroidal anti-inflammatory drugs. “Try to treat them like they have vaso-occlusive crisis,” he said. Blood cultures usually suffice in these patients; bone aspiration is rarely needed, Dr. Bridges said.

The most common organisms are Staphylococcus aureus and Salmonella, and sickle cell disease patients can have infections in more than one location, Dr. Bridges noted.

“If IV antibiotics don’t work, then these patients need surgical debridement,” he added.

Adults are prone to a higher rate of complications than are children, including joint stiffness, osteonecrosis, pathologic fracture, and chronic osteomyelitis.

Ischemic marrow from vaso-occlusion can result in bone infarction. With its severe pain, swelling, erythema, and loss of motion, bone infarction can appear similar to osteomyelitis and septic arthritis, although a high-grade fever is uncommon in bone infarction. Unlike osteomyelitis, gadolinium on MRI does not enhance in bone infarction.

Treatment “consists of supportive management with pain medications, hydration, and antibiotics until osteomyelitis is ruled out,” Dr. Bridges said.

When a patient with one of these orthopedic conditions needs surgery, there are three considerations: preoperative transfusions to achieve hemoglobin level of 10 mg/dL for major procedures; no transfusions for arthroscopy and small closed reductions; and postoperative oxygenation and hydration to prevent a vaso-occlusive event and acute chest syndrome, he said.

Dr. Bridges reported having no conflicts of interest.

FORT LAUDERDALE, FLA. – Orthopedic crises are common in patients with sickle cell disease, ranging from osteonecrosis to bone infarction, and physicians who manage these patients should know how to recognize these crises and not hesitate to consult an orthopedic surgeon early on, according to one expert at the annual meeting of the Foundation for Sickle Cell Disease Research.

Richard Mark Kirkner/MDedge News

“Sickle cell is a common entity in orthopedic surgery, so you shouldn’t hesitate in the hospital or outpatient settings to call for an orthopedic surgeon when you’re dealing with acute pain crises, medullary infarcts, and osteonecrosis,” said Mark W. Bridges, MD, an orthopedic surgeon with Orthopaedic Associates in Southern Florida.

Dr. Bridges noted that the femoral head is the most common location for osteonecrosis, one of the four major orthopedic manifestations of sickle cell disease that he reviewed. The others are septic arthritis, osteomyelitis, and bone infarction.

“Bone infarction is more common than osteomyelitis, and gadolinium-enhanced MRI can help to differentiate the two,” he said.

Osteonecrosis occurs when ischemic cells die, weakening the subchondral bone. Besides the femoral head, osteonecrosis commonly affects the humeral head of the shoulder and the femoral condyles of the knee. Dr. Bridges reviewed the five stages of the Ficat and Arlet classification of osteonecrosis:

• 0 – no pain, normal x-rays.
• I – pain, normal x-rays but abnormal MRI.
• II – pain, abnormal x-ray (sclerosis without collapse).
• III – pain (subchondral collapse without joint degeneration).
• IV – pain (arthritic changes with subchondral collapse).

For osteonecrosis of the shoulder, Dr. Bridges said four surgical options exist: core decompression for stages I and II; humeral head resurfacing for stages II and III; and hemiarthroplasty or total shoulder replacement for stages III and IV.

“No medical therapies are known to slow the progression,” he said.

Total joint replacement can be inevitable in these patients when total collapse of the joint occurs, but Dr. Bridges added a word of caution. “Overall when it comes down to replacing joints, there are more complications in patients that have [sickle cell disease],” he said. “Normally the complication rate is about 1%; that typically goes up to about 10% in SCD patients, but when you have a patient with end-stage disease – shoulder collapse or hip collapse – you have to do something.”

Septic arthritis is an infection within the joint space, most commonly the hip, and it affects 5% of children and 0.3% of adults with sickle cell disease (Clin Orthop Relat Res. 2010;468:1676-81).

“This is very similar to a vaso-occlusive crisis,” Dr. Bridges said.

MRI with gadolinium can help guide treatment, and blood cultures and joint aspiration can identify the infectious microbe. Staphylococcus aureus is the most common, Dr. Bridges said. Treatment consists of IV antibiotics, irrigation, and debridement.

Osteomyelitis is an infection within the bone with symptoms similar to those of septic arthritis, although osteomyelitis patients are typically sicker, he said. MRI with gadolinium is indicated in patients who don’t respond to IV fluid, oxygenation, and nonsteroidal anti-inflammatory drugs. “Try to treat them like they have vaso-occlusive crisis,” he said. Blood cultures usually suffice in these patients; bone aspiration is rarely needed, Dr. Bridges said.

The most common organisms are Staphylococcus aureus and Salmonella, and sickle cell disease patients can have infections in more than one location, Dr. Bridges noted.

“If IV antibiotics don’t work, then these patients need surgical debridement,” he added.

Adults are prone to a higher rate of complications than are children, including joint stiffness, osteonecrosis, pathologic fracture, and chronic osteomyelitis.

Ischemic marrow from vaso-occlusion can result in bone infarction. With its severe pain, swelling, erythema, and loss of motion, bone infarction can appear similar to osteomyelitis and septic arthritis, although a high-grade fever is uncommon in bone infarction. Unlike osteomyelitis, gadolinium on MRI does not enhance in bone infarction.

Treatment “consists of supportive management with pain medications, hydration, and antibiotics until osteomyelitis is ruled out,” Dr. Bridges said.

When a patient with one of these orthopedic conditions needs surgery, there are three considerations: preoperative transfusions to achieve hemoglobin level of 10 mg/dL for major procedures; no transfusions for arthroscopy and small closed reductions; and postoperative oxygenation and hydration to prevent a vaso-occlusive event and acute chest syndrome, he said.

Dr. Bridges reported having no conflicts of interest.

FORT LAUDERDALE, FLA. – Orthopedic crises are common in patients with sickle cell disease, ranging from osteonecrosis to bone infarction, and physicians who manage these patients should know how to recognize these crises and not hesitate to consult an orthopedic surgeon early on, according to one expert at the annual meeting of the Foundation for Sickle Cell Disease Research.

Richard Mark Kirkner/MDedge News

“Sickle cell is a common entity in orthopedic surgery, so you shouldn’t hesitate in the hospital or outpatient settings to call for an orthopedic surgeon when you’re dealing with acute pain crises, medullary infarcts, and osteonecrosis,” said Mark W. Bridges, MD, an orthopedic surgeon with Orthopaedic Associates in Southern Florida.

Dr. Bridges noted that the femoral head is the most common location for osteonecrosis, one of the four major orthopedic manifestations of sickle cell disease that he reviewed. The others are septic arthritis, osteomyelitis, and bone infarction.

“Bone infarction is more common than osteomyelitis, and gadolinium-enhanced MRI can help to differentiate the two,” he said.

Osteonecrosis occurs when ischemic cells die, weakening the subchondral bone. Besides the femoral head, osteonecrosis commonly affects the humeral head of the shoulder and the femoral condyles of the knee. Dr. Bridges reviewed the five stages of the Ficat and Arlet classification of osteonecrosis:

• 0 – no pain, normal x-rays.
• I – pain, normal x-rays but abnormal MRI.
• II – pain, abnormal x-ray (sclerosis without collapse).
• III – pain (subchondral collapse without joint degeneration).
• IV – pain (arthritic changes with subchondral collapse).

For osteonecrosis of the shoulder, Dr. Bridges said four surgical options exist: core decompression for stages I and II; humeral head resurfacing for stages II and III; and hemiarthroplasty or total shoulder replacement for stages III and IV.

“No medical therapies are known to slow the progression,” he said.

Total joint replacement can be inevitable in these patients when total collapse of the joint occurs, but Dr. Bridges added a word of caution. “Overall when it comes down to replacing joints, there are more complications in patients that have [sickle cell disease],” he said. “Normally the complication rate is about 1%; that typically goes up to about 10% in SCD patients, but when you have a patient with end-stage disease – shoulder collapse or hip collapse – you have to do something.”

Septic arthritis is an infection within the joint space, most commonly the hip, and it affects 5% of children and 0.3% of adults with sickle cell disease (Clin Orthop Relat Res. 2010;468:1676-81).

“This is very similar to a vaso-occlusive crisis,” Dr. Bridges said.

MRI with gadolinium can help guide treatment, and blood cultures and joint aspiration can identify the infectious microbe. Staphylococcus aureus is the most common, Dr. Bridges said. Treatment consists of IV antibiotics, irrigation, and debridement.

Osteomyelitis is an infection within the bone with symptoms similar to those of septic arthritis, although osteomyelitis patients are typically sicker, he said. MRI with gadolinium is indicated in patients who don’t respond to IV fluid, oxygenation, and nonsteroidal anti-inflammatory drugs. “Try to treat them like they have vaso-occlusive crisis,” he said. Blood cultures usually suffice in these patients; bone aspiration is rarely needed, Dr. Bridges said.

The most common organisms are Staphylococcus aureus and Salmonella, and sickle cell disease patients can have infections in more than one location, Dr. Bridges noted.

“If IV antibiotics don’t work, then these patients need surgical debridement,” he added.

Adults are prone to a higher rate of complications than are children, including joint stiffness, osteonecrosis, pathologic fracture, and chronic osteomyelitis.

Ischemic marrow from vaso-occlusion can result in bone infarction. With its severe pain, swelling, erythema, and loss of motion, bone infarction can appear similar to osteomyelitis and septic arthritis, although a high-grade fever is uncommon in bone infarction. Unlike osteomyelitis, gadolinium on MRI does not enhance in bone infarction.

Treatment “consists of supportive management with pain medications, hydration, and antibiotics until osteomyelitis is ruled out,” Dr. Bridges said.

When a patient with one of these orthopedic conditions needs surgery, there are three considerations: preoperative transfusions to achieve hemoglobin level of 10 mg/dL for major procedures; no transfusions for arthroscopy and small closed reductions; and postoperative oxygenation and hydration to prevent a vaso-occlusive event and acute chest syndrome, he said.

Dr. Bridges reported having no conflicts of interest.

FORT LAUDERDALE, FLA. – When the Food and Drug Administration in 2017 approved L-glutamine (Endari) to treat the symptoms of sickle cell disease (SCD), it was the first new drug indicated for the condition in nearly two decades. But a small study of sickle cell patients in New York has found that patients are having difficulty obtaining the drug and sticking to the regimen.

bubaone/DigitalVision Vectors

“We found out that there are multiple barriers, mostly insurance related, and that after 10 months only one-fifth of the patients were still actively taking this medication,” said Ugochi Ogu, MD, assistant director of the Sickle Cell Center for Adults at Montefiore Medical Center in New York. She presented preliminary study results at the annual meeting of the Foundation for Sickle Cell Disease Research.

L-glutamine oral powder is taken twice a day to treat the symptoms of SCD. GoodRx reports that the average cash price for a 60-day supply of L-glutamine is $2,773.

The study followed 101 patients prescribed L-glutamine at the Montefiore Medical Center. When they returned to the clinic, patients were asked about barriers to obtaining the medication and adherence to the twice-a-day dosing. The center used a nearby local specialty pharmacy to fill the prescriptions.

The study also evaluated adherence by calculating the mean possession ratio (MPR) utilizing pharmacy records. The average age of the patient population was 36 years, and 56% were women.

It’s the first study of L-glutamine barriers and adherence in SCD patients in the real-world setting, Dr. Ogu said.

At the end of the 10-month study period, 21% of the patients were actively taking the medication, she said. “Forty-three percent had discontinued the medication, and 33% never filled the prescriptions; 4% had received but never started Endari,” Dr. Ogu said.

Of the patients who never filled the prescriptions, Dr. Ogu reported that 27% said their insurer denied prior authorization, 19% said their deductible was too high, and 16% cited other insurance issues.

“So we can see that insurance alone accounted for over 60% of why patients did not receive or could not start the medication,” she said.

Most patients – 94% – either had Medicare or Medicaid; the remainder had private insurance.

Among the 43% of all study patients who stopped taking the medication, reasons given include poor adherence (47%), side effects (9%), pregnancy and breast feeding (5%), and no perceived benefit (5%), Dr. Ogu said. At the outset, pharmacy records estimated adherence at 74% by using the average MPR, a rate similar to the phase 3 trial adherence rate of 77.4%.

Patient education is important to eliminate these barriers to treatment for SCD, Dr. Ogu said. “The patients need to understand why they’re taking whatever medication you prescribe. We need to educate them about the side effects, and we need to make them understand why it’s important to take certain medications or how they’re going to help them,” she said.

But even more important, she added, is a systems-based method to deal with insurance barriers. “If 62% of the patients did not get the medication due to insurance issues, I don’t think we’re doing a good job of making it accessible to them.”

Dr. Ogu reported a financial relationship with Vertex.

SOURCE: Ogu U et al. FSCDR 2019, Abstract JSCDH-D-19-00041.




 

FORT LAUDERDALE, FLA. – When the Food and Drug Administration in 2017 approved L-glutamine (Endari) to treat the symptoms of sickle cell disease (SCD), it was the first new drug indicated for the condition in nearly two decades. But a small study of sickle cell patients in New York has found that patients are having difficulty obtaining the drug and sticking to the regimen.

bubaone/DigitalVision Vectors

“We found out that there are multiple barriers, mostly insurance related, and that after 10 months only one-fifth of the patients were still actively taking this medication,” said Ugochi Ogu, MD, assistant director of the Sickle Cell Center for Adults at Montefiore Medical Center in New York. She presented preliminary study results at the annual meeting of the Foundation for Sickle Cell Disease Research.

L-glutamine oral powder is taken twice a day to treat the symptoms of SCD. GoodRx reports that the average cash price for a 60-day supply of L-glutamine is $2,773.

The study followed 101 patients prescribed L-glutamine at the Montefiore Medical Center. When they returned to the clinic, patients were asked about barriers to obtaining the medication and adherence to the twice-a-day dosing. The center used a nearby local specialty pharmacy to fill the prescriptions.

The study also evaluated adherence by calculating the mean possession ratio (MPR) utilizing pharmacy records. The average age of the patient population was 36 years, and 56% were women.

It’s the first study of L-glutamine barriers and adherence in SCD patients in the real-world setting, Dr. Ogu said.

At the end of the 10-month study period, 21% of the patients were actively taking the medication, she said. “Forty-three percent had discontinued the medication, and 33% never filled the prescriptions; 4% had received but never started Endari,” Dr. Ogu said.

Of the patients who never filled the prescriptions, Dr. Ogu reported that 27% said their insurer denied prior authorization, 19% said their deductible was too high, and 16% cited other insurance issues.

“So we can see that insurance alone accounted for over 60% of why patients did not receive or could not start the medication,” she said.

Most patients – 94% – either had Medicare or Medicaid; the remainder had private insurance.

Among the 43% of all study patients who stopped taking the medication, reasons given include poor adherence (47%), side effects (9%), pregnancy and breast feeding (5%), and no perceived benefit (5%), Dr. Ogu said. At the outset, pharmacy records estimated adherence at 74% by using the average MPR, a rate similar to the phase 3 trial adherence rate of 77.4%.

Patient education is important to eliminate these barriers to treatment for SCD, Dr. Ogu said. “The patients need to understand why they’re taking whatever medication you prescribe. We need to educate them about the side effects, and we need to make them understand why it’s important to take certain medications or how they’re going to help them,” she said.

But even more important, she added, is a systems-based method to deal with insurance barriers. “If 62% of the patients did not get the medication due to insurance issues, I don’t think we’re doing a good job of making it accessible to them.”

Dr. Ogu reported a financial relationship with Vertex.

SOURCE: Ogu U et al. FSCDR 2019, Abstract JSCDH-D-19-00041.




 

FORT LAUDERDALE, FLA. – When the Food and Drug Administration in 2017 approved L-glutamine (Endari) to treat the symptoms of sickle cell disease (SCD), it was the first new drug indicated for the condition in nearly two decades. But a small study of sickle cell patients in New York has found that patients are having difficulty obtaining the drug and sticking to the regimen.

bubaone/DigitalVision Vectors

“We found out that there are multiple barriers, mostly insurance related, and that after 10 months only one-fifth of the patients were still actively taking this medication,” said Ugochi Ogu, MD, assistant director of the Sickle Cell Center for Adults at Montefiore Medical Center in New York. She presented preliminary study results at the annual meeting of the Foundation for Sickle Cell Disease Research.

L-glutamine oral powder is taken twice a day to treat the symptoms of SCD. GoodRx reports that the average cash price for a 60-day supply of L-glutamine is $2,773.

The study followed 101 patients prescribed L-glutamine at the Montefiore Medical Center. When they returned to the clinic, patients were asked about barriers to obtaining the medication and adherence to the twice-a-day dosing. The center used a nearby local specialty pharmacy to fill the prescriptions.

The study also evaluated adherence by calculating the mean possession ratio (MPR) utilizing pharmacy records. The average age of the patient population was 36 years, and 56% were women.

It’s the first study of L-glutamine barriers and adherence in SCD patients in the real-world setting, Dr. Ogu said.

At the end of the 10-month study period, 21% of the patients were actively taking the medication, she said. “Forty-three percent had discontinued the medication, and 33% never filled the prescriptions; 4% had received but never started Endari,” Dr. Ogu said.

Of the patients who never filled the prescriptions, Dr. Ogu reported that 27% said their insurer denied prior authorization, 19% said their deductible was too high, and 16% cited other insurance issues.

“So we can see that insurance alone accounted for over 60% of why patients did not receive or could not start the medication,” she said.

Most patients – 94% – either had Medicare or Medicaid; the remainder had private insurance.

Among the 43% of all study patients who stopped taking the medication, reasons given include poor adherence (47%), side effects (9%), pregnancy and breast feeding (5%), and no perceived benefit (5%), Dr. Ogu said. At the outset, pharmacy records estimated adherence at 74% by using the average MPR, a rate similar to the phase 3 trial adherence rate of 77.4%.

Patient education is important to eliminate these barriers to treatment for SCD, Dr. Ogu said. “The patients need to understand why they’re taking whatever medication you prescribe. We need to educate them about the side effects, and we need to make them understand why it’s important to take certain medications or how they’re going to help them,” she said.

But even more important, she added, is a systems-based method to deal with insurance barriers. “If 62% of the patients did not get the medication due to insurance issues, I don’t think we’re doing a good job of making it accessible to them.”

Dr. Ogu reported a financial relationship with Vertex.

SOURCE: Ogu U et al. FSCDR 2019, Abstract JSCDH-D-19-00041.




 

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

BALTIMORE – A large retrospective study found that laparoscopic repair of umbilical hernias in patients with obesity resulted in lower rates of wound complications than open repair even though the laparoscopic group had higher body mass index and rates of other key comorbidities, according to results reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“In patients with obesity, even though our laparoscopic umbilical hernia repair [UHR] group had an overall higher BMI; higher rates of diabetes, hypertension, and current smoking status; and longer operative times, they experienced decreased postoperative wound complications, compared to the open-repair group,” said Kristen Williams, MD, of TriHealth in Cincinnati.

The retrospective cohort study evaluated 12,026 adult patients with a BMI of more than 30 kg/m² in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database who had UHR in 2016. Almost four times as many patients had open rather than laparoscopic surgery (9,695 vs. 2,331, respectively)

Dr. Williams noted that two previous studies reported lower wound infection rates after laparoscopic hernia repair in patients with obesity: an analysis of ventral, not just umbilical, hernia repair based on the NSQIP database from 2009-2012 (Am J Surg. 2015;210:1029-30) and a single-institution retrospective chart review from 2003-2009 of patients who had umbilical hernia repair (Am J Surg. 2013;205:231-6). “In our study we wanted to compare the rate of postoperative complications after laparoscopic vs. open umbilical hernia repairs in patients with obesity based on NSQIP review,” she said.

The rate of composite surgical-site infections in the open group was 1.9% vs. 1.1% in the laparoscopic group (P less than .01), Dr. Williams noted. “SSI was statistically significantly higher in the open-repair group, and there was a trend toward higher deep SSI in the open group [0.3% vs. 0.1%; P = .147],” she said. Laparoscopic patients had significantly higher rates of postoperative pneumonia (0.4% vs 0.1%; P = .012), but Dr. Williams noted this was only significant in the non–elective surgery group. Operative times were significantly longer in the laparoscopic repair group (70 vs. 44 minutes). “The literature shows that longer operative times are associated with higher rates of SSI,” Dr. Williams added. “However our laparoscopic group still had lower rates of composite SSI.”

“Logistic regression was utilized and found that morbidity, defined as superficial, deep, and organ-space SSIs, was significantly increased in the open-repair group,” Dr. Williams said.

A higher percentage of patients in the laparoscopic group were women than in the open group (29.4% vs. 24.4%; P less than .001). The laparoscopic group had statistically significant higher average BMI (37.5 vs. 36.1; P less than .001) and higher rates of smoking (18.6% vs. 16.5%; P = .018), diabetes (18.4% vs. 15.8%; P = .002), and hypertension (47.5% vs. 43.8%; P = .001) than the open group.

The study also analyzed outcomes by BMI class. “As BMI class increased, superficial SSI, deep SSI, return-to-OR rates, postoperative pneumonia rates, and composite SSI increased in the open-repair group, indicating that higher BMI is associated with higher rates of complications in the open-repair group,” Dr. Williams said. Likewise, as obesity class increased, so did operative times in both the open and laparoscopic groups, she added.

She also noted that this study reported a significant increase in the proportion of laparoscopic UHRs than did a retrospective cohort study of 2009 and 2010 NSQIP files of UHR (Surg Endosc. 2014;28:741-6), 19.4% in this study versus 10.5% in that one.

Dr. Williams had no financial relationships to disclose.

SOURCE: Williams K et al. SAGES 2019, Abstract S099.

BALTIMORE – A large retrospective study found that laparoscopic repair of umbilical hernias in patients with obesity resulted in lower rates of wound complications than open repair even though the laparoscopic group had higher body mass index and rates of other key comorbidities, according to results reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“In patients with obesity, even though our laparoscopic umbilical hernia repair [UHR] group had an overall higher BMI; higher rates of diabetes, hypertension, and current smoking status; and longer operative times, they experienced decreased postoperative wound complications, compared to the open-repair group,” said Kristen Williams, MD, of TriHealth in Cincinnati.

The retrospective cohort study evaluated 12,026 adult patients with a BMI of more than 30 kg/m² in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database who had UHR in 2016. Almost four times as many patients had open rather than laparoscopic surgery (9,695 vs. 2,331, respectively)

Dr. Williams noted that two previous studies reported lower wound infection rates after laparoscopic hernia repair in patients with obesity: an analysis of ventral, not just umbilical, hernia repair based on the NSQIP database from 2009-2012 (Am J Surg. 2015;210:1029-30) and a single-institution retrospective chart review from 2003-2009 of patients who had umbilical hernia repair (Am J Surg. 2013;205:231-6). “In our study we wanted to compare the rate of postoperative complications after laparoscopic vs. open umbilical hernia repairs in patients with obesity based on NSQIP review,” she said.

The rate of composite surgical-site infections in the open group was 1.9% vs. 1.1% in the laparoscopic group (P less than .01), Dr. Williams noted. “SSI was statistically significantly higher in the open-repair group, and there was a trend toward higher deep SSI in the open group [0.3% vs. 0.1%; P = .147],” she said. Laparoscopic patients had significantly higher rates of postoperative pneumonia (0.4% vs 0.1%; P = .012), but Dr. Williams noted this was only significant in the non–elective surgery group. Operative times were significantly longer in the laparoscopic repair group (70 vs. 44 minutes). “The literature shows that longer operative times are associated with higher rates of SSI,” Dr. Williams added. “However our laparoscopic group still had lower rates of composite SSI.”

“Logistic regression was utilized and found that morbidity, defined as superficial, deep, and organ-space SSIs, was significantly increased in the open-repair group,” Dr. Williams said.

A higher percentage of patients in the laparoscopic group were women than in the open group (29.4% vs. 24.4%; P less than .001). The laparoscopic group had statistically significant higher average BMI (37.5 vs. 36.1; P less than .001) and higher rates of smoking (18.6% vs. 16.5%; P = .018), diabetes (18.4% vs. 15.8%; P = .002), and hypertension (47.5% vs. 43.8%; P = .001) than the open group.

The study also analyzed outcomes by BMI class. “As BMI class increased, superficial SSI, deep SSI, return-to-OR rates, postoperative pneumonia rates, and composite SSI increased in the open-repair group, indicating that higher BMI is associated with higher rates of complications in the open-repair group,” Dr. Williams said. Likewise, as obesity class increased, so did operative times in both the open and laparoscopic groups, she added.

She also noted that this study reported a significant increase in the proportion of laparoscopic UHRs than did a retrospective cohort study of 2009 and 2010 NSQIP files of UHR (Surg Endosc. 2014;28:741-6), 19.4% in this study versus 10.5% in that one.

Dr. Williams had no financial relationships to disclose.

SOURCE: Williams K et al. SAGES 2019, Abstract S099.

BALTIMORE – A large retrospective study found that laparoscopic repair of umbilical hernias in patients with obesity resulted in lower rates of wound complications than open repair even though the laparoscopic group had higher body mass index and rates of other key comorbidities, according to results reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“In patients with obesity, even though our laparoscopic umbilical hernia repair [UHR] group had an overall higher BMI; higher rates of diabetes, hypertension, and current smoking status; and longer operative times, they experienced decreased postoperative wound complications, compared to the open-repair group,” said Kristen Williams, MD, of TriHealth in Cincinnati.

The retrospective cohort study evaluated 12,026 adult patients with a BMI of more than 30 kg/m² in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database who had UHR in 2016. Almost four times as many patients had open rather than laparoscopic surgery (9,695 vs. 2,331, respectively)

Dr. Williams noted that two previous studies reported lower wound infection rates after laparoscopic hernia repair in patients with obesity: an analysis of ventral, not just umbilical, hernia repair based on the NSQIP database from 2009-2012 (Am J Surg. 2015;210:1029-30) and a single-institution retrospective chart review from 2003-2009 of patients who had umbilical hernia repair (Am J Surg. 2013;205:231-6). “In our study we wanted to compare the rate of postoperative complications after laparoscopic vs. open umbilical hernia repairs in patients with obesity based on NSQIP review,” she said.

The rate of composite surgical-site infections in the open group was 1.9% vs. 1.1% in the laparoscopic group (P less than .01), Dr. Williams noted. “SSI was statistically significantly higher in the open-repair group, and there was a trend toward higher deep SSI in the open group [0.3% vs. 0.1%; P = .147],” she said. Laparoscopic patients had significantly higher rates of postoperative pneumonia (0.4% vs 0.1%; P = .012), but Dr. Williams noted this was only significant in the non–elective surgery group. Operative times were significantly longer in the laparoscopic repair group (70 vs. 44 minutes). “The literature shows that longer operative times are associated with higher rates of SSI,” Dr. Williams added. “However our laparoscopic group still had lower rates of composite SSI.”

“Logistic regression was utilized and found that morbidity, defined as superficial, deep, and organ-space SSIs, was significantly increased in the open-repair group,” Dr. Williams said.

A higher percentage of patients in the laparoscopic group were women than in the open group (29.4% vs. 24.4%; P less than .001). The laparoscopic group had statistically significant higher average BMI (37.5 vs. 36.1; P less than .001) and higher rates of smoking (18.6% vs. 16.5%; P = .018), diabetes (18.4% vs. 15.8%; P = .002), and hypertension (47.5% vs. 43.8%; P = .001) than the open group.

The study also analyzed outcomes by BMI class. “As BMI class increased, superficial SSI, deep SSI, return-to-OR rates, postoperative pneumonia rates, and composite SSI increased in the open-repair group, indicating that higher BMI is associated with higher rates of complications in the open-repair group,” Dr. Williams said. Likewise, as obesity class increased, so did operative times in both the open and laparoscopic groups, she added.

She also noted that this study reported a significant increase in the proportion of laparoscopic UHRs than did a retrospective cohort study of 2009 and 2010 NSQIP files of UHR (Surg Endosc. 2014;28:741-6), 19.4% in this study versus 10.5% in that one.

Dr. Williams had no financial relationships to disclose.

SOURCE: Williams K et al. SAGES 2019, Abstract S099.

BALTIMORE – Even in a public health system like Canada’s, almost one-quarter of patients who get referrals for bariatric surgery from their primary care provider drop out before going through with the operation, and researchers have identified patient characteristics that could be predictive of dropout risk that would potentially have implications in a nonuniversal system, such as that of the United States, according to a study of almost 18,000 patients reported at the annual meeting Society of American Gastrointestinal and Endoscopic Surgeons.

“Even in a universal health care system, clear disparities exist among patient populations having bariatric surgery,” said Aristithes Doumouras, MD, of McMaster University in Hamilton, Ont. “Extensive work-ups and long wait times can have an impact on the delivery of bariatric care.”

Dr. Doumouras reported on results of a retrospective, population-based study of 17,703 patients referred for surgery during 2009-2015 in the Ontario Bariatric Network, a province-wide network of 11 hospitals credentialed to perform bariatric surgery. The study found that 23.2% of patients referred for bariatric surgery did not go through with it and that overall average wait times between referral and the operation were just short of a year – 362.2 days to be precise.

The goal of the study was to identify any factors associated with attrition, Dr. Doumouras said.

“Predictors of interest included patient demographics – age, sex, income quintile, immigration status, employment status, smoking status – and comorbidities, such as diabetes, heart failure, hypertension, sleep apnea, and renal disease,” he said. “The study also evaluated health services factors, such as overall wait time to bariatric surgery, presence of centers of excellence, and health care utilization.”

The study found that demographics with more than twice the odds of attrition were male gender and presence of a disability (P less than .01). Smokers were 60% more likely to drop out (P less than .01), he said. “To receive bariatric surgery in Ontario, smokers must go through a smoking cessation program.”

Unemployed individuals and immigrants also had higher rates of attrition, at 55% and 39%, respectively, and were more likely to not go through with the operation (P less than .01). Health factors associated with attrition, but to a lesser extent, were diabetes (odds ratio, 1.23) and heart failure (OR, 1.35; P less than .01).

“Low socioeconomic status actually had a very low impact in our system on attrition after adjustment for other demographic factors such as disability and unemployment,” Dr. Doumouras said, noting a 16% greater risk of attrition in this group (P = .02).

“Interestingly,” he noted, “there was one factor associated with less dropout – obstructive sleep apnea – probably because people hate using the CPAP machines every single night.” People with OSA were 47% less likely to drop out than were people without the disease (P less than .001).

When asked if the findings would be applicable in the United States, Dr. Doumouras said they would to an extent.

“I think we can say confidently that they would apply to most universal health care systems,” he said. “In nonuniversal health care systems, the interplay between insurance status, socioeconomic status, and the like makes it more of a complex relationship, but if you were to take any kind of health care system, even in the United States, you would probably see very similar trends in terms of who can get bariatric surgery.”

He added, “I think also the length of work-up matters. Only a 3- or 4-week work-up probably affects attrition as well. These are relatively universal things.”

Dr. Doumouras has no financial relationships to disclose.

SOURCE: Doumouras A et al. SAGES 2019, Abstract S118.

BALTIMORE – Even in a public health system like Canada’s, almost one-quarter of patients who get referrals for bariatric surgery from their primary care provider drop out before going through with the operation, and researchers have identified patient characteristics that could be predictive of dropout risk that would potentially have implications in a nonuniversal system, such as that of the United States, according to a study of almost 18,000 patients reported at the annual meeting Society of American Gastrointestinal and Endoscopic Surgeons.

“Even in a universal health care system, clear disparities exist among patient populations having bariatric surgery,” said Aristithes Doumouras, MD, of McMaster University in Hamilton, Ont. “Extensive work-ups and long wait times can have an impact on the delivery of bariatric care.”

Dr. Doumouras reported on results of a retrospective, population-based study of 17,703 patients referred for surgery during 2009-2015 in the Ontario Bariatric Network, a province-wide network of 11 hospitals credentialed to perform bariatric surgery. The study found that 23.2% of patients referred for bariatric surgery did not go through with it and that overall average wait times between referral and the operation were just short of a year – 362.2 days to be precise.

The goal of the study was to identify any factors associated with attrition, Dr. Doumouras said.

“Predictors of interest included patient demographics – age, sex, income quintile, immigration status, employment status, smoking status – and comorbidities, such as diabetes, heart failure, hypertension, sleep apnea, and renal disease,” he said. “The study also evaluated health services factors, such as overall wait time to bariatric surgery, presence of centers of excellence, and health care utilization.”

The study found that demographics with more than twice the odds of attrition were male gender and presence of a disability (P less than .01). Smokers were 60% more likely to drop out (P less than .01), he said. “To receive bariatric surgery in Ontario, smokers must go through a smoking cessation program.”

Unemployed individuals and immigrants also had higher rates of attrition, at 55% and 39%, respectively, and were more likely to not go through with the operation (P less than .01). Health factors associated with attrition, but to a lesser extent, were diabetes (odds ratio, 1.23) and heart failure (OR, 1.35; P less than .01).

“Low socioeconomic status actually had a very low impact in our system on attrition after adjustment for other demographic factors such as disability and unemployment,” Dr. Doumouras said, noting a 16% greater risk of attrition in this group (P = .02).

“Interestingly,” he noted, “there was one factor associated with less dropout – obstructive sleep apnea – probably because people hate using the CPAP machines every single night.” People with OSA were 47% less likely to drop out than were people without the disease (P less than .001).

When asked if the findings would be applicable in the United States, Dr. Doumouras said they would to an extent.

“I think we can say confidently that they would apply to most universal health care systems,” he said. “In nonuniversal health care systems, the interplay between insurance status, socioeconomic status, and the like makes it more of a complex relationship, but if you were to take any kind of health care system, even in the United States, you would probably see very similar trends in terms of who can get bariatric surgery.”

He added, “I think also the length of work-up matters. Only a 3- or 4-week work-up probably affects attrition as well. These are relatively universal things.”

Dr. Doumouras has no financial relationships to disclose.

SOURCE: Doumouras A et al. SAGES 2019, Abstract S118.

BALTIMORE – Even in a public health system like Canada’s, almost one-quarter of patients who get referrals for bariatric surgery from their primary care provider drop out before going through with the operation, and researchers have identified patient characteristics that could be predictive of dropout risk that would potentially have implications in a nonuniversal system, such as that of the United States, according to a study of almost 18,000 patients reported at the annual meeting Society of American Gastrointestinal and Endoscopic Surgeons.

“Even in a universal health care system, clear disparities exist among patient populations having bariatric surgery,” said Aristithes Doumouras, MD, of McMaster University in Hamilton, Ont. “Extensive work-ups and long wait times can have an impact on the delivery of bariatric care.”

Dr. Doumouras reported on results of a retrospective, population-based study of 17,703 patients referred for surgery during 2009-2015 in the Ontario Bariatric Network, a province-wide network of 11 hospitals credentialed to perform bariatric surgery. The study found that 23.2% of patients referred for bariatric surgery did not go through with it and that overall average wait times between referral and the operation were just short of a year – 362.2 days to be precise.

The goal of the study was to identify any factors associated with attrition, Dr. Doumouras said.

“Predictors of interest included patient demographics – age, sex, income quintile, immigration status, employment status, smoking status – and comorbidities, such as diabetes, heart failure, hypertension, sleep apnea, and renal disease,” he said. “The study also evaluated health services factors, such as overall wait time to bariatric surgery, presence of centers of excellence, and health care utilization.”

The study found that demographics with more than twice the odds of attrition were male gender and presence of a disability (P less than .01). Smokers were 60% more likely to drop out (P less than .01), he said. “To receive bariatric surgery in Ontario, smokers must go through a smoking cessation program.”

Unemployed individuals and immigrants also had higher rates of attrition, at 55% and 39%, respectively, and were more likely to not go through with the operation (P less than .01). Health factors associated with attrition, but to a lesser extent, were diabetes (odds ratio, 1.23) and heart failure (OR, 1.35; P less than .01).

“Low socioeconomic status actually had a very low impact in our system on attrition after adjustment for other demographic factors such as disability and unemployment,” Dr. Doumouras said, noting a 16% greater risk of attrition in this group (P = .02).

“Interestingly,” he noted, “there was one factor associated with less dropout – obstructive sleep apnea – probably because people hate using the CPAP machines every single night.” People with OSA were 47% less likely to drop out than were people without the disease (P less than .001).

When asked if the findings would be applicable in the United States, Dr. Doumouras said they would to an extent.

“I think we can say confidently that they would apply to most universal health care systems,” he said. “In nonuniversal health care systems, the interplay between insurance status, socioeconomic status, and the like makes it more of a complex relationship, but if you were to take any kind of health care system, even in the United States, you would probably see very similar trends in terms of who can get bariatric surgery.”

He added, “I think also the length of work-up matters. Only a 3- or 4-week work-up probably affects attrition as well. These are relatively universal things.”

Dr. Doumouras has no financial relationships to disclose.

SOURCE: Doumouras A et al. SAGES 2019, Abstract S118.

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

BALTIMORE – An analysis of sleeve gastrectomy (SG) operations reported to a statewide registry over a 5-year period has found that the proportion of patients with worsening gastroesophageal reflux disease (GERD) symptoms varied widely among surgeons despite similarities in surgeon training, experience, skills, technique, and complication rates, according to findings presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“We found that about a third of patients undergoing sleeve gastrectomy within this data registry developed worsening symptoms after sleeve gastrectomy, and the severity of these symptoms actually varied considerably, from 1 to 13.8 increase in their [GERD–Health Related Quality of Life Questionnaire (HRQL)] score,” said Oliver Varban, MD, of the University of Michigan, Ann Arbor. “Among the surgeons themselves, the rates of severe symptoms varied despite the surgeon’s experience and rate of hiatal hernia repair being similar between the groups.”

This study involved 7,358 patients in the Michigan Bariatric Surgery Collaborative (MBSC) registry who had SG from 2013 to 2017 and 52 surgeons who performed 25 or more SG cases per year. The patients completed the GERD-HRQL survey at baseline and 1 year after SG. The two scores were compared and patients were divided into terciles – mild, moderate, and severe – for worsening of symptoms, then matched with the surgeons who performed the operation. In all, 31.2% of patients (n = 2,294) reported worsening symptoms a year after SG, divided into the following terciles: mild with a 1.4-point increase in GERD-HRQL score (11.7%, n = 866); moderate, a 4.2-point increase (9.7%, n = 716); and severe, 13.8-point increase (9.7%, n = 712).

Among surgeons, the highest rate of patients with severe worsening of GERD was 44.7%, the lowest rate, 18.7%. So the researchers compared characteristics among the surgeons with the highest and lowest rates. “We found that they’re quite similar, actually, in terms of years of bariatric fellowship training, annual sleeve gastrectomy volume, total bariatric annual volume, as well as operative time,” Dr. Varban said. “Interestingly, the rate of concurrent hiatal hernia repair within these two groups is similar as well, which is about one-third for each group” (34.3% for the highest-rate group and 27% for the lowest-rate surgeons).

Likewise, 30-day risk adjusted complication rates were similar between both groups, 3.7% for the high group and 4.3% for the low group.

“Total–body weight loss or excess–body weight loss was actually fairly similar clinically between the two groups, but there was a statistical significance with more weight loss in the GERD patients who had higher severe worsening of symptoms,” Dr. Varban noted.

Surgeons with the highest rates of severe reflux symptoms in their patients tended to operate on more patients with diabetes, hypertension, and cardiovascular disease, whereas the surgeons with the lowest rate of severe symptoms had a higher proportion of patients who were male, white, and had hyperlipidemia and sleep apnea.

Dr. Varban has no financial relationships to disclose. Blue Cross Blue Shield of Michigan provided salary support through the MBSC.

SOURCE: Varban O et al. SAGES 2019; Session SS29, Abstract S139.

BALTIMORE – An analysis of sleeve gastrectomy (SG) operations reported to a statewide registry over a 5-year period has found that the proportion of patients with worsening gastroesophageal reflux disease (GERD) symptoms varied widely among surgeons despite similarities in surgeon training, experience, skills, technique, and complication rates, according to findings presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“We found that about a third of patients undergoing sleeve gastrectomy within this data registry developed worsening symptoms after sleeve gastrectomy, and the severity of these symptoms actually varied considerably, from 1 to 13.8 increase in their [GERD–Health Related Quality of Life Questionnaire (HRQL)] score,” said Oliver Varban, MD, of the University of Michigan, Ann Arbor. “Among the surgeons themselves, the rates of severe symptoms varied despite the surgeon’s experience and rate of hiatal hernia repair being similar between the groups.”

This study involved 7,358 patients in the Michigan Bariatric Surgery Collaborative (MBSC) registry who had SG from 2013 to 2017 and 52 surgeons who performed 25 or more SG cases per year. The patients completed the GERD-HRQL survey at baseline and 1 year after SG. The two scores were compared and patients were divided into terciles – mild, moderate, and severe – for worsening of symptoms, then matched with the surgeons who performed the operation. In all, 31.2% of patients (n = 2,294) reported worsening symptoms a year after SG, divided into the following terciles: mild with a 1.4-point increase in GERD-HRQL score (11.7%, n = 866); moderate, a 4.2-point increase (9.7%, n = 716); and severe, 13.8-point increase (9.7%, n = 712).

Among surgeons, the highest rate of patients with severe worsening of GERD was 44.7%, the lowest rate, 18.7%. So the researchers compared characteristics among the surgeons with the highest and lowest rates. “We found that they’re quite similar, actually, in terms of years of bariatric fellowship training, annual sleeve gastrectomy volume, total bariatric annual volume, as well as operative time,” Dr. Varban said. “Interestingly, the rate of concurrent hiatal hernia repair within these two groups is similar as well, which is about one-third for each group” (34.3% for the highest-rate group and 27% for the lowest-rate surgeons).

Likewise, 30-day risk adjusted complication rates were similar between both groups, 3.7% for the high group and 4.3% for the low group.

“Total–body weight loss or excess–body weight loss was actually fairly similar clinically between the two groups, but there was a statistical significance with more weight loss in the GERD patients who had higher severe worsening of symptoms,” Dr. Varban noted.

Surgeons with the highest rates of severe reflux symptoms in their patients tended to operate on more patients with diabetes, hypertension, and cardiovascular disease, whereas the surgeons with the lowest rate of severe symptoms had a higher proportion of patients who were male, white, and had hyperlipidemia and sleep apnea.

Dr. Varban has no financial relationships to disclose. Blue Cross Blue Shield of Michigan provided salary support through the MBSC.

SOURCE: Varban O et al. SAGES 2019; Session SS29, Abstract S139.

BALTIMORE – An analysis of sleeve gastrectomy (SG) operations reported to a statewide registry over a 5-year period has found that the proportion of patients with worsening gastroesophageal reflux disease (GERD) symptoms varied widely among surgeons despite similarities in surgeon training, experience, skills, technique, and complication rates, according to findings presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“We found that about a third of patients undergoing sleeve gastrectomy within this data registry developed worsening symptoms after sleeve gastrectomy, and the severity of these symptoms actually varied considerably, from 1 to 13.8 increase in their [GERD–Health Related Quality of Life Questionnaire (HRQL)] score,” said Oliver Varban, MD, of the University of Michigan, Ann Arbor. “Among the surgeons themselves, the rates of severe symptoms varied despite the surgeon’s experience and rate of hiatal hernia repair being similar between the groups.”

This study involved 7,358 patients in the Michigan Bariatric Surgery Collaborative (MBSC) registry who had SG from 2013 to 2017 and 52 surgeons who performed 25 or more SG cases per year. The patients completed the GERD-HRQL survey at baseline and 1 year after SG. The two scores were compared and patients were divided into terciles – mild, moderate, and severe – for worsening of symptoms, then matched with the surgeons who performed the operation. In all, 31.2% of patients (n = 2,294) reported worsening symptoms a year after SG, divided into the following terciles: mild with a 1.4-point increase in GERD-HRQL score (11.7%, n = 866); moderate, a 4.2-point increase (9.7%, n = 716); and severe, 13.8-point increase (9.7%, n = 712).

Among surgeons, the highest rate of patients with severe worsening of GERD was 44.7%, the lowest rate, 18.7%. So the researchers compared characteristics among the surgeons with the highest and lowest rates. “We found that they’re quite similar, actually, in terms of years of bariatric fellowship training, annual sleeve gastrectomy volume, total bariatric annual volume, as well as operative time,” Dr. Varban said. “Interestingly, the rate of concurrent hiatal hernia repair within these two groups is similar as well, which is about one-third for each group” (34.3% for the highest-rate group and 27% for the lowest-rate surgeons).

Likewise, 30-day risk adjusted complication rates were similar between both groups, 3.7% for the high group and 4.3% for the low group.

“Total–body weight loss or excess–body weight loss was actually fairly similar clinically between the two groups, but there was a statistical significance with more weight loss in the GERD patients who had higher severe worsening of symptoms,” Dr. Varban noted.

Surgeons with the highest rates of severe reflux symptoms in their patients tended to operate on more patients with diabetes, hypertension, and cardiovascular disease, whereas the surgeons with the lowest rate of severe symptoms had a higher proportion of patients who were male, white, and had hyperlipidemia and sleep apnea.

Dr. Varban has no financial relationships to disclose. Blue Cross Blue Shield of Michigan provided salary support through the MBSC.

SOURCE: Varban O et al. SAGES 2019; Session SS29, Abstract S139.

BALTIMORE – A head-to-head comparison of robotic and laparoscopic surgery for locally advanced rectal cancer has found that the operations achieve similar outcomes in terms of composite negative margins, overall survival, and readmissions, but that robotic surgery is associated with lower rates of conversion to open surgery and shorter hospital stays, according to an analysis of cases in the National Cancer Database presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The gold standard for how we’re taking care of our patients, of course, is how we’re doing with the cancer survival, and we found no difference for overall survival in the robotic arm and the laparoscopic arm,” said M. Benjamin Hopkins, MD, of Vanderbilt University, Nashville, Tenn. He reported on a retrospective review of 7,616 operations for rectal adenocarcinoma in the National Cancer Database from 2010 to 2014. The study population included 2,472 (32%) robotic procedures. The hazard ratio for 5-year overall survival was 0.87 (P = .18), Dr. Hopkins noted, with virtually identical Kaplan-Meier survival curves between the two approaches.

The negative margin rates were also similar between the two groups: 93.7% for the robotic patients and 92.9% for the laparoscopic cohort (odds ratio 0.86, P = .23), Dr. Hopkins noted. Readmission rates were 9% and 8%, respectively (odds ratio 1.02, P = .44).

There were two significant differences in outcomes between the two groups: The conversion rate to open surgery for the robotic group “was about half that from what we saw with laparoscopic surgery,” he said – 8% vs. 15%; and “a slightly decreased length of stay” in the robotic group – 6.3 vs. 6.7 days (P less than .001).

Dr. Hopkins noted that the science supporting robotic surgery for rectal resection is still somewhat nascent, pointing to the ROLARR randomized trial, which showed conversion rates similar to those of open between the two minimally invasive approaches (8.1% for robotic and 12.2% for laparoscopy [P = .16] JAMA. 2017; 318[16]:1569-80). “Surgeons in this study were still on their learning curve, and what the results showed was that among surgeons, even with varied experience, robotic surgery was [equal] to laparoscopic surgery in relation to conversion rates and composite margin for cancer specimens,” he said of the ROLARR trial.

That led to the premise for his group’s study. “The hypothesis that we had going into this study was that we are able to get a better composite negative margin with robotic surgery as opposed to laparoscopic surgery, which would then translate into improved cancer survival for our patients,” he said. Like the ROLARR trial, the 2010-2014 National Cancer Database dataset Dr. Hopkins and colleagues used includes a window for the learning curve, he added.

“One of the questions that always comes at us from hospital administration and from insurance companies is whether or not there’s a cost benefit for the patient: What is the value to the patient?” Dr. Hopkins noted. “I’d like to see future studies where we’re looking at this value and, as we decrease our operative time and anesthesia costs, and hopefully some decreased cost in the instrumentation, we start to see some more benefits as we get more facile with robotic surgery.”

Dr. Hopkins has no financial relationships to disclose.

SOURCE: Hopkins B et al. SAGES 2019. Session SS13; abstract S058

CORRECTION 5/14/2109 :  The hazard ratio for 5-year overall survival and p-value were updated. 

BALTIMORE – A head-to-head comparison of robotic and laparoscopic surgery for locally advanced rectal cancer has found that the operations achieve similar outcomes in terms of composite negative margins, overall survival, and readmissions, but that robotic surgery is associated with lower rates of conversion to open surgery and shorter hospital stays, according to an analysis of cases in the National Cancer Database presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The gold standard for how we’re taking care of our patients, of course, is how we’re doing with the cancer survival, and we found no difference for overall survival in the robotic arm and the laparoscopic arm,” said M. Benjamin Hopkins, MD, of Vanderbilt University, Nashville, Tenn. He reported on a retrospective review of 7,616 operations for rectal adenocarcinoma in the National Cancer Database from 2010 to 2014. The study population included 2,472 (32%) robotic procedures. The hazard ratio for 5-year overall survival was 0.87 (P = .18), Dr. Hopkins noted, with virtually identical Kaplan-Meier survival curves between the two approaches.

The negative margin rates were also similar between the two groups: 93.7% for the robotic patients and 92.9% for the laparoscopic cohort (odds ratio 0.86, P = .23), Dr. Hopkins noted. Readmission rates were 9% and 8%, respectively (odds ratio 1.02, P = .44).

There were two significant differences in outcomes between the two groups: The conversion rate to open surgery for the robotic group “was about half that from what we saw with laparoscopic surgery,” he said – 8% vs. 15%; and “a slightly decreased length of stay” in the robotic group – 6.3 vs. 6.7 days (P less than .001).

Dr. Hopkins noted that the science supporting robotic surgery for rectal resection is still somewhat nascent, pointing to the ROLARR randomized trial, which showed conversion rates similar to those of open between the two minimally invasive approaches (8.1% for robotic and 12.2% for laparoscopy [P = .16] JAMA. 2017; 318[16]:1569-80). “Surgeons in this study were still on their learning curve, and what the results showed was that among surgeons, even with varied experience, robotic surgery was [equal] to laparoscopic surgery in relation to conversion rates and composite margin for cancer specimens,” he said of the ROLARR trial.

That led to the premise for his group’s study. “The hypothesis that we had going into this study was that we are able to get a better composite negative margin with robotic surgery as opposed to laparoscopic surgery, which would then translate into improved cancer survival for our patients,” he said. Like the ROLARR trial, the 2010-2014 National Cancer Database dataset Dr. Hopkins and colleagues used includes a window for the learning curve, he added.

“One of the questions that always comes at us from hospital administration and from insurance companies is whether or not there’s a cost benefit for the patient: What is the value to the patient?” Dr. Hopkins noted. “I’d like to see future studies where we’re looking at this value and, as we decrease our operative time and anesthesia costs, and hopefully some decreased cost in the instrumentation, we start to see some more benefits as we get more facile with robotic surgery.”

Dr. Hopkins has no financial relationships to disclose.

SOURCE: Hopkins B et al. SAGES 2019. Session SS13; abstract S058

CORRECTION 5/14/2109 :  The hazard ratio for 5-year overall survival and p-value were updated. 

BALTIMORE – A head-to-head comparison of robotic and laparoscopic surgery for locally advanced rectal cancer has found that the operations achieve similar outcomes in terms of composite negative margins, overall survival, and readmissions, but that robotic surgery is associated with lower rates of conversion to open surgery and shorter hospital stays, according to an analysis of cases in the National Cancer Database presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The gold standard for how we’re taking care of our patients, of course, is how we’re doing with the cancer survival, and we found no difference for overall survival in the robotic arm and the laparoscopic arm,” said M. Benjamin Hopkins, MD, of Vanderbilt University, Nashville, Tenn. He reported on a retrospective review of 7,616 operations for rectal adenocarcinoma in the National Cancer Database from 2010 to 2014. The study population included 2,472 (32%) robotic procedures. The hazard ratio for 5-year overall survival was 0.87 (P = .18), Dr. Hopkins noted, with virtually identical Kaplan-Meier survival curves between the two approaches.

The negative margin rates were also similar between the two groups: 93.7% for the robotic patients and 92.9% for the laparoscopic cohort (odds ratio 0.86, P = .23), Dr. Hopkins noted. Readmission rates were 9% and 8%, respectively (odds ratio 1.02, P = .44).

There were two significant differences in outcomes between the two groups: The conversion rate to open surgery for the robotic group “was about half that from what we saw with laparoscopic surgery,” he said – 8% vs. 15%; and “a slightly decreased length of stay” in the robotic group – 6.3 vs. 6.7 days (P less than .001).

Dr. Hopkins noted that the science supporting robotic surgery for rectal resection is still somewhat nascent, pointing to the ROLARR randomized trial, which showed conversion rates similar to those of open between the two minimally invasive approaches (8.1% for robotic and 12.2% for laparoscopy [P = .16] JAMA. 2017; 318[16]:1569-80). “Surgeons in this study were still on their learning curve, and what the results showed was that among surgeons, even with varied experience, robotic surgery was [equal] to laparoscopic surgery in relation to conversion rates and composite margin for cancer specimens,” he said of the ROLARR trial.

That led to the premise for his group’s study. “The hypothesis that we had going into this study was that we are able to get a better composite negative margin with robotic surgery as opposed to laparoscopic surgery, which would then translate into improved cancer survival for our patients,” he said. Like the ROLARR trial, the 2010-2014 National Cancer Database dataset Dr. Hopkins and colleagues used includes a window for the learning curve, he added.

“One of the questions that always comes at us from hospital administration and from insurance companies is whether or not there’s a cost benefit for the patient: What is the value to the patient?” Dr. Hopkins noted. “I’d like to see future studies where we’re looking at this value and, as we decrease our operative time and anesthesia costs, and hopefully some decreased cost in the instrumentation, we start to see some more benefits as we get more facile with robotic surgery.”

Dr. Hopkins has no financial relationships to disclose.

SOURCE: Hopkins B et al. SAGES 2019. Session SS13; abstract S058

CORRECTION 5/14/2109 :  The hazard ratio for 5-year overall survival and p-value were updated.