ACS Surgery News

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

Salvage limbs at all costs

Aggressive limb salvage in people with diabetes leads to an overall reduction in cost not only economically, but also from the patient’s perspective. The vast majority of diabetic patients with critical ischemia are actually good candidates for limb salvage. Tragically, many of these patients are never referred for evaluation for limb salvage because of misconceptions about the pathophysiology of the disease.

An argument against limb salvage is that primary amputation prevents or shortens the course of wound care and enables patients to become ambulatory, albeit with a prosthesis, faster. However, in the modern era of vascular surgery, revascularization can be performed successfully with minimal mortality and excellent rates of limb salvage, especially when it’s done within a team-based approach.

Dr. Trissa A. Babrowski is an assistant professor of surgery, specializing in vascular surgery and endovascular therapy, at the University of Chicago Heart and Vascular Center. She had no financial relationships to disclose.

Primary amputation can be OK

I am not an amputationalist. I do practice limb salvage. In fact I’m probably the most aggressive limb salvage surgeon in my hospital. But primary amputation is a completely acceptable option for a selected group of patients with diabetes. We should not try to do limb salvage “at all costs.”

I do not find this to be a contradictory position. In fact, I think it adds credence to my support of limb salvage that I think primary amputation can be OK. In all honesty, there are very few things in life that should be done at all costs.

Dr. Timothy J. Nypaver is head of vascular surgery at Henry Ford Hospital, Detroit. He had no financial relationships to disclose.

Salvage limbs at all costs

Aggressive limb salvage in people with diabetes leads to an overall reduction in cost not only economically, but also from the patient’s perspective. The vast majority of diabetic patients with critical ischemia are actually good candidates for limb salvage. Tragically, many of these patients are never referred for evaluation for limb salvage because of misconceptions about the pathophysiology of the disease.

An argument against limb salvage is that primary amputation prevents or shortens the course of wound care and enables patients to become ambulatory, albeit with a prosthesis, faster. However, in the modern era of vascular surgery, revascularization can be performed successfully with minimal mortality and excellent rates of limb salvage, especially when it’s done within a team-based approach.

Dr. Trissa A. Babrowski is an assistant professor of surgery, specializing in vascular surgery and endovascular therapy, at the University of Chicago Heart and Vascular Center. She had no financial relationships to disclose.

Primary amputation can be OK

I am not an amputationalist. I do practice limb salvage. In fact I’m probably the most aggressive limb salvage surgeon in my hospital. But primary amputation is a completely acceptable option for a selected group of patients with diabetes. We should not try to do limb salvage “at all costs.”

I do not find this to be a contradictory position. In fact, I think it adds credence to my support of limb salvage that I think primary amputation can be OK. In all honesty, there are very few things in life that should be done at all costs.

Dr. Timothy J. Nypaver is head of vascular surgery at Henry Ford Hospital, Detroit. He had no financial relationships to disclose.

Salvage limbs at all costs

Aggressive limb salvage in people with diabetes leads to an overall reduction in cost not only economically, but also from the patient’s perspective. The vast majority of diabetic patients with critical ischemia are actually good candidates for limb salvage. Tragically, many of these patients are never referred for evaluation for limb salvage because of misconceptions about the pathophysiology of the disease.

An argument against limb salvage is that primary amputation prevents or shortens the course of wound care and enables patients to become ambulatory, albeit with a prosthesis, faster. However, in the modern era of vascular surgery, revascularization can be performed successfully with minimal mortality and excellent rates of limb salvage, especially when it’s done within a team-based approach.

Dr. Trissa A. Babrowski is an assistant professor of surgery, specializing in vascular surgery and endovascular therapy, at the University of Chicago Heart and Vascular Center. She had no financial relationships to disclose.

Primary amputation can be OK

I am not an amputationalist. I do practice limb salvage. In fact I’m probably the most aggressive limb salvage surgeon in my hospital. But primary amputation is a completely acceptable option for a selected group of patients with diabetes. We should not try to do limb salvage “at all costs.”

I do not find this to be a contradictory position. In fact, I think it adds credence to my support of limb salvage that I think primary amputation can be OK. In all honesty, there are very few things in life that should be done at all costs.

Dr. Timothy J. Nypaver is head of vascular surgery at Henry Ford Hospital, Detroit. He had no financial relationships to disclose.

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

2016 has been a year full of surprises, but not when it comes to the state leading “America’s Health Rankings.” For the fifth consecutive year, Hawaii has been named the healthiest state by the United Health Foundation’s annual report.

Also not a surprise was Mississippi’s 50th-place finish. The Magnolia State most recently finished last in 2014 and has never finished out of the bottom three in the annual ranking. Hawaii, on the other hand, has finished first eight times in the 27 years of the rankings – more than any other state – and has never finished out of the top six, according to the foundation’s 2016 report.

[email protected]

2016 has been a year full of surprises, but not when it comes to the state leading “America’s Health Rankings.” For the fifth consecutive year, Hawaii has been named the healthiest state by the United Health Foundation’s annual report.

Also not a surprise was Mississippi’s 50th-place finish. The Magnolia State most recently finished last in 2014 and has never finished out of the bottom three in the annual ranking. Hawaii, on the other hand, has finished first eight times in the 27 years of the rankings – more than any other state – and has never finished out of the top six, according to the foundation’s 2016 report.

[email protected]

2016 has been a year full of surprises, but not when it comes to the state leading “America’s Health Rankings.” For the fifth consecutive year, Hawaii has been named the healthiest state by the United Health Foundation’s annual report.

Also not a surprise was Mississippi’s 50th-place finish. The Magnolia State most recently finished last in 2014 and has never finished out of the bottom three in the annual ranking. Hawaii, on the other hand, has finished first eight times in the 27 years of the rankings – more than any other state – and has never finished out of the top six, according to the foundation’s 2016 report.

[email protected]

Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.

In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.

copyright Kativ/iStockphoto.com

• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.

• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.

• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.

• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.

• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.

• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.

It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).

When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.

Among the other study findings:

• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.

• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.

This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.

Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.

In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.

copyright Kativ/iStockphoto.com

• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.

• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.

• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.

• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.

• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.

• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.

It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).

When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.

Among the other study findings:

• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.

• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.

This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.

Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.

In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.

copyright Kativ/iStockphoto.com

• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.

• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.

• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.

• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.

• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.

• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.

It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).

When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.

Among the other study findings:

• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.

• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.

This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.

Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.

“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%

copyright decade3d/Thinkstock

This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.

[email protected]

Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.

“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%

copyright decade3d/Thinkstock

This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.

[email protected]

Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.

“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%

copyright decade3d/Thinkstock

This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.

[email protected]