Perioperative Medicine

CHICAGO – Reverse shoulder arthroplasty provides a surgical option for improving pain and ability in patients who have both arthritis and massive rotator cuff tear.

Before the procedure was approved for use in the United States in 2005, patients with this combination of conditions were very difficult to manage, said Dr. Matthew Saltzman at a symposium sponsored by the American College of Rheumatology.

"We didn’t have a solution for this problem for many, many years, but now I think we really do," said Dr. Saltzman, an orthopedic surgeon specializing in shoulder and elbow surgery at Northwestern University, Chicago.

Reverse shoulder arthroplasty basically changes the mechanics of the shoulder. It involves putting the ball in the socket, and putting the socket where the ball used to be, he said, adding that it’s "a strange concept, but it actually works."

"With reverse shoulder arthroplasty, you’re actually medializing the center of rotation, and this can be done to varying degrees depending on the implant design," he said, explaining that the procedure changes the tension on the deltoid muscle and allows the deltoid, rather than the irreparable rotator cuff musculature, to lift the arm.

Dr. Saltzman described two cases involving elderly women who underwent reverse shoulder arthroplasty and had excellent outcomes at 6-12 months. One was an 84-year-old who presented with a massive cuff tear as well as arthritis-related joint damage and loss of the joint space. Like many patients with these conditions, she had severe pain, pseudoparalysis of the shoulder, and resulting lack of function; she was able to lift her arm to only about 20 degrees.

At 6 months after the operation, she had no pain and was able to elevate her arm and rotate the arm out to the side.

The other patient was an 86-year-old who had previously lived independently, but who had slipped on ice and sustained multiple fractures of her shoulder. Although her problem wasn’t arthritis related, the reverse shoulder arthroplasty was successful, and she was able to return to independent living.

Findings from a study involving 240 consecutive reverse shoulder arthroplasty procedures in 232 patients (average age, nearly 73 years) showed that average forward elevation increased from 86 degrees to 137 degrees, and average constant score (a validated measure of shoulder function) improved from 23 to 60 at the latest follow-up, indicating substantial improvement, Dr. Saltzman said (J. Bone Joint Surg. Am. 2007;89:1476-85).

In that study, patients with cuff tear arthropathy, osteoarthritis plus cuff tear, or massive cuff tear fared better, whereas those with posttraumatic arthritis and those undergoing revision arthroplasty had worse outcomes.

Of course, patients need to be healthy enough to withstand surgery, but in appropriately selected patients this procedure provides a really nice result, he said.

"You’re taking a very severe problem and giving people a much better quality of life," he added.

Dr. Saltzman disclosed that he serves on the speakers bureau of Carefusion, has made paid presentations for DJO Surgical, and has received research support from Arthrex.

CHICAGO – Reverse shoulder arthroplasty provides a surgical option for improving pain and ability in patients who have both arthritis and massive rotator cuff tear.

Before the procedure was approved for use in the United States in 2005, patients with this combination of conditions were very difficult to manage, said Dr. Matthew Saltzman at a symposium sponsored by the American College of Rheumatology.

"We didn’t have a solution for this problem for many, many years, but now I think we really do," said Dr. Saltzman, an orthopedic surgeon specializing in shoulder and elbow surgery at Northwestern University, Chicago.

Reverse shoulder arthroplasty basically changes the mechanics of the shoulder. It involves putting the ball in the socket, and putting the socket where the ball used to be, he said, adding that it’s "a strange concept, but it actually works."

"With reverse shoulder arthroplasty, you’re actually medializing the center of rotation, and this can be done to varying degrees depending on the implant design," he said, explaining that the procedure changes the tension on the deltoid muscle and allows the deltoid, rather than the irreparable rotator cuff musculature, to lift the arm.

Dr. Saltzman described two cases involving elderly women who underwent reverse shoulder arthroplasty and had excellent outcomes at 6-12 months. One was an 84-year-old who presented with a massive cuff tear as well as arthritis-related joint damage and loss of the joint space. Like many patients with these conditions, she had severe pain, pseudoparalysis of the shoulder, and resulting lack of function; she was able to lift her arm to only about 20 degrees.

At 6 months after the operation, she had no pain and was able to elevate her arm and rotate the arm out to the side.

The other patient was an 86-year-old who had previously lived independently, but who had slipped on ice and sustained multiple fractures of her shoulder. Although her problem wasn’t arthritis related, the reverse shoulder arthroplasty was successful, and she was able to return to independent living.

Findings from a study involving 240 consecutive reverse shoulder arthroplasty procedures in 232 patients (average age, nearly 73 years) showed that average forward elevation increased from 86 degrees to 137 degrees, and average constant score (a validated measure of shoulder function) improved from 23 to 60 at the latest follow-up, indicating substantial improvement, Dr. Saltzman said (J. Bone Joint Surg. Am. 2007;89:1476-85).

In that study, patients with cuff tear arthropathy, osteoarthritis plus cuff tear, or massive cuff tear fared better, whereas those with posttraumatic arthritis and those undergoing revision arthroplasty had worse outcomes.

Of course, patients need to be healthy enough to withstand surgery, but in appropriately selected patients this procedure provides a really nice result, he said.

"You’re taking a very severe problem and giving people a much better quality of life," he added.

Dr. Saltzman disclosed that he serves on the speakers bureau of Carefusion, has made paid presentations for DJO Surgical, and has received research support from Arthrex.

CHICAGO – Reverse shoulder arthroplasty provides a surgical option for improving pain and ability in patients who have both arthritis and massive rotator cuff tear.

Before the procedure was approved for use in the United States in 2005, patients with this combination of conditions were very difficult to manage, said Dr. Matthew Saltzman at a symposium sponsored by the American College of Rheumatology.

"We didn’t have a solution for this problem for many, many years, but now I think we really do," said Dr. Saltzman, an orthopedic surgeon specializing in shoulder and elbow surgery at Northwestern University, Chicago.

Reverse shoulder arthroplasty basically changes the mechanics of the shoulder. It involves putting the ball in the socket, and putting the socket where the ball used to be, he said, adding that it’s "a strange concept, but it actually works."

"With reverse shoulder arthroplasty, you’re actually medializing the center of rotation, and this can be done to varying degrees depending on the implant design," he said, explaining that the procedure changes the tension on the deltoid muscle and allows the deltoid, rather than the irreparable rotator cuff musculature, to lift the arm.

Dr. Saltzman described two cases involving elderly women who underwent reverse shoulder arthroplasty and had excellent outcomes at 6-12 months. One was an 84-year-old who presented with a massive cuff tear as well as arthritis-related joint damage and loss of the joint space. Like many patients with these conditions, she had severe pain, pseudoparalysis of the shoulder, and resulting lack of function; she was able to lift her arm to only about 20 degrees.

At 6 months after the operation, she had no pain and was able to elevate her arm and rotate the arm out to the side.

The other patient was an 86-year-old who had previously lived independently, but who had slipped on ice and sustained multiple fractures of her shoulder. Although her problem wasn’t arthritis related, the reverse shoulder arthroplasty was successful, and she was able to return to independent living.

Findings from a study involving 240 consecutive reverse shoulder arthroplasty procedures in 232 patients (average age, nearly 73 years) showed that average forward elevation increased from 86 degrees to 137 degrees, and average constant score (a validated measure of shoulder function) improved from 23 to 60 at the latest follow-up, indicating substantial improvement, Dr. Saltzman said (J. Bone Joint Surg. Am. 2007;89:1476-85).

In that study, patients with cuff tear arthropathy, osteoarthritis plus cuff tear, or massive cuff tear fared better, whereas those with posttraumatic arthritis and those undergoing revision arthroplasty had worse outcomes.

Of course, patients need to be healthy enough to withstand surgery, but in appropriately selected patients this procedure provides a really nice result, he said.

"You’re taking a very severe problem and giving people a much better quality of life," he added.

Dr. Saltzman disclosed that he serves on the speakers bureau of Carefusion, has made paid presentations for DJO Surgical, and has received research support from Arthrex.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

Mortality after primary total hip arthroplasty has declined somewhat over time, and mortality after revision arthroplasty has remained stable, according to a report in the April 20 issue of JAMA.

In the 18-year longitudinal study of Medicare data, both of these reassuring trends occurred despite a substantial increase in patient complexity, said Dr. Peter Cram of the University of Iowa, Iowa City.

However, two concerning trends also were noted: The number of total hip arthroplasty patients discharged to postacute care facilities (such as nursing homes and rehabilitation centers) instead of to home increased substantially, and the number of hospital readmissions following total hip arthroplasty rose markedly.

Dr. Cram and his colleagues noted that objective evaluations of total hip arthroplasty outcomes are lacking in the literature. It is generally assumed that increasing experience with the procedure has inevitably produced better patient outcomes, "but rigorous empirical data documenting such improvement are limited."

They assessed trends in patient outcomes using data on Medicare fee-for-service beneficiaries who underwent primary (1,453,493 patients) or revision (348,596 patients) total hip arthroplasties over an 18-year period. "More than 60% of all total hip arthroplasty procedures are performed on Medicare enrollees, making this an appropriate data set for studying" the surgery.

During 1991-2008, the medical complexity of patients who underwent these procedures increased. For primary arthroplasty, the mean patient age rose from 74 to 75 years, the prevalence of diabetes more than doubled from 7% to 15%, and the prevalence of obesity more than tripled from 2% to 7%. The prevalence of heart failure climbed from just under 3% to just over 4%, and that of renal failure rose tenfold, from 0.4% to 4%. The mean number of comorbid conditions doubled from one to two.

Despite the increasing patient complexity, the mean 30-day mortality for primary total hip arthroplasty dropped from 0.7% to 0.3% during this interval, and mean 90-day mortality decreased from 1.3% to 0.7%, the investigators said (JAMA 2011;305:1560-7).

For revision hip arthroplasty, which often is done in an emergent setting, 30-day mortality remained steady at approximately 2% and 90-day mortality was steady at 4.5% throughout the study period.

For primary hip arthroplasty, hospital length of stay also decreased approximately 60% over time, from 9.1 days to 3.7 days. But this trend is not as encouraging as it appears to be at first glance, because the number of patients discharged to home declined dramatically, whereas the proportion discharged to skilled or intermediate care facilities approximately doubled.

In addition, the 30-day readmission rate, which some consider a gauge of the inappropriateness of a short length of stay (LOS), also rose markedly from 5.9% to 8.5%. The patterns were similar for revision hip arthroplasty, Dr. Cram and his associates said.

These LOS findings "may have policy implications." Hospitals clearly are motivated "to reduce LOS under the Medicare prospective payment system," but these results indicate that the practice is not benefiting patients.

This study was supported by the National Center for Research Resources, the Robert Wood Johnson Physician Faculty Scholars Program, and the National Heart, Lung, and Blood Institute. No financial conflicts of interest were reported.

Mortality after primary total hip arthroplasty has declined somewhat over time, and mortality after revision arthroplasty has remained stable, according to a report in the April 20 issue of JAMA.

In the 18-year longitudinal study of Medicare data, both of these reassuring trends occurred despite a substantial increase in patient complexity, said Dr. Peter Cram of the University of Iowa, Iowa City.

However, two concerning trends also were noted: The number of total hip arthroplasty patients discharged to postacute care facilities (such as nursing homes and rehabilitation centers) instead of to home increased substantially, and the number of hospital readmissions following total hip arthroplasty rose markedly.

Dr. Cram and his colleagues noted that objective evaluations of total hip arthroplasty outcomes are lacking in the literature. It is generally assumed that increasing experience with the procedure has inevitably produced better patient outcomes, "but rigorous empirical data documenting such improvement are limited."

They assessed trends in patient outcomes using data on Medicare fee-for-service beneficiaries who underwent primary (1,453,493 patients) or revision (348,596 patients) total hip arthroplasties over an 18-year period. "More than 60% of all total hip arthroplasty procedures are performed on Medicare enrollees, making this an appropriate data set for studying" the surgery.

During 1991-2008, the medical complexity of patients who underwent these procedures increased. For primary arthroplasty, the mean patient age rose from 74 to 75 years, the prevalence of diabetes more than doubled from 7% to 15%, and the prevalence of obesity more than tripled from 2% to 7%. The prevalence of heart failure climbed from just under 3% to just over 4%, and that of renal failure rose tenfold, from 0.4% to 4%. The mean number of comorbid conditions doubled from one to two.

Despite the increasing patient complexity, the mean 30-day mortality for primary total hip arthroplasty dropped from 0.7% to 0.3% during this interval, and mean 90-day mortality decreased from 1.3% to 0.7%, the investigators said (JAMA 2011;305:1560-7).

For revision hip arthroplasty, which often is done in an emergent setting, 30-day mortality remained steady at approximately 2% and 90-day mortality was steady at 4.5% throughout the study period.

For primary hip arthroplasty, hospital length of stay also decreased approximately 60% over time, from 9.1 days to 3.7 days. But this trend is not as encouraging as it appears to be at first glance, because the number of patients discharged to home declined dramatically, whereas the proportion discharged to skilled or intermediate care facilities approximately doubled.

In addition, the 30-day readmission rate, which some consider a gauge of the inappropriateness of a short length of stay (LOS), also rose markedly from 5.9% to 8.5%. The patterns were similar for revision hip arthroplasty, Dr. Cram and his associates said.

These LOS findings "may have policy implications." Hospitals clearly are motivated "to reduce LOS under the Medicare prospective payment system," but these results indicate that the practice is not benefiting patients.

This study was supported by the National Center for Research Resources, the Robert Wood Johnson Physician Faculty Scholars Program, and the National Heart, Lung, and Blood Institute. No financial conflicts of interest were reported.

Mortality after primary total hip arthroplasty has declined somewhat over time, and mortality after revision arthroplasty has remained stable, according to a report in the April 20 issue of JAMA.

In the 18-year longitudinal study of Medicare data, both of these reassuring trends occurred despite a substantial increase in patient complexity, said Dr. Peter Cram of the University of Iowa, Iowa City.

However, two concerning trends also were noted: The number of total hip arthroplasty patients discharged to postacute care facilities (such as nursing homes and rehabilitation centers) instead of to home increased substantially, and the number of hospital readmissions following total hip arthroplasty rose markedly.

Dr. Cram and his colleagues noted that objective evaluations of total hip arthroplasty outcomes are lacking in the literature. It is generally assumed that increasing experience with the procedure has inevitably produced better patient outcomes, "but rigorous empirical data documenting such improvement are limited."

They assessed trends in patient outcomes using data on Medicare fee-for-service beneficiaries who underwent primary (1,453,493 patients) or revision (348,596 patients) total hip arthroplasties over an 18-year period. "More than 60% of all total hip arthroplasty procedures are performed on Medicare enrollees, making this an appropriate data set for studying" the surgery.

During 1991-2008, the medical complexity of patients who underwent these procedures increased. For primary arthroplasty, the mean patient age rose from 74 to 75 years, the prevalence of diabetes more than doubled from 7% to 15%, and the prevalence of obesity more than tripled from 2% to 7%. The prevalence of heart failure climbed from just under 3% to just over 4%, and that of renal failure rose tenfold, from 0.4% to 4%. The mean number of comorbid conditions doubled from one to two.

Despite the increasing patient complexity, the mean 30-day mortality for primary total hip arthroplasty dropped from 0.7% to 0.3% during this interval, and mean 90-day mortality decreased from 1.3% to 0.7%, the investigators said (JAMA 2011;305:1560-7).

For revision hip arthroplasty, which often is done in an emergent setting, 30-day mortality remained steady at approximately 2% and 90-day mortality was steady at 4.5% throughout the study period.

For primary hip arthroplasty, hospital length of stay also decreased approximately 60% over time, from 9.1 days to 3.7 days. But this trend is not as encouraging as it appears to be at first glance, because the number of patients discharged to home declined dramatically, whereas the proportion discharged to skilled or intermediate care facilities approximately doubled.

In addition, the 30-day readmission rate, which some consider a gauge of the inappropriateness of a short length of stay (LOS), also rose markedly from 5.9% to 8.5%. The patterns were similar for revision hip arthroplasty, Dr. Cram and his associates said.

These LOS findings "may have policy implications." Hospitals clearly are motivated "to reduce LOS under the Medicare prospective payment system," but these results indicate that the practice is not benefiting patients.

This study was supported by the National Center for Research Resources, the Robert Wood Johnson Physician Faculty Scholars Program, and the National Heart, Lung, and Blood Institute. No financial conflicts of interest were reported.

A simple bedside technique – gently probing the loosely closed surgical incision to clean it – dramatically reduced infections of contaminated abdominal surgical wounds without increasing pain, according to a report in the April issue of Archives of Surgery.

Use of this wound-probing technique for surgical incisions "will reduce surgical site infection and decrease hospital stay, both of which may result in improved rates of long-term outcomes such as fascial dehiscence and incisional hernias, reduced labor for wound care by nursing staff and physicians, improved cosmetic outcome with primary closure, and possibly reduced overall cost," said Dr. Shirin Towfigh of Cedars-Sinai Medical Center, Los Angeles, and her associates.

"We recommend that wound probing be practiced in the first-line management of incisions after open surgery, such as bowel resection, in the face of contamination," they noted.

Until now, no local wound therapy – including topical antibiotics, subcutaneous drain placement, or delayed primary closure – has been proved to decrease surgical site infection in a rigorous clinical trial. "There is no standard wound management for contaminated wounds, [and] the topic has not been aggressively pursued for decades," the investigators said.

According to surveillance of nosocomial infections in the United States, the infection rate for contaminated surgical wounds is 7% overall, and can rise as high as 50% in certain subgroups of patients.

Some surgeons, including Dr. Towfigh, routinely use this probing technique and report good results anecdotally. In what they described as the first prospective clinical trial of the technique, Dr. Towfigh and her colleagues assessed surgical site infections in 76 adults who underwent appendectomy for perforated appendicitis at a single academic medical center over a 3-year period.

Half of the patients were randomly assigned to have standard primary skin closure with staples (control group), and the other half had loose primary skin closure with staples placed at 2-cm intervals. Postoperatively, the control group had daily swabbing of their closed incision with povidone iodine.

The intervention group had this standard postoperative care followed by wound probing in which dry, sterile, cotton-tip applicators were used to penetrate the skin and soft tissue between the staples, reaching down to the external oblique fascia. Any fluid that was extruded was blotted dry, and the wound was covered with a dry dressing. This process was repeated once daily until the wound was dry and no longer penetrable in this fashion, which usually took 3 days.

The two study groups were similar in terms of demographic characteristics as well as comorbidities that might affect wound healing, such as the presence of diabetes, larger abdominal girth, and higher body mass index. Both groups had similar incisional lengths (approximately 8 cm).

Study subjects were assessed throughout hospitalization, as well as at 2 weeks and 3 months following hospital discharge; 64% of subjects completed the 3-month follow-up. The primary outcome measure was the rate of surgical site infections, defined by both subjective daily evaluation by a surgical team blinded to treatment assignment and objective scores on the ASEPSIS (Additional Treatment, Presence of Serous Discharge, Erythema, Purulent Exudate, and Separation of the Deep Tissues, Isolation of Bacteria, and Duration of Inpatient Stay) instrument.

Only one patient (3%) in the intervention group developed surgical site infection, compared with seven patients (19%) in the control group (P = .03). Moreover, patients in the intervention group did not report greater pain than did those in the control group, either immediately after surgery or at follow-up, Dr. Towfigh and her associates said (Arch. Surg. 2011;146:448-52).

By reducing surgical site infections, the intervention also significantly decreased length of stay, compared with the control group (5 days vs. 7 days, respectively; P = .049), as well as the amount of time that caregivers spent on wound care.

"When primary closure fails or is deemed inappropriate, the wound is opened and allowed to close by secondary intention [that is, packing an open wound multiple times a day]. Closure by secondary intention can be painful to the patient, can be labor intensive, and has a poor cosmetic outcome. Nevertheless it is the most widely used closure technique in adults with contaminated wounds," the researchers said.

"We recommend that wound probing be practiced for contaminated wounds due to open appendectomy for perforated appendicitis. We believe that our results can also be extrapolated to other contaminated abdominal wounds regardless of their incisional length," they added.

The exact mechanism by which this technique prevents surgical site infection is not yet clear, but the investigators surmised that it "allows for drainage of contaminated fluid within the soft tissue, thus reducing the bacterial count while maintaining a moist wound for improved healing.

"We are currently analyzing the bacteriology data gathered from this study to gain insight into the process," Dr. Towfigh and her associates added.

This study was supported in part by a James H. Zumberge Faculty Research and Innovation grant from the University of Southern California, Los Angeles. No financial conflicts of interest were reported.

A simple bedside technique – gently probing the loosely closed surgical incision to clean it – dramatically reduced infections of contaminated abdominal surgical wounds without increasing pain, according to a report in the April issue of Archives of Surgery.

Use of this wound-probing technique for surgical incisions "will reduce surgical site infection and decrease hospital stay, both of which may result in improved rates of long-term outcomes such as fascial dehiscence and incisional hernias, reduced labor for wound care by nursing staff and physicians, improved cosmetic outcome with primary closure, and possibly reduced overall cost," said Dr. Shirin Towfigh of Cedars-Sinai Medical Center, Los Angeles, and her associates.

"We recommend that wound probing be practiced in the first-line management of incisions after open surgery, such as bowel resection, in the face of contamination," they noted.

Until now, no local wound therapy – including topical antibiotics, subcutaneous drain placement, or delayed primary closure – has been proved to decrease surgical site infection in a rigorous clinical trial. "There is no standard wound management for contaminated wounds, [and] the topic has not been aggressively pursued for decades," the investigators said.

According to surveillance of nosocomial infections in the United States, the infection rate for contaminated surgical wounds is 7% overall, and can rise as high as 50% in certain subgroups of patients.

Some surgeons, including Dr. Towfigh, routinely use this probing technique and report good results anecdotally. In what they described as the first prospective clinical trial of the technique, Dr. Towfigh and her colleagues assessed surgical site infections in 76 adults who underwent appendectomy for perforated appendicitis at a single academic medical center over a 3-year period.

Half of the patients were randomly assigned to have standard primary skin closure with staples (control group), and the other half had loose primary skin closure with staples placed at 2-cm intervals. Postoperatively, the control group had daily swabbing of their closed incision with povidone iodine.

The intervention group had this standard postoperative care followed by wound probing in which dry, sterile, cotton-tip applicators were used to penetrate the skin and soft tissue between the staples, reaching down to the external oblique fascia. Any fluid that was extruded was blotted dry, and the wound was covered with a dry dressing. This process was repeated once daily until the wound was dry and no longer penetrable in this fashion, which usually took 3 days.

The two study groups were similar in terms of demographic characteristics as well as comorbidities that might affect wound healing, such as the presence of diabetes, larger abdominal girth, and higher body mass index. Both groups had similar incisional lengths (approximately 8 cm).

Study subjects were assessed throughout hospitalization, as well as at 2 weeks and 3 months following hospital discharge; 64% of subjects completed the 3-month follow-up. The primary outcome measure was the rate of surgical site infections, defined by both subjective daily evaluation by a surgical team blinded to treatment assignment and objective scores on the ASEPSIS (Additional Treatment, Presence of Serous Discharge, Erythema, Purulent Exudate, and Separation of the Deep Tissues, Isolation of Bacteria, and Duration of Inpatient Stay) instrument.

Only one patient (3%) in the intervention group developed surgical site infection, compared with seven patients (19%) in the control group (P = .03). Moreover, patients in the intervention group did not report greater pain than did those in the control group, either immediately after surgery or at follow-up, Dr. Towfigh and her associates said (Arch. Surg. 2011;146:448-52).

By reducing surgical site infections, the intervention also significantly decreased length of stay, compared with the control group (5 days vs. 7 days, respectively; P = .049), as well as the amount of time that caregivers spent on wound care.

"When primary closure fails or is deemed inappropriate, the wound is opened and allowed to close by secondary intention [that is, packing an open wound multiple times a day]. Closure by secondary intention can be painful to the patient, can be labor intensive, and has a poor cosmetic outcome. Nevertheless it is the most widely used closure technique in adults with contaminated wounds," the researchers said.

"We recommend that wound probing be practiced for contaminated wounds due to open appendectomy for perforated appendicitis. We believe that our results can also be extrapolated to other contaminated abdominal wounds regardless of their incisional length," they added.

The exact mechanism by which this technique prevents surgical site infection is not yet clear, but the investigators surmised that it "allows for drainage of contaminated fluid within the soft tissue, thus reducing the bacterial count while maintaining a moist wound for improved healing.

"We are currently analyzing the bacteriology data gathered from this study to gain insight into the process," Dr. Towfigh and her associates added.

This study was supported in part by a James H. Zumberge Faculty Research and Innovation grant from the University of Southern California, Los Angeles. No financial conflicts of interest were reported.

A simple bedside technique – gently probing the loosely closed surgical incision to clean it – dramatically reduced infections of contaminated abdominal surgical wounds without increasing pain, according to a report in the April issue of Archives of Surgery.

Use of this wound-probing technique for surgical incisions "will reduce surgical site infection and decrease hospital stay, both of which may result in improved rates of long-term outcomes such as fascial dehiscence and incisional hernias, reduced labor for wound care by nursing staff and physicians, improved cosmetic outcome with primary closure, and possibly reduced overall cost," said Dr. Shirin Towfigh of Cedars-Sinai Medical Center, Los Angeles, and her associates.

"We recommend that wound probing be practiced in the first-line management of incisions after open surgery, such as bowel resection, in the face of contamination," they noted.

Until now, no local wound therapy – including topical antibiotics, subcutaneous drain placement, or delayed primary closure – has been proved to decrease surgical site infection in a rigorous clinical trial. "There is no standard wound management for contaminated wounds, [and] the topic has not been aggressively pursued for decades," the investigators said.

According to surveillance of nosocomial infections in the United States, the infection rate for contaminated surgical wounds is 7% overall, and can rise as high as 50% in certain subgroups of patients.

Some surgeons, including Dr. Towfigh, routinely use this probing technique and report good results anecdotally. In what they described as the first prospective clinical trial of the technique, Dr. Towfigh and her colleagues assessed surgical site infections in 76 adults who underwent appendectomy for perforated appendicitis at a single academic medical center over a 3-year period.

Half of the patients were randomly assigned to have standard primary skin closure with staples (control group), and the other half had loose primary skin closure with staples placed at 2-cm intervals. Postoperatively, the control group had daily swabbing of their closed incision with povidone iodine.

The intervention group had this standard postoperative care followed by wound probing in which dry, sterile, cotton-tip applicators were used to penetrate the skin and soft tissue between the staples, reaching down to the external oblique fascia. Any fluid that was extruded was blotted dry, and the wound was covered with a dry dressing. This process was repeated once daily until the wound was dry and no longer penetrable in this fashion, which usually took 3 days.

The two study groups were similar in terms of demographic characteristics as well as comorbidities that might affect wound healing, such as the presence of diabetes, larger abdominal girth, and higher body mass index. Both groups had similar incisional lengths (approximately 8 cm).

Study subjects were assessed throughout hospitalization, as well as at 2 weeks and 3 months following hospital discharge; 64% of subjects completed the 3-month follow-up. The primary outcome measure was the rate of surgical site infections, defined by both subjective daily evaluation by a surgical team blinded to treatment assignment and objective scores on the ASEPSIS (Additional Treatment, Presence of Serous Discharge, Erythema, Purulent Exudate, and Separation of the Deep Tissues, Isolation of Bacteria, and Duration of Inpatient Stay) instrument.

Only one patient (3%) in the intervention group developed surgical site infection, compared with seven patients (19%) in the control group (P = .03). Moreover, patients in the intervention group did not report greater pain than did those in the control group, either immediately after surgery or at follow-up, Dr. Towfigh and her associates said (Arch. Surg. 2011;146:448-52).

By reducing surgical site infections, the intervention also significantly decreased length of stay, compared with the control group (5 days vs. 7 days, respectively; P = .049), as well as the amount of time that caregivers spent on wound care.

"When primary closure fails or is deemed inappropriate, the wound is opened and allowed to close by secondary intention [that is, packing an open wound multiple times a day]. Closure by secondary intention can be painful to the patient, can be labor intensive, and has a poor cosmetic outcome. Nevertheless it is the most widely used closure technique in adults with contaminated wounds," the researchers said.

"We recommend that wound probing be practiced for contaminated wounds due to open appendectomy for perforated appendicitis. We believe that our results can also be extrapolated to other contaminated abdominal wounds regardless of their incisional length," they added.

The exact mechanism by which this technique prevents surgical site infection is not yet clear, but the investigators surmised that it "allows for drainage of contaminated fluid within the soft tissue, thus reducing the bacterial count while maintaining a moist wound for improved healing.

"We are currently analyzing the bacteriology data gathered from this study to gain insight into the process," Dr. Towfigh and her associates added.

This study was supported in part by a James H. Zumberge Faculty Research and Innovation grant from the University of Southern California, Los Angeles. No financial conflicts of interest were reported.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

Robotic surgery is continuing to expand its reach, with widespread interest in the technology for endometrial cancer staging and recent exploration of its viability for complex pancreatic resections and reconstructions.

Gynecologic oncologists and pancreatic surgeons aren’t the only ones vying for time with the da Vinci Surgical System (Intuitive Surgical) – the only such system currently on the market. Their experiences, however, offer perspective on some of the key issues – from operative time and cost effectiveness to training needs – that are being raised as robotic technology is adopted.

Photo credit: University of Pittsburgh Medical Center

Pancreatic Surgery

"Robotic-assisted pancreatic resections and reconstructions can be performed safely with postoperative complication rates and fistula formation comparable to results observed with open techniques," according to Dr. Herbert J. Zeh III, and Dr. A. James Moser, codirectors of University of Pittsburgh Medical Center’s pancreatic cancer center, who reported their results with 30 robotic-assisted major pancreatic resections and reconstructions, including 24 pancreaticoduodenectomies (Arch. Surg. 2011:146:256-61).

By now, they said in an interview, they have used a robotic approach for more than 110 major pancreatic resections and reconstructions, including approximately 60 robotic-assisted pancreaticoduodenectomies, or Whipple procedures.

Together with surgeons at the Cleveland Clinic, the Mayo Clinic in Rochester, Minn., and the University of Pisa in Italy, Dr. Moser and Dr. Zeh have pooled outcomes data, and a combined report has been submitted for publication.

"We’ve established comparable safety, and we’re at the point now where our operating times are dropping steadily and we can start to see feasibility and applicability down the road," said Dr. Zeh of the department of surgery at the University of Pittsburgh. "In the next year or two, we’ll start to see whether there are real advantages such as decreased blood loss and better outcomes resulting from a diminished physiologic impact on the patient."

Reductions in postoperative morbidity could make the complex Whipple procedure "less fearsome" for many of the patients with early pancreatic cancer who currently refuse definitive treatment. Robotic surgery might also enable more patients to recover quickly and be well enough to complete chemotherapy, said Dr. Moser of the departments of surgery and cell biology at the university. With the open approach, almost 40%-50% of patients never recover enough to complete their chemotherapy regimens, he said.

Dr. Moser and Dr. Zeh, neither of whom has any financial relationship with Intuitive, began exploring minimally invasive approaches to the Whipple procedure about 2½ years ago. They have been using laparoscopy for distal pancreatectomies since 2001, but were concerned about their ability to take a traditional laparoscopic approach with the Whipple procedure, which involves complex reconstruction.

"The first laparoscopic pancreaticoduodenectomy was described in 1994, and between then and 2010 there were only about 150 cases reported. It didn’t catch on. I think it’s because it takes such a Herculean effort to overcome the limits of the technology [with its two-dimensional imaging and limited range of instrument motion]," said Dr. Zeh.

"We wanted to completely duplicate the open Whipple with a minimally invasive technique without making any compromises or altering any surgical principles because of the limitations of the technology," added Dr. Moser.

Dr. Michael L. Kendrick, who last year published one of the two largest series of totally laparoscopic Whipple procedures, covering 62 patients (Arch. Surg. 2010;145:19-23), maintains that he makes "no alternations or adaptations in surgical principle" with the purely laparoscopic approach, compared with open surgery.

Whether this approach or a robotic-assisted laparoscopic approach is best for patients needing a pancreaticoduodenectomy appears at this time to be "completely the surgeon’s choice" and not driven by any patient characteristics or clinical indications, according to Dr. Kendrick, who chairs the division of gastroenterologic and general surgery at the Mayo Clinic. Proving "any additional clinical advantage of robotic assistance over pure laparoscopy will be very difficult and is unlikely," he said, but "pancreas surgeons may prefer the robotic approach because it is easier to learn and master."

Dr. Kendrick’s experience might be unique. He performed his first laparoscopic Whipple procedure in 2007 and then added the robotic-assisted Whipple to his armamentarium in 2008. To date, he has performed approximately 135 minimally invasive pancreaticoduodenectomies, of which about 30 have been robotically assisted.

The Pittsburgh surgeons, who perform their robotic-assisted Whipple procedures together, place the learning curve for robotic-assisted Whipple at approximately 60 operations – about the same number experts consider necessary with the open approach. While the median operating time in their first reported series of robotic-assisted pancreaticoduodenectomies was almost 9 ½ hours (at least several hours longer than needed for an experienced surgeon to complete an open Whipple), it has steadily dropped to 7-8 hours, they said.

An early laparoscopic Whipple for Dr. Kendrick also took approximately 10 hours, "but within 20-30 cases, it was down to 4 or 5 hours, sometimes 6," he said. "There’s a lower average operative time for laparoscopic Whipple ... but [in the end], is that really an important factor if the patient still gains the benefits of [the minimally invasive surgery]?"

Gynecologic Surgery

In gynecologic oncology, where robotic surgery in recent years has been rapidly embraced as a tool for performing minimally invasive endometrial cancer staging, operating time and cost are factors in an "ongoing debate in over whether robotics provides an advantage over laparoscopy for lymph node dissection," said Dr. James E. Delmore, director of gynecologic oncology for the University of Kansas, Wichita.

At least a half-dozen studies have found that robotic-assisted hysterectomy and lymphadenectomy for endometrial cancer results in significantly shorter hospital stays as well as fewer wound infections and postoperative complications compared with an open approach, according to Dr. Delmore, who has served as a proctor for Intuitive. However, fewer studies have compared all three approaches (robotic assisted, traditional laparoscopy, and open).

"It’s hard to determine and analyze procedure costs in many hospital systems," he said. But "from what we can tell thus far, purely laparoscopic hysterectomy with removal of the lymph nodes is the least expensive approach, followed by robotics and then abdominal."

Such cost differentials were demonstrated in a study comparing the outcomes and cost of endometrial cancer staging performed via traditional laparotomy, standard laparoscopy, and robotic techniques. Dr. Maria C. Bell performed all of the procedures (40 robotic, 40 laparotomy, and 30 laparoscopic) at the Sanford Clinic in Sioux Falls, S.D.

Robotic hysterectomy took about an hour longer to perform than did hysterectomy completed via laparotomy (with no significant difference in operating time, compared with pure laparoscopy), but resulted in the lowest complication rate of the three approaches and the shortest average return to normal activity. Estimated blood loss and average length of stay were both significantly reduced for the robotic cohort, compared with laparotomy, and were comparable to laparoscopy. There were no differences in lymph node retrieval among the three groups (Gyn. Oncol. 2008;111:407-11).

When both direct and indirect costs were considered (including a measure by the Lewin Group of "societal/productivity" costs and the cost of the robot on a 5-year amortization schedule), the total average costs for hysterectomy with staging were $12,943 with laparotomy, $7,569 for standard laparoscopy, and $8,212 for robotic assistance.

The overall decreased cost for robotic surgery was unexpected and could be a result of money "invested up front [being] recouped by less time rounding ... and less time taking care of complications," as well as lower societal costs, wrote Dr. Bell, also of the University of South Dakota, Vermillion.

"I was very surprised that laparotomy was the most costly to the hospital," Dr. Bell said in an interview. (One of the coauthors of the report, Usha Seshadri-Kreaden, is employed by Intuitive, and Dr. Bell is a proctor for Intuitive, but the company did not sponsor the study.)

Other investigators who have compared robotic-assisted and conventional laparoscopic hysterectomies have reported higher per-case hospital costs with the robot. With hysterectomy having surpassed prostatectomy in 2010 as the highest-volume procedure for the da Vinci Surgical System, according to its manufacturer, the value of robotics for routine hysterectomy may well be increasingly scrutinized.

The da Vinci is used to treat more than 90% of endometrial cancer patients at Dr. Bell’s and Dr. Delmore’s institutions, but both surgeons are quick to emphasize the need for more data on outcomes and cost-effectiveness. "The temptation of ‘the patient wants it, so we need to offer it’ needs to be tempered with the question ‘are we making progress doing it?’ " said Dr. Delmore.

Training Needs

Institutions are individually grappling with how best to train residents in robotic-assisted surgery. The University of Kansas model includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies. Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. use this training.

Within the realm of hepatobiliary and pancreatic surgery, where a minimally invasive approach is younger and where training models for the open Whipple procedure are still deliberated, "there is a dramatic appetite for minimally invasive skills," Dr. Kendrick said. HBP fellows at the Mayo Clinic currently are exposed to minimally invasive surgery, but "our goal over the next 2 years is to incorporate an even more significant focus" on robotics and laparoscopy, he said.

At the University of Pittsburgh, surgical oncology and HBP fellows and residents receive training with the robot in a "dry lab" format, Dr. Moser said. Trainees also can sit during actual cases at a second "teaching console" that is part of the current da Vinci Surgical System.

"We typically teach robotic cholecystectomy and sewing of the duodenojejunostomy during the Whipple procedure and allow them to do these portions of the procedure," Dr. Moser said.

Dr. Kendrick, who said he has no disclosures to make relevant to this article, hopes to see several fellowships established nationwide to address minimally invasive pancreas and liver surgery. However, "we have to be cautious about credentialing and assessing the adequacy of training. There’s a real mortality rate and a major complication rate [with the Whipple procedure] ... We’re trying to make it lower and lower with time, and not go backward."

Robotic surgery is continuing to expand its reach, with widespread interest in the technology for endometrial cancer staging and recent exploration of its viability for complex pancreatic resections and reconstructions.

Gynecologic oncologists and pancreatic surgeons aren’t the only ones vying for time with the da Vinci Surgical System (Intuitive Surgical) – the only such system currently on the market. Their experiences, however, offer perspective on some of the key issues – from operative time and cost effectiveness to training needs – that are being raised as robotic technology is adopted.

Photo credit: University of Pittsburgh Medical Center

Pancreatic Surgery

"Robotic-assisted pancreatic resections and reconstructions can be performed safely with postoperative complication rates and fistula formation comparable to results observed with open techniques," according to Dr. Herbert J. Zeh III, and Dr. A. James Moser, codirectors of University of Pittsburgh Medical Center’s pancreatic cancer center, who reported their results with 30 robotic-assisted major pancreatic resections and reconstructions, including 24 pancreaticoduodenectomies (Arch. Surg. 2011:146:256-61).

By now, they said in an interview, they have used a robotic approach for more than 110 major pancreatic resections and reconstructions, including approximately 60 robotic-assisted pancreaticoduodenectomies, or Whipple procedures.

Together with surgeons at the Cleveland Clinic, the Mayo Clinic in Rochester, Minn., and the University of Pisa in Italy, Dr. Moser and Dr. Zeh have pooled outcomes data, and a combined report has been submitted for publication.

"We’ve established comparable safety, and we’re at the point now where our operating times are dropping steadily and we can start to see feasibility and applicability down the road," said Dr. Zeh of the department of surgery at the University of Pittsburgh. "In the next year or two, we’ll start to see whether there are real advantages such as decreased blood loss and better outcomes resulting from a diminished physiologic impact on the patient."

Reductions in postoperative morbidity could make the complex Whipple procedure "less fearsome" for many of the patients with early pancreatic cancer who currently refuse definitive treatment. Robotic surgery might also enable more patients to recover quickly and be well enough to complete chemotherapy, said Dr. Moser of the departments of surgery and cell biology at the university. With the open approach, almost 40%-50% of patients never recover enough to complete their chemotherapy regimens, he said.

Dr. Moser and Dr. Zeh, neither of whom has any financial relationship with Intuitive, began exploring minimally invasive approaches to the Whipple procedure about 2½ years ago. They have been using laparoscopy for distal pancreatectomies since 2001, but were concerned about their ability to take a traditional laparoscopic approach with the Whipple procedure, which involves complex reconstruction.

"The first laparoscopic pancreaticoduodenectomy was described in 1994, and between then and 2010 there were only about 150 cases reported. It didn’t catch on. I think it’s because it takes such a Herculean effort to overcome the limits of the technology [with its two-dimensional imaging and limited range of instrument motion]," said Dr. Zeh.

"We wanted to completely duplicate the open Whipple with a minimally invasive technique without making any compromises or altering any surgical principles because of the limitations of the technology," added Dr. Moser.

Dr. Michael L. Kendrick, who last year published one of the two largest series of totally laparoscopic Whipple procedures, covering 62 patients (Arch. Surg. 2010;145:19-23), maintains that he makes "no alternations or adaptations in surgical principle" with the purely laparoscopic approach, compared with open surgery.

Whether this approach or a robotic-assisted laparoscopic approach is best for patients needing a pancreaticoduodenectomy appears at this time to be "completely the surgeon’s choice" and not driven by any patient characteristics or clinical indications, according to Dr. Kendrick, who chairs the division of gastroenterologic and general surgery at the Mayo Clinic. Proving "any additional clinical advantage of robotic assistance over pure laparoscopy will be very difficult and is unlikely," he said, but "pancreas surgeons may prefer the robotic approach because it is easier to learn and master."

Dr. Kendrick’s experience might be unique. He performed his first laparoscopic Whipple procedure in 2007 and then added the robotic-assisted Whipple to his armamentarium in 2008. To date, he has performed approximately 135 minimally invasive pancreaticoduodenectomies, of which about 30 have been robotically assisted.

The Pittsburgh surgeons, who perform their robotic-assisted Whipple procedures together, place the learning curve for robotic-assisted Whipple at approximately 60 operations – about the same number experts consider necessary with the open approach. While the median operating time in their first reported series of robotic-assisted pancreaticoduodenectomies was almost 9 ½ hours (at least several hours longer than needed for an experienced surgeon to complete an open Whipple), it has steadily dropped to 7-8 hours, they said.

An early laparoscopic Whipple for Dr. Kendrick also took approximately 10 hours, "but within 20-30 cases, it was down to 4 or 5 hours, sometimes 6," he said. "There’s a lower average operative time for laparoscopic Whipple ... but [in the end], is that really an important factor if the patient still gains the benefits of [the minimally invasive surgery]?"

Gynecologic Surgery

In gynecologic oncology, where robotic surgery in recent years has been rapidly embraced as a tool for performing minimally invasive endometrial cancer staging, operating time and cost are factors in an "ongoing debate in over whether robotics provides an advantage over laparoscopy for lymph node dissection," said Dr. James E. Delmore, director of gynecologic oncology for the University of Kansas, Wichita.

At least a half-dozen studies have found that robotic-assisted hysterectomy and lymphadenectomy for endometrial cancer results in significantly shorter hospital stays as well as fewer wound infections and postoperative complications compared with an open approach, according to Dr. Delmore, who has served as a proctor for Intuitive. However, fewer studies have compared all three approaches (robotic assisted, traditional laparoscopy, and open).

"It’s hard to determine and analyze procedure costs in many hospital systems," he said. But "from what we can tell thus far, purely laparoscopic hysterectomy with removal of the lymph nodes is the least expensive approach, followed by robotics and then abdominal."

Such cost differentials were demonstrated in a study comparing the outcomes and cost of endometrial cancer staging performed via traditional laparotomy, standard laparoscopy, and robotic techniques. Dr. Maria C. Bell performed all of the procedures (40 robotic, 40 laparotomy, and 30 laparoscopic) at the Sanford Clinic in Sioux Falls, S.D.

Robotic hysterectomy took about an hour longer to perform than did hysterectomy completed via laparotomy (with no significant difference in operating time, compared with pure laparoscopy), but resulted in the lowest complication rate of the three approaches and the shortest average return to normal activity. Estimated blood loss and average length of stay were both significantly reduced for the robotic cohort, compared with laparotomy, and were comparable to laparoscopy. There were no differences in lymph node retrieval among the three groups (Gyn. Oncol. 2008;111:407-11).

When both direct and indirect costs were considered (including a measure by the Lewin Group of "societal/productivity" costs and the cost of the robot on a 5-year amortization schedule), the total average costs for hysterectomy with staging were $12,943 with laparotomy, $7,569 for standard laparoscopy, and $8,212 for robotic assistance.

The overall decreased cost for robotic surgery was unexpected and could be a result of money "invested up front [being] recouped by less time rounding ... and less time taking care of complications," as well as lower societal costs, wrote Dr. Bell, also of the University of South Dakota, Vermillion.

"I was very surprised that laparotomy was the most costly to the hospital," Dr. Bell said in an interview. (One of the coauthors of the report, Usha Seshadri-Kreaden, is employed by Intuitive, and Dr. Bell is a proctor for Intuitive, but the company did not sponsor the study.)

Other investigators who have compared robotic-assisted and conventional laparoscopic hysterectomies have reported higher per-case hospital costs with the robot. With hysterectomy having surpassed prostatectomy in 2010 as the highest-volume procedure for the da Vinci Surgical System, according to its manufacturer, the value of robotics for routine hysterectomy may well be increasingly scrutinized.

The da Vinci is used to treat more than 90% of endometrial cancer patients at Dr. Bell’s and Dr. Delmore’s institutions, but both surgeons are quick to emphasize the need for more data on outcomes and cost-effectiveness. "The temptation of ‘the patient wants it, so we need to offer it’ needs to be tempered with the question ‘are we making progress doing it?’ " said Dr. Delmore.

Training Needs

Institutions are individually grappling with how best to train residents in robotic-assisted surgery. The University of Kansas model includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies. Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. use this training.

Within the realm of hepatobiliary and pancreatic surgery, where a minimally invasive approach is younger and where training models for the open Whipple procedure are still deliberated, "there is a dramatic appetite for minimally invasive skills," Dr. Kendrick said. HBP fellows at the Mayo Clinic currently are exposed to minimally invasive surgery, but "our goal over the next 2 years is to incorporate an even more significant focus" on robotics and laparoscopy, he said.

At the University of Pittsburgh, surgical oncology and HBP fellows and residents receive training with the robot in a "dry lab" format, Dr. Moser said. Trainees also can sit during actual cases at a second "teaching console" that is part of the current da Vinci Surgical System.

"We typically teach robotic cholecystectomy and sewing of the duodenojejunostomy during the Whipple procedure and allow them to do these portions of the procedure," Dr. Moser said.

Dr. Kendrick, who said he has no disclosures to make relevant to this article, hopes to see several fellowships established nationwide to address minimally invasive pancreas and liver surgery. However, "we have to be cautious about credentialing and assessing the adequacy of training. There’s a real mortality rate and a major complication rate [with the Whipple procedure] ... We’re trying to make it lower and lower with time, and not go backward."

Robotic surgery is continuing to expand its reach, with widespread interest in the technology for endometrial cancer staging and recent exploration of its viability for complex pancreatic resections and reconstructions.

Gynecologic oncologists and pancreatic surgeons aren’t the only ones vying for time with the da Vinci Surgical System (Intuitive Surgical) – the only such system currently on the market. Their experiences, however, offer perspective on some of the key issues – from operative time and cost effectiveness to training needs – that are being raised as robotic technology is adopted.

Photo credit: University of Pittsburgh Medical Center

Pancreatic Surgery

"Robotic-assisted pancreatic resections and reconstructions can be performed safely with postoperative complication rates and fistula formation comparable to results observed with open techniques," according to Dr. Herbert J. Zeh III, and Dr. A. James Moser, codirectors of University of Pittsburgh Medical Center’s pancreatic cancer center, who reported their results with 30 robotic-assisted major pancreatic resections and reconstructions, including 24 pancreaticoduodenectomies (Arch. Surg. 2011:146:256-61).

By now, they said in an interview, they have used a robotic approach for more than 110 major pancreatic resections and reconstructions, including approximately 60 robotic-assisted pancreaticoduodenectomies, or Whipple procedures.

Together with surgeons at the Cleveland Clinic, the Mayo Clinic in Rochester, Minn., and the University of Pisa in Italy, Dr. Moser and Dr. Zeh have pooled outcomes data, and a combined report has been submitted for publication.

"We’ve established comparable safety, and we’re at the point now where our operating times are dropping steadily and we can start to see feasibility and applicability down the road," said Dr. Zeh of the department of surgery at the University of Pittsburgh. "In the next year or two, we’ll start to see whether there are real advantages such as decreased blood loss and better outcomes resulting from a diminished physiologic impact on the patient."

Reductions in postoperative morbidity could make the complex Whipple procedure "less fearsome" for many of the patients with early pancreatic cancer who currently refuse definitive treatment. Robotic surgery might also enable more patients to recover quickly and be well enough to complete chemotherapy, said Dr. Moser of the departments of surgery and cell biology at the university. With the open approach, almost 40%-50% of patients never recover enough to complete their chemotherapy regimens, he said.

Dr. Moser and Dr. Zeh, neither of whom has any financial relationship with Intuitive, began exploring minimally invasive approaches to the Whipple procedure about 2½ years ago. They have been using laparoscopy for distal pancreatectomies since 2001, but were concerned about their ability to take a traditional laparoscopic approach with the Whipple procedure, which involves complex reconstruction.

"The first laparoscopic pancreaticoduodenectomy was described in 1994, and between then and 2010 there were only about 150 cases reported. It didn’t catch on. I think it’s because it takes such a Herculean effort to overcome the limits of the technology [with its two-dimensional imaging and limited range of instrument motion]," said Dr. Zeh.

"We wanted to completely duplicate the open Whipple with a minimally invasive technique without making any compromises or altering any surgical principles because of the limitations of the technology," added Dr. Moser.

Dr. Michael L. Kendrick, who last year published one of the two largest series of totally laparoscopic Whipple procedures, covering 62 patients (Arch. Surg. 2010;145:19-23), maintains that he makes "no alternations or adaptations in surgical principle" with the purely laparoscopic approach, compared with open surgery.

Whether this approach or a robotic-assisted laparoscopic approach is best for patients needing a pancreaticoduodenectomy appears at this time to be "completely the surgeon’s choice" and not driven by any patient characteristics or clinical indications, according to Dr. Kendrick, who chairs the division of gastroenterologic and general surgery at the Mayo Clinic. Proving "any additional clinical advantage of robotic assistance over pure laparoscopy will be very difficult and is unlikely," he said, but "pancreas surgeons may prefer the robotic approach because it is easier to learn and master."

Dr. Kendrick’s experience might be unique. He performed his first laparoscopic Whipple procedure in 2007 and then added the robotic-assisted Whipple to his armamentarium in 2008. To date, he has performed approximately 135 minimally invasive pancreaticoduodenectomies, of which about 30 have been robotically assisted.

The Pittsburgh surgeons, who perform their robotic-assisted Whipple procedures together, place the learning curve for robotic-assisted Whipple at approximately 60 operations – about the same number experts consider necessary with the open approach. While the median operating time in their first reported series of robotic-assisted pancreaticoduodenectomies was almost 9 ½ hours (at least several hours longer than needed for an experienced surgeon to complete an open Whipple), it has steadily dropped to 7-8 hours, they said.

An early laparoscopic Whipple for Dr. Kendrick also took approximately 10 hours, "but within 20-30 cases, it was down to 4 or 5 hours, sometimes 6," he said. "There’s a lower average operative time for laparoscopic Whipple ... but [in the end], is that really an important factor if the patient still gains the benefits of [the minimally invasive surgery]?"

Gynecologic Surgery

In gynecologic oncology, where robotic surgery in recent years has been rapidly embraced as a tool for performing minimally invasive endometrial cancer staging, operating time and cost are factors in an "ongoing debate in over whether robotics provides an advantage over laparoscopy for lymph node dissection," said Dr. James E. Delmore, director of gynecologic oncology for the University of Kansas, Wichita.

At least a half-dozen studies have found that robotic-assisted hysterectomy and lymphadenectomy for endometrial cancer results in significantly shorter hospital stays as well as fewer wound infections and postoperative complications compared with an open approach, according to Dr. Delmore, who has served as a proctor for Intuitive. However, fewer studies have compared all three approaches (robotic assisted, traditional laparoscopy, and open).

"It’s hard to determine and analyze procedure costs in many hospital systems," he said. But "from what we can tell thus far, purely laparoscopic hysterectomy with removal of the lymph nodes is the least expensive approach, followed by robotics and then abdominal."

Such cost differentials were demonstrated in a study comparing the outcomes and cost of endometrial cancer staging performed via traditional laparotomy, standard laparoscopy, and robotic techniques. Dr. Maria C. Bell performed all of the procedures (40 robotic, 40 laparotomy, and 30 laparoscopic) at the Sanford Clinic in Sioux Falls, S.D.

Robotic hysterectomy took about an hour longer to perform than did hysterectomy completed via laparotomy (with no significant difference in operating time, compared with pure laparoscopy), but resulted in the lowest complication rate of the three approaches and the shortest average return to normal activity. Estimated blood loss and average length of stay were both significantly reduced for the robotic cohort, compared with laparotomy, and were comparable to laparoscopy. There were no differences in lymph node retrieval among the three groups (Gyn. Oncol. 2008;111:407-11).

When both direct and indirect costs were considered (including a measure by the Lewin Group of "societal/productivity" costs and the cost of the robot on a 5-year amortization schedule), the total average costs for hysterectomy with staging were $12,943 with laparotomy, $7,569 for standard laparoscopy, and $8,212 for robotic assistance.

The overall decreased cost for robotic surgery was unexpected and could be a result of money "invested up front [being] recouped by less time rounding ... and less time taking care of complications," as well as lower societal costs, wrote Dr. Bell, also of the University of South Dakota, Vermillion.

"I was very surprised that laparotomy was the most costly to the hospital," Dr. Bell said in an interview. (One of the coauthors of the report, Usha Seshadri-Kreaden, is employed by Intuitive, and Dr. Bell is a proctor for Intuitive, but the company did not sponsor the study.)

Other investigators who have compared robotic-assisted and conventional laparoscopic hysterectomies have reported higher per-case hospital costs with the robot. With hysterectomy having surpassed prostatectomy in 2010 as the highest-volume procedure for the da Vinci Surgical System, according to its manufacturer, the value of robotics for routine hysterectomy may well be increasingly scrutinized.

The da Vinci is used to treat more than 90% of endometrial cancer patients at Dr. Bell’s and Dr. Delmore’s institutions, but both surgeons are quick to emphasize the need for more data on outcomes and cost-effectiveness. "The temptation of ‘the patient wants it, so we need to offer it’ needs to be tempered with the question ‘are we making progress doing it?’ " said Dr. Delmore.

Training Needs

Institutions are individually grappling with how best to train residents in robotic-assisted surgery. The University of Kansas model includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies. Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. use this training.

Within the realm of hepatobiliary and pancreatic surgery, where a minimally invasive approach is younger and where training models for the open Whipple procedure are still deliberated, "there is a dramatic appetite for minimally invasive skills," Dr. Kendrick said. HBP fellows at the Mayo Clinic currently are exposed to minimally invasive surgery, but "our goal over the next 2 years is to incorporate an even more significant focus" on robotics and laparoscopy, he said.

At the University of Pittsburgh, surgical oncology and HBP fellows and residents receive training with the robot in a "dry lab" format, Dr. Moser said. Trainees also can sit during actual cases at a second "teaching console" that is part of the current da Vinci Surgical System.

"We typically teach robotic cholecystectomy and sewing of the duodenojejunostomy during the Whipple procedure and allow them to do these portions of the procedure," Dr. Moser said.

Dr. Kendrick, who said he has no disclosures to make relevant to this article, hopes to see several fellowships established nationwide to address minimally invasive pancreas and liver surgery. However, "we have to be cautious about credentialing and assessing the adequacy of training. There’s a real mortality rate and a major complication rate [with the Whipple procedure] ... We’re trying to make it lower and lower with time, and not go backward."

LAKE BUENA VISTA, FLA.  – Primary, primary-assisted, and secondary patency and limb salvage rates are similar in transplant and nontransplant populations, but renal transplant patients have slightly – though not significantly – worse outcomes than do heart transplant patients, according to findings from a study of endovascular peripheral interventions in these populations.

A total of 122 lesions in 58 renal or cardiac transplant patients were identified using information from a prospective lower-extremity database encompassing more than 1,500 interventions performed from 2004 through 2010 at a single, high-volume vascular and transplant center. The data were cross-referenced with heart failure and renal transplant registries from the same center, Dr. Katherine A. Gallagher said at the annual meeting of the Society for Clinical Vascular Surgery.

The transplant patients – 44 men and 14 women with a mean age of 63.5 years – all were on active immunosuppressive treatment and were followed clinically and with noninvasive laboratory testing for 30 months. Indications for lower-extremity interventions were claudication in 48% of cases and critical limb ischemia in 52% of cases. Mean lesion length was 108.6 mm, said Dr. Gallagher of Weill Cornell/Columbia University, New York.

Primary, primary-assisted, and secondary patency and limb salvage rates were "essentially the same" at 50 months in the transplant patients and in 1,162 nontransplant control patents, at about 40% vs. 45%, 55% vs. 60%, 60% vs. 65%, and 70% vs. 65% cumulative survival, respectively, she said.

Subgroup analyses showed that heart transplant patients showed a trend for better primary patency rates than did renal transplant patients with similar TASC classification and comorbid conditions (about 75% vs. 55%) , although the heart recipients had less critical limb ischemia.

After controlling for potential confounding factors, the researchers found in subgroup analyses that male transplant patients had significantly less severe disease and much better outcomes, Dr. Gallagher said in an interview.

Mean follow-up in these patients was 18.6 months, Dr. Gallagher noted.

Percutaneous intervention has become the first-line treatment for many patient groups, but outcomes in transplant patients prior to this study were relatively unknown, she said.

"We do know that the incidence of peripheral artery disease [PAD] is high in patients with renal insufficiency, and we know that both open and endovascular outcomes in this patient cohort portend poor patency and limb salvage rates," she said, adding that there is evidence that renal transplant patients have a high incidence of PAD, but outcomes following endovascular intervention in these populations are unknown.

"We can theorize that they might have improved outcomes because they have improved renal function, but they might also have poorer outcomes because of the deleterious effects of immunosuppression as it relates to hyperlipidemia and hyperglycemia," she said.

Furthermore, it is known that cardiac transplant patients are at risk for PAD, but the effects of immunosuppression in this population are unknown.

"Specifically these patients are on a lot of tacrolimus and sirolimus, which have been well studied in drug-eluting stents, but we don’t know the effects of these drugs on endovascular interventions," she said.

In this study, transplant patients had higher rates of diabetes and renal insufficiency – two factors shown to be independent predictors of poor outcome – so they would be expected to have poorer outcomes than would nontransplant patients, yet outcomes between the two groups were very similar.

"We believe this is potentially due to protective effects from systemic immunosuppression, although this requires further investigation, she concluded.

Dr. Gallagher said that she had no relevant financial disclosures.

LAKE BUENA VISTA, FLA.  – Primary, primary-assisted, and secondary patency and limb salvage rates are similar in transplant and nontransplant populations, but renal transplant patients have slightly – though not significantly – worse outcomes than do heart transplant patients, according to findings from a study of endovascular peripheral interventions in these populations.

A total of 122 lesions in 58 renal or cardiac transplant patients were identified using information from a prospective lower-extremity database encompassing more than 1,500 interventions performed from 2004 through 2010 at a single, high-volume vascular and transplant center. The data were cross-referenced with heart failure and renal transplant registries from the same center, Dr. Katherine A. Gallagher said at the annual meeting of the Society for Clinical Vascular Surgery.

The transplant patients – 44 men and 14 women with a mean age of 63.5 years – all were on active immunosuppressive treatment and were followed clinically and with noninvasive laboratory testing for 30 months. Indications for lower-extremity interventions were claudication in 48% of cases and critical limb ischemia in 52% of cases. Mean lesion length was 108.6 mm, said Dr. Gallagher of Weill Cornell/Columbia University, New York.

Primary, primary-assisted, and secondary patency and limb salvage rates were "essentially the same" at 50 months in the transplant patients and in 1,162 nontransplant control patents, at about 40% vs. 45%, 55% vs. 60%, 60% vs. 65%, and 70% vs. 65% cumulative survival, respectively, she said.

Subgroup analyses showed that heart transplant patients showed a trend for better primary patency rates than did renal transplant patients with similar TASC classification and comorbid conditions (about 75% vs. 55%) , although the heart recipients had less critical limb ischemia.

After controlling for potential confounding factors, the researchers found in subgroup analyses that male transplant patients had significantly less severe disease and much better outcomes, Dr. Gallagher said in an interview.

Mean follow-up in these patients was 18.6 months, Dr. Gallagher noted.

Percutaneous intervention has become the first-line treatment for many patient groups, but outcomes in transplant patients prior to this study were relatively unknown, she said.

"We do know that the incidence of peripheral artery disease [PAD] is high in patients with renal insufficiency, and we know that both open and endovascular outcomes in this patient cohort portend poor patency and limb salvage rates," she said, adding that there is evidence that renal transplant patients have a high incidence of PAD, but outcomes following endovascular intervention in these populations are unknown.

"We can theorize that they might have improved outcomes because they have improved renal function, but they might also have poorer outcomes because of the deleterious effects of immunosuppression as it relates to hyperlipidemia and hyperglycemia," she said.

Furthermore, it is known that cardiac transplant patients are at risk for PAD, but the effects of immunosuppression in this population are unknown.

"Specifically these patients are on a lot of tacrolimus and sirolimus, which have been well studied in drug-eluting stents, but we don’t know the effects of these drugs on endovascular interventions," she said.

In this study, transplant patients had higher rates of diabetes and renal insufficiency – two factors shown to be independent predictors of poor outcome – so they would be expected to have poorer outcomes than would nontransplant patients, yet outcomes between the two groups were very similar.

"We believe this is potentially due to protective effects from systemic immunosuppression, although this requires further investigation, she concluded.

Dr. Gallagher said that she had no relevant financial disclosures.

LAKE BUENA VISTA, FLA.  – Primary, primary-assisted, and secondary patency and limb salvage rates are similar in transplant and nontransplant populations, but renal transplant patients have slightly – though not significantly – worse outcomes than do heart transplant patients, according to findings from a study of endovascular peripheral interventions in these populations.

A total of 122 lesions in 58 renal or cardiac transplant patients were identified using information from a prospective lower-extremity database encompassing more than 1,500 interventions performed from 2004 through 2010 at a single, high-volume vascular and transplant center. The data were cross-referenced with heart failure and renal transplant registries from the same center, Dr. Katherine A. Gallagher said at the annual meeting of the Society for Clinical Vascular Surgery.

The transplant patients – 44 men and 14 women with a mean age of 63.5 years – all were on active immunosuppressive treatment and were followed clinically and with noninvasive laboratory testing for 30 months. Indications for lower-extremity interventions were claudication in 48% of cases and critical limb ischemia in 52% of cases. Mean lesion length was 108.6 mm, said Dr. Gallagher of Weill Cornell/Columbia University, New York.

Primary, primary-assisted, and secondary patency and limb salvage rates were "essentially the same" at 50 months in the transplant patients and in 1,162 nontransplant control patents, at about 40% vs. 45%, 55% vs. 60%, 60% vs. 65%, and 70% vs. 65% cumulative survival, respectively, she said.

Subgroup analyses showed that heart transplant patients showed a trend for better primary patency rates than did renal transplant patients with similar TASC classification and comorbid conditions (about 75% vs. 55%) , although the heart recipients had less critical limb ischemia.

After controlling for potential confounding factors, the researchers found in subgroup analyses that male transplant patients had significantly less severe disease and much better outcomes, Dr. Gallagher said in an interview.

Mean follow-up in these patients was 18.6 months, Dr. Gallagher noted.

Percutaneous intervention has become the first-line treatment for many patient groups, but outcomes in transplant patients prior to this study were relatively unknown, she said.

"We do know that the incidence of peripheral artery disease [PAD] is high in patients with renal insufficiency, and we know that both open and endovascular outcomes in this patient cohort portend poor patency and limb salvage rates," she said, adding that there is evidence that renal transplant patients have a high incidence of PAD, but outcomes following endovascular intervention in these populations are unknown.

"We can theorize that they might have improved outcomes because they have improved renal function, but they might also have poorer outcomes because of the deleterious effects of immunosuppression as it relates to hyperlipidemia and hyperglycemia," she said.

Furthermore, it is known that cardiac transplant patients are at risk for PAD, but the effects of immunosuppression in this population are unknown.

"Specifically these patients are on a lot of tacrolimus and sirolimus, which have been well studied in drug-eluting stents, but we don’t know the effects of these drugs on endovascular interventions," she said.

In this study, transplant patients had higher rates of diabetes and renal insufficiency – two factors shown to be independent predictors of poor outcome – so they would be expected to have poorer outcomes than would nontransplant patients, yet outcomes between the two groups were very similar.

"We believe this is potentially due to protective effects from systemic immunosuppression, although this requires further investigation, she concluded.

Dr. Gallagher said that she had no relevant financial disclosures.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.