ACS Surgery News

SAN DIEGO – Inpatient infliximab rescue for severe, steroid-refractory ulcerative colitis is more likely to work if patients receive a second infusion 3 days after the first, according to a review of 55 University of Michigan, Ann Arbor, patients.

The traditional approach is one inpatient 5-mg/kg infusion, followed by either colectomy or subsequent outpatient infusions, depending on response. In 2013, physicians at the university began offering a second infusion at 72 hours to patients whose C-reactive protein (CRP) levels did not drop below 0.7 mg/dL after their first infusion, and they also began opting more often for 10-mg/kg dosing.

The review found that 90-day colectomy-free survival was 50% in the 16 accelerated-dosing patients, up from 10.2% in the 36 patients treated with the traditional approach (P less than .001). The finding has led to a new, more aggressive infliximab protocol for inpatient ulcerative colitis.

Among patients who did undergo colectomies, postoperative complications were similar between the two groups. But for reasons that are not clear, 30-day postoperative readmission rates were higher in accelerated patients (58% vs. 25%).

In an interview at the annual Digestive Disease Week, lead investigator Dr. Shail Govani of the University of Michigan explained the thinking behind the new approach, how CRP/albumin ratios come into play, and how to counsel patients in light of the findings.

 [email protected]

SAN DIEGO – Inpatient infliximab rescue for severe, steroid-refractory ulcerative colitis is more likely to work if patients receive a second infusion 3 days after the first, according to a review of 55 University of Michigan, Ann Arbor, patients.

The traditional approach is one inpatient 5-mg/kg infusion, followed by either colectomy or subsequent outpatient infusions, depending on response. In 2013, physicians at the university began offering a second infusion at 72 hours to patients whose C-reactive protein (CRP) levels did not drop below 0.7 mg/dL after their first infusion, and they also began opting more often for 10-mg/kg dosing.

The review found that 90-day colectomy-free survival was 50% in the 16 accelerated-dosing patients, up from 10.2% in the 36 patients treated with the traditional approach (P less than .001). The finding has led to a new, more aggressive infliximab protocol for inpatient ulcerative colitis.

Among patients who did undergo colectomies, postoperative complications were similar between the two groups. But for reasons that are not clear, 30-day postoperative readmission rates were higher in accelerated patients (58% vs. 25%).

In an interview at the annual Digestive Disease Week, lead investigator Dr. Shail Govani of the University of Michigan explained the thinking behind the new approach, how CRP/albumin ratios come into play, and how to counsel patients in light of the findings.

 [email protected]

SAN DIEGO – Inpatient infliximab rescue for severe, steroid-refractory ulcerative colitis is more likely to work if patients receive a second infusion 3 days after the first, according to a review of 55 University of Michigan, Ann Arbor, patients.

The traditional approach is one inpatient 5-mg/kg infusion, followed by either colectomy or subsequent outpatient infusions, depending on response. In 2013, physicians at the university began offering a second infusion at 72 hours to patients whose C-reactive protein (CRP) levels did not drop below 0.7 mg/dL after their first infusion, and they also began opting more often for 10-mg/kg dosing.

The review found that 90-day colectomy-free survival was 50% in the 16 accelerated-dosing patients, up from 10.2% in the 36 patients treated with the traditional approach (P less than .001). The finding has led to a new, more aggressive infliximab protocol for inpatient ulcerative colitis.

Among patients who did undergo colectomies, postoperative complications were similar between the two groups. But for reasons that are not clear, 30-day postoperative readmission rates were higher in accelerated patients (58% vs. 25%).

In an interview at the annual Digestive Disease Week, lead investigator Dr. Shail Govani of the University of Michigan explained the thinking behind the new approach, how CRP/albumin ratios come into play, and how to counsel patients in light of the findings.

 [email protected]

ORLANDO – Radiofrequency (RF) ablation is a safe and effective procedure for treating focal adrenal tumors in patients who are poor surgical candidates or who refuse adrenalectomy. With a short treatment time and minimal hospital stay, RF ablation can provide rapid clinical and biochemical improvement.

Dr. Lima Lawrence, an internal medicine resident at the University of Illinois at Chicago/Advocate Christ Medical Center in Oak Lawn, presented a case report and a review of the literature during an oral abstract session at the annual meeting of the American Association of Clinical Endocrinologists. The patient was a 65-year-old woman who presented with weight gain, decreased energy, and muscle weakness. On physical exam, she was hypertensive, anxious, obese, and had prominent supraclavicular fat pads. Salivary cortisol and overnight dexamethasone suppression tests were both elevated, and ACTH levels were depressed, confirming the diagnosis of a cortisol-secreting tumor causing adrenal Cushing’s syndrome. Computed tomography (CT) surveillance showed a progressively enlarging right-sided adrenal mass. A peritoneal biopsy revealed a low-grade serous neoplasm of peritoneal origin.

Her medical history included type 2 diabetes, uncontrolled hypertension, mixed connective tissue disease, depression, and total abdominal hysterectomy with bilateral salpingo-oophorectomy for ovarian cancer.

Dr. Lawrence said the patient had been scheduled for adrenalectomy, but it was not performed because of an intraoperative finding of peritoneal studding from what turned out to be metastatic ovarian cancer. Therefore, she underwent CT-guided RF ablation of the adrenal mass using a 14-gauge probe that heated a 3.5-cm ablation zone to 50-60 C for 8-10 minutes to achieve complete tumor necrosis.

The patient showed dramatic “clinical and biochemical improvement,” Dr. Lawrence said. The patient had no procedural complications and no blood loss and was observed for 23 hours before being discharged to home. A CT scan 8 weeks later showed a slightly decreased mass with marked decreased radiographic attenuation post-contrast from 30.2 Hounsfield Units (HU) preoperatively to 17 HU on follow-up.

Potential adverse outcomes using RF ablation include a risk of pneumothorax, hemothorax, and tumor seeding along the catheter track, but this last possibility can be mitigated by continuing to heat the RF probe as it is withdrawn.

Published evidence supports use of RF ablation. “To date there have been no randomized clinical trials comparing the safety, efficacy, and survival benefits of adrenalectomy vs. radio frequency ablation,” she said. It may not be feasible to do a randomized trial. But a review of the literature generally supports the efficacy of the technique although the publications each involved a small series of patients, Dr. Lawrence said in an interview.

A 2003 series (Cancer. 2003;97:554-60) of 15 primary or metastatic adrenal cell carcinomas that were unresectable or were in patients who were not surgical candidates showed nonenhancement and no growth in 8 (53%) at a mean follow-up of 10.3 months. Eight of the 12 tumors of 5 cm or smaller had complete loss of radiographic enhancement and a decrease in size.

From a retrospective series of 13 patients with functional adrenal neoplasms over 7 years, there was 100% resolution of biochemical abnormalities and clinical symptoms at a mean follow-up of 21.2 months. One small pneumothorax and one limited hemothorax occurred, neither of which required hospital admission. There were two instances of transient, self-remitting hypertension associated with the procedures (Radiology. 2011;258:308-16).

In 2015, one group of investigators followed 11 patients for 12 weeks postprocedure. Eight of nine patients with Conn’s syndrome attained normal serum aldosterone levels. One with a nodule close to the inferior vena cava had incomplete ablation. Two of two Cushing’s patients had normal cortisol levels after the procedure (J Vasc Interv Radiol. 2015;26:1459-64).

A retrospective analysis of 16 adrenal metastases showed that 13 (81%) had no local progression over 14 months after ablation. In two of three functional adrenal neoplasms, clinical and biochemical abnormalities resolved (Eur J Radiol. 2012.81:1717-23).

A retrospective series of 10 adrenal metastases showed that one recurred at 7 months after image-guided thermal ablation, with no recurrence of the rest at 26.6 months. There was no tumor recurrence for any of the cases of metastatic disease localized to the RF ablation site (J Vasc Interv Radiol. 2014;25:593-8).

Results were somewhat less good in a retrospective evaluation of 35 patients with unresectable adrenal masses over 9 years. Although 33 of 35 (94%) lost tumor enhancement after the initial adrenal RF ablation, there was local tumor progression in 8 of 35 (23%) patients at a mean follow-up of 30.1 months (Radiology. 2015;277:584-93).

Finally, Dr. Lawrence discussed a systematic literature review on adrenalectomy vs. stereotactic ablative body radiotherapy (SABR) and percutaneous catheter ablation (PCA) in the treatment of adrenal metastases: 30 papers on adrenalectomy on 818 patients; 9 papers on SABR on 178 patients; and 6 papers on PCA, including RF ablation, on 51 patients. The authors concluded that there was “insufficient evidence to determine the best local treatment modality for isolated or limited adrenal metastases.” Adrenalectomy appeared to be a reasonable treatment for suitable patients. SABR was a valid alternative for nonsurgical candidates, but they did not recommend PCA until more long-term outcomes were available (Cancer Treat Rev. 2014;40:838-46).

Dr. Lawrence concurred, based on her case study and literature review. She said RF ablation “offers patients a minimally invasive option for treating focal adrenal tumors” and is a “safe and effective procedure … in patients who are poor surgical candidates or refuse adrenalectomy.” More long-term follow-up studies are needed before RF ablation could replace adrenalectomy, she noted.

ORLANDO – Radiofrequency (RF) ablation is a safe and effective procedure for treating focal adrenal tumors in patients who are poor surgical candidates or who refuse adrenalectomy. With a short treatment time and minimal hospital stay, RF ablation can provide rapid clinical and biochemical improvement.

Dr. Lima Lawrence, an internal medicine resident at the University of Illinois at Chicago/Advocate Christ Medical Center in Oak Lawn, presented a case report and a review of the literature during an oral abstract session at the annual meeting of the American Association of Clinical Endocrinologists. The patient was a 65-year-old woman who presented with weight gain, decreased energy, and muscle weakness. On physical exam, she was hypertensive, anxious, obese, and had prominent supraclavicular fat pads. Salivary cortisol and overnight dexamethasone suppression tests were both elevated, and ACTH levels were depressed, confirming the diagnosis of a cortisol-secreting tumor causing adrenal Cushing’s syndrome. Computed tomography (CT) surveillance showed a progressively enlarging right-sided adrenal mass. A peritoneal biopsy revealed a low-grade serous neoplasm of peritoneal origin.

Her medical history included type 2 diabetes, uncontrolled hypertension, mixed connective tissue disease, depression, and total abdominal hysterectomy with bilateral salpingo-oophorectomy for ovarian cancer.

Dr. Lawrence said the patient had been scheduled for adrenalectomy, but it was not performed because of an intraoperative finding of peritoneal studding from what turned out to be metastatic ovarian cancer. Therefore, she underwent CT-guided RF ablation of the adrenal mass using a 14-gauge probe that heated a 3.5-cm ablation zone to 50-60 C for 8-10 minutes to achieve complete tumor necrosis.

The patient showed dramatic “clinical and biochemical improvement,” Dr. Lawrence said. The patient had no procedural complications and no blood loss and was observed for 23 hours before being discharged to home. A CT scan 8 weeks later showed a slightly decreased mass with marked decreased radiographic attenuation post-contrast from 30.2 Hounsfield Units (HU) preoperatively to 17 HU on follow-up.

Potential adverse outcomes using RF ablation include a risk of pneumothorax, hemothorax, and tumor seeding along the catheter track, but this last possibility can be mitigated by continuing to heat the RF probe as it is withdrawn.

Published evidence supports use of RF ablation. “To date there have been no randomized clinical trials comparing the safety, efficacy, and survival benefits of adrenalectomy vs. radio frequency ablation,” she said. It may not be feasible to do a randomized trial. But a review of the literature generally supports the efficacy of the technique although the publications each involved a small series of patients, Dr. Lawrence said in an interview.

A 2003 series (Cancer. 2003;97:554-60) of 15 primary or metastatic adrenal cell carcinomas that were unresectable or were in patients who were not surgical candidates showed nonenhancement and no growth in 8 (53%) at a mean follow-up of 10.3 months. Eight of the 12 tumors of 5 cm or smaller had complete loss of radiographic enhancement and a decrease in size.

From a retrospective series of 13 patients with functional adrenal neoplasms over 7 years, there was 100% resolution of biochemical abnormalities and clinical symptoms at a mean follow-up of 21.2 months. One small pneumothorax and one limited hemothorax occurred, neither of which required hospital admission. There were two instances of transient, self-remitting hypertension associated with the procedures (Radiology. 2011;258:308-16).

In 2015, one group of investigators followed 11 patients for 12 weeks postprocedure. Eight of nine patients with Conn’s syndrome attained normal serum aldosterone levels. One with a nodule close to the inferior vena cava had incomplete ablation. Two of two Cushing’s patients had normal cortisol levels after the procedure (J Vasc Interv Radiol. 2015;26:1459-64).

A retrospective analysis of 16 adrenal metastases showed that 13 (81%) had no local progression over 14 months after ablation. In two of three functional adrenal neoplasms, clinical and biochemical abnormalities resolved (Eur J Radiol. 2012.81:1717-23).

A retrospective series of 10 adrenal metastases showed that one recurred at 7 months after image-guided thermal ablation, with no recurrence of the rest at 26.6 months. There was no tumor recurrence for any of the cases of metastatic disease localized to the RF ablation site (J Vasc Interv Radiol. 2014;25:593-8).

Results were somewhat less good in a retrospective evaluation of 35 patients with unresectable adrenal masses over 9 years. Although 33 of 35 (94%) lost tumor enhancement after the initial adrenal RF ablation, there was local tumor progression in 8 of 35 (23%) patients at a mean follow-up of 30.1 months (Radiology. 2015;277:584-93).

Finally, Dr. Lawrence discussed a systematic literature review on adrenalectomy vs. stereotactic ablative body radiotherapy (SABR) and percutaneous catheter ablation (PCA) in the treatment of adrenal metastases: 30 papers on adrenalectomy on 818 patients; 9 papers on SABR on 178 patients; and 6 papers on PCA, including RF ablation, on 51 patients. The authors concluded that there was “insufficient evidence to determine the best local treatment modality for isolated or limited adrenal metastases.” Adrenalectomy appeared to be a reasonable treatment for suitable patients. SABR was a valid alternative for nonsurgical candidates, but they did not recommend PCA until more long-term outcomes were available (Cancer Treat Rev. 2014;40:838-46).

Dr. Lawrence concurred, based on her case study and literature review. She said RF ablation “offers patients a minimally invasive option for treating focal adrenal tumors” and is a “safe and effective procedure … in patients who are poor surgical candidates or refuse adrenalectomy.” More long-term follow-up studies are needed before RF ablation could replace adrenalectomy, she noted.

ORLANDO – Radiofrequency (RF) ablation is a safe and effective procedure for treating focal adrenal tumors in patients who are poor surgical candidates or who refuse adrenalectomy. With a short treatment time and minimal hospital stay, RF ablation can provide rapid clinical and biochemical improvement.

Dr. Lima Lawrence, an internal medicine resident at the University of Illinois at Chicago/Advocate Christ Medical Center in Oak Lawn, presented a case report and a review of the literature during an oral abstract session at the annual meeting of the American Association of Clinical Endocrinologists. The patient was a 65-year-old woman who presented with weight gain, decreased energy, and muscle weakness. On physical exam, she was hypertensive, anxious, obese, and had prominent supraclavicular fat pads. Salivary cortisol and overnight dexamethasone suppression tests were both elevated, and ACTH levels were depressed, confirming the diagnosis of a cortisol-secreting tumor causing adrenal Cushing’s syndrome. Computed tomography (CT) surveillance showed a progressively enlarging right-sided adrenal mass. A peritoneal biopsy revealed a low-grade serous neoplasm of peritoneal origin.

Her medical history included type 2 diabetes, uncontrolled hypertension, mixed connective tissue disease, depression, and total abdominal hysterectomy with bilateral salpingo-oophorectomy for ovarian cancer.

Dr. Lawrence said the patient had been scheduled for adrenalectomy, but it was not performed because of an intraoperative finding of peritoneal studding from what turned out to be metastatic ovarian cancer. Therefore, she underwent CT-guided RF ablation of the adrenal mass using a 14-gauge probe that heated a 3.5-cm ablation zone to 50-60 C for 8-10 minutes to achieve complete tumor necrosis.

The patient showed dramatic “clinical and biochemical improvement,” Dr. Lawrence said. The patient had no procedural complications and no blood loss and was observed for 23 hours before being discharged to home. A CT scan 8 weeks later showed a slightly decreased mass with marked decreased radiographic attenuation post-contrast from 30.2 Hounsfield Units (HU) preoperatively to 17 HU on follow-up.

Potential adverse outcomes using RF ablation include a risk of pneumothorax, hemothorax, and tumor seeding along the catheter track, but this last possibility can be mitigated by continuing to heat the RF probe as it is withdrawn.

Published evidence supports use of RF ablation. “To date there have been no randomized clinical trials comparing the safety, efficacy, and survival benefits of adrenalectomy vs. radio frequency ablation,” she said. It may not be feasible to do a randomized trial. But a review of the literature generally supports the efficacy of the technique although the publications each involved a small series of patients, Dr. Lawrence said in an interview.

A 2003 series (Cancer. 2003;97:554-60) of 15 primary or metastatic adrenal cell carcinomas that were unresectable or were in patients who were not surgical candidates showed nonenhancement and no growth in 8 (53%) at a mean follow-up of 10.3 months. Eight of the 12 tumors of 5 cm or smaller had complete loss of radiographic enhancement and a decrease in size.

From a retrospective series of 13 patients with functional adrenal neoplasms over 7 years, there was 100% resolution of biochemical abnormalities and clinical symptoms at a mean follow-up of 21.2 months. One small pneumothorax and one limited hemothorax occurred, neither of which required hospital admission. There were two instances of transient, self-remitting hypertension associated with the procedures (Radiology. 2011;258:308-16).

In 2015, one group of investigators followed 11 patients for 12 weeks postprocedure. Eight of nine patients with Conn’s syndrome attained normal serum aldosterone levels. One with a nodule close to the inferior vena cava had incomplete ablation. Two of two Cushing’s patients had normal cortisol levels after the procedure (J Vasc Interv Radiol. 2015;26:1459-64).

A retrospective analysis of 16 adrenal metastases showed that 13 (81%) had no local progression over 14 months after ablation. In two of three functional adrenal neoplasms, clinical and biochemical abnormalities resolved (Eur J Radiol. 2012.81:1717-23).

A retrospective series of 10 adrenal metastases showed that one recurred at 7 months after image-guided thermal ablation, with no recurrence of the rest at 26.6 months. There was no tumor recurrence for any of the cases of metastatic disease localized to the RF ablation site (J Vasc Interv Radiol. 2014;25:593-8).

Results were somewhat less good in a retrospective evaluation of 35 patients with unresectable adrenal masses over 9 years. Although 33 of 35 (94%) lost tumor enhancement after the initial adrenal RF ablation, there was local tumor progression in 8 of 35 (23%) patients at a mean follow-up of 30.1 months (Radiology. 2015;277:584-93).

Finally, Dr. Lawrence discussed a systematic literature review on adrenalectomy vs. stereotactic ablative body radiotherapy (SABR) and percutaneous catheter ablation (PCA) in the treatment of adrenal metastases: 30 papers on adrenalectomy on 818 patients; 9 papers on SABR on 178 patients; and 6 papers on PCA, including RF ablation, on 51 patients. The authors concluded that there was “insufficient evidence to determine the best local treatment modality for isolated or limited adrenal metastases.” Adrenalectomy appeared to be a reasonable treatment for suitable patients. SABR was a valid alternative for nonsurgical candidates, but they did not recommend PCA until more long-term outcomes were available (Cancer Treat Rev. 2014;40:838-46).

Dr. Lawrence concurred, based on her case study and literature review. She said RF ablation “offers patients a minimally invasive option for treating focal adrenal tumors” and is a “safe and effective procedure … in patients who are poor surgical candidates or refuse adrenalectomy.” More long-term follow-up studies are needed before RF ablation could replace adrenalectomy, she noted.

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV₁) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV₁/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV₁) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV₁/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV₁) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV₁/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

WASHINGTON – Sodium fluorescein is proving to be an excellent agent for helping to verify ureteral efflux during intraoperative cystoscopy, Dr. Jay Goldberg said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Goldberg said he first read about the use of the dye as an alternative to indigo carmine, which is no longer available, in a study published in 2015; the study reported good results with a 10% preparation of sodium fluorescein administered at 0.25-1 mL intravenously during intraoperative cystoscopy (Obstet Gynecol. 2015 Mar;125[3]:548-50).

Since then, he and his colleagues at Einstein Medical Center, Philadelphia, have been evaluating the use of 0.1 mL of 10% sodium fluorescein IV during cystoscopies performed at the end of gynecologic surgeries, measuring the time to visualization and the level of satisfaction with the dye.

Thus far, in more than 50 cases, the average time until colored ureteral jets were seen has been 4.3 minutes (a range of 2-6.8 minutes, consistent with the 2015 study). And according to questionnaires completed by each surgeon, the degree of certainty for visualizing the ureteral jets was improved with fluorescein (a rating of 5 on a 5-point scale, compared with 2.9 without the dye).

Compared with both indigo carmine and methylene blue, fluorescein was preferred, Dr. Goldberg reported, with surgeons citing quicker onset, better color contrast, cheaper cost, and fewer side effects.

“Given that it’s at least equivalent and probably better, and that it’s 50 times cheaper [than indigo carmine], even if indigo carmine comes back again, I’m certainly not going to be switching back,” Dr. Goldberg said during a seminar on cystoscopy after hysterectomy.

Intravenous sodium fluorescein is routinely used in ophthalmology in retinal angiography, at a dosage of 5 mL of 10% fluorescein, he said. The most common complications reported in the literature are nausea, vomiting, and flushing or rash (rates of 2.9%, 1.2%, and 0.5%, respectively, according to a 1991 report). None of their patients has experienced any complications, Dr. Goldberg said.

Methylene blue (50 mg IV over a period of 5 minutes) appears to have been a common go-to dye for gynecologic surgeons, along with pyridium (a 200-mg oral dose prior to surgery), ever since production of indigo carmine was discontinued because of a lack of raw material.

“But with methylene blue, it may take longer to see the blue urine efflux from the ureteral orifices,” Dr. Goldberg said. And with pyridium, “by the time cystoscopy is performed, the bladder will have already been stained orange, making it more difficult to see the same colored urine jets.”

“Sodium fluorescein is very quick in onset. I wait [to have it administered] until I am actually ready to insert the cystoscope,” he said.

And at 60 cents per dose, fluorescein is less expensive than methylene blue ($1.50) and significantly less expensive than indigo carmine ($30 a dose), he said.

Dr. Goldberg reported having no relevant financial conflicts.

WASHINGTON – Sodium fluorescein is proving to be an excellent agent for helping to verify ureteral efflux during intraoperative cystoscopy, Dr. Jay Goldberg said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Goldberg said he first read about the use of the dye as an alternative to indigo carmine, which is no longer available, in a study published in 2015; the study reported good results with a 10% preparation of sodium fluorescein administered at 0.25-1 mL intravenously during intraoperative cystoscopy (Obstet Gynecol. 2015 Mar;125[3]:548-50).

Since then, he and his colleagues at Einstein Medical Center, Philadelphia, have been evaluating the use of 0.1 mL of 10% sodium fluorescein IV during cystoscopies performed at the end of gynecologic surgeries, measuring the time to visualization and the level of satisfaction with the dye.

Thus far, in more than 50 cases, the average time until colored ureteral jets were seen has been 4.3 minutes (a range of 2-6.8 minutes, consistent with the 2015 study). And according to questionnaires completed by each surgeon, the degree of certainty for visualizing the ureteral jets was improved with fluorescein (a rating of 5 on a 5-point scale, compared with 2.9 without the dye).

Compared with both indigo carmine and methylene blue, fluorescein was preferred, Dr. Goldberg reported, with surgeons citing quicker onset, better color contrast, cheaper cost, and fewer side effects.

“Given that it’s at least equivalent and probably better, and that it’s 50 times cheaper [than indigo carmine], even if indigo carmine comes back again, I’m certainly not going to be switching back,” Dr. Goldberg said during a seminar on cystoscopy after hysterectomy.

Intravenous sodium fluorescein is routinely used in ophthalmology in retinal angiography, at a dosage of 5 mL of 10% fluorescein, he said. The most common complications reported in the literature are nausea, vomiting, and flushing or rash (rates of 2.9%, 1.2%, and 0.5%, respectively, according to a 1991 report). None of their patients has experienced any complications, Dr. Goldberg said.

Methylene blue (50 mg IV over a period of 5 minutes) appears to have been a common go-to dye for gynecologic surgeons, along with pyridium (a 200-mg oral dose prior to surgery), ever since production of indigo carmine was discontinued because of a lack of raw material.

“But with methylene blue, it may take longer to see the blue urine efflux from the ureteral orifices,” Dr. Goldberg said. And with pyridium, “by the time cystoscopy is performed, the bladder will have already been stained orange, making it more difficult to see the same colored urine jets.”

“Sodium fluorescein is very quick in onset. I wait [to have it administered] until I am actually ready to insert the cystoscope,” he said.

And at 60 cents per dose, fluorescein is less expensive than methylene blue ($1.50) and significantly less expensive than indigo carmine ($30 a dose), he said.

Dr. Goldberg reported having no relevant financial conflicts.

WASHINGTON – Sodium fluorescein is proving to be an excellent agent for helping to verify ureteral efflux during intraoperative cystoscopy, Dr. Jay Goldberg said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Goldberg said he first read about the use of the dye as an alternative to indigo carmine, which is no longer available, in a study published in 2015; the study reported good results with a 10% preparation of sodium fluorescein administered at 0.25-1 mL intravenously during intraoperative cystoscopy (Obstet Gynecol. 2015 Mar;125[3]:548-50).

Since then, he and his colleagues at Einstein Medical Center, Philadelphia, have been evaluating the use of 0.1 mL of 10% sodium fluorescein IV during cystoscopies performed at the end of gynecologic surgeries, measuring the time to visualization and the level of satisfaction with the dye.

Thus far, in more than 50 cases, the average time until colored ureteral jets were seen has been 4.3 minutes (a range of 2-6.8 minutes, consistent with the 2015 study). And according to questionnaires completed by each surgeon, the degree of certainty for visualizing the ureteral jets was improved with fluorescein (a rating of 5 on a 5-point scale, compared with 2.9 without the dye).

Compared with both indigo carmine and methylene blue, fluorescein was preferred, Dr. Goldberg reported, with surgeons citing quicker onset, better color contrast, cheaper cost, and fewer side effects.

“Given that it’s at least equivalent and probably better, and that it’s 50 times cheaper [than indigo carmine], even if indigo carmine comes back again, I’m certainly not going to be switching back,” Dr. Goldberg said during a seminar on cystoscopy after hysterectomy.

Intravenous sodium fluorescein is routinely used in ophthalmology in retinal angiography, at a dosage of 5 mL of 10% fluorescein, he said. The most common complications reported in the literature are nausea, vomiting, and flushing or rash (rates of 2.9%, 1.2%, and 0.5%, respectively, according to a 1991 report). None of their patients has experienced any complications, Dr. Goldberg said.

Methylene blue (50 mg IV over a period of 5 minutes) appears to have been a common go-to dye for gynecologic surgeons, along with pyridium (a 200-mg oral dose prior to surgery), ever since production of indigo carmine was discontinued because of a lack of raw material.

“But with methylene blue, it may take longer to see the blue urine efflux from the ureteral orifices,” Dr. Goldberg said. And with pyridium, “by the time cystoscopy is performed, the bladder will have already been stained orange, making it more difficult to see the same colored urine jets.”

“Sodium fluorescein is very quick in onset. I wait [to have it administered] until I am actually ready to insert the cystoscope,” he said.

And at 60 cents per dose, fluorescein is less expensive than methylene blue ($1.50) and significantly less expensive than indigo carmine ($30 a dose), he said.

Dr. Goldberg reported having no relevant financial conflicts.

PARIS – The first-ever study of the long-term durability of transcatheter bioprosthetic aortic valves has documented a disturbing rise in the valve degeneration rate occurring 5-7 years post implant.

Prior consistently reassuring follow-up studies have been intermediate in length, with a maximum of 5 years. The PARTNER 2A trial, which generated enormous enthusiasm for moving TAVR to intermediate-risk patients on the basis of positive results presented at the 2016 meeting of the American College of Cardiology, reported 2-year results.

Bruce Jancin/Frontline Medical News

“We found, as have others, that there’s very little degeneration in the first 4 years: 94% freedom from degeneration. But at 6 years, it’s 82%, and we estimate that by 8 years, it’s about 50%,” Dr. Danny Dvir reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We need to be cautious: This is our first look at the data. But we have a signal for a problem,” said Dr. Dvir of St. Paul’s Hospital in Vancouver.

He presented a retrospective study of 378 patients who underwent TAVR 5-14 years ago at two pioneering centers for the procedure: St. Paul’s and Charles Nicolle Hospital in Rouen, France. Patients’ average age at the time of TAVR was 82.3 years, with an STS score of 8.3%. The study featured serial echocardiography conducted during house calls in this frail elderly population.

Thirty-five patients developed prosthetic valve degeneration, defined by at least moderate regurgitation and/or a mean gradient of at least 20 mm Hg in 23 cases and stenosis in 12. The risk of degeneration was unrelated to the use of warfarin, a finding that suggests the valve deterioration issue is unrelated to clotting. The strongest risk factor for transcatheter valve degeneration in this study was baseline renal failure at the time of TAVR.

Dr. Dvir’s presentation was the talk of the meeting, and it cast a pall over the proceedings. The red flag raised by the study regarding valve durability has major implications regarding the current enthusiasm among many interventional cardiologists to routinely extend TAVR to intermediate and even lower-risk patients. As one audience member later confessed, “I have felt sick since hearing that presentation.”

Bruce Jancin/Frontline Medical News

Discussant Dr. A. Pieter Kappetein observed that transcatheter heart valve durability was a hot topic of discussion about 4 years ago but subsequently faded below the radar as a concern – until Dr. Dvir’s study.

“This is a very important study that puts transcatheter heart valve implantation in a little bit different light,” said Dr. Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

He noted that the surgical aortic valve replacement (SAVR) literature shows that the rate of structural valve deterioration is age related. It’s higher in 75-year-olds than in 85-year-olds, and higher still in 65-year-olds.

“Valve degeneration didn’t play a major role when we were doing TAVR in 80- and 85-year-olds because of their limited life expectancy, but it will play a role in younger patients. So I think we have to be careful before we move toward lower-risk patients,” the surgeon continued.

Dr. Jean-Francois Obadia, who performs both SAVR and TAVR, noted that the median duration of freedom from valve degeneration for Edwards Lifescience’s Carpentier surgical aortic valve is a hefty 17.9 years.

“This should be the gold standard,” declared Dr. Obadia, head of the department of adult cardiovascular surgery and heart transplantation at the Louis Pradel Cardiothoracic Hospital of Claude Bernard University in Lyon, France.

“Dr. Dvir’s study is one of the key messages we all should take back home: a 50% rate of valve deterioration at 8 years. Valve deterioration is the Achilles’ heel of bioprostheses. There is a lot of improvement left to do for the TAVR,” he said.

Dr. Dvir and others were quick to note that his long-term study was of necessity restricted to early-generation, balloon-expandable devices: the Cribier Edwards, Edwards Sapien, and Sapien XT valves. Contemporary valves, patient selection methods, and procedural techniques are far advanced in comparison.

“The Sapien 3 has much less paravalvular leakage than earlier-generation valves. Maybe with less paravalvular leakage and better hemodynamics there will be a decreased rate of degeneration. It could be. We need to see. We have to wait a few more years to see if later-generation transcatheter heart valves are more durable,” Dr. Dvir said.

To gain a better understanding of the full dimensions of the valve degeneration issue, he and his coinvestigators have formed the VALID (VAlve Long-term Durability International Data) registry. Operators interested in contributing patients to what is hoped will be a very large and informative data base are encouraged to contact Dr. Dvir ([email protected]).

In the meantime, he has reservations about extending TAVR to intermediate-risk patients outside of the rigorous clinical trial setting. He added that he’d feel far more comfortable in performing TAVR in intermediate-risk 70- to 75-year-olds if there was a tried and true valve-in-valve replacement method, something that doesn’t yet exist. The major limitation of current attempts at valve-in-valve replacement is underexpansion because the former valve doesn’t allow sufficient room for the new one to expand fully, resulting in residual stenosis.

“If you tell me that you can implant a platform that will enable a safe valve-in-valve procedure in 5, 7, 10 years – a less invasive bailout for a failed prosthetic valve – if you can do that safely and effectively I would be more keen to do TAVR even in a young patient,” the interventional cardiologist said.

He and others are working on this unmet need. Dr. Dvir’s novel valve, being developed with Edwards Lifesciences, has performed well in valve-in-valve procedures in cadavers and animals. The first clinical trials are being planned.

“We need to think always that a bioprosthetic valve is not a cure, it’s a palliation. We treat the patients, they feel better, but we leave them with some kind of a chronic disease that’s prone to thrombosis, prone to degeneration and failure, prone to many different things,” he reflected.

The study was conducted without commercial support. Dr. Dvir reported serving as a consultant to Edwards Lifesciences, Medtronic, and St. Jude Medical.

[email protected]

PARIS – The first-ever study of the long-term durability of transcatheter bioprosthetic aortic valves has documented a disturbing rise in the valve degeneration rate occurring 5-7 years post implant.

Prior consistently reassuring follow-up studies have been intermediate in length, with a maximum of 5 years. The PARTNER 2A trial, which generated enormous enthusiasm for moving TAVR to intermediate-risk patients on the basis of positive results presented at the 2016 meeting of the American College of Cardiology, reported 2-year results.

Bruce Jancin/Frontline Medical News

“We found, as have others, that there’s very little degeneration in the first 4 years: 94% freedom from degeneration. But at 6 years, it’s 82%, and we estimate that by 8 years, it’s about 50%,” Dr. Danny Dvir reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We need to be cautious: This is our first look at the data. But we have a signal for a problem,” said Dr. Dvir of St. Paul’s Hospital in Vancouver.

He presented a retrospective study of 378 patients who underwent TAVR 5-14 years ago at two pioneering centers for the procedure: St. Paul’s and Charles Nicolle Hospital in Rouen, France. Patients’ average age at the time of TAVR was 82.3 years, with an STS score of 8.3%. The study featured serial echocardiography conducted during house calls in this frail elderly population.

Thirty-five patients developed prosthetic valve degeneration, defined by at least moderate regurgitation and/or a mean gradient of at least 20 mm Hg in 23 cases and stenosis in 12. The risk of degeneration was unrelated to the use of warfarin, a finding that suggests the valve deterioration issue is unrelated to clotting. The strongest risk factor for transcatheter valve degeneration in this study was baseline renal failure at the time of TAVR.

Dr. Dvir’s presentation was the talk of the meeting, and it cast a pall over the proceedings. The red flag raised by the study regarding valve durability has major implications regarding the current enthusiasm among many interventional cardiologists to routinely extend TAVR to intermediate and even lower-risk patients. As one audience member later confessed, “I have felt sick since hearing that presentation.”

Bruce Jancin/Frontline Medical News

Discussant Dr. A. Pieter Kappetein observed that transcatheter heart valve durability was a hot topic of discussion about 4 years ago but subsequently faded below the radar as a concern – until Dr. Dvir’s study.

“This is a very important study that puts transcatheter heart valve implantation in a little bit different light,” said Dr. Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

He noted that the surgical aortic valve replacement (SAVR) literature shows that the rate of structural valve deterioration is age related. It’s higher in 75-year-olds than in 85-year-olds, and higher still in 65-year-olds.

“Valve degeneration didn’t play a major role when we were doing TAVR in 80- and 85-year-olds because of their limited life expectancy, but it will play a role in younger patients. So I think we have to be careful before we move toward lower-risk patients,” the surgeon continued.

Dr. Jean-Francois Obadia, who performs both SAVR and TAVR, noted that the median duration of freedom from valve degeneration for Edwards Lifescience’s Carpentier surgical aortic valve is a hefty 17.9 years.

“This should be the gold standard,” declared Dr. Obadia, head of the department of adult cardiovascular surgery and heart transplantation at the Louis Pradel Cardiothoracic Hospital of Claude Bernard University in Lyon, France.

“Dr. Dvir’s study is one of the key messages we all should take back home: a 50% rate of valve deterioration at 8 years. Valve deterioration is the Achilles’ heel of bioprostheses. There is a lot of improvement left to do for the TAVR,” he said.

Dr. Dvir and others were quick to note that his long-term study was of necessity restricted to early-generation, balloon-expandable devices: the Cribier Edwards, Edwards Sapien, and Sapien XT valves. Contemporary valves, patient selection methods, and procedural techniques are far advanced in comparison.

“The Sapien 3 has much less paravalvular leakage than earlier-generation valves. Maybe with less paravalvular leakage and better hemodynamics there will be a decreased rate of degeneration. It could be. We need to see. We have to wait a few more years to see if later-generation transcatheter heart valves are more durable,” Dr. Dvir said.

To gain a better understanding of the full dimensions of the valve degeneration issue, he and his coinvestigators have formed the VALID (VAlve Long-term Durability International Data) registry. Operators interested in contributing patients to what is hoped will be a very large and informative data base are encouraged to contact Dr. Dvir ([email protected]).

In the meantime, he has reservations about extending TAVR to intermediate-risk patients outside of the rigorous clinical trial setting. He added that he’d feel far more comfortable in performing TAVR in intermediate-risk 70- to 75-year-olds if there was a tried and true valve-in-valve replacement method, something that doesn’t yet exist. The major limitation of current attempts at valve-in-valve replacement is underexpansion because the former valve doesn’t allow sufficient room for the new one to expand fully, resulting in residual stenosis.

“If you tell me that you can implant a platform that will enable a safe valve-in-valve procedure in 5, 7, 10 years – a less invasive bailout for a failed prosthetic valve – if you can do that safely and effectively I would be more keen to do TAVR even in a young patient,” the interventional cardiologist said.

He and others are working on this unmet need. Dr. Dvir’s novel valve, being developed with Edwards Lifesciences, has performed well in valve-in-valve procedures in cadavers and animals. The first clinical trials are being planned.

“We need to think always that a bioprosthetic valve is not a cure, it’s a palliation. We treat the patients, they feel better, but we leave them with some kind of a chronic disease that’s prone to thrombosis, prone to degeneration and failure, prone to many different things,” he reflected.

The study was conducted without commercial support. Dr. Dvir reported serving as a consultant to Edwards Lifesciences, Medtronic, and St. Jude Medical.

[email protected]

PARIS – The first-ever study of the long-term durability of transcatheter bioprosthetic aortic valves has documented a disturbing rise in the valve degeneration rate occurring 5-7 years post implant.

Prior consistently reassuring follow-up studies have been intermediate in length, with a maximum of 5 years. The PARTNER 2A trial, which generated enormous enthusiasm for moving TAVR to intermediate-risk patients on the basis of positive results presented at the 2016 meeting of the American College of Cardiology, reported 2-year results.

Bruce Jancin/Frontline Medical News

“We found, as have others, that there’s very little degeneration in the first 4 years: 94% freedom from degeneration. But at 6 years, it’s 82%, and we estimate that by 8 years, it’s about 50%,” Dr. Danny Dvir reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We need to be cautious: This is our first look at the data. But we have a signal for a problem,” said Dr. Dvir of St. Paul’s Hospital in Vancouver.

He presented a retrospective study of 378 patients who underwent TAVR 5-14 years ago at two pioneering centers for the procedure: St. Paul’s and Charles Nicolle Hospital in Rouen, France. Patients’ average age at the time of TAVR was 82.3 years, with an STS score of 8.3%. The study featured serial echocardiography conducted during house calls in this frail elderly population.

Thirty-five patients developed prosthetic valve degeneration, defined by at least moderate regurgitation and/or a mean gradient of at least 20 mm Hg in 23 cases and stenosis in 12. The risk of degeneration was unrelated to the use of warfarin, a finding that suggests the valve deterioration issue is unrelated to clotting. The strongest risk factor for transcatheter valve degeneration in this study was baseline renal failure at the time of TAVR.

Dr. Dvir’s presentation was the talk of the meeting, and it cast a pall over the proceedings. The red flag raised by the study regarding valve durability has major implications regarding the current enthusiasm among many interventional cardiologists to routinely extend TAVR to intermediate and even lower-risk patients. As one audience member later confessed, “I have felt sick since hearing that presentation.”

Bruce Jancin/Frontline Medical News

Discussant Dr. A. Pieter Kappetein observed that transcatheter heart valve durability was a hot topic of discussion about 4 years ago but subsequently faded below the radar as a concern – until Dr. Dvir’s study.

“This is a very important study that puts transcatheter heart valve implantation in a little bit different light,” said Dr. Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

He noted that the surgical aortic valve replacement (SAVR) literature shows that the rate of structural valve deterioration is age related. It’s higher in 75-year-olds than in 85-year-olds, and higher still in 65-year-olds.

“Valve degeneration didn’t play a major role when we were doing TAVR in 80- and 85-year-olds because of their limited life expectancy, but it will play a role in younger patients. So I think we have to be careful before we move toward lower-risk patients,” the surgeon continued.

Dr. Jean-Francois Obadia, who performs both SAVR and TAVR, noted that the median duration of freedom from valve degeneration for Edwards Lifescience’s Carpentier surgical aortic valve is a hefty 17.9 years.

“This should be the gold standard,” declared Dr. Obadia, head of the department of adult cardiovascular surgery and heart transplantation at the Louis Pradel Cardiothoracic Hospital of Claude Bernard University in Lyon, France.

“Dr. Dvir’s study is one of the key messages we all should take back home: a 50% rate of valve deterioration at 8 years. Valve deterioration is the Achilles’ heel of bioprostheses. There is a lot of improvement left to do for the TAVR,” he said.

Dr. Dvir and others were quick to note that his long-term study was of necessity restricted to early-generation, balloon-expandable devices: the Cribier Edwards, Edwards Sapien, and Sapien XT valves. Contemporary valves, patient selection methods, and procedural techniques are far advanced in comparison.

“The Sapien 3 has much less paravalvular leakage than earlier-generation valves. Maybe with less paravalvular leakage and better hemodynamics there will be a decreased rate of degeneration. It could be. We need to see. We have to wait a few more years to see if later-generation transcatheter heart valves are more durable,” Dr. Dvir said.

To gain a better understanding of the full dimensions of the valve degeneration issue, he and his coinvestigators have formed the VALID (VAlve Long-term Durability International Data) registry. Operators interested in contributing patients to what is hoped will be a very large and informative data base are encouraged to contact Dr. Dvir ([email protected]).

In the meantime, he has reservations about extending TAVR to intermediate-risk patients outside of the rigorous clinical trial setting. He added that he’d feel far more comfortable in performing TAVR in intermediate-risk 70- to 75-year-olds if there was a tried and true valve-in-valve replacement method, something that doesn’t yet exist. The major limitation of current attempts at valve-in-valve replacement is underexpansion because the former valve doesn’t allow sufficient room for the new one to expand fully, resulting in residual stenosis.

“If you tell me that you can implant a platform that will enable a safe valve-in-valve procedure in 5, 7, 10 years – a less invasive bailout for a failed prosthetic valve – if you can do that safely and effectively I would be more keen to do TAVR even in a young patient,” the interventional cardiologist said.

He and others are working on this unmet need. Dr. Dvir’s novel valve, being developed with Edwards Lifesciences, has performed well in valve-in-valve procedures in cadavers and animals. The first clinical trials are being planned.

“We need to think always that a bioprosthetic valve is not a cure, it’s a palliation. We treat the patients, they feel better, but we leave them with some kind of a chronic disease that’s prone to thrombosis, prone to degeneration and failure, prone to many different things,” he reflected.

The study was conducted without commercial support. Dr. Dvir reported serving as a consultant to Edwards Lifesciences, Medtronic, and St. Jude Medical.

[email protected]

CHICAGO – Elective ventral hernia repair improves hernia-related quality of life for low- to moderate-risk patients, according to findings from a prospective patient-centered study.

The findings suggest that the risks and benefits of a conservative operative strategy should be reassessed, and that patient-centered outcomes should be considered, Dr. Julie Holihan reported at the annual meeting of the American Surgical Association.

Of 152 patients with a ventral hernia from a single hernia clinic, 97 were managed non-operatively, and 55 were managed operatively. In a propensity-matched cohort of 90 patients with similar demographics, baseline comorbidities, and quality of life scores, only operatively managed patients had improved quality of life scores at 6 months (improvement from 34.7 to 56.9 vs. from 35.6 to 36.6), according to Dr. Holihan of the University of Texas, Houston.

Further, satisfaction scores increased significantly more in the operative than in the non-operative group at follow-up (from a median score of 2 at baseline in both groups to scores of 9 and 3, respectively), and pain scores decreased significantly more in the operative group than in the non-operative group (from a baseline score of 5 down to 3 in the operative group, with no change [score of 6] in the non-operative group).

Two surgical site infections and one hernia recurrence occurred in the operative group.

Notably, the predicted risk of surgery in the cohort was much greater than the observed risk.

“We may be overestimating surgical risk in these patients,” she said.

Based on a multivariable analysis in the overall cohort, non-operative management was strongly associated with lower quality of life score (coefficient, -26.5), Dr. Holihan said.

Nonoperative management of ventral hernias is often recommended for patients, particularly in those with increased risk of surgical complications due to factors such as obesity, poorly controlled diabetes, smoking, or significant comorbidities like coronary artery disease, but this approach to management has not been well studied with respect to patient-centered outcomes such as quality of life and function, she explained.

Traditional outcomes that have been studied, including infection and hernia recurrence, may not be the outcomes that are most important to patients, she added.

For the current study, patients with ventral hernias were prospectively enrolled between June 2014 and June 2015. Non-operative management was recommended for smokers, those with a body mass index greater than 33 kg/m², and those with poorly controlled diabetes. Measured outcomes included surgical site infection, hernia recurrence, and quality of life using a validated quality of life measure.

This is the first prospective study comparing management strategies in ventral hernia patients with comorbidities, Dr. Holihan said.

She concluded that “the elective repair of ventral hernia, compared with non-operative management, improves patient-centered outcomes in similar-risk patients.”

“Furthermore, the low occurrence of complications suggests that we may be overestimating surgical risk and that we may be too conservative in our patient selection for elective ventral hernia repair. It may be time to reevaluate patient selection criteria in order to better incorporate patient-centered outcomes,” she said.

In response to a question about managing patients with higher risk and/or higher BMI, Dr. Holihan’s coauthor, Dr. Mike K. Liang, also of the University of Texas, Houston, noted that the findings of the study provide estimates for potential future randomized trials. He also noted that the moderate-risk patients at the center often undergo “prehabilitation,” or a preoperative exercise and diet program designed to help optimize outcomes. Currently, patients with BMI of 30-40 kg/m² are randomized to preoperative rehabilitation vs. current care.

“BMI is a very important decision making factor. We were not able to pick a standardized point [with respect to BMI] for when to operate vs. non-operate. Because of that, we used BMI as a factor in developing our propensity score,” he said, explaining that this is why the propensity-matched groups had similar BMI, while the non-operative group in the overall cohort had substantially higher BMI.

A randomized trial on prehabilitation may be able to provide some insight into the effects of rapid changes in weight and how they affect outcomes in order to make the best choices regarding surgery.

“We do hypothesize that significant weight loss prior to surgery may improve outcomes, and may make the abdominal wall more compliant and enable us to tackle more challenging hernias. We also hypothesize that patients who have a sudden increase in weight after having their ventral hernia repaired may end up having worse outcomes. Hopefully in the next year we will be able to shed more light on these very important questions.”

The authors reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

CHICAGO – Elective ventral hernia repair improves hernia-related quality of life for low- to moderate-risk patients, according to findings from a prospective patient-centered study.

The findings suggest that the risks and benefits of a conservative operative strategy should be reassessed, and that patient-centered outcomes should be considered, Dr. Julie Holihan reported at the annual meeting of the American Surgical Association.

Of 152 patients with a ventral hernia from a single hernia clinic, 97 were managed non-operatively, and 55 were managed operatively. In a propensity-matched cohort of 90 patients with similar demographics, baseline comorbidities, and quality of life scores, only operatively managed patients had improved quality of life scores at 6 months (improvement from 34.7 to 56.9 vs. from 35.6 to 36.6), according to Dr. Holihan of the University of Texas, Houston.

Further, satisfaction scores increased significantly more in the operative than in the non-operative group at follow-up (from a median score of 2 at baseline in both groups to scores of 9 and 3, respectively), and pain scores decreased significantly more in the operative group than in the non-operative group (from a baseline score of 5 down to 3 in the operative group, with no change [score of 6] in the non-operative group).

Two surgical site infections and one hernia recurrence occurred in the operative group.

Notably, the predicted risk of surgery in the cohort was much greater than the observed risk.

“We may be overestimating surgical risk in these patients,” she said.

Based on a multivariable analysis in the overall cohort, non-operative management was strongly associated with lower quality of life score (coefficient, -26.5), Dr. Holihan said.

Nonoperative management of ventral hernias is often recommended for patients, particularly in those with increased risk of surgical complications due to factors such as obesity, poorly controlled diabetes, smoking, or significant comorbidities like coronary artery disease, but this approach to management has not been well studied with respect to patient-centered outcomes such as quality of life and function, she explained.

Traditional outcomes that have been studied, including infection and hernia recurrence, may not be the outcomes that are most important to patients, she added.

For the current study, patients with ventral hernias were prospectively enrolled between June 2014 and June 2015. Non-operative management was recommended for smokers, those with a body mass index greater than 33 kg/m², and those with poorly controlled diabetes. Measured outcomes included surgical site infection, hernia recurrence, and quality of life using a validated quality of life measure.

This is the first prospective study comparing management strategies in ventral hernia patients with comorbidities, Dr. Holihan said.

She concluded that “the elective repair of ventral hernia, compared with non-operative management, improves patient-centered outcomes in similar-risk patients.”

“Furthermore, the low occurrence of complications suggests that we may be overestimating surgical risk and that we may be too conservative in our patient selection for elective ventral hernia repair. It may be time to reevaluate patient selection criteria in order to better incorporate patient-centered outcomes,” she said.

In response to a question about managing patients with higher risk and/or higher BMI, Dr. Holihan’s coauthor, Dr. Mike K. Liang, also of the University of Texas, Houston, noted that the findings of the study provide estimates for potential future randomized trials. He also noted that the moderate-risk patients at the center often undergo “prehabilitation,” or a preoperative exercise and diet program designed to help optimize outcomes. Currently, patients with BMI of 30-40 kg/m² are randomized to preoperative rehabilitation vs. current care.

“BMI is a very important decision making factor. We were not able to pick a standardized point [with respect to BMI] for when to operate vs. non-operate. Because of that, we used BMI as a factor in developing our propensity score,” he said, explaining that this is why the propensity-matched groups had similar BMI, while the non-operative group in the overall cohort had substantially higher BMI.

A randomized trial on prehabilitation may be able to provide some insight into the effects of rapid changes in weight and how they affect outcomes in order to make the best choices regarding surgery.

“We do hypothesize that significant weight loss prior to surgery may improve outcomes, and may make the abdominal wall more compliant and enable us to tackle more challenging hernias. We also hypothesize that patients who have a sudden increase in weight after having their ventral hernia repaired may end up having worse outcomes. Hopefully in the next year we will be able to shed more light on these very important questions.”

The authors reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

CHICAGO – Elective ventral hernia repair improves hernia-related quality of life for low- to moderate-risk patients, according to findings from a prospective patient-centered study.

The findings suggest that the risks and benefits of a conservative operative strategy should be reassessed, and that patient-centered outcomes should be considered, Dr. Julie Holihan reported at the annual meeting of the American Surgical Association.

Of 152 patients with a ventral hernia from a single hernia clinic, 97 were managed non-operatively, and 55 were managed operatively. In a propensity-matched cohort of 90 patients with similar demographics, baseline comorbidities, and quality of life scores, only operatively managed patients had improved quality of life scores at 6 months (improvement from 34.7 to 56.9 vs. from 35.6 to 36.6), according to Dr. Holihan of the University of Texas, Houston.

Further, satisfaction scores increased significantly more in the operative than in the non-operative group at follow-up (from a median score of 2 at baseline in both groups to scores of 9 and 3, respectively), and pain scores decreased significantly more in the operative group than in the non-operative group (from a baseline score of 5 down to 3 in the operative group, with no change [score of 6] in the non-operative group).

Two surgical site infections and one hernia recurrence occurred in the operative group.

Notably, the predicted risk of surgery in the cohort was much greater than the observed risk.

“We may be overestimating surgical risk in these patients,” she said.

Based on a multivariable analysis in the overall cohort, non-operative management was strongly associated with lower quality of life score (coefficient, -26.5), Dr. Holihan said.

Nonoperative management of ventral hernias is often recommended for patients, particularly in those with increased risk of surgical complications due to factors such as obesity, poorly controlled diabetes, smoking, or significant comorbidities like coronary artery disease, but this approach to management has not been well studied with respect to patient-centered outcomes such as quality of life and function, she explained.

Traditional outcomes that have been studied, including infection and hernia recurrence, may not be the outcomes that are most important to patients, she added.

For the current study, patients with ventral hernias were prospectively enrolled between June 2014 and June 2015. Non-operative management was recommended for smokers, those with a body mass index greater than 33 kg/m², and those with poorly controlled diabetes. Measured outcomes included surgical site infection, hernia recurrence, and quality of life using a validated quality of life measure.

This is the first prospective study comparing management strategies in ventral hernia patients with comorbidities, Dr. Holihan said.

She concluded that “the elective repair of ventral hernia, compared with non-operative management, improves patient-centered outcomes in similar-risk patients.”

“Furthermore, the low occurrence of complications suggests that we may be overestimating surgical risk and that we may be too conservative in our patient selection for elective ventral hernia repair. It may be time to reevaluate patient selection criteria in order to better incorporate patient-centered outcomes,” she said.

In response to a question about managing patients with higher risk and/or higher BMI, Dr. Holihan’s coauthor, Dr. Mike K. Liang, also of the University of Texas, Houston, noted that the findings of the study provide estimates for potential future randomized trials. He also noted that the moderate-risk patients at the center often undergo “prehabilitation,” or a preoperative exercise and diet program designed to help optimize outcomes. Currently, patients with BMI of 30-40 kg/m² are randomized to preoperative rehabilitation vs. current care.

“BMI is a very important decision making factor. We were not able to pick a standardized point [with respect to BMI] for when to operate vs. non-operate. Because of that, we used BMI as a factor in developing our propensity score,” he said, explaining that this is why the propensity-matched groups had similar BMI, while the non-operative group in the overall cohort had substantially higher BMI.

A randomized trial on prehabilitation may be able to provide some insight into the effects of rapid changes in weight and how they affect outcomes in order to make the best choices regarding surgery.

“We do hypothesize that significant weight loss prior to surgery may improve outcomes, and may make the abdominal wall more compliant and enable us to tackle more challenging hernias. We also hypothesize that patients who have a sudden increase in weight after having their ventral hernia repaired may end up having worse outcomes. Hopefully in the next year we will be able to shed more light on these very important questions.”

The authors reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

WASHINGTON – Universal cystoscopy at the time of hysterectomy – or at least more frequent use of the procedure – is worth considering since delayed diagnosis of urinary tract injury causes increased morbidity for patients, and in all likelihood increases litigation, Dr. Jay Goldberg and Dr. Cheung Kim suggested at the annual meeting of the American College of Obstetricians and Gynecologists.

“We’re often hesitant to do cystoscopy because we don’t want to add time,” said Dr. Kim. “But I always feel that no matter how much time it takes, I’ll be happier in the end if I do it. [And] if you have [experience], a routine, and readily available equipment, it can take as little as 10 minutes.”

Christine Kilgore/ Frontline Medical News

Universal cystoscopy to confirm ureteral patency is “fairly straightforward, low risk, and more likely to detect most injuries [than visual inspection alone], particularly ureteral injuries,” Dr. Kim said. On the other hand, it adds to operating time and increases procedure cost, and there is some research suggesting it may be relatively “low yield” and lead to some false positives.

Dr. Kim and Dr. Goldberg both practice at the Einstein Healthcare Network in Philadelphia. Here are some of the findings they shared, and advice they gave, on the use of cystoscopy – universal or selective – after hysterectomy.

Conflicting findings

There is conflicting opinion as to whether universal or selective cystoscopy after hysterectomy is best, and “there’s data on both sides,” said Dr. Goldberg, vice chairman of ob.gyn. and director of the Philadelphia Fibroid Center at Einstein.

A prospective study done at Louisiana State University, New Orleans, to evaluate the impact of a universal approach, for instance, showed an incidence of urinary tract injury of 4.3% (2.9% bladder injury, 1.8% ureteral injury, plus cases of simultaneous injury) in 839 hysterectomies for benign disease. The injury detection rate using intraoperative cystoscopy was 97.4%, and the majority of injuries – 76% – were not suspected prior to cystoscopy being performed (Obstet Gynecol. 2009 Jan;113[1]:6-10).

But researchers in Boston who looked retrospectively at 1,982 hysterectomies performed for any gynecologic indication found a much lower incidence of complications, and reported that cystoscopy did not detect any of the bladder injuries (0.71%) or ureteral injuries (0.25%) incurred in the group. Cystoscopy was performed selectively, however, in 250 of the patients, and was either normal or omitted in the patients who had complications (Obstet Gynecol. 2012 Dec;120[6]:1363-70).

Cystoscopy failed to detect any of the bladder injuries, but “all five of the ureteral injuries occurred in patients who had not undergone cystoscopy,” said Dr. Kim, chairman of ob.gyn. at Einstein Medical Center Montgomery in East Norriton, Pa.

Possible false-positives

Cystoscopy may lead on occasion to an incorrect presumption of a ureteral injury in patients with a pre-existing nonfunctional kidney, Dr. Goldberg noted.

He relayed the case of a 42-year-old patient who underwent a total abdominal hysterectomy without apparent complication. Cystoscopy was then performed with indigo carmine. An efflux of dye was seen from the left ureteral orifice but not from the right orifice.

Urology was consulted and investigated the presumed ureteral injury with additional surgical exploration. An intraoperative intravenous pyelogram (IVP) was eventually performed and was unable to identify the right kidney. A CT then showed an atrophic right kidney with compensatory hypertrophy of the left kidney, probably due to congenital right multicystic dysplastic kidney.

An estimated 0.2% of the population – 1 in 500 – will have a unilateral nonfunctional kidney, the majority of which have not been previously diagnosed. Etiologies include multicystic dysplastic kidney, congenital unilateral renal agenesis, and vascular events. “As we do more and more cystoscopies, this scenario is going to come up every so often,” said Dr. Goldberg, who reported on two such cases last year (Obstet Gynecol. 2015 Sep;126[3]:635-7).

It is also possible, Dr. Kim noted, that a weak urine jet observed on cystoscopy may not necessarily reflect injury. In the LSU study evaluating a universal approach, there was no injury detected on further evaluation in each of the 21 cases of low, subnormal dye efflux from the ureteral orifices. “So it’s not a benign process to undergo cystoscopy in terms of what the ramifications might be,” Dr. Kim said.

Increasing use

Ob.gyn. residents are required by the Accreditation Council for Graduate Medical Education to have completed 15 cystoscopies by the time they graduate, and according to recent survey findings, residents are more likely to utilize universal cystoscopy at the time of hysterectomy than currently practicing gynecologic surgeons.

The survey of ob.gyn residents (n = 56) shows universal cystoscopy (defined as greater than 90%) was performed in only a minority of cases during residency: 27% of total laparoscopic hysterectomies (TLH), 14% of laparoscopically assisted vaginal hysterectomies (LAVH), 12% of vaginal hysterectomies (VH), 2% of total abdominal hysterectomies (TAH), and 0% of supracervical hysterectomies (SCH), for instance.

Yet for every hysterectomy type, residents planned to perform universal cystoscopy post-residency more often than they had during their training (49% TLH, 34% LAVH, 34% VH, 15% TAH, 12% SCH), and “residents familiar with the literature on cystoscopy were statistically more likely to plan to perform universal cystoscopy,” said Dr. Goldberg, the senior author of the paper (Womens Health (Lond Engl). 2015 Nov;11[6]:825-31).

Litigation possible

Failure to detect a urinary tract injury at the time of hysterectomy may result in the need for future additional surgeries. Litigation in the Philadelphia market suggests that “if you have an injury that’s missed, there’s a chance that litigation may result,” Dr. Kim said.

Plaintiff’s attorneys have argued that not recognizing ureteral injury during surgery is a deviation from acceptable practice, while defense attorneys have contended that unavoidable complications occur and that no evaluation is required, or supported by the medical literature, when injury is not intraoperatively suspected. Currently, as cystoscopy is performed less than 25% of the time for all types of hysterectomy, the standard of care does not require the procedure intraoperatively if no injury is suspected, Dr. Goldberg said.

Primary prevention of urinary tract injury is most important, both physicians emphasized. The best way to accomplish this is to meticulously identify the anatomy and know the path of the ureter, and to document that the ureter has been identified and viewed as outside of the operative area, they said.

Dr. Kim and Dr. Goldberg reported having no relevant financial disclosures.

[email protected]

WASHINGTON – Universal cystoscopy at the time of hysterectomy – or at least more frequent use of the procedure – is worth considering since delayed diagnosis of urinary tract injury causes increased morbidity for patients, and in all likelihood increases litigation, Dr. Jay Goldberg and Dr. Cheung Kim suggested at the annual meeting of the American College of Obstetricians and Gynecologists.

“We’re often hesitant to do cystoscopy because we don’t want to add time,” said Dr. Kim. “But I always feel that no matter how much time it takes, I’ll be happier in the end if I do it. [And] if you have [experience], a routine, and readily available equipment, it can take as little as 10 minutes.”

Christine Kilgore/ Frontline Medical News

Universal cystoscopy to confirm ureteral patency is “fairly straightforward, low risk, and more likely to detect most injuries [than visual inspection alone], particularly ureteral injuries,” Dr. Kim said. On the other hand, it adds to operating time and increases procedure cost, and there is some research suggesting it may be relatively “low yield” and lead to some false positives.

Dr. Kim and Dr. Goldberg both practice at the Einstein Healthcare Network in Philadelphia. Here are some of the findings they shared, and advice they gave, on the use of cystoscopy – universal or selective – after hysterectomy.

Conflicting findings

There is conflicting opinion as to whether universal or selective cystoscopy after hysterectomy is best, and “there’s data on both sides,” said Dr. Goldberg, vice chairman of ob.gyn. and director of the Philadelphia Fibroid Center at Einstein.

A prospective study done at Louisiana State University, New Orleans, to evaluate the impact of a universal approach, for instance, showed an incidence of urinary tract injury of 4.3% (2.9% bladder injury, 1.8% ureteral injury, plus cases of simultaneous injury) in 839 hysterectomies for benign disease. The injury detection rate using intraoperative cystoscopy was 97.4%, and the majority of injuries – 76% – were not suspected prior to cystoscopy being performed (Obstet Gynecol. 2009 Jan;113[1]:6-10).

But researchers in Boston who looked retrospectively at 1,982 hysterectomies performed for any gynecologic indication found a much lower incidence of complications, and reported that cystoscopy did not detect any of the bladder injuries (0.71%) or ureteral injuries (0.25%) incurred in the group. Cystoscopy was performed selectively, however, in 250 of the patients, and was either normal or omitted in the patients who had complications (Obstet Gynecol. 2012 Dec;120[6]:1363-70).

Cystoscopy failed to detect any of the bladder injuries, but “all five of the ureteral injuries occurred in patients who had not undergone cystoscopy,” said Dr. Kim, chairman of ob.gyn. at Einstein Medical Center Montgomery in East Norriton, Pa.

Possible false-positives

Cystoscopy may lead on occasion to an incorrect presumption of a ureteral injury in patients with a pre-existing nonfunctional kidney, Dr. Goldberg noted.

He relayed the case of a 42-year-old patient who underwent a total abdominal hysterectomy without apparent complication. Cystoscopy was then performed with indigo carmine. An efflux of dye was seen from the left ureteral orifice but not from the right orifice.

Urology was consulted and investigated the presumed ureteral injury with additional surgical exploration. An intraoperative intravenous pyelogram (IVP) was eventually performed and was unable to identify the right kidney. A CT then showed an atrophic right kidney with compensatory hypertrophy of the left kidney, probably due to congenital right multicystic dysplastic kidney.

An estimated 0.2% of the population – 1 in 500 – will have a unilateral nonfunctional kidney, the majority of which have not been previously diagnosed. Etiologies include multicystic dysplastic kidney, congenital unilateral renal agenesis, and vascular events. “As we do more and more cystoscopies, this scenario is going to come up every so often,” said Dr. Goldberg, who reported on two such cases last year (Obstet Gynecol. 2015 Sep;126[3]:635-7).

It is also possible, Dr. Kim noted, that a weak urine jet observed on cystoscopy may not necessarily reflect injury. In the LSU study evaluating a universal approach, there was no injury detected on further evaluation in each of the 21 cases of low, subnormal dye efflux from the ureteral orifices. “So it’s not a benign process to undergo cystoscopy in terms of what the ramifications might be,” Dr. Kim said.

Increasing use

Ob.gyn. residents are required by the Accreditation Council for Graduate Medical Education to have completed 15 cystoscopies by the time they graduate, and according to recent survey findings, residents are more likely to utilize universal cystoscopy at the time of hysterectomy than currently practicing gynecologic surgeons.

The survey of ob.gyn residents (n = 56) shows universal cystoscopy (defined as greater than 90%) was performed in only a minority of cases during residency: 27% of total laparoscopic hysterectomies (TLH), 14% of laparoscopically assisted vaginal hysterectomies (LAVH), 12% of vaginal hysterectomies (VH), 2% of total abdominal hysterectomies (TAH), and 0% of supracervical hysterectomies (SCH), for instance.

Yet for every hysterectomy type, residents planned to perform universal cystoscopy post-residency more often than they had during their training (49% TLH, 34% LAVH, 34% VH, 15% TAH, 12% SCH), and “residents familiar with the literature on cystoscopy were statistically more likely to plan to perform universal cystoscopy,” said Dr. Goldberg, the senior author of the paper (Womens Health (Lond Engl). 2015 Nov;11[6]:825-31).

Litigation possible

Failure to detect a urinary tract injury at the time of hysterectomy may result in the need for future additional surgeries. Litigation in the Philadelphia market suggests that “if you have an injury that’s missed, there’s a chance that litigation may result,” Dr. Kim said.

Plaintiff’s attorneys have argued that not recognizing ureteral injury during surgery is a deviation from acceptable practice, while defense attorneys have contended that unavoidable complications occur and that no evaluation is required, or supported by the medical literature, when injury is not intraoperatively suspected. Currently, as cystoscopy is performed less than 25% of the time for all types of hysterectomy, the standard of care does not require the procedure intraoperatively if no injury is suspected, Dr. Goldberg said.

Primary prevention of urinary tract injury is most important, both physicians emphasized. The best way to accomplish this is to meticulously identify the anatomy and know the path of the ureter, and to document that the ureter has been identified and viewed as outside of the operative area, they said.

Dr. Kim and Dr. Goldberg reported having no relevant financial disclosures.

[email protected]

WASHINGTON – Universal cystoscopy at the time of hysterectomy – or at least more frequent use of the procedure – is worth considering since delayed diagnosis of urinary tract injury causes increased morbidity for patients, and in all likelihood increases litigation, Dr. Jay Goldberg and Dr. Cheung Kim suggested at the annual meeting of the American College of Obstetricians and Gynecologists.

“We’re often hesitant to do cystoscopy because we don’t want to add time,” said Dr. Kim. “But I always feel that no matter how much time it takes, I’ll be happier in the end if I do it. [And] if you have [experience], a routine, and readily available equipment, it can take as little as 10 minutes.”

Christine Kilgore/ Frontline Medical News

Universal cystoscopy to confirm ureteral patency is “fairly straightforward, low risk, and more likely to detect most injuries [than visual inspection alone], particularly ureteral injuries,” Dr. Kim said. On the other hand, it adds to operating time and increases procedure cost, and there is some research suggesting it may be relatively “low yield” and lead to some false positives.

Dr. Kim and Dr. Goldberg both practice at the Einstein Healthcare Network in Philadelphia. Here are some of the findings they shared, and advice they gave, on the use of cystoscopy – universal or selective – after hysterectomy.

Conflicting findings

There is conflicting opinion as to whether universal or selective cystoscopy after hysterectomy is best, and “there’s data on both sides,” said Dr. Goldberg, vice chairman of ob.gyn. and director of the Philadelphia Fibroid Center at Einstein.

A prospective study done at Louisiana State University, New Orleans, to evaluate the impact of a universal approach, for instance, showed an incidence of urinary tract injury of 4.3% (2.9% bladder injury, 1.8% ureteral injury, plus cases of simultaneous injury) in 839 hysterectomies for benign disease. The injury detection rate using intraoperative cystoscopy was 97.4%, and the majority of injuries – 76% – were not suspected prior to cystoscopy being performed (Obstet Gynecol. 2009 Jan;113[1]:6-10).

But researchers in Boston who looked retrospectively at 1,982 hysterectomies performed for any gynecologic indication found a much lower incidence of complications, and reported that cystoscopy did not detect any of the bladder injuries (0.71%) or ureteral injuries (0.25%) incurred in the group. Cystoscopy was performed selectively, however, in 250 of the patients, and was either normal or omitted in the patients who had complications (Obstet Gynecol. 2012 Dec;120[6]:1363-70).

Cystoscopy failed to detect any of the bladder injuries, but “all five of the ureteral injuries occurred in patients who had not undergone cystoscopy,” said Dr. Kim, chairman of ob.gyn. at Einstein Medical Center Montgomery in East Norriton, Pa.

Possible false-positives

Cystoscopy may lead on occasion to an incorrect presumption of a ureteral injury in patients with a pre-existing nonfunctional kidney, Dr. Goldberg noted.

He relayed the case of a 42-year-old patient who underwent a total abdominal hysterectomy without apparent complication. Cystoscopy was then performed with indigo carmine. An efflux of dye was seen from the left ureteral orifice but not from the right orifice.

Urology was consulted and investigated the presumed ureteral injury with additional surgical exploration. An intraoperative intravenous pyelogram (IVP) was eventually performed and was unable to identify the right kidney. A CT then showed an atrophic right kidney with compensatory hypertrophy of the left kidney, probably due to congenital right multicystic dysplastic kidney.

An estimated 0.2% of the population – 1 in 500 – will have a unilateral nonfunctional kidney, the majority of which have not been previously diagnosed. Etiologies include multicystic dysplastic kidney, congenital unilateral renal agenesis, and vascular events. “As we do more and more cystoscopies, this scenario is going to come up every so often,” said Dr. Goldberg, who reported on two such cases last year (Obstet Gynecol. 2015 Sep;126[3]:635-7).

It is also possible, Dr. Kim noted, that a weak urine jet observed on cystoscopy may not necessarily reflect injury. In the LSU study evaluating a universal approach, there was no injury detected on further evaluation in each of the 21 cases of low, subnormal dye efflux from the ureteral orifices. “So it’s not a benign process to undergo cystoscopy in terms of what the ramifications might be,” Dr. Kim said.

Increasing use

Ob.gyn. residents are required by the Accreditation Council for Graduate Medical Education to have completed 15 cystoscopies by the time they graduate, and according to recent survey findings, residents are more likely to utilize universal cystoscopy at the time of hysterectomy than currently practicing gynecologic surgeons.

The survey of ob.gyn residents (n = 56) shows universal cystoscopy (defined as greater than 90%) was performed in only a minority of cases during residency: 27% of total laparoscopic hysterectomies (TLH), 14% of laparoscopically assisted vaginal hysterectomies (LAVH), 12% of vaginal hysterectomies (VH), 2% of total abdominal hysterectomies (TAH), and 0% of supracervical hysterectomies (SCH), for instance.

Yet for every hysterectomy type, residents planned to perform universal cystoscopy post-residency more often than they had during their training (49% TLH, 34% LAVH, 34% VH, 15% TAH, 12% SCH), and “residents familiar with the literature on cystoscopy were statistically more likely to plan to perform universal cystoscopy,” said Dr. Goldberg, the senior author of the paper (Womens Health (Lond Engl). 2015 Nov;11[6]:825-31).

Litigation possible

Failure to detect a urinary tract injury at the time of hysterectomy may result in the need for future additional surgeries. Litigation in the Philadelphia market suggests that “if you have an injury that’s missed, there’s a chance that litigation may result,” Dr. Kim said.

Plaintiff’s attorneys have argued that not recognizing ureteral injury during surgery is a deviation from acceptable practice, while defense attorneys have contended that unavoidable complications occur and that no evaluation is required, or supported by the medical literature, when injury is not intraoperatively suspected. Currently, as cystoscopy is performed less than 25% of the time for all types of hysterectomy, the standard of care does not require the procedure intraoperatively if no injury is suspected, Dr. Goldberg said.

Primary prevention of urinary tract injury is most important, both physicians emphasized. The best way to accomplish this is to meticulously identify the anatomy and know the path of the ureter, and to document that the ureter has been identified and viewed as outside of the operative area, they said.

Dr. Kim and Dr. Goldberg reported having no relevant financial disclosures.

[email protected]