Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut to levels paid for under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.
Seema Verma
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.
Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut to levels paid for under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.
Seema Verma
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.
Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut to levels paid for under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.
Seema Verma
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.
Orlando – A fast-track protocol for pediatric patients with noncomplicated appendicitis significantly reduced length of stay and improved other measures of quality care, according to results from a recent single-center quality improvement project.
After implementation of the multidisciplinary clinical pathway, postoperative narcotic use decreased, while use of a standard antibiotic regimen increased, said Angela M. Kao, MD, a surgical resident with Carolinas Medical Center, Charlotte, N.C.
Of the patients treated according to the fast-track pathway, 90% were discharged within 8 hours of surgery or immediately after morning rounds with no increase in complications or readmissions, said Dr. Kao, who was named the Trainee Abstract Competition Winner based on this research presented at the American College of Surgeons Quality and Safety Conference.
While same-day discharge after laparoscopic appendectomy is safe for most children with nonperforated acute appendicitis, there is wide variability in its perioperative management, Dr. Kao said in an oral abstract presentation.
“At our institution, we noted that no standardized protocol existed for patients with noncomplicated appendicitis, leading to wide variations in postoperative length of stay,” she said.
In addition, preoperative antibiotics and postoperative pain regimens were largely based on provider preference, she added.
Accordingly, a multidisciplinary team used information from the American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) to identify areas for improvement, including multimodal analgesia, standardization of antibiotics, early mobilization, and discharge initiated by nursing.
They also created a designated pre- and postoperative unit staffed by nurses trained in ERAS (Enhanced Recovery After Surgery), which greatly facilitated the goals of the project, Dr. Kao and her coauthors said.
The study results included 61 patients with noncomplicated acute appendicitis who underwent laparoscopic appendectomy after implementation of the fast-track pathway initiative. They were compared with a historical cohort of 58 patients treated in the year leading up to implementation of the pathway.
Dr. Kao and her colleagues found that 87% of fast-track patients received the standard recommended dosing of a third-generation cephalosporin and metronidazole, compared with just 13.8% among those in the period before the fast track’s implementation. In addition, duplicate antibiotic dosing was seen in 6.6% of cases, down from 49%.
Postoperative nausea was minimal, with 9% of fast-tracked patients requiring antiemetic, down from 18.9% in the previous period.
Postoperative IV narcotic use decreased from 86% to 54% because of the use of multimodal analgesia, Dr. Kao added.
Total hospital length of stay decreased 43% to a mean of 16 hours, and the postoperative length of stay decreased by 60% to a mean of 8 hours with no differences in complications or readmission, compared with the period before the fast track’s implementation, according to Dr. Kao.
Almost all of the fast-track patients (90.2%) were discharged within 8 hours or, in the case of procedures performed between midnight and 7 a.m., discharged immediately after morning rounds, according to data presented by the investigators.
“At our institution, a transition from patients discharged by the surgical team to nursing-initiated recovery and discharge was a key component,” Dr. Kao said at the meeting. “Earlier discharge was largely facilitated by nursing-initiated discharge, which allowed for more frequent evaluation of discharge readiness, compared to surgeon providers.”
Dr. Kao had no disclosures relevant to her presentation.
Orlando – A fast-track protocol for pediatric patients with noncomplicated appendicitis significantly reduced length of stay and improved other measures of quality care, according to results from a recent single-center quality improvement project.
After implementation of the multidisciplinary clinical pathway, postoperative narcotic use decreased, while use of a standard antibiotic regimen increased, said Angela M. Kao, MD, a surgical resident with Carolinas Medical Center, Charlotte, N.C.
Of the patients treated according to the fast-track pathway, 90% were discharged within 8 hours of surgery or immediately after morning rounds with no increase in complications or readmissions, said Dr. Kao, who was named the Trainee Abstract Competition Winner based on this research presented at the American College of Surgeons Quality and Safety Conference.
While same-day discharge after laparoscopic appendectomy is safe for most children with nonperforated acute appendicitis, there is wide variability in its perioperative management, Dr. Kao said in an oral abstract presentation.
“At our institution, we noted that no standardized protocol existed for patients with noncomplicated appendicitis, leading to wide variations in postoperative length of stay,” she said.
In addition, preoperative antibiotics and postoperative pain regimens were largely based on provider preference, she added.
Accordingly, a multidisciplinary team used information from the American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) to identify areas for improvement, including multimodal analgesia, standardization of antibiotics, early mobilization, and discharge initiated by nursing.
They also created a designated pre- and postoperative unit staffed by nurses trained in ERAS (Enhanced Recovery After Surgery), which greatly facilitated the goals of the project, Dr. Kao and her coauthors said.
The study results included 61 patients with noncomplicated acute appendicitis who underwent laparoscopic appendectomy after implementation of the fast-track pathway initiative. They were compared with a historical cohort of 58 patients treated in the year leading up to implementation of the pathway.
Dr. Kao and her colleagues found that 87% of fast-track patients received the standard recommended dosing of a third-generation cephalosporin and metronidazole, compared with just 13.8% among those in the period before the fast track’s implementation. In addition, duplicate antibiotic dosing was seen in 6.6% of cases, down from 49%.
Postoperative nausea was minimal, with 9% of fast-tracked patients requiring antiemetic, down from 18.9% in the previous period.
Postoperative IV narcotic use decreased from 86% to 54% because of the use of multimodal analgesia, Dr. Kao added.
Total hospital length of stay decreased 43% to a mean of 16 hours, and the postoperative length of stay decreased by 60% to a mean of 8 hours with no differences in complications or readmission, compared with the period before the fast track’s implementation, according to Dr. Kao.
Almost all of the fast-track patients (90.2%) were discharged within 8 hours or, in the case of procedures performed between midnight and 7 a.m., discharged immediately after morning rounds, according to data presented by the investigators.
“At our institution, a transition from patients discharged by the surgical team to nursing-initiated recovery and discharge was a key component,” Dr. Kao said at the meeting. “Earlier discharge was largely facilitated by nursing-initiated discharge, which allowed for more frequent evaluation of discharge readiness, compared to surgeon providers.”
Dr. Kao had no disclosures relevant to her presentation.
Orlando – A fast-track protocol for pediatric patients with noncomplicated appendicitis significantly reduced length of stay and improved other measures of quality care, according to results from a recent single-center quality improvement project.
After implementation of the multidisciplinary clinical pathway, postoperative narcotic use decreased, while use of a standard antibiotic regimen increased, said Angela M. Kao, MD, a surgical resident with Carolinas Medical Center, Charlotte, N.C.
Of the patients treated according to the fast-track pathway, 90% were discharged within 8 hours of surgery or immediately after morning rounds with no increase in complications or readmissions, said Dr. Kao, who was named the Trainee Abstract Competition Winner based on this research presented at the American College of Surgeons Quality and Safety Conference.
While same-day discharge after laparoscopic appendectomy is safe for most children with nonperforated acute appendicitis, there is wide variability in its perioperative management, Dr. Kao said in an oral abstract presentation.
“At our institution, we noted that no standardized protocol existed for patients with noncomplicated appendicitis, leading to wide variations in postoperative length of stay,” she said.
In addition, preoperative antibiotics and postoperative pain regimens were largely based on provider preference, she added.
Accordingly, a multidisciplinary team used information from the American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) to identify areas for improvement, including multimodal analgesia, standardization of antibiotics, early mobilization, and discharge initiated by nursing.
They also created a designated pre- and postoperative unit staffed by nurses trained in ERAS (Enhanced Recovery After Surgery), which greatly facilitated the goals of the project, Dr. Kao and her coauthors said.
The study results included 61 patients with noncomplicated acute appendicitis who underwent laparoscopic appendectomy after implementation of the fast-track pathway initiative. They were compared with a historical cohort of 58 patients treated in the year leading up to implementation of the pathway.
Dr. Kao and her colleagues found that 87% of fast-track patients received the standard recommended dosing of a third-generation cephalosporin and metronidazole, compared with just 13.8% among those in the period before the fast track’s implementation. In addition, duplicate antibiotic dosing was seen in 6.6% of cases, down from 49%.
Postoperative nausea was minimal, with 9% of fast-tracked patients requiring antiemetic, down from 18.9% in the previous period.
Postoperative IV narcotic use decreased from 86% to 54% because of the use of multimodal analgesia, Dr. Kao added.
Total hospital length of stay decreased 43% to a mean of 16 hours, and the postoperative length of stay decreased by 60% to a mean of 8 hours with no differences in complications or readmission, compared with the period before the fast track’s implementation, according to Dr. Kao.
Almost all of the fast-track patients (90.2%) were discharged within 8 hours or, in the case of procedures performed between midnight and 7 a.m., discharged immediately after morning rounds, according to data presented by the investigators.
“At our institution, a transition from patients discharged by the surgical team to nursing-initiated recovery and discharge was a key component,” Dr. Kao said at the meeting. “Earlier discharge was largely facilitated by nursing-initiated discharge, which allowed for more frequent evaluation of discharge readiness, compared to surgeon providers.”
Dr. Kao had no disclosures relevant to her presentation.
Prehospital administration of plasma to trauma patients at risk for hemorrhagic shock improves odds of survival, according to the Prehospital Air Medical Plasma (PAMPer) trial.
Patients who received plasma also had a decreased median prothrombin to time ratio, compared with those who received standard-care resuscitation alone.
Spotmatik/ThinkStock
Modern trauma patients benefit “from receiving less crystalloid-based therapy and early balanced blood component–based therapy once they arrive at a facility for definitive care,” Jason L. Sperry, MD, of the University of Pittsburgh and his coauthors wrote in the New England Journal of Medicine. These newer strategies aim to mitigate coagulopathy and its associated downstream complications.
Still, “a majority of deaths from traumatic hemorrhage continue to occur in the first hours after arrival at the trauma center, which underscores the importance of the prehospital environment for early interventions that provide benefit,” the investigators noted.
The PAMPer trial (NCT01818427) examined the efficacy and safety of prehospital plasma resuscitation, comparing it with standard-care resuscitation, in severely injured patients. The phase 3, randomized, superiority trial involved 501 trauma patients at risk for hemorrhagic shock who were transported from 27 air medical bases to nine trauma centers. In total, 230 patients received prehospital plasma and standard-care resuscitation, and 271 patients received standard-care alone. Standard-care included infusion of crystalloid fluids in a goal-directed manner. Air medical bases delivered each type of care in 1-month intervals.
Patients were eligible if they exhibited severe hypotension (systolic blood pressure less than 70 mm Hg) or both hypotension (systolic blood pressure less than 90 mm Hg) and tachycardia (greater than 108 beats per minute).
Eligible patients received two units of thawed plasma, which was completely delivered before administration of any other fluids. If infusion of plasma was not complete upon arrival at the trauma center, infusion was completed before any in-hospital fluids were administered. Following preexisting local protocols, 13 of 27 air transport teams carried 2U of red blood cells. If red blood cells were delivered, then this was performed after plasma administration if the patient was still hypotensive or obviously bleeding.
The 30-day mortality rate among all patients was 29.6%. Approximately one in three patients received a prehospital red blood cell transfusion, and nearly 60% underwent surgery within 24 hours of hospital admission.
A greater percentage of patients in the standard-care group were given red blood cell transfusions, compared with those in the plasma group. The standard-care patients also received greater volumes of crystalloid solution than did those receiving plasma.
The primary outcome, 30-day mortality, was 9.8% lower for patients who received plasma, compared with patients who received standard-care alone (23.2% vs. 33.0%; P = .03). Multivariate regression analysis revealed that plasma delivery accounted for a 39% lower risk of death within 30 days, compared with standard care (P = .02). Within 3 hours of randomization, Kaplan-Meier curves revealed a separation between the two treatment groups that persisted until 30 days.
Median prothrombin to time ratio, the only statistically significant secondary outcome, was lower in the plasma group than it was in the standard-care group (1.2 vs. 1.3; P less than .001).
Other measured parameters were similar between the two main treatment groups, including rates of nosocomial infections, allergic or transfusion-related reactions, acute lung injury/acute respiratory distress syndrome, and multiorgan failure.
“Although we cannot determine the independent or additive effects of prehospital administration of plasma and packed red cells, the survival benefits attributable to plasma administration persisted after adjustment for prehospital red-cell administration, and a subgroup analysis showed no heterogeneity of the treatment effect,” the investigators wrote.
The PAMPer trial was supported by a grant from the U.S. Army Medical Research and Materiel Command. One author reported funding from Janssen Pharmaceuticals, CSL Behring, Haemonetics, and Accriva Diagnostics, as well as having been named on a patent on TLR4 inhibitors for the treatment of inflammatory and infectious disorders.
The Prehospital Air Medical Plasma (PAMPer) trial shows that prehospital plasma improves survival rates in trauma patients at risk for hemorrhagic shock, and its implementation should therefore be considered, according to Jeremy W. Cannon, MD.
“Severe hemorrhage from injury claims the lives of nearly 50,000 Americans every year,” Dr. Cannon wrote in an accompanying editorial. “Because many of these deaths occur in young, vital people, this number translates to an astounding loss of almost 2,000,000 years of productive life.”
Since most deaths occur in less than 2 hours, severe hemorrhage requires rapid intervention; however, the best methods of intervention are unclear. In 1994, Bickell et al. demonstrated that administration of crystalloid-based therapy was more beneficial in a goal-directed, operative setting than it was in transit to a trauma center. Other studies have shown that rapid transport and tourniquet application, when appropriate, are essential.
“But what about patients who have blunt injuries and longer transport times?” asked Dr. Cannon. Recently, damage-control resuscitation has proven effective in the trauma center – a combination of red cells, plasma, and platelets in approximately equal proportions, with minimal nonhemostatic crystalloid solution. Researchers now ask whether this intervention has a place in the prehospital setting.
The PAMPer trial suggests that the number needed to treat is 10 to save one life. These results “should motivate trauma center personnel and air medical crews across the country to consider implementing this lifesaving approach,” Dr. Cannon wrote.
Several blood products are candidates for prehospital resuscitation; their selection depends on both logistical and medical factors. Although fresh-frozen plasma was used in the PAMPer trial, it has a shelf life of only 5 days once thawed, leading to more frequent replenishment. Never-frozen plasma lasts 26 days, which could be easier to keep in stock. Beyond plasma, “refrigerated whole blood has a shelf life of 21 days and offers the benefit of both platelets and oxygen delivery, making it perhaps the ideal product for prehospital resuscitation,” Dr. Cannon wrote.
Jeremy W. Cannon, MD, is at the University of Pennsylvania in Philadelphia and the Uniformed Services University in Bethesda, Md. These comments are adapted from an accompanying editorial (N Engl J Med. 2018 Jul 26;379[4]:387-8). Dr. Cannon reported nonfinancial support from Prytime Medical Devices outside the submitted work and institutional participation in a research network funded by the Department of Defense.
The Prehospital Air Medical Plasma (PAMPer) trial shows that prehospital plasma improves survival rates in trauma patients at risk for hemorrhagic shock, and its implementation should therefore be considered, according to Jeremy W. Cannon, MD.
“Severe hemorrhage from injury claims the lives of nearly 50,000 Americans every year,” Dr. Cannon wrote in an accompanying editorial. “Because many of these deaths occur in young, vital people, this number translates to an astounding loss of almost 2,000,000 years of productive life.”
Since most deaths occur in less than 2 hours, severe hemorrhage requires rapid intervention; however, the best methods of intervention are unclear. In 1994, Bickell et al. demonstrated that administration of crystalloid-based therapy was more beneficial in a goal-directed, operative setting than it was in transit to a trauma center. Other studies have shown that rapid transport and tourniquet application, when appropriate, are essential.
“But what about patients who have blunt injuries and longer transport times?” asked Dr. Cannon. Recently, damage-control resuscitation has proven effective in the trauma center – a combination of red cells, plasma, and platelets in approximately equal proportions, with minimal nonhemostatic crystalloid solution. Researchers now ask whether this intervention has a place in the prehospital setting.
The PAMPer trial suggests that the number needed to treat is 10 to save one life. These results “should motivate trauma center personnel and air medical crews across the country to consider implementing this lifesaving approach,” Dr. Cannon wrote.
Several blood products are candidates for prehospital resuscitation; their selection depends on both logistical and medical factors. Although fresh-frozen plasma was used in the PAMPer trial, it has a shelf life of only 5 days once thawed, leading to more frequent replenishment. Never-frozen plasma lasts 26 days, which could be easier to keep in stock. Beyond plasma, “refrigerated whole blood has a shelf life of 21 days and offers the benefit of both platelets and oxygen delivery, making it perhaps the ideal product for prehospital resuscitation,” Dr. Cannon wrote.
Jeremy W. Cannon, MD, is at the University of Pennsylvania in Philadelphia and the Uniformed Services University in Bethesda, Md. These comments are adapted from an accompanying editorial (N Engl J Med. 2018 Jul 26;379[4]:387-8). Dr. Cannon reported nonfinancial support from Prytime Medical Devices outside the submitted work and institutional participation in a research network funded by the Department of Defense.
Body
The Prehospital Air Medical Plasma (PAMPer) trial shows that prehospital plasma improves survival rates in trauma patients at risk for hemorrhagic shock, and its implementation should therefore be considered, according to Jeremy W. Cannon, MD.
“Severe hemorrhage from injury claims the lives of nearly 50,000 Americans every year,” Dr. Cannon wrote in an accompanying editorial. “Because many of these deaths occur in young, vital people, this number translates to an astounding loss of almost 2,000,000 years of productive life.”
Since most deaths occur in less than 2 hours, severe hemorrhage requires rapid intervention; however, the best methods of intervention are unclear. In 1994, Bickell et al. demonstrated that administration of crystalloid-based therapy was more beneficial in a goal-directed, operative setting than it was in transit to a trauma center. Other studies have shown that rapid transport and tourniquet application, when appropriate, are essential.
“But what about patients who have blunt injuries and longer transport times?” asked Dr. Cannon. Recently, damage-control resuscitation has proven effective in the trauma center – a combination of red cells, plasma, and platelets in approximately equal proportions, with minimal nonhemostatic crystalloid solution. Researchers now ask whether this intervention has a place in the prehospital setting.
The PAMPer trial suggests that the number needed to treat is 10 to save one life. These results “should motivate trauma center personnel and air medical crews across the country to consider implementing this lifesaving approach,” Dr. Cannon wrote.
Several blood products are candidates for prehospital resuscitation; their selection depends on both logistical and medical factors. Although fresh-frozen plasma was used in the PAMPer trial, it has a shelf life of only 5 days once thawed, leading to more frequent replenishment. Never-frozen plasma lasts 26 days, which could be easier to keep in stock. Beyond plasma, “refrigerated whole blood has a shelf life of 21 days and offers the benefit of both platelets and oxygen delivery, making it perhaps the ideal product for prehospital resuscitation,” Dr. Cannon wrote.
Jeremy W. Cannon, MD, is at the University of Pennsylvania in Philadelphia and the Uniformed Services University in Bethesda, Md. These comments are adapted from an accompanying editorial (N Engl J Med. 2018 Jul 26;379[4]:387-8). Dr. Cannon reported nonfinancial support from Prytime Medical Devices outside the submitted work and institutional participation in a research network funded by the Department of Defense.
Title
Prehospital plasma deserves consideration
Prehospital plasma deserves consideration
Prehospital administration of plasma to trauma patients at risk for hemorrhagic shock improves odds of survival, according to the Prehospital Air Medical Plasma (PAMPer) trial.
Patients who received plasma also had a decreased median prothrombin to time ratio, compared with those who received standard-care resuscitation alone.
Spotmatik/ThinkStock
Modern trauma patients benefit “from receiving less crystalloid-based therapy and early balanced blood component–based therapy once they arrive at a facility for definitive care,” Jason L. Sperry, MD, of the University of Pittsburgh and his coauthors wrote in the New England Journal of Medicine. These newer strategies aim to mitigate coagulopathy and its associated downstream complications.
Still, “a majority of deaths from traumatic hemorrhage continue to occur in the first hours after arrival at the trauma center, which underscores the importance of the prehospital environment for early interventions that provide benefit,” the investigators noted.
The PAMPer trial (NCT01818427) examined the efficacy and safety of prehospital plasma resuscitation, comparing it with standard-care resuscitation, in severely injured patients. The phase 3, randomized, superiority trial involved 501 trauma patients at risk for hemorrhagic shock who were transported from 27 air medical bases to nine trauma centers. In total, 230 patients received prehospital plasma and standard-care resuscitation, and 271 patients received standard-care alone. Standard-care included infusion of crystalloid fluids in a goal-directed manner. Air medical bases delivered each type of care in 1-month intervals.
Patients were eligible if they exhibited severe hypotension (systolic blood pressure less than 70 mm Hg) or both hypotension (systolic blood pressure less than 90 mm Hg) and tachycardia (greater than 108 beats per minute).
Eligible patients received two units of thawed plasma, which was completely delivered before administration of any other fluids. If infusion of plasma was not complete upon arrival at the trauma center, infusion was completed before any in-hospital fluids were administered. Following preexisting local protocols, 13 of 27 air transport teams carried 2U of red blood cells. If red blood cells were delivered, then this was performed after plasma administration if the patient was still hypotensive or obviously bleeding.
The 30-day mortality rate among all patients was 29.6%. Approximately one in three patients received a prehospital red blood cell transfusion, and nearly 60% underwent surgery within 24 hours of hospital admission.
A greater percentage of patients in the standard-care group were given red blood cell transfusions, compared with those in the plasma group. The standard-care patients also received greater volumes of crystalloid solution than did those receiving plasma.
The primary outcome, 30-day mortality, was 9.8% lower for patients who received plasma, compared with patients who received standard-care alone (23.2% vs. 33.0%; P = .03). Multivariate regression analysis revealed that plasma delivery accounted for a 39% lower risk of death within 30 days, compared with standard care (P = .02). Within 3 hours of randomization, Kaplan-Meier curves revealed a separation between the two treatment groups that persisted until 30 days.
Median prothrombin to time ratio, the only statistically significant secondary outcome, was lower in the plasma group than it was in the standard-care group (1.2 vs. 1.3; P less than .001).
Other measured parameters were similar between the two main treatment groups, including rates of nosocomial infections, allergic or transfusion-related reactions, acute lung injury/acute respiratory distress syndrome, and multiorgan failure.
“Although we cannot determine the independent or additive effects of prehospital administration of plasma and packed red cells, the survival benefits attributable to plasma administration persisted after adjustment for prehospital red-cell administration, and a subgroup analysis showed no heterogeneity of the treatment effect,” the investigators wrote.
The PAMPer trial was supported by a grant from the U.S. Army Medical Research and Materiel Command. One author reported funding from Janssen Pharmaceuticals, CSL Behring, Haemonetics, and Accriva Diagnostics, as well as having been named on a patent on TLR4 inhibitors for the treatment of inflammatory and infectious disorders.
Prehospital administration of plasma to trauma patients at risk for hemorrhagic shock improves odds of survival, according to the Prehospital Air Medical Plasma (PAMPer) trial.
Patients who received plasma also had a decreased median prothrombin to time ratio, compared with those who received standard-care resuscitation alone.
Spotmatik/ThinkStock
Modern trauma patients benefit “from receiving less crystalloid-based therapy and early balanced blood component–based therapy once they arrive at a facility for definitive care,” Jason L. Sperry, MD, of the University of Pittsburgh and his coauthors wrote in the New England Journal of Medicine. These newer strategies aim to mitigate coagulopathy and its associated downstream complications.
Still, “a majority of deaths from traumatic hemorrhage continue to occur in the first hours after arrival at the trauma center, which underscores the importance of the prehospital environment for early interventions that provide benefit,” the investigators noted.
The PAMPer trial (NCT01818427) examined the efficacy and safety of prehospital plasma resuscitation, comparing it with standard-care resuscitation, in severely injured patients. The phase 3, randomized, superiority trial involved 501 trauma patients at risk for hemorrhagic shock who were transported from 27 air medical bases to nine trauma centers. In total, 230 patients received prehospital plasma and standard-care resuscitation, and 271 patients received standard-care alone. Standard-care included infusion of crystalloid fluids in a goal-directed manner. Air medical bases delivered each type of care in 1-month intervals.
Patients were eligible if they exhibited severe hypotension (systolic blood pressure less than 70 mm Hg) or both hypotension (systolic blood pressure less than 90 mm Hg) and tachycardia (greater than 108 beats per minute).
Eligible patients received two units of thawed plasma, which was completely delivered before administration of any other fluids. If infusion of plasma was not complete upon arrival at the trauma center, infusion was completed before any in-hospital fluids were administered. Following preexisting local protocols, 13 of 27 air transport teams carried 2U of red blood cells. If red blood cells were delivered, then this was performed after plasma administration if the patient was still hypotensive or obviously bleeding.
The 30-day mortality rate among all patients was 29.6%. Approximately one in three patients received a prehospital red blood cell transfusion, and nearly 60% underwent surgery within 24 hours of hospital admission.
A greater percentage of patients in the standard-care group were given red blood cell transfusions, compared with those in the plasma group. The standard-care patients also received greater volumes of crystalloid solution than did those receiving plasma.
The primary outcome, 30-day mortality, was 9.8% lower for patients who received plasma, compared with patients who received standard-care alone (23.2% vs. 33.0%; P = .03). Multivariate regression analysis revealed that plasma delivery accounted for a 39% lower risk of death within 30 days, compared with standard care (P = .02). Within 3 hours of randomization, Kaplan-Meier curves revealed a separation between the two treatment groups that persisted until 30 days.
Median prothrombin to time ratio, the only statistically significant secondary outcome, was lower in the plasma group than it was in the standard-care group (1.2 vs. 1.3; P less than .001).
Other measured parameters were similar between the two main treatment groups, including rates of nosocomial infections, allergic or transfusion-related reactions, acute lung injury/acute respiratory distress syndrome, and multiorgan failure.
“Although we cannot determine the independent or additive effects of prehospital administration of plasma and packed red cells, the survival benefits attributable to plasma administration persisted after adjustment for prehospital red-cell administration, and a subgroup analysis showed no heterogeneity of the treatment effect,” the investigators wrote.
The PAMPer trial was supported by a grant from the U.S. Army Medical Research and Materiel Command. One author reported funding from Janssen Pharmaceuticals, CSL Behring, Haemonetics, and Accriva Diagnostics, as well as having been named on a patent on TLR4 inhibitors for the treatment of inflammatory and infectious disorders.
Key clinical point: For trauma patients at risk for hemorrhagic shock, prehospital plasma outperformed standard resuscitation.
Major finding: Thirty-day mortality was 9.8 percentage points lower for patients receiving plasma, compared with patients receiving standard care (23.2% vs. 33.0%; P = .03).
Study details: A randomized, controlled superiority trial involving 501 trauma patients at risk for hemorrhagic shock, with 230 patients receiving plasma and 271 receiving standard-care during air medical transport.
Disclosures: The study was supported by a grant from the U.S. Army Medical Research and Materiel Command. One author reported funding from Janssen Pharmaceuticals, CSL Behring, Haemonetics, and Accriva Diagnostics, as well as having been named on a patent on TLR4 inhibitors for the treatment of inflammatory and infectious disorders.
Source: Sperry JL et al. N Engl J Med. 2018 Jul 26;379(4):315-26.
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ORLANDO – A pilot survey to generate patient-reported outcomes (PRO) data through a national surgical quality initiative had a high response rate and yielded clinically meaningful data, an investigator reported at the American College of Surgeons Quality and Safety Conference.
The 45-question electronic survey, conducted as part of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) had 1,300 respondents with a response rate of 20%, according to Jason B. Liu, MD, an ACS Clinical Scholar-in-Residence and general surgery resident at the University of Chicago.
Results to date have demonstrated that in patients undergoing total knee arthroplasty (TKA), pain had a greater impact on daily activities than for other procedures, Dr. Liu said in a general session presentation the conference.
“Overall, the lesson learned is that in the current health care landscape, with its regulations and privacy issues, it is indeed both feasible and acceptable to electronically measure patient-reported outcomes using the ACS NSQIP platform,” Dr. Liu said at the meeting.
Eighteen hospitals in the United States and Canada participated in the pilot survey, which elicited responses from patients with a median age of 63 years, representing more than 340 types of operations.
The survey incorporates measurements from the PROMIS Pain Interference instrument, which measures how much pain hinders daily activities; PROMIS Global Health, which measures physical and mental health; and aspects of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS), Dr. Liu said.
The TKA finding is just one example of the data obtained through the pilot, he said. Looking at PROMIS Pain Interference, pain had more impact in TKA patients compared with open GI, breast hernia, and laparoscopic GI procedures. Difference between means ranged from 3.2 to 9.4 for TKA, compared with those procedures.
Conducting the pilot has been an “uphill battle,” according to Dr. Liu, citing critics who wondered if the program would generate meaningful data, whether older patients would respond to an electronic survey, and whether patients would take time to fill out a 45-question survey.
In fact, the average completion time for the survey was just 6.4 minutes, and the median number of items missing was zero, meaning that patients who started the survey tended to finish it, he said.
“We really hope to expand what we’ve learned across all of the [ACS] quality programs so that we can begin to really incorporate the patients’ perspective in improving national surgical quality,” he said.
ORLANDO – A pilot survey to generate patient-reported outcomes (PRO) data through a national surgical quality initiative had a high response rate and yielded clinically meaningful data, an investigator reported at the American College of Surgeons Quality and Safety Conference.
The 45-question electronic survey, conducted as part of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) had 1,300 respondents with a response rate of 20%, according to Jason B. Liu, MD, an ACS Clinical Scholar-in-Residence and general surgery resident at the University of Chicago.
Results to date have demonstrated that in patients undergoing total knee arthroplasty (TKA), pain had a greater impact on daily activities than for other procedures, Dr. Liu said in a general session presentation the conference.
“Overall, the lesson learned is that in the current health care landscape, with its regulations and privacy issues, it is indeed both feasible and acceptable to electronically measure patient-reported outcomes using the ACS NSQIP platform,” Dr. Liu said at the meeting.
Eighteen hospitals in the United States and Canada participated in the pilot survey, which elicited responses from patients with a median age of 63 years, representing more than 340 types of operations.
The survey incorporates measurements from the PROMIS Pain Interference instrument, which measures how much pain hinders daily activities; PROMIS Global Health, which measures physical and mental health; and aspects of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS), Dr. Liu said.
The TKA finding is just one example of the data obtained through the pilot, he said. Looking at PROMIS Pain Interference, pain had more impact in TKA patients compared with open GI, breast hernia, and laparoscopic GI procedures. Difference between means ranged from 3.2 to 9.4 for TKA, compared with those procedures.
Conducting the pilot has been an “uphill battle,” according to Dr. Liu, citing critics who wondered if the program would generate meaningful data, whether older patients would respond to an electronic survey, and whether patients would take time to fill out a 45-question survey.
In fact, the average completion time for the survey was just 6.4 minutes, and the median number of items missing was zero, meaning that patients who started the survey tended to finish it, he said.
“We really hope to expand what we’ve learned across all of the [ACS] quality programs so that we can begin to really incorporate the patients’ perspective in improving national surgical quality,” he said.
Dr. Liu had no disclosures to report.
ORLANDO – A pilot survey to generate patient-reported outcomes (PRO) data through a national surgical quality initiative had a high response rate and yielded clinically meaningful data, an investigator reported at the American College of Surgeons Quality and Safety Conference.
The 45-question electronic survey, conducted as part of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) had 1,300 respondents with a response rate of 20%, according to Jason B. Liu, MD, an ACS Clinical Scholar-in-Residence and general surgery resident at the University of Chicago.
Results to date have demonstrated that in patients undergoing total knee arthroplasty (TKA), pain had a greater impact on daily activities than for other procedures, Dr. Liu said in a general session presentation the conference.
“Overall, the lesson learned is that in the current health care landscape, with its regulations and privacy issues, it is indeed both feasible and acceptable to electronically measure patient-reported outcomes using the ACS NSQIP platform,” Dr. Liu said at the meeting.
Eighteen hospitals in the United States and Canada participated in the pilot survey, which elicited responses from patients with a median age of 63 years, representing more than 340 types of operations.
The survey incorporates measurements from the PROMIS Pain Interference instrument, which measures how much pain hinders daily activities; PROMIS Global Health, which measures physical and mental health; and aspects of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS), Dr. Liu said.
The TKA finding is just one example of the data obtained through the pilot, he said. Looking at PROMIS Pain Interference, pain had more impact in TKA patients compared with open GI, breast hernia, and laparoscopic GI procedures. Difference between means ranged from 3.2 to 9.4 for TKA, compared with those procedures.
Conducting the pilot has been an “uphill battle,” according to Dr. Liu, citing critics who wondered if the program would generate meaningful data, whether older patients would respond to an electronic survey, and whether patients would take time to fill out a 45-question survey.
In fact, the average completion time for the survey was just 6.4 minutes, and the median number of items missing was zero, meaning that patients who started the survey tended to finish it, he said.
“We really hope to expand what we’ve learned across all of the [ACS] quality programs so that we can begin to really incorporate the patients’ perspective in improving national surgical quality,” he said.
ORLANDO – Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Dr. Stacy A. Brethauer
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Dr. Stacy A. Brethauer
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Dr. Stacy A. Brethauer
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
Key clinical point: An evidence-based enhanced recovery protocol reduced length of stay for bariatric surgery patients.
Major finding: Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers.
Study details: Data on 36 bariatric surgery centers and 4,700 patients who underwent procedures in the first 6 months of the data collection period.
Disclosures: Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
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ORLANDO – By cutting the number of pills prescribed after a surgical procedure, exposure to opioids can be minimized in a largely opioid-naive patient population at risk of new, persistent use, according to Michael J. Englesbe, MD, FACS, professor of surgery at the University of Michigan, Ann Arbor, who is leading a Michigan initiative to tailor acute care prescribing.
Dr. Michael J. Englesbe
About 90% of surgically patients are opioid-naive, and of those, studies suggest about 6% may become new, persistent opioid users, according to Dr. Englesbe, codirector of the Michigan Opioid Prescribing and Engagement Network (Michigan-OPEN), a state-wide effort to transform acute pain prescribing across all surgical specialties.
“This is a very vulnerable population where their operation can lead to life-changing events way beyond their surgical outcomes,” Dr. Englesbe said in a presentation at the American College of Surgeons Quality and Safety Conference.
“We have to really worry about them,” he added. “It’s hard to identify who they are, and I think minimizing exposure to opioids is the best we have at this point.”
By following evidence-based prescribing guidelines after laparoscopic cholecystectomy, Dr. Englesbe and his colleagues were able to reduce prescription size by 63% with no increase in refills and no change in pain score, according to a research letter recently published in JAMA Surgery.
After adopting the guidelines, median postoperative opioid use dropped from 30 mg to 20 mg (P = .04), they reported.
Laparoscopic cholecystectomy patients could be prescribed as few as 10 5-mg tablets of oxycodone, according to recommendations developed by Michigan-OPEN that are published on opioidprescribing.info. Dr. Englesbe called the website figures “precise prescribing recommendations” that are still relatively generous, meeting or exceeding self-reported use for 75% of patients.
“I think this is an important template for change,” he said. “We’ve found the surgeons in the state very receptive, but more importantly, we’ve been able to partner with other really important stakeholders.” For example, one insurer in the state now aligns some hospital incentive reimbursement based on some of these prescribing methods, he added.
Dr. Englesbe reported no commercial disclosures related to his presentation.
ORLANDO – By cutting the number of pills prescribed after a surgical procedure, exposure to opioids can be minimized in a largely opioid-naive patient population at risk of new, persistent use, according to Michael J. Englesbe, MD, FACS, professor of surgery at the University of Michigan, Ann Arbor, who is leading a Michigan initiative to tailor acute care prescribing.
Dr. Michael J. Englesbe
About 90% of surgically patients are opioid-naive, and of those, studies suggest about 6% may become new, persistent opioid users, according to Dr. Englesbe, codirector of the Michigan Opioid Prescribing and Engagement Network (Michigan-OPEN), a state-wide effort to transform acute pain prescribing across all surgical specialties.
“This is a very vulnerable population where their operation can lead to life-changing events way beyond their surgical outcomes,” Dr. Englesbe said in a presentation at the American College of Surgeons Quality and Safety Conference.
“We have to really worry about them,” he added. “It’s hard to identify who they are, and I think minimizing exposure to opioids is the best we have at this point.”
By following evidence-based prescribing guidelines after laparoscopic cholecystectomy, Dr. Englesbe and his colleagues were able to reduce prescription size by 63% with no increase in refills and no change in pain score, according to a research letter recently published in JAMA Surgery.
After adopting the guidelines, median postoperative opioid use dropped from 30 mg to 20 mg (P = .04), they reported.
Laparoscopic cholecystectomy patients could be prescribed as few as 10 5-mg tablets of oxycodone, according to recommendations developed by Michigan-OPEN that are published on opioidprescribing.info. Dr. Englesbe called the website figures “precise prescribing recommendations” that are still relatively generous, meeting or exceeding self-reported use for 75% of patients.
“I think this is an important template for change,” he said. “We’ve found the surgeons in the state very receptive, but more importantly, we’ve been able to partner with other really important stakeholders.” For example, one insurer in the state now aligns some hospital incentive reimbursement based on some of these prescribing methods, he added.
Dr. Englesbe reported no commercial disclosures related to his presentation.
ORLANDO – By cutting the number of pills prescribed after a surgical procedure, exposure to opioids can be minimized in a largely opioid-naive patient population at risk of new, persistent use, according to Michael J. Englesbe, MD, FACS, professor of surgery at the University of Michigan, Ann Arbor, who is leading a Michigan initiative to tailor acute care prescribing.
Dr. Michael J. Englesbe
About 90% of surgically patients are opioid-naive, and of those, studies suggest about 6% may become new, persistent opioid users, according to Dr. Englesbe, codirector of the Michigan Opioid Prescribing and Engagement Network (Michigan-OPEN), a state-wide effort to transform acute pain prescribing across all surgical specialties.
“This is a very vulnerable population where their operation can lead to life-changing events way beyond their surgical outcomes,” Dr. Englesbe said in a presentation at the American College of Surgeons Quality and Safety Conference.
“We have to really worry about them,” he added. “It’s hard to identify who they are, and I think minimizing exposure to opioids is the best we have at this point.”
By following evidence-based prescribing guidelines after laparoscopic cholecystectomy, Dr. Englesbe and his colleagues were able to reduce prescription size by 63% with no increase in refills and no change in pain score, according to a research letter recently published in JAMA Surgery.
After adopting the guidelines, median postoperative opioid use dropped from 30 mg to 20 mg (P = .04), they reported.
Laparoscopic cholecystectomy patients could be prescribed as few as 10 5-mg tablets of oxycodone, according to recommendations developed by Michigan-OPEN that are published on opioidprescribing.info. Dr. Englesbe called the website figures “precise prescribing recommendations” that are still relatively generous, meeting or exceeding self-reported use for 75% of patients.
“I think this is an important template for change,” he said. “We’ve found the surgeons in the state very receptive, but more importantly, we’ve been able to partner with other really important stakeholders.” For example, one insurer in the state now aligns some hospital incentive reimbursement based on some of these prescribing methods, he added.
Dr. Englesbe reported no commercial disclosures related to his presentation.
Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.
Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.
Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
Prevention
Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.
An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.
VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
Work-up
Courtesy of John Miklos, MD
This drawing shows the location of a typical posthysterectomy fistula.
Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.
I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.
Courtesy of John Miklos, MD
Using a right angle clamp and a cystoscope confirms the fistula.
It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.
Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.
Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
Surgical treatment
VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.
Courtesy of Dionysios Veronikis, MD
A pediatric Foley catheter can be used for traction prior to fistula closure.
Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.
Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.
Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.
The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.
In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.
The first layer of closure with delayed absorbable sutures. Some surgeons prefer a running suture instead of interrupted.
There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.
A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.
Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.
The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.
Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.
Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.
Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.
Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
Prevention
Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.
An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.
VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
Work-up
Courtesy of John Miklos, MD
This drawing shows the location of a typical posthysterectomy fistula.
Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.
I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.
Courtesy of John Miklos, MD
Using a right angle clamp and a cystoscope confirms the fistula.
It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.
Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.
Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
Surgical treatment
VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.
Courtesy of Dionysios Veronikis, MD
A pediatric Foley catheter can be used for traction prior to fistula closure.
Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.
Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.
Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.
The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.
In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.
The first layer of closure with delayed absorbable sutures. Some surgeons prefer a running suture instead of interrupted.
There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.
A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.
Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.
The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.
Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.
Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.
Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.
Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
Prevention
Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.
An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.
VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
Work-up
Courtesy of John Miklos, MD
This drawing shows the location of a typical posthysterectomy fistula.
Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.
I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.
Courtesy of John Miklos, MD
Using a right angle clamp and a cystoscope confirms the fistula.
It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.
Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.
Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
Surgical treatment
VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.
Courtesy of Dionysios Veronikis, MD
A pediatric Foley catheter can be used for traction prior to fistula closure.
Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.
Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.
Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.
The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.
In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.
The first layer of closure with delayed absorbable sutures. Some surgeons prefer a running suture instead of interrupted.
There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.
A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.
Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.
The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.
Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.
Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.
Dr. Charles E. Miller
The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).
In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.
It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.
Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.
Dr. Charles E. Miller
The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).
In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.
It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.
Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.
Dr. Charles E. Miller
The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).
In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.
It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.
Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.
Dr. Joceline V. Vu
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.
Dr. Joceline V. Vu
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.
Dr. Joceline V. Vu
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
Key clinical point: Minimally invasive surgery remains underused as a method for managing inguinal hernias.
Major finding: Overall, 75% of MIS hernia repairs were performed by 14% of the surgeons.
Study details: The data come from a retrospective cohort study of 6,723 hernia surgery patients treated between 2012 and 2016.
Disclosures: Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
Source: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.
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Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.
Dr. Emma C. Rossi
Pitfalls
Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.
It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.1 Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.3 We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.
It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.
An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.4 A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.5 The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.
The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.6 However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.7 Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.
Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.8 Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
Preoperative evaluation
As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.
Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.9
Substituting LEEP or cone with hysterectomy
In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.
Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.
References
1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.
2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.
3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.
5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.
8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.
9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.
Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.
Dr. Emma C. Rossi
Pitfalls
Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.
It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.1 Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.3 We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.
It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.
An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.4 A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.5 The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.
The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.6 However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.7 Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.
Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.8 Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
Preoperative evaluation
As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.
Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.9
Substituting LEEP or cone with hysterectomy
In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.
Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.
References
1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.
2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.
3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.
5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.
8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.
9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.
Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.
Dr. Emma C. Rossi
Pitfalls
Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.
It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.1 Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.3 We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.
It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.
An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.4 A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.5 The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.
The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.6 However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.7 Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.
Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.8 Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
Preoperative evaluation
As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.
Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.9
Substituting LEEP or cone with hysterectomy
In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.
Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.
References
1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.
2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.
3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.
5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.
8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.
9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.
