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ASA: Bowel prep, oral antibiotics cut postop colorectal complications
SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.
Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.
Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.
Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.
On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.
Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.
Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.
Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.
Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.
The authors reported no conflicts of interest.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.
Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.
Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.
Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.
On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.
Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.
Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.
Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.
Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.
The authors reported no conflicts of interest.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.
Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.
Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.
Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.
On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.
Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.
Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.
Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.
Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.
The authors reported no conflicts of interest.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: A combination of mechanical cleansing and oral antibiotics reduced major colorectal surgery complications by nearly one-half.
Major findings: Mechanical bowel preparation combined with oral antibiotics resulted in reduced colorectal surgery complications, with odds ratios of 0.43 for surgical site infections, 0.71 for ileus, and 0.56 for anastomotic leak; overall mortality was also reduced.
Data source: Retrospective multivariable analysis of data for 8,644 surgical patients undergoing elective colorectal resection in 2012; targeted colectomy data drawn from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database.
Disclosures: The authors reported no conflicts of interest.
FDA proposes 1-year blood donor deferral for gay and bisexual men
Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.
The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.
The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.
Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.
The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.
The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.
Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.
“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”
The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.
On Twitter @alz_gal
Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.
The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.
The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.
Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.
The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.
The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.
Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.
“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”
The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.
On Twitter @alz_gal
Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.
The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.
The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.
Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.
The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.
The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.
Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.
“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”
The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.
On Twitter @alz_gal
VIDEO: Esophagectomy outcomes better in hospitals that handle complex cases
SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.
“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.
The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.
Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.
“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.
The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.
Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.
“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.
The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.
Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE AATS ANNUAL MEETING
VIDEO: Are birthing centers a safe choice for women?
SAN FRANCISCO – The number of babies delivered at birthing centers in the United States is still very low, but freestanding birthing facilities are growing rapidly. Are these centers, many of which are not accredited, safe choices for women who are looking for a noninstitutional birth experience?
At the annual meeting of the American Congress of Obstetricians and Gynecologists, Dr. Edward R. Yeomans, chair of the department of ob.gyn. at Texas Tech University, Lubbock, faced off against Ginger Breedlove, Ph.D., president of the American College of Nurse-Midwives, in a debate about the preferred site for delivery.
Dr. Yeomans, who favors hospital-based deliveries, said that safety is the major issue. Birthing centers are not equipped to deal with emergencies that can arise even in low-risk pregnancies and may require immediate access to surgery or a blood bank.
Dr. Breedlove countered that accredited birthing centers have strict standards for the cases they accept and have transport plans in place for emergencies. She added that she supports accreditation for all freestanding birthing centers.
On Twitter @maryellenny
SAN FRANCISCO – The number of babies delivered at birthing centers in the United States is still very low, but freestanding birthing facilities are growing rapidly. Are these centers, many of which are not accredited, safe choices for women who are looking for a noninstitutional birth experience?
At the annual meeting of the American Congress of Obstetricians and Gynecologists, Dr. Edward R. Yeomans, chair of the department of ob.gyn. at Texas Tech University, Lubbock, faced off against Ginger Breedlove, Ph.D., president of the American College of Nurse-Midwives, in a debate about the preferred site for delivery.
Dr. Yeomans, who favors hospital-based deliveries, said that safety is the major issue. Birthing centers are not equipped to deal with emergencies that can arise even in low-risk pregnancies and may require immediate access to surgery or a blood bank.
Dr. Breedlove countered that accredited birthing centers have strict standards for the cases they accept and have transport plans in place for emergencies. She added that she supports accreditation for all freestanding birthing centers.
On Twitter @maryellenny
SAN FRANCISCO – The number of babies delivered at birthing centers in the United States is still very low, but freestanding birthing facilities are growing rapidly. Are these centers, many of which are not accredited, safe choices for women who are looking for a noninstitutional birth experience?
At the annual meeting of the American Congress of Obstetricians and Gynecologists, Dr. Edward R. Yeomans, chair of the department of ob.gyn. at Texas Tech University, Lubbock, faced off against Ginger Breedlove, Ph.D., president of the American College of Nurse-Midwives, in a debate about the preferred site for delivery.
Dr. Yeomans, who favors hospital-based deliveries, said that safety is the major issue. Birthing centers are not equipped to deal with emergencies that can arise even in low-risk pregnancies and may require immediate access to surgery or a blood bank.
Dr. Breedlove countered that accredited birthing centers have strict standards for the cases they accept and have transport plans in place for emergencies. She added that she supports accreditation for all freestanding birthing centers.
On Twitter @maryellenny
AT THE ACOG ANNUAL CLINICAL MEETING
Spray-dried fibrin sealant for surgical use approved by FDA
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
FDA requests more data on antiseptics used in health care settings
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
PAS: Fewer readmissions with narrow-spectrum antibiotics in children with appendicitis
SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.
The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.
“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”
Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.
Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.
Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.
Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.
The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.
“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”
Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.
SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.
The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.
“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”
Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.
Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.
Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.
Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.
The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.
“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”
Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.
SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.
The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.
“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”
Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.
Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.
Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.
Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.
The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.
“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”
Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.
AT THE PAS ANNUAL MEETING
Key clinical point: Children with appendicitis who are treated with narrow-spectrum antibiotics experience comparable clinical outcomes to children who receive broad-spectrum antibiotics and, in some instances, achieve even better outcomes.
Major finding: The 30-day readmission rates were consistently higher in children who received broad-spectrum antibiotics, compared with narrow-spectrum antibiotics (1.4% vs. 0.9% in uncomplicated cases, 6.8% vs. 4.4% in complicated cases).
Data source: A retrospective cohort study of 27,306 patients aged 3-18 years, admitted to one of 23 hospitals from 2011 to 2013.
Disclosures: Dr. Kronman did not report any financial conflicts of interest. The study was supported in part by the Clinical Research Scholars Program at Seattle Children’s Hospital, and by the National Center of Advancing Translational Sciences of the National Institutes of Health.
Linking registries, databases may reduce surgical site infections
Surveillance of cardiac surgical site infections (SSIs) improved significantly when registry and infection control surveillance data were linked with electronic health records, a retrospective analysis showed.
Over the course of a 47-month period starting in 2011, Vaidehi Nayar of the Children’s Hospital of Philadelphia and her coinvestigators launched a quality improvement initiative at their institution that linked administrative databases with their clinical registry, allowing caregivers to more accurately monitor and assess SSIs and provide more effective adjudication and treatments thereafter. The investigators chose to link their hospital’s electronic health record (EHR) billing information and reporting from the infection surveillance database for the National Healthcare Safety Network with data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD).
To further facilitate the flow and interpretation of data, the investigators used a visualization tool to analyze the STS-CHSD for case ascertainment; to resolve discrepancies among STS-CHSD, infection surveillance, and billing SSI cases; and to assess the impact of the hospital’s quality improvement protocols. These protocols consisted of wound alert reports from the EHR, bedside reviews for SSI adjudication, inpatient and outpatient SSI prevention bundles, prophylactic antibiotic dosing changes, removal of steroids from the bypass circuit, and biller education on SSIs.
Control charts in the data visualization tool allowed for statistical monitoring of SSI rate changes, and SSI case discrepancies across the databases were reviewed to ensure that differences were the result of variations in SSI reporting criteria for each database, not inaccurate surveillance population ascertainment or inaccurate SSI identification, according to Ms. Nayar and her colleagues,
“Workflow changes, including the wound alert report and bedside reviews, facilitated communication among providers and improved adjudication of suspected SSIs,” she said in presenting the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons in San Diego earlier this year.
In total, 156 SSIs were identified via the STS-CHSD, 79 via the infection surveillance database, and 433 via billing. There was a significant decrease in the rolling 12-month SSI rate from 2.48% (21/848 in January 2013) to 0.76% (11/1,442 in January 2014), based on the STS-CHSD data, although Ms. Nayar pointed out that this decline could not definitely be attributed to reporting improvements or to the specific quality improvement initiatives that were implemented. Ms. Nayar also explained that there was a “general improvement in reporting, as shown by the stark drop in billing” and “a general alignment of all three data sources.”
“Accurate assessment of morbidity data, including [SSIs], has implications for public reporting, benchmarking, assessment of [quality improvement] impact, and possible denial of payments,” said Ms. Nayar. “In summary, we achieved our two simultaneous goals of improving SSI reporting – or decreasing the data errors – and decreasing SSI incidents by improving overall patient care.”
During discussion, Ms. Nayar elaborated on the study’s generalizability and potential application to other facets of congenital heart disease treatments, saying that such application is, in fact, possible.
“Yes, this is very generalizable, but one key important fact is relevant: As long as there is a source of truth for case ascertainment, this methodology can be used in several different areas,” she explained. “For example, we are currently working at our institution to integrate and link the [Pediatric Cardiac Critical Care Consortium] database to be able to better monitor any critical care–related morbidity information and ultimately use similar methodology to assess the impact of outcomes in the critical care field.”
Ms. Nayar said that she did not have any relevant financial conflicts of interest to disclose.
This study demonstrates dramatically different surgical site infection (SSI) rates for the same patient cohort as detected by three different surveillance methods: hospital billing (derived from the electronic health records), a surgical database, and a tracking system developed by the Centers for Disease Control and Prevention.
On the low end, 79 SSIs were reported by one system, 156 by another, and 433 by the third method – a more than fivefold discrepancy. The authors developed a technique to reconcile the three systems and then evaluated a variety of interventions designed to reduce the SSI rate. As a result of this initiative, the quality of event reporting was improved (with greater agreement between reporting methods) and the rate of SSIs was reduced.
The implications of this report are sobering and should be of great interest to all surgeons and hospital administrators for several reasons. First and fundamentally, the report suggests that widely used reporting systems may be inaccurate and produce conflicting results. Since the results of these reports are used to assess and modify clinical practice, this is very disturbing. Additionally, the results may be used by payers as a basis for financial reward (or penalty) and therefore must be accurate. Finally, exposure of the use of erroneous information as the source data for billing may render an institution vulnerable to civil and criminal penalties. For all of these reasons, the present report should prompt self-assessment by all institutions, if it has not already been undertaken.
Dr. Robert Jaquiss is associate medical editor for congenital heart disease for Thoracic Surgery News.
This study demonstrates dramatically different surgical site infection (SSI) rates for the same patient cohort as detected by three different surveillance methods: hospital billing (derived from the electronic health records), a surgical database, and a tracking system developed by the Centers for Disease Control and Prevention.
On the low end, 79 SSIs were reported by one system, 156 by another, and 433 by the third method – a more than fivefold discrepancy. The authors developed a technique to reconcile the three systems and then evaluated a variety of interventions designed to reduce the SSI rate. As a result of this initiative, the quality of event reporting was improved (with greater agreement between reporting methods) and the rate of SSIs was reduced.
The implications of this report are sobering and should be of great interest to all surgeons and hospital administrators for several reasons. First and fundamentally, the report suggests that widely used reporting systems may be inaccurate and produce conflicting results. Since the results of these reports are used to assess and modify clinical practice, this is very disturbing. Additionally, the results may be used by payers as a basis for financial reward (or penalty) and therefore must be accurate. Finally, exposure of the use of erroneous information as the source data for billing may render an institution vulnerable to civil and criminal penalties. For all of these reasons, the present report should prompt self-assessment by all institutions, if it has not already been undertaken.
Dr. Robert Jaquiss is associate medical editor for congenital heart disease for Thoracic Surgery News.
This study demonstrates dramatically different surgical site infection (SSI) rates for the same patient cohort as detected by three different surveillance methods: hospital billing (derived from the electronic health records), a surgical database, and a tracking system developed by the Centers for Disease Control and Prevention.
On the low end, 79 SSIs were reported by one system, 156 by another, and 433 by the third method – a more than fivefold discrepancy. The authors developed a technique to reconcile the three systems and then evaluated a variety of interventions designed to reduce the SSI rate. As a result of this initiative, the quality of event reporting was improved (with greater agreement between reporting methods) and the rate of SSIs was reduced.
The implications of this report are sobering and should be of great interest to all surgeons and hospital administrators for several reasons. First and fundamentally, the report suggests that widely used reporting systems may be inaccurate and produce conflicting results. Since the results of these reports are used to assess and modify clinical practice, this is very disturbing. Additionally, the results may be used by payers as a basis for financial reward (or penalty) and therefore must be accurate. Finally, exposure of the use of erroneous information as the source data for billing may render an institution vulnerable to civil and criminal penalties. For all of these reasons, the present report should prompt self-assessment by all institutions, if it has not already been undertaken.
Dr. Robert Jaquiss is associate medical editor for congenital heart disease for Thoracic Surgery News.
Surveillance of cardiac surgical site infections (SSIs) improved significantly when registry and infection control surveillance data were linked with electronic health records, a retrospective analysis showed.
Over the course of a 47-month period starting in 2011, Vaidehi Nayar of the Children’s Hospital of Philadelphia and her coinvestigators launched a quality improvement initiative at their institution that linked administrative databases with their clinical registry, allowing caregivers to more accurately monitor and assess SSIs and provide more effective adjudication and treatments thereafter. The investigators chose to link their hospital’s electronic health record (EHR) billing information and reporting from the infection surveillance database for the National Healthcare Safety Network with data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD).
To further facilitate the flow and interpretation of data, the investigators used a visualization tool to analyze the STS-CHSD for case ascertainment; to resolve discrepancies among STS-CHSD, infection surveillance, and billing SSI cases; and to assess the impact of the hospital’s quality improvement protocols. These protocols consisted of wound alert reports from the EHR, bedside reviews for SSI adjudication, inpatient and outpatient SSI prevention bundles, prophylactic antibiotic dosing changes, removal of steroids from the bypass circuit, and biller education on SSIs.
Control charts in the data visualization tool allowed for statistical monitoring of SSI rate changes, and SSI case discrepancies across the databases were reviewed to ensure that differences were the result of variations in SSI reporting criteria for each database, not inaccurate surveillance population ascertainment or inaccurate SSI identification, according to Ms. Nayar and her colleagues,
“Workflow changes, including the wound alert report and bedside reviews, facilitated communication among providers and improved adjudication of suspected SSIs,” she said in presenting the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons in San Diego earlier this year.
In total, 156 SSIs were identified via the STS-CHSD, 79 via the infection surveillance database, and 433 via billing. There was a significant decrease in the rolling 12-month SSI rate from 2.48% (21/848 in January 2013) to 0.76% (11/1,442 in January 2014), based on the STS-CHSD data, although Ms. Nayar pointed out that this decline could not definitely be attributed to reporting improvements or to the specific quality improvement initiatives that were implemented. Ms. Nayar also explained that there was a “general improvement in reporting, as shown by the stark drop in billing” and “a general alignment of all three data sources.”
“Accurate assessment of morbidity data, including [SSIs], has implications for public reporting, benchmarking, assessment of [quality improvement] impact, and possible denial of payments,” said Ms. Nayar. “In summary, we achieved our two simultaneous goals of improving SSI reporting – or decreasing the data errors – and decreasing SSI incidents by improving overall patient care.”
During discussion, Ms. Nayar elaborated on the study’s generalizability and potential application to other facets of congenital heart disease treatments, saying that such application is, in fact, possible.
“Yes, this is very generalizable, but one key important fact is relevant: As long as there is a source of truth for case ascertainment, this methodology can be used in several different areas,” she explained. “For example, we are currently working at our institution to integrate and link the [Pediatric Cardiac Critical Care Consortium] database to be able to better monitor any critical care–related morbidity information and ultimately use similar methodology to assess the impact of outcomes in the critical care field.”
Ms. Nayar said that she did not have any relevant financial conflicts of interest to disclose.
Surveillance of cardiac surgical site infections (SSIs) improved significantly when registry and infection control surveillance data were linked with electronic health records, a retrospective analysis showed.
Over the course of a 47-month period starting in 2011, Vaidehi Nayar of the Children’s Hospital of Philadelphia and her coinvestigators launched a quality improvement initiative at their institution that linked administrative databases with their clinical registry, allowing caregivers to more accurately monitor and assess SSIs and provide more effective adjudication and treatments thereafter. The investigators chose to link their hospital’s electronic health record (EHR) billing information and reporting from the infection surveillance database for the National Healthcare Safety Network with data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD).
To further facilitate the flow and interpretation of data, the investigators used a visualization tool to analyze the STS-CHSD for case ascertainment; to resolve discrepancies among STS-CHSD, infection surveillance, and billing SSI cases; and to assess the impact of the hospital’s quality improvement protocols. These protocols consisted of wound alert reports from the EHR, bedside reviews for SSI adjudication, inpatient and outpatient SSI prevention bundles, prophylactic antibiotic dosing changes, removal of steroids from the bypass circuit, and biller education on SSIs.
Control charts in the data visualization tool allowed for statistical monitoring of SSI rate changes, and SSI case discrepancies across the databases were reviewed to ensure that differences were the result of variations in SSI reporting criteria for each database, not inaccurate surveillance population ascertainment or inaccurate SSI identification, according to Ms. Nayar and her colleagues,
“Workflow changes, including the wound alert report and bedside reviews, facilitated communication among providers and improved adjudication of suspected SSIs,” she said in presenting the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons in San Diego earlier this year.
In total, 156 SSIs were identified via the STS-CHSD, 79 via the infection surveillance database, and 433 via billing. There was a significant decrease in the rolling 12-month SSI rate from 2.48% (21/848 in January 2013) to 0.76% (11/1,442 in January 2014), based on the STS-CHSD data, although Ms. Nayar pointed out that this decline could not definitely be attributed to reporting improvements or to the specific quality improvement initiatives that were implemented. Ms. Nayar also explained that there was a “general improvement in reporting, as shown by the stark drop in billing” and “a general alignment of all three data sources.”
“Accurate assessment of morbidity data, including [SSIs], has implications for public reporting, benchmarking, assessment of [quality improvement] impact, and possible denial of payments,” said Ms. Nayar. “In summary, we achieved our two simultaneous goals of improving SSI reporting – or decreasing the data errors – and decreasing SSI incidents by improving overall patient care.”
During discussion, Ms. Nayar elaborated on the study’s generalizability and potential application to other facets of congenital heart disease treatments, saying that such application is, in fact, possible.
“Yes, this is very generalizable, but one key important fact is relevant: As long as there is a source of truth for case ascertainment, this methodology can be used in several different areas,” she explained. “For example, we are currently working at our institution to integrate and link the [Pediatric Cardiac Critical Care Consortium] database to be able to better monitor any critical care–related morbidity information and ultimately use similar methodology to assess the impact of outcomes in the critical care field.”
Ms. Nayar said that she did not have any relevant financial conflicts of interest to disclose.
Key clinical point: Linking registry and infection control data with a hospital’s electronic health records can significantly improve surveillance of SSIs, as the linkage allows for improved visualization abilities, communication within and between departments, facilitated adjudication of SSIs, and improved assessment of quality improvement initiatives to prevent further SSIs.
Major finding: Over the 47-month study period, 156 SSIs were identified via the STS-CHSD, 79 via the infection surveillance database, and 433 via billing. The rolling 12-month SSI rate based on the STS-CHSD decreased from 2.48% (21/848) to 0.76% (11/1,442).
Data source: A retrospective analysis of 668 cases in the STS-CHSD database over the course of 47 months.
Disclosures: Ms. Nayar reported that she had no relevant financial conflicts.
Multiple systems showcase TAVR’s advances
SAN DIEGO – Three separate reports of pivotal trial results from three different systems for performing transcatheter aortic valve replacement performed during three distinct periods highlighted the rapid advances of this intervention that have now put it on the cusp of being the preferred, default strategy for replacing stenosed aortic valves in older patients.
First SAPIEN 3 U.S. outcomes reported
The most recent technologic advance in transcatheter aortic valve replacement (TAVR), showcased in one of the three presentations at the annual meeting of the American College of Cardiology, was the SAPIEN 3 System, the lowest-profile TAVR system so far to undergo U.S. testing with a 14F delivery system for all valve sizes except the largest, 29 mm valves, which require a 16F system. SAPIEN 3 produced 30-day outcome results so good that one TAVR operator expressed shock at the dramatic, short-term success.
After 30 days follow-up, SAPIEN 3 produced a 2% mortality rate and a 2% stroke rate in 583 “high-risk” patients treated during 2013 and 2014 who were an average of 83 years old and had an average Society of Thoracic Surgeons (STS) risk score of 8.6%, Dr. Susheel K. Kodali reported at the meeting. By contrast, in the pivotal trial of the first-generation SAPIEN TAVR system, run during 2007-2009, in 348 “high-risk” patients (who averaged 84 years old and had an average STS risk score of 11.8%) the 30-day mortality ran 5% and 30-day strokes affected 6%, Dr. Kodali noted.
The new trial also enrolled 1,076 “intermediate”-risk patients, who averaged 82 years old with an average STS score of 5.3%. Their 30-day mortality rate was 1% and their total stroke rate was 3%, with a disabling stroke rate (modified Rankin scale score of 2 or more) of 1%.
These excellent results prompted Edwards, the company developing the SAPIEN 3 System, to apply for Food and Drug Administration approval for the device in high-risk patients, Dr. Kodali noted. In March, Edwards released a statement in which it said it expects SAPIEN 3 to receive U.S. marketing approval within a year. While Dr. Kodali said longer-term follow-up is needed for the intermediate-risk patients, the outcome results he has seen make him rethink the TAVR’s role, compared with conventional aortic valve replacement by open surgery.
“With surgery, these [intermediate-risk] patients would have a 5% mortality rate. The conversation now may need to change,” he said. “We have always said we use TAVR when surgery is not a good option, but based on the recent, 2-year findings with the CoreValve and our data, with a 1% mortality and a 1% disabling stroke rate [in intermediate-risk patients] maybe TAVR is now the preferred option, at least for 80-year-olds, said Dr. Kodali, codirector of the Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center.
Commenting on the SAPIEN 3 results as well as excellent 2-year results from the CoreValve TAVR System pivotal trial, Dr. Jeffrey J. Popma attributed the success to three factors: improved patient selection, refined and routinely used imaging methods for sizing the aortic annulus to better match the TAVR valve size to the annulus size, and improved TAVR techniques based on what is now about an 8-year clinical experience using TAVR.
“All this now puts us in a place where the bar has been set very high for surgery. How does surgery compete?” asked Dr. Popma, professor of medicine at Harvard University and an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston. “The results are so clean at 30 days, what more information do we really need” for device approval? Dr. Popma, one of the discussants for the meeting report by Dr. Kodali, asked.
“I’m shocked the SAPIEN 3 data were so good,” said Dr. Stephen Ramee, an interventional cardiologist and medical director of the Structural and Valvular Heart Center at the Ochsner Medical Center in New Orleans. “We’ll need to wait to do intermediate-risk patients routinely, but the handwriting is on the wall with these data and the CoreValve results. I think TAVR will be preferred for all high-risk patients and for intermediate-risk patients who are at least 80 years old,” Dr. Ramee said in an interview.
Commenting on whether the FDA should approve SAPIEN 3 based on 30-day outcomes in high-risk patients, Dr. Popma noted that SAPIEN 3 is “an iteration of what has been demonstrated” in long-term results with the first-generation SAPIEN device. “Do we really need a randomized clinical trail with several thousand patients after the [SAPIEN] platform was already established?” he asked.
“We don’t demand that for iterations of surgical valves,” agreed Dr. Kodali.
CoreValve looks good longer-term
While SAPIEN 3’s performance turned heads, 2-year results from the CoreValve’s pivotal trial reported at the meeting further deepened the impression that TAVR offered substantial advantages, compared with surgical aortic valve replacement in high-risk patients. The 2-year outcomes followed the trial’s primary endpoint reported last year, the 1-year results, which had shown a statistically significant advantage in survival, compared with surgery (N. Engl. J. Med. 2014;370:1790-8).
The 2-year follow-up showed this advantage was “sustainable, durable, and widening,” reported Dr. Michael Reardon, professor of cardiothoracic surgery at the Methodist Hospital in Houston.
For example, 2-year all-cause mortality stood at 29% in patients who underwent surgical valve replacement and 22% in those who received TAVR with CoreValve, a statistically significant widening of the between-group gap, compared with the respective 19% and 14% mortality rates after 1 year. The rate of all-cause death or major stroke after 2 years ran 33% and 24% with surgical valve replacement or TAVR, respectively, compared with rates of 23% and 16% after 1 year.
Concern about excess strokes with TAVR, “one of our early worries, seems to have been put to bed,” Dr. Reardon said. The results also showed CoreValve substantially surpassed open surgery for valvular blood flow metrics across the full range of follow-up time points.
Several factors might have produced the widening outcomes between years 1 and 2 following a different one-time intervention, Dr. Reardon said, such as significant differences in the incident rate following intervention for disabling or life-threatening bleeding, atrial fibrillation, and acute kidney injury. All three complications occurred significantly more often in the surgery patients, compared with those treated with TAVR, and while the bulk of the difference in incidence showed up within the first month after intervention, each of these complications could have important long-term effects on survival and stroke rates, Dr. Reardon explained. On the other side of the ledger, open surgery when compared with CoreValve resulted in significantly fewer acute and long-term episodes of vascular complications and fewer new pacemakers, but these complications likely have less impact on stroke and mortality than the three that occur more often with surgery.
Overall, the widening gap in outcomes between surgery and TAVR “suggests that TAVR with a self-expanding valve [CoreValve] should be considered the preferred treatment,” compared with surgery in high-risk patients, Dr. Reardon said during his presentation at the meeting, a similar conclusion to what Dr. Kodali said about SAPIEN 3.
“These results really do move the needle forward,” said Dr. Popma, a CoreValve trial coinvestigator. “We see for the first time that [TAVR] may indeed be superior, and although durability remains a long-term question we have 2-year data that CoreValve has held up.”
First-generation SAPIEN TAVR shows 5-year stability
The third piece of the TAVR trilogy reported at the meeting was 5-year follow-up results from the first U.S. TAVR pivotal trial (PARTNER 1) using the first-generation SAPIEN device, which is no longer available in the United States. Those results from patients treated during 2007-2009 showed continuation of the statistical overlap between surgical valve replacement and SAPIEN TAVR for all-cause mortality, stroke, and other outcomes (Lancet 2015 [doi:10.1016/S0140-6736(15)60290-2]). Importantly, the results also showed no suggestions of deteriorating function in the TAVR valve after 5 years, reported Dr. Michael J. Mack at the meeting.
“It’s very encouraging, but we’d all like to go out to 10-12 years, and then we’d feel a lot better about it,” commented Dr. Reardon, who did not participate in the PARTNER trial. But given 5 years of apparently reliable function from a TAVR valve, the issue of long-term durability of these valves, an open question at the start of the SAPIEN trial, may be now coming to resolution, he suggested, at least for octogenarians, who are emerging as the prime demographic for TAVR.
“Tissue valves we place surgically deteriorate at different rates depending on a patient’s age when you put them in. In 30-year-olds many valves deteriorate after 10 years; in 50-year-olds maybe 15% will deteriorate, and in 70-year-olds almost none,” Dr. Reardon explained. “No one knows why.” Because many TAVR patients are at least 80 years old “it may take 10 years to see a signal of deterioration, or we might never see a signal,” he said.
SAPIEN versus CoreValve?
Although SAPIEN 3 may be on the U.S. market within the next year, for the time being routine U.S. TAVR practice is limited to two options, approved for high-risk or inoperable patients but not patients at intermediate risk: the CoreValve, which has now clearly bested surgery for all major endpoints over at least the midterm, and the SAPIEN XT model, the second-generation SAPIEN TAVR system that sits between the first generation and SAPIEN 3 and showed documented performance that roughly tracked with the original SAPIEN model. When approving the SAPIEN XT for U.S. marketing in June 2014 for operable high-risk patients as well as inoperable patients, the agency said the evidence indicated that XT was “noninferior” to SAPIEN in high-risk patients.
Several experts at the meeting agreed that despite this difference in performance between CoreValve and SAPIEN XT when each was compared with open surgery, the CoreValve experience better reflected more contemporary performance expectations for TAVR as a class, regardless of device. They cited improvements in valve sizing with imaging, better patient selection, and better TAVR technique as critical in boosting more favorable outcomes, factors that are not valve specific.
They also cited technical factors that may favor the SAPIEN XT device, notably more accurate valve placement using SAPIEN’s balloon-expandable format, compared with the self-expanding CoreValve.
Dr. Ramee said that outside of trials he’s now using SAPIEN XT for about 60% of his cases because of its “more predictable deployment. With CoreValve, you never know exactly where it will end up.” On the other hand, CoreValve works best for a more calcified aortic annulus because self-expanding placement is gentler and less likely to rupture a fragile annulus. That advantage gives CoreValve the edge for about 40% of his patients, Dr. Ramee said in an interview.
“There has been a general forward movement of the TAVR field” in which the focus has been TAVR versus surgery rather than CoreValve versus SAPIEN, Dr. Reardon said in an interview. Some anatomic features favor balloon expandable, others favor self-expanding. New TAVR systems in development by other manufacturers are mostly self-expanding models because of their ability to allow for repositioning, he noted.
Dr. Kodali has an equity interest in Thubrikar Aortic Valve; he has received honoraria from St. Jude; he has served on the steering committee for trials sponsored by Edwards, which markets the SAPIEN systems, Claret Medical, and Meril; and he has received research support from Edwards. Dr. Popma has been a consultant to Abbott, Abiomed, Boston Scientific, Cordis, and Abbott Vascular, and he has received research grants from Medtronic, which markets the CoreValve, and from five other companies. Dr. Reardon has served on an advisory board for Medtronic, Dr. Ramee has received honoraria from Edwards and from Medtronic and has a financial interest in several other companies developing TAVR systems.
On Twitter @mitchelzoler
SAN DIEGO – Three separate reports of pivotal trial results from three different systems for performing transcatheter aortic valve replacement performed during three distinct periods highlighted the rapid advances of this intervention that have now put it on the cusp of being the preferred, default strategy for replacing stenosed aortic valves in older patients.
First SAPIEN 3 U.S. outcomes reported
The most recent technologic advance in transcatheter aortic valve replacement (TAVR), showcased in one of the three presentations at the annual meeting of the American College of Cardiology, was the SAPIEN 3 System, the lowest-profile TAVR system so far to undergo U.S. testing with a 14F delivery system for all valve sizes except the largest, 29 mm valves, which require a 16F system. SAPIEN 3 produced 30-day outcome results so good that one TAVR operator expressed shock at the dramatic, short-term success.
After 30 days follow-up, SAPIEN 3 produced a 2% mortality rate and a 2% stroke rate in 583 “high-risk” patients treated during 2013 and 2014 who were an average of 83 years old and had an average Society of Thoracic Surgeons (STS) risk score of 8.6%, Dr. Susheel K. Kodali reported at the meeting. By contrast, in the pivotal trial of the first-generation SAPIEN TAVR system, run during 2007-2009, in 348 “high-risk” patients (who averaged 84 years old and had an average STS risk score of 11.8%) the 30-day mortality ran 5% and 30-day strokes affected 6%, Dr. Kodali noted.
The new trial also enrolled 1,076 “intermediate”-risk patients, who averaged 82 years old with an average STS score of 5.3%. Their 30-day mortality rate was 1% and their total stroke rate was 3%, with a disabling stroke rate (modified Rankin scale score of 2 or more) of 1%.
These excellent results prompted Edwards, the company developing the SAPIEN 3 System, to apply for Food and Drug Administration approval for the device in high-risk patients, Dr. Kodali noted. In March, Edwards released a statement in which it said it expects SAPIEN 3 to receive U.S. marketing approval within a year. While Dr. Kodali said longer-term follow-up is needed for the intermediate-risk patients, the outcome results he has seen make him rethink the TAVR’s role, compared with conventional aortic valve replacement by open surgery.
“With surgery, these [intermediate-risk] patients would have a 5% mortality rate. The conversation now may need to change,” he said. “We have always said we use TAVR when surgery is not a good option, but based on the recent, 2-year findings with the CoreValve and our data, with a 1% mortality and a 1% disabling stroke rate [in intermediate-risk patients] maybe TAVR is now the preferred option, at least for 80-year-olds, said Dr. Kodali, codirector of the Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center.
Commenting on the SAPIEN 3 results as well as excellent 2-year results from the CoreValve TAVR System pivotal trial, Dr. Jeffrey J. Popma attributed the success to three factors: improved patient selection, refined and routinely used imaging methods for sizing the aortic annulus to better match the TAVR valve size to the annulus size, and improved TAVR techniques based on what is now about an 8-year clinical experience using TAVR.
“All this now puts us in a place where the bar has been set very high for surgery. How does surgery compete?” asked Dr. Popma, professor of medicine at Harvard University and an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston. “The results are so clean at 30 days, what more information do we really need” for device approval? Dr. Popma, one of the discussants for the meeting report by Dr. Kodali, asked.
“I’m shocked the SAPIEN 3 data were so good,” said Dr. Stephen Ramee, an interventional cardiologist and medical director of the Structural and Valvular Heart Center at the Ochsner Medical Center in New Orleans. “We’ll need to wait to do intermediate-risk patients routinely, but the handwriting is on the wall with these data and the CoreValve results. I think TAVR will be preferred for all high-risk patients and for intermediate-risk patients who are at least 80 years old,” Dr. Ramee said in an interview.
Commenting on whether the FDA should approve SAPIEN 3 based on 30-day outcomes in high-risk patients, Dr. Popma noted that SAPIEN 3 is “an iteration of what has been demonstrated” in long-term results with the first-generation SAPIEN device. “Do we really need a randomized clinical trail with several thousand patients after the [SAPIEN] platform was already established?” he asked.
“We don’t demand that for iterations of surgical valves,” agreed Dr. Kodali.
CoreValve looks good longer-term
While SAPIEN 3’s performance turned heads, 2-year results from the CoreValve’s pivotal trial reported at the meeting further deepened the impression that TAVR offered substantial advantages, compared with surgical aortic valve replacement in high-risk patients. The 2-year outcomes followed the trial’s primary endpoint reported last year, the 1-year results, which had shown a statistically significant advantage in survival, compared with surgery (N. Engl. J. Med. 2014;370:1790-8).
The 2-year follow-up showed this advantage was “sustainable, durable, and widening,” reported Dr. Michael Reardon, professor of cardiothoracic surgery at the Methodist Hospital in Houston.
For example, 2-year all-cause mortality stood at 29% in patients who underwent surgical valve replacement and 22% in those who received TAVR with CoreValve, a statistically significant widening of the between-group gap, compared with the respective 19% and 14% mortality rates after 1 year. The rate of all-cause death or major stroke after 2 years ran 33% and 24% with surgical valve replacement or TAVR, respectively, compared with rates of 23% and 16% after 1 year.
Concern about excess strokes with TAVR, “one of our early worries, seems to have been put to bed,” Dr. Reardon said. The results also showed CoreValve substantially surpassed open surgery for valvular blood flow metrics across the full range of follow-up time points.
Several factors might have produced the widening outcomes between years 1 and 2 following a different one-time intervention, Dr. Reardon said, such as significant differences in the incident rate following intervention for disabling or life-threatening bleeding, atrial fibrillation, and acute kidney injury. All three complications occurred significantly more often in the surgery patients, compared with those treated with TAVR, and while the bulk of the difference in incidence showed up within the first month after intervention, each of these complications could have important long-term effects on survival and stroke rates, Dr. Reardon explained. On the other side of the ledger, open surgery when compared with CoreValve resulted in significantly fewer acute and long-term episodes of vascular complications and fewer new pacemakers, but these complications likely have less impact on stroke and mortality than the three that occur more often with surgery.
Overall, the widening gap in outcomes between surgery and TAVR “suggests that TAVR with a self-expanding valve [CoreValve] should be considered the preferred treatment,” compared with surgery in high-risk patients, Dr. Reardon said during his presentation at the meeting, a similar conclusion to what Dr. Kodali said about SAPIEN 3.
“These results really do move the needle forward,” said Dr. Popma, a CoreValve trial coinvestigator. “We see for the first time that [TAVR] may indeed be superior, and although durability remains a long-term question we have 2-year data that CoreValve has held up.”
First-generation SAPIEN TAVR shows 5-year stability
The third piece of the TAVR trilogy reported at the meeting was 5-year follow-up results from the first U.S. TAVR pivotal trial (PARTNER 1) using the first-generation SAPIEN device, which is no longer available in the United States. Those results from patients treated during 2007-2009 showed continuation of the statistical overlap between surgical valve replacement and SAPIEN TAVR for all-cause mortality, stroke, and other outcomes (Lancet 2015 [doi:10.1016/S0140-6736(15)60290-2]). Importantly, the results also showed no suggestions of deteriorating function in the TAVR valve after 5 years, reported Dr. Michael J. Mack at the meeting.
“It’s very encouraging, but we’d all like to go out to 10-12 years, and then we’d feel a lot better about it,” commented Dr. Reardon, who did not participate in the PARTNER trial. But given 5 years of apparently reliable function from a TAVR valve, the issue of long-term durability of these valves, an open question at the start of the SAPIEN trial, may be now coming to resolution, he suggested, at least for octogenarians, who are emerging as the prime demographic for TAVR.
“Tissue valves we place surgically deteriorate at different rates depending on a patient’s age when you put them in. In 30-year-olds many valves deteriorate after 10 years; in 50-year-olds maybe 15% will deteriorate, and in 70-year-olds almost none,” Dr. Reardon explained. “No one knows why.” Because many TAVR patients are at least 80 years old “it may take 10 years to see a signal of deterioration, or we might never see a signal,” he said.
SAPIEN versus CoreValve?
Although SAPIEN 3 may be on the U.S. market within the next year, for the time being routine U.S. TAVR practice is limited to two options, approved for high-risk or inoperable patients but not patients at intermediate risk: the CoreValve, which has now clearly bested surgery for all major endpoints over at least the midterm, and the SAPIEN XT model, the second-generation SAPIEN TAVR system that sits between the first generation and SAPIEN 3 and showed documented performance that roughly tracked with the original SAPIEN model. When approving the SAPIEN XT for U.S. marketing in June 2014 for operable high-risk patients as well as inoperable patients, the agency said the evidence indicated that XT was “noninferior” to SAPIEN in high-risk patients.
Several experts at the meeting agreed that despite this difference in performance between CoreValve and SAPIEN XT when each was compared with open surgery, the CoreValve experience better reflected more contemporary performance expectations for TAVR as a class, regardless of device. They cited improvements in valve sizing with imaging, better patient selection, and better TAVR technique as critical in boosting more favorable outcomes, factors that are not valve specific.
They also cited technical factors that may favor the SAPIEN XT device, notably more accurate valve placement using SAPIEN’s balloon-expandable format, compared with the self-expanding CoreValve.
Dr. Ramee said that outside of trials he’s now using SAPIEN XT for about 60% of his cases because of its “more predictable deployment. With CoreValve, you never know exactly where it will end up.” On the other hand, CoreValve works best for a more calcified aortic annulus because self-expanding placement is gentler and less likely to rupture a fragile annulus. That advantage gives CoreValve the edge for about 40% of his patients, Dr. Ramee said in an interview.
“There has been a general forward movement of the TAVR field” in which the focus has been TAVR versus surgery rather than CoreValve versus SAPIEN, Dr. Reardon said in an interview. Some anatomic features favor balloon expandable, others favor self-expanding. New TAVR systems in development by other manufacturers are mostly self-expanding models because of their ability to allow for repositioning, he noted.
Dr. Kodali has an equity interest in Thubrikar Aortic Valve; he has received honoraria from St. Jude; he has served on the steering committee for trials sponsored by Edwards, which markets the SAPIEN systems, Claret Medical, and Meril; and he has received research support from Edwards. Dr. Popma has been a consultant to Abbott, Abiomed, Boston Scientific, Cordis, and Abbott Vascular, and he has received research grants from Medtronic, which markets the CoreValve, and from five other companies. Dr. Reardon has served on an advisory board for Medtronic, Dr. Ramee has received honoraria from Edwards and from Medtronic and has a financial interest in several other companies developing TAVR systems.
On Twitter @mitchelzoler
SAN DIEGO – Three separate reports of pivotal trial results from three different systems for performing transcatheter aortic valve replacement performed during three distinct periods highlighted the rapid advances of this intervention that have now put it on the cusp of being the preferred, default strategy for replacing stenosed aortic valves in older patients.
First SAPIEN 3 U.S. outcomes reported
The most recent technologic advance in transcatheter aortic valve replacement (TAVR), showcased in one of the three presentations at the annual meeting of the American College of Cardiology, was the SAPIEN 3 System, the lowest-profile TAVR system so far to undergo U.S. testing with a 14F delivery system for all valve sizes except the largest, 29 mm valves, which require a 16F system. SAPIEN 3 produced 30-day outcome results so good that one TAVR operator expressed shock at the dramatic, short-term success.
After 30 days follow-up, SAPIEN 3 produced a 2% mortality rate and a 2% stroke rate in 583 “high-risk” patients treated during 2013 and 2014 who were an average of 83 years old and had an average Society of Thoracic Surgeons (STS) risk score of 8.6%, Dr. Susheel K. Kodali reported at the meeting. By contrast, in the pivotal trial of the first-generation SAPIEN TAVR system, run during 2007-2009, in 348 “high-risk” patients (who averaged 84 years old and had an average STS risk score of 11.8%) the 30-day mortality ran 5% and 30-day strokes affected 6%, Dr. Kodali noted.
The new trial also enrolled 1,076 “intermediate”-risk patients, who averaged 82 years old with an average STS score of 5.3%. Their 30-day mortality rate was 1% and their total stroke rate was 3%, with a disabling stroke rate (modified Rankin scale score of 2 or more) of 1%.
These excellent results prompted Edwards, the company developing the SAPIEN 3 System, to apply for Food and Drug Administration approval for the device in high-risk patients, Dr. Kodali noted. In March, Edwards released a statement in which it said it expects SAPIEN 3 to receive U.S. marketing approval within a year. While Dr. Kodali said longer-term follow-up is needed for the intermediate-risk patients, the outcome results he has seen make him rethink the TAVR’s role, compared with conventional aortic valve replacement by open surgery.
“With surgery, these [intermediate-risk] patients would have a 5% mortality rate. The conversation now may need to change,” he said. “We have always said we use TAVR when surgery is not a good option, but based on the recent, 2-year findings with the CoreValve and our data, with a 1% mortality and a 1% disabling stroke rate [in intermediate-risk patients] maybe TAVR is now the preferred option, at least for 80-year-olds, said Dr. Kodali, codirector of the Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center.
Commenting on the SAPIEN 3 results as well as excellent 2-year results from the CoreValve TAVR System pivotal trial, Dr. Jeffrey J. Popma attributed the success to three factors: improved patient selection, refined and routinely used imaging methods for sizing the aortic annulus to better match the TAVR valve size to the annulus size, and improved TAVR techniques based on what is now about an 8-year clinical experience using TAVR.
“All this now puts us in a place where the bar has been set very high for surgery. How does surgery compete?” asked Dr. Popma, professor of medicine at Harvard University and an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston. “The results are so clean at 30 days, what more information do we really need” for device approval? Dr. Popma, one of the discussants for the meeting report by Dr. Kodali, asked.
“I’m shocked the SAPIEN 3 data were so good,” said Dr. Stephen Ramee, an interventional cardiologist and medical director of the Structural and Valvular Heart Center at the Ochsner Medical Center in New Orleans. “We’ll need to wait to do intermediate-risk patients routinely, but the handwriting is on the wall with these data and the CoreValve results. I think TAVR will be preferred for all high-risk patients and for intermediate-risk patients who are at least 80 years old,” Dr. Ramee said in an interview.
Commenting on whether the FDA should approve SAPIEN 3 based on 30-day outcomes in high-risk patients, Dr. Popma noted that SAPIEN 3 is “an iteration of what has been demonstrated” in long-term results with the first-generation SAPIEN device. “Do we really need a randomized clinical trail with several thousand patients after the [SAPIEN] platform was already established?” he asked.
“We don’t demand that for iterations of surgical valves,” agreed Dr. Kodali.
CoreValve looks good longer-term
While SAPIEN 3’s performance turned heads, 2-year results from the CoreValve’s pivotal trial reported at the meeting further deepened the impression that TAVR offered substantial advantages, compared with surgical aortic valve replacement in high-risk patients. The 2-year outcomes followed the trial’s primary endpoint reported last year, the 1-year results, which had shown a statistically significant advantage in survival, compared with surgery (N. Engl. J. Med. 2014;370:1790-8).
The 2-year follow-up showed this advantage was “sustainable, durable, and widening,” reported Dr. Michael Reardon, professor of cardiothoracic surgery at the Methodist Hospital in Houston.
For example, 2-year all-cause mortality stood at 29% in patients who underwent surgical valve replacement and 22% in those who received TAVR with CoreValve, a statistically significant widening of the between-group gap, compared with the respective 19% and 14% mortality rates after 1 year. The rate of all-cause death or major stroke after 2 years ran 33% and 24% with surgical valve replacement or TAVR, respectively, compared with rates of 23% and 16% after 1 year.
Concern about excess strokes with TAVR, “one of our early worries, seems to have been put to bed,” Dr. Reardon said. The results also showed CoreValve substantially surpassed open surgery for valvular blood flow metrics across the full range of follow-up time points.
Several factors might have produced the widening outcomes between years 1 and 2 following a different one-time intervention, Dr. Reardon said, such as significant differences in the incident rate following intervention for disabling or life-threatening bleeding, atrial fibrillation, and acute kidney injury. All three complications occurred significantly more often in the surgery patients, compared with those treated with TAVR, and while the bulk of the difference in incidence showed up within the first month after intervention, each of these complications could have important long-term effects on survival and stroke rates, Dr. Reardon explained. On the other side of the ledger, open surgery when compared with CoreValve resulted in significantly fewer acute and long-term episodes of vascular complications and fewer new pacemakers, but these complications likely have less impact on stroke and mortality than the three that occur more often with surgery.
Overall, the widening gap in outcomes between surgery and TAVR “suggests that TAVR with a self-expanding valve [CoreValve] should be considered the preferred treatment,” compared with surgery in high-risk patients, Dr. Reardon said during his presentation at the meeting, a similar conclusion to what Dr. Kodali said about SAPIEN 3.
“These results really do move the needle forward,” said Dr. Popma, a CoreValve trial coinvestigator. “We see for the first time that [TAVR] may indeed be superior, and although durability remains a long-term question we have 2-year data that CoreValve has held up.”
First-generation SAPIEN TAVR shows 5-year stability
The third piece of the TAVR trilogy reported at the meeting was 5-year follow-up results from the first U.S. TAVR pivotal trial (PARTNER 1) using the first-generation SAPIEN device, which is no longer available in the United States. Those results from patients treated during 2007-2009 showed continuation of the statistical overlap between surgical valve replacement and SAPIEN TAVR for all-cause mortality, stroke, and other outcomes (Lancet 2015 [doi:10.1016/S0140-6736(15)60290-2]). Importantly, the results also showed no suggestions of deteriorating function in the TAVR valve after 5 years, reported Dr. Michael J. Mack at the meeting.
“It’s very encouraging, but we’d all like to go out to 10-12 years, and then we’d feel a lot better about it,” commented Dr. Reardon, who did not participate in the PARTNER trial. But given 5 years of apparently reliable function from a TAVR valve, the issue of long-term durability of these valves, an open question at the start of the SAPIEN trial, may be now coming to resolution, he suggested, at least for octogenarians, who are emerging as the prime demographic for TAVR.
“Tissue valves we place surgically deteriorate at different rates depending on a patient’s age when you put them in. In 30-year-olds many valves deteriorate after 10 years; in 50-year-olds maybe 15% will deteriorate, and in 70-year-olds almost none,” Dr. Reardon explained. “No one knows why.” Because many TAVR patients are at least 80 years old “it may take 10 years to see a signal of deterioration, or we might never see a signal,” he said.
SAPIEN versus CoreValve?
Although SAPIEN 3 may be on the U.S. market within the next year, for the time being routine U.S. TAVR practice is limited to two options, approved for high-risk or inoperable patients but not patients at intermediate risk: the CoreValve, which has now clearly bested surgery for all major endpoints over at least the midterm, and the SAPIEN XT model, the second-generation SAPIEN TAVR system that sits between the first generation and SAPIEN 3 and showed documented performance that roughly tracked with the original SAPIEN model. When approving the SAPIEN XT for U.S. marketing in June 2014 for operable high-risk patients as well as inoperable patients, the agency said the evidence indicated that XT was “noninferior” to SAPIEN in high-risk patients.
Several experts at the meeting agreed that despite this difference in performance between CoreValve and SAPIEN XT when each was compared with open surgery, the CoreValve experience better reflected more contemporary performance expectations for TAVR as a class, regardless of device. They cited improvements in valve sizing with imaging, better patient selection, and better TAVR technique as critical in boosting more favorable outcomes, factors that are not valve specific.
They also cited technical factors that may favor the SAPIEN XT device, notably more accurate valve placement using SAPIEN’s balloon-expandable format, compared with the self-expanding CoreValve.
Dr. Ramee said that outside of trials he’s now using SAPIEN XT for about 60% of his cases because of its “more predictable deployment. With CoreValve, you never know exactly where it will end up.” On the other hand, CoreValve works best for a more calcified aortic annulus because self-expanding placement is gentler and less likely to rupture a fragile annulus. That advantage gives CoreValve the edge for about 40% of his patients, Dr. Ramee said in an interview.
“There has been a general forward movement of the TAVR field” in which the focus has been TAVR versus surgery rather than CoreValve versus SAPIEN, Dr. Reardon said in an interview. Some anatomic features favor balloon expandable, others favor self-expanding. New TAVR systems in development by other manufacturers are mostly self-expanding models because of their ability to allow for repositioning, he noted.
Dr. Kodali has an equity interest in Thubrikar Aortic Valve; he has received honoraria from St. Jude; he has served on the steering committee for trials sponsored by Edwards, which markets the SAPIEN systems, Claret Medical, and Meril; and he has received research support from Edwards. Dr. Popma has been a consultant to Abbott, Abiomed, Boston Scientific, Cordis, and Abbott Vascular, and he has received research grants from Medtronic, which markets the CoreValve, and from five other companies. Dr. Reardon has served on an advisory board for Medtronic, Dr. Ramee has received honoraria from Edwards and from Medtronic and has a financial interest in several other companies developing TAVR systems.
On Twitter @mitchelzoler
AT ACC 2015
SSIs a factor in postop colon cancer survival
HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.
Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.
Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.
“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.
Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.
The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.
Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).
In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).
When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).
Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).
To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).
They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)
Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.
The study was internally supported. Dr. Barden reported having no conflicts of interest.
HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.
Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.
Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.
“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.
Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.
The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.
Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).
In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).
When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).
Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).
To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).
They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)
Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.
The study was internally supported. Dr. Barden reported having no conflicts of interest.
HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.
Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.
Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.
“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.
Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.
The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.
Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).
In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).
When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).
Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).
To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).
They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)
Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.
The study was internally supported. Dr. Barden reported having no conflicts of interest.
AT SSO 2015
Key clinical point: Surgical site infections in patients with colon cancer are associated with both worse overall survival and lower chance of receiving adjuvant chemotherapy.
Major finding: Median overall survival for stage III patients with SSIs was 29 months, vs. 33 for no SSIs.
Data source: Retrospective cohort study of 9,946 patients who underwent radical colon cancer resection with curative intent.
Disclosures: The study was internally supported. Dr. Barden reported having no conflicts of interest.
