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Official Newspaper of the American College of Surgeons
Malpractice premiums dip again
Malpractice premiums continue to inch down but wide disparities in total cost still linger across states.
Internists, general surgeons, and obstetrician-gynecologists experienced a respective 1% drop in their medical liability premiums last year, according to the 2017 Medical Liability Monitor Annual Rate Survey. The rate drop follows an ongoing trend of decreasing premiums over the last decade.
“The takeaways for doctors are really all good ones in that the rates remain very stable,” said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2017 MLM Survey report. “The market for physician coverage remains very competitive because there are so many players involved for what is really a shrinking number of buyers, so the groups and individual physicians that are buying are seeing favorable pricing.” 
Premiums differed vastly across geographic area, consistent with previous years. Southern Florida internists for example, paid $47,707 for malpractice insurance last year, while their Minnesota colleagues paid $3,375. For ob.gyns., premiums ranged from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida paid $190,829 in 2016, while those in Wisconsin paid $10,868.
Overall, no states experienced a premium rate change in the double digits, and physicians in only five states – Hawaii, Kansas, Michigan, Montana, and Ohio – saw premium decreases of more than 5%. No states experienced rate increases of more than 5%.
Fewer claims filed by plaintiffs’ attorneys is one factor contributing to the continued stability of malpractice premiums, according to analysts. However, there are signs that high verdicts are on the rise, said Michael Matray, editor of the Medical Liability Monitor and chief content officer for Cunningham Group. Survey data show claims closing at greater than $1 million are increasing.
“There is data that indicates claim severity has experienced a slight uptick,” Mr. Matray said in an interview. “It obviously hasn’t affected rates, yet. This could be due to the positive effect state-level tort reforms have had – where plaintiff attorneys are only bringing cases that are a slam dunk and carry a larger dollar value.”
Continued practice consolidation and the increase in employed physicians also helped keep premiums steady, Mr. Greve said in an interview. Consolidation means fewer buyers and a more competitive market, which helps keep premiums low and stable.
The jury is still out on how the move to value-based care might impact medical malpractice insurance payments. There is concern that the methods required to determine health care value could unwittingly increase malpractice risk, Mr. Matray said.
“To support value-based reimbursement models, a health care system must manage a vast network of public and private data used by various entities in order to monitor quality and cost,” Mr. Matray said. “The collection of that data requires using electronic health record technology that many physicians find onerous. This leads to physician burnout and dangerous EHR workarounds, such as copy-and-paste practices where previous EHR entries are cloned and inserted into a new progress note, as well as disabling or overriding burdensome safety alerts, to save time and increase efficiency. You can see how this would increase medical liability claim risk.”
The MLM survey is published yearly based on July 1 premium data from the major malpractice insurers and examines premium rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.
Malpractice premiums continue to inch down but wide disparities in total cost still linger across states.
Internists, general surgeons, and obstetrician-gynecologists experienced a respective 1% drop in their medical liability premiums last year, according to the 2017 Medical Liability Monitor Annual Rate Survey. The rate drop follows an ongoing trend of decreasing premiums over the last decade.
“The takeaways for doctors are really all good ones in that the rates remain very stable,” said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2017 MLM Survey report. “The market for physician coverage remains very competitive because there are so many players involved for what is really a shrinking number of buyers, so the groups and individual physicians that are buying are seeing favorable pricing.”
Premiums differed vastly across geographic area, consistent with previous years. Southern Florida internists for example, paid $47,707 for malpractice insurance last year, while their Minnesota colleagues paid $3,375. For ob.gyns., premiums ranged from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida paid $190,829 in 2016, while those in Wisconsin paid $10,868.
Overall, no states experienced a premium rate change in the double digits, and physicians in only five states – Hawaii, Kansas, Michigan, Montana, and Ohio – saw premium decreases of more than 5%. No states experienced rate increases of more than 5%.
Fewer claims filed by plaintiffs’ attorneys is one factor contributing to the continued stability of malpractice premiums, according to analysts. However, there are signs that high verdicts are on the rise, said Michael Matray, editor of the Medical Liability Monitor and chief content officer for Cunningham Group. Survey data show claims closing at greater than $1 million are increasing.
“There is data that indicates claim severity has experienced a slight uptick,” Mr. Matray said in an interview. “It obviously hasn’t affected rates, yet. This could be due to the positive effect state-level tort reforms have had – where plaintiff attorneys are only bringing cases that are a slam dunk and carry a larger dollar value.”
Continued practice consolidation and the increase in employed physicians also helped keep premiums steady, Mr. Greve said in an interview. Consolidation means fewer buyers and a more competitive market, which helps keep premiums low and stable.
The jury is still out on how the move to value-based care might impact medical malpractice insurance payments. There is concern that the methods required to determine health care value could unwittingly increase malpractice risk, Mr. Matray said.
“To support value-based reimbursement models, a health care system must manage a vast network of public and private data used by various entities in order to monitor quality and cost,” Mr. Matray said. “The collection of that data requires using electronic health record technology that many physicians find onerous. This leads to physician burnout and dangerous EHR workarounds, such as copy-and-paste practices where previous EHR entries are cloned and inserted into a new progress note, as well as disabling or overriding burdensome safety alerts, to save time and increase efficiency. You can see how this would increase medical liability claim risk.”
The MLM survey is published yearly based on July 1 premium data from the major malpractice insurers and examines premium rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.
Malpractice premiums continue to inch down but wide disparities in total cost still linger across states.
Internists, general surgeons, and obstetrician-gynecologists experienced a respective 1% drop in their medical liability premiums last year, according to the 2017 Medical Liability Monitor Annual Rate Survey. The rate drop follows an ongoing trend of decreasing premiums over the last decade.
“The takeaways for doctors are really all good ones in that the rates remain very stable,” said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2017 MLM Survey report. “The market for physician coverage remains very competitive because there are so many players involved for what is really a shrinking number of buyers, so the groups and individual physicians that are buying are seeing favorable pricing.”
Premiums differed vastly across geographic area, consistent with previous years. Southern Florida internists for example, paid $47,707 for malpractice insurance last year, while their Minnesota colleagues paid $3,375. For ob.gyns., premiums ranged from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida paid $190,829 in 2016, while those in Wisconsin paid $10,868.
Overall, no states experienced a premium rate change in the double digits, and physicians in only five states – Hawaii, Kansas, Michigan, Montana, and Ohio – saw premium decreases of more than 5%. No states experienced rate increases of more than 5%.
Fewer claims filed by plaintiffs’ attorneys is one factor contributing to the continued stability of malpractice premiums, according to analysts. However, there are signs that high verdicts are on the rise, said Michael Matray, editor of the Medical Liability Monitor and chief content officer for Cunningham Group. Survey data show claims closing at greater than $1 million are increasing.
“There is data that indicates claim severity has experienced a slight uptick,” Mr. Matray said in an interview. “It obviously hasn’t affected rates, yet. This could be due to the positive effect state-level tort reforms have had – where plaintiff attorneys are only bringing cases that are a slam dunk and carry a larger dollar value.”
Continued practice consolidation and the increase in employed physicians also helped keep premiums steady, Mr. Greve said in an interview. Consolidation means fewer buyers and a more competitive market, which helps keep premiums low and stable.
The jury is still out on how the move to value-based care might impact medical malpractice insurance payments. There is concern that the methods required to determine health care value could unwittingly increase malpractice risk, Mr. Matray said.
“To support value-based reimbursement models, a health care system must manage a vast network of public and private data used by various entities in order to monitor quality and cost,” Mr. Matray said. “The collection of that data requires using electronic health record technology that many physicians find onerous. This leads to physician burnout and dangerous EHR workarounds, such as copy-and-paste practices where previous EHR entries are cloned and inserted into a new progress note, as well as disabling or overriding burdensome safety alerts, to save time and increase efficiency. You can see how this would increase medical liability claim risk.”
The MLM survey is published yearly based on July 1 premium data from the major malpractice insurers and examines premium rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.
Gastric bypass T2D benefit can fade over time
but the effect diminished over time, according to findings published Jan. 16 in JAMA.
In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A1c (HbA1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .
At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.
The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m2.
Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.
At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA1c level of 9.6%, compared with a mean BMI of 34.9 and HbA1c level of 9.6% in the gastric bypass group.
Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.
Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).
The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).
The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.
“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.
Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.
SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.
but the effect diminished over time, according to findings published Jan. 16 in JAMA.
In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A1c (HbA1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .
At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.
The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m2.
Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.
At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA1c level of 9.6%, compared with a mean BMI of 34.9 and HbA1c level of 9.6% in the gastric bypass group.
Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.
Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).
The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).
The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.
“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.
Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.
SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.
but the effect diminished over time, according to findings published Jan. 16 in JAMA.
In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A1c (HbA1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .
At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.
The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m2.
Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.
At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA1c level of 9.6%, compared with a mean BMI of 34.9 and HbA1c level of 9.6% in the gastric bypass group.
Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.
Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).
The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).
The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.
“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.
Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.
SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.
FROM JAMA
Key clinical point: Adding gastric bypass surgery to lifestyle and medical management improves diabetes outcomes – but with diminished effect over time.
Major finding: Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group.
Data source: A randomized study of 113 patients at four sites in the United States and Taiwan with a HbA1c level of 8% or higher and a BMI of 30-39.9 kg/m2.
Disclosures: Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics
SOURCE: Ikramuddin S et al. JAMA. 2018;319(3):266-278.
Five pearls target wound healing
MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.
In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
Avoid opioids for postoperative pain
“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”
“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”
The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
Consider skipping epidermal sutures in some cases
Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”
A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.
“Forget epidermal sutures if you’re brave enough,” he said.
Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”
And speaking of wound edges …
When debriding a nonhealing wound ...
There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.
“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
If a patient is unusually anxious or stressed
Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.
“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.
“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.
“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
Two technologies still look good for scarless donor sites
Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.
With epidermal grafting, dermatologists can apply a device to lift up on the epidermis from a donor site. The CelluTome Epidermal Harvesting System, for example, achieves this feat by applying both a little heat and some suction. “It creates little domes [of epidermis] in this Easy Bake oven looking device,” Dr. Kirsner said. Without any anesthetic, you place this device on the skin and you get these epidermal grafts in 30 minutes. Then you can transfer them to a sterile dressing and place them on the wound.”
As pointed out in a previous report in Dermatology News, avoiding the need for donor site anesthesia is one advantage of the epidermal grafting technique. In addition, the procedure is generally bloodless because the device does not go deep enough to reach the blood vessels, Dr. Kirsner said. In addition, healing of the donor site can be seen on histology in as little as 2 days.
Transferring the epidermis can promote healing because it also transfers keratinocytes and melanocytes to the wound.
“This technique is also excellent to add skin or cells to someone with pyoderma gangrenosum,” Dr. Kirsner said. “Because of the simplicity and the lack of trauma, you don’t get the pathergy you normally see on someone with pyoderma gangrenosum.”
An Autologous Regeneration of Tissue or ART device that transfers columns of healthy skin to a wound to help regenerate tissue and promote healing is a second technology with a lot of potential, Dr. Kirsner said. “With a fractional laser, you create a hole, and that hole heals without scarring. Instead of making holes, R. Rox Anderson, MD, professor of dermatology at Harvard University, Boston, created a device that picks out the microcolumns of skin.” When these full skin thickness columns of skin are transferred to a wound, Dr. Kirsner noted, “in 3 weeks you can pretty much have no visible or a much improved cosmetic scar. Histologically you don’t see a scar either.”
Dr. Kirsner said he had no relevant financial disclosures.
MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.
In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
Avoid opioids for postoperative pain
“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”
“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”
The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
Consider skipping epidermal sutures in some cases
Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”
A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.
“Forget epidermal sutures if you’re brave enough,” he said.
Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”
And speaking of wound edges …
When debriding a nonhealing wound ...
There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.
“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
If a patient is unusually anxious or stressed
Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.
“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.
“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.
“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
Two technologies still look good for scarless donor sites
Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.
With epidermal grafting, dermatologists can apply a device to lift up on the epidermis from a donor site. The CelluTome Epidermal Harvesting System, for example, achieves this feat by applying both a little heat and some suction. “It creates little domes [of epidermis] in this Easy Bake oven looking device,” Dr. Kirsner said. Without any anesthetic, you place this device on the skin and you get these epidermal grafts in 30 minutes. Then you can transfer them to a sterile dressing and place them on the wound.”
As pointed out in a previous report in Dermatology News, avoiding the need for donor site anesthesia is one advantage of the epidermal grafting technique. In addition, the procedure is generally bloodless because the device does not go deep enough to reach the blood vessels, Dr. Kirsner said. In addition, healing of the donor site can be seen on histology in as little as 2 days.
Transferring the epidermis can promote healing because it also transfers keratinocytes and melanocytes to the wound.
“This technique is also excellent to add skin or cells to someone with pyoderma gangrenosum,” Dr. Kirsner said. “Because of the simplicity and the lack of trauma, you don’t get the pathergy you normally see on someone with pyoderma gangrenosum.”
An Autologous Regeneration of Tissue or ART device that transfers columns of healthy skin to a wound to help regenerate tissue and promote healing is a second technology with a lot of potential, Dr. Kirsner said. “With a fractional laser, you create a hole, and that hole heals without scarring. Instead of making holes, R. Rox Anderson, MD, professor of dermatology at Harvard University, Boston, created a device that picks out the microcolumns of skin.” When these full skin thickness columns of skin are transferred to a wound, Dr. Kirsner noted, “in 3 weeks you can pretty much have no visible or a much improved cosmetic scar. Histologically you don’t see a scar either.”
Dr. Kirsner said he had no relevant financial disclosures.
MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.
In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
Avoid opioids for postoperative pain
“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”
“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”
The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
Consider skipping epidermal sutures in some cases
Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”
A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.
“Forget epidermal sutures if you’re brave enough,” he said.
Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”
And speaking of wound edges …
When debriding a nonhealing wound ...
There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.
“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
If a patient is unusually anxious or stressed
Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.
“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.
“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.
“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
Two technologies still look good for scarless donor sites
Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.
With epidermal grafting, dermatologists can apply a device to lift up on the epidermis from a donor site. The CelluTome Epidermal Harvesting System, for example, achieves this feat by applying both a little heat and some suction. “It creates little domes [of epidermis] in this Easy Bake oven looking device,” Dr. Kirsner said. Without any anesthetic, you place this device on the skin and you get these epidermal grafts in 30 minutes. Then you can transfer them to a sterile dressing and place them on the wound.”
As pointed out in a previous report in Dermatology News, avoiding the need for donor site anesthesia is one advantage of the epidermal grafting technique. In addition, the procedure is generally bloodless because the device does not go deep enough to reach the blood vessels, Dr. Kirsner said. In addition, healing of the donor site can be seen on histology in as little as 2 days.
Transferring the epidermis can promote healing because it also transfers keratinocytes and melanocytes to the wound.
“This technique is also excellent to add skin or cells to someone with pyoderma gangrenosum,” Dr. Kirsner said. “Because of the simplicity and the lack of trauma, you don’t get the pathergy you normally see on someone with pyoderma gangrenosum.”
An Autologous Regeneration of Tissue or ART device that transfers columns of healthy skin to a wound to help regenerate tissue and promote healing is a second technology with a lot of potential, Dr. Kirsner said. “With a fractional laser, you create a hole, and that hole heals without scarring. Instead of making holes, R. Rox Anderson, MD, professor of dermatology at Harvard University, Boston, created a device that picks out the microcolumns of skin.” When these full skin thickness columns of skin are transferred to a wound, Dr. Kirsner noted, “in 3 weeks you can pretty much have no visible or a much improved cosmetic scar. Histologically you don’t see a scar either.”
Dr. Kirsner said he had no relevant financial disclosures.
EXPERT ANALYSIS FROM ODAC 2018
Transcatheter aortic valve-in-ring for mitral disease a winner
DENVER – Transseptal mitral valve implantation of an off-the-shelf, commercially available TAVR valve in high-surgical-risk patients with a failing surgically implanted mitral ring prosthesis has become a reasonable treatment strategy in light of the interim findings of the ground-breaking MITRAL trial, Mayra E. Guerrero, MD, said at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
Her presentation of the preliminary results of the MITRAL (Mitral Implantation of Transcatheter Valves) trial showed this valve-in-ring (ViR) treatment strategy using the Sapien 3 valve was associated with low 30-day morbidity and mortality rates and impressive symptomatic improvement.
In contrast, another arm of the MITRAL trial showed that placement of the Sapien 3 TAVR valve in high-surgical-risk patients with severe mitral stenosis due to mitral annular calcification (MAC) of their native valve is a treatment strategy that’s not yet ready for prime time, she added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“Transcatheter mitral valve replacement in MAC is a challenging procedure associated with complications,” Dr. Guerrero observed. “It may become a reasonable alternative for high-surgical-risk patients with favorable anatomy, but techniques require further refinement.”
The ViR arm of the observational multicenter prospective MITRAL trial included 30 patients with extremely high surgical risk and either severe mitral stenosis as defined by a mitral valve area of 1.5 cm2 or less or moderate mitral stenosis plus severe mitral regurgitation. The most common type of failing ring was the Edwards Physio, in nine patients. Access for transcatheter mitral valve replacement (TMVR) was transseptal in 100% of patients.
The technical success rate at exit from the catheterization lab was 70%. The procedural success rate at 30 days was 62%.
Six patients required a second valve. This was mainly because of malpositioning of the first valve with resultant mitral regurgitation; however, this problem became a nonissue as operator experience grew. All six affected patients were alive at 30 days, and four of the six were New York Heart Association (NYHA) functional class I or II.
In-hospital and 30-day mortality rates were low. There was a single cardiovascular death and one noncardiac death in hospital, with no additional deaths through 30 days. No cases of stroke, acute MI, or valve embolization or thrombosis occurred. The mean mitral valve area at 30 days was 2.1 cm2, although three patients still had a mitral valve area of less 1.5 cm2. Three patients experienced acute renal failure requiring hemodialysis. Seventy-five percent of patients had no or trace mitral regurgitation by echocardiography; the rest had mild regurgitation.
Although at baseline more than 60% of the patients were New York Heart Association class III, 10% were class IV, and the rest were class II, at 30 days more than 30% were New York Heart Association class I, 40% were class II, and the rest were class III.
The 30-day all-cause mortality rate of 6.8% in the MITRAL study is roughly half that reported for ViR patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Dr. Guerrero attributed this to refined procedural techniques and improved patient selection through the use of CT imaging and echocardiography.
Heart valve design changes, such as a longer inner skirt, might further improve the technical success rate for ViR, according to Dr. Guerrero, an interventional cardiologist at NorthShore University Health System in Evanston, Ill.
Picking the right ring
Given that studies show one-third of recipients of a surgical mitral ring or surgical mitral valve will require a repeat intervention within 10 years, she made a plea to surgeons: “If we are going to be treating patients with valve-in-ring TMVR, that means when surgeons do a repair they should pick a ring that is amenable to a ViR procedure. So don’t use flexible incomplete bands or very rigid rings because those are really difficult to treat later on. We should pick a ring thinking of the future. That ring is going to fail at some point, and when it fails it’s going to make our lives much easier if we’d picked the right ring.”
MAC TMVR needs more work
In the MAC arm of the MITRAL trial, 96 patients were screened so the researchers could find 30 candidates for TMVR. The 61 rejections were for high risk of left ventricular outflow tract obstruction (LVOTO), embolization, or both.
Fourteen patients underwent transseptal TMVR, and one with anatomy unsuitable for a transseptal procedure had a transapical approach. The other 15 patients had a transatrial surgical approach, which allows resection of the anterior leaflet to reduce the risk of LVOTO and placement of sutures to reduce the embolization risk. However, this came at the cost of increased mortality risk: Three of the five in-hospital deaths were in the transatrial TMVR group.
The technical success rate at exit from the cath lab in the MAC patients was 73%, with a 30-day procedural success rate of 46% and a 19% 30-day mortality. Three patients developed severe LVOTO with hemodynamic compromise.
One transseptal and one transapical TMVR were complicated by LVOTO, both treated by bailout alcohol septal ablation. This led Dr. Guerrero and her coinvestigators to the concept of preemptive alcohol septal ablation, which they used in seven patients deemed at high risk for LVOTO an average of 6 weeks prior to transseptal TMVR as a successful risk reduction strategy.
Survival climbing with operator experience
“In the early days of the TMVR MAC registry, the 30-day mortality rate was 37%. It came down to 22% in the middle third of the registry, then about 18% in the final third. Now we’ve got it down in MITRAL to 16.7%, but when you separate the rate in the transseptal versus the transatrial patients, it’s 13% versus 20%. The difference is not statistically significant, but it’s promising, and I think we are making great progress,” Dr. Guerrero said.
Safety and efficacy endpoints in MITRAL will be reported again at 1 year of follow-up.
The MITRAL trial was partially supported by Edwards Lifesciences. Dr. Guerrero reported receiving a research grant from that company and serving as a consultant to Tendyne Holdings/Abbott and on a speakers bureau for Abiomed.
SOURCE: Guerrero M. No abstract.
DENVER – Transseptal mitral valve implantation of an off-the-shelf, commercially available TAVR valve in high-surgical-risk patients with a failing surgically implanted mitral ring prosthesis has become a reasonable treatment strategy in light of the interim findings of the ground-breaking MITRAL trial, Mayra E. Guerrero, MD, said at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
Her presentation of the preliminary results of the MITRAL (Mitral Implantation of Transcatheter Valves) trial showed this valve-in-ring (ViR) treatment strategy using the Sapien 3 valve was associated with low 30-day morbidity and mortality rates and impressive symptomatic improvement.
In contrast, another arm of the MITRAL trial showed that placement of the Sapien 3 TAVR valve in high-surgical-risk patients with severe mitral stenosis due to mitral annular calcification (MAC) of their native valve is a treatment strategy that’s not yet ready for prime time, she added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“Transcatheter mitral valve replacement in MAC is a challenging procedure associated with complications,” Dr. Guerrero observed. “It may become a reasonable alternative for high-surgical-risk patients with favorable anatomy, but techniques require further refinement.”
The ViR arm of the observational multicenter prospective MITRAL trial included 30 patients with extremely high surgical risk and either severe mitral stenosis as defined by a mitral valve area of 1.5 cm2 or less or moderate mitral stenosis plus severe mitral regurgitation. The most common type of failing ring was the Edwards Physio, in nine patients. Access for transcatheter mitral valve replacement (TMVR) was transseptal in 100% of patients.
The technical success rate at exit from the catheterization lab was 70%. The procedural success rate at 30 days was 62%.
Six patients required a second valve. This was mainly because of malpositioning of the first valve with resultant mitral regurgitation; however, this problem became a nonissue as operator experience grew. All six affected patients were alive at 30 days, and four of the six were New York Heart Association (NYHA) functional class I or II.
In-hospital and 30-day mortality rates were low. There was a single cardiovascular death and one noncardiac death in hospital, with no additional deaths through 30 days. No cases of stroke, acute MI, or valve embolization or thrombosis occurred. The mean mitral valve area at 30 days was 2.1 cm2, although three patients still had a mitral valve area of less 1.5 cm2. Three patients experienced acute renal failure requiring hemodialysis. Seventy-five percent of patients had no or trace mitral regurgitation by echocardiography; the rest had mild regurgitation.
Although at baseline more than 60% of the patients were New York Heart Association class III, 10% were class IV, and the rest were class II, at 30 days more than 30% were New York Heart Association class I, 40% were class II, and the rest were class III.
The 30-day all-cause mortality rate of 6.8% in the MITRAL study is roughly half that reported for ViR patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Dr. Guerrero attributed this to refined procedural techniques and improved patient selection through the use of CT imaging and echocardiography.
Heart valve design changes, such as a longer inner skirt, might further improve the technical success rate for ViR, according to Dr. Guerrero, an interventional cardiologist at NorthShore University Health System in Evanston, Ill.
Picking the right ring
Given that studies show one-third of recipients of a surgical mitral ring or surgical mitral valve will require a repeat intervention within 10 years, she made a plea to surgeons: “If we are going to be treating patients with valve-in-ring TMVR, that means when surgeons do a repair they should pick a ring that is amenable to a ViR procedure. So don’t use flexible incomplete bands or very rigid rings because those are really difficult to treat later on. We should pick a ring thinking of the future. That ring is going to fail at some point, and when it fails it’s going to make our lives much easier if we’d picked the right ring.”
MAC TMVR needs more work
In the MAC arm of the MITRAL trial, 96 patients were screened so the researchers could find 30 candidates for TMVR. The 61 rejections were for high risk of left ventricular outflow tract obstruction (LVOTO), embolization, or both.
Fourteen patients underwent transseptal TMVR, and one with anatomy unsuitable for a transseptal procedure had a transapical approach. The other 15 patients had a transatrial surgical approach, which allows resection of the anterior leaflet to reduce the risk of LVOTO and placement of sutures to reduce the embolization risk. However, this came at the cost of increased mortality risk: Three of the five in-hospital deaths were in the transatrial TMVR group.
The technical success rate at exit from the cath lab in the MAC patients was 73%, with a 30-day procedural success rate of 46% and a 19% 30-day mortality. Three patients developed severe LVOTO with hemodynamic compromise.
One transseptal and one transapical TMVR were complicated by LVOTO, both treated by bailout alcohol septal ablation. This led Dr. Guerrero and her coinvestigators to the concept of preemptive alcohol septal ablation, which they used in seven patients deemed at high risk for LVOTO an average of 6 weeks prior to transseptal TMVR as a successful risk reduction strategy.
Survival climbing with operator experience
“In the early days of the TMVR MAC registry, the 30-day mortality rate was 37%. It came down to 22% in the middle third of the registry, then about 18% in the final third. Now we’ve got it down in MITRAL to 16.7%, but when you separate the rate in the transseptal versus the transatrial patients, it’s 13% versus 20%. The difference is not statistically significant, but it’s promising, and I think we are making great progress,” Dr. Guerrero said.
Safety and efficacy endpoints in MITRAL will be reported again at 1 year of follow-up.
The MITRAL trial was partially supported by Edwards Lifesciences. Dr. Guerrero reported receiving a research grant from that company and serving as a consultant to Tendyne Holdings/Abbott and on a speakers bureau for Abiomed.
SOURCE: Guerrero M. No abstract.
DENVER – Transseptal mitral valve implantation of an off-the-shelf, commercially available TAVR valve in high-surgical-risk patients with a failing surgically implanted mitral ring prosthesis has become a reasonable treatment strategy in light of the interim findings of the ground-breaking MITRAL trial, Mayra E. Guerrero, MD, said at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
Her presentation of the preliminary results of the MITRAL (Mitral Implantation of Transcatheter Valves) trial showed this valve-in-ring (ViR) treatment strategy using the Sapien 3 valve was associated with low 30-day morbidity and mortality rates and impressive symptomatic improvement.
In contrast, another arm of the MITRAL trial showed that placement of the Sapien 3 TAVR valve in high-surgical-risk patients with severe mitral stenosis due to mitral annular calcification (MAC) of their native valve is a treatment strategy that’s not yet ready for prime time, she added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“Transcatheter mitral valve replacement in MAC is a challenging procedure associated with complications,” Dr. Guerrero observed. “It may become a reasonable alternative for high-surgical-risk patients with favorable anatomy, but techniques require further refinement.”
The ViR arm of the observational multicenter prospective MITRAL trial included 30 patients with extremely high surgical risk and either severe mitral stenosis as defined by a mitral valve area of 1.5 cm2 or less or moderate mitral stenosis plus severe mitral regurgitation. The most common type of failing ring was the Edwards Physio, in nine patients. Access for transcatheter mitral valve replacement (TMVR) was transseptal in 100% of patients.
The technical success rate at exit from the catheterization lab was 70%. The procedural success rate at 30 days was 62%.
Six patients required a second valve. This was mainly because of malpositioning of the first valve with resultant mitral regurgitation; however, this problem became a nonissue as operator experience grew. All six affected patients were alive at 30 days, and four of the six were New York Heart Association (NYHA) functional class I or II.
In-hospital and 30-day mortality rates were low. There was a single cardiovascular death and one noncardiac death in hospital, with no additional deaths through 30 days. No cases of stroke, acute MI, or valve embolization or thrombosis occurred. The mean mitral valve area at 30 days was 2.1 cm2, although three patients still had a mitral valve area of less 1.5 cm2. Three patients experienced acute renal failure requiring hemodialysis. Seventy-five percent of patients had no or trace mitral regurgitation by echocardiography; the rest had mild regurgitation.
Although at baseline more than 60% of the patients were New York Heart Association class III, 10% were class IV, and the rest were class II, at 30 days more than 30% were New York Heart Association class I, 40% were class II, and the rest were class III.
The 30-day all-cause mortality rate of 6.8% in the MITRAL study is roughly half that reported for ViR patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Dr. Guerrero attributed this to refined procedural techniques and improved patient selection through the use of CT imaging and echocardiography.
Heart valve design changes, such as a longer inner skirt, might further improve the technical success rate for ViR, according to Dr. Guerrero, an interventional cardiologist at NorthShore University Health System in Evanston, Ill.
Picking the right ring
Given that studies show one-third of recipients of a surgical mitral ring or surgical mitral valve will require a repeat intervention within 10 years, she made a plea to surgeons: “If we are going to be treating patients with valve-in-ring TMVR, that means when surgeons do a repair they should pick a ring that is amenable to a ViR procedure. So don’t use flexible incomplete bands or very rigid rings because those are really difficult to treat later on. We should pick a ring thinking of the future. That ring is going to fail at some point, and when it fails it’s going to make our lives much easier if we’d picked the right ring.”
MAC TMVR needs more work
In the MAC arm of the MITRAL trial, 96 patients were screened so the researchers could find 30 candidates for TMVR. The 61 rejections were for high risk of left ventricular outflow tract obstruction (LVOTO), embolization, or both.
Fourteen patients underwent transseptal TMVR, and one with anatomy unsuitable for a transseptal procedure had a transapical approach. The other 15 patients had a transatrial surgical approach, which allows resection of the anterior leaflet to reduce the risk of LVOTO and placement of sutures to reduce the embolization risk. However, this came at the cost of increased mortality risk: Three of the five in-hospital deaths were in the transatrial TMVR group.
The technical success rate at exit from the cath lab in the MAC patients was 73%, with a 30-day procedural success rate of 46% and a 19% 30-day mortality. Three patients developed severe LVOTO with hemodynamic compromise.
One transseptal and one transapical TMVR were complicated by LVOTO, both treated by bailout alcohol septal ablation. This led Dr. Guerrero and her coinvestigators to the concept of preemptive alcohol septal ablation, which they used in seven patients deemed at high risk for LVOTO an average of 6 weeks prior to transseptal TMVR as a successful risk reduction strategy.
Survival climbing with operator experience
“In the early days of the TMVR MAC registry, the 30-day mortality rate was 37%. It came down to 22% in the middle third of the registry, then about 18% in the final third. Now we’ve got it down in MITRAL to 16.7%, but when you separate the rate in the transseptal versus the transatrial patients, it’s 13% versus 20%. The difference is not statistically significant, but it’s promising, and I think we are making great progress,” Dr. Guerrero said.
Safety and efficacy endpoints in MITRAL will be reported again at 1 year of follow-up.
The MITRAL trial was partially supported by Edwards Lifesciences. Dr. Guerrero reported receiving a research grant from that company and serving as a consultant to Tendyne Holdings/Abbott and on a speakers bureau for Abiomed.
SOURCE: Guerrero M. No abstract.
REPORTING FROM TCT 2017
Key clinical point: .
Major finding: Thirty-day all-cause mortality following a transcatheter valve-in-ring procedure in unacceptably high surgical-risk patients with severe mitral valve disease due to a failing annuloplasty ring was 6.8%.
Study details: This prospective observational study included 60 patients who underwent transcatheter mitral valve replacement for severe mitral valve disease, half due to a failed annuloplasty ring and half secondary to mitral annular calcification.
Disclosures: The MITRAL trial was partially supported by Edwards Lifesciences. The study presenter reported receiving a research grant from the company.
Source: Guerrero M. No abstract.
Pendulum swings on mesenteric venous thrombosis treatment
CHICAGO – Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.
“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.
Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.
The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
Diagnosis
MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.
“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.
He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).
The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.
CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
Treatment
The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.
How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.
In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.
“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.
Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.
Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.
Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
Prognosis
A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.
The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).
These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.
“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.
He reported having no financial conflicts regarding his presentation.
CHICAGO – Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.
“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.
Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.
The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
Diagnosis
MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.
“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.
He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).
The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.
CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
Treatment
The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.
How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.
In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.
“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.
Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.
Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.
Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
Prognosis
A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.
The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).
These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.
“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.
He reported having no financial conflicts regarding his presentation.
CHICAGO – Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.
“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.
Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.
The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
Diagnosis
MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.
“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.
He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).
The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.
CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
Treatment
The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.
How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.
In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.
“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.
Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.
Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.
Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
Prognosis
A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.
The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).
These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.
“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.
He reported having no financial conflicts regarding his presentation.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
HIPEC shows survival benefit for advanced ovarian cancer
Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.
After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.
Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.
Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.
They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.
Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.
“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”
This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.
SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
Although the data reported by Dr. van Driel and her colleagues represent an important first step, the findings “should not drive changes in practice yet,” according to David R. Spriggs, MD, and Oliver Zivanovick, MD.
Dr. Spriggs and Dr. Zivanovic raised questions surrounding the efficacy of adding HIPEC to surgery and suggested that the benefit observed by Dr. van Driel and her coauthors could be attributed to several variables such as the route of intraperitoneal administration or the skill level of the attending surgeon.
Currently, certain patients with advanced ovarian cancer receive primary surgery instead of neoadjuvant chemotherapy. HIPEC does not change that approach, Dr. Spriggs and Dr. Zivanovic said.
They went on to note that further “well-designed” research could reveal other patient subgroups that warrant further investigation such as those who underwent an optimal cytoreductive procedure.
“These considerations will be important for clinical trial investigators as they focus on the positive effect of HIPEC as an intervention as compared with the effects of promising new agent combinations or immunotherapy treatments,” they wrote.
Dr. Spriggs is the associate director for clinical and translational research at Memorial Sloan Kettering Cancer Center in New York, and Dr. Zivanovic is a gynecologic oncologic surgeon at Sloan Kettering. These remarks were taken from their invited commentary on the report by Dr. van Driel and her associates. Dr. Spriggs reported that he is employed by the New England Journal of Medicine as an associate editor. Dr. Zivanovic reported no relevant financial disclosures.
SOURCE: Spriggs DR et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMe1714556.
Although the data reported by Dr. van Driel and her colleagues represent an important first step, the findings “should not drive changes in practice yet,” according to David R. Spriggs, MD, and Oliver Zivanovick, MD.
Dr. Spriggs and Dr. Zivanovic raised questions surrounding the efficacy of adding HIPEC to surgery and suggested that the benefit observed by Dr. van Driel and her coauthors could be attributed to several variables such as the route of intraperitoneal administration or the skill level of the attending surgeon.
Currently, certain patients with advanced ovarian cancer receive primary surgery instead of neoadjuvant chemotherapy. HIPEC does not change that approach, Dr. Spriggs and Dr. Zivanovic said.
They went on to note that further “well-designed” research could reveal other patient subgroups that warrant further investigation such as those who underwent an optimal cytoreductive procedure.
“These considerations will be important for clinical trial investigators as they focus on the positive effect of HIPEC as an intervention as compared with the effects of promising new agent combinations or immunotherapy treatments,” they wrote.
Dr. Spriggs is the associate director for clinical and translational research at Memorial Sloan Kettering Cancer Center in New York, and Dr. Zivanovic is a gynecologic oncologic surgeon at Sloan Kettering. These remarks were taken from their invited commentary on the report by Dr. van Driel and her associates. Dr. Spriggs reported that he is employed by the New England Journal of Medicine as an associate editor. Dr. Zivanovic reported no relevant financial disclosures.
SOURCE: Spriggs DR et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMe1714556.
Although the data reported by Dr. van Driel and her colleagues represent an important first step, the findings “should not drive changes in practice yet,” according to David R. Spriggs, MD, and Oliver Zivanovick, MD.
Dr. Spriggs and Dr. Zivanovic raised questions surrounding the efficacy of adding HIPEC to surgery and suggested that the benefit observed by Dr. van Driel and her coauthors could be attributed to several variables such as the route of intraperitoneal administration or the skill level of the attending surgeon.
Currently, certain patients with advanced ovarian cancer receive primary surgery instead of neoadjuvant chemotherapy. HIPEC does not change that approach, Dr. Spriggs and Dr. Zivanovic said.
They went on to note that further “well-designed” research could reveal other patient subgroups that warrant further investigation such as those who underwent an optimal cytoreductive procedure.
“These considerations will be important for clinical trial investigators as they focus on the positive effect of HIPEC as an intervention as compared with the effects of promising new agent combinations or immunotherapy treatments,” they wrote.
Dr. Spriggs is the associate director for clinical and translational research at Memorial Sloan Kettering Cancer Center in New York, and Dr. Zivanovic is a gynecologic oncologic surgeon at Sloan Kettering. These remarks were taken from their invited commentary on the report by Dr. van Driel and her associates. Dr. Spriggs reported that he is employed by the New England Journal of Medicine as an associate editor. Dr. Zivanovic reported no relevant financial disclosures.
SOURCE: Spriggs DR et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMe1714556.
Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.
After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.
Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.
Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.
They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.
Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.
“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”
This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.
SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.
After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.
Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.
Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.
They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.
Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.
“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”
This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.
SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Administering HIPEC during interval cytoreductive surgery lengthened survival without increasing safety risk for patients with advanced-stage ovarian cancer.
Major finding: Patients who received HIPEC experienced a median recurrence-free survival that was 3.5 months longer and overall survival that was 11.8 months longer than patients who received surgery alone.
Study details: A multicenter, open-label phase 3 trial that randomly assigned patients who had received neoadjuvant chemotherapy to receive either HIPEC or surgery alone with an endpoint of recurrence-free survival.
Disclosures: This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.
Source: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
Finance Committee votes on Azar HHS nomination
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
REPORTING FROM A SENATE FINANCE COMMITTEE HEARING
Clinical rule decreased pediatric trauma CT scans
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
REPORTING FROM EAST 2018
Key clinical point: New prediction model successfully identified patients with intra-abdominal injury (IAI) and IAI patients who require acute intervention (IAI-I).
Major finding: The test had a negative predictive value of 99.3% in IAI patients and 100% in IAI-I patients when either had no abnormalities.
Study details: Prospective study of 2,345 pediatric patients with IAI or IAI-I, the data for which was collected from the Pediatric Emergency Care Applied Research Network.
Disclosures: Dr. Arbra reported no relevant financial disclosures.
Source: Arbra CA. EAST Scientific Assembly 2018, paper #7.
Carotid stenting isn’t safer than endarterectomy with contralateral carotid occlusion
CHICAGO – Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.
The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?
To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.
In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.
“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.
The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.
The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.
Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.
In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.
A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.
Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.
SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.
CHICAGO – Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.
The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?
To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.
In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.
“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.
The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.
The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.
Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.
In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.
A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.
Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.
SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.
CHICAGO – Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.
The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?
To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.
In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.
“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.
The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.
The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.
Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.
In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.
A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.
Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.
SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
Nominations now open for the 2018 Surgical Volunteerism and Humanitarian Awards
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.