Cardiothoracic Surgery

What’s in a name?

Since its early inception, the Home Care NetWork was created to share expertise at home. Initially, this was uncommon and largely in survivors of the polio epidemics. Today, home-based ventilation is given for a wide variety of diseases, including neuromuscular diseases, chronic lung diseases, central hypoventilation syndromes, spinal cord injuries, and many others. The number of individuals has been growing exponentially. Even over the last 10 to 20 years, this growth has continued both domestically and internationally. As just one example, the largest pediatric home ventilation program in Canada saw an increase from two children in 1991 to 156 in 2011 (Amin et al. Pediatr Pulmonol. 2014;49:816). At the same time, support is being increasingly provided with noninvasive ventilation, including up to 24-hour ventilator requirements, and new equipment and skills are being developed on a regular basis to facilitate this support.

There are also many challenges that accompany this growing population. One priority our steering committee has repeatedly heard is that patients with progressive neuromuscular diseases, especially in adulthood, are having difficulties finding clinicians to provide appropriate noninvasive ventilation. And even when they do and are well cared for, they risk receiving a tracheostomy when they are admitted to hospitals after admissions for acute decompensations, despite experience and literature suggesting this is often avoidable.

We have also come to realize that CHEST members seeking out resources in this area have not always known what the Home Care NetWork did. As such, to continue to provide and improve the support to the CHEST community, the Home Care NetWork has been renamed the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork.

Changes to our practice climate

Health-care providers continue to hear reports on the initiatives underway to change the cost curve and increase the value of health care. CMS continues its efforts with meaningful use, PQRS, and value-based payment modifiers. Eligible providers’ performance in 2015 is being assessed for payment adjustments to be phased in yearly from large groups in 2015 to all providers by 2017. Individual CMS beneficiaries are being assigned to physician groups using stepwise methodology and tax identification numbers of providers to track quality and cost performance.

For years, hospitals have been attuned to the needs to optimize quality and cost performance for populations of CMS patients. Physician groups similarly must now focus on process improvement to align with CMS goals for quality and cost for both inpatient and outpatient care. In doing so, payments to those provider groups from CMS will be adjusted upwards, be held neutral, or adjusted downwards based upon their success.

If you are interested in assisting your colleagues in preparing for changes to our practice climate like those outlined above, we welcome you to join the Practice Operations NetWork. For those interested, please contact [email protected], or simply drop in and visit us at CHEST 2015 during our NetWork Featured Lecture – Comparing the Canadian Healthcare Model to the US Model on Tuesday, October 27, in Montreal! We hope to see you there!

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/valuebasedpaymentmodifier.html

Lung transplantation and the quest for donor lungs

With improving survival rates and increasing recognition of quality-of-life benefits, more patients are being referred and listed for lung transplantation. However, each year, patients die while awaiting lung transplantation. Obtaining enough suitable donor lungs remains a challenge.

Potential donor lungs are declined for many reasons, one of which is concerns about quality. The best way to accurately assess and predict a deceased donor lung’s function remains unknown. Although more marginal donors are now considered and used based on the study by Ware and colleagues in 2002 (Lancet. 2002;360[9333]:619), further research is needed to better assess the lungs declined today.

Several strategies are being pursued to expand the availability of donor lungs. There has been expanding recognition that lungs from donors after cardiac death (DCD) can be used successfully. About 15% of US donors are now DCD donors (UNOS Data Trends 2014 from www.unos.org), and these are an important source of potential donor lungs.

Ex vivo lung perfusion (EVLP) techniques may help to further assess and potentially repair donor lungs that might have otherwise been considered marginal or declined. Although not yet approved for widespread use, lungs that may have been declined for concerns about quality may soon have a chance to be further evaluated on EVLP systems.

Ongoing research focusing on improved strategies for procuring lungs from DCD donors and for rehabilitating donor lungs on EVLP should lead to increased availability of donor lungs. Perhaps soon, every listed patient may be offered a chance for a successful lung transplant.

FDA pregnancy risk classification system removed

As of June 30, 2015, the US FDA removed the well known A, B, C, D, and X pregnancy risk classification system for prescription drugs and biological products [FDA HHS. Fed Regist. 2014;79(233):72063] The old classification system did not always consistently communicate differences in fetal risk and failed to take into account the risk of the untreated condition, resulting in a tendency to oversimplify risk assessment of drug safety in perinatal women. The new “Pregnancy and Lactation Labeling Rule” (PLLR) requires the elimination of the letter categories from labeling and may impact over 6 million women taking prescription medication during gestation.

The PLLR includes three subsections, Pregnancy, Lactation, and Females and Males of Reproductive Potential. The PLLR mandates that labeling include data on dosing and potential fetal risks. Although previously not required, manufacturers must now provide information about pregnancy exposure registries that collect and maintain data on pregnant women when available.

The lactation subsection includes information about the amount of drug in breast milk and potential effects on breastfed infants. A new subsection includes information about pregnancy testing, contraception, and infertility.

The PLLR does not affect over-the-counter medicines, and medications approved after 30 June 2001 will be phased in gradually. With the new format and additional data, health-care professionals are able to better inform and counsel patients requiring medication during pregnancy or while breastfeeding, while allowing greater numbers of women to participate in registries designed to collect data on a patient population that is often under-represented in research studies.

The opinions herein are those of the author and do not necessarily represent those of the Department of the Navy, the Department of Defense, or the United States government.

What’s in a name?

Since its early inception, the Home Care NetWork was created to share expertise at home. Initially, this was uncommon and largely in survivors of the polio epidemics. Today, home-based ventilation is given for a wide variety of diseases, including neuromuscular diseases, chronic lung diseases, central hypoventilation syndromes, spinal cord injuries, and many others. The number of individuals has been growing exponentially. Even over the last 10 to 20 years, this growth has continued both domestically and internationally. As just one example, the largest pediatric home ventilation program in Canada saw an increase from two children in 1991 to 156 in 2011 (Amin et al. Pediatr Pulmonol. 2014;49:816). At the same time, support is being increasingly provided with noninvasive ventilation, including up to 24-hour ventilator requirements, and new equipment and skills are being developed on a regular basis to facilitate this support.

There are also many challenges that accompany this growing population. One priority our steering committee has repeatedly heard is that patients with progressive neuromuscular diseases, especially in adulthood, are having difficulties finding clinicians to provide appropriate noninvasive ventilation. And even when they do and are well cared for, they risk receiving a tracheostomy when they are admitted to hospitals after admissions for acute decompensations, despite experience and literature suggesting this is often avoidable.

We have also come to realize that CHEST members seeking out resources in this area have not always known what the Home Care NetWork did. As such, to continue to provide and improve the support to the CHEST community, the Home Care NetWork has been renamed the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork.

Changes to our practice climate

Health-care providers continue to hear reports on the initiatives underway to change the cost curve and increase the value of health care. CMS continues its efforts with meaningful use, PQRS, and value-based payment modifiers. Eligible providers’ performance in 2015 is being assessed for payment adjustments to be phased in yearly from large groups in 2015 to all providers by 2017. Individual CMS beneficiaries are being assigned to physician groups using stepwise methodology and tax identification numbers of providers to track quality and cost performance.

For years, hospitals have been attuned to the needs to optimize quality and cost performance for populations of CMS patients. Physician groups similarly must now focus on process improvement to align with CMS goals for quality and cost for both inpatient and outpatient care. In doing so, payments to those provider groups from CMS will be adjusted upwards, be held neutral, or adjusted downwards based upon their success.

If you are interested in assisting your colleagues in preparing for changes to our practice climate like those outlined above, we welcome you to join the Practice Operations NetWork. For those interested, please contact [email protected], or simply drop in and visit us at CHEST 2015 during our NetWork Featured Lecture – Comparing the Canadian Healthcare Model to the US Model on Tuesday, October 27, in Montreal! We hope to see you there!

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/valuebasedpaymentmodifier.html

Lung transplantation and the quest for donor lungs

With improving survival rates and increasing recognition of quality-of-life benefits, more patients are being referred and listed for lung transplantation. However, each year, patients die while awaiting lung transplantation. Obtaining enough suitable donor lungs remains a challenge.

Potential donor lungs are declined for many reasons, one of which is concerns about quality. The best way to accurately assess and predict a deceased donor lung’s function remains unknown. Although more marginal donors are now considered and used based on the study by Ware and colleagues in 2002 (Lancet. 2002;360[9333]:619), further research is needed to better assess the lungs declined today.

Several strategies are being pursued to expand the availability of donor lungs. There has been expanding recognition that lungs from donors after cardiac death (DCD) can be used successfully. About 15% of US donors are now DCD donors (UNOS Data Trends 2014 from www.unos.org), and these are an important source of potential donor lungs.

Ex vivo lung perfusion (EVLP) techniques may help to further assess and potentially repair donor lungs that might have otherwise been considered marginal or declined. Although not yet approved for widespread use, lungs that may have been declined for concerns about quality may soon have a chance to be further evaluated on EVLP systems.

Ongoing research focusing on improved strategies for procuring lungs from DCD donors and for rehabilitating donor lungs on EVLP should lead to increased availability of donor lungs. Perhaps soon, every listed patient may be offered a chance for a successful lung transplant.

FDA pregnancy risk classification system removed

As of June 30, 2015, the US FDA removed the well known A, B, C, D, and X pregnancy risk classification system for prescription drugs and biological products [FDA HHS. Fed Regist. 2014;79(233):72063] The old classification system did not always consistently communicate differences in fetal risk and failed to take into account the risk of the untreated condition, resulting in a tendency to oversimplify risk assessment of drug safety in perinatal women. The new “Pregnancy and Lactation Labeling Rule” (PLLR) requires the elimination of the letter categories from labeling and may impact over 6 million women taking prescription medication during gestation.

The PLLR includes three subsections, Pregnancy, Lactation, and Females and Males of Reproductive Potential. The PLLR mandates that labeling include data on dosing and potential fetal risks. Although previously not required, manufacturers must now provide information about pregnancy exposure registries that collect and maintain data on pregnant women when available.

The lactation subsection includes information about the amount of drug in breast milk and potential effects on breastfed infants. A new subsection includes information about pregnancy testing, contraception, and infertility.

The PLLR does not affect over-the-counter medicines, and medications approved after 30 June 2001 will be phased in gradually. With the new format and additional data, health-care professionals are able to better inform and counsel patients requiring medication during pregnancy or while breastfeeding, while allowing greater numbers of women to participate in registries designed to collect data on a patient population that is often under-represented in research studies.

The opinions herein are those of the author and do not necessarily represent those of the Department of the Navy, the Department of Defense, or the United States government.

What’s in a name?

Since its early inception, the Home Care NetWork was created to share expertise at home. Initially, this was uncommon and largely in survivors of the polio epidemics. Today, home-based ventilation is given for a wide variety of diseases, including neuromuscular diseases, chronic lung diseases, central hypoventilation syndromes, spinal cord injuries, and many others. The number of individuals has been growing exponentially. Even over the last 10 to 20 years, this growth has continued both domestically and internationally. As just one example, the largest pediatric home ventilation program in Canada saw an increase from two children in 1991 to 156 in 2011 (Amin et al. Pediatr Pulmonol. 2014;49:816). At the same time, support is being increasingly provided with noninvasive ventilation, including up to 24-hour ventilator requirements, and new equipment and skills are being developed on a regular basis to facilitate this support.

There are also many challenges that accompany this growing population. One priority our steering committee has repeatedly heard is that patients with progressive neuromuscular diseases, especially in adulthood, are having difficulties finding clinicians to provide appropriate noninvasive ventilation. And even when they do and are well cared for, they risk receiving a tracheostomy when they are admitted to hospitals after admissions for acute decompensations, despite experience and literature suggesting this is often avoidable.

We have also come to realize that CHEST members seeking out resources in this area have not always known what the Home Care NetWork did. As such, to continue to provide and improve the support to the CHEST community, the Home Care NetWork has been renamed the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork.

Changes to our practice climate

Health-care providers continue to hear reports on the initiatives underway to change the cost curve and increase the value of health care. CMS continues its efforts with meaningful use, PQRS, and value-based payment modifiers. Eligible providers’ performance in 2015 is being assessed for payment adjustments to be phased in yearly from large groups in 2015 to all providers by 2017. Individual CMS beneficiaries are being assigned to physician groups using stepwise methodology and tax identification numbers of providers to track quality and cost performance.

For years, hospitals have been attuned to the needs to optimize quality and cost performance for populations of CMS patients. Physician groups similarly must now focus on process improvement to align with CMS goals for quality and cost for both inpatient and outpatient care. In doing so, payments to those provider groups from CMS will be adjusted upwards, be held neutral, or adjusted downwards based upon their success.

If you are interested in assisting your colleagues in preparing for changes to our practice climate like those outlined above, we welcome you to join the Practice Operations NetWork. For those interested, please contact [email protected], or simply drop in and visit us at CHEST 2015 during our NetWork Featured Lecture – Comparing the Canadian Healthcare Model to the US Model on Tuesday, October 27, in Montreal! We hope to see you there!

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/valuebasedpaymentmodifier.html

Lung transplantation and the quest for donor lungs

With improving survival rates and increasing recognition of quality-of-life benefits, more patients are being referred and listed for lung transplantation. However, each year, patients die while awaiting lung transplantation. Obtaining enough suitable donor lungs remains a challenge.

Potential donor lungs are declined for many reasons, one of which is concerns about quality. The best way to accurately assess and predict a deceased donor lung’s function remains unknown. Although more marginal donors are now considered and used based on the study by Ware and colleagues in 2002 (Lancet. 2002;360[9333]:619), further research is needed to better assess the lungs declined today.

Several strategies are being pursued to expand the availability of donor lungs. There has been expanding recognition that lungs from donors after cardiac death (DCD) can be used successfully. About 15% of US donors are now DCD donors (UNOS Data Trends 2014 from www.unos.org), and these are an important source of potential donor lungs.

Ex vivo lung perfusion (EVLP) techniques may help to further assess and potentially repair donor lungs that might have otherwise been considered marginal or declined. Although not yet approved for widespread use, lungs that may have been declined for concerns about quality may soon have a chance to be further evaluated on EVLP systems.

Ongoing research focusing on improved strategies for procuring lungs from DCD donors and for rehabilitating donor lungs on EVLP should lead to increased availability of donor lungs. Perhaps soon, every listed patient may be offered a chance for a successful lung transplant.

FDA pregnancy risk classification system removed

As of June 30, 2015, the US FDA removed the well known A, B, C, D, and X pregnancy risk classification system for prescription drugs and biological products [FDA HHS. Fed Regist. 2014;79(233):72063] The old classification system did not always consistently communicate differences in fetal risk and failed to take into account the risk of the untreated condition, resulting in a tendency to oversimplify risk assessment of drug safety in perinatal women. The new “Pregnancy and Lactation Labeling Rule” (PLLR) requires the elimination of the letter categories from labeling and may impact over 6 million women taking prescription medication during gestation.

The PLLR includes three subsections, Pregnancy, Lactation, and Females and Males of Reproductive Potential. The PLLR mandates that labeling include data on dosing and potential fetal risks. Although previously not required, manufacturers must now provide information about pregnancy exposure registries that collect and maintain data on pregnant women when available.

The lactation subsection includes information about the amount of drug in breast milk and potential effects on breastfed infants. A new subsection includes information about pregnancy testing, contraception, and infertility.

The PLLR does not affect over-the-counter medicines, and medications approved after 30 June 2001 will be phased in gradually. With the new format and additional data, health-care professionals are able to better inform and counsel patients requiring medication during pregnancy or while breastfeeding, while allowing greater numbers of women to participate in registries designed to collect data on a patient population that is often under-represented in research studies.

The opinions herein are those of the author and do not necessarily represent those of the Department of the Navy, the Department of Defense, or the United States government.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.

Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.

“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).

The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).

The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).

Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).

“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”

Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.

Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.

For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.

Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.

“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).

The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).

The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).

Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).

“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”

Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.

Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.

For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.

Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.

“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).

The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).

The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).

Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).

“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”

Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.

Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.

CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

[email protected]

CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

[email protected]

CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

[email protected]

CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

[email protected]

CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

[email protected]

CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

[email protected]

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.