Cardiothoracic Surgery

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).

Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.

The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.

Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV₁) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.

The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.

Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.

“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.

“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.

The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.

[email protected]

A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).

Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.

The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.

Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV₁) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.

The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.

Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.

“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.

“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.

The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.

[email protected]

A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).

Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.

The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.

Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV₁) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.

The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.

Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.

“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.

“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.

The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.

[email protected]

PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.

Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.

Mitchel L. Zoler/Frontline Medical News

Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.

Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.

Mitchel L. Zoler/Frontline Medical News

“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.

Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.

But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.

“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.

“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.

“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”

The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).

“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.

Mitchel L. Zoler/Frontline Medical News

More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.

“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.

Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).

Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.

Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.

Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.

Mitchel L. Zoler/Frontline Medical News

Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.

Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.

Mitchel L. Zoler/Frontline Medical News

“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.

Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.

But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.

“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.

“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.

“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”

The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).

“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.

Mitchel L. Zoler/Frontline Medical News

More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.

“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.

Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).

Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.

Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Cardiothoracic surgeons who implant left ventricular assist devices in patients with failing hearts remain at a loss to fully explain why they started seeing a sharp increase in thrombus clogging in these devices in 2012, but nevertheless they are gaining a better sense of how to minimize the risk.

Three key principles for minimizing thrombosis risk are selecting the right patients to receive left ventricular assist devices (LVAD), applying optimal management strategies once patients receive a LVAD, and maintaining adequate flow of blood through the pump, Dr. Francis D. Pagani said in a talk at a session devoted to pump thrombosis at the annual meeting of the Society of Thoracic Surgeons.

Mitchel L. Zoler/Frontline Medical News

Other critical aspects include optimal implantation technique, quick work-up of patients to rule out reversible LVAD inflow or outflow problems once pump thrombosis is suspected, and ceasing medical therapy of the thrombosis if it proves ineffective and instead progress to surgical pump exchange, pump explantation, or heart transplant when necessary, said Dr. Ahmet Kilic, a cardiothoracic surgeon at the Ohio State University, Columbus.

Another key issue is that, now that the pump thrombosis incidence is averaging about 10% of LVAD recipients, with an incidence rate during 2-year follow-up as high as 24% reported from one series, surgeons and physicians who care for LVAD patients must have a high index of suspicion and routinely screen LVAD recipients for early signs of pump thrombosis. The best way to catch pump thrombosis early seems to be by regularly measuring patients’ serum level of lactate dehydrogenase (LDH), said Dr. Robert L. Kormos, professor of surgery and director of the artificial heart program at the University of Pittsburgh.

Mitchel L. Zoler/Frontline Medical News

“We measure LDH on most clinic visits, whether or not the patient has an indication of pump thrombosis. We need to screen [LDH levels] much more routinely than we used to,” he said during the session. “Elevated LDH is probably the first and most reliable early sign, but you need to also assess LDH isoenzymes because we’ve had patients with an elevation but no sign of pump thrombosis, and their isoenzymes showed that the increased LDH was coming from their liver,” Dr. Kormos said in an interview.

Although serial measurements and isoenzyme analysis can establish a sharp rise in heart-specific LDH in an individual patient, a report at the meeting documented that in a series of 53 patients with pump thrombosis treated at either of two U.S. centers, an LDH level of at least 1,155 IU/L flagged pump thrombosis with a fairly high sensitivity and specificity. This LDH level is roughly five times the upper limit of normal, noted Dr. Pagani, professor of surgery and surgical director of adult heart transplantation at the University of Michigan, Ann Arbor, and a senior author on this report.

But prior to this report Dr. Kormos said that he regarded a LDH level of 600-800 IU/L as enough of an elevation above normal to prompt concern and investigation. And he criticized some LVAD programs that allow LDH levels to rise much higher.

“I know of clinicians who see a LDH of 1,500-2,000 IU/L but the patient seems okay and they wonder if they should change out the pump. For me, it’s a no brainer. Others try to list a patient like this for a heart transplant so they can avoid doing a pump exchange. I think that’s dangerous; it risks liver failure or renal failure. I would not sit on any LVAD that is starting to produce signs of hemolysis syndrome, but some places do this,” Dr. Kormos said in an interview.

“Pump thrombosis probably did not get addressed in as timely a fashion as it should have been” when it was first seen on the rise in 2012, noted Dr. James K. Kirklin, professor of surgery and director of cardiothoracic surgery at the University of Alabama, Birmingham. “It is now being addressed, and we realize that this is not just a pump problem but also involves patient factors and management factors that we need to learn more about. We are quite ignorant of the patient factors and understanding their contributions to bleeding and thrombosis,” said Dr. Kirklin. He also acknowledged that whatever role the current generation of LVAD pumps play in causing thrombosis will not quickly resolve.

“I’m looking forward to a new generation of pumps, but the pumps we have today will probably remain for another 3-5 years.”

The issue of LVAD pump thrombosis first came into clear focus with publication at the start of 2014 of a report that tracked its incidence from 2004 to mid-2013 at three U.S. centers that had placed a total of 895 LVADs in 837 patients. The annual rate of new episodes of pump thrombosis jumped from about 1%-2% of LVAD recipients throughout the first part of the study period through the end of 2011, to an annual rate of about 10% by mid 2013 (N Engl J Med. 2014 Jan 2;370[1]:33-40).

“The inflection occurred in about 2012,” noted Dr. Nicholas G. Smedira, a cardiothoracic surgeon at the Cleveland Clinic. “No one has figured out why” the incidence suddenly spiked starting in 2012 and intensified in 2013, he said. This epidemic of pump thrombosis has produced “devastating complications” that have led to multiple readmissions and reduced cost-effectiveness of LVADs and has affected how the heart transplant community allocates hearts, Dr. Smedira said during his talk at the session. He noted that once the surge in pump thrombosis started, the timing of the appearance of significant thrombus shifted earlier, often occurring within 2-3 months after LVAD placement. There now is “increasing device-related pessimism” and increasing demoralization among clinicians because of this recurring complication, he said.

Mitchel L. Zoler/Frontline Medical News

More recent data show the trend toward increasingly higher rates of pump thrombosis continuing through the end of 2013, with the situation during 2014 a bit less clear. Late last year, data from 9,808 U.S. patients who received an LVAD and entered the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed that the incidence of pump thrombosis during the first 6 months following an implant rose from 1% in 2008 to 2% in 2009 and in 2010, 4% in 2011, 7% in 2012, 8% in 2013, and then eased back to 5% in the first half of 2014 (J Heart Lung Transplant. 2015 Dec;34[12]:1515-26). The annual rate rose from 2% in 2008 to a peak of 11% in 2013, with 12-month data from 2014 not yet available at the time of this report.

“The modest reduction of observed pump thrombosis at 6 months during 2014 has occurred in a milieu of heightened intensity of anti-coagulation management, greater surgical awareness of optimal pump implantation and positioning and pump speed management. Thus, one may speculate that current thrombosis risk-mitigation strategies have contributed to reducing but not eliminating the increased thrombosis risk observed since 2011,” concluded the authors of the report.

Surgeons and cardiologists must now have a high index of suspicion for pump thrombosis in LVAD recipients, and be especially on the lookout for four key flags of a problem, said Dr. Kormos. The first is a rising LDH level, but additional flags include an isolated power elevation that doesn’t correlate with anything else, evidence of hemolysis, and new-onset heart failure symptoms. These can occur individually or in some combination. He recommended following a diagnostic algorithm first presented in 2013 that remains very valid today (J Heart Lung Transplant. 2013 July;32[7]:667-70).

Dr. Kormos also highlighted that the presentation of pump thrombosis can differ between the two LVADs most commonly used in U.S. practice, the HeartMate II and the HeartWare devices. A LDH elevation is primarily an indicator for HeartMate II, while both that model and the HeartWare device show sustained, isolated power elevations when thrombosis occurs.

Dr. Pagani, Dr. Kirklin, and Dr. Smedira had no disclosures. Dr. Kormos has received travel support from HeartWare. Dr. Kilic has been a consultant to Thoratec and a speaker on behalf of Baxter International.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.

“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”

Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.

Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.

Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).

All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.

To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.

Dr. Marulli reported having no financial disclosures.

[email protected]

PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.

“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”

Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.

Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.

Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).

All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.

To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.

Dr. Marulli reported having no financial disclosures.

[email protected]

PHOENIX – Cadaveric allograft sternal replacement has proven to be safe, providing optimal stability to the chest wall and protection of surrounding organs, an analysis of 18 cases demonstrated.

“The allograft was biologically well tolerated, allowing a perfect integration into the host,” Dr. Giuseppe Marulli said at the annual meeting of the Society of Thoracic Surgeons. “Donor cryopreserved sternochondral allograft may become the ideal way for anterior chest wall reconstruction, particularly for wide resections.”

Dr. Marulli, a thoracic surgeon at the University of Padova, Italy, noted that prior experimental studies have demonstrated that cryopreserved bone allografts preserve osteoconduction and osteoinduction capacity (Eur Spine J. 2001 Oct;10:S96-101). “Therefore, they form the basis for new bone tissue formation, allowing for the capillary and perivascular blood supply,” he said.

Limitations of current materials used for sternal reconstruction include “excessive rigidity with risk of erosion and insufficient support for large chest wall defects,” he said. Perceived advantages of using cadaveric bone allograft include easy incorporation, no risk of rejection, and a low risk of infection. For each procedure used in the current analysis, cadaveric allograft sternums with costal cartilages were harvested with an aseptic method and treated with an antibiotic solution for 72 hours. Next, they were cryopreserved at –80º C and underwent microbiologic testing for at least 1 month to ensure sterility and absence of immunogenic capacity.

Dr. Marulli reported results from 18 patients who underwent the procedure between January 2009 and January 2015, 13 of whom were female. Their median age was 59 years, their median tumor diameter was 4.75 cm, most (88%) had undergone preoperative needle biopsy, and 50% had undergone induction therapy. The main indication for sternectomy was a single-site sternal metastasis (nine patients), primary chondrosarcoma (four cases), sternal dehiscence after cardiac surgery (two cases), malignant fibrous tumor (one case), radioinduced soft-tissue sarcoma (one case), and a thymic carcinoma invading the sternum (one case).

All patients were extubated in the OR, and one patient died in the hospital from a pulmonary embolism. Two patients (11%) developed postoperative complications: one case of Candida urinary infection and one case of bleeding at the site of the muscle flap. The median postoperative length of stay was 11 days.

To date, no infections or rejections of the grafts have occurred, Dr. Marulli said. After a median of 36 months, 13 patients are alive and 4 are dead (3 from a metastatic recurrence and 1 from an unrelated cause). One patient required removal of a clavicular screw for dislocation 4 months after the operation.

Dr. Marulli reported having no financial disclosures.

[email protected]

SNOWMASS, COLO. – A clear message from the first-ever randomized trial of surgical mitral valve repair versus replacement for patients with severe ischemic mitral regurgitation is that replacement should be utilized more liberally, Dr. Michael J. Mack said at the Annual Cardiovascular Conference at Snowmass.

The results of prosthetic valve implantation proved far more durable than repair. At 2 years of follow-up in this 251-patient multicenter trial conducted by the Cardiothoracic Surgical Trials Network (CSTN), the incidence of recurrent moderate or severe mitral regurgitation was just 3.8% in the valve replacement group, compared with 58.8% with repair via restrictive annuloplasty. As a result, the repair group had significantly more heart failure–related adverse events and cardiovascular hospitalizations and a lower rate of clinically meaningful improvement in quality of life scores, noted Dr. Mack, an investigator in the trial and medical director of the Baylor Health Care System in Plano, Tex.

“I think surgical mitral valve replacement has had a bad name over the years, and one of the reasons is because of the worse left ventricular function afterwards. However, that was a casualty of excising the mitral valve and the subvalvular apparatus, causing atrial-ventricular disconnection. We’ve gotten smarter about this. The techniques we now use are valve sparing,” the cardiothoracic surgeon said.

He was quick to add, however, that the CSTN study results are by no means the death knell for restrictive mitral annuloplasty. Indeed, participants in the mitral valve repair group who didn’t develop recurrent regurgitation actually experienced significant positive reverse remodeling as reflected by improvement in their left ventricular end-systolic volume index, the primary endpoint of the study (N Engl J Med. 2016;374:344-35).

The key to successful outcomes in mitral valve repair is to save the procedure for patients who are unlikely to develop recurrent regurgitation. And a substudy of the CTSN trial led by Dr. Irving L. Kron, professor of surgery at the University of Virginia, Charlottesville, provides practical guidance on that score. The investigators conducted a logistic regression analysis of the mitral valve repair group’s baseline echocardiographic and clinical characteristics and identified a collection of strong predictors of recurrent regurgitation within 2 years (J Thorac Cardiovasc Surg. 2015 Mar;149[3]:752-61).

“The bottom line is, the more tethering you have of the mitral valve leaflets, the more likely you are to have recurrent mitral regurgitation after mitral valve annuloplasty,” Dr. Mack said.

The predictors of recurrent regurgitation included a coaptation depth greater than 10 mm, a posterior leaflet angle in excess of 45 degrees, a distal anterior leaflet angle greater than 25 degrees, inferior basal aneurysm, mitral annular calcification, and a left ventricular end diastolic diameter greater than 65 mm, as well as other indices of advanced left ventricular remodeling.

No or only mild annular dilation, as occurs, for example, in patients whose mitral regurgitation is caused by atrial fibrillation, is another independent predictor of recurrent regurgitation post repair.

“Shrinking the annulus isn’t going to make a difference if the annulus wasn’t dilated to begin with,” the surgeon observed. “If surgery is performed, we now know those patients who are most likely to recur – and they should have mitral valve replacement. If those factors are not present, then repair is still a viable option,” according to Dr. Mack.

That being said, it’s still not known whether correcting severe ischemic mitral regurgitation prolongs life or improves quality of life long term, compared with guideline-directed medical therapy, he stressed.

“Secondary mitral regurgitation is a disease of the left ventricle, not the mitral valve. So it’s possible that mitral regurgitation reduction has no benefit because the regurgitation is a surrogate marker not causally related to outcome. I don’t think so, but it is a possibility,” Dr. Mack conceded.

This is a clinically important unresolved question because secondary mitral regurgitation is extremely common. In a retrospective echocardiographic study of 558 heart failure patients with a left ventricular ejection fraction of 35% or less and class III-IV symptoms, 90% of them had some degree of mitral regurgitation (J Card Fail. 2004 Aug;10[4]:285-91).

Together with Columbia University cardiologist Dr. Gregg W. Stone, Dr. Mack is coprincipal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, which is expected to provide an answer to this key question. The multicenter U.S. study involves a planned 420 patients with severely symptomatic secondary mitral regurgitation who are deemed at prohibitive risk for surgery. They are to be randomized to guideline-directed medical therapy with or without transcatheter mitral valve repair using the MitraClip device. Enrollment should be completed by May, with initial results available in late 2017.

Dr. Mack reported receiving research grants from Abbott Vascular, which is sponsoring the COAPT trial, as well as from Edwards Lifesciences.

[email protected]

SNOWMASS, COLO. – A clear message from the first-ever randomized trial of surgical mitral valve repair versus replacement for patients with severe ischemic mitral regurgitation is that replacement should be utilized more liberally, Dr. Michael J. Mack said at the Annual Cardiovascular Conference at Snowmass.

The results of prosthetic valve implantation proved far more durable than repair. At 2 years of follow-up in this 251-patient multicenter trial conducted by the Cardiothoracic Surgical Trials Network (CSTN), the incidence of recurrent moderate or severe mitral regurgitation was just 3.8% in the valve replacement group, compared with 58.8% with repair via restrictive annuloplasty. As a result, the repair group had significantly more heart failure–related adverse events and cardiovascular hospitalizations and a lower rate of clinically meaningful improvement in quality of life scores, noted Dr. Mack, an investigator in the trial and medical director of the Baylor Health Care System in Plano, Tex.

“I think surgical mitral valve replacement has had a bad name over the years, and one of the reasons is because of the worse left ventricular function afterwards. However, that was a casualty of excising the mitral valve and the subvalvular apparatus, causing atrial-ventricular disconnection. We’ve gotten smarter about this. The techniques we now use are valve sparing,” the cardiothoracic surgeon said.

He was quick to add, however, that the CSTN study results are by no means the death knell for restrictive mitral annuloplasty. Indeed, participants in the mitral valve repair group who didn’t develop recurrent regurgitation actually experienced significant positive reverse remodeling as reflected by improvement in their left ventricular end-systolic volume index, the primary endpoint of the study (N Engl J Med. 2016;374:344-35).

The key to successful outcomes in mitral valve repair is to save the procedure for patients who are unlikely to develop recurrent regurgitation. And a substudy of the CTSN trial led by Dr. Irving L. Kron, professor of surgery at the University of Virginia, Charlottesville, provides practical guidance on that score. The investigators conducted a logistic regression analysis of the mitral valve repair group’s baseline echocardiographic and clinical characteristics and identified a collection of strong predictors of recurrent regurgitation within 2 years (J Thorac Cardiovasc Surg. 2015 Mar;149[3]:752-61).

“The bottom line is, the more tethering you have of the mitral valve leaflets, the more likely you are to have recurrent mitral regurgitation after mitral valve annuloplasty,” Dr. Mack said.

The predictors of recurrent regurgitation included a coaptation depth greater than 10 mm, a posterior leaflet angle in excess of 45 degrees, a distal anterior leaflet angle greater than 25 degrees, inferior basal aneurysm, mitral annular calcification, and a left ventricular end diastolic diameter greater than 65 mm, as well as other indices of advanced left ventricular remodeling.

No or only mild annular dilation, as occurs, for example, in patients whose mitral regurgitation is caused by atrial fibrillation, is another independent predictor of recurrent regurgitation post repair.

“Shrinking the annulus isn’t going to make a difference if the annulus wasn’t dilated to begin with,” the surgeon observed. “If surgery is performed, we now know those patients who are most likely to recur – and they should have mitral valve replacement. If those factors are not present, then repair is still a viable option,” according to Dr. Mack.

That being said, it’s still not known whether correcting severe ischemic mitral regurgitation prolongs life or improves quality of life long term, compared with guideline-directed medical therapy, he stressed.

“Secondary mitral regurgitation is a disease of the left ventricle, not the mitral valve. So it’s possible that mitral regurgitation reduction has no benefit because the regurgitation is a surrogate marker not causally related to outcome. I don’t think so, but it is a possibility,” Dr. Mack conceded.

This is a clinically important unresolved question because secondary mitral regurgitation is extremely common. In a retrospective echocardiographic study of 558 heart failure patients with a left ventricular ejection fraction of 35% or less and class III-IV symptoms, 90% of them had some degree of mitral regurgitation (J Card Fail. 2004 Aug;10[4]:285-91).

Together with Columbia University cardiologist Dr. Gregg W. Stone, Dr. Mack is coprincipal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, which is expected to provide an answer to this key question. The multicenter U.S. study involves a planned 420 patients with severely symptomatic secondary mitral regurgitation who are deemed at prohibitive risk for surgery. They are to be randomized to guideline-directed medical therapy with or without transcatheter mitral valve repair using the MitraClip device. Enrollment should be completed by May, with initial results available in late 2017.

Dr. Mack reported receiving research grants from Abbott Vascular, which is sponsoring the COAPT trial, as well as from Edwards Lifesciences.

[email protected]

SNOWMASS, COLO. – A clear message from the first-ever randomized trial of surgical mitral valve repair versus replacement for patients with severe ischemic mitral regurgitation is that replacement should be utilized more liberally, Dr. Michael J. Mack said at the Annual Cardiovascular Conference at Snowmass.

The results of prosthetic valve implantation proved far more durable than repair. At 2 years of follow-up in this 251-patient multicenter trial conducted by the Cardiothoracic Surgical Trials Network (CSTN), the incidence of recurrent moderate or severe mitral regurgitation was just 3.8% in the valve replacement group, compared with 58.8% with repair via restrictive annuloplasty. As a result, the repair group had significantly more heart failure–related adverse events and cardiovascular hospitalizations and a lower rate of clinically meaningful improvement in quality of life scores, noted Dr. Mack, an investigator in the trial and medical director of the Baylor Health Care System in Plano, Tex.

“I think surgical mitral valve replacement has had a bad name over the years, and one of the reasons is because of the worse left ventricular function afterwards. However, that was a casualty of excising the mitral valve and the subvalvular apparatus, causing atrial-ventricular disconnection. We’ve gotten smarter about this. The techniques we now use are valve sparing,” the cardiothoracic surgeon said.

He was quick to add, however, that the CSTN study results are by no means the death knell for restrictive mitral annuloplasty. Indeed, participants in the mitral valve repair group who didn’t develop recurrent regurgitation actually experienced significant positive reverse remodeling as reflected by improvement in their left ventricular end-systolic volume index, the primary endpoint of the study (N Engl J Med. 2016;374:344-35).

The key to successful outcomes in mitral valve repair is to save the procedure for patients who are unlikely to develop recurrent regurgitation. And a substudy of the CTSN trial led by Dr. Irving L. Kron, professor of surgery at the University of Virginia, Charlottesville, provides practical guidance on that score. The investigators conducted a logistic regression analysis of the mitral valve repair group’s baseline echocardiographic and clinical characteristics and identified a collection of strong predictors of recurrent regurgitation within 2 years (J Thorac Cardiovasc Surg. 2015 Mar;149[3]:752-61).

“The bottom line is, the more tethering you have of the mitral valve leaflets, the more likely you are to have recurrent mitral regurgitation after mitral valve annuloplasty,” Dr. Mack said.

The predictors of recurrent regurgitation included a coaptation depth greater than 10 mm, a posterior leaflet angle in excess of 45 degrees, a distal anterior leaflet angle greater than 25 degrees, inferior basal aneurysm, mitral annular calcification, and a left ventricular end diastolic diameter greater than 65 mm, as well as other indices of advanced left ventricular remodeling.

No or only mild annular dilation, as occurs, for example, in patients whose mitral regurgitation is caused by atrial fibrillation, is another independent predictor of recurrent regurgitation post repair.

“Shrinking the annulus isn’t going to make a difference if the annulus wasn’t dilated to begin with,” the surgeon observed. “If surgery is performed, we now know those patients who are most likely to recur – and they should have mitral valve replacement. If those factors are not present, then repair is still a viable option,” according to Dr. Mack.

That being said, it’s still not known whether correcting severe ischemic mitral regurgitation prolongs life or improves quality of life long term, compared with guideline-directed medical therapy, he stressed.

“Secondary mitral regurgitation is a disease of the left ventricle, not the mitral valve. So it’s possible that mitral regurgitation reduction has no benefit because the regurgitation is a surrogate marker not causally related to outcome. I don’t think so, but it is a possibility,” Dr. Mack conceded.

This is a clinically important unresolved question because secondary mitral regurgitation is extremely common. In a retrospective echocardiographic study of 558 heart failure patients with a left ventricular ejection fraction of 35% or less and class III-IV symptoms, 90% of them had some degree of mitral regurgitation (J Card Fail. 2004 Aug;10[4]:285-91).

Together with Columbia University cardiologist Dr. Gregg W. Stone, Dr. Mack is coprincipal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, which is expected to provide an answer to this key question. The multicenter U.S. study involves a planned 420 patients with severely symptomatic secondary mitral regurgitation who are deemed at prohibitive risk for surgery. They are to be randomized to guideline-directed medical therapy with or without transcatheter mitral valve repair using the MitraClip device. Enrollment should be completed by May, with initial results available in late 2017.

Dr. Mack reported receiving research grants from Abbott Vascular, which is sponsoring the COAPT trial, as well as from Edwards Lifesciences.

[email protected]

PHOENIX – Use of transcatheter aortic valve replacement continued to expand through the first half of 2015, but the procedure remained primarily targeted to patients at least 80 years old, according to data collected in a U.S. postmarketing registry.

When the Food and Drug Administration first approved a transcatheter aortic valve replacement (TAVR) system for routine U.S. use in late 2011, the patients who underwent TAVR “were either at very high risk or inoperable, and we’ve seen that move into high-risk patients – and I’m sure we’ll see more introduction of this into patients who are at medium risk,” said Dr. Frederick L. Grover in a video interview at the annual meeting of the Society of Thoracic Surgeons.

Despite this downward trend in risk level, the median and average ages of TAVR patients remain above 80 years.

In 2015, U.S. TAVR recipients had a median age of 83 years and a mean age of 81 years, virtually unchanged from the 84-year median and 82-year mean during routine U.S. practice in 2012, the first year for data collection by the STS and American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Dr. Grover reported the latest data from the registry at the meeting, through roughly the first half of 2015.

“There has been some movement downward” from 2012 to 2014 in the predicted 30-day mortality rate of patients as measured by their preprocedural STS risk score. The rate declined from an average predicted mortality rate of 7.05% in 2012 to an average of 6.69% among patients treated during 2014.

Despite this shift, TAVR patients remain highly vulnerable to surgical complications because of their advanced age and frailty, said Dr. Grover, a professor of cardiothoracic surgery at the University of Colorado in Aurora and vice chairman of the registry steering committee.

STS encourages surgeons and cardiologists who collaborate on the heart teams that judge patient suitability for TAVR to measure frailty with the 5-meter walk test, run sequentially three times. Patients who take an average of 6 seconds or more to complete the test are deemed frail and eligible for TAVR. Registry data show that during 2012-2014, 81% of TAVR patients met this frailty criterion.

Perhaps the most notable statistics in the registry are the snowballing numbers of procedures performed, which have come close to doubling each year.

In the first full year of commercial use, 2012, 4,601 patients underwent TAVR, which jumped to 9,128 patients in 2013, 16,314 patients in 2014, and 23,002 patients during just the first part of 2015, Dr. Grover reported.

Dr. Grover had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Use of transcatheter aortic valve replacement continued to expand through the first half of 2015, but the procedure remained primarily targeted to patients at least 80 years old, according to data collected in a U.S. postmarketing registry.

When the Food and Drug Administration first approved a transcatheter aortic valve replacement (TAVR) system for routine U.S. use in late 2011, the patients who underwent TAVR “were either at very high risk or inoperable, and we’ve seen that move into high-risk patients – and I’m sure we’ll see more introduction of this into patients who are at medium risk,” said Dr. Frederick L. Grover in a video interview at the annual meeting of the Society of Thoracic Surgeons.

Despite this downward trend in risk level, the median and average ages of TAVR patients remain above 80 years.

In 2015, U.S. TAVR recipients had a median age of 83 years and a mean age of 81 years, virtually unchanged from the 84-year median and 82-year mean during routine U.S. practice in 2012, the first year for data collection by the STS and American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Dr. Grover reported the latest data from the registry at the meeting, through roughly the first half of 2015.

“There has been some movement downward” from 2012 to 2014 in the predicted 30-day mortality rate of patients as measured by their preprocedural STS risk score. The rate declined from an average predicted mortality rate of 7.05% in 2012 to an average of 6.69% among patients treated during 2014.

Despite this shift, TAVR patients remain highly vulnerable to surgical complications because of their advanced age and frailty, said Dr. Grover, a professor of cardiothoracic surgery at the University of Colorado in Aurora and vice chairman of the registry steering committee.

STS encourages surgeons and cardiologists who collaborate on the heart teams that judge patient suitability for TAVR to measure frailty with the 5-meter walk test, run sequentially three times. Patients who take an average of 6 seconds or more to complete the test are deemed frail and eligible for TAVR. Registry data show that during 2012-2014, 81% of TAVR patients met this frailty criterion.

Perhaps the most notable statistics in the registry are the snowballing numbers of procedures performed, which have come close to doubling each year.

In the first full year of commercial use, 2012, 4,601 patients underwent TAVR, which jumped to 9,128 patients in 2013, 16,314 patients in 2014, and 23,002 patients during just the first part of 2015, Dr. Grover reported.

Dr. Grover had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Use of transcatheter aortic valve replacement continued to expand through the first half of 2015, but the procedure remained primarily targeted to patients at least 80 years old, according to data collected in a U.S. postmarketing registry.

When the Food and Drug Administration first approved a transcatheter aortic valve replacement (TAVR) system for routine U.S. use in late 2011, the patients who underwent TAVR “were either at very high risk or inoperable, and we’ve seen that move into high-risk patients – and I’m sure we’ll see more introduction of this into patients who are at medium risk,” said Dr. Frederick L. Grover in a video interview at the annual meeting of the Society of Thoracic Surgeons.

Despite this downward trend in risk level, the median and average ages of TAVR patients remain above 80 years.

In 2015, U.S. TAVR recipients had a median age of 83 years and a mean age of 81 years, virtually unchanged from the 84-year median and 82-year mean during routine U.S. practice in 2012, the first year for data collection by the STS and American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Dr. Grover reported the latest data from the registry at the meeting, through roughly the first half of 2015.

“There has been some movement downward” from 2012 to 2014 in the predicted 30-day mortality rate of patients as measured by their preprocedural STS risk score. The rate declined from an average predicted mortality rate of 7.05% in 2012 to an average of 6.69% among patients treated during 2014.

Despite this shift, TAVR patients remain highly vulnerable to surgical complications because of their advanced age and frailty, said Dr. Grover, a professor of cardiothoracic surgery at the University of Colorado in Aurora and vice chairman of the registry steering committee.

STS encourages surgeons and cardiologists who collaborate on the heart teams that judge patient suitability for TAVR to measure frailty with the 5-meter walk test, run sequentially three times. Patients who take an average of 6 seconds or more to complete the test are deemed frail and eligible for TAVR. Registry data show that during 2012-2014, 81% of TAVR patients met this frailty criterion.

Perhaps the most notable statistics in the registry are the snowballing numbers of procedures performed, which have come close to doubling each year.

In the first full year of commercial use, 2012, 4,601 patients underwent TAVR, which jumped to 9,128 patients in 2013, 16,314 patients in 2014, and 23,002 patients during just the first part of 2015, Dr. Grover reported.

Dr. Grover had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Patients who are stable following a myocardial infarction and need isolated coronary artery bypass surgery (CABG) don’t need to wait 5 or so days for their surgery, a delay that many surgeons and cardiologists often impose.

The operation can safely occur after just a 1- or 2-day gap following either an ST-elevation MI or a non–ST-elevation MI, based on real-world outcomes seen in more than 3,000 patients treated at any of seven U.S. medical centers.

“Waiting an arbitrary 5 days is not important,” Elizabeth L. Nichols said during a video interview and during her report at the annual meeting of the Society of Thoracic Surgeons.

Ms. Nichols and her associates analyzed the in-hospital mortality rates among 3,060 patients who underwent isolated CABG during 2008-2014 at any of the seven medical centers that participate in the Northern New England Cardiovascular Disease Study Group and offer CABG. They included patients who had their surgery within 21 days of their MI, and excluded patients who had their CABG within 6 hours of their MI, had emergency surgery, or those with shock or incomplete data. The study group included 529 patients who had a ST-elevation MI and 2,531 patients with a non-ST-elevation MI.

The analysis divided patients into four groups based on timing of their CABG: 99 patients (3%) had surgery within the first 24 hours, 369 patients (12%) had their surgery 1-2 days after their MI, 1,966 (64%) had their operation 3-7 days following their MI, and 626 (21%) had their surgery 8-21 days after the MI.

The unadjusted mortality rates for these four subgroups were 5.1%, 1.6%, 1.6%, and 2.7%, respectively, reported Ms. Nichols, a health services researcher at the Dartmouth Institute for Health Policy & Clinical Practice, Lebanon, N.H.

After researchers adjusted for several demographic and clinical variables, the mortality rates remained identical for patients who underwent CABG 1 or 2 days following their MI, compared with patients whose surgery was deferred until 3-7 days after the MI. Patients with surgery 8-21 days following the MI had a small but not statistically significant higher rate of in-hospital death.

Patients who had their surgery 7-23 hours following an MI had a statistically significant increased hospital mortality following surgery that ran more than threefold greater than patients who underwent CABG 3-7 days after their MI.

The main message from the analysis is that for the typical, stable MI patient who requires CABG to treat multivessel coronary disease, no need exists to wait several days following an MI to do the surgery, Ms. Nichols explained. A delay of just 1 or 2 days is safe and sufficient, as long as it provides adequate time for any acutely administered antiplatelet or antithrombotic drugs to clear.

The findings “provide a degree of comfort for not waiting the 3-5 days that had previously been thought necessary,” said Dr. Jock N. McCullough, chief of cardiac surgery at Dartmouth-Hitchcock Medical Center in Lebanon and a collaborator on the study.

The findings are not meant to supersede clinical judgment, both Dr. McCullough and Ms. Nichols emphasized. Individual patients might have good reasons to either undergo faster surgery or to wait at least 8 days following their MI.

“The patients who waited 8-21 days had a lot of comorbidities and were sicker patients, and their delay is often warranted” to make sure the patient is stable enough for surgery, Ms. Nichols explained. Other patients might be worsening following their MI and need to undergo their surgery within 24 hours of their MI.

“Clinical judgment is always the trump card,” Ms. Nichols said.

Ms. Nichols and Dr. McCullough had no disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Patients who are stable following a myocardial infarction and need isolated coronary artery bypass surgery (CABG) don’t need to wait 5 or so days for their surgery, a delay that many surgeons and cardiologists often impose.

The operation can safely occur after just a 1- or 2-day gap following either an ST-elevation MI or a non–ST-elevation MI, based on real-world outcomes seen in more than 3,000 patients treated at any of seven U.S. medical centers.

“Waiting an arbitrary 5 days is not important,” Elizabeth L. Nichols said during a video interview and during her report at the annual meeting of the Society of Thoracic Surgeons.

Ms. Nichols and her associates analyzed the in-hospital mortality rates among 3,060 patients who underwent isolated CABG during 2008-2014 at any of the seven medical centers that participate in the Northern New England Cardiovascular Disease Study Group and offer CABG. They included patients who had their surgery within 21 days of their MI, and excluded patients who had their CABG within 6 hours of their MI, had emergency surgery, or those with shock or incomplete data. The study group included 529 patients who had a ST-elevation MI and 2,531 patients with a non-ST-elevation MI.

The analysis divided patients into four groups based on timing of their CABG: 99 patients (3%) had surgery within the first 24 hours, 369 patients (12%) had their surgery 1-2 days after their MI, 1,966 (64%) had their operation 3-7 days following their MI, and 626 (21%) had their surgery 8-21 days after the MI.

The unadjusted mortality rates for these four subgroups were 5.1%, 1.6%, 1.6%, and 2.7%, respectively, reported Ms. Nichols, a health services researcher at the Dartmouth Institute for Health Policy & Clinical Practice, Lebanon, N.H.

After researchers adjusted for several demographic and clinical variables, the mortality rates remained identical for patients who underwent CABG 1 or 2 days following their MI, compared with patients whose surgery was deferred until 3-7 days after the MI. Patients with surgery 8-21 days following the MI had a small but not statistically significant higher rate of in-hospital death.

Patients who had their surgery 7-23 hours following an MI had a statistically significant increased hospital mortality following surgery that ran more than threefold greater than patients who underwent CABG 3-7 days after their MI.

The main message from the analysis is that for the typical, stable MI patient who requires CABG to treat multivessel coronary disease, no need exists to wait several days following an MI to do the surgery, Ms. Nichols explained. A delay of just 1 or 2 days is safe and sufficient, as long as it provides adequate time for any acutely administered antiplatelet or antithrombotic drugs to clear.

The findings “provide a degree of comfort for not waiting the 3-5 days that had previously been thought necessary,” said Dr. Jock N. McCullough, chief of cardiac surgery at Dartmouth-Hitchcock Medical Center in Lebanon and a collaborator on the study.

The findings are not meant to supersede clinical judgment, both Dr. McCullough and Ms. Nichols emphasized. Individual patients might have good reasons to either undergo faster surgery or to wait at least 8 days following their MI.

“The patients who waited 8-21 days had a lot of comorbidities and were sicker patients, and their delay is often warranted” to make sure the patient is stable enough for surgery, Ms. Nichols explained. Other patients might be worsening following their MI and need to undergo their surgery within 24 hours of their MI.

“Clinical judgment is always the trump card,” Ms. Nichols said.

Ms. Nichols and Dr. McCullough had no disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – Patients who are stable following a myocardial infarction and need isolated coronary artery bypass surgery (CABG) don’t need to wait 5 or so days for their surgery, a delay that many surgeons and cardiologists often impose.

The operation can safely occur after just a 1- or 2-day gap following either an ST-elevation MI or a non–ST-elevation MI, based on real-world outcomes seen in more than 3,000 patients treated at any of seven U.S. medical centers.

“Waiting an arbitrary 5 days is not important,” Elizabeth L. Nichols said during a video interview and during her report at the annual meeting of the Society of Thoracic Surgeons.

Ms. Nichols and her associates analyzed the in-hospital mortality rates among 3,060 patients who underwent isolated CABG during 2008-2014 at any of the seven medical centers that participate in the Northern New England Cardiovascular Disease Study Group and offer CABG. They included patients who had their surgery within 21 days of their MI, and excluded patients who had their CABG within 6 hours of their MI, had emergency surgery, or those with shock or incomplete data. The study group included 529 patients who had a ST-elevation MI and 2,531 patients with a non-ST-elevation MI.

The analysis divided patients into four groups based on timing of their CABG: 99 patients (3%) had surgery within the first 24 hours, 369 patients (12%) had their surgery 1-2 days after their MI, 1,966 (64%) had their operation 3-7 days following their MI, and 626 (21%) had their surgery 8-21 days after the MI.

The unadjusted mortality rates for these four subgroups were 5.1%, 1.6%, 1.6%, and 2.7%, respectively, reported Ms. Nichols, a health services researcher at the Dartmouth Institute for Health Policy & Clinical Practice, Lebanon, N.H.

After researchers adjusted for several demographic and clinical variables, the mortality rates remained identical for patients who underwent CABG 1 or 2 days following their MI, compared with patients whose surgery was deferred until 3-7 days after the MI. Patients with surgery 8-21 days following the MI had a small but not statistically significant higher rate of in-hospital death.

Patients who had their surgery 7-23 hours following an MI had a statistically significant increased hospital mortality following surgery that ran more than threefold greater than patients who underwent CABG 3-7 days after their MI.

The main message from the analysis is that for the typical, stable MI patient who requires CABG to treat multivessel coronary disease, no need exists to wait several days following an MI to do the surgery, Ms. Nichols explained. A delay of just 1 or 2 days is safe and sufficient, as long as it provides adequate time for any acutely administered antiplatelet or antithrombotic drugs to clear.

The findings “provide a degree of comfort for not waiting the 3-5 days that had previously been thought necessary,” said Dr. Jock N. McCullough, chief of cardiac surgery at Dartmouth-Hitchcock Medical Center in Lebanon and a collaborator on the study.

The findings are not meant to supersede clinical judgment, both Dr. McCullough and Ms. Nichols emphasized. Individual patients might have good reasons to either undergo faster surgery or to wait at least 8 days following their MI.

“The patients who waited 8-21 days had a lot of comorbidities and were sicker patients, and their delay is often warranted” to make sure the patient is stable enough for surgery, Ms. Nichols explained. Other patients might be worsening following their MI and need to undergo their surgery within 24 hours of their MI.

“Clinical judgment is always the trump card,” Ms. Nichols said.

Ms. Nichols and Dr. McCullough had no disclosures.

[email protected]

On Twitter @mitchelzoler

PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.

“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”

Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.

Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).

At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.

“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”

Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.

[email protected]

PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.

“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”

Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.

Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).

At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.

“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”

Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.

[email protected]

PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.

“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”

Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.

Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).

At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.

“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”

Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.

[email protected]

PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.

“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”

Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.

According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m²); 33.5% were normal weight (18.5-24.9 kg/m²); 35.4% were overweight (25-29.9 kg/m²); 18.1% were obese I (30-34.9 kg/m²); 6.4% were obese II (35-39.9 kg/m²), and 3.6% were obese III (40 kg/m² or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.

Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”

He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”

Dr. Williams reported having no financial disclosures.

[email protected]

PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.

“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”

Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.

According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m²); 33.5% were normal weight (18.5-24.9 kg/m²); 35.4% were overweight (25-29.9 kg/m²); 18.1% were obese I (30-34.9 kg/m²); 6.4% were obese II (35-39.9 kg/m²), and 3.6% were obese III (40 kg/m² or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.

Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”

He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”

Dr. Williams reported having no financial disclosures.

[email protected]

PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.

“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”

Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.

According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m²); 33.5% were normal weight (18.5-24.9 kg/m²); 35.4% were overweight (25-29.9 kg/m²); 18.1% were obese I (30-34.9 kg/m²); 6.4% were obese II (35-39.9 kg/m²), and 3.6% were obese III (40 kg/m² or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.

Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”

He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”

Dr. Williams reported having no financial disclosures.

[email protected]

PHOENIX – Each year more than 250,000 patients present with ground-glass opacities and other solitary pulmonary nodules, and they are difficult to locate.

“There’s been a need for our field to develop new technologies to find these nodules in the OR,” Dr. Sunil Singhal said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “The fallback plan has always been that we can make a thoracotomy. Some studies have shown that in about one out of every two cases you end up opening a patient just to find a tiny little nodule.”

Dr. Singhal of the division of cardiothoracic surgery at the University of Pennsylvania School of Medicine, Philadelphia, discussed preoperative and intraoperative localization methods, including an investigational technology in which patients receive an intravascular dye that localizes the pulmonary tumor. “When we put our video-assisted thoracoscopic surgery camera in, the tumors are glowing,” he said. “We can then do a localized wedge excision and confirm margins of the staple line. We’ve done this [in] about 80 patients, and it’s been non-toxic, very safe, and very effective. Our biggest limitation has been our depth of penetration.”

Dr. Singhal reported having no financial disclosures.

[email protected]

PHOENIX – Each year more than 250,000 patients present with ground-glass opacities and other solitary pulmonary nodules, and they are difficult to locate.

“There’s been a need for our field to develop new technologies to find these nodules in the OR,” Dr. Sunil Singhal said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “The fallback plan has always been that we can make a thoracotomy. Some studies have shown that in about one out of every two cases you end up opening a patient just to find a tiny little nodule.”

Dr. Singhal of the division of cardiothoracic surgery at the University of Pennsylvania School of Medicine, Philadelphia, discussed preoperative and intraoperative localization methods, including an investigational technology in which patients receive an intravascular dye that localizes the pulmonary tumor. “When we put our video-assisted thoracoscopic surgery camera in, the tumors are glowing,” he said. “We can then do a localized wedge excision and confirm margins of the staple line. We’ve done this [in] about 80 patients, and it’s been non-toxic, very safe, and very effective. Our biggest limitation has been our depth of penetration.”

Dr. Singhal reported having no financial disclosures.

[email protected]

PHOENIX – Each year more than 250,000 patients present with ground-glass opacities and other solitary pulmonary nodules, and they are difficult to locate.

“There’s been a need for our field to develop new technologies to find these nodules in the OR,” Dr. Sunil Singhal said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “The fallback plan has always been that we can make a thoracotomy. Some studies have shown that in about one out of every two cases you end up opening a patient just to find a tiny little nodule.”

Dr. Singhal of the division of cardiothoracic surgery at the University of Pennsylvania School of Medicine, Philadelphia, discussed preoperative and intraoperative localization methods, including an investigational technology in which patients receive an intravascular dye that localizes the pulmonary tumor. “When we put our video-assisted thoracoscopic surgery camera in, the tumors are glowing,” he said. “We can then do a localized wedge excision and confirm margins of the staple line. We’ve done this [in] about 80 patients, and it’s been non-toxic, very safe, and very effective. Our biggest limitation has been our depth of penetration.”

Dr. Singhal reported having no financial disclosures.

[email protected]