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Prediction: LVADs will rule end-stage heart failure
SNOWMASS, COLO. – Multifaceted progress in mechanical circulatory support as long-term therapy in end-stage heart failure is happening at a brisk pace, Y. Joseph C. Woo, MD, reported at the Annual Cardiovascular Conference at Snowmass.
declared Dr. Woo, professor and chair of the department of cardiothoracic surgery at Stanford (Calif.) University.
That’s quite a prediction, especially considering the source: Stanford is where the late Dr. Norman Shumway – widely considered “the father of heart transplantation” – performed the first adult heart transplant in the United States in 1968.
Dr. Woo was coauthor of an American Heart Association policy statement on the future of cardiovascular disease in the United States, which forecast a 25% increase in heart failure between 2010 and 2030 (Circulation. 2011 Mar 1;123[8]:933-44). There is simply no way that heart transplantation can begin to meet the projected growing need for effective therapy in patients with end-stage disease.
Here’s what Dr. Woo sees as the future of MCS:
Minimally invasive implantation
At Stanford, LVAD implantations are now routinely done off-pump on a beating heart.
“We clamp only when there is a sound reason, like the presence of left ventricular thrombus, where you run the risk of embolization without the cross clamp,” the surgeon said.
Concomitant valvular surgery
At Stanford and other centers of excellence, surgeons perform additional procedures as warranted while they implant an LVAD, including atrial fibrillation ablation, revascularization of the right heart coronaries, patent foramen ovale closure, and repair of the tricuspid, pulmonic, or aortic valves.
Enhanced right ventricular management
Survival is greatly impaired if a patient with an LVAD later requires the addition of a right ventricular assist device. This realization has led to the development of multiple preoperative risk scoring systems by the Stanford group (Ann Thorac Surg. 2013 Sep;96[3]:857-63) and others, including investigators at the Deutsche Herzzentrum Berlin, the world’s busiest heart transplant center. The purpose is to identify upfront those patients who are likely to later develop right heart failure so they can receive biventricular MCS from the start.
Adjunctive biologic therapies
Intramyocardial injection of 25 million allogeneic mesenchymal precursor cells during LVAD implantation appeared to be safe and showed a promising efficacy signal in a 30-patient, multicenter, double-blind, placebo-controlled, National Institutes of Health–sponsored proof of concept study in which Dr. Woo was a coinvestigator (Circulation. 2014 Jun 3;129[22]:2287-96).
The goal of this research effort is to provide a cell therapy assist to the LVAD as a bridge to recovery of left ventricular function such that the device might eventually no longer be needed, he explained.
These cells are immune privileged. They can be transplanted into recipients without need for immunosuppressive therapy or HLA matching, basically as an off the shelf product. Rather than transforming into cardiomyocytes, it appears that the mechanism by which the donor cells enhance cardiac performance in heart failure is via secretion of a shower of growth and angiogenic factors.
Based upon the encouraging results of the initial study, a 90-patient, phase II, double-blind clinical trial is underway. In order to better evaluate efficacy, this time the patients will receive 150 million mesenchymal precursor cells rather than 25 million.
New technologies
The developmental pipeline is chock full of MCS devices. The trend is to go smaller and simpler. HeartWare is developing a miniaturized version of its approved continuous flow centrifugal force LVAD. The ReliantHeart aVAD, an intraventricular device less than 2.5 cm in diameter, is approved in Europe and under study in the U.S. The Thoratec HeartMate III is a smaller version of the HeartMate II, which is FDA-approved as destination therapy. And the Circulite Synergy micropump, designed to provide partial circulatory support to patients who don’t require a full-force LVAD, is the size of a AA battery.
Dr. Woo reported having no financial conflicts.
[email protected]
SNOWMASS, COLO. – Multifaceted progress in mechanical circulatory support as long-term therapy in end-stage heart failure is happening at a brisk pace, Y. Joseph C. Woo, MD, reported at the Annual Cardiovascular Conference at Snowmass.
declared Dr. Woo, professor and chair of the department of cardiothoracic surgery at Stanford (Calif.) University.
That’s quite a prediction, especially considering the source: Stanford is where the late Dr. Norman Shumway – widely considered “the father of heart transplantation” – performed the first adult heart transplant in the United States in 1968.
Dr. Woo was coauthor of an American Heart Association policy statement on the future of cardiovascular disease in the United States, which forecast a 25% increase in heart failure between 2010 and 2030 (Circulation. 2011 Mar 1;123[8]:933-44). There is simply no way that heart transplantation can begin to meet the projected growing need for effective therapy in patients with end-stage disease.
Here’s what Dr. Woo sees as the future of MCS:
Minimally invasive implantation
At Stanford, LVAD implantations are now routinely done off-pump on a beating heart.
“We clamp only when there is a sound reason, like the presence of left ventricular thrombus, where you run the risk of embolization without the cross clamp,” the surgeon said.
Concomitant valvular surgery
At Stanford and other centers of excellence, surgeons perform additional procedures as warranted while they implant an LVAD, including atrial fibrillation ablation, revascularization of the right heart coronaries, patent foramen ovale closure, and repair of the tricuspid, pulmonic, or aortic valves.
Enhanced right ventricular management
Survival is greatly impaired if a patient with an LVAD later requires the addition of a right ventricular assist device. This realization has led to the development of multiple preoperative risk scoring systems by the Stanford group (Ann Thorac Surg. 2013 Sep;96[3]:857-63) and others, including investigators at the Deutsche Herzzentrum Berlin, the world’s busiest heart transplant center. The purpose is to identify upfront those patients who are likely to later develop right heart failure so they can receive biventricular MCS from the start.
Adjunctive biologic therapies
Intramyocardial injection of 25 million allogeneic mesenchymal precursor cells during LVAD implantation appeared to be safe and showed a promising efficacy signal in a 30-patient, multicenter, double-blind, placebo-controlled, National Institutes of Health–sponsored proof of concept study in which Dr. Woo was a coinvestigator (Circulation. 2014 Jun 3;129[22]:2287-96).
The goal of this research effort is to provide a cell therapy assist to the LVAD as a bridge to recovery of left ventricular function such that the device might eventually no longer be needed, he explained.
These cells are immune privileged. They can be transplanted into recipients without need for immunosuppressive therapy or HLA matching, basically as an off the shelf product. Rather than transforming into cardiomyocytes, it appears that the mechanism by which the donor cells enhance cardiac performance in heart failure is via secretion of a shower of growth and angiogenic factors.
Based upon the encouraging results of the initial study, a 90-patient, phase II, double-blind clinical trial is underway. In order to better evaluate efficacy, this time the patients will receive 150 million mesenchymal precursor cells rather than 25 million.
New technologies
The developmental pipeline is chock full of MCS devices. The trend is to go smaller and simpler. HeartWare is developing a miniaturized version of its approved continuous flow centrifugal force LVAD. The ReliantHeart aVAD, an intraventricular device less than 2.5 cm in diameter, is approved in Europe and under study in the U.S. The Thoratec HeartMate III is a smaller version of the HeartMate II, which is FDA-approved as destination therapy. And the Circulite Synergy micropump, designed to provide partial circulatory support to patients who don’t require a full-force LVAD, is the size of a AA battery.
Dr. Woo reported having no financial conflicts.
[email protected]
SNOWMASS, COLO. – Multifaceted progress in mechanical circulatory support as long-term therapy in end-stage heart failure is happening at a brisk pace, Y. Joseph C. Woo, MD, reported at the Annual Cardiovascular Conference at Snowmass.
declared Dr. Woo, professor and chair of the department of cardiothoracic surgery at Stanford (Calif.) University.
That’s quite a prediction, especially considering the source: Stanford is where the late Dr. Norman Shumway – widely considered “the father of heart transplantation” – performed the first adult heart transplant in the United States in 1968.
Dr. Woo was coauthor of an American Heart Association policy statement on the future of cardiovascular disease in the United States, which forecast a 25% increase in heart failure between 2010 and 2030 (Circulation. 2011 Mar 1;123[8]:933-44). There is simply no way that heart transplantation can begin to meet the projected growing need for effective therapy in patients with end-stage disease.
Here’s what Dr. Woo sees as the future of MCS:
Minimally invasive implantation
At Stanford, LVAD implantations are now routinely done off-pump on a beating heart.
“We clamp only when there is a sound reason, like the presence of left ventricular thrombus, where you run the risk of embolization without the cross clamp,” the surgeon said.
Concomitant valvular surgery
At Stanford and other centers of excellence, surgeons perform additional procedures as warranted while they implant an LVAD, including atrial fibrillation ablation, revascularization of the right heart coronaries, patent foramen ovale closure, and repair of the tricuspid, pulmonic, or aortic valves.
Enhanced right ventricular management
Survival is greatly impaired if a patient with an LVAD later requires the addition of a right ventricular assist device. This realization has led to the development of multiple preoperative risk scoring systems by the Stanford group (Ann Thorac Surg. 2013 Sep;96[3]:857-63) and others, including investigators at the Deutsche Herzzentrum Berlin, the world’s busiest heart transplant center. The purpose is to identify upfront those patients who are likely to later develop right heart failure so they can receive biventricular MCS from the start.
Adjunctive biologic therapies
Intramyocardial injection of 25 million allogeneic mesenchymal precursor cells during LVAD implantation appeared to be safe and showed a promising efficacy signal in a 30-patient, multicenter, double-blind, placebo-controlled, National Institutes of Health–sponsored proof of concept study in which Dr. Woo was a coinvestigator (Circulation. 2014 Jun 3;129[22]:2287-96).
The goal of this research effort is to provide a cell therapy assist to the LVAD as a bridge to recovery of left ventricular function such that the device might eventually no longer be needed, he explained.
These cells are immune privileged. They can be transplanted into recipients without need for immunosuppressive therapy or HLA matching, basically as an off the shelf product. Rather than transforming into cardiomyocytes, it appears that the mechanism by which the donor cells enhance cardiac performance in heart failure is via secretion of a shower of growth and angiogenic factors.
Based upon the encouraging results of the initial study, a 90-patient, phase II, double-blind clinical trial is underway. In order to better evaluate efficacy, this time the patients will receive 150 million mesenchymal precursor cells rather than 25 million.
New technologies
The developmental pipeline is chock full of MCS devices. The trend is to go smaller and simpler. HeartWare is developing a miniaturized version of its approved continuous flow centrifugal force LVAD. The ReliantHeart aVAD, an intraventricular device less than 2.5 cm in diameter, is approved in Europe and under study in the U.S. The Thoratec HeartMate III is a smaller version of the HeartMate II, which is FDA-approved as destination therapy. And the Circulite Synergy micropump, designed to provide partial circulatory support to patients who don’t require a full-force LVAD, is the size of a AA battery.
Dr. Woo reported having no financial conflicts.
[email protected]
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Robotic PCI success rates higher with radial access
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
AT CRT 2017
Key clinical point: Registry data shows higher success rate for radial versus femoral access in robotic percutaneous coronary interventions.
Major finding: In robotic PCI, the clinical success rate was 99.4% with radial access and 94.7% (P = .002) with femoral access.
Data source: A nonrandomized, retrospective analysis.
Disclosures: Dr. Pourdjabbar reported no financial relationships to disclose.
Aortic repair in Loeys-Dietz syndrome requires close follow-up
The knowledge about Loeys-Dietz syndrome has evolved quickly since Hal Dietz, MD, and Bart Loeys, MD, at Johns Hopkins University, Baltimore, first reported on it in 2005. Now, another team of Johns Hopkins investigators have reported that an aggressive approach with aortic root replacement coupled with valve-sparing whenever possible produces favorable results, but that clinicians must follow these patients closely with cardiovascular imaging.
“Growing experience with Loeys-Dietz syndrome has confirmed early impressions of its aggressive nature and proclivity toward aortic catastrophe,” Nishant D. Patel, MD, and his coauthors said in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:406-12). They reported on results of all 79 patients with Loeys-Dietz syndrome (LDS) who had cardiovascular surgery at Johns Hopkins. There were two (3%) deaths during surgery and eight (10%) late deaths.
Patients with LDS are at risk for dissection early when the aortic root reaches 4 cm. Despite what they termed “favorable” outcomes of surgery, Dr. Patel and his coauthors acknowledged that reintervention rates for this population are high – 19 patients (24%) had subsequent operations. That suggests cardiac surgeons must closely monitor these patients. “Meticulous follow-up with cardiovascular surveillance imaging remains important for management, particularly as clinical LDS subtypes are characterized and more tailored treatment is developed,” Dr. Patel and his coauthors reported.
They advise echocardiography every 3 to 6 months for the first year after surgery and then every 6 to 12 months afterward. Full-body imaging should occur at least every 2 years.
“In particular, patients with type B dissections should be monitored aggressively for aneurysm growth,” Dr. Patel and his coauthors said. They recommend imaging at seven to 14 days after dissection, then repeat imaging at 1, 3, 6, and 12 months, and then yearly thereafter.
They noted that four LDS subtypes have been identified. Although those with LDS1 and 2 subtypes are prone to aortic rupture at an earlier age and at smaller aortic diameters than other connective tissue disorders, the medical and surgical management for all subtypes are similar, Dr. Patel and his coauthors indicated.
“Certain congenital heart defects are more common among patients with LDS, compared with the normal population, including patent ductus arteriosus and mitral valve prolapse/insufficiency,” they said. Genotype is one factor that determines the need for surgery in LDS patients, Dr. Patel and his coauthors said. Others are growth rate, aortic valve function, family history, and severity of noncardiac phenotype.
The 79 patients in the study were divided almost evenly between gender, and the average age at first operation was 24.9 years; 38 were children younger than 18 years and 20 had a previous sternotomy.
Aortic root replacement represented the predominant operation in the group, accounting for 65 operations (82.3%), of which 52 (80%) were valve-sparing procedures and the remainder were composite valve-graft procedures. The other procedures the researchers performed were nine aortic arch replacements (11.4%), three open thoracoabdominal repairs (3.8%) and two ascending aorta replacements (2.5%).
“Valve-sparing root replacement has become a safe and reliable option for appropriately selected younger patients with LDS,” Dr. Patel and his coauthors wrote. Five patients needed a second operation on the aortic valve or root; three of them had a Florida sleeve procedure. “Based on these initial outcomes with the Florida sleeve at our institution, we have abandoned this procedure in favor of conventional valve-sparing root replacement,” Dr. Patel and his coauthors stated.
Dr. Patel and his coauthors had no financial relationships to disclose.
This report by Dr. Patel and his coauthors confirms the need for close surveillance of individuals with Loeys-Dietz syndrome who have had aortic operations, John S. Ikonomidis, MD, PhD, of the Medical University of South Carolina, Charleston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:413-4).
Dr. Ikonomidis noted this study is important because of its population size. “This is probably the largest single-center surgical report of this kind in the world,” he said.
The study highlighted a number of issues germane to LDS patients who have cardiovascular surgery, among them a critical need for genetic testing to help cardiac surgeons determine the disease genotype and what operation to perform, Dr. Ikonomidis said.
But Dr. Ikonomidis also pointed out the variation in aortic root size in the study patients. The smallest root in the series was 2 cm and 21 of 65 patients with a maximum root diameter smaller than 4 cm had root surgery. “This is a testament to the fact that surgical decision making in this population is dependent not just on the known genotype and aortic dimensions, but also on the rate of growth, aortic valve function, severity of noncardiac phenotype, and family history,” Dr. Ikonomidis said.
Dr. Ikonomidis had no financial relationships to disclose.
This report by Dr. Patel and his coauthors confirms the need for close surveillance of individuals with Loeys-Dietz syndrome who have had aortic operations, John S. Ikonomidis, MD, PhD, of the Medical University of South Carolina, Charleston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:413-4).
Dr. Ikonomidis noted this study is important because of its population size. “This is probably the largest single-center surgical report of this kind in the world,” he said.
The study highlighted a number of issues germane to LDS patients who have cardiovascular surgery, among them a critical need for genetic testing to help cardiac surgeons determine the disease genotype and what operation to perform, Dr. Ikonomidis said.
But Dr. Ikonomidis also pointed out the variation in aortic root size in the study patients. The smallest root in the series was 2 cm and 21 of 65 patients with a maximum root diameter smaller than 4 cm had root surgery. “This is a testament to the fact that surgical decision making in this population is dependent not just on the known genotype and aortic dimensions, but also on the rate of growth, aortic valve function, severity of noncardiac phenotype, and family history,” Dr. Ikonomidis said.
Dr. Ikonomidis had no financial relationships to disclose.
This report by Dr. Patel and his coauthors confirms the need for close surveillance of individuals with Loeys-Dietz syndrome who have had aortic operations, John S. Ikonomidis, MD, PhD, of the Medical University of South Carolina, Charleston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:413-4).
Dr. Ikonomidis noted this study is important because of its population size. “This is probably the largest single-center surgical report of this kind in the world,” he said.
The study highlighted a number of issues germane to LDS patients who have cardiovascular surgery, among them a critical need for genetic testing to help cardiac surgeons determine the disease genotype and what operation to perform, Dr. Ikonomidis said.
But Dr. Ikonomidis also pointed out the variation in aortic root size in the study patients. The smallest root in the series was 2 cm and 21 of 65 patients with a maximum root diameter smaller than 4 cm had root surgery. “This is a testament to the fact that surgical decision making in this population is dependent not just on the known genotype and aortic dimensions, but also on the rate of growth, aortic valve function, severity of noncardiac phenotype, and family history,” Dr. Ikonomidis said.
Dr. Ikonomidis had no financial relationships to disclose.
The knowledge about Loeys-Dietz syndrome has evolved quickly since Hal Dietz, MD, and Bart Loeys, MD, at Johns Hopkins University, Baltimore, first reported on it in 2005. Now, another team of Johns Hopkins investigators have reported that an aggressive approach with aortic root replacement coupled with valve-sparing whenever possible produces favorable results, but that clinicians must follow these patients closely with cardiovascular imaging.
“Growing experience with Loeys-Dietz syndrome has confirmed early impressions of its aggressive nature and proclivity toward aortic catastrophe,” Nishant D. Patel, MD, and his coauthors said in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:406-12). They reported on results of all 79 patients with Loeys-Dietz syndrome (LDS) who had cardiovascular surgery at Johns Hopkins. There were two (3%) deaths during surgery and eight (10%) late deaths.
Patients with LDS are at risk for dissection early when the aortic root reaches 4 cm. Despite what they termed “favorable” outcomes of surgery, Dr. Patel and his coauthors acknowledged that reintervention rates for this population are high – 19 patients (24%) had subsequent operations. That suggests cardiac surgeons must closely monitor these patients. “Meticulous follow-up with cardiovascular surveillance imaging remains important for management, particularly as clinical LDS subtypes are characterized and more tailored treatment is developed,” Dr. Patel and his coauthors reported.
They advise echocardiography every 3 to 6 months for the first year after surgery and then every 6 to 12 months afterward. Full-body imaging should occur at least every 2 years.
“In particular, patients with type B dissections should be monitored aggressively for aneurysm growth,” Dr. Patel and his coauthors said. They recommend imaging at seven to 14 days after dissection, then repeat imaging at 1, 3, 6, and 12 months, and then yearly thereafter.
They noted that four LDS subtypes have been identified. Although those with LDS1 and 2 subtypes are prone to aortic rupture at an earlier age and at smaller aortic diameters than other connective tissue disorders, the medical and surgical management for all subtypes are similar, Dr. Patel and his coauthors indicated.
“Certain congenital heart defects are more common among patients with LDS, compared with the normal population, including patent ductus arteriosus and mitral valve prolapse/insufficiency,” they said. Genotype is one factor that determines the need for surgery in LDS patients, Dr. Patel and his coauthors said. Others are growth rate, aortic valve function, family history, and severity of noncardiac phenotype.
The 79 patients in the study were divided almost evenly between gender, and the average age at first operation was 24.9 years; 38 were children younger than 18 years and 20 had a previous sternotomy.
Aortic root replacement represented the predominant operation in the group, accounting for 65 operations (82.3%), of which 52 (80%) were valve-sparing procedures and the remainder were composite valve-graft procedures. The other procedures the researchers performed were nine aortic arch replacements (11.4%), three open thoracoabdominal repairs (3.8%) and two ascending aorta replacements (2.5%).
“Valve-sparing root replacement has become a safe and reliable option for appropriately selected younger patients with LDS,” Dr. Patel and his coauthors wrote. Five patients needed a second operation on the aortic valve or root; three of them had a Florida sleeve procedure. “Based on these initial outcomes with the Florida sleeve at our institution, we have abandoned this procedure in favor of conventional valve-sparing root replacement,” Dr. Patel and his coauthors stated.
Dr. Patel and his coauthors had no financial relationships to disclose.
The knowledge about Loeys-Dietz syndrome has evolved quickly since Hal Dietz, MD, and Bart Loeys, MD, at Johns Hopkins University, Baltimore, first reported on it in 2005. Now, another team of Johns Hopkins investigators have reported that an aggressive approach with aortic root replacement coupled with valve-sparing whenever possible produces favorable results, but that clinicians must follow these patients closely with cardiovascular imaging.
“Growing experience with Loeys-Dietz syndrome has confirmed early impressions of its aggressive nature and proclivity toward aortic catastrophe,” Nishant D. Patel, MD, and his coauthors said in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:406-12). They reported on results of all 79 patients with Loeys-Dietz syndrome (LDS) who had cardiovascular surgery at Johns Hopkins. There were two (3%) deaths during surgery and eight (10%) late deaths.
Patients with LDS are at risk for dissection early when the aortic root reaches 4 cm. Despite what they termed “favorable” outcomes of surgery, Dr. Patel and his coauthors acknowledged that reintervention rates for this population are high – 19 patients (24%) had subsequent operations. That suggests cardiac surgeons must closely monitor these patients. “Meticulous follow-up with cardiovascular surveillance imaging remains important for management, particularly as clinical LDS subtypes are characterized and more tailored treatment is developed,” Dr. Patel and his coauthors reported.
They advise echocardiography every 3 to 6 months for the first year after surgery and then every 6 to 12 months afterward. Full-body imaging should occur at least every 2 years.
“In particular, patients with type B dissections should be monitored aggressively for aneurysm growth,” Dr. Patel and his coauthors said. They recommend imaging at seven to 14 days after dissection, then repeat imaging at 1, 3, 6, and 12 months, and then yearly thereafter.
They noted that four LDS subtypes have been identified. Although those with LDS1 and 2 subtypes are prone to aortic rupture at an earlier age and at smaller aortic diameters than other connective tissue disorders, the medical and surgical management for all subtypes are similar, Dr. Patel and his coauthors indicated.
“Certain congenital heart defects are more common among patients with LDS, compared with the normal population, including patent ductus arteriosus and mitral valve prolapse/insufficiency,” they said. Genotype is one factor that determines the need for surgery in LDS patients, Dr. Patel and his coauthors said. Others are growth rate, aortic valve function, family history, and severity of noncardiac phenotype.
The 79 patients in the study were divided almost evenly between gender, and the average age at first operation was 24.9 years; 38 were children younger than 18 years and 20 had a previous sternotomy.
Aortic root replacement represented the predominant operation in the group, accounting for 65 operations (82.3%), of which 52 (80%) were valve-sparing procedures and the remainder were composite valve-graft procedures. The other procedures the researchers performed were nine aortic arch replacements (11.4%), three open thoracoabdominal repairs (3.8%) and two ascending aorta replacements (2.5%).
“Valve-sparing root replacement has become a safe and reliable option for appropriately selected younger patients with LDS,” Dr. Patel and his coauthors wrote. Five patients needed a second operation on the aortic valve or root; three of them had a Florida sleeve procedure. “Based on these initial outcomes with the Florida sleeve at our institution, we have abandoned this procedure in favor of conventional valve-sparing root replacement,” Dr. Patel and his coauthors stated.
Dr. Patel and his coauthors had no financial relationships to disclose.
Key clinical point: Outcomes for aortic surgery in Loeys-Dietz syndrome are favorable, but reintervention rates are high.
Major finding: Patients require close postoperative follow-up with cardiovascular imaging.
Data source: Retrospective review of 79 patients who had cardiovascular surgery for LDS over 26 years at Johns Hopkins University.
Disclosure: Dr. Patel and his coauthors reported having no relevant financial disclosures.
Will genome editing advance animal-to-human transplantation?
Advances in gene editing are pushing the possibility of raising pigs for organs that may be transplanted into humans with immunosuppression regimens comparable to those now used in human-to-human transplants, coauthors James Butler, MD, and A. Joseph Tector, MD, PhD, stated in an expert opinion in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:488-92).
Developments in genome editing could bring new approaches to management of cardiopulmonary diseases, Dr. Butler and Dr. Tector noted. “Recently, cardiac-specific and lung-specific applications have been described, which will allow for the rapid creation of new models of heart and lung disease,” they said. Specifically, they noted gene targeting might eventually offer a way to treat challenging genetic problems “like the heterogeneous nature of nonsquamous cell lung cancer.”
Dr. Butler is with the department of surgery at Indiana University, Indianapolis, and Dr. Tector is with the department of surgery at the University of Alabama at Birmingham.
CRISPR technology has been used in developing multiple gene knockout pigs and neutralizing three separate porcine genes that encode human xenoantigens in a single reaction, leading to efficient methods for creating pigs with multiple genetic modifications.
According to the website of the Broad Institute of MIT and Harvard, Cambridge, Mass., where researchers perfected the system to work in eukaryotes, CRISPR works by using short RNA sequences designed by researchers to guide the system to matching sequences of DNA. When the target DNA is found, Cas9 – one of the enzymes produced by the CRISPR system – binds to the DNA and cuts it, shutting the targeted gene off.
“By facilitating high-throughput model creation, CRISPR has elucidated which modifications are necessary and which are not; despite the ability to alter many loci concurrently, recent evidence has implicated three porcine genes that are responsible for the majority of human-antiporcine humoral immunity,” Dr. Butler and Dr. Tector wrote.
Those genes are the Gal[alpha]1-3 epitope (Gal-alpha), CMAH and B4GaINT2 genes. “Each of these three genes is expressed in pigs but has been evolutionarily silenced in humans,” the coauthors added.
While CRISPR genome editing has yet to reach its full potential, researchers and clinicians should pay attention, according to Dr. Butler and Dr. Tector.
More recent modifications of CRISPR technology have shown promise in not just knocking out or turning off specific genes, but rather guiding directed replacement of genes with researcher-designed substitutes. This can enable permanent transformation of functional genes with altered behavior, according to the Broad Institute website.
Dr. Tector disclosed he has received funding from United Therapeutics and founded Xenobridge with patents for xenotransplantation. Dr. Butler has no relevant financial relationships to disclose.
CRISPR and CRISPR-associated proteins have emerged as effective genome editing techniques that may lead to cardiac and lung models and possibly xenotransplantation, Ari A. Mennander, MD, PhD, of the Tampere (Finland) University Heart Hospital, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:492).
The concept Dr. Butler and Dr. Tector discuss involves not using antibodies to ameliorate porcine antibodies that cause rejection in humans, but rather reengineering the genetic composition of pigs to eliminate those antibodies. “According to the wildest of dreams, these genes affecting porcine glycan expression may be silenced, and the human–antiporcine humoral immunity is controlled down to the level comparable with human allograft rejection,” Dr. Mennander said.
However, such a breakthrough carries with it consequences, Dr. Mennander said. “Should one worry about the induction of zoonosis, as well as the ethical aspects of transplanting the patient a whole organ of a pig? Would even a successful xenotransplant program seriously compete with artificial hearts or allografts?” Embracing the method too early would open its advocates to ridicule, he said.
“We are to applaud the researchers for ever-lasting and exemplary enthusiasm for a futuristic new surgical solution; the future may lie as much in current clinical solutions as in innovative discoveries based on persistent scientific experiments,” Dr. Mennander said.
Dr. Mennander had no relevant financial relationships to disclose.
CRISPR and CRISPR-associated proteins have emerged as effective genome editing techniques that may lead to cardiac and lung models and possibly xenotransplantation, Ari A. Mennander, MD, PhD, of the Tampere (Finland) University Heart Hospital, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:492).
The concept Dr. Butler and Dr. Tector discuss involves not using antibodies to ameliorate porcine antibodies that cause rejection in humans, but rather reengineering the genetic composition of pigs to eliminate those antibodies. “According to the wildest of dreams, these genes affecting porcine glycan expression may be silenced, and the human–antiporcine humoral immunity is controlled down to the level comparable with human allograft rejection,” Dr. Mennander said.
However, such a breakthrough carries with it consequences, Dr. Mennander said. “Should one worry about the induction of zoonosis, as well as the ethical aspects of transplanting the patient a whole organ of a pig? Would even a successful xenotransplant program seriously compete with artificial hearts or allografts?” Embracing the method too early would open its advocates to ridicule, he said.
“We are to applaud the researchers for ever-lasting and exemplary enthusiasm for a futuristic new surgical solution; the future may lie as much in current clinical solutions as in innovative discoveries based on persistent scientific experiments,” Dr. Mennander said.
Dr. Mennander had no relevant financial relationships to disclose.
CRISPR and CRISPR-associated proteins have emerged as effective genome editing techniques that may lead to cardiac and lung models and possibly xenotransplantation, Ari A. Mennander, MD, PhD, of the Tampere (Finland) University Heart Hospital, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:492).
The concept Dr. Butler and Dr. Tector discuss involves not using antibodies to ameliorate porcine antibodies that cause rejection in humans, but rather reengineering the genetic composition of pigs to eliminate those antibodies. “According to the wildest of dreams, these genes affecting porcine glycan expression may be silenced, and the human–antiporcine humoral immunity is controlled down to the level comparable with human allograft rejection,” Dr. Mennander said.
However, such a breakthrough carries with it consequences, Dr. Mennander said. “Should one worry about the induction of zoonosis, as well as the ethical aspects of transplanting the patient a whole organ of a pig? Would even a successful xenotransplant program seriously compete with artificial hearts or allografts?” Embracing the method too early would open its advocates to ridicule, he said.
“We are to applaud the researchers for ever-lasting and exemplary enthusiasm for a futuristic new surgical solution; the future may lie as much in current clinical solutions as in innovative discoveries based on persistent scientific experiments,” Dr. Mennander said.
Dr. Mennander had no relevant financial relationships to disclose.
Advances in gene editing are pushing the possibility of raising pigs for organs that may be transplanted into humans with immunosuppression regimens comparable to those now used in human-to-human transplants, coauthors James Butler, MD, and A. Joseph Tector, MD, PhD, stated in an expert opinion in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:488-92).
Developments in genome editing could bring new approaches to management of cardiopulmonary diseases, Dr. Butler and Dr. Tector noted. “Recently, cardiac-specific and lung-specific applications have been described, which will allow for the rapid creation of new models of heart and lung disease,” they said. Specifically, they noted gene targeting might eventually offer a way to treat challenging genetic problems “like the heterogeneous nature of nonsquamous cell lung cancer.”
Dr. Butler is with the department of surgery at Indiana University, Indianapolis, and Dr. Tector is with the department of surgery at the University of Alabama at Birmingham.
CRISPR technology has been used in developing multiple gene knockout pigs and neutralizing three separate porcine genes that encode human xenoantigens in a single reaction, leading to efficient methods for creating pigs with multiple genetic modifications.
According to the website of the Broad Institute of MIT and Harvard, Cambridge, Mass., where researchers perfected the system to work in eukaryotes, CRISPR works by using short RNA sequences designed by researchers to guide the system to matching sequences of DNA. When the target DNA is found, Cas9 – one of the enzymes produced by the CRISPR system – binds to the DNA and cuts it, shutting the targeted gene off.
“By facilitating high-throughput model creation, CRISPR has elucidated which modifications are necessary and which are not; despite the ability to alter many loci concurrently, recent evidence has implicated three porcine genes that are responsible for the majority of human-antiporcine humoral immunity,” Dr. Butler and Dr. Tector wrote.
Those genes are the Gal[alpha]1-3 epitope (Gal-alpha), CMAH and B4GaINT2 genes. “Each of these three genes is expressed in pigs but has been evolutionarily silenced in humans,” the coauthors added.
While CRISPR genome editing has yet to reach its full potential, researchers and clinicians should pay attention, according to Dr. Butler and Dr. Tector.
More recent modifications of CRISPR technology have shown promise in not just knocking out or turning off specific genes, but rather guiding directed replacement of genes with researcher-designed substitutes. This can enable permanent transformation of functional genes with altered behavior, according to the Broad Institute website.
Dr. Tector disclosed he has received funding from United Therapeutics and founded Xenobridge with patents for xenotransplantation. Dr. Butler has no relevant financial relationships to disclose.
Advances in gene editing are pushing the possibility of raising pigs for organs that may be transplanted into humans with immunosuppression regimens comparable to those now used in human-to-human transplants, coauthors James Butler, MD, and A. Joseph Tector, MD, PhD, stated in an expert opinion in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:488-92).
Developments in genome editing could bring new approaches to management of cardiopulmonary diseases, Dr. Butler and Dr. Tector noted. “Recently, cardiac-specific and lung-specific applications have been described, which will allow for the rapid creation of new models of heart and lung disease,” they said. Specifically, they noted gene targeting might eventually offer a way to treat challenging genetic problems “like the heterogeneous nature of nonsquamous cell lung cancer.”
Dr. Butler is with the department of surgery at Indiana University, Indianapolis, and Dr. Tector is with the department of surgery at the University of Alabama at Birmingham.
CRISPR technology has been used in developing multiple gene knockout pigs and neutralizing three separate porcine genes that encode human xenoantigens in a single reaction, leading to efficient methods for creating pigs with multiple genetic modifications.
According to the website of the Broad Institute of MIT and Harvard, Cambridge, Mass., where researchers perfected the system to work in eukaryotes, CRISPR works by using short RNA sequences designed by researchers to guide the system to matching sequences of DNA. When the target DNA is found, Cas9 – one of the enzymes produced by the CRISPR system – binds to the DNA and cuts it, shutting the targeted gene off.
“By facilitating high-throughput model creation, CRISPR has elucidated which modifications are necessary and which are not; despite the ability to alter many loci concurrently, recent evidence has implicated three porcine genes that are responsible for the majority of human-antiporcine humoral immunity,” Dr. Butler and Dr. Tector wrote.
Those genes are the Gal[alpha]1-3 epitope (Gal-alpha), CMAH and B4GaINT2 genes. “Each of these three genes is expressed in pigs but has been evolutionarily silenced in humans,” the coauthors added.
While CRISPR genome editing has yet to reach its full potential, researchers and clinicians should pay attention, according to Dr. Butler and Dr. Tector.
More recent modifications of CRISPR technology have shown promise in not just knocking out or turning off specific genes, but rather guiding directed replacement of genes with researcher-designed substitutes. This can enable permanent transformation of functional genes with altered behavior, according to the Broad Institute website.
Dr. Tector disclosed he has received funding from United Therapeutics and founded Xenobridge with patents for xenotransplantation. Dr. Butler has no relevant financial relationships to disclose.
Key clinical point: CRISPR/Cas9 genome editing is advancing the creation of animal models for xenotransplantation into humans.
Major finding: Genome editing tools are moving xenotransplantation models quickly toward potential treatments for cardiopulmonary disease.
Data source: Expert opinion with literature review.
Disclosures: Dr. Tector disclosed he has received funding from United Therapeutics and founded Xenobridge with patents for xenotransplantation. Dr. Butler reported having no relevant financial disclosures.
Use of bilateral internal mammary arteries in CABG stagnates
HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.
“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”
The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.
“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”
A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.
HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.
“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”
The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.
“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”
A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.
HOUSTON – Over the past 5 years there has been no growth in bilateral internal mammary artery use among Medicare beneficiaries, and the frequency of bilateral internal mammary artery use during coronary artery bypass grafting remained low, according to a large observational analysis.
“Despite a growing evidence base supporting bilateral internal mammary artery use with regard to long-term survival and freedom from repeat revascularization, rates of bilateral internal mammary artery [BIMA] use remain low, with no evidence of growth,” Alexander Iribarne, MD, said during an interview at the annual meeting of the Society of Thoracic Surgeons. “Therefore, there is significant opportunity for adoption of bilateral internal mammary artery grafting in the United States.”
The most recent report of CABG trends in the United States published from the STS database showed that in 2009, fewer than 5% of patients who underwent CABG received a BIMA (J Thorac Cardiovasc Surg. 2012 Feb;143[2]:273-81). In an effort to characterize the adoption rate and regional variation of BIMA use in the United States, Dr. Iribarne, director of cardiac surgical research in the section of cardiac surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates examined records from nearly 150 million Medicare beneficiaries from 2009-2014. “This work is unique in that we not only looked at trends in rates of usage but also how this varied by geographic location,” he said.
“I was surprised to find that despite the growing literature supporting BIMA use, there was no growth in rates of usage over the 5-year study period, with rates remaining low,” Dr. Iribarne said. “I was also surprised to see that there was significant regional variation in use that appeared to correlate, in part, with overall CABG volume, although the moderate correlation coefficient indicates that additional factors beyond CABG volume are involved.”
A key limitation of the study, he said, was that its patients were aged 65 and older. Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: The absolute national rate of BIMA use fell from 0.216 claims per 1,000 beneficiaries in 2009 to 0.143 in 2014 (P less than .001).
Data source: An analysis of medical records from nearly 150 million Medicare beneficiaries during 2009-2014.
Disclosures: Dr. Iribarne disclosed that he receives grant funding from the American Association for Thoracic Surgery Graham Foundation and the Dartmouth SYNERGY Clinical and Translational Science Institute.
Esophageal retractor found handy tool in AF ablation
ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.
When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.
The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.
The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.
“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.
The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m2. The mean CHA2DS2-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.
After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.
Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.
The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.
In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.
According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.
“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.
Dr. Parikh has no industry relationships relevant to this study.
ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.
When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.
The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.
The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.
“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.
The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m2. The mean CHA2DS2-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.
After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.
Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.
The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.
In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.
According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.
“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.
Dr. Parikh has no industry relationships relevant to this study.
ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.
When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.
The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.
The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.
“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.
The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m2. The mean CHA2DS2-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.
After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.
Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.
The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.
In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.
According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.
“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.
Dr. Parikh has no industry relationships relevant to this study.
AT THE INTERNATIONAL AF SYMPOSIUM
Key clinical point: The efficacy of a tool to move the esophagus out of the way when performing ablation for atrial fibrillation is supported by a multicenter study.
Major finding: In 101 consecutive cases at four centers, all ablations were completed successfully with no esophageal temperature rise.
Data source: Prospective observational study.
Disclosures: Dr. Parikh has no industry relationships relevant to this study.
New ACC guidance on periprocedural management of anticoagulation in A-fib falls short
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Moderate stenosis in coronary arteries grows severe over time
HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.
“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.
“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).
In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.
The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.
“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”
Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.
HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.
“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.
“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).
In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.
The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.
“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”
Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.
HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.
“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.
“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).
In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.
The researchers found that at 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs, respectively; in 55%, 73%, 84%, and 87% of ITA-grafted MSCAs, and in 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After Dr. Sabik and his associates adjusted for patient characteristics, disease progression in MSCAs was significantly higher with ITA and SV grafting, compared with nongrafting (odds ratios, 3.6 and 9.9, respectively). At 1, 5, 10, and 15 years, occlusion in grafts to MSCAs was 8%, 9%, 11%, and 15%, respectively, for ITA grafts and 13%, 32%, 46%, and 56% for SV grafts. At these same time points, protection from myocardial ischemia in ITA-grafted vs. nongrafted MSCAs was 29%, 47%, 59%, and 61%.
“Our opinion is you that shouldn’t ignore moderate lesions,” Dr. Sabik, surgeon-in-chief and vice president for surgical operations for the University Hospitals system, said in an interview at the meeting. “Although it may not help that patient over the next short period of time, over their lifespan it will. What works for intervention doesn’t necessarily mean it’s right for bypass surgery. If you have a vessel that’s only moderately stenosed you should at least consider grafting it, because moderate lesions progress over time. Bypassing it helps people live longer when you use an internal thoracic artery graft, because they are likely to remain patent. You always have to individualize the therapy, but the key is to use your grafts in the best way possible.”
Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: At 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 72% of nongrafted coronary arteries, in 87% of internal thoracic artery–grafted arteries, and in 92% of saphenous vein–grafted moderately stenosed coronary arteries.
Data source: An analysis of medical records from 55,567 patients who underwent primary isolated CABG at the Cleveland Clinic from 1972 to 2011.
Disclosures: Dr. Sabik disclosed that he has received research grants from Medtronic, Abbott Vascular, and Edwards Lifesciences.
Nicardipine okay to use after pediatric cardiac surgery
HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.
“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”
In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.
Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.
No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.
“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.
“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”
Dr. Stone reported having no financial disclosures.
HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.
“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”
In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.
Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.
No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.
“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.
“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”
Dr. Stone reported having no financial disclosures.
HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.
“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”
In their study, Dr. Stone, a first-year fellow in the division of cardiothoracic surgery at the University of Virginia Health System, Charlottesville, and his associates noted that nicardipine offers a favorable pharmacokinetic profile with both rapid onset and short half-life. The purpose of the study was to evaluate the use of nicardipine as a first-line agent for treatment of postoperative hypertension and to compare outcomes between children younger than 6 months of age and those older than 6 months. The researchers retrospectively reviewed the medical records of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery at the University of Virginia during 2010-2015. They compared the incidence of adverse postoperative events between 33 children who were younger than 6 months (group 1) and 35 who were older than 6 months (group 2). Major events including stroke or cardiogenic shock were considered failure of therapy.
Dr. Stone and his associates found that all children received nicardipine within a median of 90 minutes following cardiac surgery; 22 (33%) were started on the drug prior to leaving the operating room and most required dosing for less than 24 hours. Clinically significant hypertension that required dose titration or cessation of therapy occurred in 13% of patients, but there were no significant differences between age groups (17% in group 1 vs. 9% in group 2; P = 0.47). “While the incidence of hypotension following nicardipine administration did not reach statistical significance, it’s important to note that going forward, a lower starting dose in infants less than 6 months of age may be most appropriate. This would certainly be an important focus for future prospective study in the development of postoperative blood pressure control protocols,” said Dr. Stone.
No significant adverse events including stroke or cardiogenic shock occurred in either group. In addition, no operative or postoperative factors reviewed were associated with the development of complications during administration of nicardipine. This included cardiopulmonary bypass time, cross-clamp time, ventilator time, nicardipine duration, ICU length of stay, and hospital length of stay.
“Our traditional hesitation to use this class of agents in infants should be reevaluated,” Dr. Stone concluded. “As we move toward standardization and optimization of perioperative care, our study supports the use and prospective clinical study of nicardipine. Additionally, further pharmacologic study of dose-specific responses within myocardial and vascular smooth muscle cells may further optimize this treatment strategy and provide a more reliable standard with which to control blood pressure.
“Our traditional agents such as beta-blockers and nitroprusside have side effects that need to be considered, the most significant of which being myocardial depression and cyanide toxicity. In a limited number of very-high-risk children, we’ve shown that nicardipine may provide an option with less deleterious side effects. It’s a foundation for future study.”
Dr. Stone reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: The incidence of adverse postoperative events was similar between children who were younger than 6 months and those who were older than 6 months (17% vs. 9%, respectively), but no significant adverse events, including stroke and cardiogenic shock, occurred in either group.
Data source: A retrospective review of 68 children who received nicardipine for postoperative hypertension after undergoing cardiac surgery during 2010-2015.
Disclosures: Dr. Stone reported having no financial disclosures.
Study finds community-hospital lung cancer screening feasible
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
Key clinical point:
Major finding: Of patients who participated in a community screening program over the course of 1 year, 88% were diagnosed with Lung-RADS 1 or 2, 7% were Lung-RADS 3, and 5% were Lung-RADS 4.
Data source: A 12-month prospective study of 278 patients at risk for lung cancer.
Disclosures: One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.