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Megamerger rulings may chill future consolidations
Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.
A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.
“Both of these decisions are likely to chill future mergers,” Mr. Dahlquist said in an interview. “We have the FTC [Federal Trade Commission] winning on the provider side. Now we have the DOJ [Department of Justice] winning on the insurer side. While they are different players in the marketplace, the law that is being applied is very similar, if not the same. The one-sided victories by the government are creating a situation of imbalance.”
Ruling positive and negative for providers
Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.
“The [insurers] already have a huge market position so they can already hammer [providers] with low rates,” Mr. Greer said in an interview. “The reason why [the rulings are] such a big win for providers, is there won’t be this huge concentration of power. Anthem may not be able to hammer them quite as much as if they would’ve merged with Cigna.”
However, the rulings may discourage future health care consolidations between insurers and among health providers, Mr. Dahlquist noted. In recent years, the government has scored a series of legal wins that have blocked provider mergers. In 2013 for example, the Federal Trade Commission successfully stopped the acquisition of Palmyra Medical Center by Phoebe Putney Memorial Hospital (Albany, Ga.), followed by a 2014 win that barred St. Luke’s Health System’s acquisition of Saltzer Medical Group (Nampa, Idaho), an independent physician practice. In 2016, the FTC successfully blocked the merger of Penn State Hershey (Pa.) Medical Center’s merger with PinnacleHealth System (Harrisburg, Penn.).
“Every merger needs to be looked at [based on] the facts of that merger, and the facts of that case, the markets they compete in, [and] the markets they want to expand into,” Mr. Dahlquist said. “That’s why you shouldn’t look at all mergers of health care providers or health insurers as inherently bad, and I think that’s what these [decisions] are unfortunately driving toward.”
A broader takeaway is that the insurance industry needs to develop a better business model, said Barak D. Richman, PhD, an antitrust expert and law professor at Duke University in Durham, N.C. Mr. Richman consulted with several state departments of insurance as they were reviewing the Anthem-Cigna mergers.
“The general story here is that the insurance industry, over a number of years, has been consolidating and has reached a point where it now has passed a threshold where antitrust scrutiny will be very real,” Mr. Richman said in an interview. “One thing that the court cases revealed is that there is a certain prevailing business model in insurance which is: Get as big as you can, balance risk through volume, and use buying leverage to negotiate favorable prices from providers. It looks like that business model has reached its limits and really is not going to be sustainable any longer.”
The current market demands business models that center on value, not volume, Mr. Richman continued. Insurance companies will need to be more deliberate and analytical about how to provide value to patients and generate cost effective care.
“That really is the takeaway, that we need a real shift in the business of health insurance,” he said.
Anthem banking on new administration
Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.
To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.
“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”
Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.
Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.
“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.
On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.
“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”
“I don’t expect to see any change in the government’s approach in continuing to challenge anticompetitive health care transactions,” Ms. Feinstein said during at interview at the meeting.
[email protected]
On Twitter @legal_med
Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.
A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.
“Both of these decisions are likely to chill future mergers,” Mr. Dahlquist said in an interview. “We have the FTC [Federal Trade Commission] winning on the provider side. Now we have the DOJ [Department of Justice] winning on the insurer side. While they are different players in the marketplace, the law that is being applied is very similar, if not the same. The one-sided victories by the government are creating a situation of imbalance.”
Ruling positive and negative for providers
Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.
“The [insurers] already have a huge market position so they can already hammer [providers] with low rates,” Mr. Greer said in an interview. “The reason why [the rulings are] such a big win for providers, is there won’t be this huge concentration of power. Anthem may not be able to hammer them quite as much as if they would’ve merged with Cigna.”
However, the rulings may discourage future health care consolidations between insurers and among health providers, Mr. Dahlquist noted. In recent years, the government has scored a series of legal wins that have blocked provider mergers. In 2013 for example, the Federal Trade Commission successfully stopped the acquisition of Palmyra Medical Center by Phoebe Putney Memorial Hospital (Albany, Ga.), followed by a 2014 win that barred St. Luke’s Health System’s acquisition of Saltzer Medical Group (Nampa, Idaho), an independent physician practice. In 2016, the FTC successfully blocked the merger of Penn State Hershey (Pa.) Medical Center’s merger with PinnacleHealth System (Harrisburg, Penn.).
“Every merger needs to be looked at [based on] the facts of that merger, and the facts of that case, the markets they compete in, [and] the markets they want to expand into,” Mr. Dahlquist said. “That’s why you shouldn’t look at all mergers of health care providers or health insurers as inherently bad, and I think that’s what these [decisions] are unfortunately driving toward.”
A broader takeaway is that the insurance industry needs to develop a better business model, said Barak D. Richman, PhD, an antitrust expert and law professor at Duke University in Durham, N.C. Mr. Richman consulted with several state departments of insurance as they were reviewing the Anthem-Cigna mergers.
“The general story here is that the insurance industry, over a number of years, has been consolidating and has reached a point where it now has passed a threshold where antitrust scrutiny will be very real,” Mr. Richman said in an interview. “One thing that the court cases revealed is that there is a certain prevailing business model in insurance which is: Get as big as you can, balance risk through volume, and use buying leverage to negotiate favorable prices from providers. It looks like that business model has reached its limits and really is not going to be sustainable any longer.”
The current market demands business models that center on value, not volume, Mr. Richman continued. Insurance companies will need to be more deliberate and analytical about how to provide value to patients and generate cost effective care.
“That really is the takeaway, that we need a real shift in the business of health insurance,” he said.
Anthem banking on new administration
Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.
To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.
“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”
Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.
Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.
“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.
On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.
“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”
“I don’t expect to see any change in the government’s approach in continuing to challenge anticompetitive health care transactions,” Ms. Feinstein said during at interview at the meeting.
[email protected]
On Twitter @legal_med
Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.
A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.
“Both of these decisions are likely to chill future mergers,” Mr. Dahlquist said in an interview. “We have the FTC [Federal Trade Commission] winning on the provider side. Now we have the DOJ [Department of Justice] winning on the insurer side. While they are different players in the marketplace, the law that is being applied is very similar, if not the same. The one-sided victories by the government are creating a situation of imbalance.”
Ruling positive and negative for providers
Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.
“The [insurers] already have a huge market position so they can already hammer [providers] with low rates,” Mr. Greer said in an interview. “The reason why [the rulings are] such a big win for providers, is there won’t be this huge concentration of power. Anthem may not be able to hammer them quite as much as if they would’ve merged with Cigna.”
However, the rulings may discourage future health care consolidations between insurers and among health providers, Mr. Dahlquist noted. In recent years, the government has scored a series of legal wins that have blocked provider mergers. In 2013 for example, the Federal Trade Commission successfully stopped the acquisition of Palmyra Medical Center by Phoebe Putney Memorial Hospital (Albany, Ga.), followed by a 2014 win that barred St. Luke’s Health System’s acquisition of Saltzer Medical Group (Nampa, Idaho), an independent physician practice. In 2016, the FTC successfully blocked the merger of Penn State Hershey (Pa.) Medical Center’s merger with PinnacleHealth System (Harrisburg, Penn.).
“Every merger needs to be looked at [based on] the facts of that merger, and the facts of that case, the markets they compete in, [and] the markets they want to expand into,” Mr. Dahlquist said. “That’s why you shouldn’t look at all mergers of health care providers or health insurers as inherently bad, and I think that’s what these [decisions] are unfortunately driving toward.”
A broader takeaway is that the insurance industry needs to develop a better business model, said Barak D. Richman, PhD, an antitrust expert and law professor at Duke University in Durham, N.C. Mr. Richman consulted with several state departments of insurance as they were reviewing the Anthem-Cigna mergers.
“The general story here is that the insurance industry, over a number of years, has been consolidating and has reached a point where it now has passed a threshold where antitrust scrutiny will be very real,” Mr. Richman said in an interview. “One thing that the court cases revealed is that there is a certain prevailing business model in insurance which is: Get as big as you can, balance risk through volume, and use buying leverage to negotiate favorable prices from providers. It looks like that business model has reached its limits and really is not going to be sustainable any longer.”
The current market demands business models that center on value, not volume, Mr. Richman continued. Insurance companies will need to be more deliberate and analytical about how to provide value to patients and generate cost effective care.
“That really is the takeaway, that we need a real shift in the business of health insurance,” he said.
Anthem banking on new administration
Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.
To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.
“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”
Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.
Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.
“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.
On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.
“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”
“I don’t expect to see any change in the government’s approach in continuing to challenge anticompetitive health care transactions,” Ms. Feinstein said during at interview at the meeting.
[email protected]
On Twitter @legal_med
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
Prolonged dual-antiplatelet therapy after PCI challenged
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
EXPERT ANALYSIS FROM CRT 2017
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.
CMS to alert docs of their MIPS status soon
ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.
Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.
- Do the bare minimum and face no penalties.
- Submit 90 days worth of data and be eligible for a small bonus payment.
- Submit for the full year and be eligible for the full bonus that is to be determined.
Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.
“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”
She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”
ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.
Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.
- Do the bare minimum and face no penalties.
- Submit 90 days worth of data and be eligible for a small bonus payment.
- Submit for the full year and be eligible for the full bonus that is to be determined.
Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.
“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”
She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”
ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.
Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.
- Do the bare minimum and face no penalties.
- Submit 90 days worth of data and be eligible for a small bonus payment.
- Submit for the full year and be eligible for the full bonus that is to be determined.
Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.
“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”
She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”
AT HIMSS 2017
Consider ultraslow thrombolysis for mechanical valve thrombosis
SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn. 
He added that he and his Mayo colleagues have begun using the novel therapy and are favorably impressed with the resultant complete normalization of valve gradients and low complication rate.
Dr. Nishimura was cochair of the writing committee for the current American College of Cardiology/American Heart Association guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643). Those guidelines state that emergency surgery is the treatment of choice for thrombosis of a left-sided mechanical heart valve. That strong recommendation was based on a dozen nonrandomized studies reported prior to 2013 which showed a 95% success rate with surgery compared with 75% with conventional large-bolus thrombolytic therapy, a high 10%-12% mortality with either form of therapy, and a stroke risk of 12%-14% with thrombolytic therapy, substantially higher than for surgery.
Since release of the ACC/AHA guidelines, however, there’s been an important new development: Three groups outside of the United States have pioneered ultraslow thrombolytic therapy for mechanical prosthetic valve thrombosis. The supporting evidence comes from cohort studies, with no randomized trials done to date. But the collective reported experience from these three research teams shows a 90%-95% success rate – comparable to surgery – along with stroke and mortality rates in the low single digits.
The Turkish group waits until the patient’s international normalized ratio (INR) is below 2.5, then administers 25 mg of tissue plasminogen activator guided by transesophageal echocardiography (TEE) over 25 hours.
“We traditionally give 90 mg over 1 hour, so this is very, very slow therapy,” Dr. Nishimura observed.
After the 24-hour infusion, TEE is repeated. If imaging shows the clot is not resolved, another 25 mg of tissue plasminogen activator is given over 24 hours. This process is repeated for up to 8 days as needed (Am Heart J. 2015 Aug;170[2]:409-18).
Dr. Nishimura advised reserving ultraslow thrombolytic therapy for patients who are hemodynamically stable; this treatment takes a while to work, so patients in severe heart failure should be sent straight away to surgery. The novel therapy is best suited for patients with recent-onset mechanical valve thrombosis, a low INR, TEE evidence that the clot isn’t huge, and/or when surgical expertise isn’t readily available.
Before you can treat a prosthetic mechanical valve thrombosis, however, you have to make the diagnosis. Here’s what Dr. Nishimura recommends: First, suspect the condition on the basis of clinical symptoms of heart failure and dull, muffled S1 and S2 sounds on auscultation, especially in a patient who presents with a low INR.
Next, prove that obstruction is present via Doppler echocardiographic evidence of an abnormal gradient across the mechanical valve.
Finally, determine if the mechanical valve shows abnormal disc motion with sticking leaflets. TEE is excellent for visualizing a mechanical mitral valve but isn’t helpful if it’s a mechanical aortic valve.
“Old-fashioned fluoroscopy is the best approach for looking at leaflet motion in the atrial valve and mitral valve. We’ve got 3-D cine now that provides beautiful images, but if you can get the same information with a quick fluoroscopy, go with the fluoroscopy,” the cardiologist suggested.
He reported having no financial conflicts of interest.
SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
He added that he and his Mayo colleagues have begun using the novel therapy and are favorably impressed with the resultant complete normalization of valve gradients and low complication rate.
Dr. Nishimura was cochair of the writing committee for the current American College of Cardiology/American Heart Association guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643). Those guidelines state that emergency surgery is the treatment of choice for thrombosis of a left-sided mechanical heart valve. That strong recommendation was based on a dozen nonrandomized studies reported prior to 2013 which showed a 95% success rate with surgery compared with 75% with conventional large-bolus thrombolytic therapy, a high 10%-12% mortality with either form of therapy, and a stroke risk of 12%-14% with thrombolytic therapy, substantially higher than for surgery.
Since release of the ACC/AHA guidelines, however, there’s been an important new development: Three groups outside of the United States have pioneered ultraslow thrombolytic therapy for mechanical prosthetic valve thrombosis. The supporting evidence comes from cohort studies, with no randomized trials done to date. But the collective reported experience from these three research teams shows a 90%-95% success rate – comparable to surgery – along with stroke and mortality rates in the low single digits.
The Turkish group waits until the patient’s international normalized ratio (INR) is below 2.5, then administers 25 mg of tissue plasminogen activator guided by transesophageal echocardiography (TEE) over 25 hours.
“We traditionally give 90 mg over 1 hour, so this is very, very slow therapy,” Dr. Nishimura observed.
After the 24-hour infusion, TEE is repeated. If imaging shows the clot is not resolved, another 25 mg of tissue plasminogen activator is given over 24 hours. This process is repeated for up to 8 days as needed (Am Heart J. 2015 Aug;170[2]:409-18).
Dr. Nishimura advised reserving ultraslow thrombolytic therapy for patients who are hemodynamically stable; this treatment takes a while to work, so patients in severe heart failure should be sent straight away to surgery. The novel therapy is best suited for patients with recent-onset mechanical valve thrombosis, a low INR, TEE evidence that the clot isn’t huge, and/or when surgical expertise isn’t readily available.
Before you can treat a prosthetic mechanical valve thrombosis, however, you have to make the diagnosis. Here’s what Dr. Nishimura recommends: First, suspect the condition on the basis of clinical symptoms of heart failure and dull, muffled S1 and S2 sounds on auscultation, especially in a patient who presents with a low INR.
Next, prove that obstruction is present via Doppler echocardiographic evidence of an abnormal gradient across the mechanical valve.
Finally, determine if the mechanical valve shows abnormal disc motion with sticking leaflets. TEE is excellent for visualizing a mechanical mitral valve but isn’t helpful if it’s a mechanical aortic valve.
“Old-fashioned fluoroscopy is the best approach for looking at leaflet motion in the atrial valve and mitral valve. We’ve got 3-D cine now that provides beautiful images, but if you can get the same information with a quick fluoroscopy, go with the fluoroscopy,” the cardiologist suggested.
He reported having no financial conflicts of interest.
SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
He added that he and his Mayo colleagues have begun using the novel therapy and are favorably impressed with the resultant complete normalization of valve gradients and low complication rate.
Dr. Nishimura was cochair of the writing committee for the current American College of Cardiology/American Heart Association guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643). Those guidelines state that emergency surgery is the treatment of choice for thrombosis of a left-sided mechanical heart valve. That strong recommendation was based on a dozen nonrandomized studies reported prior to 2013 which showed a 95% success rate with surgery compared with 75% with conventional large-bolus thrombolytic therapy, a high 10%-12% mortality with either form of therapy, and a stroke risk of 12%-14% with thrombolytic therapy, substantially higher than for surgery.
Since release of the ACC/AHA guidelines, however, there’s been an important new development: Three groups outside of the United States have pioneered ultraslow thrombolytic therapy for mechanical prosthetic valve thrombosis. The supporting evidence comes from cohort studies, with no randomized trials done to date. But the collective reported experience from these three research teams shows a 90%-95% success rate – comparable to surgery – along with stroke and mortality rates in the low single digits.
The Turkish group waits until the patient’s international normalized ratio (INR) is below 2.5, then administers 25 mg of tissue plasminogen activator guided by transesophageal echocardiography (TEE) over 25 hours.
“We traditionally give 90 mg over 1 hour, so this is very, very slow therapy,” Dr. Nishimura observed.
After the 24-hour infusion, TEE is repeated. If imaging shows the clot is not resolved, another 25 mg of tissue plasminogen activator is given over 24 hours. This process is repeated for up to 8 days as needed (Am Heart J. 2015 Aug;170[2]:409-18).
Dr. Nishimura advised reserving ultraslow thrombolytic therapy for patients who are hemodynamically stable; this treatment takes a while to work, so patients in severe heart failure should be sent straight away to surgery. The novel therapy is best suited for patients with recent-onset mechanical valve thrombosis, a low INR, TEE evidence that the clot isn’t huge, and/or when surgical expertise isn’t readily available.
Before you can treat a prosthetic mechanical valve thrombosis, however, you have to make the diagnosis. Here’s what Dr. Nishimura recommends: First, suspect the condition on the basis of clinical symptoms of heart failure and dull, muffled S1 and S2 sounds on auscultation, especially in a patient who presents with a low INR.
Next, prove that obstruction is present via Doppler echocardiographic evidence of an abnormal gradient across the mechanical valve.
Finally, determine if the mechanical valve shows abnormal disc motion with sticking leaflets. TEE is excellent for visualizing a mechanical mitral valve but isn’t helpful if it’s a mechanical aortic valve.
“Old-fashioned fluoroscopy is the best approach for looking at leaflet motion in the atrial valve and mitral valve. We’ve got 3-D cine now that provides beautiful images, but if you can get the same information with a quick fluoroscopy, go with the fluoroscopy,” the cardiologist suggested.
He reported having no financial conflicts of interest.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Small study: Drug combo achieves negative bacterial culture in all TB patients
SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.
The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.
The mortality rate among study participants was less than 6%.
“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.
Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.
Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.
Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.
Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.
Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.
Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.
The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.
Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.
SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.
The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.
The mortality rate among study participants was less than 6%.
“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.
Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.
Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.
Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.
Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.
Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.
Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.
The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.
Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.
SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.
The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.
The mortality rate among study participants was less than 6%.
“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.
Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.
Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.
Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.
Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.
Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.
Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.
The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.
Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.
AT CROI
Key clinical point: An oral, three-drug combination led to undetectable bacteria levels.
Major finding: All of the patients in the study were culture negative at 4 months.
Data source: Open-label trial of 72 patients at two centers.
Disclosures: Dr. Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.
Most lung recipients gain 2-year survival benefit
Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.
In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.
“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.
Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).
Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.
However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.
“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”
Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.
Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.
However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.
“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.
The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.
Lung transplantation is the only option available for patients with treatment-resistant end-stage lung disease. However, the ability of this intervention to extend survival is still actively debated. The authors demonstrate that most adults undergoing lung transplantation experience a survival benefit that is mainly driven by the value of the lung allocation score at the time of transplantation and by the underlying lung disease.
It is reassuring to see that the two studies published so far that accounted for the course of patient disease after placement on a wait list reached essentially the same conclusions: Most of the patients experienced a survival benefit from lung transplantation.
Dr. Gabriel Thabut is from the service de pneumologie B and transplantation pulmonaire at the University of Paris. These comments are taken from an accompanying editorial (Ann Am Thorac Soc. 2017;14:163-4. doi: 10.1513/AnnalsATS.201611-853ED). No conflicts of interest were declared.
Lung transplantation is the only option available for patients with treatment-resistant end-stage lung disease. However, the ability of this intervention to extend survival is still actively debated. The authors demonstrate that most adults undergoing lung transplantation experience a survival benefit that is mainly driven by the value of the lung allocation score at the time of transplantation and by the underlying lung disease.
It is reassuring to see that the two studies published so far that accounted for the course of patient disease after placement on a wait list reached essentially the same conclusions: Most of the patients experienced a survival benefit from lung transplantation.
Dr. Gabriel Thabut is from the service de pneumologie B and transplantation pulmonaire at the University of Paris. These comments are taken from an accompanying editorial (Ann Am Thorac Soc. 2017;14:163-4. doi: 10.1513/AnnalsATS.201611-853ED). No conflicts of interest were declared.
Lung transplantation is the only option available for patients with treatment-resistant end-stage lung disease. However, the ability of this intervention to extend survival is still actively debated. The authors demonstrate that most adults undergoing lung transplantation experience a survival benefit that is mainly driven by the value of the lung allocation score at the time of transplantation and by the underlying lung disease.
It is reassuring to see that the two studies published so far that accounted for the course of patient disease after placement on a wait list reached essentially the same conclusions: Most of the patients experienced a survival benefit from lung transplantation.
Dr. Gabriel Thabut is from the service de pneumologie B and transplantation pulmonaire at the University of Paris. These comments are taken from an accompanying editorial (Ann Am Thorac Soc. 2017;14:163-4. doi: 10.1513/AnnalsATS.201611-853ED). No conflicts of interest were declared.
Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.
In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.
“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.
Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).
Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.
However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.
“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”
Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.
Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.
However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.
“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.
The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.
Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.
In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.
“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.
Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).
Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.
However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.
“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”
Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.
Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.
However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.
“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.
The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.
FROM ANNALS OF THE AMERICAN THORACIC SOCIETY
Key clinical point: Nearly three-quarters of lung transplant recipients are predicted to achieve a 2-year survival benefit with transplantation.
Major finding: Research suggests 73.8% of transplant recipients are likely to achieve a 2-year survival benefit with transplantation.
Data source: A structural nested accelerated failure time model of the survival benefit of lung transplantation using data from 13,040 adults listed for lung transplantation.
Disclosures: The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.
Watch and wait often better than resecting in ground-glass opacities
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
FROM CHEST
Key clinical point:
Major finding: Of 226 patients with ground-glass opacity lesions 3 cm or less in size, 124 had resection, 57 required no further follow-up, and 45 continue to receive follow-up.
Data source: Long-term study of 226 patients with pure or mixed ground-glass opacities of 3 cm or less given regular CT imaging between 2000 and 2005.
Disclosures: Neither the investigators nor the editorial writer had any relevant disclosures.
Want better patient engagement? Use social media
ORLANDO – Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.
That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.
“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.
He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.
“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”
Video messaging also helps doctors support their peers, Dr. Campbell said.
“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”
Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.
“The patient benefits because there are more brains thinking about their problem,” he noted.
Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.
But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.
“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”
The caveat, of course, is that specific, protected information cannot be shared or posted.
“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”
Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.
“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.
Dr. Campbell reported no conflicts of interest.
ORLANDO – Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.
That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.
“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.
He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.
“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”
Video messaging also helps doctors support their peers, Dr. Campbell said.
“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”
Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.
“The patient benefits because there are more brains thinking about their problem,” he noted.
Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.
But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.
“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”
The caveat, of course, is that specific, protected information cannot be shared or posted.
“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”
Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.
“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.
Dr. Campbell reported no conflicts of interest.
ORLANDO – Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.
That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.
“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.
He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.
“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”
Video messaging also helps doctors support their peers, Dr. Campbell said.
“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”
Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.
“The patient benefits because there are more brains thinking about their problem,” he noted.
Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.
But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.
“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”
The caveat, of course, is that specific, protected information cannot be shared or posted.
“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”
Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.
“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.
Dr. Campbell reported no conflicts of interest.
AT HIMSS17