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The Official Newspaper of the American Association for Thoracic Surgery
OpenNotes: Patient engagement with low physician hassle
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
AT HIMSS 2017
Intensive ventilation precedes lesser pulmonary complications
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
FROM ISICEM
Key clinical point: Intensive lung recruitment during mechanical ventilation of hypoxemic cardiac surgery patients was followed by less severe pulmonary complications, compared with moderate lung recruitment.
Major finding: Compared with moderate alveolar recruitment, intensive recruitment nearly doubled the odds that patients had a lower pulmonary complications score (odds ratio, 1.9; 95% confidence interval, 1.2 to 2.8; P = .003).
Data source: A single-center randomized trial of 320 adults with no history of pulmonary disease who developed hypoxemia after undergoing elective cardiac surgery.
Disclosures: FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Levosimendan does not improve 30-day mortality following cardiac surgery
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Key clinical point:
Major finding: Among other things, 30-day mortality rates between levosimendan (12.9%) and placebo (12.8%) cohorts were not significantly different (P = .97).
Data source: The CHEETAH study is a multicenter, randomized, double-blind, placebo-controlled trial of 506 cardiac surgery patients recommended for perioperative hemodynamic support.
Disclosures: Funded by the Italian Ministry of Health. Several coauthors reported potentially relevant conflicts of interest.
LVADs achieve cardiac palliation in muscular dystrophies
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A left ventricular assist device can be used as destination therapy in patients with Duchenne muscular dystrophy dystrophinopathies and end-stage dilated cardiomyopathy.
Major finding: Four of seven patients who had LVAD survived long term, and survival for the three who died ranged from 15 to 44 months.
Data source: Single-center, retrospective review of seven patients with DMD who had LVAD for DCM from February 2011 to February 2016.
Disclosure: Dr. Perri and his coauthors reported having no relevant financial disclosures.
Preoperative variables can predict prolonged air leak
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Preoperative variables can be evaluated to determine patient risk for prolonged air leak (PAL) in lung resection for cancer.
Major finding: A nomogram demonstrated 76% discriminatory accuracy in predicting PAL after lung resection.
Data source: Analysis of 2,522 pulmonary resections performed at eight hospitals within the University of Pittsburgh health system from January 2009 to June 2014.
Disclosures: The researchers had no conflicts of interest to disclose.
VIDEO: Subclinical leaflet thrombosis frequent after TAVR, SAVR
WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.
In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Makkar and his associates studied this issue by analyzing data in the RESOLVE (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and its Treatment with Anticoagulation) registry at Cedars-Sinai and the SAVORY (Subclinical Aortic Valve Biosprosthesis Thrombosis Assessed with Four-Dimensional CT) registry at the Rigshospitalet Heart Center in Copenhagen. Their study focused on enrolled patients who underwent either TAVR (626 patients) or SAVR (264 patients) and then had high-resolution CT scans done at various times after implantation. All the CT scans were analyzed in blinded fashion, and the study participants were followed for a mean of 540 days.
The prevalence of subclinical leaflet thrombosis was significantly higher in TAVR valves (13%) than in SAVR valves (4%). The severity of the thrombosis also was significantly higher in TAVR valves, when measured by the extent of leaflet motion restriction (71.0% vs. 56.9%).
One possible reason for this discrepancy is that traumatic injury to the pericardial leaflets, which theoretically could predispose to thrombus formation, may be more likely to occur during crimping and deployment of balloon-expandable and self-expanding stent valves in TAVR. Another possibility is that resection of the calcified native aortic valves during SAVR might improve flow dynamics after valve replacement, compared with leaving native aortic valve cusps in situ during TAVR. A third possibility is that inadvertent incomplete expansion or overexpansion of transcatheter valves might alter mechanical stress on the leaflets, predisposing them to thrombus formation, compared with the uniform expansion of valves placed surgically, the investigator said.
“Nevertheless, these findings should be interpreted in the context of findings from multiple randomized controlled trials showing similar mortality and stroke rates, better hemodynamics, and equivalent durability of transcatheter aortic valves at 5 years, compared with surgical valves,” he noted.
Patients taking novel oral anticoagulants (NOACs) or warfarin for anticoagulation before valve replacement were less likely to develop subclinical leaflet thrombosis than patients not taking those anticoagulants. And the thrombosis appeared to resolve in all patients treated with NOACs or warfarin for 30 days after it was found on CT, but it persisted or progressed in those not treated with anticoagulation. Thus, “anticoagulation with NOACs or warfarin was effective in prevention and treatment of reduced leaflet motion, but dual-antiplatelet therapy, which is the standard of care, was not,” the investigators said (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2.
“Our study challenges the American College of Cardiology and American Heart Association and European Society of Cardiology and European Association for Cardio-Thoracic Surgery guidelines, which recommend dual-antiplatelet therapy after TAVR and do not recommend routine anticoagulation after TAVR,” he noted.
However, routine anticoagulation for all TAVR and SAVR patients, or even for all who develop leaflet thrombosis, cannot be recommended on the basis of results from a single observational study. The benefit of anticoagulation may not offset the risk of bleeding in this predominantly elderly population with multiple comorbidities, he said.
There were no significant differences between patients who developed subclinical leaflet thrombosis and those who did not regarding rates of death, MI, or stroke. However, “reduced leaflet wall motion was significantly associated with increased rates of all TIAs [transient ischemic attacks], nonprocedural TIAs, and post-CT TIAs.” Dr. Makkar said.
Based on his new findings, Dr. Makkar suggested that clinicians keep possible leaflet thrombosis on a replaced aortic valve in mind if they see clinical evidence for it, such as an increase in the valve’s pressure gradient or development of a TIA or stroke.* These events should trigger further investigation of the valve with CT angiography, and if thrombosis is then confirmed, the patient should receive treatment with an anticoagulant, although the appropriate duration of anticoagulant treatment remains unclear, he said in a video interview. Dr. Makkar also said that trials are needed to determine whether routine CT angiography assessment or routine prophylactic treatment with an anticoagulant is warranted because the antiplatelet therapy that patients currently receive after aortic valve replacement seems unable to prevent leaflet thrombosis.
Since this was an observational study based on data from nonrandomized registries, the findings cannot prove causality but only an association between leaflet thrombosis and TIA. They must be substantiated in further studies, including “the current Food and Drug Administration–mandated imaging substudies in randomized clinical trials.”
Dr. Makkar has received consultant fees and/or honoraria from Abbott Vascular, Medtronic, Cordis, and Entourage Medical, and research grants from Edwards Lifesciences and St. Jude Medical.
Mitchel L. Zoler contributed to this report.
Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.
The study by Dr. Makkar and his coinvestigators provides important new information to guide future research, but changing clinical practice or guidelines on the basis of this information would be premature.
In particular, whether to recommend anticoagulation therapy to TAVR and SAVR patients is unknown, given the risks of chronic anticoagulation. We do not yet know whether such a recommendation should be guided by CT or echocardiographic imaging, and, if so, at what intervals? We don’t yet know the optimal duration of anticoagulation treatment, or whether NOAC’s are as good as or better than warfarin in this setting. And we don’t yet know whether the risk of bleeding is offset by a reduction in stroke or any other meaningful clinical sequelae.
Jeroen J. Bax, MD, is in the department of cardiology at Leiden (the Netherlands) University Medical Center. Gregg W. Stone, MD, is at Columbia University Medical Center and the Cardiovascular Research Foundation, both in New York. Dr. Bax’s institution has received unrestricted research grants from Biotronik, Medtronic, Boston Scientific, and Edwards LifeScience; Dr. Stone reported ties to numerous industry sources. Dr. Bax and Dr. Stone made these remarks in an editorial accompanying the Lancet report (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2).
The study by Dr. Makkar and his coinvestigators provides important new information to guide future research, but changing clinical practice or guidelines on the basis of this information would be premature.
In particular, whether to recommend anticoagulation therapy to TAVR and SAVR patients is unknown, given the risks of chronic anticoagulation. We do not yet know whether such a recommendation should be guided by CT or echocardiographic imaging, and, if so, at what intervals? We don’t yet know the optimal duration of anticoagulation treatment, or whether NOAC’s are as good as or better than warfarin in this setting. And we don’t yet know whether the risk of bleeding is offset by a reduction in stroke or any other meaningful clinical sequelae.
Jeroen J. Bax, MD, is in the department of cardiology at Leiden (the Netherlands) University Medical Center. Gregg W. Stone, MD, is at Columbia University Medical Center and the Cardiovascular Research Foundation, both in New York. Dr. Bax’s institution has received unrestricted research grants from Biotronik, Medtronic, Boston Scientific, and Edwards LifeScience; Dr. Stone reported ties to numerous industry sources. Dr. Bax and Dr. Stone made these remarks in an editorial accompanying the Lancet report (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2).
The study by Dr. Makkar and his coinvestigators provides important new information to guide future research, but changing clinical practice or guidelines on the basis of this information would be premature.
In particular, whether to recommend anticoagulation therapy to TAVR and SAVR patients is unknown, given the risks of chronic anticoagulation. We do not yet know whether such a recommendation should be guided by CT or echocardiographic imaging, and, if so, at what intervals? We don’t yet know the optimal duration of anticoagulation treatment, or whether NOAC’s are as good as or better than warfarin in this setting. And we don’t yet know whether the risk of bleeding is offset by a reduction in stroke or any other meaningful clinical sequelae.
Jeroen J. Bax, MD, is in the department of cardiology at Leiden (the Netherlands) University Medical Center. Gregg W. Stone, MD, is at Columbia University Medical Center and the Cardiovascular Research Foundation, both in New York. Dr. Bax’s institution has received unrestricted research grants from Biotronik, Medtronic, Boston Scientific, and Edwards LifeScience; Dr. Stone reported ties to numerous industry sources. Dr. Bax and Dr. Stone made these remarks in an editorial accompanying the Lancet report (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2).
WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.
In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Makkar and his associates studied this issue by analyzing data in the RESOLVE (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and its Treatment with Anticoagulation) registry at Cedars-Sinai and the SAVORY (Subclinical Aortic Valve Biosprosthesis Thrombosis Assessed with Four-Dimensional CT) registry at the Rigshospitalet Heart Center in Copenhagen. Their study focused on enrolled patients who underwent either TAVR (626 patients) or SAVR (264 patients) and then had high-resolution CT scans done at various times after implantation. All the CT scans were analyzed in blinded fashion, and the study participants were followed for a mean of 540 days.
The prevalence of subclinical leaflet thrombosis was significantly higher in TAVR valves (13%) than in SAVR valves (4%). The severity of the thrombosis also was significantly higher in TAVR valves, when measured by the extent of leaflet motion restriction (71.0% vs. 56.9%).
One possible reason for this discrepancy is that traumatic injury to the pericardial leaflets, which theoretically could predispose to thrombus formation, may be more likely to occur during crimping and deployment of balloon-expandable and self-expanding stent valves in TAVR. Another possibility is that resection of the calcified native aortic valves during SAVR might improve flow dynamics after valve replacement, compared with leaving native aortic valve cusps in situ during TAVR. A third possibility is that inadvertent incomplete expansion or overexpansion of transcatheter valves might alter mechanical stress on the leaflets, predisposing them to thrombus formation, compared with the uniform expansion of valves placed surgically, the investigator said.
“Nevertheless, these findings should be interpreted in the context of findings from multiple randomized controlled trials showing similar mortality and stroke rates, better hemodynamics, and equivalent durability of transcatheter aortic valves at 5 years, compared with surgical valves,” he noted.
Patients taking novel oral anticoagulants (NOACs) or warfarin for anticoagulation before valve replacement were less likely to develop subclinical leaflet thrombosis than patients not taking those anticoagulants. And the thrombosis appeared to resolve in all patients treated with NOACs or warfarin for 30 days after it was found on CT, but it persisted or progressed in those not treated with anticoagulation. Thus, “anticoagulation with NOACs or warfarin was effective in prevention and treatment of reduced leaflet motion, but dual-antiplatelet therapy, which is the standard of care, was not,” the investigators said (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2.
“Our study challenges the American College of Cardiology and American Heart Association and European Society of Cardiology and European Association for Cardio-Thoracic Surgery guidelines, which recommend dual-antiplatelet therapy after TAVR and do not recommend routine anticoagulation after TAVR,” he noted.
However, routine anticoagulation for all TAVR and SAVR patients, or even for all who develop leaflet thrombosis, cannot be recommended on the basis of results from a single observational study. The benefit of anticoagulation may not offset the risk of bleeding in this predominantly elderly population with multiple comorbidities, he said.
There were no significant differences between patients who developed subclinical leaflet thrombosis and those who did not regarding rates of death, MI, or stroke. However, “reduced leaflet wall motion was significantly associated with increased rates of all TIAs [transient ischemic attacks], nonprocedural TIAs, and post-CT TIAs.” Dr. Makkar said.
Based on his new findings, Dr. Makkar suggested that clinicians keep possible leaflet thrombosis on a replaced aortic valve in mind if they see clinical evidence for it, such as an increase in the valve’s pressure gradient or development of a TIA or stroke.* These events should trigger further investigation of the valve with CT angiography, and if thrombosis is then confirmed, the patient should receive treatment with an anticoagulant, although the appropriate duration of anticoagulant treatment remains unclear, he said in a video interview. Dr. Makkar also said that trials are needed to determine whether routine CT angiography assessment or routine prophylactic treatment with an anticoagulant is warranted because the antiplatelet therapy that patients currently receive after aortic valve replacement seems unable to prevent leaflet thrombosis.
Since this was an observational study based on data from nonrandomized registries, the findings cannot prove causality but only an association between leaflet thrombosis and TIA. They must be substantiated in further studies, including “the current Food and Drug Administration–mandated imaging substudies in randomized clinical trials.”
Dr. Makkar has received consultant fees and/or honoraria from Abbott Vascular, Medtronic, Cordis, and Entourage Medical, and research grants from Edwards Lifesciences and St. Jude Medical.
Mitchel L. Zoler contributed to this report.
Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.
WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.
In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Makkar and his associates studied this issue by analyzing data in the RESOLVE (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and its Treatment with Anticoagulation) registry at Cedars-Sinai and the SAVORY (Subclinical Aortic Valve Biosprosthesis Thrombosis Assessed with Four-Dimensional CT) registry at the Rigshospitalet Heart Center in Copenhagen. Their study focused on enrolled patients who underwent either TAVR (626 patients) or SAVR (264 patients) and then had high-resolution CT scans done at various times after implantation. All the CT scans were analyzed in blinded fashion, and the study participants were followed for a mean of 540 days.
The prevalence of subclinical leaflet thrombosis was significantly higher in TAVR valves (13%) than in SAVR valves (4%). The severity of the thrombosis also was significantly higher in TAVR valves, when measured by the extent of leaflet motion restriction (71.0% vs. 56.9%).
One possible reason for this discrepancy is that traumatic injury to the pericardial leaflets, which theoretically could predispose to thrombus formation, may be more likely to occur during crimping and deployment of balloon-expandable and self-expanding stent valves in TAVR. Another possibility is that resection of the calcified native aortic valves during SAVR might improve flow dynamics after valve replacement, compared with leaving native aortic valve cusps in situ during TAVR. A third possibility is that inadvertent incomplete expansion or overexpansion of transcatheter valves might alter mechanical stress on the leaflets, predisposing them to thrombus formation, compared with the uniform expansion of valves placed surgically, the investigator said.
“Nevertheless, these findings should be interpreted in the context of findings from multiple randomized controlled trials showing similar mortality and stroke rates, better hemodynamics, and equivalent durability of transcatheter aortic valves at 5 years, compared with surgical valves,” he noted.
Patients taking novel oral anticoagulants (NOACs) or warfarin for anticoagulation before valve replacement were less likely to develop subclinical leaflet thrombosis than patients not taking those anticoagulants. And the thrombosis appeared to resolve in all patients treated with NOACs or warfarin for 30 days after it was found on CT, but it persisted or progressed in those not treated with anticoagulation. Thus, “anticoagulation with NOACs or warfarin was effective in prevention and treatment of reduced leaflet motion, but dual-antiplatelet therapy, which is the standard of care, was not,” the investigators said (Lancet 2017 Mar 19. doi: 10.1016/S0140-6736(17)30757-2.
“Our study challenges the American College of Cardiology and American Heart Association and European Society of Cardiology and European Association for Cardio-Thoracic Surgery guidelines, which recommend dual-antiplatelet therapy after TAVR and do not recommend routine anticoagulation after TAVR,” he noted.
However, routine anticoagulation for all TAVR and SAVR patients, or even for all who develop leaflet thrombosis, cannot be recommended on the basis of results from a single observational study. The benefit of anticoagulation may not offset the risk of bleeding in this predominantly elderly population with multiple comorbidities, he said.
There were no significant differences between patients who developed subclinical leaflet thrombosis and those who did not regarding rates of death, MI, or stroke. However, “reduced leaflet wall motion was significantly associated with increased rates of all TIAs [transient ischemic attacks], nonprocedural TIAs, and post-CT TIAs.” Dr. Makkar said.
Based on his new findings, Dr. Makkar suggested that clinicians keep possible leaflet thrombosis on a replaced aortic valve in mind if they see clinical evidence for it, such as an increase in the valve’s pressure gradient or development of a TIA or stroke.* These events should trigger further investigation of the valve with CT angiography, and if thrombosis is then confirmed, the patient should receive treatment with an anticoagulant, although the appropriate duration of anticoagulant treatment remains unclear, he said in a video interview. Dr. Makkar also said that trials are needed to determine whether routine CT angiography assessment or routine prophylactic treatment with an anticoagulant is warranted because the antiplatelet therapy that patients currently receive after aortic valve replacement seems unable to prevent leaflet thrombosis.
Since this was an observational study based on data from nonrandomized registries, the findings cannot prove causality but only an association between leaflet thrombosis and TIA. They must be substantiated in further studies, including “the current Food and Drug Administration–mandated imaging substudies in randomized clinical trials.”
Dr. Makkar has received consultant fees and/or honoraria from Abbott Vascular, Medtronic, Cordis, and Entourage Medical, and research grants from Edwards Lifesciences and St. Jude Medical.
Mitchel L. Zoler contributed to this report.
Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.
AT ACC 17
Key clinical point: Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically.
Major finding: Reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%).
Data source: An observational cohort study involving 890 patients enrolled in two registries who underwent high-resolution CT to detect leaflet thrombosis after either TAVR or SAVR.
Disclosures: The RESOLVE study was funded by Cedars-Sinai Heart Institute and the SAVORY study was funded by Rigshospitalet. Dr. Makkar has received consultant fees and/or honoraria from Abbott Vascular, Medtronic, Cordis, and Entourage Medical, and research grants from Edwards Lifesciences and St. Jude Medical.
VIDEO: SURTAVI results ‘tremendously important’ for decision making
Washington – Heart teams will have more options when making treatment decisions for patients with severe aortic stenosis who are at intermediate risk, now that the results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial have been presented.
Those results showed that transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis at intermediate risk was not only noninferior to surgical replacement, “but in my mind superior, because you don’t get your chest cracked, you get home earlier, and you have fewer strokes [in this trial], Roxana Mehran, MD, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York, said in a video interview at the annual meeting of the American College of Cardiology.
In SURTAVI, which used Medtronic’s self-expanding CoreValve and Evolut-R bioprostheses in 863 patients randomized to TAVR, 12.6% met the study’s primary endpoint – death from any cause or disabling stroke at 24 months – versus 14% of the 796 patients randomized to surgery, a statistically nonsignificant difference. Notably, the risk of any type of stroke at 30 days was statistically superior for TAVR, 3.4%, compared with 5.6% for surgical replacement.
“It’s tremendously important to see the change in how we’re going to be evaluating patients with aortic stenosis,” Dr. Mehran said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Washington – Heart teams will have more options when making treatment decisions for patients with severe aortic stenosis who are at intermediate risk, now that the results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial have been presented.
Those results showed that transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis at intermediate risk was not only noninferior to surgical replacement, “but in my mind superior, because you don’t get your chest cracked, you get home earlier, and you have fewer strokes [in this trial], Roxana Mehran, MD, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York, said in a video interview at the annual meeting of the American College of Cardiology.
In SURTAVI, which used Medtronic’s self-expanding CoreValve and Evolut-R bioprostheses in 863 patients randomized to TAVR, 12.6% met the study’s primary endpoint – death from any cause or disabling stroke at 24 months – versus 14% of the 796 patients randomized to surgery, a statistically nonsignificant difference. Notably, the risk of any type of stroke at 30 days was statistically superior for TAVR, 3.4%, compared with 5.6% for surgical replacement.
“It’s tremendously important to see the change in how we’re going to be evaluating patients with aortic stenosis,” Dr. Mehran said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Washington – Heart teams will have more options when making treatment decisions for patients with severe aortic stenosis who are at intermediate risk, now that the results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial have been presented.
Those results showed that transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis at intermediate risk was not only noninferior to surgical replacement, “but in my mind superior, because you don’t get your chest cracked, you get home earlier, and you have fewer strokes [in this trial], Roxana Mehran, MD, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York, said in a video interview at the annual meeting of the American College of Cardiology.
In SURTAVI, which used Medtronic’s self-expanding CoreValve and Evolut-R bioprostheses in 863 patients randomized to TAVR, 12.6% met the study’s primary endpoint – death from any cause or disabling stroke at 24 months – versus 14% of the 796 patients randomized to surgery, a statistically nonsignificant difference. Notably, the risk of any type of stroke at 30 days was statistically superior for TAVR, 3.4%, compared with 5.6% for surgical replacement.
“It’s tremendously important to see the change in how we’re going to be evaluating patients with aortic stenosis,” Dr. Mehran said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACC 17
STAS predictive for lung SCC recurrence
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC ONCOLOGY
Key clinical point: Spread through air spaces (STAS) is a prognostic histologic finding in lung squamous cell carcinoma.
Major finding: STAS was observed in 30% of patients and frequency increased with age.
Data source: Retrospective analysis of 445 resections for solitary stage I-III lung squamous cell carcinoma at Memorial Sloan-Kettering Cancer Center between 1999 and 2009.
Disclosure: Dr. Lu and coauthors reported having no relevant financial disclosures.
Can better operations improve CABG in women?
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Survival rates after CABG are worse for women than for men.
Major finding: In both men and women, complete revascularization and use of bilateral-ITA grafting achieve better long-term survival than incomplete revascularization and single-ITA grafting.
Data source: Analysis of 57,943 adults who had primary isolated CABG from 1972 to 2011 at Cleveland Clinic.
Disclosure: Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial disclosures.
By The Numbers: Trump’s choice for FDA chief is versatile, entrenched in Pharma
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.