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Embolism major cause of stroke after open arch surgery in patients with carotid/intracranial stenosis
Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.
Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.
Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).
After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.
Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).
The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.
Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.
“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.
The authors reported that they had no disclosures.
During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).
Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.
This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.
“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.
Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.
During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).
Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.
This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.
“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.
Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.
During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).
Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.
This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.
“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.
Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.
Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.
Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.
Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).
After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.
Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).
The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.
Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.
“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.
The authors reported that they had no disclosures.
Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.
Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.
Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).
After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.
Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).
The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.
Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.
“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.
The authors reported that they had no disclosures.
Key clinical point:
Major finding: Previous cerebrovascular accident and shaggy aorta were significant determinants of neurologic morbidity.
Data source: Retrospective study of 200 consecutive patients undergoing elective aortic arch surgery at a single institution.
Disclosures: The authors reported having no conflicts of interest.
Confronting the open chest – Samuel J. Meltzer and the first AATS annual meeting
In retrospect, the founding of the American Association for Thoracic Surgery (AATS) in 1917 may seem surprisingly optimistic, given the status of cardiothoracic surgery as a discipline at that time. While important strides had been made in dealing with open chest wounds, to the modern eye, the field in the second decade of the 20th century seems more characterized by what was not yet possible rather than by what was.
One of the most critical issues holding back the development of cardiothoracic surgery in this early period was the problem of acute pneumothorax that occurred whenever the chest was opened.
As Willy Meyer (1858-1932), second president of the AATS, described the problem at the first AATS annual meeting in 1917: “What is it that happens when the thorax is opened, let us say [for example] by a stab wound in an intercostal space in an affray on the street? Immediately air rushes into the pleural cavity and this normal atmospheric pressure, being greater than the normal pressure within ... the lung contracts to a very small organ around its hilum. Air fills the space formerly occupied by the lung. This condition, with its immediate clinical pathologic consequences, is called ‘acute pneumothorax.’ It has been the stumbling block for almost a century to the proper development of the surgery of the chest. … Carbonic acid is retained in the blood … The accumulation of CO, with its deleterious effect increases, finally ending in the patient’s death.”
But in the first decade of the 20th century, two major and competing techniques evolved to solve the problem, each one represented by the first and second presidents of the fledgling AATS. For a short period of time a controversy seemed to separate the two men, but their views were expressly reconciled at the first annual meeting of the AATS.
The Meltzer/Auer technique was significantly improved upon by the addition of a carbon dioxide absorption method and the creation of a closed circuit apparatus by Dennis Jackson, MD (1878-1980) in 1915. “This fulfilled the criteria of oxygen supply, carbon dioxide absorption, and ether regulation with a hand bag-breather. With this apparatus, respiration could be maintained with the open thorax,” said pioneering thoracic surgeon Rudolf Nissen, MD, and Roger H.L. Wilson, MD, in their Pages in the History of Chest Surgery (Springfield, IL: Charles C. Thomas, 1960).
However, insufflation was not universally applauded when it was first introduced. It was considered a poor second by many who instead embraced the alternate method of preventing chest collapse – the differential pressure–maintaining Sauerbruch chamber. The Sauerbruch chamber was developed by Ernst Ferdinand Sauerbruch (1875-1951) and first reported in 1904 in his paper, “The pathology of open pneumothorax and the bases of my methods for its elimination.”
As described by Nissen and Wilson, “He transformed the operating room into a kind of extended or enlarged pleural cavity, lowering the atmospheric pressure by vacuum. The head of the patient was outside the operating room, tightly sealed at the neck. This ‘pneumatic chamber’ solved in an ideal way the problem of negative pleural pressure.”
Sauerbruch was aware of the Meltzer/Auer technique, but specifically rejected it, and his powerful influence in Germany helped to prevent it from being adopted there.
Among the earliest and most vocal advocates of using the Sauerbruch negative pressure chamber approach in the United States was Dr. Meyer. Both he and Dr. Meltzer addressed the issue and the controversy at the first meeting of the AATS in 1917.
“You probably remember the little battle between differential pressure and intratracheal insufflation. It occurred only 8 years ago; but it seems now like history. When I presented my paper on intratracheal insufflation at the New York Academy of Medicine, my views were opposed, in the interest of conservatism in surgery, by three able surgeons,” Dr. Meltzer said in his address.
“Now, these same surgeons are among the principal founders of the American Association for Thoracic Surgery, and my being the first presiding officer of the Association is due exclusively to their generous spirit and not to any merits of mine. This is my little story of how the introduction of a stomach tube carried a mere medical man into the presidential chair of a national surgical association.”
Dr. Meyer, one of the three surgeons mentioned by Dr. Meltzer, responded shortly thereafter in his own speech at the meeting: “Dr. Meltzer mentioned in his inaugural address today that, in the discussion following his presentation of the matter before the New York Academy of Medicine his views were opposed, in the interest of conservatism in surgery, by three surgeons.
“Inasmuch as I was one of the three, I would, in explanation, here state that ... at that very time it was reported to me that Dr. Meltzer had stated that in his opinion thoracic operations on human beings could be done in a much simpler way than by working in the negative chamber; that a catheter in the trachea and bellows was all that was needed. He, a physiologist who had always done scientific surgical work on animals, certainly found these paraphernalia sufficient. I personally had meanwhile seen and learned to admire the absolutely reliable working of the mechanism of the chamber, without the possibility of doing the slightest harm to the patient.
“In my remarks on that memorable evening at the New York Academy of Medicine, I therefore tried to impress upon my colleagues the great importance of absolute safety. I stated that no matter what apparatus we might use in thoracic surgery on the usually much run down human being, it must be so constructed that it could not possibly do harm to the patient. I further stated that I would be only too happy to personally use intratracheal insufflation as soon as it was sufficiently perfected to render it safe under all conditions. … I want to lay stress upon the statement that I for my part have never been in opposition, but rather in full accord with his splendid discovery. The fact is that I personally have been among the very first in New York to use intratracheal insufflation in thoracic operations upon the human subject,” said Dr. Meyer.
“But, please bear in mind … that only the use of the differential pressure method – no matter what the apparatus – enables the surgeon to work in the thorax with the same equanimity and tranquility as in the abdomen,” he summarized.
So by the early years of the founding of the AATS, no matter the barriers that remained, the fact that thoracic surgery had reached the same level of confidence in terms of attempting operations as had already existed for the abdomen permitted the fledgling association to move forward with a confidence and optimism that had not existed before, when opening the chest in the operating room was generally considered deadly.
Sources
Meltzer, S. J., 1917. First President’s Address. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/First-Presidents-Address.cgi
Meyer, W., 1917. Surgery Within the Past Fourteen Years. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/A-Review-of-the-Evolution-of-Thoracic-Surgery-Within-the-Pas.cgi
Nissen, R., Wilson, R.H.L. Pages in the History of Chest Surgery. Springfield, IL: Charles C. Thomas, 1960.
In retrospect, the founding of the American Association for Thoracic Surgery (AATS) in 1917 may seem surprisingly optimistic, given the status of cardiothoracic surgery as a discipline at that time. While important strides had been made in dealing with open chest wounds, to the modern eye, the field in the second decade of the 20th century seems more characterized by what was not yet possible rather than by what was.
One of the most critical issues holding back the development of cardiothoracic surgery in this early period was the problem of acute pneumothorax that occurred whenever the chest was opened.
As Willy Meyer (1858-1932), second president of the AATS, described the problem at the first AATS annual meeting in 1917: “What is it that happens when the thorax is opened, let us say [for example] by a stab wound in an intercostal space in an affray on the street? Immediately air rushes into the pleural cavity and this normal atmospheric pressure, being greater than the normal pressure within ... the lung contracts to a very small organ around its hilum. Air fills the space formerly occupied by the lung. This condition, with its immediate clinical pathologic consequences, is called ‘acute pneumothorax.’ It has been the stumbling block for almost a century to the proper development of the surgery of the chest. … Carbonic acid is retained in the blood … The accumulation of CO, with its deleterious effect increases, finally ending in the patient’s death.”
But in the first decade of the 20th century, two major and competing techniques evolved to solve the problem, each one represented by the first and second presidents of the fledgling AATS. For a short period of time a controversy seemed to separate the two men, but their views were expressly reconciled at the first annual meeting of the AATS.
The Meltzer/Auer technique was significantly improved upon by the addition of a carbon dioxide absorption method and the creation of a closed circuit apparatus by Dennis Jackson, MD (1878-1980) in 1915. “This fulfilled the criteria of oxygen supply, carbon dioxide absorption, and ether regulation with a hand bag-breather. With this apparatus, respiration could be maintained with the open thorax,” said pioneering thoracic surgeon Rudolf Nissen, MD, and Roger H.L. Wilson, MD, in their Pages in the History of Chest Surgery (Springfield, IL: Charles C. Thomas, 1960).
However, insufflation was not universally applauded when it was first introduced. It was considered a poor second by many who instead embraced the alternate method of preventing chest collapse – the differential pressure–maintaining Sauerbruch chamber. The Sauerbruch chamber was developed by Ernst Ferdinand Sauerbruch (1875-1951) and first reported in 1904 in his paper, “The pathology of open pneumothorax and the bases of my methods for its elimination.”
As described by Nissen and Wilson, “He transformed the operating room into a kind of extended or enlarged pleural cavity, lowering the atmospheric pressure by vacuum. The head of the patient was outside the operating room, tightly sealed at the neck. This ‘pneumatic chamber’ solved in an ideal way the problem of negative pleural pressure.”
Sauerbruch was aware of the Meltzer/Auer technique, but specifically rejected it, and his powerful influence in Germany helped to prevent it from being adopted there.
Among the earliest and most vocal advocates of using the Sauerbruch negative pressure chamber approach in the United States was Dr. Meyer. Both he and Dr. Meltzer addressed the issue and the controversy at the first meeting of the AATS in 1917.
“You probably remember the little battle between differential pressure and intratracheal insufflation. It occurred only 8 years ago; but it seems now like history. When I presented my paper on intratracheal insufflation at the New York Academy of Medicine, my views were opposed, in the interest of conservatism in surgery, by three able surgeons,” Dr. Meltzer said in his address.
“Now, these same surgeons are among the principal founders of the American Association for Thoracic Surgery, and my being the first presiding officer of the Association is due exclusively to their generous spirit and not to any merits of mine. This is my little story of how the introduction of a stomach tube carried a mere medical man into the presidential chair of a national surgical association.”
Dr. Meyer, one of the three surgeons mentioned by Dr. Meltzer, responded shortly thereafter in his own speech at the meeting: “Dr. Meltzer mentioned in his inaugural address today that, in the discussion following his presentation of the matter before the New York Academy of Medicine his views were opposed, in the interest of conservatism in surgery, by three surgeons.
“Inasmuch as I was one of the three, I would, in explanation, here state that ... at that very time it was reported to me that Dr. Meltzer had stated that in his opinion thoracic operations on human beings could be done in a much simpler way than by working in the negative chamber; that a catheter in the trachea and bellows was all that was needed. He, a physiologist who had always done scientific surgical work on animals, certainly found these paraphernalia sufficient. I personally had meanwhile seen and learned to admire the absolutely reliable working of the mechanism of the chamber, without the possibility of doing the slightest harm to the patient.
“In my remarks on that memorable evening at the New York Academy of Medicine, I therefore tried to impress upon my colleagues the great importance of absolute safety. I stated that no matter what apparatus we might use in thoracic surgery on the usually much run down human being, it must be so constructed that it could not possibly do harm to the patient. I further stated that I would be only too happy to personally use intratracheal insufflation as soon as it was sufficiently perfected to render it safe under all conditions. … I want to lay stress upon the statement that I for my part have never been in opposition, but rather in full accord with his splendid discovery. The fact is that I personally have been among the very first in New York to use intratracheal insufflation in thoracic operations upon the human subject,” said Dr. Meyer.
“But, please bear in mind … that only the use of the differential pressure method – no matter what the apparatus – enables the surgeon to work in the thorax with the same equanimity and tranquility as in the abdomen,” he summarized.
So by the early years of the founding of the AATS, no matter the barriers that remained, the fact that thoracic surgery had reached the same level of confidence in terms of attempting operations as had already existed for the abdomen permitted the fledgling association to move forward with a confidence and optimism that had not existed before, when opening the chest in the operating room was generally considered deadly.
Sources
Meltzer, S. J., 1917. First President’s Address. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/First-Presidents-Address.cgi
Meyer, W., 1917. Surgery Within the Past Fourteen Years. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/A-Review-of-the-Evolution-of-Thoracic-Surgery-Within-the-Pas.cgi
Nissen, R., Wilson, R.H.L. Pages in the History of Chest Surgery. Springfield, IL: Charles C. Thomas, 1960.
In retrospect, the founding of the American Association for Thoracic Surgery (AATS) in 1917 may seem surprisingly optimistic, given the status of cardiothoracic surgery as a discipline at that time. While important strides had been made in dealing with open chest wounds, to the modern eye, the field in the second decade of the 20th century seems more characterized by what was not yet possible rather than by what was.
One of the most critical issues holding back the development of cardiothoracic surgery in this early period was the problem of acute pneumothorax that occurred whenever the chest was opened.
As Willy Meyer (1858-1932), second president of the AATS, described the problem at the first AATS annual meeting in 1917: “What is it that happens when the thorax is opened, let us say [for example] by a stab wound in an intercostal space in an affray on the street? Immediately air rushes into the pleural cavity and this normal atmospheric pressure, being greater than the normal pressure within ... the lung contracts to a very small organ around its hilum. Air fills the space formerly occupied by the lung. This condition, with its immediate clinical pathologic consequences, is called ‘acute pneumothorax.’ It has been the stumbling block for almost a century to the proper development of the surgery of the chest. … Carbonic acid is retained in the blood … The accumulation of CO, with its deleterious effect increases, finally ending in the patient’s death.”
But in the first decade of the 20th century, two major and competing techniques evolved to solve the problem, each one represented by the first and second presidents of the fledgling AATS. For a short period of time a controversy seemed to separate the two men, but their views were expressly reconciled at the first annual meeting of the AATS.
The Meltzer/Auer technique was significantly improved upon by the addition of a carbon dioxide absorption method and the creation of a closed circuit apparatus by Dennis Jackson, MD (1878-1980) in 1915. “This fulfilled the criteria of oxygen supply, carbon dioxide absorption, and ether regulation with a hand bag-breather. With this apparatus, respiration could be maintained with the open thorax,” said pioneering thoracic surgeon Rudolf Nissen, MD, and Roger H.L. Wilson, MD, in their Pages in the History of Chest Surgery (Springfield, IL: Charles C. Thomas, 1960).
However, insufflation was not universally applauded when it was first introduced. It was considered a poor second by many who instead embraced the alternate method of preventing chest collapse – the differential pressure–maintaining Sauerbruch chamber. The Sauerbruch chamber was developed by Ernst Ferdinand Sauerbruch (1875-1951) and first reported in 1904 in his paper, “The pathology of open pneumothorax and the bases of my methods for its elimination.”
As described by Nissen and Wilson, “He transformed the operating room into a kind of extended or enlarged pleural cavity, lowering the atmospheric pressure by vacuum. The head of the patient was outside the operating room, tightly sealed at the neck. This ‘pneumatic chamber’ solved in an ideal way the problem of negative pleural pressure.”
Sauerbruch was aware of the Meltzer/Auer technique, but specifically rejected it, and his powerful influence in Germany helped to prevent it from being adopted there.
Among the earliest and most vocal advocates of using the Sauerbruch negative pressure chamber approach in the United States was Dr. Meyer. Both he and Dr. Meltzer addressed the issue and the controversy at the first meeting of the AATS in 1917.
“You probably remember the little battle between differential pressure and intratracheal insufflation. It occurred only 8 years ago; but it seems now like history. When I presented my paper on intratracheal insufflation at the New York Academy of Medicine, my views were opposed, in the interest of conservatism in surgery, by three able surgeons,” Dr. Meltzer said in his address.
“Now, these same surgeons are among the principal founders of the American Association for Thoracic Surgery, and my being the first presiding officer of the Association is due exclusively to their generous spirit and not to any merits of mine. This is my little story of how the introduction of a stomach tube carried a mere medical man into the presidential chair of a national surgical association.”
Dr. Meyer, one of the three surgeons mentioned by Dr. Meltzer, responded shortly thereafter in his own speech at the meeting: “Dr. Meltzer mentioned in his inaugural address today that, in the discussion following his presentation of the matter before the New York Academy of Medicine his views were opposed, in the interest of conservatism in surgery, by three surgeons.
“Inasmuch as I was one of the three, I would, in explanation, here state that ... at that very time it was reported to me that Dr. Meltzer had stated that in his opinion thoracic operations on human beings could be done in a much simpler way than by working in the negative chamber; that a catheter in the trachea and bellows was all that was needed. He, a physiologist who had always done scientific surgical work on animals, certainly found these paraphernalia sufficient. I personally had meanwhile seen and learned to admire the absolutely reliable working of the mechanism of the chamber, without the possibility of doing the slightest harm to the patient.
“In my remarks on that memorable evening at the New York Academy of Medicine, I therefore tried to impress upon my colleagues the great importance of absolute safety. I stated that no matter what apparatus we might use in thoracic surgery on the usually much run down human being, it must be so constructed that it could not possibly do harm to the patient. I further stated that I would be only too happy to personally use intratracheal insufflation as soon as it was sufficiently perfected to render it safe under all conditions. … I want to lay stress upon the statement that I for my part have never been in opposition, but rather in full accord with his splendid discovery. The fact is that I personally have been among the very first in New York to use intratracheal insufflation in thoracic operations upon the human subject,” said Dr. Meyer.
“But, please bear in mind … that only the use of the differential pressure method – no matter what the apparatus – enables the surgeon to work in the thorax with the same equanimity and tranquility as in the abdomen,” he summarized.
So by the early years of the founding of the AATS, no matter the barriers that remained, the fact that thoracic surgery had reached the same level of confidence in terms of attempting operations as had already existed for the abdomen permitted the fledgling association to move forward with a confidence and optimism that had not existed before, when opening the chest in the operating room was generally considered deadly.
Sources
Meltzer, S. J., 1917. First President’s Address. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/First-Presidents-Address.cgi
Meyer, W., 1917. Surgery Within the Past Fourteen Years. http://t.aats.org/annualmeeting/Program-Books/50th-Anniversary-Book/A-Review-of-the-Evolution-of-Thoracic-Surgery-Within-the-Pas.cgi
Nissen, R., Wilson, R.H.L. Pages in the History of Chest Surgery. Springfield, IL: Charles C. Thomas, 1960.
Esophageal cancers: Apples and oranges wrongly lumped together
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
FROM NATURE
Key clinical point:
Major finding: Molecular analysis showed esophageal squamous cell carcinoma is more like other squamous cell carcinomas than esophageal adenocarcinoma, which itself resembles chromosomal-instability gastric cancer.
Data source: A molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
Disclosures: The authors reported that they had no competing financial interests.
ECMO patients need less sedation, pain meds than previously reported
Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.
In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.
This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).
“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”
Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.
The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.
On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).
In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.
In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.
Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.
“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.
The authors reported that they had no disclosures.
Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.
In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.
This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).
“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”
Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.
The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.
On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).
In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.
In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.
Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.
“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.
The authors reported that they had no disclosures.
Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.
In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.
This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).
“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”
Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.
The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.
On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).
In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.
In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.
Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.
“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.
The authors reported that they had no disclosures.
FROM JOURNAL OF CRITICAL CARE
Key clinical point:
Major finding: Patients required lower doses of opioids and sedatives than previously reported and did not need increasing doses.
Data source: A single-institution, prospective study of 32 patients on extracorporeal membrane oxygenation.
Disclosures: Dr. DeGrado reported having no financial disclosures.
Midterm results of thoracic stenting for acute type B dissection promising
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
LAS VEGAS – Patients with acute, complicated type B aortic dissections are reported to have a greater than 50% likelihood of dying from their condition. Three-year results of the Valiant thoracic stent graft in the treatment of these dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%, according to Ali Azizzadeh, MD.
Dr. Azizzadeh presented the midterm results of the Medtronic Dissection US IDE trial of endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic) in acute, complicated type B aortic dissection patients at the 2016 Vascular Interventional Advances meeting.
One-year outcomes of the trial were reported last year in the Annals of Thoracic Surgery (2015 Sep;100:802-9).
Dr. Azizzadeh is a vascular surgeon at the Memorial Hermann Heart and Vascular Institute, Houston.
Between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled at 16 clinical sites in the United States in this multicenter, prospective, nonrandomized trial with a planned 5-year follow-up.
The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
A total of 28 patients completed their 3-year follow-up. Through 3 years, there were no postindex ruptures or conversions to open surgical repair reported in the trial.
At 3 years, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, according to Dr. Azizzadeh. False lumen diameter remained stable or decreased in 69.3% of patients, and the false lumen was partially or completely thrombosed in 75% of patients.
One death (from sepsis) occurred between years 2 and 3; and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection.
Although these midterm results are encouraging, said Dr. Azizzadeh, longer-term outcomes are needed to assess the durability of the stent graft in this indication.
The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
AT VIVA16 LAS VEGAS
Key clinical point:
Major finding: Three-year results of the Valiant thoracic stent graft in the treatment of acute type B dissections showed freedom from all-cause mortality of 79.4%, and a freedom from dissection-related mortality of 90%.
Data source: Midterm results were presented from the multicenter, prospective, nonrandomized Medtronic Dissection US IDE trial.
Disclosures: The trial was sponsored by Medtronic. Dr. Azizzadeh has consulted for and received research/trial funding from W.L. Gore & Associates and Medtronic.
Endovascular construction of arteriovenous fistulas shows promise
LAS VEGAS – Patients who had an arteriovenous fistula (AVF) created endovascularly using a new magnetic catheter system required fewer interventions and had fewer health care costs than patients whose AVF was created surgically, according to a late-breaking trial presented by Charmaine E. Lok, MD, at the 2016 Vascular Interventional Advances meeting.
The study compared AVF postcreation interventions between patients undergoing surgical (sAVF) creation and those whose fistula was created using a new endovascular AVF (endoAVF) system.
Medicare Standard Analytical Files were used to determine patient demographic and clinical characteristics and to identify and determine rates of sAVF postcreation interventions in patients with sAVF created from 2011 to 2013, according to Dr. Lok, a professor of medicine at the University of Toronto and senior scientist at the Toronto General Research Institute.
The rates of postcreation interventions per patient-year were determined based on patients’ outpatient and physician claims. Demographics and clinical information for patients with endoAVF were obtained from the single-arm Novel Endovascular Access Trial (NEAT) performed in Canada, Australia, and New Zealand.
The researchers determined the rates of postcreation interventions per patient-year from the trial based on patients’ outpatient and physician claims during specified follow-up.
Propensity score matching based on clinical and demographic factors was successful for comparing 60 Medicare patients who had surgical AVFs to NEAT patients. The matched surgical cohort had a significantly higher number of interventions than the endovascular cohort (3.4 vs. 0.6 per patient-year, respectively; P less than .0001). The associated average annual costs were $11,240 less for the endovascular patients, compared with the surgical patients.
In a breakdown of procedures, the endovascular cohort had lower event rates for angioplasty (0.04 vs. 0.93),respectively; thrombectomy (0.04 vs. 0.20); embolization/ligation of vein (0.13 vs. 0.1); revision (0.04 vs. 0.17); new AVF or transposition (0.11 vs. 0.30); catheter placement (0.11 vs. 0.43); vascular access–related infection (0.02 vs. 1.23), and arteriovenous graft placement (0.02 vs. 0.07), according to Dr. Lok.
The NEAT study assessed the FLEX system, which percutaneously creates a fistula in chronic kidney disease patients who require hemodialysis vascular access.
The FLEX system uses two catheters delivered percutaneously to an artery and a vein in proximity to each other in the arm. The catheters use magnets for alignment and a radio frequency system as an energy source. The catheters are magnetically aligned and an RF pulse creates an arteriovenous fistula endovascularly between the artery and vein and the catheters are then removed.
The technology used is not commercially available in the United States and is pending Food and Drug Administration review, according to Dr. Lok
The study was sponsored by TVA Medical. Dr. Lok has received honoraria from Maquet and W.L. Gore, and is a consultant for TVA Medical and W. L. Gore, and has received research funding from Maquet, Proteon, and TVA Medical.
LAS VEGAS – Patients who had an arteriovenous fistula (AVF) created endovascularly using a new magnetic catheter system required fewer interventions and had fewer health care costs than patients whose AVF was created surgically, according to a late-breaking trial presented by Charmaine E. Lok, MD, at the 2016 Vascular Interventional Advances meeting.
The study compared AVF postcreation interventions between patients undergoing surgical (sAVF) creation and those whose fistula was created using a new endovascular AVF (endoAVF) system.
Medicare Standard Analytical Files were used to determine patient demographic and clinical characteristics and to identify and determine rates of sAVF postcreation interventions in patients with sAVF created from 2011 to 2013, according to Dr. Lok, a professor of medicine at the University of Toronto and senior scientist at the Toronto General Research Institute.
The rates of postcreation interventions per patient-year were determined based on patients’ outpatient and physician claims. Demographics and clinical information for patients with endoAVF were obtained from the single-arm Novel Endovascular Access Trial (NEAT) performed in Canada, Australia, and New Zealand.
The researchers determined the rates of postcreation interventions per patient-year from the trial based on patients’ outpatient and physician claims during specified follow-up.
Propensity score matching based on clinical and demographic factors was successful for comparing 60 Medicare patients who had surgical AVFs to NEAT patients. The matched surgical cohort had a significantly higher number of interventions than the endovascular cohort (3.4 vs. 0.6 per patient-year, respectively; P less than .0001). The associated average annual costs were $11,240 less for the endovascular patients, compared with the surgical patients.
In a breakdown of procedures, the endovascular cohort had lower event rates for angioplasty (0.04 vs. 0.93),respectively; thrombectomy (0.04 vs. 0.20); embolization/ligation of vein (0.13 vs. 0.1); revision (0.04 vs. 0.17); new AVF or transposition (0.11 vs. 0.30); catheter placement (0.11 vs. 0.43); vascular access–related infection (0.02 vs. 1.23), and arteriovenous graft placement (0.02 vs. 0.07), according to Dr. Lok.
The NEAT study assessed the FLEX system, which percutaneously creates a fistula in chronic kidney disease patients who require hemodialysis vascular access.
The FLEX system uses two catheters delivered percutaneously to an artery and a vein in proximity to each other in the arm. The catheters use magnets for alignment and a radio frequency system as an energy source. The catheters are magnetically aligned and an RF pulse creates an arteriovenous fistula endovascularly between the artery and vein and the catheters are then removed.
The technology used is not commercially available in the United States and is pending Food and Drug Administration review, according to Dr. Lok
The study was sponsored by TVA Medical. Dr. Lok has received honoraria from Maquet and W.L. Gore, and is a consultant for TVA Medical and W. L. Gore, and has received research funding from Maquet, Proteon, and TVA Medical.
LAS VEGAS – Patients who had an arteriovenous fistula (AVF) created endovascularly using a new magnetic catheter system required fewer interventions and had fewer health care costs than patients whose AVF was created surgically, according to a late-breaking trial presented by Charmaine E. Lok, MD, at the 2016 Vascular Interventional Advances meeting.
The study compared AVF postcreation interventions between patients undergoing surgical (sAVF) creation and those whose fistula was created using a new endovascular AVF (endoAVF) system.
Medicare Standard Analytical Files were used to determine patient demographic and clinical characteristics and to identify and determine rates of sAVF postcreation interventions in patients with sAVF created from 2011 to 2013, according to Dr. Lok, a professor of medicine at the University of Toronto and senior scientist at the Toronto General Research Institute.
The rates of postcreation interventions per patient-year were determined based on patients’ outpatient and physician claims. Demographics and clinical information for patients with endoAVF were obtained from the single-arm Novel Endovascular Access Trial (NEAT) performed in Canada, Australia, and New Zealand.
The researchers determined the rates of postcreation interventions per patient-year from the trial based on patients’ outpatient and physician claims during specified follow-up.
Propensity score matching based on clinical and demographic factors was successful for comparing 60 Medicare patients who had surgical AVFs to NEAT patients. The matched surgical cohort had a significantly higher number of interventions than the endovascular cohort (3.4 vs. 0.6 per patient-year, respectively; P less than .0001). The associated average annual costs were $11,240 less for the endovascular patients, compared with the surgical patients.
In a breakdown of procedures, the endovascular cohort had lower event rates for angioplasty (0.04 vs. 0.93),respectively; thrombectomy (0.04 vs. 0.20); embolization/ligation of vein (0.13 vs. 0.1); revision (0.04 vs. 0.17); new AVF or transposition (0.11 vs. 0.30); catheter placement (0.11 vs. 0.43); vascular access–related infection (0.02 vs. 1.23), and arteriovenous graft placement (0.02 vs. 0.07), according to Dr. Lok.
The NEAT study assessed the FLEX system, which percutaneously creates a fistula in chronic kidney disease patients who require hemodialysis vascular access.
The FLEX system uses two catheters delivered percutaneously to an artery and a vein in proximity to each other in the arm. The catheters use magnets for alignment and a radio frequency system as an energy source. The catheters are magnetically aligned and an RF pulse creates an arteriovenous fistula endovascularly between the artery and vein and the catheters are then removed.
The technology used is not commercially available in the United States and is pending Food and Drug Administration review, according to Dr. Lok
The study was sponsored by TVA Medical. Dr. Lok has received honoraria from Maquet and W.L. Gore, and is a consultant for TVA Medical and W. L. Gore, and has received research funding from Maquet, Proteon, and TVA Medical.
Key clinical point: than patients whose AVF was created surgically
Major finding: A matched surgical cohort of patients with surgically constructed AVFs had a significantly higher number of interventions than an endovascular AVF cohort (3.4 vs. 0.6 per patient-year).
Data source: Researchers performed a propensity-matching analysis of Medicare patients to those patient who received an endovascularly created AVF in the NEAT trial.
Disclosures: The study was sponsored by TVA Medical. Dr. Lok has received honoraria from Maquet and W.L. Gore, and is a consultant for TVA Medical and W. L. Gore, and has received research funding from Maquet, Proteon, and TVA Medical.
Fast-Track EVAR protocol shown safe, effective, and cheaper
LAS VEGAS – A ‘fast-track” stenting method for endovascular abdominal aortic aneurysm repair (EVAR) enabled patients to be treated safely and effectively without general anesthetic or ICU admission, and with next-day discharge, Zvonimir Krajcer, MD, said at the 2016 Vascular Interventional Advances meeting.
Dr. Krajcer discussed the final results of the Prospective LIFE Registry, which followed 250 patients treated with the Ovation Abdominal Stent Graft platform, who had suitable femoral arteries to allow the use of the Perclose ProGlide Suture-Mediated Closure (SMC) System.
For the Fast-Track patients, vascular access, stent graft delivery, and deployment were successful. The Fast-Track EVAR protocol was successfully completed in 216 (87%) of the patients. In comparing the Fast-Track cohort (n = 216) to the non–Fast-Track cohort (n = 34), procedure time was found to be 84 vs. 110 minutes, the use of general anesthesia was 0% vs. 18%, and the need for ICU stay was 0% vs. 32%. Hospital stay for the two groups was 1.2 vs. 1.9 days, respectively.
Quality of life score improvement from baseline to 30 days as assessed via the EQ-5D questionnaire, was significantly greater in the Fast-Track patients, compared with the EVAR controls, said Dr. Krajcer, an interventional cardiologist at Texas Heart Institute and St. Luke’s Hospital, Houston, and a clinical professor of medicine at Baylor College of Medicine.
To determine adverse events, patients were followed through 1 month after treatment. The researchers found no device- or procedure-related major adverse events, abdominal aortic aneurysm (AAA) ruptures, surgical conversions, or AAA-related secondary interventions. One patient in the fast-track group died from acute respiratory failure. Overall, for the Fast-Track and control groups, the freedom from type I/III endoleak was 99% and 100%, respectively.
Dr. Krajcer reported that the 30-day hospital readmission rate in the LIFE study was 1.6%, compared to 8% reported for EVAR from the American College of Surgeons National Surgical Quality Improvement Program.
The economic analysis was performed comparing the Fast-Track patients to a control group, which consisted of a database of 8,306 patients treated with elective infrarenal EVAR at 3,750 U.S. hospitals based on inpatient discharge between 2012 and 2015. The researchers calculated costs related to access, anesthesia, ICU stay, and hospital stay.
The Fast-Track protocol showed $21,000 in perioperative cost savings relative to standard EVAR, largely driven by differences in hospital stay costs, according to Dr. Krajcer.
“Fast-track EVAR using the Ovation Prime stent graft is safe and feasible and lowers perioperative costs,” said Dr. Krajcer. “Our results warrant the establishment of a Fast-Track EVAR protocol in experienced EVAR centers,” he concluded.
Dr. Krajcer had nothing to disclose.
LAS VEGAS – A ‘fast-track” stenting method for endovascular abdominal aortic aneurysm repair (EVAR) enabled patients to be treated safely and effectively without general anesthetic or ICU admission, and with next-day discharge, Zvonimir Krajcer, MD, said at the 2016 Vascular Interventional Advances meeting.
Dr. Krajcer discussed the final results of the Prospective LIFE Registry, which followed 250 patients treated with the Ovation Abdominal Stent Graft platform, who had suitable femoral arteries to allow the use of the Perclose ProGlide Suture-Mediated Closure (SMC) System.
For the Fast-Track patients, vascular access, stent graft delivery, and deployment were successful. The Fast-Track EVAR protocol was successfully completed in 216 (87%) of the patients. In comparing the Fast-Track cohort (n = 216) to the non–Fast-Track cohort (n = 34), procedure time was found to be 84 vs. 110 minutes, the use of general anesthesia was 0% vs. 18%, and the need for ICU stay was 0% vs. 32%. Hospital stay for the two groups was 1.2 vs. 1.9 days, respectively.
Quality of life score improvement from baseline to 30 days as assessed via the EQ-5D questionnaire, was significantly greater in the Fast-Track patients, compared with the EVAR controls, said Dr. Krajcer, an interventional cardiologist at Texas Heart Institute and St. Luke’s Hospital, Houston, and a clinical professor of medicine at Baylor College of Medicine.
To determine adverse events, patients were followed through 1 month after treatment. The researchers found no device- or procedure-related major adverse events, abdominal aortic aneurysm (AAA) ruptures, surgical conversions, or AAA-related secondary interventions. One patient in the fast-track group died from acute respiratory failure. Overall, for the Fast-Track and control groups, the freedom from type I/III endoleak was 99% and 100%, respectively.
Dr. Krajcer reported that the 30-day hospital readmission rate in the LIFE study was 1.6%, compared to 8% reported for EVAR from the American College of Surgeons National Surgical Quality Improvement Program.
The economic analysis was performed comparing the Fast-Track patients to a control group, which consisted of a database of 8,306 patients treated with elective infrarenal EVAR at 3,750 U.S. hospitals based on inpatient discharge between 2012 and 2015. The researchers calculated costs related to access, anesthesia, ICU stay, and hospital stay.
The Fast-Track protocol showed $21,000 in perioperative cost savings relative to standard EVAR, largely driven by differences in hospital stay costs, according to Dr. Krajcer.
“Fast-track EVAR using the Ovation Prime stent graft is safe and feasible and lowers perioperative costs,” said Dr. Krajcer. “Our results warrant the establishment of a Fast-Track EVAR protocol in experienced EVAR centers,” he concluded.
Dr. Krajcer had nothing to disclose.
LAS VEGAS – A ‘fast-track” stenting method for endovascular abdominal aortic aneurysm repair (EVAR) enabled patients to be treated safely and effectively without general anesthetic or ICU admission, and with next-day discharge, Zvonimir Krajcer, MD, said at the 2016 Vascular Interventional Advances meeting.
Dr. Krajcer discussed the final results of the Prospective LIFE Registry, which followed 250 patients treated with the Ovation Abdominal Stent Graft platform, who had suitable femoral arteries to allow the use of the Perclose ProGlide Suture-Mediated Closure (SMC) System.
For the Fast-Track patients, vascular access, stent graft delivery, and deployment were successful. The Fast-Track EVAR protocol was successfully completed in 216 (87%) of the patients. In comparing the Fast-Track cohort (n = 216) to the non–Fast-Track cohort (n = 34), procedure time was found to be 84 vs. 110 minutes, the use of general anesthesia was 0% vs. 18%, and the need for ICU stay was 0% vs. 32%. Hospital stay for the two groups was 1.2 vs. 1.9 days, respectively.
Quality of life score improvement from baseline to 30 days as assessed via the EQ-5D questionnaire, was significantly greater in the Fast-Track patients, compared with the EVAR controls, said Dr. Krajcer, an interventional cardiologist at Texas Heart Institute and St. Luke’s Hospital, Houston, and a clinical professor of medicine at Baylor College of Medicine.
To determine adverse events, patients were followed through 1 month after treatment. The researchers found no device- or procedure-related major adverse events, abdominal aortic aneurysm (AAA) ruptures, surgical conversions, or AAA-related secondary interventions. One patient in the fast-track group died from acute respiratory failure. Overall, for the Fast-Track and control groups, the freedom from type I/III endoleak was 99% and 100%, respectively.
Dr. Krajcer reported that the 30-day hospital readmission rate in the LIFE study was 1.6%, compared to 8% reported for EVAR from the American College of Surgeons National Surgical Quality Improvement Program.
The economic analysis was performed comparing the Fast-Track patients to a control group, which consisted of a database of 8,306 patients treated with elective infrarenal EVAR at 3,750 U.S. hospitals based on inpatient discharge between 2012 and 2015. The researchers calculated costs related to access, anesthesia, ICU stay, and hospital stay.
The Fast-Track protocol showed $21,000 in perioperative cost savings relative to standard EVAR, largely driven by differences in hospital stay costs, according to Dr. Krajcer.
“Fast-track EVAR using the Ovation Prime stent graft is safe and feasible and lowers perioperative costs,” said Dr. Krajcer. “Our results warrant the establishment of a Fast-Track EVAR protocol in experienced EVAR centers,” he concluded.
Dr. Krajcer had nothing to disclose.
AT VIVA16
Key clinical point:
Major finding: Quality of life score improvement from baseline to 30 days was significantly greater in the Fast-Track patients, compared with the EVAR controls.
Data source: The researchers assessed 250 patients in the Prospective LIFE Registry and compared results to more than 8,000 patients in an EVAR database as controls.
Disclosures: Dr. Krajcer had nothing to disclose.
VIVA: Assessing aortic repair and more in the latest trials
Along with a strong focus on peripheral arterial disease, VIVA late-breaking clinical trial reports will also address other critical areas of the vascular domain, from the aorta to the carotids.
On Tuesday morning, the results of two trials will be presented, which are investigating endovascular aortic repair. Ali Azizzadeh, MD, Memorial Hermann Heart and Vascular Institute, Houston, will discuss the 3-year results from the Valiant IDE Study, examining endovascular repair in acute, complicated type B aortic dissection.
Then, Zvonimir Krajcer, MD, Texas Heart Institute, Houston, will present the final results from the Prospective LIFE Registry, looking at fast-track endovascular aortic repair.
Also on Tuesday morning, the issue of interventions after the creation of an arteriovenous fistula (AVF) will be addressed by Charmaine Lok, MD, Toronto General Hospital, comparing traditional surgical AVF creation with a new endovascular approach.
Wednesday morning, Ido Weinberg, MD, Massachusetts General Hospital, Boston, will address the issue of carotid stent fractures, demonstrating that they are not associated with restenosis, stroke, myocardial infarction, or death based on the results from the ACT 1 Multicenter Randomized Trial.
Along with a strong focus on peripheral arterial disease, VIVA late-breaking clinical trial reports will also address other critical areas of the vascular domain, from the aorta to the carotids.
On Tuesday morning, the results of two trials will be presented, which are investigating endovascular aortic repair. Ali Azizzadeh, MD, Memorial Hermann Heart and Vascular Institute, Houston, will discuss the 3-year results from the Valiant IDE Study, examining endovascular repair in acute, complicated type B aortic dissection.
Then, Zvonimir Krajcer, MD, Texas Heart Institute, Houston, will present the final results from the Prospective LIFE Registry, looking at fast-track endovascular aortic repair.
Also on Tuesday morning, the issue of interventions after the creation of an arteriovenous fistula (AVF) will be addressed by Charmaine Lok, MD, Toronto General Hospital, comparing traditional surgical AVF creation with a new endovascular approach.
Wednesday morning, Ido Weinberg, MD, Massachusetts General Hospital, Boston, will address the issue of carotid stent fractures, demonstrating that they are not associated with restenosis, stroke, myocardial infarction, or death based on the results from the ACT 1 Multicenter Randomized Trial.
Along with a strong focus on peripheral arterial disease, VIVA late-breaking clinical trial reports will also address other critical areas of the vascular domain, from the aorta to the carotids.
On Tuesday morning, the results of two trials will be presented, which are investigating endovascular aortic repair. Ali Azizzadeh, MD, Memorial Hermann Heart and Vascular Institute, Houston, will discuss the 3-year results from the Valiant IDE Study, examining endovascular repair in acute, complicated type B aortic dissection.
Then, Zvonimir Krajcer, MD, Texas Heart Institute, Houston, will present the final results from the Prospective LIFE Registry, looking at fast-track endovascular aortic repair.
Also on Tuesday morning, the issue of interventions after the creation of an arteriovenous fistula (AVF) will be addressed by Charmaine Lok, MD, Toronto General Hospital, comparing traditional surgical AVF creation with a new endovascular approach.
Wednesday morning, Ido Weinberg, MD, Massachusetts General Hospital, Boston, will address the issue of carotid stent fractures, demonstrating that they are not associated with restenosis, stroke, myocardial infarction, or death based on the results from the ACT 1 Multicenter Randomized Trial.
Not so peripheral anymore: VIVA late-breakers address PAD/CLI trials
After years of relative neglect, compared with the attention given to aortic disease, studies and devices designed to expand and improve treatment of peripheral arterial disease are moving to the forefront.
At this year’s VIVA Vascular meeting, the majority of late-breaking clinical trials have a focus on peripheral arterial disease (PAD) and critical limb ischemia (CLI), emphasizing the tremendous growth of research in this area. The following are some of the latest trials for which results will be presented:
On Monday morning, Michael P. Murphy, MD, will present results from the MOBILE clinical trial, which examines the use of the MarrowStim™ PAD Kit for the treatment of CLI in subjects with severe PAD. The treatment involves removing bone marrow from the hips, which is then processed in the MarrowStim device to separate stem cells for delivery by injection to multiple sites in the affected leg.
A report on the 6-month results from the two-phase DISRUPT PAD study to assess the safety and performance of the Shockwave Lithoplasty® System in treating calcified peripheral vascular lesions will then be presented by Thomas Zeller, MD, principal investigator for the study. “Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation,” according to a company report.
In addition, results from the IN.PACT SFA randomized trial will be presented by Prakash Krishnan, MD, and data from the VIRTUS US Iliofemoral Stenting IDE Trial will be addressed by Stephen Black, MD, and Michael R. Jaff, DO, will present insights on the use of drug-coated balloon treatment for patients with intermittent claudication based on results from the IN.PACT Global full clinical cohort.
On Tuesday morning, Stefan Müller-Hülsbeck, MD, will present the 2-year results plus subgroup analysis of the Majestic Trial, which examined the efficacy benefit of using the Eluvia drug-eluting stent for treating lesions in the femoropopliteal arteries.
This will be followed by Antonio Micari, MD, PhD, who will present the 2-year results of from the SFA-Long Study, which examines the use of paclitaxel coated balloons for long femoropopliteal artery disease.
On Wednesday morning, the 3-Year Results of the Evaluation of the ESPRIT Bioresorbable Vascular Scaffold (ESPRIT BVS) in The Treatment of Patients with Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries (ESPRIT I Trial) will be presented by Michael R. Jaff, DO.
This will be followed by a presentation of the 12-month results from the DANCE Trial Atherectomy Cohort by Chris D. Owens, MD, and John Laird, MD, discussing the 9-month results of the Prospective, Multicenter BOLSTER Trial, which examined the use of an expanded polytetrafluoroethylene balloon-expandable covered stent for obstructive lesions in the iliac artery.
In further research addressing the peripheral vascular system, Dr. Laird will also address the 24-month results from the TIGRIS randomized trial, assessing the use of a novel nitinol stent for long lesions in the SFA and the proximal popliteal artery.
Afterwards, Richard Saxon, MD, will discuss the PRISM Indigo Aspiration System as a potential frontline tool for vacuum-assisted aspiration thrombectomy in the periphery.
After years of relative neglect, compared with the attention given to aortic disease, studies and devices designed to expand and improve treatment of peripheral arterial disease are moving to the forefront.
At this year’s VIVA Vascular meeting, the majority of late-breaking clinical trials have a focus on peripheral arterial disease (PAD) and critical limb ischemia (CLI), emphasizing the tremendous growth of research in this area. The following are some of the latest trials for which results will be presented:
On Monday morning, Michael P. Murphy, MD, will present results from the MOBILE clinical trial, which examines the use of the MarrowStim™ PAD Kit for the treatment of CLI in subjects with severe PAD. The treatment involves removing bone marrow from the hips, which is then processed in the MarrowStim device to separate stem cells for delivery by injection to multiple sites in the affected leg.
A report on the 6-month results from the two-phase DISRUPT PAD study to assess the safety and performance of the Shockwave Lithoplasty® System in treating calcified peripheral vascular lesions will then be presented by Thomas Zeller, MD, principal investigator for the study. “Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation,” according to a company report.
In addition, results from the IN.PACT SFA randomized trial will be presented by Prakash Krishnan, MD, and data from the VIRTUS US Iliofemoral Stenting IDE Trial will be addressed by Stephen Black, MD, and Michael R. Jaff, DO, will present insights on the use of drug-coated balloon treatment for patients with intermittent claudication based on results from the IN.PACT Global full clinical cohort.
On Tuesday morning, Stefan Müller-Hülsbeck, MD, will present the 2-year results plus subgroup analysis of the Majestic Trial, which examined the efficacy benefit of using the Eluvia drug-eluting stent for treating lesions in the femoropopliteal arteries.
This will be followed by Antonio Micari, MD, PhD, who will present the 2-year results of from the SFA-Long Study, which examines the use of paclitaxel coated balloons for long femoropopliteal artery disease.
On Wednesday morning, the 3-Year Results of the Evaluation of the ESPRIT Bioresorbable Vascular Scaffold (ESPRIT BVS) in The Treatment of Patients with Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries (ESPRIT I Trial) will be presented by Michael R. Jaff, DO.
This will be followed by a presentation of the 12-month results from the DANCE Trial Atherectomy Cohort by Chris D. Owens, MD, and John Laird, MD, discussing the 9-month results of the Prospective, Multicenter BOLSTER Trial, which examined the use of an expanded polytetrafluoroethylene balloon-expandable covered stent for obstructive lesions in the iliac artery.
In further research addressing the peripheral vascular system, Dr. Laird will also address the 24-month results from the TIGRIS randomized trial, assessing the use of a novel nitinol stent for long lesions in the SFA and the proximal popliteal artery.
Afterwards, Richard Saxon, MD, will discuss the PRISM Indigo Aspiration System as a potential frontline tool for vacuum-assisted aspiration thrombectomy in the periphery.
After years of relative neglect, compared with the attention given to aortic disease, studies and devices designed to expand and improve treatment of peripheral arterial disease are moving to the forefront.
At this year’s VIVA Vascular meeting, the majority of late-breaking clinical trials have a focus on peripheral arterial disease (PAD) and critical limb ischemia (CLI), emphasizing the tremendous growth of research in this area. The following are some of the latest trials for which results will be presented:
On Monday morning, Michael P. Murphy, MD, will present results from the MOBILE clinical trial, which examines the use of the MarrowStim™ PAD Kit for the treatment of CLI in subjects with severe PAD. The treatment involves removing bone marrow from the hips, which is then processed in the MarrowStim device to separate stem cells for delivery by injection to multiple sites in the affected leg.
A report on the 6-month results from the two-phase DISRUPT PAD study to assess the safety and performance of the Shockwave Lithoplasty® System in treating calcified peripheral vascular lesions will then be presented by Thomas Zeller, MD, principal investigator for the study. “Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation,” according to a company report.
In addition, results from the IN.PACT SFA randomized trial will be presented by Prakash Krishnan, MD, and data from the VIRTUS US Iliofemoral Stenting IDE Trial will be addressed by Stephen Black, MD, and Michael R. Jaff, DO, will present insights on the use of drug-coated balloon treatment for patients with intermittent claudication based on results from the IN.PACT Global full clinical cohort.
On Tuesday morning, Stefan Müller-Hülsbeck, MD, will present the 2-year results plus subgroup analysis of the Majestic Trial, which examined the efficacy benefit of using the Eluvia drug-eluting stent for treating lesions in the femoropopliteal arteries.
This will be followed by Antonio Micari, MD, PhD, who will present the 2-year results of from the SFA-Long Study, which examines the use of paclitaxel coated balloons for long femoropopliteal artery disease.
On Wednesday morning, the 3-Year Results of the Evaluation of the ESPRIT Bioresorbable Vascular Scaffold (ESPRIT BVS) in The Treatment of Patients with Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries (ESPRIT I Trial) will be presented by Michael R. Jaff, DO.
This will be followed by a presentation of the 12-month results from the DANCE Trial Atherectomy Cohort by Chris D. Owens, MD, and John Laird, MD, discussing the 9-month results of the Prospective, Multicenter BOLSTER Trial, which examined the use of an expanded polytetrafluoroethylene balloon-expandable covered stent for obstructive lesions in the iliac artery.
In further research addressing the peripheral vascular system, Dr. Laird will also address the 24-month results from the TIGRIS randomized trial, assessing the use of a novel nitinol stent for long lesions in the SFA and the proximal popliteal artery.
Afterwards, Richard Saxon, MD, will discuss the PRISM Indigo Aspiration System as a potential frontline tool for vacuum-assisted aspiration thrombectomy in the periphery.
Vascular surgeons assisting nonvascular colleagues require depth/breadth of experience
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
FROM JAMA SURGERY
Key clinical point: Intraoperative assistance of vascular surgeons in nonvascular procedures accounted for nearly 7% of vascular work at a single institution and uniformly required open repair.
Major finding: Patients who required any intraoperative vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery.
Data source: The study was a retrospective review of all 299 patients undergoing nonvascular surgery who required intraoperative vascular surgery assistance at a single institution between January 2010 and June 2014.
Disclosures: The authors reported that they had no disclosures.