ACS Surgery News

SEATTLE – The presentation of the late-breaking HISTORIC-AF Trial by Dr. Claudio Muneretto and his colleagues “is a very interesting one, which brings to the table a very different approach of hybrid procedures to treat stand-alone atrial fibrillation,” said Dr. Niv Ad of Inova Heart and Vascular Institute, Falls Church, Va.

Dr. Ad gave his comments in a video interview at the annual meeting of the American Association for Thoracic Surgery.

In his assessment, Dr. Ad noted that such studies are useful and can stimulate discussion, even if he would prefer a prospective, comparative study of all procedures. “I hope someday we can create an algorithm where everything has a place: catheter ablation, hybrid procedures where you do catheter ablation and surgical procedure together or in stage, and the stand-alone Maze procedure on pump,” Dr. Ad said.

tborden@frontlinemedcom.com

SEATTLE – The presentation of the late-breaking HISTORIC-AF Trial by Dr. Claudio Muneretto and his colleagues “is a very interesting one, which brings to the table a very different approach of hybrid procedures to treat stand-alone atrial fibrillation,” said Dr. Niv Ad of Inova Heart and Vascular Institute, Falls Church, Va.

Dr. Ad gave his comments in a video interview at the annual meeting of the American Association for Thoracic Surgery.

In his assessment, Dr. Ad noted that such studies are useful and can stimulate discussion, even if he would prefer a prospective, comparative study of all procedures. “I hope someday we can create an algorithm where everything has a place: catheter ablation, hybrid procedures where you do catheter ablation and surgical procedure together or in stage, and the stand-alone Maze procedure on pump,” Dr. Ad said.

tborden@frontlinemedcom.com

SEATTLE – The presentation of the late-breaking HISTORIC-AF Trial by Dr. Claudio Muneretto and his colleagues “is a very interesting one, which brings to the table a very different approach of hybrid procedures to treat stand-alone atrial fibrillation,” said Dr. Niv Ad of Inova Heart and Vascular Institute, Falls Church, Va.

Dr. Ad gave his comments in a video interview at the annual meeting of the American Association for Thoracic Surgery.

In his assessment, Dr. Ad noted that such studies are useful and can stimulate discussion, even if he would prefer a prospective, comparative study of all procedures. “I hope someday we can create an algorithm where everything has a place: catheter ablation, hybrid procedures where you do catheter ablation and surgical procedure together or in stage, and the stand-alone Maze procedure on pump,” Dr. Ad said.

tborden@frontlinemedcom.com

SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.

“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.

The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.

aotto@frontlinemedcom.com

SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.

“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.

The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.

aotto@frontlinemedcom.com

SEATTLE – Hospitals that perform at least one nongastric conduit esophageal reconstruction per year have half the esophagectomy mortality of hospitals that do not, according to a review by the Mayo Clinic in Rochester, Minn., of 11,211 esophagectomies in the Nationwide Inpatient Sample database from 2000 to 2011.

“There is tremendous variation in outcome after esophagectomy, and some advocate for regionalization to high-volume hospitals,” the investigators said. The findings suggest that case complexity could be one of the things that help define which hospitals do it best, they added.

The study seems to confirm that hospital case volume makes a difference in surgical outcomes, said Dr. Nabil Rizk, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Rizk, a discussant on the paper at the American Association for Thoracic Surgery annual meeting, explained how the study fits into regionalization trends, but also shared his concerns about the work in an interview at the meeting.

aotto@frontlinemedcom.com

SEATTLE – Autologous stem cell therapy improves surgery outcomes in children with hypoplastic left heart syndrome, according to the results of a small prospective trial from Okayama University in Japan.

The investigators cultured cardiosphere-derived cells (CDCs) – cardiac progenitor cells – from right atrium samples taken during stage 2 or 3 surgical palliations in seven HLHS children. A month later, they injected 300,000 CDCs/kg into the children’s coronary arteries by catheter, with each child getting cells cultured from their own tissue.

The cells seemed to jump-start the intrinsic regenerative properties of very young hearts. At 30 months follow-up, right ventricular mass and ejection fractions were about 10% greater in CDC treated patients compared to seven controls. Treated children also had better growth.

It’s possible the technique could help older children, too, and even adults, said lead investigator Dr. Shunji Sano, professor and chairman of the department of cardiovascular surgery at Okayama. He explained the work, its implications, and the next phase of research in an interview at the annual meeting of the American Association for Thoracic Surgery.

aotto@frontlinemedcom.com

SEATTLE – Autologous stem cell therapy improves surgery outcomes in children with hypoplastic left heart syndrome, according to the results of a small prospective trial from Okayama University in Japan.

The investigators cultured cardiosphere-derived cells (CDCs) – cardiac progenitor cells – from right atrium samples taken during stage 2 or 3 surgical palliations in seven HLHS children. A month later, they injected 300,000 CDCs/kg into the children’s coronary arteries by catheter, with each child getting cells cultured from their own tissue.

The cells seemed to jump-start the intrinsic regenerative properties of very young hearts. At 30 months follow-up, right ventricular mass and ejection fractions were about 10% greater in CDC treated patients compared to seven controls. Treated children also had better growth.

It’s possible the technique could help older children, too, and even adults, said lead investigator Dr. Shunji Sano, professor and chairman of the department of cardiovascular surgery at Okayama. He explained the work, its implications, and the next phase of research in an interview at the annual meeting of the American Association for Thoracic Surgery.

aotto@frontlinemedcom.com

SEATTLE – Autologous stem cell therapy improves surgery outcomes in children with hypoplastic left heart syndrome, according to the results of a small prospective trial from Okayama University in Japan.

The investigators cultured cardiosphere-derived cells (CDCs) – cardiac progenitor cells – from right atrium samples taken during stage 2 or 3 surgical palliations in seven HLHS children. A month later, they injected 300,000 CDCs/kg into the children’s coronary arteries by catheter, with each child getting cells cultured from their own tissue.

The cells seemed to jump-start the intrinsic regenerative properties of very young hearts. At 30 months follow-up, right ventricular mass and ejection fractions were about 10% greater in CDC treated patients compared to seven controls. Treated children also had better growth.

It’s possible the technique could help older children, too, and even adults, said lead investigator Dr. Shunji Sano, professor and chairman of the department of cardiovascular surgery at Okayama. He explained the work, its implications, and the next phase of research in an interview at the annual meeting of the American Association for Thoracic Surgery.

aotto@frontlinemedcom.com

SEATTLE – Sano shunts outperform Blalock-Taussig shunts for Norwood procedures in neonates with hypoplastic left heart syndrome, according to a research registry study of 322 patients at the Cleveland Clinic and elsewhere.

The 166 newborns who had Sano shunts were matched to 166 who had Blalock-Taussig (BT) shunts.

“For comparable neonates with HLHS [hypoplastic left heart syndrome] undergoing Norwood operations, Sano offers better late survival [more than 3 years], less late tricuspid regurgitation, and perhaps less late right ventricular dysfunction than BT,” the investigators concluded.

Even so, Dr. Richard Ohye, professor of cardiac surgery at the University of Michigan, Ann Arbor, said the jury is still out on which shunt is best. He explained why in an interview at the American Association for Thoracic Surgery annual meeting. He also shared tips on shunt selection and explained a novel technique he has developed for doing a Sano shunt with a smaller hole in the right ventricle.

aotto@frontlinemedcom.com

SEATTLE – Sano shunts outperform Blalock-Taussig shunts for Norwood procedures in neonates with hypoplastic left heart syndrome, according to a research registry study of 322 patients at the Cleveland Clinic and elsewhere.

The 166 newborns who had Sano shunts were matched to 166 who had Blalock-Taussig (BT) shunts.

“For comparable neonates with HLHS [hypoplastic left heart syndrome] undergoing Norwood operations, Sano offers better late survival [more than 3 years], less late tricuspid regurgitation, and perhaps less late right ventricular dysfunction than BT,” the investigators concluded.

Even so, Dr. Richard Ohye, professor of cardiac surgery at the University of Michigan, Ann Arbor, said the jury is still out on which shunt is best. He explained why in an interview at the American Association for Thoracic Surgery annual meeting. He also shared tips on shunt selection and explained a novel technique he has developed for doing a Sano shunt with a smaller hole in the right ventricle.

aotto@frontlinemedcom.com

SEATTLE – Sano shunts outperform Blalock-Taussig shunts for Norwood procedures in neonates with hypoplastic left heart syndrome, according to a research registry study of 322 patients at the Cleveland Clinic and elsewhere.

The 166 newborns who had Sano shunts were matched to 166 who had Blalock-Taussig (BT) shunts.

“For comparable neonates with HLHS [hypoplastic left heart syndrome] undergoing Norwood operations, Sano offers better late survival [more than 3 years], less late tricuspid regurgitation, and perhaps less late right ventricular dysfunction than BT,” the investigators concluded.

Even so, Dr. Richard Ohye, professor of cardiac surgery at the University of Michigan, Ann Arbor, said the jury is still out on which shunt is best. He explained why in an interview at the American Association for Thoracic Surgery annual meeting. He also shared tips on shunt selection and explained a novel technique he has developed for doing a Sano shunt with a smaller hole in the right ventricle.

aotto@frontlinemedcom.com

WASHINGTON – An implantable device that stimulates the sphenopalatine ganglion nerve bundle either reduced or eliminated pain in 68% of more than 5,000 cluster headaches, a 3-year study has determined.

The device, which is approved in Europe, was more effective in attacks of moderate severity, with a 78% rate of pain reduction or elimination, Dr. Jose Miguel Lainez reported at the annual meeting of the American Academy of Neurology.

Courtesy Autonomic Technologies Inc.

The Pulsante System, manufactured by Autonomic Technologiesof Redwood City, Calif., consists of a neurostimulator about the size of an almond, and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the sphenopalatine ganglion (SPG) nerve and the neurostimulator is affixed to the zygomatic process.

A hand-held remote controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.

Dr. Lainez, professor of neurology at Catholic University of Valencia (Spain), presented 3-year follow-up data from Pathway CH-1, a randomized, sham-controlled trial of 43 patients with cluster headache. Of these, 33 completed the 3-year follow-up period. Of the remaining 10, 1 was lost from observation, 5 violated protocol, 1 had the device implanted incorrectly, and 3 had the device explanted because of incorrect placement or lead migration.

Most of the patients were male. Mean age was 41 years. They had a mean disease duration of 10 years and averaged 17 cluster headaches per week but ranged from 4 to 70 attacks per week. Over the 3 years, 5,130 attacks were treated; the mean stimulation duration for these was 14 minutes with a mean response time of 11 minutes. Therapy was considered effective in 65% (3,354) of these attacks based on a clinically meaningful reduction in pain or pain elimination.

Dr. Lainez did not parse these results. However, in the initial 28-week phase of the Pathway CH-1 study, pain was reduced in 68% of attacks treated with the device and 7% of those treated with the sham control. Pain freedom by 15 minutes was achieved in 34% of attacks with full stimulation, compared with 1.5% of those treated with sham.

In the follow-up study, the device seemed most effective in attacks of moderate severity (78% response rate of pain reduction or elimination). The response rate was 59% in mild attacks and 51% in severe attacks. Most attacks treated with the device (77%) did not involve the use of abortive therapy.

Dr. Lainez did not mention adverse events related to the device. However, in the 28-week study, there were 92, including parasthesias and numbness; facial and tooth pain; and swelling. Others were considered mild and included dry eye, nose bleed, and facial asymmetry.

The device is currently being investigated in a U.S. study. The open-label Pathway-CH2 study aims to recruit 120 patients. For information on Pathway CH-2, contact Anthony Caparso.

The trial was sponsored by Autonomic Technologies Inc. Dr. Lainez had no financial ties with the company.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – An implantable device that stimulates the sphenopalatine ganglion nerve bundle either reduced or eliminated pain in 68% of more than 5,000 cluster headaches, a 3-year study has determined.

The device, which is approved in Europe, was more effective in attacks of moderate severity, with a 78% rate of pain reduction or elimination, Dr. Jose Miguel Lainez reported at the annual meeting of the American Academy of Neurology.

Courtesy Autonomic Technologies Inc.

The Pulsante System, manufactured by Autonomic Technologiesof Redwood City, Calif., consists of a neurostimulator about the size of an almond, and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the sphenopalatine ganglion (SPG) nerve and the neurostimulator is affixed to the zygomatic process.

A hand-held remote controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.

Dr. Lainez, professor of neurology at Catholic University of Valencia (Spain), presented 3-year follow-up data from Pathway CH-1, a randomized, sham-controlled trial of 43 patients with cluster headache. Of these, 33 completed the 3-year follow-up period. Of the remaining 10, 1 was lost from observation, 5 violated protocol, 1 had the device implanted incorrectly, and 3 had the device explanted because of incorrect placement or lead migration.

Most of the patients were male. Mean age was 41 years. They had a mean disease duration of 10 years and averaged 17 cluster headaches per week but ranged from 4 to 70 attacks per week. Over the 3 years, 5,130 attacks were treated; the mean stimulation duration for these was 14 minutes with a mean response time of 11 minutes. Therapy was considered effective in 65% (3,354) of these attacks based on a clinically meaningful reduction in pain or pain elimination.

Dr. Lainez did not parse these results. However, in the initial 28-week phase of the Pathway CH-1 study, pain was reduced in 68% of attacks treated with the device and 7% of those treated with the sham control. Pain freedom by 15 minutes was achieved in 34% of attacks with full stimulation, compared with 1.5% of those treated with sham.

In the follow-up study, the device seemed most effective in attacks of moderate severity (78% response rate of pain reduction or elimination). The response rate was 59% in mild attacks and 51% in severe attacks. Most attacks treated with the device (77%) did not involve the use of abortive therapy.

Dr. Lainez did not mention adverse events related to the device. However, in the 28-week study, there were 92, including parasthesias and numbness; facial and tooth pain; and swelling. Others were considered mild and included dry eye, nose bleed, and facial asymmetry.

The device is currently being investigated in a U.S. study. The open-label Pathway-CH2 study aims to recruit 120 patients. For information on Pathway CH-2, contact Anthony Caparso.

The trial was sponsored by Autonomic Technologies Inc. Dr. Lainez had no financial ties with the company.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – An implantable device that stimulates the sphenopalatine ganglion nerve bundle either reduced or eliminated pain in 68% of more than 5,000 cluster headaches, a 3-year study has determined.

The device, which is approved in Europe, was more effective in attacks of moderate severity, with a 78% rate of pain reduction or elimination, Dr. Jose Miguel Lainez reported at the annual meeting of the American Academy of Neurology.

Courtesy Autonomic Technologies Inc.

The Pulsante System, manufactured by Autonomic Technologiesof Redwood City, Calif., consists of a neurostimulator about the size of an almond, and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the sphenopalatine ganglion (SPG) nerve and the neurostimulator is affixed to the zygomatic process.

A hand-held remote controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.

Dr. Lainez, professor of neurology at Catholic University of Valencia (Spain), presented 3-year follow-up data from Pathway CH-1, a randomized, sham-controlled trial of 43 patients with cluster headache. Of these, 33 completed the 3-year follow-up period. Of the remaining 10, 1 was lost from observation, 5 violated protocol, 1 had the device implanted incorrectly, and 3 had the device explanted because of incorrect placement or lead migration.

Most of the patients were male. Mean age was 41 years. They had a mean disease duration of 10 years and averaged 17 cluster headaches per week but ranged from 4 to 70 attacks per week. Over the 3 years, 5,130 attacks were treated; the mean stimulation duration for these was 14 minutes with a mean response time of 11 minutes. Therapy was considered effective in 65% (3,354) of these attacks based on a clinically meaningful reduction in pain or pain elimination.

Dr. Lainez did not parse these results. However, in the initial 28-week phase of the Pathway CH-1 study, pain was reduced in 68% of attacks treated with the device and 7% of those treated with the sham control. Pain freedom by 15 minutes was achieved in 34% of attacks with full stimulation, compared with 1.5% of those treated with sham.

In the follow-up study, the device seemed most effective in attacks of moderate severity (78% response rate of pain reduction or elimination). The response rate was 59% in mild attacks and 51% in severe attacks. Most attacks treated with the device (77%) did not involve the use of abortive therapy.

Dr. Lainez did not mention adverse events related to the device. However, in the 28-week study, there were 92, including parasthesias and numbness; facial and tooth pain; and swelling. Others were considered mild and included dry eye, nose bleed, and facial asymmetry.

The device is currently being investigated in a U.S. study. The open-label Pathway-CH2 study aims to recruit 120 patients. For information on Pathway CH-2, contact Anthony Caparso.

The trial was sponsored by Autonomic Technologies Inc. Dr. Lainez had no financial ties with the company.

msullivan@frontlinemedcom.com

On Twitter @alz_gal