Cardiothoracic

PHOENIX – According to Dr. Moishe Liberman, promising lesions for bronchoscopic endoluminal treatment include endobronchial lesions and intraluminal exophytic tumors within the trachea or main bronchus, provided that the distal airway lumen is visible and you can get past the tumor with a flexible endoscope.

“We always teach the fellows that if you get pus back when you’re trying to get around the tumor or play with the tumor, you’re usually going to have a very good result,” said Dr. Liberman, a thoracic surgeon who directs the endoscopic tracheo-bronchial and oesophageal center at the Centre hospitalier de l’Université de Montréal, Quebec, Canada. “If you play with the tumor and you get the tumor out and you get nothing back, usually the CT scan or the X-ray postoperatively is going to look just like it did preoperatively, even though endoscopically you might have a good result.”

Central lesions are also excellent candidates for endoluminal therapy, he said in a video interview at the meeting. Distal lesions in the small bronchi “are candidates but are much more difficult and require more specialized tools. The shorter the lesion, the more likely you are to have good success.”

Available options for delivering energy endoscopically include electrocautery, argon plasma coagulation, laser, and cryotherapy. A disadvantage of all of the thermal modalities except for cryotherapy “include the potential for airway fire and you have to work with low FiO2s [fraction of inspired oxygen],” Dr. Liberman noted. “A lot of these patients need high FiO2s to saturate, so I think that’s always an issue. We never go on cardiopulmonary bypass to do these cases and we never cannulate patients to do these cases. You also have to worry about gas emboli, especially when you open up big vessels. These modalities can also cause inadvertent airway injury, delayed effects, and bronchoscope damage.”

In general, he continued, laser-tissue interactions depend on the power and the wavelength of the laser as well as the color and the water content of the target tissue. “The power density of the wavelength you choose determines its ability to cut, coagulate, or vaporize the tissue,” he said.

“As the power density increases, the laser fiber approaches the target tissue. Power density is more important than the energy delivered.”

The Nd:YAG (neodymium-doped yttrium aluminium garnet) laser, which causes more destruction in the deep tissue than on the surface, is the most common laser used in interventional airway procedures, he said. Two other commonly used lasers include the KTP (potassium titanyl phosphate) and the CO₂. “I like CO₂s a lot for upper airway and subglottic problems as well as vocal cord problems,” Dr. Liberman said. “It’s very precise and has low penetration. The Nd:YAG is very good for deep penetration. You need familiarity with these. I don’t think you can just take one of these off the shelf if you’ve never used it before. Sometimes your ENT [ear nose and throat] or urology colleagues can help you, because they’re using a lot more of these lasers than we are.”

Contraindications for laser bronchoscopy include operable lesions. Dr. Liberman said that while he and his associates use lasers in a preoperative setting, “we’re very careful not to damage proximal or distal airway when we know we’re going to do a sleeve resection or pneumonectomy.”

Other contraindications for laser bronchoscopy include patients with a poor short-term prognosis, severe coagulation disorder, extrinsic airway obstruction, tracheoesophageal fistula or T-Med fistula, those with extensive submucosal disease causing obstruction, and those with lesion adjacent to the esophagus or to a major vessel.

Dr. Liberman reported having received research grants from Ethicon, Boston Scientific, Olympus, Covidien, and Baxter.

[email protected]

PHOENIX – According to Dr. Moishe Liberman, promising lesions for bronchoscopic endoluminal treatment include endobronchial lesions and intraluminal exophytic tumors within the trachea or main bronchus, provided that the distal airway lumen is visible and you can get past the tumor with a flexible endoscope.

“We always teach the fellows that if you get pus back when you’re trying to get around the tumor or play with the tumor, you’re usually going to have a very good result,” said Dr. Liberman, a thoracic surgeon who directs the endoscopic tracheo-bronchial and oesophageal center at the Centre hospitalier de l’Université de Montréal, Quebec, Canada. “If you play with the tumor and you get the tumor out and you get nothing back, usually the CT scan or the X-ray postoperatively is going to look just like it did preoperatively, even though endoscopically you might have a good result.”

Central lesions are also excellent candidates for endoluminal therapy, he said in a video interview at the meeting. Distal lesions in the small bronchi “are candidates but are much more difficult and require more specialized tools. The shorter the lesion, the more likely you are to have good success.”

Available options for delivering energy endoscopically include electrocautery, argon plasma coagulation, laser, and cryotherapy. A disadvantage of all of the thermal modalities except for cryotherapy “include the potential for airway fire and you have to work with low FiO2s [fraction of inspired oxygen],” Dr. Liberman noted. “A lot of these patients need high FiO2s to saturate, so I think that’s always an issue. We never go on cardiopulmonary bypass to do these cases and we never cannulate patients to do these cases. You also have to worry about gas emboli, especially when you open up big vessels. These modalities can also cause inadvertent airway injury, delayed effects, and bronchoscope damage.”

In general, he continued, laser-tissue interactions depend on the power and the wavelength of the laser as well as the color and the water content of the target tissue. “The power density of the wavelength you choose determines its ability to cut, coagulate, or vaporize the tissue,” he said.

“As the power density increases, the laser fiber approaches the target tissue. Power density is more important than the energy delivered.”

The Nd:YAG (neodymium-doped yttrium aluminium garnet) laser, which causes more destruction in the deep tissue than on the surface, is the most common laser used in interventional airway procedures, he said. Two other commonly used lasers include the KTP (potassium titanyl phosphate) and the CO₂. “I like CO₂s a lot for upper airway and subglottic problems as well as vocal cord problems,” Dr. Liberman said. “It’s very precise and has low penetration. The Nd:YAG is very good for deep penetration. You need familiarity with these. I don’t think you can just take one of these off the shelf if you’ve never used it before. Sometimes your ENT [ear nose and throat] or urology colleagues can help you, because they’re using a lot more of these lasers than we are.”

Contraindications for laser bronchoscopy include operable lesions. Dr. Liberman said that while he and his associates use lasers in a preoperative setting, “we’re very careful not to damage proximal or distal airway when we know we’re going to do a sleeve resection or pneumonectomy.”

Other contraindications for laser bronchoscopy include patients with a poor short-term prognosis, severe coagulation disorder, extrinsic airway obstruction, tracheoesophageal fistula or T-Med fistula, those with extensive submucosal disease causing obstruction, and those with lesion adjacent to the esophagus or to a major vessel.

Dr. Liberman reported having received research grants from Ethicon, Boston Scientific, Olympus, Covidien, and Baxter.

[email protected]

PHOENIX – According to Dr. Moishe Liberman, promising lesions for bronchoscopic endoluminal treatment include endobronchial lesions and intraluminal exophytic tumors within the trachea or main bronchus, provided that the distal airway lumen is visible and you can get past the tumor with a flexible endoscope.

“We always teach the fellows that if you get pus back when you’re trying to get around the tumor or play with the tumor, you’re usually going to have a very good result,” said Dr. Liberman, a thoracic surgeon who directs the endoscopic tracheo-bronchial and oesophageal center at the Centre hospitalier de l’Université de Montréal, Quebec, Canada. “If you play with the tumor and you get the tumor out and you get nothing back, usually the CT scan or the X-ray postoperatively is going to look just like it did preoperatively, even though endoscopically you might have a good result.”

Central lesions are also excellent candidates for endoluminal therapy, he said in a video interview at the meeting. Distal lesions in the small bronchi “are candidates but are much more difficult and require more specialized tools. The shorter the lesion, the more likely you are to have good success.”

Available options for delivering energy endoscopically include electrocautery, argon plasma coagulation, laser, and cryotherapy. A disadvantage of all of the thermal modalities except for cryotherapy “include the potential for airway fire and you have to work with low FiO2s [fraction of inspired oxygen],” Dr. Liberman noted. “A lot of these patients need high FiO2s to saturate, so I think that’s always an issue. We never go on cardiopulmonary bypass to do these cases and we never cannulate patients to do these cases. You also have to worry about gas emboli, especially when you open up big vessels. These modalities can also cause inadvertent airway injury, delayed effects, and bronchoscope damage.”

In general, he continued, laser-tissue interactions depend on the power and the wavelength of the laser as well as the color and the water content of the target tissue. “The power density of the wavelength you choose determines its ability to cut, coagulate, or vaporize the tissue,” he said.

“As the power density increases, the laser fiber approaches the target tissue. Power density is more important than the energy delivered.”

The Nd:YAG (neodymium-doped yttrium aluminium garnet) laser, which causes more destruction in the deep tissue than on the surface, is the most common laser used in interventional airway procedures, he said. Two other commonly used lasers include the KTP (potassium titanyl phosphate) and the CO₂. “I like CO₂s a lot for upper airway and subglottic problems as well as vocal cord problems,” Dr. Liberman said. “It’s very precise and has low penetration. The Nd:YAG is very good for deep penetration. You need familiarity with these. I don’t think you can just take one of these off the shelf if you’ve never used it before. Sometimes your ENT [ear nose and throat] or urology colleagues can help you, because they’re using a lot more of these lasers than we are.”

Contraindications for laser bronchoscopy include operable lesions. Dr. Liberman said that while he and his associates use lasers in a preoperative setting, “we’re very careful not to damage proximal or distal airway when we know we’re going to do a sleeve resection or pneumonectomy.”

Other contraindications for laser bronchoscopy include patients with a poor short-term prognosis, severe coagulation disorder, extrinsic airway obstruction, tracheoesophageal fistula or T-Med fistula, those with extensive submucosal disease causing obstruction, and those with lesion adjacent to the esophagus or to a major vessel.

Dr. Liberman reported having received research grants from Ethicon, Boston Scientific, Olympus, Covidien, and Baxter.

[email protected]

The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.

Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.

“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.

The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.

The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.

All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.

Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.

The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.

This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.

They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.

The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.

The study authors had no conflicts to disclose.

The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.

Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.

“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.

The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.

The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.

All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.

Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.

The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.

This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.

They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.

The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.

The study authors had no conflicts to disclose.

The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.

Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.

“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.

The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.

The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.

All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.

Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.

The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.

This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.

They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.

The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.

The study authors had no conflicts to disclose.

Claims that off-pump coronary artery bypass (OPCAB) carries a lower risk of short-term stroke than conventional on-pump coronary artery bypass grafting (CABG) have been the subject of contradicting evidence, mostly because of the small size of the studies that showed a benefit, but European investigators published a meta-analysis involving more than 19,000 cases that showed what they called a “significant reduction” in the odds of a stroke.

“OPCAB was associated with a significant (28%) reduction in the odds of stroke compared with CABG,” said lead author Dr. Mariusz Kowalewski of Copernicus University in Bydgoszcz, Poland, and coauthors. The meta-analysis appeared in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:60-77).

The coauthors represent 10 different centers throughout Europe. Dr. Kowalewski and three other coauthors are also with the Systemic Investigation and Research on Interventions and Outcomes MEDICINE Research Network based in Düsseldorf, Germany.

Dr. Kowalewski and colleagues said this is the largest meta-analysis of randomized clinical trials comparing short-term outcomes of the two approaches to coronary bypass. “By its unique design, this analysis is the first report to investigate the causal relationship between underlying patient risk profile and the benefits of off-pump coronary revascularization,” they noted.

The meta-analysis looked at results of three primary outcomes: death within 30 days of the operation (2.25% overall, 2% in the OPCAB group and 2.04% in the CABG group); MI 30 days after surgery (4.49% overall, 4.3% for OPCAB and 4.67% for CABG); and 30-day occurrence of stroke (1.67% overall, 1.34% for OPCAB group and 2% for CABG).

In the meta-analysis, the researchers evaluated 100 studies for potential bias and conducted three separate analyses: one of all studies; and then separate analyses of studies of more than 50 and 100 subjects, respectively. Their goal was to check if small studies were driving the results.

Dr. Kowalewski and the study team acknowledged the conflicting science surrounding the benefits of the off-pump vs. conventional bypass. They pointed out that a host of randomized studies failed to show significant differences in stroke rates between the two approaches, and that conflicting European and American guidelines on the role of off-pump surgery to provide a better neurologic outcome do not help to clarify the relative risk.

“This apparent contradiction with the available registries’ data reporting a significantly decreased incidence of stroke with OPCAB may be explained by the fact that cerebral stroke represents a relatively rare entity after CABG, and thus even the largest randomized studies are underpowered to prove a possible advantage of one technique over the other,” Dr. Kowalewski and colleagues said.

They cited the CORONARY trial (N Engl J Med. 2012;366:1489-97), the largest trial to date, with 4,752 patients, which found no difference in the rate of stroke between the two groups. Three previous meta-analyses demonstrated 30%-50% reductions in stroke, but a systemic review called those results into question (Cochrane Database Syst. Rev. 2012;3:CD007224).

The “most important” finding of their study may be the confirmation of what large registries have reported: that OPCAB is safer and more effective than conventional bypass surgery in older and sicker patients. But they acknowledged that why this is the case “remains a subject of ongoing debate.”

Dr. Kowalewski and coresearchers acknowledged a number of limitations of their meta-analysis, namely that sensitivity analysis may have missed clinically important differences in patient results and broad patient inclusion criteria. However, the random-effects model they used accounted for study variations. “The findings on significant risk profile meta-regression are further corroborated in the analysis of MI and stroke,” they said.

Coauthor Dr. Eliano Pio Navarese disclosed honoraria from Eli Lilly. The other coauthors had no relationships to disclose.

Claims that off-pump coronary artery bypass (OPCAB) carries a lower risk of short-term stroke than conventional on-pump coronary artery bypass grafting (CABG) have been the subject of contradicting evidence, mostly because of the small size of the studies that showed a benefit, but European investigators published a meta-analysis involving more than 19,000 cases that showed what they called a “significant reduction” in the odds of a stroke.

“OPCAB was associated with a significant (28%) reduction in the odds of stroke compared with CABG,” said lead author Dr. Mariusz Kowalewski of Copernicus University in Bydgoszcz, Poland, and coauthors. The meta-analysis appeared in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:60-77).

The coauthors represent 10 different centers throughout Europe. Dr. Kowalewski and three other coauthors are also with the Systemic Investigation and Research on Interventions and Outcomes MEDICINE Research Network based in Düsseldorf, Germany.

Dr. Kowalewski and colleagues said this is the largest meta-analysis of randomized clinical trials comparing short-term outcomes of the two approaches to coronary bypass. “By its unique design, this analysis is the first report to investigate the causal relationship between underlying patient risk profile and the benefits of off-pump coronary revascularization,” they noted.

The meta-analysis looked at results of three primary outcomes: death within 30 days of the operation (2.25% overall, 2% in the OPCAB group and 2.04% in the CABG group); MI 30 days after surgery (4.49% overall, 4.3% for OPCAB and 4.67% for CABG); and 30-day occurrence of stroke (1.67% overall, 1.34% for OPCAB group and 2% for CABG).

In the meta-analysis, the researchers evaluated 100 studies for potential bias and conducted three separate analyses: one of all studies; and then separate analyses of studies of more than 50 and 100 subjects, respectively. Their goal was to check if small studies were driving the results.

Dr. Kowalewski and the study team acknowledged the conflicting science surrounding the benefits of the off-pump vs. conventional bypass. They pointed out that a host of randomized studies failed to show significant differences in stroke rates between the two approaches, and that conflicting European and American guidelines on the role of off-pump surgery to provide a better neurologic outcome do not help to clarify the relative risk.

“This apparent contradiction with the available registries’ data reporting a significantly decreased incidence of stroke with OPCAB may be explained by the fact that cerebral stroke represents a relatively rare entity after CABG, and thus even the largest randomized studies are underpowered to prove a possible advantage of one technique over the other,” Dr. Kowalewski and colleagues said.

They cited the CORONARY trial (N Engl J Med. 2012;366:1489-97), the largest trial to date, with 4,752 patients, which found no difference in the rate of stroke between the two groups. Three previous meta-analyses demonstrated 30%-50% reductions in stroke, but a systemic review called those results into question (Cochrane Database Syst. Rev. 2012;3:CD007224).

The “most important” finding of their study may be the confirmation of what large registries have reported: that OPCAB is safer and more effective than conventional bypass surgery in older and sicker patients. But they acknowledged that why this is the case “remains a subject of ongoing debate.”

Dr. Kowalewski and coresearchers acknowledged a number of limitations of their meta-analysis, namely that sensitivity analysis may have missed clinically important differences in patient results and broad patient inclusion criteria. However, the random-effects model they used accounted for study variations. “The findings on significant risk profile meta-regression are further corroborated in the analysis of MI and stroke,” they said.

Coauthor Dr. Eliano Pio Navarese disclosed honoraria from Eli Lilly. The other coauthors had no relationships to disclose.

Claims that off-pump coronary artery bypass (OPCAB) carries a lower risk of short-term stroke than conventional on-pump coronary artery bypass grafting (CABG) have been the subject of contradicting evidence, mostly because of the small size of the studies that showed a benefit, but European investigators published a meta-analysis involving more than 19,000 cases that showed what they called a “significant reduction” in the odds of a stroke.

“OPCAB was associated with a significant (28%) reduction in the odds of stroke compared with CABG,” said lead author Dr. Mariusz Kowalewski of Copernicus University in Bydgoszcz, Poland, and coauthors. The meta-analysis appeared in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:60-77).

The coauthors represent 10 different centers throughout Europe. Dr. Kowalewski and three other coauthors are also with the Systemic Investigation and Research on Interventions and Outcomes MEDICINE Research Network based in Düsseldorf, Germany.

Dr. Kowalewski and colleagues said this is the largest meta-analysis of randomized clinical trials comparing short-term outcomes of the two approaches to coronary bypass. “By its unique design, this analysis is the first report to investigate the causal relationship between underlying patient risk profile and the benefits of off-pump coronary revascularization,” they noted.

The meta-analysis looked at results of three primary outcomes: death within 30 days of the operation (2.25% overall, 2% in the OPCAB group and 2.04% in the CABG group); MI 30 days after surgery (4.49% overall, 4.3% for OPCAB and 4.67% for CABG); and 30-day occurrence of stroke (1.67% overall, 1.34% for OPCAB group and 2% for CABG).

In the meta-analysis, the researchers evaluated 100 studies for potential bias and conducted three separate analyses: one of all studies; and then separate analyses of studies of more than 50 and 100 subjects, respectively. Their goal was to check if small studies were driving the results.

Dr. Kowalewski and the study team acknowledged the conflicting science surrounding the benefits of the off-pump vs. conventional bypass. They pointed out that a host of randomized studies failed to show significant differences in stroke rates between the two approaches, and that conflicting European and American guidelines on the role of off-pump surgery to provide a better neurologic outcome do not help to clarify the relative risk.

“This apparent contradiction with the available registries’ data reporting a significantly decreased incidence of stroke with OPCAB may be explained by the fact that cerebral stroke represents a relatively rare entity after CABG, and thus even the largest randomized studies are underpowered to prove a possible advantage of one technique over the other,” Dr. Kowalewski and colleagues said.

They cited the CORONARY trial (N Engl J Med. 2012;366:1489-97), the largest trial to date, with 4,752 patients, which found no difference in the rate of stroke between the two groups. Three previous meta-analyses demonstrated 30%-50% reductions in stroke, but a systemic review called those results into question (Cochrane Database Syst. Rev. 2012;3:CD007224).

The “most important” finding of their study may be the confirmation of what large registries have reported: that OPCAB is safer and more effective than conventional bypass surgery in older and sicker patients. But they acknowledged that why this is the case “remains a subject of ongoing debate.”

Dr. Kowalewski and coresearchers acknowledged a number of limitations of their meta-analysis, namely that sensitivity analysis may have missed clinically important differences in patient results and broad patient inclusion criteria. However, the random-effects model they used accounted for study variations. “The findings on significant risk profile meta-regression are further corroborated in the analysis of MI and stroke,” they said.

Coauthor Dr. Eliano Pio Navarese disclosed honoraria from Eli Lilly. The other coauthors had no relationships to disclose.

In patients who undergo transcatheter mitral valve repair for mitral valve regurgitation (MR), residual mild (+2) regurgitation has been considered procedural success, but a team of Italian investigators has provided evidence that such a result may actually foretell far worse long-term outcomes than residual trace (≤1) MR.

The investigators from San Raffaele Scientific Institute in Milan reported their findings in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg 2016;151:88-96). They compared follow-up outcomes of 223 consecutive patients with residual MR 2+ and MR ≤1 after implantation of the MitraClip system (Abbott Vascular). The procedures were performed between October 2008 and December 2014.

“In this study we found a clear unfavorable impact on follow-up outcomes of acute residual 2+ MR after MitraClip repair when compared to residual ≤1+ MR,” lead author Dr. Nicola Buzzatti and colleagues said.

The study cited a scarcity of data on the long-term impact of residual mild MR. “This topic is therefore particularly of interest, especially when assessing the convenience to expand transcatheter mitral repair procedures to intermediate or low-risk patients,” Dr. Buzzatti and coauthors said.

The study group all had moderate or greater (≥3+) MR when they underwent mitral valve repair (MVR). The post-MVR study cohort excluded patients who had residual MR of 3 or greater, which was considered a procedural failure. Four patients died within 30 days, each from a different cause: multi-organ failure, lung rupture, pneumonia with heart failure, and sudden death. The overall 30-day death rate was 1.8%.

Among the remainder of patients, the average follow-up was 20.5 months, with some follow-up extending to 75 months. The overall survival was 74.4% at 24 months and 63% at 48 months.

The study calculated the cumulative incidence function, or the probability of failure, of cardiac death in patients with residual MR ≤1 at 7.1% at 24 months and 10.9% at 48 months, compared with 26.9% at 24 months and 35.3% at 48 months in those with MR 2+. The probability of failure of recurrence of moderate or severe MR with residual MR ≤1 was 5.6% at 24 months and 13.3% at 48 months, compared with 45.2% at both 24 and 48 months with residual MR 2+. “The difference between MR ≤1 and MR=2 was significant,” Dr. Buzzatti and colleagues said.

The researchers separately evaluated outcomes among those who had functional MR (FMR) and degenerative MR (DMR). In FMR, patients with MR 2+ had a higher risk profile at baseline because of a slightly higher rate of advanced heart disease; they typically had larger ventricles with larger mitral valves and greater pulmonary pressure than the ≤1 MR patients. “Notably, these features could have impaired the surgeon’s ability to achieve acute optimal MR reduction during the MitraClip procedure,” Dr. Buzzatti and coauthors said. “For sure, advanced left ventricle remodeling was a strong independent predictor of increased cardiac death.” The study authors could not draw a similar conclusion with DMR because only three patients in the group died of cardiac causes.

MR recurrence was “remarkably higher” in MR 2+ patients, compared with the MR ≤1 group with FMR and DMR, and MR 2+ developed in 21.4% of the FMR group within 30 days of the procedure. “This poor efficacy results in a population of patients who were supposed to have had a ‘procedural success’ is striking,” Dr. Buzzatti and coauthors noted.

Dr. Buzzatti and coauthor Dr. Paolo Denti disclosed receiving consultant fees from Abbott Vascular. Coauthor Dr. Fabio Barili disclosed receiving consultant fees from St. Jude Medical. The other coauthors had no relationships to disclose.

In patients who undergo transcatheter mitral valve repair for mitral valve regurgitation (MR), residual mild (+2) regurgitation has been considered procedural success, but a team of Italian investigators has provided evidence that such a result may actually foretell far worse long-term outcomes than residual trace (≤1) MR.

The investigators from San Raffaele Scientific Institute in Milan reported their findings in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg 2016;151:88-96). They compared follow-up outcomes of 223 consecutive patients with residual MR 2+ and MR ≤1 after implantation of the MitraClip system (Abbott Vascular). The procedures were performed between October 2008 and December 2014.

“In this study we found a clear unfavorable impact on follow-up outcomes of acute residual 2+ MR after MitraClip repair when compared to residual ≤1+ MR,” lead author Dr. Nicola Buzzatti and colleagues said.

The study cited a scarcity of data on the long-term impact of residual mild MR. “This topic is therefore particularly of interest, especially when assessing the convenience to expand transcatheter mitral repair procedures to intermediate or low-risk patients,” Dr. Buzzatti and coauthors said.

The study group all had moderate or greater (≥3+) MR when they underwent mitral valve repair (MVR). The post-MVR study cohort excluded patients who had residual MR of 3 or greater, which was considered a procedural failure. Four patients died within 30 days, each from a different cause: multi-organ failure, lung rupture, pneumonia with heart failure, and sudden death. The overall 30-day death rate was 1.8%.

Among the remainder of patients, the average follow-up was 20.5 months, with some follow-up extending to 75 months. The overall survival was 74.4% at 24 months and 63% at 48 months.

The study calculated the cumulative incidence function, or the probability of failure, of cardiac death in patients with residual MR ≤1 at 7.1% at 24 months and 10.9% at 48 months, compared with 26.9% at 24 months and 35.3% at 48 months in those with MR 2+. The probability of failure of recurrence of moderate or severe MR with residual MR ≤1 was 5.6% at 24 months and 13.3% at 48 months, compared with 45.2% at both 24 and 48 months with residual MR 2+. “The difference between MR ≤1 and MR=2 was significant,” Dr. Buzzatti and colleagues said.

The researchers separately evaluated outcomes among those who had functional MR (FMR) and degenerative MR (DMR). In FMR, patients with MR 2+ had a higher risk profile at baseline because of a slightly higher rate of advanced heart disease; they typically had larger ventricles with larger mitral valves and greater pulmonary pressure than the ≤1 MR patients. “Notably, these features could have impaired the surgeon’s ability to achieve acute optimal MR reduction during the MitraClip procedure,” Dr. Buzzatti and coauthors said. “For sure, advanced left ventricle remodeling was a strong independent predictor of increased cardiac death.” The study authors could not draw a similar conclusion with DMR because only three patients in the group died of cardiac causes.

MR recurrence was “remarkably higher” in MR 2+ patients, compared with the MR ≤1 group with FMR and DMR, and MR 2+ developed in 21.4% of the FMR group within 30 days of the procedure. “This poor efficacy results in a population of patients who were supposed to have had a ‘procedural success’ is striking,” Dr. Buzzatti and coauthors noted.

Dr. Buzzatti and coauthor Dr. Paolo Denti disclosed receiving consultant fees from Abbott Vascular. Coauthor Dr. Fabio Barili disclosed receiving consultant fees from St. Jude Medical. The other coauthors had no relationships to disclose.

In patients who undergo transcatheter mitral valve repair for mitral valve regurgitation (MR), residual mild (+2) regurgitation has been considered procedural success, but a team of Italian investigators has provided evidence that such a result may actually foretell far worse long-term outcomes than residual trace (≤1) MR.

The investigators from San Raffaele Scientific Institute in Milan reported their findings in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg 2016;151:88-96). They compared follow-up outcomes of 223 consecutive patients with residual MR 2+ and MR ≤1 after implantation of the MitraClip system (Abbott Vascular). The procedures were performed between October 2008 and December 2014.

“In this study we found a clear unfavorable impact on follow-up outcomes of acute residual 2+ MR after MitraClip repair when compared to residual ≤1+ MR,” lead author Dr. Nicola Buzzatti and colleagues said.

The study cited a scarcity of data on the long-term impact of residual mild MR. “This topic is therefore particularly of interest, especially when assessing the convenience to expand transcatheter mitral repair procedures to intermediate or low-risk patients,” Dr. Buzzatti and coauthors said.

The study group all had moderate or greater (≥3+) MR when they underwent mitral valve repair (MVR). The post-MVR study cohort excluded patients who had residual MR of 3 or greater, which was considered a procedural failure. Four patients died within 30 days, each from a different cause: multi-organ failure, lung rupture, pneumonia with heart failure, and sudden death. The overall 30-day death rate was 1.8%.

Among the remainder of patients, the average follow-up was 20.5 months, with some follow-up extending to 75 months. The overall survival was 74.4% at 24 months and 63% at 48 months.

The study calculated the cumulative incidence function, or the probability of failure, of cardiac death in patients with residual MR ≤1 at 7.1% at 24 months and 10.9% at 48 months, compared with 26.9% at 24 months and 35.3% at 48 months in those with MR 2+. The probability of failure of recurrence of moderate or severe MR with residual MR ≤1 was 5.6% at 24 months and 13.3% at 48 months, compared with 45.2% at both 24 and 48 months with residual MR 2+. “The difference between MR ≤1 and MR=2 was significant,” Dr. Buzzatti and colleagues said.

The researchers separately evaluated outcomes among those who had functional MR (FMR) and degenerative MR (DMR). In FMR, patients with MR 2+ had a higher risk profile at baseline because of a slightly higher rate of advanced heart disease; they typically had larger ventricles with larger mitral valves and greater pulmonary pressure than the ≤1 MR patients. “Notably, these features could have impaired the surgeon’s ability to achieve acute optimal MR reduction during the MitraClip procedure,” Dr. Buzzatti and coauthors said. “For sure, advanced left ventricle remodeling was a strong independent predictor of increased cardiac death.” The study authors could not draw a similar conclusion with DMR because only three patients in the group died of cardiac causes.

MR recurrence was “remarkably higher” in MR 2+ patients, compared with the MR ≤1 group with FMR and DMR, and MR 2+ developed in 21.4% of the FMR group within 30 days of the procedure. “This poor efficacy results in a population of patients who were supposed to have had a ‘procedural success’ is striking,” Dr. Buzzatti and coauthors noted.

Dr. Buzzatti and coauthor Dr. Paolo Denti disclosed receiving consultant fees from Abbott Vascular. Coauthor Dr. Fabio Barili disclosed receiving consultant fees from St. Jude Medical. The other coauthors had no relationships to disclose.

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.

Three-dimensional transesophageal echocardiography identified several significant predictors of aortic regurgitation after transcatheter aortic valve replacement, according to a study published online Jan. 5 in JACC Cardiovascular Imaging.

“This is the first study to demonstrate that large prosthetic expansion, elliptical prosthetic shape, and anti-anatomical position are 3D features associated with transvalvular AR,” said Dr. Kentaro Shibayama of Cedars-Sinai Heart Institute in Los Angeles, and his associates. The study also showed that paravalvular AR was inversely related to effective area oversizing, the investigators said (JACC Cardiovasc Imag. 2016 Jan. 6).

Post-TAVR AR continues to affect substantial numbers of patients, despite progress in prosthesis design. Past research has linked paravalvular AR to prosthetic undersizing, long-axis malpositioning, and aortic annular calcification, but the causes of transvalvular AR have not been adequately studied, the researchers said. Using intraprocedural 3D transesophageal echocardiography, they imaged the native annuluses and postoperative prosthetic valves of 201 patients with severe aortic stenosis who received the Edwards SAPIEN device. The investigators also used transthoracic echocardiography to separately grade post-TAVR transvalvular and paravalvular AR as none or trivial, mild, moderate, or severe according to the 2012 Valve Academic Research Consortium criteria (J Am Coll Cardiol. 2012;60:1438-54).Fully 44% of patients developed mild or moderate aortic regurgitation after TAVR, while the rest had no or trivial AR, the investigators said. About three-quarters of AR cases were mild, nearly 25% were moderate, and none were severe. Only 3% of patients had transvalvular AR only, 34% had paravalvular AR only, and 7% had both types of AR. Patients with post-TAVR transvalvular AR had significantly more prosthetic expansion (P less than .05), a more elliptical prosthetic shape at the level of the prosthetic commissure (P less than .01), and malpositioning of the prosthetic commissures in relation to the native commissures (P less than .001), compared with patients without transvalvular AR.

Patients were more likely to have paravalvular AR if they had a lower percentage of effective area oversizing, defined as the prosthetic frame area divided by the area of the native aortic annulus (odds ratio, 0.97; 95% CI: 0.93-0.99, P less than .05). “A mismatch between a larger native aortic valve annulus area and a smaller deployed prosthesis found by intra-procedural 3D TEE may increase the risk of developing mild or greater paravalvular AR,” the researchers explained. Older age also was slightly but significantly linked with mild or moderate paravalvular AR(OR, 1.05; 95% CI, 1.01-1.09, P less than .05).

“Abnormalities related to transvalvular AR after TAVR found in this study may contribute to further deterioration of the prosthesis, warranting careful prospective studies to assess the long-term prognosis of these patients,” the investigators concluded. They cautioned that the number of patients with post-TAVR transvalvular AR was too small to carry out detailed analyses.

The researchers reported no funding sources. Senior author Dr. Takahiro Shiota reported being a speaker for Philips Ultrasound, and three of the other seven coinvestigators reported financial relationships with Edwards, Medtronic, Abbott, Capricor, St. Jude Medical, Philips Ultrasound, and Venus Medtech.

Three-dimensional transesophageal echocardiography identified several significant predictors of aortic regurgitation after transcatheter aortic valve replacement, according to a study published online Jan. 5 in JACC Cardiovascular Imaging.

“This is the first study to demonstrate that large prosthetic expansion, elliptical prosthetic shape, and anti-anatomical position are 3D features associated with transvalvular AR,” said Dr. Kentaro Shibayama of Cedars-Sinai Heart Institute in Los Angeles, and his associates. The study also showed that paravalvular AR was inversely related to effective area oversizing, the investigators said (JACC Cardiovasc Imag. 2016 Jan. 6).

Post-TAVR AR continues to affect substantial numbers of patients, despite progress in prosthesis design. Past research has linked paravalvular AR to prosthetic undersizing, long-axis malpositioning, and aortic annular calcification, but the causes of transvalvular AR have not been adequately studied, the researchers said. Using intraprocedural 3D transesophageal echocardiography, they imaged the native annuluses and postoperative prosthetic valves of 201 patients with severe aortic stenosis who received the Edwards SAPIEN device. The investigators also used transthoracic echocardiography to separately grade post-TAVR transvalvular and paravalvular AR as none or trivial, mild, moderate, or severe according to the 2012 Valve Academic Research Consortium criteria (J Am Coll Cardiol. 2012;60:1438-54).Fully 44% of patients developed mild or moderate aortic regurgitation after TAVR, while the rest had no or trivial AR, the investigators said. About three-quarters of AR cases were mild, nearly 25% were moderate, and none were severe. Only 3% of patients had transvalvular AR only, 34% had paravalvular AR only, and 7% had both types of AR. Patients with post-TAVR transvalvular AR had significantly more prosthetic expansion (P less than .05), a more elliptical prosthetic shape at the level of the prosthetic commissure (P less than .01), and malpositioning of the prosthetic commissures in relation to the native commissures (P less than .001), compared with patients without transvalvular AR.

Patients were more likely to have paravalvular AR if they had a lower percentage of effective area oversizing, defined as the prosthetic frame area divided by the area of the native aortic annulus (odds ratio, 0.97; 95% CI: 0.93-0.99, P less than .05). “A mismatch between a larger native aortic valve annulus area and a smaller deployed prosthesis found by intra-procedural 3D TEE may increase the risk of developing mild or greater paravalvular AR,” the researchers explained. Older age also was slightly but significantly linked with mild or moderate paravalvular AR(OR, 1.05; 95% CI, 1.01-1.09, P less than .05).

“Abnormalities related to transvalvular AR after TAVR found in this study may contribute to further deterioration of the prosthesis, warranting careful prospective studies to assess the long-term prognosis of these patients,” the investigators concluded. They cautioned that the number of patients with post-TAVR transvalvular AR was too small to carry out detailed analyses.

The researchers reported no funding sources. Senior author Dr. Takahiro Shiota reported being a speaker for Philips Ultrasound, and three of the other seven coinvestigators reported financial relationships with Edwards, Medtronic, Abbott, Capricor, St. Jude Medical, Philips Ultrasound, and Venus Medtech.

Three-dimensional transesophageal echocardiography identified several significant predictors of aortic regurgitation after transcatheter aortic valve replacement, according to a study published online Jan. 5 in JACC Cardiovascular Imaging.

“This is the first study to demonstrate that large prosthetic expansion, elliptical prosthetic shape, and anti-anatomical position are 3D features associated with transvalvular AR,” said Dr. Kentaro Shibayama of Cedars-Sinai Heart Institute in Los Angeles, and his associates. The study also showed that paravalvular AR was inversely related to effective area oversizing, the investigators said (JACC Cardiovasc Imag. 2016 Jan. 6).

Post-TAVR AR continues to affect substantial numbers of patients, despite progress in prosthesis design. Past research has linked paravalvular AR to prosthetic undersizing, long-axis malpositioning, and aortic annular calcification, but the causes of transvalvular AR have not been adequately studied, the researchers said. Using intraprocedural 3D transesophageal echocardiography, they imaged the native annuluses and postoperative prosthetic valves of 201 patients with severe aortic stenosis who received the Edwards SAPIEN device. The investigators also used transthoracic echocardiography to separately grade post-TAVR transvalvular and paravalvular AR as none or trivial, mild, moderate, or severe according to the 2012 Valve Academic Research Consortium criteria (J Am Coll Cardiol. 2012;60:1438-54).Fully 44% of patients developed mild or moderate aortic regurgitation after TAVR, while the rest had no or trivial AR, the investigators said. About three-quarters of AR cases were mild, nearly 25% were moderate, and none were severe. Only 3% of patients had transvalvular AR only, 34% had paravalvular AR only, and 7% had both types of AR. Patients with post-TAVR transvalvular AR had significantly more prosthetic expansion (P less than .05), a more elliptical prosthetic shape at the level of the prosthetic commissure (P less than .01), and malpositioning of the prosthetic commissures in relation to the native commissures (P less than .001), compared with patients without transvalvular AR.

Patients were more likely to have paravalvular AR if they had a lower percentage of effective area oversizing, defined as the prosthetic frame area divided by the area of the native aortic annulus (odds ratio, 0.97; 95% CI: 0.93-0.99, P less than .05). “A mismatch between a larger native aortic valve annulus area and a smaller deployed prosthesis found by intra-procedural 3D TEE may increase the risk of developing mild or greater paravalvular AR,” the researchers explained. Older age also was slightly but significantly linked with mild or moderate paravalvular AR(OR, 1.05; 95% CI, 1.01-1.09, P less than .05).

“Abnormalities related to transvalvular AR after TAVR found in this study may contribute to further deterioration of the prosthesis, warranting careful prospective studies to assess the long-term prognosis of these patients,” the investigators concluded. They cautioned that the number of patients with post-TAVR transvalvular AR was too small to carry out detailed analyses.

The researchers reported no funding sources. Senior author Dr. Takahiro Shiota reported being a speaker for Philips Ultrasound, and three of the other seven coinvestigators reported financial relationships with Edwards, Medtronic, Abbott, Capricor, St. Jude Medical, Philips Ultrasound, and Venus Medtech.

In Germany, almost all of the marked increase in the use of transcatheter aortic valve replacement (TAVR) since the procedure’s introduction in 2007 occurred in patients unsuited to a surgical approach because of their advanced age or elevated risk, according to an analysis published online Dec. 17 in the New England Journal of Medicine.

The surgical aortic valve replacement (SAVR) is still the standard of care, but many have questioned how the relatively new transcatheter approach has affected clinical practice overall, said Dr. Jochen Reinöhl of the Heart Center, University of Freiburg (Germany) and his associates.

To assess the evolution of treatment since TAVR was introduced, the investigators analyzed data from the Institute for the Hospital Remuneration System, which tracks all patient data regarding diagnoses, comorbidities, and procedures throughout the country. They focused on all 88,573 admissions for isolated surgical aortic valve replacements (55,992 procedures) and for isolated TAVR (32,581 procedures) performed in Germany during 2007-2013.

The number of TAVR procedures increased markedly over time, from 144 to 9,147 per year, while the number of SAVRs declined only slightly, from 8,622 to 7,048 per year. Patients aged 80 years and older accounted for almost all of the dramatic increase in transcatheter procedures, the investigators said (N Engl J Med. 2015 Dec 17;373:2438-47 [doi:10.1056/NEJMoa1500893]).

Overall in-hospital mortality was significantly higher with TAVR (6.5%) than with SAVR (2.8%), for an odds ratio of 2.41. This likely reflects the significantly greater risk of patients selected for TAVR, compared with those undergoing surgery, they said.

Mortality decreased over time in both patient groups, from 3.8% to 2.2% with surgery and from 13.2% to 5.4% with TAVR. In the case of TAVR, this decline is likely from a “learning curve” effect among clinicians, improvements in patient care, and advances in treatment devices. In the case of surgery, the mortality decline is probably due in part to the shift of high-risk patients from SAVR to the transcatheter approach, Dr. Reinöhl and his associates said.

Similarly, complications were significantly more common with TAVR. The need for permanent pacemaker implantation was the most frequently reported complication of TAVR, occurring in 17.7% of the transcatheter group but only 4.0% of the surgical group. Stroke rates (2.5% vs. 1.8%) and rates of acute kidney injury (5.5% vs. 3.0%) followed a similar pattern. In contrast, bleeding complications were more frequent with surgery (14.0% vs. 8.2%).

In Germany, almost all of the marked increase in the use of transcatheter aortic valve replacement (TAVR) since the procedure’s introduction in 2007 occurred in patients unsuited to a surgical approach because of their advanced age or elevated risk, according to an analysis published online Dec. 17 in the New England Journal of Medicine.

The surgical aortic valve replacement (SAVR) is still the standard of care, but many have questioned how the relatively new transcatheter approach has affected clinical practice overall, said Dr. Jochen Reinöhl of the Heart Center, University of Freiburg (Germany) and his associates.

To assess the evolution of treatment since TAVR was introduced, the investigators analyzed data from the Institute for the Hospital Remuneration System, which tracks all patient data regarding diagnoses, comorbidities, and procedures throughout the country. They focused on all 88,573 admissions for isolated surgical aortic valve replacements (55,992 procedures) and for isolated TAVR (32,581 procedures) performed in Germany during 2007-2013.

The number of TAVR procedures increased markedly over time, from 144 to 9,147 per year, while the number of SAVRs declined only slightly, from 8,622 to 7,048 per year. Patients aged 80 years and older accounted for almost all of the dramatic increase in transcatheter procedures, the investigators said (N Engl J Med. 2015 Dec 17;373:2438-47 [doi:10.1056/NEJMoa1500893]).

Overall in-hospital mortality was significantly higher with TAVR (6.5%) than with SAVR (2.8%), for an odds ratio of 2.41. This likely reflects the significantly greater risk of patients selected for TAVR, compared with those undergoing surgery, they said.

Mortality decreased over time in both patient groups, from 3.8% to 2.2% with surgery and from 13.2% to 5.4% with TAVR. In the case of TAVR, this decline is likely from a “learning curve” effect among clinicians, improvements in patient care, and advances in treatment devices. In the case of surgery, the mortality decline is probably due in part to the shift of high-risk patients from SAVR to the transcatheter approach, Dr. Reinöhl and his associates said.

Similarly, complications were significantly more common with TAVR. The need for permanent pacemaker implantation was the most frequently reported complication of TAVR, occurring in 17.7% of the transcatheter group but only 4.0% of the surgical group. Stroke rates (2.5% vs. 1.8%) and rates of acute kidney injury (5.5% vs. 3.0%) followed a similar pattern. In contrast, bleeding complications were more frequent with surgery (14.0% vs. 8.2%).

In Germany, almost all of the marked increase in the use of transcatheter aortic valve replacement (TAVR) since the procedure’s introduction in 2007 occurred in patients unsuited to a surgical approach because of their advanced age or elevated risk, according to an analysis published online Dec. 17 in the New England Journal of Medicine.

The surgical aortic valve replacement (SAVR) is still the standard of care, but many have questioned how the relatively new transcatheter approach has affected clinical practice overall, said Dr. Jochen Reinöhl of the Heart Center, University of Freiburg (Germany) and his associates.

To assess the evolution of treatment since TAVR was introduced, the investigators analyzed data from the Institute for the Hospital Remuneration System, which tracks all patient data regarding diagnoses, comorbidities, and procedures throughout the country. They focused on all 88,573 admissions for isolated surgical aortic valve replacements (55,992 procedures) and for isolated TAVR (32,581 procedures) performed in Germany during 2007-2013.

The number of TAVR procedures increased markedly over time, from 144 to 9,147 per year, while the number of SAVRs declined only slightly, from 8,622 to 7,048 per year. Patients aged 80 years and older accounted for almost all of the dramatic increase in transcatheter procedures, the investigators said (N Engl J Med. 2015 Dec 17;373:2438-47 [doi:10.1056/NEJMoa1500893]).

Overall in-hospital mortality was significantly higher with TAVR (6.5%) than with SAVR (2.8%), for an odds ratio of 2.41. This likely reflects the significantly greater risk of patients selected for TAVR, compared with those undergoing surgery, they said.

Mortality decreased over time in both patient groups, from 3.8% to 2.2% with surgery and from 13.2% to 5.4% with TAVR. In the case of TAVR, this decline is likely from a “learning curve” effect among clinicians, improvements in patient care, and advances in treatment devices. In the case of surgery, the mortality decline is probably due in part to the shift of high-risk patients from SAVR to the transcatheter approach, Dr. Reinöhl and his associates said.

Similarly, complications were significantly more common with TAVR. The need for permanent pacemaker implantation was the most frequently reported complication of TAVR, occurring in 17.7% of the transcatheter group but only 4.0% of the surgical group. Stroke rates (2.5% vs. 1.8%) and rates of acute kidney injury (5.5% vs. 3.0%) followed a similar pattern. In contrast, bleeding complications were more frequent with surgery (14.0% vs. 8.2%).