Cardiothoracic

CHICAGO – The “groundbreaking” results from the PARTNER 2 trial of transcatheter aortic valve replacement in patients at intermediate risk for death or complications from surgical replacement of a stenotic aortic valve provide substantially increased certainty that the transcatheter approach is at least as good as surgical valve replacement, commented Dr. Roxana Mehran in a video interview at the annual meeting of the American College of Cardiology.

In addition to providing important new data on the equivalence of surgical and transcatheter aortic valve replacement (TAVR) in a new target population--intermediate-risk patients, the findings from the randomized, multicenter PARTNER trial, which enrolled 2,032 patients, may also lead to expansion of the Food and Drug Administration labeling of the balloon-expandable TAVR device used in the study, the Sapien XT, to intermediate-risk patients. This expanded indication may also apply to the newer, smaller and more advanced iteration of this device, the Sapien 3, which has largely replaced the XT in U.S. practice, Dr. Mehran suggested.

Although the results came from the XT TAVR system, “these results have big relevance” to current U.S. practice said Dr. Mehran, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York.

The primary outcome of the Placement of Aortic Transcatheter Valves (PARTNER) 2 trial showed that all-cause mortality or disabling stroke after 2 years follow-up occurred in 21.2% (695) of the surgery patients and 19.3% (775) of the TAVR patients, meeting the prespecified noninferiority endpoint, with a P value of .001. Full results from the study were published online concurrent with their presentation at the meeting (New Engl J Med 2016;doi:10.1056/NEJMoa1514616).

Dr. Mehran has received consultant fees and honoraria from Abbott Vascular, AstraZeneca, and Bayer.

[email protected]

On Twitter @mitchelzoler

CHICAGO – The “groundbreaking” results from the PARTNER 2 trial of transcatheter aortic valve replacement in patients at intermediate risk for death or complications from surgical replacement of a stenotic aortic valve provide substantially increased certainty that the transcatheter approach is at least as good as surgical valve replacement, commented Dr. Roxana Mehran in a video interview at the annual meeting of the American College of Cardiology.

In addition to providing important new data on the equivalence of surgical and transcatheter aortic valve replacement (TAVR) in a new target population--intermediate-risk patients, the findings from the randomized, multicenter PARTNER trial, which enrolled 2,032 patients, may also lead to expansion of the Food and Drug Administration labeling of the balloon-expandable TAVR device used in the study, the Sapien XT, to intermediate-risk patients. This expanded indication may also apply to the newer, smaller and more advanced iteration of this device, the Sapien 3, which has largely replaced the XT in U.S. practice, Dr. Mehran suggested.

Although the results came from the XT TAVR system, “these results have big relevance” to current U.S. practice said Dr. Mehran, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York.

The primary outcome of the Placement of Aortic Transcatheter Valves (PARTNER) 2 trial showed that all-cause mortality or disabling stroke after 2 years follow-up occurred in 21.2% (695) of the surgery patients and 19.3% (775) of the TAVR patients, meeting the prespecified noninferiority endpoint, with a P value of .001. Full results from the study were published online concurrent with their presentation at the meeting (New Engl J Med 2016;doi:10.1056/NEJMoa1514616).

Dr. Mehran has received consultant fees and honoraria from Abbott Vascular, AstraZeneca, and Bayer.

[email protected]

On Twitter @mitchelzoler

CHICAGO – The “groundbreaking” results from the PARTNER 2 trial of transcatheter aortic valve replacement in patients at intermediate risk for death or complications from surgical replacement of a stenotic aortic valve provide substantially increased certainty that the transcatheter approach is at least as good as surgical valve replacement, commented Dr. Roxana Mehran in a video interview at the annual meeting of the American College of Cardiology.

In addition to providing important new data on the equivalence of surgical and transcatheter aortic valve replacement (TAVR) in a new target population--intermediate-risk patients, the findings from the randomized, multicenter PARTNER trial, which enrolled 2,032 patients, may also lead to expansion of the Food and Drug Administration labeling of the balloon-expandable TAVR device used in the study, the Sapien XT, to intermediate-risk patients. This expanded indication may also apply to the newer, smaller and more advanced iteration of this device, the Sapien 3, which has largely replaced the XT in U.S. practice, Dr. Mehran suggested.

Although the results came from the XT TAVR system, “these results have big relevance” to current U.S. practice said Dr. Mehran, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York.

The primary outcome of the Placement of Aortic Transcatheter Valves (PARTNER) 2 trial showed that all-cause mortality or disabling stroke after 2 years follow-up occurred in 21.2% (695) of the surgery patients and 19.3% (775) of the TAVR patients, meeting the prespecified noninferiority endpoint, with a P value of .001. Full results from the study were published online concurrent with their presentation at the meeting (New Engl J Med 2016;doi:10.1056/NEJMoa1514616).

Dr. Mehran has received consultant fees and honoraria from Abbott Vascular, AstraZeneca, and Bayer.

[email protected]

On Twitter @mitchelzoler

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been recommended for diagnosis of suspected sarcoidosis or suspected tuberculosis with adenopathy and may be used as an initial diagnostic test for suspected lymphoma, according to guidelines issued by CHEST (the American College of Chest Physicians).

The guidelines, which are primarily focused on technical aspects of EBUS-TBNA, also advise obtaining additional samples for the purpose of molecular analysis in patients who undergo the procedure for the diagnosis or staging of non–small cell lung cancer.

The guidelines are based on a systematic review and critical analysis of the literature by an expert panel chaired by Dr. Momen M. Wahidi of Duke University Medical Center, Durham, N.C. Of the 12 guideline statements by the panel, 7 were graded evidence-based recommendations and 5 were ungraded consensus-based statements.

Ktg usa/Wikimedia Commons/CC-ASA3.0

The guideline (Chest. 2016 Mar;149[3]:816-35) has been endorsed by the American Association of Bronchology and Interventional Pulmonology, American Association for Thoracic Surgery, Canadian Thoracic Society, European Association for Bronchology and Interventional Pulmonology, and Society of Thoracic Surgeons.

Use of EBUS-TBNA for diagnosis in patients with suspected sarcoidosis with mediastinal and/or hilar adenopathy is ranked Grade 1C (strong recommendation, low-quality evidence, benefits outweigh risks). The guideline writers concluded that EBUS-TBNA provides safe and minimally invasive access to the mediastinal and hilar lymph nodes with a pooled diagnostic accuracy of 79.1%. They qualified, however, that it may be difficult to use EBUS-TBNA to obtain adequate tissue from fibrotic lymph nodes and conventional bronchoscopic techniques such as transbronchial lung biopsy and endobronchial biopsy may be needed in selected patients.

One systematic review and meta-analysis study included 15 studies with a total of 553 patients with sarcoidosis. The diagnostic yield of EBUS-TBNA ranged from 54% to 93%, with the pooled diagnostic accuracy of 79% (95% confidence interval, 71-86). Ten additional studies including 573 combined patients were identified through updated searches of the systematic review, and led to a pooled diagnostic accuracy of 78.2%.

Similarly, a Grade 1C recommendation was made for using EBUS-TBNA for diagnosis in when other modalities are not diagnostic in patients with suspected tuberculosis with mediastinal and/or hilar adenopathy who require lymph node sampling. However, “it must be noted that no single study assessed the role of EBUS-TBNA for the diagnosis of TB [tuberculosis] as the primary outcome measure,” they wrote. Various techniques are available for the diagnosis of TB and should be incorporated during the diagnostic evaluation.

In patients with suspected lymphoma, EBUS-TBNA is an acceptable initial, minimally invasive diagnostic test, the guideline writers said in an Ungraded Consensus-Based Statement.

In some conditions, minimally invasive EBUS-TBNA may be preferred over surgical intervention. Repeat mediastinoscopy or surgical biopsy after treatment for relapsed lymphoma can be challenging, for example, with a lower diagnostic yield and higher complication rate.

Because treatment regimens for both non-Hodgkin and Hodgkin lymphoma depend on the specific subtype and histologic grade, a definitive diagnosis of lymphoma requires the evaluation of cell morphology, immunophenotype, and the overall architecture of the tissue. Reed-Sternberg cells, diagnostic of Hodgkin lymphoma, are usually scarce in cytologic aspirates, and it often is impossible to evaluate the overall background architecture. Currently available EBUS-TBNA needles provide only cytologic specimens, with reported high discordance between cytologic specimens and histologic specimens.

In five retrospective studies with a total of 212 patients undergoing EBUS-TBNA for suspected lymphoma, the pooled diagnostic accuracy was 68.7%, and there was heterogeneity across studies in the proportion of patients with de novo lymphoma and relapsed lymphoma. Higher diagnostic yield was noted for relapsed lymphoma, compared with de novo lymphoma. Also, the two studies with the highest yield included cases as diagnostic, even when additional tissue sampling was necessary to subclassify the lymphoma for clinical management.

The panel gave a weak recommendation (Grade 2C) based on low-quality evidence to their conclusion that moderate or deep sedation is acceptable for EBUS-TBNA, based on three studies. Moderate sedation allows patients to respond purposefully to verbal commands while maintaining a functional airway, spontaneous ventilation, and cardiovascular function. In deep sedation, patients cannot be easily aroused but respond purposefully to repeated or painful stimulation and may have compromised airway function and spontaneous ventilation; cardiovascular function usually is maintained.

In one retrospective multivariable analysis of 309 patients at two centers, deep sedation had a statistically significant benefit on diagnostic yield. In a prospective randomized, controlled study of 149 patients at a single center with a single operator, there was no difference in diagnostic yield for moderate and deep sedation. However, fewer patients in the moderate sedation group were able to complete the procedure, compared with the deep-sedation group. Patient comfort and satisfaction were similar for the two sedation groups, and no patients had major complications or needed escalation of care.

In terms of diagnostic yield, there was insufficient evidence to recommend for or against using an artificial airway when inserting the EBUS bronchoscope, the authors said. Reported practice is scattered and is largely based on expert opinion, operator comfort, sedation type, and institutional standards.

The placement of the endotracheal tube may block the ultrasonographic view of the higher paratracheal lymph nodes (lymph node stations 1, 2R, 2L, and 3P) and should be avoided if one of these lymph nodes is the sampling target of the procedure, they advised.

If using a transoral artificial airway, a bite block should be considered to protect the bronchoscope from bite damage; this approach is recommended independent of the depth of sedation. A minimum size of 8.0 should be used if placing an endotracheal tube for EBUS-TBNA to accommodate the scope diameter and leave room for gas exchange.

In an Ungraded Consensus-Based Statement, the guideline authors said that ultrasonographic features, such as size, shape, border, heterogeneity, central hilar structure, and necrosis can be used to predict malignant and benign diagnoses, but tissue samples still should be obtained to confirm a diagnosis.

Nine studies provided analysis of the characteristics of lymph nodes that predict malignancy during EBUS; however, the ultrasonographic features assessed were not the same in each study or they had varying definitions of what constituted “abnormal.” As a result, the ultrasonographic predictors of malignancy in lymph nodes are not reliable enough to forgo biopsy to obtain a definitive tissue diagnosis. However, the ultrasound features can be useful to guide sampling from lymph nodes most likely to be malignant.

A round shape, distinct margins, heterogeneous echogenicity, and a central necrosis sign were independently predictive of malignancy in one multivariate analysis that included more than 1,000 lymph nodes in nearly 500 patients. Furthermore, when all four factors were absent, 96% of the lymph nodes were benign.

In three additional studies, size criteria had conflicting results; one found size was not a reliable indicator, two others found that larger lymph nodes are more likely to harbor metastases. These studies also confirmed that round-shaped lymph nodes were more likely malignant than were triangular or draping lymph nodes. The measures used to define size may have caused the inconsistencies.

In a study that examined vascular image patterns within lymph nodes as a way to predict malignancy, nodes were considered malignant if vessel involvement increased in the node to rich flow with more than four vessels (grades 2 and 3) with a sensitivity of 87.7% and a specificity of 69.6%, suggesting that increased vascularity assessed by using power/color Doppler mode ultrasound is useful in predicting malignancy.

Two studies have assessed ultrasound features of lymph nodes in patients with sarcoidosis. In the first, lymph nodes with homogeneous echogenicity and a germinal center were more likely to indicate sarcoidosis than lung cancer. In the second, coagulation necrosis and heterogeneous echogenicity within lymph nodes were more likely to be present in tuberculosis as opposed to sarcoidosis.

In another Ungraded Consensus-Based Statement, the guideline authors said tissue sampling may be performed either with or without suction. In cases in which EBUS-TBNA is being performed with suction and the samples obtained are bloody, operators should consider switching to the use of no suction at the same sampling site. If intranodal blood vessels are visualized on EBUS imaging with or without Doppler imaging, operators should also consider obtaining samples without suction.

Needle choice should be determined by the operator, and the use of either a 21- or 22-gauge needle are acceptable options based on five trials comparing needle sizes, the authors said in a Grade 1C recommendation. No data are available on the use of 25-gauge needles.

“Future studies should investigate if ... smaller or more flexible needles would improve sampling at station 4L (known for its slightly angulated location) or if smaller needles would result in less blood contamination when sampling more vascular nodes. Studies should also examine if a particular needle size should be used depending on how the specimens are being processed (histopathology vs. cytopathology) and if needle size can affect the diagnosis of diseases that are more difficult to diagnose by EBUS-TBNA, such as lymphoma,” the authors wrote.

In the absence of rapid on-site evaluation (ROSE), the authors advised a minimum of three separate needle passes per sampling site in patients suspected of having lung cancer. The recommendation is an Ungraded Consensus-Based Statement.

Just one study of 102 patients with potentially operable non–small cell lung cancer and mediastinal adenopathy has examined the number of needle passes per sampling site. The results indicated optimal diagnostic values are reached after three passes. Each pass typically includes 5-15 agitations of the needle within the target site.

Sample adequacy was 90.1% after the first pass, 98.1% after two passes, and reached 100% after three passes. The sensitivity for differentiating malignant from benign lymph node stations was 69.8%, 83.7%, 95.3%, and 95.3% for one, two, three, and four passes, respectively.

No data exist regarding the number of needle passes required to obtain a sufficient diagnostic yield for lymphoma or nonmalignant diseases of the mediastinum.

In a Grade 1C recommendation, the authors said that tissue sampling can be performed with or without rapid on-site evaluation. ROSE does not affect the diagnostic yield in EBUS-TBNA procedures, but it may decrease the number of punctures and reduce the need for additional staging and diagnostic procedures. ROSE may be beneficial in judging the quantity of available malignant cells when testing for molecular markers is planned in patients with advanced adenocarcinoma of the lung.

In another Grade 1C recommendation, the authors said that patients undergoing EBUS-TBNA for the diagnosis or staging of suspected or known non–small cell lung cancer should have additional samples obtained for molecular analysis.

Molecular marker testing is necessary for tailoring chemotherapy to the cancer characteristics of each individual patient. The current data are insufficient to identify the number of passes needed to obtain adequate tissue for molecular marker testing, but it is strongly suggested that additional samples, over the proposed diagnostic threshold of three passes are recommended.

The guideline authors found insufficient quality of evidence to support any route of bronchoscope insertion for EBUS-TBNA over another. Translating the experience and literature from conventional flexible bronchoscopy given the size and rigidity of the EBUS bronchoscope distal tip, as well as the limited bronchoscopic view, is difficult, according to the guideline writers.

They noted that no studies were found that addressed the use of saline-filled balloons to overcome poor contact between the ultrasound probe and the bronchial wall. Although the saline-filled balloon can enhance image acquisition, it is unclear whether that translates into a better diagnostic yield, thus, no recommendations or suggestions can be made.

In a Grade 2C recommendation, they advised that low-fidelity inanimate mechanical airway models and high-fidelity computer-based electronic simulation be incorporated into training. In the three studies that compared conventional EBUS-TBNA training and simulation-based training incorporating either a low- or high-fidelity simulation tool, the same level of training could be acquired via conventional or simulation-based training; however, simulation-based training minimizes novice operators’ practice on patients.

In an Ungraded Consensus-Based Statement, the guideline authors advised that validated EBUS skills assessment tests be used to objectively assess skill level, but added that “none of the included simulation studies examined whether the skills demonstrated on a simulation assessment are transferred to an improvement in clinical skills as performed in patients.”

[email protected]

On Twitter @maryjodales

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been recommended for diagnosis of suspected sarcoidosis or suspected tuberculosis with adenopathy and may be used as an initial diagnostic test for suspected lymphoma, according to guidelines issued by CHEST (the American College of Chest Physicians).

The guidelines, which are primarily focused on technical aspects of EBUS-TBNA, also advise obtaining additional samples for the purpose of molecular analysis in patients who undergo the procedure for the diagnosis or staging of non–small cell lung cancer.

The guidelines are based on a systematic review and critical analysis of the literature by an expert panel chaired by Dr. Momen M. Wahidi of Duke University Medical Center, Durham, N.C. Of the 12 guideline statements by the panel, 7 were graded evidence-based recommendations and 5 were ungraded consensus-based statements.

Ktg usa/Wikimedia Commons/CC-ASA3.0

The guideline (Chest. 2016 Mar;149[3]:816-35) has been endorsed by the American Association of Bronchology and Interventional Pulmonology, American Association for Thoracic Surgery, Canadian Thoracic Society, European Association for Bronchology and Interventional Pulmonology, and Society of Thoracic Surgeons.

Use of EBUS-TBNA for diagnosis in patients with suspected sarcoidosis with mediastinal and/or hilar adenopathy is ranked Grade 1C (strong recommendation, low-quality evidence, benefits outweigh risks). The guideline writers concluded that EBUS-TBNA provides safe and minimally invasive access to the mediastinal and hilar lymph nodes with a pooled diagnostic accuracy of 79.1%. They qualified, however, that it may be difficult to use EBUS-TBNA to obtain adequate tissue from fibrotic lymph nodes and conventional bronchoscopic techniques such as transbronchial lung biopsy and endobronchial biopsy may be needed in selected patients.

One systematic review and meta-analysis study included 15 studies with a total of 553 patients with sarcoidosis. The diagnostic yield of EBUS-TBNA ranged from 54% to 93%, with the pooled diagnostic accuracy of 79% (95% confidence interval, 71-86). Ten additional studies including 573 combined patients were identified through updated searches of the systematic review, and led to a pooled diagnostic accuracy of 78.2%.

Similarly, a Grade 1C recommendation was made for using EBUS-TBNA for diagnosis in when other modalities are not diagnostic in patients with suspected tuberculosis with mediastinal and/or hilar adenopathy who require lymph node sampling. However, “it must be noted that no single study assessed the role of EBUS-TBNA for the diagnosis of TB [tuberculosis] as the primary outcome measure,” they wrote. Various techniques are available for the diagnosis of TB and should be incorporated during the diagnostic evaluation.

In patients with suspected lymphoma, EBUS-TBNA is an acceptable initial, minimally invasive diagnostic test, the guideline writers said in an Ungraded Consensus-Based Statement.

In some conditions, minimally invasive EBUS-TBNA may be preferred over surgical intervention. Repeat mediastinoscopy or surgical biopsy after treatment for relapsed lymphoma can be challenging, for example, with a lower diagnostic yield and higher complication rate.

Because treatment regimens for both non-Hodgkin and Hodgkin lymphoma depend on the specific subtype and histologic grade, a definitive diagnosis of lymphoma requires the evaluation of cell morphology, immunophenotype, and the overall architecture of the tissue. Reed-Sternberg cells, diagnostic of Hodgkin lymphoma, are usually scarce in cytologic aspirates, and it often is impossible to evaluate the overall background architecture. Currently available EBUS-TBNA needles provide only cytologic specimens, with reported high discordance between cytologic specimens and histologic specimens.

In five retrospective studies with a total of 212 patients undergoing EBUS-TBNA for suspected lymphoma, the pooled diagnostic accuracy was 68.7%, and there was heterogeneity across studies in the proportion of patients with de novo lymphoma and relapsed lymphoma. Higher diagnostic yield was noted for relapsed lymphoma, compared with de novo lymphoma. Also, the two studies with the highest yield included cases as diagnostic, even when additional tissue sampling was necessary to subclassify the lymphoma for clinical management.

The panel gave a weak recommendation (Grade 2C) based on low-quality evidence to their conclusion that moderate or deep sedation is acceptable for EBUS-TBNA, based on three studies. Moderate sedation allows patients to respond purposefully to verbal commands while maintaining a functional airway, spontaneous ventilation, and cardiovascular function. In deep sedation, patients cannot be easily aroused but respond purposefully to repeated or painful stimulation and may have compromised airway function and spontaneous ventilation; cardiovascular function usually is maintained.

In one retrospective multivariable analysis of 309 patients at two centers, deep sedation had a statistically significant benefit on diagnostic yield. In a prospective randomized, controlled study of 149 patients at a single center with a single operator, there was no difference in diagnostic yield for moderate and deep sedation. However, fewer patients in the moderate sedation group were able to complete the procedure, compared with the deep-sedation group. Patient comfort and satisfaction were similar for the two sedation groups, and no patients had major complications or needed escalation of care.

In terms of diagnostic yield, there was insufficient evidence to recommend for or against using an artificial airway when inserting the EBUS bronchoscope, the authors said. Reported practice is scattered and is largely based on expert opinion, operator comfort, sedation type, and institutional standards.

The placement of the endotracheal tube may block the ultrasonographic view of the higher paratracheal lymph nodes (lymph node stations 1, 2R, 2L, and 3P) and should be avoided if one of these lymph nodes is the sampling target of the procedure, they advised.

If using a transoral artificial airway, a bite block should be considered to protect the bronchoscope from bite damage; this approach is recommended independent of the depth of sedation. A minimum size of 8.0 should be used if placing an endotracheal tube for EBUS-TBNA to accommodate the scope diameter and leave room for gas exchange.

In an Ungraded Consensus-Based Statement, the guideline authors said that ultrasonographic features, such as size, shape, border, heterogeneity, central hilar structure, and necrosis can be used to predict malignant and benign diagnoses, but tissue samples still should be obtained to confirm a diagnosis.

Nine studies provided analysis of the characteristics of lymph nodes that predict malignancy during EBUS; however, the ultrasonographic features assessed were not the same in each study or they had varying definitions of what constituted “abnormal.” As a result, the ultrasonographic predictors of malignancy in lymph nodes are not reliable enough to forgo biopsy to obtain a definitive tissue diagnosis. However, the ultrasound features can be useful to guide sampling from lymph nodes most likely to be malignant.

A round shape, distinct margins, heterogeneous echogenicity, and a central necrosis sign were independently predictive of malignancy in one multivariate analysis that included more than 1,000 lymph nodes in nearly 500 patients. Furthermore, when all four factors were absent, 96% of the lymph nodes were benign.

In three additional studies, size criteria had conflicting results; one found size was not a reliable indicator, two others found that larger lymph nodes are more likely to harbor metastases. These studies also confirmed that round-shaped lymph nodes were more likely malignant than were triangular or draping lymph nodes. The measures used to define size may have caused the inconsistencies.

In a study that examined vascular image patterns within lymph nodes as a way to predict malignancy, nodes were considered malignant if vessel involvement increased in the node to rich flow with more than four vessels (grades 2 and 3) with a sensitivity of 87.7% and a specificity of 69.6%, suggesting that increased vascularity assessed by using power/color Doppler mode ultrasound is useful in predicting malignancy.

Two studies have assessed ultrasound features of lymph nodes in patients with sarcoidosis. In the first, lymph nodes with homogeneous echogenicity and a germinal center were more likely to indicate sarcoidosis than lung cancer. In the second, coagulation necrosis and heterogeneous echogenicity within lymph nodes were more likely to be present in tuberculosis as opposed to sarcoidosis.

In another Ungraded Consensus-Based Statement, the guideline authors said tissue sampling may be performed either with or without suction. In cases in which EBUS-TBNA is being performed with suction and the samples obtained are bloody, operators should consider switching to the use of no suction at the same sampling site. If intranodal blood vessels are visualized on EBUS imaging with or without Doppler imaging, operators should also consider obtaining samples without suction.

Needle choice should be determined by the operator, and the use of either a 21- or 22-gauge needle are acceptable options based on five trials comparing needle sizes, the authors said in a Grade 1C recommendation. No data are available on the use of 25-gauge needles.

“Future studies should investigate if ... smaller or more flexible needles would improve sampling at station 4L (known for its slightly angulated location) or if smaller needles would result in less blood contamination when sampling more vascular nodes. Studies should also examine if a particular needle size should be used depending on how the specimens are being processed (histopathology vs. cytopathology) and if needle size can affect the diagnosis of diseases that are more difficult to diagnose by EBUS-TBNA, such as lymphoma,” the authors wrote.

In the absence of rapid on-site evaluation (ROSE), the authors advised a minimum of three separate needle passes per sampling site in patients suspected of having lung cancer. The recommendation is an Ungraded Consensus-Based Statement.

Just one study of 102 patients with potentially operable non–small cell lung cancer and mediastinal adenopathy has examined the number of needle passes per sampling site. The results indicated optimal diagnostic values are reached after three passes. Each pass typically includes 5-15 agitations of the needle within the target site.

Sample adequacy was 90.1% after the first pass, 98.1% after two passes, and reached 100% after three passes. The sensitivity for differentiating malignant from benign lymph node stations was 69.8%, 83.7%, 95.3%, and 95.3% for one, two, three, and four passes, respectively.

No data exist regarding the number of needle passes required to obtain a sufficient diagnostic yield for lymphoma or nonmalignant diseases of the mediastinum.

In a Grade 1C recommendation, the authors said that tissue sampling can be performed with or without rapid on-site evaluation. ROSE does not affect the diagnostic yield in EBUS-TBNA procedures, but it may decrease the number of punctures and reduce the need for additional staging and diagnostic procedures. ROSE may be beneficial in judging the quantity of available malignant cells when testing for molecular markers is planned in patients with advanced adenocarcinoma of the lung.

In another Grade 1C recommendation, the authors said that patients undergoing EBUS-TBNA for the diagnosis or staging of suspected or known non–small cell lung cancer should have additional samples obtained for molecular analysis.

Molecular marker testing is necessary for tailoring chemotherapy to the cancer characteristics of each individual patient. The current data are insufficient to identify the number of passes needed to obtain adequate tissue for molecular marker testing, but it is strongly suggested that additional samples, over the proposed diagnostic threshold of three passes are recommended.

The guideline authors found insufficient quality of evidence to support any route of bronchoscope insertion for EBUS-TBNA over another. Translating the experience and literature from conventional flexible bronchoscopy given the size and rigidity of the EBUS bronchoscope distal tip, as well as the limited bronchoscopic view, is difficult, according to the guideline writers.

They noted that no studies were found that addressed the use of saline-filled balloons to overcome poor contact between the ultrasound probe and the bronchial wall. Although the saline-filled balloon can enhance image acquisition, it is unclear whether that translates into a better diagnostic yield, thus, no recommendations or suggestions can be made.

In a Grade 2C recommendation, they advised that low-fidelity inanimate mechanical airway models and high-fidelity computer-based electronic simulation be incorporated into training. In the three studies that compared conventional EBUS-TBNA training and simulation-based training incorporating either a low- or high-fidelity simulation tool, the same level of training could be acquired via conventional or simulation-based training; however, simulation-based training minimizes novice operators’ practice on patients.

In an Ungraded Consensus-Based Statement, the guideline authors advised that validated EBUS skills assessment tests be used to objectively assess skill level, but added that “none of the included simulation studies examined whether the skills demonstrated on a simulation assessment are transferred to an improvement in clinical skills as performed in patients.”

[email protected]

On Twitter @maryjodales

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been recommended for diagnosis of suspected sarcoidosis or suspected tuberculosis with adenopathy and may be used as an initial diagnostic test for suspected lymphoma, according to guidelines issued by CHEST (the American College of Chest Physicians).

The guidelines, which are primarily focused on technical aspects of EBUS-TBNA, also advise obtaining additional samples for the purpose of molecular analysis in patients who undergo the procedure for the diagnosis or staging of non–small cell lung cancer.

The guidelines are based on a systematic review and critical analysis of the literature by an expert panel chaired by Dr. Momen M. Wahidi of Duke University Medical Center, Durham, N.C. Of the 12 guideline statements by the panel, 7 were graded evidence-based recommendations and 5 were ungraded consensus-based statements.

Ktg usa/Wikimedia Commons/CC-ASA3.0

The guideline (Chest. 2016 Mar;149[3]:816-35) has been endorsed by the American Association of Bronchology and Interventional Pulmonology, American Association for Thoracic Surgery, Canadian Thoracic Society, European Association for Bronchology and Interventional Pulmonology, and Society of Thoracic Surgeons.

Use of EBUS-TBNA for diagnosis in patients with suspected sarcoidosis with mediastinal and/or hilar adenopathy is ranked Grade 1C (strong recommendation, low-quality evidence, benefits outweigh risks). The guideline writers concluded that EBUS-TBNA provides safe and minimally invasive access to the mediastinal and hilar lymph nodes with a pooled diagnostic accuracy of 79.1%. They qualified, however, that it may be difficult to use EBUS-TBNA to obtain adequate tissue from fibrotic lymph nodes and conventional bronchoscopic techniques such as transbronchial lung biopsy and endobronchial biopsy may be needed in selected patients.

One systematic review and meta-analysis study included 15 studies with a total of 553 patients with sarcoidosis. The diagnostic yield of EBUS-TBNA ranged from 54% to 93%, with the pooled diagnostic accuracy of 79% (95% confidence interval, 71-86). Ten additional studies including 573 combined patients were identified through updated searches of the systematic review, and led to a pooled diagnostic accuracy of 78.2%.

Similarly, a Grade 1C recommendation was made for using EBUS-TBNA for diagnosis in when other modalities are not diagnostic in patients with suspected tuberculosis with mediastinal and/or hilar adenopathy who require lymph node sampling. However, “it must be noted that no single study assessed the role of EBUS-TBNA for the diagnosis of TB [tuberculosis] as the primary outcome measure,” they wrote. Various techniques are available for the diagnosis of TB and should be incorporated during the diagnostic evaluation.

In patients with suspected lymphoma, EBUS-TBNA is an acceptable initial, minimally invasive diagnostic test, the guideline writers said in an Ungraded Consensus-Based Statement.

In some conditions, minimally invasive EBUS-TBNA may be preferred over surgical intervention. Repeat mediastinoscopy or surgical biopsy after treatment for relapsed lymphoma can be challenging, for example, with a lower diagnostic yield and higher complication rate.

Because treatment regimens for both non-Hodgkin and Hodgkin lymphoma depend on the specific subtype and histologic grade, a definitive diagnosis of lymphoma requires the evaluation of cell morphology, immunophenotype, and the overall architecture of the tissue. Reed-Sternberg cells, diagnostic of Hodgkin lymphoma, are usually scarce in cytologic aspirates, and it often is impossible to evaluate the overall background architecture. Currently available EBUS-TBNA needles provide only cytologic specimens, with reported high discordance between cytologic specimens and histologic specimens.

In five retrospective studies with a total of 212 patients undergoing EBUS-TBNA for suspected lymphoma, the pooled diagnostic accuracy was 68.7%, and there was heterogeneity across studies in the proportion of patients with de novo lymphoma and relapsed lymphoma. Higher diagnostic yield was noted for relapsed lymphoma, compared with de novo lymphoma. Also, the two studies with the highest yield included cases as diagnostic, even when additional tissue sampling was necessary to subclassify the lymphoma for clinical management.

The panel gave a weak recommendation (Grade 2C) based on low-quality evidence to their conclusion that moderate or deep sedation is acceptable for EBUS-TBNA, based on three studies. Moderate sedation allows patients to respond purposefully to verbal commands while maintaining a functional airway, spontaneous ventilation, and cardiovascular function. In deep sedation, patients cannot be easily aroused but respond purposefully to repeated or painful stimulation and may have compromised airway function and spontaneous ventilation; cardiovascular function usually is maintained.

In one retrospective multivariable analysis of 309 patients at two centers, deep sedation had a statistically significant benefit on diagnostic yield. In a prospective randomized, controlled study of 149 patients at a single center with a single operator, there was no difference in diagnostic yield for moderate and deep sedation. However, fewer patients in the moderate sedation group were able to complete the procedure, compared with the deep-sedation group. Patient comfort and satisfaction were similar for the two sedation groups, and no patients had major complications or needed escalation of care.

In terms of diagnostic yield, there was insufficient evidence to recommend for or against using an artificial airway when inserting the EBUS bronchoscope, the authors said. Reported practice is scattered and is largely based on expert opinion, operator comfort, sedation type, and institutional standards.

The placement of the endotracheal tube may block the ultrasonographic view of the higher paratracheal lymph nodes (lymph node stations 1, 2R, 2L, and 3P) and should be avoided if one of these lymph nodes is the sampling target of the procedure, they advised.

If using a transoral artificial airway, a bite block should be considered to protect the bronchoscope from bite damage; this approach is recommended independent of the depth of sedation. A minimum size of 8.0 should be used if placing an endotracheal tube for EBUS-TBNA to accommodate the scope diameter and leave room for gas exchange.

In an Ungraded Consensus-Based Statement, the guideline authors said that ultrasonographic features, such as size, shape, border, heterogeneity, central hilar structure, and necrosis can be used to predict malignant and benign diagnoses, but tissue samples still should be obtained to confirm a diagnosis.

Nine studies provided analysis of the characteristics of lymph nodes that predict malignancy during EBUS; however, the ultrasonographic features assessed were not the same in each study or they had varying definitions of what constituted “abnormal.” As a result, the ultrasonographic predictors of malignancy in lymph nodes are not reliable enough to forgo biopsy to obtain a definitive tissue diagnosis. However, the ultrasound features can be useful to guide sampling from lymph nodes most likely to be malignant.

A round shape, distinct margins, heterogeneous echogenicity, and a central necrosis sign were independently predictive of malignancy in one multivariate analysis that included more than 1,000 lymph nodes in nearly 500 patients. Furthermore, when all four factors were absent, 96% of the lymph nodes were benign.

In three additional studies, size criteria had conflicting results; one found size was not a reliable indicator, two others found that larger lymph nodes are more likely to harbor metastases. These studies also confirmed that round-shaped lymph nodes were more likely malignant than were triangular or draping lymph nodes. The measures used to define size may have caused the inconsistencies.

In a study that examined vascular image patterns within lymph nodes as a way to predict malignancy, nodes were considered malignant if vessel involvement increased in the node to rich flow with more than four vessels (grades 2 and 3) with a sensitivity of 87.7% and a specificity of 69.6%, suggesting that increased vascularity assessed by using power/color Doppler mode ultrasound is useful in predicting malignancy.

Two studies have assessed ultrasound features of lymph nodes in patients with sarcoidosis. In the first, lymph nodes with homogeneous echogenicity and a germinal center were more likely to indicate sarcoidosis than lung cancer. In the second, coagulation necrosis and heterogeneous echogenicity within lymph nodes were more likely to be present in tuberculosis as opposed to sarcoidosis.

In another Ungraded Consensus-Based Statement, the guideline authors said tissue sampling may be performed either with or without suction. In cases in which EBUS-TBNA is being performed with suction and the samples obtained are bloody, operators should consider switching to the use of no suction at the same sampling site. If intranodal blood vessels are visualized on EBUS imaging with or without Doppler imaging, operators should also consider obtaining samples without suction.

Needle choice should be determined by the operator, and the use of either a 21- or 22-gauge needle are acceptable options based on five trials comparing needle sizes, the authors said in a Grade 1C recommendation. No data are available on the use of 25-gauge needles.

“Future studies should investigate if ... smaller or more flexible needles would improve sampling at station 4L (known for its slightly angulated location) or if smaller needles would result in less blood contamination when sampling more vascular nodes. Studies should also examine if a particular needle size should be used depending on how the specimens are being processed (histopathology vs. cytopathology) and if needle size can affect the diagnosis of diseases that are more difficult to diagnose by EBUS-TBNA, such as lymphoma,” the authors wrote.

In the absence of rapid on-site evaluation (ROSE), the authors advised a minimum of three separate needle passes per sampling site in patients suspected of having lung cancer. The recommendation is an Ungraded Consensus-Based Statement.

Just one study of 102 patients with potentially operable non–small cell lung cancer and mediastinal adenopathy has examined the number of needle passes per sampling site. The results indicated optimal diagnostic values are reached after three passes. Each pass typically includes 5-15 agitations of the needle within the target site.

Sample adequacy was 90.1% after the first pass, 98.1% after two passes, and reached 100% after three passes. The sensitivity for differentiating malignant from benign lymph node stations was 69.8%, 83.7%, 95.3%, and 95.3% for one, two, three, and four passes, respectively.

No data exist regarding the number of needle passes required to obtain a sufficient diagnostic yield for lymphoma or nonmalignant diseases of the mediastinum.

In a Grade 1C recommendation, the authors said that tissue sampling can be performed with or without rapid on-site evaluation. ROSE does not affect the diagnostic yield in EBUS-TBNA procedures, but it may decrease the number of punctures and reduce the need for additional staging and diagnostic procedures. ROSE may be beneficial in judging the quantity of available malignant cells when testing for molecular markers is planned in patients with advanced adenocarcinoma of the lung.

In another Grade 1C recommendation, the authors said that patients undergoing EBUS-TBNA for the diagnosis or staging of suspected or known non–small cell lung cancer should have additional samples obtained for molecular analysis.

Molecular marker testing is necessary for tailoring chemotherapy to the cancer characteristics of each individual patient. The current data are insufficient to identify the number of passes needed to obtain adequate tissue for molecular marker testing, but it is strongly suggested that additional samples, over the proposed diagnostic threshold of three passes are recommended.

The guideline authors found insufficient quality of evidence to support any route of bronchoscope insertion for EBUS-TBNA over another. Translating the experience and literature from conventional flexible bronchoscopy given the size and rigidity of the EBUS bronchoscope distal tip, as well as the limited bronchoscopic view, is difficult, according to the guideline writers.

They noted that no studies were found that addressed the use of saline-filled balloons to overcome poor contact between the ultrasound probe and the bronchial wall. Although the saline-filled balloon can enhance image acquisition, it is unclear whether that translates into a better diagnostic yield, thus, no recommendations or suggestions can be made.

In a Grade 2C recommendation, they advised that low-fidelity inanimate mechanical airway models and high-fidelity computer-based electronic simulation be incorporated into training. In the three studies that compared conventional EBUS-TBNA training and simulation-based training incorporating either a low- or high-fidelity simulation tool, the same level of training could be acquired via conventional or simulation-based training; however, simulation-based training minimizes novice operators’ practice on patients.

In an Ungraded Consensus-Based Statement, the guideline authors advised that validated EBUS skills assessment tests be used to objectively assess skill level, but added that “none of the included simulation studies examined whether the skills demonstrated on a simulation assessment are transferred to an improvement in clinical skills as performed in patients.”

[email protected]

On Twitter @maryjodales

Controversy has surrounded the idea of concomitant tricuspid annuloplasty (TAP) with mitral valve surgery (MVR) as a way to prevent further progression of tricuspid regurgitation, and while several reports have suggested the procedures can be done safely and effectively, few reports have explored the idea of concomitant procedures in people with moderate or mild tricuspid regurgitation (TR) as a measure to prevent progression to more severe TR.

But investigators at Sungkyunkwan University in Seoul have found that TAP at the same time as MVR can be done without increasing surgical risks for patients, according to a report in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:788-95).

“Although prophylactic TAP showed marginal clinical benefits for patients with less than moderate TR, we believe it is plausible to anticipate a long-term trend of a benefit of TAP in longer-term follow-up studies,“ Dr. Heemoon Lee and coauthors wrote. “Many other longer-term prospective randomized studies are needed to confirm our study findings and to ascertain clinical benefits of prophylactic TAP during mitral valve surgery.”

Despite existing clinical guidelines that recommend tricuspid valve repair for severe TR associated with mitral valve disease that requires MVR, prophylactic TAP for patients with less than moderate TR at the time of left-side valve surgery remains controversial because TR has been linked to multiple complex factors. They include etiology, whether degenerative or rheumatic; concomitant atrial fibrillation (AF); unreliable TR grading; or measurement of tricuspid annular diameter.

The investigators performed primary mechanical MVR on two groups of patients between November 1994 and December 2010: 151 with TAP; and 142 without TAP. All operations were performed through a standard median sternotomy and median follow-up was 107 months.

They looked at both early and late outcomes. There was no early mortality in either group; two bleeding episodes that required further surgery and one pacemaker insertion in the no-TAP group; and no bleeding complications and heart blocks requiring pacemaker insertion in the TAP group. While ICU stays were similar for both groups, the TAP group had significantly shorter hospital stays: 9 days vs. 11 days (P less than .001).

In terms of overall and cardiac-related deaths at 10 years, the investigators reported no significant differences between the two groups. “TAP did not appear to improve cardiac-related mortality,” Dr. Lee and coauthors said. Nor did freedom from tricuspid valve–related events differ appreciably between the two groups: 84.8% in TAP and 77.5% in no-TAP at year 10 (P = .087).

But the TAP group showed far lower rates of progression to late TR at 10 years – one in the TAP group; one (less than 1%) vs. nine (6.3%) in the no-TAP group; 96.8% in the TAP group were free from TR recurrence of grade 2 or greater vs. 85.6% in no-TAP.

“TAP can be performed safely without increases in early mortality and morbidities, including heart block,” Dr. Lee and coauthors said. “We also found that prophylactic TAP can prevent progression of late moderate or greater TR. TAP showed a tendency to prevent tricuspid valve–related events and was marginally significant.”

The researchers also evaluated the role of AF as a risk factor for progression of late TR; the effects of TAP on recurrence of moderate or greater TR were “prominent” in patients with sinus rhythm vs. AF at discharge. “These findings may reflect that the maze procedure is more important than prophylactic TAP in improving late outcomes in mitral valve disease with AF,” Dr. Lee and colleagues wrote.

The investigators acknowledged a number of limits of their study: its retrospective nature; how indications and techniques of MVR, TAP, and the maze procedure evolved over the study duration; and that the maze procedure and prophylactic TAP were not widely embraced in the early years of the study.

Dr. Lee and colleagues had no financial relationships to disclose.

Controversy has surrounded the idea of concomitant tricuspid annuloplasty (TAP) with mitral valve surgery (MVR) as a way to prevent further progression of tricuspid regurgitation, and while several reports have suggested the procedures can be done safely and effectively, few reports have explored the idea of concomitant procedures in people with moderate or mild tricuspid regurgitation (TR) as a measure to prevent progression to more severe TR.

But investigators at Sungkyunkwan University in Seoul have found that TAP at the same time as MVR can be done without increasing surgical risks for patients, according to a report in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:788-95).

“Although prophylactic TAP showed marginal clinical benefits for patients with less than moderate TR, we believe it is plausible to anticipate a long-term trend of a benefit of TAP in longer-term follow-up studies,“ Dr. Heemoon Lee and coauthors wrote. “Many other longer-term prospective randomized studies are needed to confirm our study findings and to ascertain clinical benefits of prophylactic TAP during mitral valve surgery.”

Despite existing clinical guidelines that recommend tricuspid valve repair for severe TR associated with mitral valve disease that requires MVR, prophylactic TAP for patients with less than moderate TR at the time of left-side valve surgery remains controversial because TR has been linked to multiple complex factors. They include etiology, whether degenerative or rheumatic; concomitant atrial fibrillation (AF); unreliable TR grading; or measurement of tricuspid annular diameter.

The investigators performed primary mechanical MVR on two groups of patients between November 1994 and December 2010: 151 with TAP; and 142 without TAP. All operations were performed through a standard median sternotomy and median follow-up was 107 months.

They looked at both early and late outcomes. There was no early mortality in either group; two bleeding episodes that required further surgery and one pacemaker insertion in the no-TAP group; and no bleeding complications and heart blocks requiring pacemaker insertion in the TAP group. While ICU stays were similar for both groups, the TAP group had significantly shorter hospital stays: 9 days vs. 11 days (P less than .001).

In terms of overall and cardiac-related deaths at 10 years, the investigators reported no significant differences between the two groups. “TAP did not appear to improve cardiac-related mortality,” Dr. Lee and coauthors said. Nor did freedom from tricuspid valve–related events differ appreciably between the two groups: 84.8% in TAP and 77.5% in no-TAP at year 10 (P = .087).

But the TAP group showed far lower rates of progression to late TR at 10 years – one in the TAP group; one (less than 1%) vs. nine (6.3%) in the no-TAP group; 96.8% in the TAP group were free from TR recurrence of grade 2 or greater vs. 85.6% in no-TAP.

“TAP can be performed safely without increases in early mortality and morbidities, including heart block,” Dr. Lee and coauthors said. “We also found that prophylactic TAP can prevent progression of late moderate or greater TR. TAP showed a tendency to prevent tricuspid valve–related events and was marginally significant.”

The researchers also evaluated the role of AF as a risk factor for progression of late TR; the effects of TAP on recurrence of moderate or greater TR were “prominent” in patients with sinus rhythm vs. AF at discharge. “These findings may reflect that the maze procedure is more important than prophylactic TAP in improving late outcomes in mitral valve disease with AF,” Dr. Lee and colleagues wrote.

The investigators acknowledged a number of limits of their study: its retrospective nature; how indications and techniques of MVR, TAP, and the maze procedure evolved over the study duration; and that the maze procedure and prophylactic TAP were not widely embraced in the early years of the study.

Dr. Lee and colleagues had no financial relationships to disclose.

Controversy has surrounded the idea of concomitant tricuspid annuloplasty (TAP) with mitral valve surgery (MVR) as a way to prevent further progression of tricuspid regurgitation, and while several reports have suggested the procedures can be done safely and effectively, few reports have explored the idea of concomitant procedures in people with moderate or mild tricuspid regurgitation (TR) as a measure to prevent progression to more severe TR.

But investigators at Sungkyunkwan University in Seoul have found that TAP at the same time as MVR can be done without increasing surgical risks for patients, according to a report in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:788-95).

“Although prophylactic TAP showed marginal clinical benefits for patients with less than moderate TR, we believe it is plausible to anticipate a long-term trend of a benefit of TAP in longer-term follow-up studies,“ Dr. Heemoon Lee and coauthors wrote. “Many other longer-term prospective randomized studies are needed to confirm our study findings and to ascertain clinical benefits of prophylactic TAP during mitral valve surgery.”

Despite existing clinical guidelines that recommend tricuspid valve repair for severe TR associated with mitral valve disease that requires MVR, prophylactic TAP for patients with less than moderate TR at the time of left-side valve surgery remains controversial because TR has been linked to multiple complex factors. They include etiology, whether degenerative or rheumatic; concomitant atrial fibrillation (AF); unreliable TR grading; or measurement of tricuspid annular diameter.

The investigators performed primary mechanical MVR on two groups of patients between November 1994 and December 2010: 151 with TAP; and 142 without TAP. All operations were performed through a standard median sternotomy and median follow-up was 107 months.

They looked at both early and late outcomes. There was no early mortality in either group; two bleeding episodes that required further surgery and one pacemaker insertion in the no-TAP group; and no bleeding complications and heart blocks requiring pacemaker insertion in the TAP group. While ICU stays were similar for both groups, the TAP group had significantly shorter hospital stays: 9 days vs. 11 days (P less than .001).

In terms of overall and cardiac-related deaths at 10 years, the investigators reported no significant differences between the two groups. “TAP did not appear to improve cardiac-related mortality,” Dr. Lee and coauthors said. Nor did freedom from tricuspid valve–related events differ appreciably between the two groups: 84.8% in TAP and 77.5% in no-TAP at year 10 (P = .087).

But the TAP group showed far lower rates of progression to late TR at 10 years – one in the TAP group; one (less than 1%) vs. nine (6.3%) in the no-TAP group; 96.8% in the TAP group were free from TR recurrence of grade 2 or greater vs. 85.6% in no-TAP.

“TAP can be performed safely without increases in early mortality and morbidities, including heart block,” Dr. Lee and coauthors said. “We also found that prophylactic TAP can prevent progression of late moderate or greater TR. TAP showed a tendency to prevent tricuspid valve–related events and was marginally significant.”

The researchers also evaluated the role of AF as a risk factor for progression of late TR; the effects of TAP on recurrence of moderate or greater TR were “prominent” in patients with sinus rhythm vs. AF at discharge. “These findings may reflect that the maze procedure is more important than prophylactic TAP in improving late outcomes in mitral valve disease with AF,” Dr. Lee and colleagues wrote.

The investigators acknowledged a number of limits of their study: its retrospective nature; how indications and techniques of MVR, TAP, and the maze procedure evolved over the study duration; and that the maze procedure and prophylactic TAP were not widely embraced in the early years of the study.

Dr. Lee and colleagues had no financial relationships to disclose.

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.

Experts in the Society for Thoracic Surgeons and the American College of Cardiology used data from more than 13,000 consecutive transcatheter aortic valve replacement procedures to develop a new tool for predicting the risk of in-hospital mortality in patients undergoing TAVR, according to a report published online March 9 in JAMA Cardiology.

Their risk-prediction model was only “modestly” accurate but performed better than any existing methods for assessing risk in this patient population. It should be considered the first iteration of this tool and will be modified as the procedure itself evolves and as more data concerning TAVR are collected and analyzed. Ongoing analysis “may well define clinical subsets of patients who accrue particular benefit from the procedure or, conversely, reveal subsets not well served by TAVR,” said Dr. Fred H. Edwards and his associates on the steering committee of the STS/ACC Transcatheter Valve Therapy Registry.

They noted that more models soon will be developed to predict 30-day and 1-year mortality after TAVR. Models to predict the risk of neurologic deficit following TAVR are currently being developed, and models for other nonfatal outcomes will be developed soon.

This tool predicting in-hospital mortality is expected to become “a valuable adjunct for patient counseling, performance assessment, local quality improvement, and national monitoring of the appropriateness of patient selection for TAVR,” said Dr. Edwards, who is also in the department of surgery, University of Florida, Jacksonville, and his associates.

They began by analyzing the registry data for virtually every commercial TAVR performed at 265 participating sites in the United States during a 27-month period. In general, patients were selected for TAVR because they were considered unsuitable candidates for surgical aortic valve replacement. The mean patient age was 82.1 years. A total of 730 patients died before leaving the hospital, for an in-hospital mortality of 5.3%.

Working from an initial list of 39 possible patient variables to include in their statistical prediction model, the researchers narrowed it down to the 7 most predictive factors available in the registry data: older age, poorer glomerular filtration rate, the need for hemodialysis, NYHA class IV status, the presence of severe chronic lung disease, a category 2 or 4 critical hemodynamic state (i.e., preprocedural acuity status), and need for a nonfemoral approach during the procedure.

The model was then tested in a separate validation cohort of 6,868 patients (52% men) treated at 314 sites during a 7-month period. It performed better at predicting in-hospital mortality than did either the EuroSCORE (European System for Cardiac Operative Risk Evaluation) or the FRANCE 2 (French Aortic National Corevalve and Edwards 2) models.

This STS/ACC model should assist clinicians in patient selection for TAVR, not by dictating which patients are candidates for TAVR, but by being used as “one element in the selection process, to be considered in concert with history, physical examination, laboratory information, and clinical judgment. The model may also provide useful information for patient counseling,” the investigators said (JAMA Cardiol. 2016 Mar 9. doi: 10.1001/jamacardiol.2015.0326). One factor that is generally recognized as an important risk predictor but isn’t yet incorporated into this tool is a measure of patient frailty. Data on frailty are not yet collected consistently in the STS/ACC registry. As more complete data become available, frailty likely will be included as a predictive factor in this tool.

Another important issue that eventually should be considered alongside survival prediction is the effect TAVR has on quality of life. The STS/ACC registry “is one of the few clinical registries to collect quality-of-life data,” and it could prove to be a critical adjunct to patient selection. A given patient might have a favorable outlook regarding mortality after the procedure, but would still be a poor candidate if he or she wouldn’t derive significant benefit from it, Dr. Edwards and his associates said.

Experts in the Society for Thoracic Surgeons and the American College of Cardiology used data from more than 13,000 consecutive transcatheter aortic valve replacement procedures to develop a new tool for predicting the risk of in-hospital mortality in patients undergoing TAVR, according to a report published online March 9 in JAMA Cardiology.

Their risk-prediction model was only “modestly” accurate but performed better than any existing methods for assessing risk in this patient population. It should be considered the first iteration of this tool and will be modified as the procedure itself evolves and as more data concerning TAVR are collected and analyzed. Ongoing analysis “may well define clinical subsets of patients who accrue particular benefit from the procedure or, conversely, reveal subsets not well served by TAVR,” said Dr. Fred H. Edwards and his associates on the steering committee of the STS/ACC Transcatheter Valve Therapy Registry.

They noted that more models soon will be developed to predict 30-day and 1-year mortality after TAVR. Models to predict the risk of neurologic deficit following TAVR are currently being developed, and models for other nonfatal outcomes will be developed soon.

This tool predicting in-hospital mortality is expected to become “a valuable adjunct for patient counseling, performance assessment, local quality improvement, and national monitoring of the appropriateness of patient selection for TAVR,” said Dr. Edwards, who is also in the department of surgery, University of Florida, Jacksonville, and his associates.

They began by analyzing the registry data for virtually every commercial TAVR performed at 265 participating sites in the United States during a 27-month period. In general, patients were selected for TAVR because they were considered unsuitable candidates for surgical aortic valve replacement. The mean patient age was 82.1 years. A total of 730 patients died before leaving the hospital, for an in-hospital mortality of 5.3%.

Working from an initial list of 39 possible patient variables to include in their statistical prediction model, the researchers narrowed it down to the 7 most predictive factors available in the registry data: older age, poorer glomerular filtration rate, the need for hemodialysis, NYHA class IV status, the presence of severe chronic lung disease, a category 2 or 4 critical hemodynamic state (i.e., preprocedural acuity status), and need for a nonfemoral approach during the procedure.

The model was then tested in a separate validation cohort of 6,868 patients (52% men) treated at 314 sites during a 7-month period. It performed better at predicting in-hospital mortality than did either the EuroSCORE (European System for Cardiac Operative Risk Evaluation) or the FRANCE 2 (French Aortic National Corevalve and Edwards 2) models.

This STS/ACC model should assist clinicians in patient selection for TAVR, not by dictating which patients are candidates for TAVR, but by being used as “one element in the selection process, to be considered in concert with history, physical examination, laboratory information, and clinical judgment. The model may also provide useful information for patient counseling,” the investigators said (JAMA Cardiol. 2016 Mar 9. doi: 10.1001/jamacardiol.2015.0326). One factor that is generally recognized as an important risk predictor but isn’t yet incorporated into this tool is a measure of patient frailty. Data on frailty are not yet collected consistently in the STS/ACC registry. As more complete data become available, frailty likely will be included as a predictive factor in this tool.

Another important issue that eventually should be considered alongside survival prediction is the effect TAVR has on quality of life. The STS/ACC registry “is one of the few clinical registries to collect quality-of-life data,” and it could prove to be a critical adjunct to patient selection. A given patient might have a favorable outlook regarding mortality after the procedure, but would still be a poor candidate if he or she wouldn’t derive significant benefit from it, Dr. Edwards and his associates said.

Experts in the Society for Thoracic Surgeons and the American College of Cardiology used data from more than 13,000 consecutive transcatheter aortic valve replacement procedures to develop a new tool for predicting the risk of in-hospital mortality in patients undergoing TAVR, according to a report published online March 9 in JAMA Cardiology.

Their risk-prediction model was only “modestly” accurate but performed better than any existing methods for assessing risk in this patient population. It should be considered the first iteration of this tool and will be modified as the procedure itself evolves and as more data concerning TAVR are collected and analyzed. Ongoing analysis “may well define clinical subsets of patients who accrue particular benefit from the procedure or, conversely, reveal subsets not well served by TAVR,” said Dr. Fred H. Edwards and his associates on the steering committee of the STS/ACC Transcatheter Valve Therapy Registry.

They noted that more models soon will be developed to predict 30-day and 1-year mortality after TAVR. Models to predict the risk of neurologic deficit following TAVR are currently being developed, and models for other nonfatal outcomes will be developed soon.

This tool predicting in-hospital mortality is expected to become “a valuable adjunct for patient counseling, performance assessment, local quality improvement, and national monitoring of the appropriateness of patient selection for TAVR,” said Dr. Edwards, who is also in the department of surgery, University of Florida, Jacksonville, and his associates.

They began by analyzing the registry data for virtually every commercial TAVR performed at 265 participating sites in the United States during a 27-month period. In general, patients were selected for TAVR because they were considered unsuitable candidates for surgical aortic valve replacement. The mean patient age was 82.1 years. A total of 730 patients died before leaving the hospital, for an in-hospital mortality of 5.3%.

Working from an initial list of 39 possible patient variables to include in their statistical prediction model, the researchers narrowed it down to the 7 most predictive factors available in the registry data: older age, poorer glomerular filtration rate, the need for hemodialysis, NYHA class IV status, the presence of severe chronic lung disease, a category 2 or 4 critical hemodynamic state (i.e., preprocedural acuity status), and need for a nonfemoral approach during the procedure.

The model was then tested in a separate validation cohort of 6,868 patients (52% men) treated at 314 sites during a 7-month period. It performed better at predicting in-hospital mortality than did either the EuroSCORE (European System for Cardiac Operative Risk Evaluation) or the FRANCE 2 (French Aortic National Corevalve and Edwards 2) models.

This STS/ACC model should assist clinicians in patient selection for TAVR, not by dictating which patients are candidates for TAVR, but by being used as “one element in the selection process, to be considered in concert with history, physical examination, laboratory information, and clinical judgment. The model may also provide useful information for patient counseling,” the investigators said (JAMA Cardiol. 2016 Mar 9. doi: 10.1001/jamacardiol.2015.0326). One factor that is generally recognized as an important risk predictor but isn’t yet incorporated into this tool is a measure of patient frailty. Data on frailty are not yet collected consistently in the STS/ACC registry. As more complete data become available, frailty likely will be included as a predictive factor in this tool.

Another important issue that eventually should be considered alongside survival prediction is the effect TAVR has on quality of life. The STS/ACC registry “is one of the few clinical registries to collect quality-of-life data,” and it could prove to be a critical adjunct to patient selection. A given patient might have a favorable outlook regarding mortality after the procedure, but would still be a poor candidate if he or she wouldn’t derive significant benefit from it, Dr. Edwards and his associates said.