Cardiothoracic Surgery

SAN DIEGO – The few trauma patients who will survive a high-risk thoracotomy procedure for cardiac arrest can be predicted by the presence of cardiac motion as detected by a quick and inexpensive bedside ultrasound, a prospective study conducted at a level I trauma center showed.

Focused assessment with sonography in trauma (FAST) was 100% sensitive and 62% specific in predicting those who would survive or be eligible for organ donation after receiving a resuscitative thoracotomy for traumatic cardiac arrest, said Dr. Kenji Inaba of the department of surgery at the University of Southern California Medical Center in Los Angeles.

Ryan McVay/Thinkstock

Resuscitative thoracotomy, said Dr. Inaba, is a salvage procedure performed after cardiac arrest. It is a “high-risk, resource-intensive procedure, with a low quantitative yield. And yet, patients do survive.” Previous retrospective studies found that of those receiving resuscitative thoracotomy for traumatic arrest, 7.4% survived, with more than 90% of survivors retaining neurologic function; an additional 4.2% of recipients were potentially eligible for organ donation. Thus, a tool to identify potential survivors among those who present in post-traumatic cardiac arrest would help avoid unnecessary use of a procedure with such risks and resource burdens.

FAST, an inexpensive procedure that is standard for other indications in trauma, has been effective in identifying potential survivors in thoracotomy for nontrauma cardiac arrests, Dr. Inaba said at the annual meeting of the American Surgical Association.

The technique “has near-universal availability, can be performed immediately at the bedside without moving the patient, and yields real-time results with no radiation involved,” he said.

For the current prospective study, the specific aim was to examine the ability of FAST to differentiate survivors and potential organ donors from those who would not survive resuscitative thoracotomy among those presenting in traumatic cardiac arrest. Dr. Inaba and his associates examined the predictive value of cardiac motion and the presence of pericardial fluid for survival, as well as the adequacy of the FAST study for each patient.

The single-center study, conducted from 2010 to 2014, enrolled 187 patients (mean age, 31; 84.5% male) presenting in traumatic arrest who received resuscitative thoracotomy in the emergency department and also received a FAST. The scans were performed by emergency medicine residents under direct faculty supervision. Of the 187 patients studied, 6 (3.2%) survived, 3 (1.6%) became organ donors, and 178 (95.2%) died but were not organ donor eligible.

Cardiac motion was detected by FAST in 54 (28.9%) individuals in the total study population; among these were all nine of the survivors and donors, yielding a sensitivity of 100% and a specificity of 73.7% for survival (P < .001). All 16 of the patients with pericardial fluid detected by FAST died, as did all 7 patients in whom the study was deemed inadequate. Put simply, Dr. Inaba said, “no cardiac motion equals no survival.”

If thoracotomies had been performed only on patients in the study group who had cardiac motion on FAST, more than half of the unsuccessful resuscitative thoracotomies would have been avoided, Dr. Inaba noted. The study, he said, has particular application for lower-volume trauma centers, which must carefully weigh the prolonged use of limited resources required in a resuscitative thoracotomy.

Dr. David Spain, chief of trauma and critical care surgery at Stanford (Calif.) University, asked whether the study captured the mechanism of injury. Though the study did not do so, said Dr. Inaba, he and his colleagues realized that a subset of patients who went immediately to the operating room were not included in the study, a potential limitation. This group of patients included those with a penetrating cardiac injury – a possible reason, he said, why no patients among the survivors had a cardiac injury.

The authors reported no relevant financial disclosures.

SAN DIEGO – The few trauma patients who will survive a high-risk thoracotomy procedure for cardiac arrest can be predicted by the presence of cardiac motion as detected by a quick and inexpensive bedside ultrasound, a prospective study conducted at a level I trauma center showed.

Focused assessment with sonography in trauma (FAST) was 100% sensitive and 62% specific in predicting those who would survive or be eligible for organ donation after receiving a resuscitative thoracotomy for traumatic cardiac arrest, said Dr. Kenji Inaba of the department of surgery at the University of Southern California Medical Center in Los Angeles.

Ryan McVay/Thinkstock

Resuscitative thoracotomy, said Dr. Inaba, is a salvage procedure performed after cardiac arrest. It is a “high-risk, resource-intensive procedure, with a low quantitative yield. And yet, patients do survive.” Previous retrospective studies found that of those receiving resuscitative thoracotomy for traumatic arrest, 7.4% survived, with more than 90% of survivors retaining neurologic function; an additional 4.2% of recipients were potentially eligible for organ donation. Thus, a tool to identify potential survivors among those who present in post-traumatic cardiac arrest would help avoid unnecessary use of a procedure with such risks and resource burdens.

FAST, an inexpensive procedure that is standard for other indications in trauma, has been effective in identifying potential survivors in thoracotomy for nontrauma cardiac arrests, Dr. Inaba said at the annual meeting of the American Surgical Association.

The technique “has near-universal availability, can be performed immediately at the bedside without moving the patient, and yields real-time results with no radiation involved,” he said.

For the current prospective study, the specific aim was to examine the ability of FAST to differentiate survivors and potential organ donors from those who would not survive resuscitative thoracotomy among those presenting in traumatic cardiac arrest. Dr. Inaba and his associates examined the predictive value of cardiac motion and the presence of pericardial fluid for survival, as well as the adequacy of the FAST study for each patient.

The single-center study, conducted from 2010 to 2014, enrolled 187 patients (mean age, 31; 84.5% male) presenting in traumatic arrest who received resuscitative thoracotomy in the emergency department and also received a FAST. The scans were performed by emergency medicine residents under direct faculty supervision. Of the 187 patients studied, 6 (3.2%) survived, 3 (1.6%) became organ donors, and 178 (95.2%) died but were not organ donor eligible.

Cardiac motion was detected by FAST in 54 (28.9%) individuals in the total study population; among these were all nine of the survivors and donors, yielding a sensitivity of 100% and a specificity of 73.7% for survival (P < .001). All 16 of the patients with pericardial fluid detected by FAST died, as did all 7 patients in whom the study was deemed inadequate. Put simply, Dr. Inaba said, “no cardiac motion equals no survival.”

If thoracotomies had been performed only on patients in the study group who had cardiac motion on FAST, more than half of the unsuccessful resuscitative thoracotomies would have been avoided, Dr. Inaba noted. The study, he said, has particular application for lower-volume trauma centers, which must carefully weigh the prolonged use of limited resources required in a resuscitative thoracotomy.

Dr. David Spain, chief of trauma and critical care surgery at Stanford (Calif.) University, asked whether the study captured the mechanism of injury. Though the study did not do so, said Dr. Inaba, he and his colleagues realized that a subset of patients who went immediately to the operating room were not included in the study, a potential limitation. This group of patients included those with a penetrating cardiac injury – a possible reason, he said, why no patients among the survivors had a cardiac injury.

The authors reported no relevant financial disclosures.

SAN DIEGO – The few trauma patients who will survive a high-risk thoracotomy procedure for cardiac arrest can be predicted by the presence of cardiac motion as detected by a quick and inexpensive bedside ultrasound, a prospective study conducted at a level I trauma center showed.

Focused assessment with sonography in trauma (FAST) was 100% sensitive and 62% specific in predicting those who would survive or be eligible for organ donation after receiving a resuscitative thoracotomy for traumatic cardiac arrest, said Dr. Kenji Inaba of the department of surgery at the University of Southern California Medical Center in Los Angeles.

Ryan McVay/Thinkstock

Resuscitative thoracotomy, said Dr. Inaba, is a salvage procedure performed after cardiac arrest. It is a “high-risk, resource-intensive procedure, with a low quantitative yield. And yet, patients do survive.” Previous retrospective studies found that of those receiving resuscitative thoracotomy for traumatic arrest, 7.4% survived, with more than 90% of survivors retaining neurologic function; an additional 4.2% of recipients were potentially eligible for organ donation. Thus, a tool to identify potential survivors among those who present in post-traumatic cardiac arrest would help avoid unnecessary use of a procedure with such risks and resource burdens.

FAST, an inexpensive procedure that is standard for other indications in trauma, has been effective in identifying potential survivors in thoracotomy for nontrauma cardiac arrests, Dr. Inaba said at the annual meeting of the American Surgical Association.

The technique “has near-universal availability, can be performed immediately at the bedside without moving the patient, and yields real-time results with no radiation involved,” he said.

For the current prospective study, the specific aim was to examine the ability of FAST to differentiate survivors and potential organ donors from those who would not survive resuscitative thoracotomy among those presenting in traumatic cardiac arrest. Dr. Inaba and his associates examined the predictive value of cardiac motion and the presence of pericardial fluid for survival, as well as the adequacy of the FAST study for each patient.

The single-center study, conducted from 2010 to 2014, enrolled 187 patients (mean age, 31; 84.5% male) presenting in traumatic arrest who received resuscitative thoracotomy in the emergency department and also received a FAST. The scans were performed by emergency medicine residents under direct faculty supervision. Of the 187 patients studied, 6 (3.2%) survived, 3 (1.6%) became organ donors, and 178 (95.2%) died but were not organ donor eligible.

Cardiac motion was detected by FAST in 54 (28.9%) individuals in the total study population; among these were all nine of the survivors and donors, yielding a sensitivity of 100% and a specificity of 73.7% for survival (P < .001). All 16 of the patients with pericardial fluid detected by FAST died, as did all 7 patients in whom the study was deemed inadequate. Put simply, Dr. Inaba said, “no cardiac motion equals no survival.”

If thoracotomies had been performed only on patients in the study group who had cardiac motion on FAST, more than half of the unsuccessful resuscitative thoracotomies would have been avoided, Dr. Inaba noted. The study, he said, has particular application for lower-volume trauma centers, which must carefully weigh the prolonged use of limited resources required in a resuscitative thoracotomy.

Dr. David Spain, chief of trauma and critical care surgery at Stanford (Calif.) University, asked whether the study captured the mechanism of injury. Though the study did not do so, said Dr. Inaba, he and his colleagues realized that a subset of patients who went immediately to the operating room were not included in the study, a potential limitation. This group of patients included those with a penetrating cardiac injury – a possible reason, he said, why no patients among the survivors had a cardiac injury.

The authors reported no relevant financial disclosures.

A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.

The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.

“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.

Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.

The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”

The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.

[email protected]

A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.

The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.

“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.

Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.

The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”

The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.

[email protected]

A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.

The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.

“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.

Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.

The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”

The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.

[email protected]

The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.

“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.

Courtesy Wikimedia Commons/ FitzColinGerald/Creative Commons License

Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.

“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”

The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.

[email protected]

The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.

“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.

Courtesy Wikimedia Commons/ FitzColinGerald/Creative Commons License

Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.

“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”

The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.

[email protected]

The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.

“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.

Courtesy Wikimedia Commons/ FitzColinGerald/Creative Commons License

Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.

“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”

The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.

[email protected]

Interventional Chest/Diagnostic Procedures

The use of bronchoscopically deployed valves for the treatment of bronchopleural fistula has been reported broadly. Currently, the Spiration IBV™ is approved as a Humanitarian Device by FDA for use in “prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery” (Spiration IBV Instructions For Use URL www.spiration.com/IFU). In the absence of extensive study, this technique has been granted several CPT codes for placement (31647 and 31651) and removal (31649) and the accompanying balloon occlusion to identify the leak (31634) (Kovitz et al. CHEST. 2013;144[2]:661). Success has been widely reported and complications rare. Interesting, the most widely reported use of these devices is for nonapproved indications. Valves have been used in patients in the ICU on ventilators and ECMO (Mahajan et al. J Thorac Cardiovasc Surg. 2013;145[3]:626); in patients with CF bronchiectasis as a bridge to transplant, for complications of TB and various other disease-specific spontaneous as well as iatrogenic complications (Fischer et al. J Heart Lung Transplant. 2012;31:334) (El-Sameed et al. Lung. 2012;190[3]:347). In most cases, precise balloon localization is performed but also total lobar treatment reported. The largest series by Travaline et al. (CHEST. 2009;136[2]:355), with 40 patients, only 8 of 40 had postsurgical indications; 1-9 Emphasys EBV valves were used; and there was a median air leak of 119 days prior to valve implantation with 93% of patients improving. Therefore, the largest study available is not the approved device, not the approved indication, and not the typical patient for which the cost-saving indication of early postoperative air leaks could be made. This certainly more reflects the clinical challenges of these complex patients present leaving us with an untenable clinical problem.

Reimbursement data are lacking. Medicare claims data will not be available until 2016, and coverage decisions are spotty because of the “experimental” designation. Since these devices are greater than $2,000 each and one to four valves are used in each case with higher numbers reported, this technique requires a high risk to institutions. While there may be cost savings for treatment of patients confined to the hospital for prolonged air leak to expedite discharge of approved and unapproved indications under the DRG; outpatient management make these devices cost prohibitive in the absence of positive coverage decisions. Further investigation of actual utility in the wide range of possible off-label indications, complications, and cost effectiveness is desperately needed before institutions take on the financial risks of offering valve treatment. Standard thoracic surgery management and/or other potentially less expensive techniques must be explored first until valve therapy is further defined.

Thoracic Oncology

In a landmark decision, the Centers for Medicare & Medicaid Services announced in February a final national coverage determination providing for Medicare coverage of lung cancer screening with low-dose CT scanning (LDCT) (http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274; http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-05.html). CMS indicated that coverage would be effective immediately, though codes for the various services associated with the lung cancer screening process are still forthcoming.

Several members of the CHEST Thoracic Oncology NetWork contributed to the recent joint ACCP/ATS Policy Statement on lung cancer screening, which helped inform the CMS decision (Mazzone et al. CHEST. 2015;147[2]:295). The policy statement defines nine components necessary for high-quality lung cancer screening programs:

1. Who is offered screening? Adults aged 55-77 years with at least a 30 pack-year history of smoking, currently smoking, or having quit within the past 15 years. Note: Screening may not be appropriate for patients with substantial comorbid conditions.

2. How often and for how long to screen? Screening should be performed annually until age 77 years and discontinued if smoking has ceased for 15 years or if health problems develop that limit life expectancy or the ability/willingness to undergo curative treatment.

3. How the CT is performed. LDCT should be performed according to ACR-STR specifications, including compliance with recommended mean radiation dose.

4. Lung nodule identification. Establish a standard approach defining a “positive” finding, based on nodule size and characteristics.

5. Structured reporting. Establish use of a structured reporting system for description of nodules.

6. Lung nodule management algorithms. Develop standardized approaches to lung nodule management, including access to technology and technical expertise for nodule evaluation (PET imaging, minimally invasive thoracic surgery, nonsurgical approaches, etc), and incorporate a tracking system for nodule management and patient/provider communication.

7. Smoking cessation. Screening programs must have an integrated smoking cessation program.

8. Patient and provider education. Providers and patients should be educated in the benefits and harms of screening to inform decision support discussions, with development of educational materials and tools.

9. Data collection. Screening programs should collect data relating to program quality, as outlined above. Data should be collected about screening outcomes (complications, cancer diagnoses, survival, etc). An annual summary should be reported to an oversight body with the authority to credential screening programs.

For the full policy statement: Mazzone et al. Components necessary for high-quality lung caner screening: American College of Chest Physicians and American Thoracic Society Policy Statement. CHEST. 2015;147[2]:295.

Interventional Chest/Diagnostic Procedures

The use of bronchoscopically deployed valves for the treatment of bronchopleural fistula has been reported broadly. Currently, the Spiration IBV™ is approved as a Humanitarian Device by FDA for use in “prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery” (Spiration IBV Instructions For Use URL www.spiration.com/IFU). In the absence of extensive study, this technique has been granted several CPT codes for placement (31647 and 31651) and removal (31649) and the accompanying balloon occlusion to identify the leak (31634) (Kovitz et al. CHEST. 2013;144[2]:661). Success has been widely reported and complications rare. Interesting, the most widely reported use of these devices is for nonapproved indications. Valves have been used in patients in the ICU on ventilators and ECMO (Mahajan et al. J Thorac Cardiovasc Surg. 2013;145[3]:626); in patients with CF bronchiectasis as a bridge to transplant, for complications of TB and various other disease-specific spontaneous as well as iatrogenic complications (Fischer et al. J Heart Lung Transplant. 2012;31:334) (El-Sameed et al. Lung. 2012;190[3]:347). In most cases, precise balloon localization is performed but also total lobar treatment reported. The largest series by Travaline et al. (CHEST. 2009;136[2]:355), with 40 patients, only 8 of 40 had postsurgical indications; 1-9 Emphasys EBV valves were used; and there was a median air leak of 119 days prior to valve implantation with 93% of patients improving. Therefore, the largest study available is not the approved device, not the approved indication, and not the typical patient for which the cost-saving indication of early postoperative air leaks could be made. This certainly more reflects the clinical challenges of these complex patients present leaving us with an untenable clinical problem.

Reimbursement data are lacking. Medicare claims data will not be available until 2016, and coverage decisions are spotty because of the “experimental” designation. Since these devices are greater than $2,000 each and one to four valves are used in each case with higher numbers reported, this technique requires a high risk to institutions. While there may be cost savings for treatment of patients confined to the hospital for prolonged air leak to expedite discharge of approved and unapproved indications under the DRG; outpatient management make these devices cost prohibitive in the absence of positive coverage decisions. Further investigation of actual utility in the wide range of possible off-label indications, complications, and cost effectiveness is desperately needed before institutions take on the financial risks of offering valve treatment. Standard thoracic surgery management and/or other potentially less expensive techniques must be explored first until valve therapy is further defined.

Thoracic Oncology

In a landmark decision, the Centers for Medicare & Medicaid Services announced in February a final national coverage determination providing for Medicare coverage of lung cancer screening with low-dose CT scanning (LDCT) (http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274; http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-05.html). CMS indicated that coverage would be effective immediately, though codes for the various services associated with the lung cancer screening process are still forthcoming.

Several members of the CHEST Thoracic Oncology NetWork contributed to the recent joint ACCP/ATS Policy Statement on lung cancer screening, which helped inform the CMS decision (Mazzone et al. CHEST. 2015;147[2]:295). The policy statement defines nine components necessary for high-quality lung cancer screening programs:

1. Who is offered screening? Adults aged 55-77 years with at least a 30 pack-year history of smoking, currently smoking, or having quit within the past 15 years. Note: Screening may not be appropriate for patients with substantial comorbid conditions.

2. How often and for how long to screen? Screening should be performed annually until age 77 years and discontinued if smoking has ceased for 15 years or if health problems develop that limit life expectancy or the ability/willingness to undergo curative treatment.

3. How the CT is performed. LDCT should be performed according to ACR-STR specifications, including compliance with recommended mean radiation dose.

4. Lung nodule identification. Establish a standard approach defining a “positive” finding, based on nodule size and characteristics.

5. Structured reporting. Establish use of a structured reporting system for description of nodules.

6. Lung nodule management algorithms. Develop standardized approaches to lung nodule management, including access to technology and technical expertise for nodule evaluation (PET imaging, minimally invasive thoracic surgery, nonsurgical approaches, etc), and incorporate a tracking system for nodule management and patient/provider communication.

7. Smoking cessation. Screening programs must have an integrated smoking cessation program.

8. Patient and provider education. Providers and patients should be educated in the benefits and harms of screening to inform decision support discussions, with development of educational materials and tools.

9. Data collection. Screening programs should collect data relating to program quality, as outlined above. Data should be collected about screening outcomes (complications, cancer diagnoses, survival, etc). An annual summary should be reported to an oversight body with the authority to credential screening programs.

For the full policy statement: Mazzone et al. Components necessary for high-quality lung caner screening: American College of Chest Physicians and American Thoracic Society Policy Statement. CHEST. 2015;147[2]:295.

Interventional Chest/Diagnostic Procedures

The use of bronchoscopically deployed valves for the treatment of bronchopleural fistula has been reported broadly. Currently, the Spiration IBV™ is approved as a Humanitarian Device by FDA for use in “prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery” (Spiration IBV Instructions For Use URL www.spiration.com/IFU). In the absence of extensive study, this technique has been granted several CPT codes for placement (31647 and 31651) and removal (31649) and the accompanying balloon occlusion to identify the leak (31634) (Kovitz et al. CHEST. 2013;144[2]:661). Success has been widely reported and complications rare. Interesting, the most widely reported use of these devices is for nonapproved indications. Valves have been used in patients in the ICU on ventilators and ECMO (Mahajan et al. J Thorac Cardiovasc Surg. 2013;145[3]:626); in patients with CF bronchiectasis as a bridge to transplant, for complications of TB and various other disease-specific spontaneous as well as iatrogenic complications (Fischer et al. J Heart Lung Transplant. 2012;31:334) (El-Sameed et al. Lung. 2012;190[3]:347). In most cases, precise balloon localization is performed but also total lobar treatment reported. The largest series by Travaline et al. (CHEST. 2009;136[2]:355), with 40 patients, only 8 of 40 had postsurgical indications; 1-9 Emphasys EBV valves were used; and there was a median air leak of 119 days prior to valve implantation with 93% of patients improving. Therefore, the largest study available is not the approved device, not the approved indication, and not the typical patient for which the cost-saving indication of early postoperative air leaks could be made. This certainly more reflects the clinical challenges of these complex patients present leaving us with an untenable clinical problem.

Reimbursement data are lacking. Medicare claims data will not be available until 2016, and coverage decisions are spotty because of the “experimental” designation. Since these devices are greater than $2,000 each and one to four valves are used in each case with higher numbers reported, this technique requires a high risk to institutions. While there may be cost savings for treatment of patients confined to the hospital for prolonged air leak to expedite discharge of approved and unapproved indications under the DRG; outpatient management make these devices cost prohibitive in the absence of positive coverage decisions. Further investigation of actual utility in the wide range of possible off-label indications, complications, and cost effectiveness is desperately needed before institutions take on the financial risks of offering valve treatment. Standard thoracic surgery management and/or other potentially less expensive techniques must be explored first until valve therapy is further defined.

Thoracic Oncology

In a landmark decision, the Centers for Medicare & Medicaid Services announced in February a final national coverage determination providing for Medicare coverage of lung cancer screening with low-dose CT scanning (LDCT) (http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274; http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-05.html). CMS indicated that coverage would be effective immediately, though codes for the various services associated with the lung cancer screening process are still forthcoming.

Several members of the CHEST Thoracic Oncology NetWork contributed to the recent joint ACCP/ATS Policy Statement on lung cancer screening, which helped inform the CMS decision (Mazzone et al. CHEST. 2015;147[2]:295). The policy statement defines nine components necessary for high-quality lung cancer screening programs:

1. Who is offered screening? Adults aged 55-77 years with at least a 30 pack-year history of smoking, currently smoking, or having quit within the past 15 years. Note: Screening may not be appropriate for patients with substantial comorbid conditions.

2. How often and for how long to screen? Screening should be performed annually until age 77 years and discontinued if smoking has ceased for 15 years or if health problems develop that limit life expectancy or the ability/willingness to undergo curative treatment.

3. How the CT is performed. LDCT should be performed according to ACR-STR specifications, including compliance with recommended mean radiation dose.

4. Lung nodule identification. Establish a standard approach defining a “positive” finding, based on nodule size and characteristics.

5. Structured reporting. Establish use of a structured reporting system for description of nodules.

6. Lung nodule management algorithms. Develop standardized approaches to lung nodule management, including access to technology and technical expertise for nodule evaluation (PET imaging, minimally invasive thoracic surgery, nonsurgical approaches, etc), and incorporate a tracking system for nodule management and patient/provider communication.

7. Smoking cessation. Screening programs must have an integrated smoking cessation program.

8. Patient and provider education. Providers and patients should be educated in the benefits and harms of screening to inform decision support discussions, with development of educational materials and tools.

9. Data collection. Screening programs should collect data relating to program quality, as outlined above. Data should be collected about screening outcomes (complications, cancer diagnoses, survival, etc). An annual summary should be reported to an oversight body with the authority to credential screening programs.

For the full policy statement: Mazzone et al. Components necessary for high-quality lung caner screening: American College of Chest Physicians and American Thoracic Society Policy Statement. CHEST. 2015;147[2]:295.

Surgical lung biopsy performs well and is relatively safe for evaluating suspected interstitial lung diseases, but may be especially helpful in confirming the diagnosis and directing the treatment of patients with idiopathic pulmonary fibrosis with atypical signs and symptoms, researchers have found.

In patients with immune disorders or severe respiratory dysfunction, or on mechanical ventilation, clinicians should weigh the diagnostic benefits of surgical lung biopsy (SLB) against its potential risks, according to a systematic review and meta-analysis of 23 studies published between 2000 and 2014, comprising 2,148 patients. Dr. Qian Han of the Guangzhou Institute of Respiratory Disease in China led the investigative team. The findings were published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

The meta-analysis focused on diagnostic yield of biopsy samples and postbiopsy mortality within 90 days of surgery (J. Thorac. Cardiovasc. Surg. 2014 [doi:10.1016/j.jtcvs.2014.12.057). The mean age of patients across the studies ranged from 36 to 62 years. The population of the meta-analysis included 1,632 (76%) who had undergone video-assisted thoracic surgery (VATS) and 268 (12.5%) who had open-lung biopsy.

Slightly more than one third (33.5%) of diagnoses involved idiopathic pulmonary fibrosis, followed by nonspecific interstitial pneumonia (12%), hypersensitivity pneumonitis (9.6%), cryptogenic organizing pneumonia (7.5%), sarcoidosis (6.8%), and connective tissue disease related to interstitial lung disease (4%).

The median diagnostic yield across all studies was 95%, ranging from 42% to 100% depending on the study. One study showed a diagnostic yield below 70%. Eight studies showed that the biopsy influenced a change in the treatment plan 42%-90% of the time. In the entire meta-analysis, treatment plans were altered for 59.5% of patients who received a specific diagnosis and in 55.2% of those without a definitive diagnosis.

“These results suggested that an alteration in treatment may not be directed by a definitive histological diagnosis and nonspecific histological results could also be useful in clinical practice,” Dr. Han said.

Eleven of the studies used CT guidance to obtain biopsies without a preference to lobe, but two studies predisposed to the right lobes had diagnostic yields of 84% and 94%. One study avoided the lingual or middle lobe, with a diagnostic yield of 97%, and another focused on the lingular lobe only, with a 100% yield. Two studies showed that biopsy samples from lingual or middle lobes had the same diagnostic yield as did those from other lobes.

With regard to diagnostic performance based on biopsy numbers, one study showed that multiple biopsies may increase the diagnostic yield. Twelve studies obtained one to three samples, and among them eight studies suggested one sample containing both lesion and normal tissue was sufficient to represent pathological changes. One study showed that multiple biopsies may increase diagnostic yield.

Of the 16 studies that provided sufficient data on mortality rates, the pooled 30- and 90-day mortality rates were 2.2% (95% CI 1.0-4.0%) and 3.4% (95% CI 1.8-5.5%), respectively. The composite postoperative mortality rate was 3.6% (95% CI 2.1%-5.5%).

In their discussion, Dr. Han and colleagues addressed the controversy surrounding lingual vs. middle lobe biopsy by noting that high-resolution CT (HRCT) can be valuable in identifying the appropriate biopsy location. While multiple studies supported the effectiveness of only one biopsy as long as it contained both normal and abnormal tissue, the researchers pointed out that future studies evaluating biopsy samples would do well to evaluate biopsy number combined with sample size.

HRCT, while highly specific, may be less sensitive than SLB in the diagnosis of idiopathic pulmonary fibrosis, they found. Two studies the meta-analysis looked at compared the diagnostic yield between SLB and HRCT; SLB finally diagnosed idiopathic pulmonary fibrosis in 75%-91% of suspected cases and in 19%-74% of cases when HRCT did not raise suspicion of the disease. “These findings suggested that HRCT, albeit highly specific, is less sensitive in the diagnosis of IPF, therefore necessitating the utility of SLB in the diagnosis of these HRCT-omitted cases,” Dr. Han said.

On the safety issue, while studies that excluded patients on mechanical ventilation reported lower mortality rates and two studies identified ventilator dependence as an independent risk factor for mortality, the investigators reported that the higher mortality rates were probably the result of a sicker patient population rather than the SLB procedure itself. They wrote that to “indiscreetly refuse” to perform SLB in these patients is “overcautious and inappropriate” given the benefits of SLB in validating diagnoses and influencing treatment plans.

Dr. Han and his colleagues reported having no relevant disclosures.

Surgical lung biopsy performs well and is relatively safe for evaluating suspected interstitial lung diseases, but may be especially helpful in confirming the diagnosis and directing the treatment of patients with idiopathic pulmonary fibrosis with atypical signs and symptoms, researchers have found.

In patients with immune disorders or severe respiratory dysfunction, or on mechanical ventilation, clinicians should weigh the diagnostic benefits of surgical lung biopsy (SLB) against its potential risks, according to a systematic review and meta-analysis of 23 studies published between 2000 and 2014, comprising 2,148 patients. Dr. Qian Han of the Guangzhou Institute of Respiratory Disease in China led the investigative team. The findings were published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

The meta-analysis focused on diagnostic yield of biopsy samples and postbiopsy mortality within 90 days of surgery (J. Thorac. Cardiovasc. Surg. 2014 [doi:10.1016/j.jtcvs.2014.12.057). The mean age of patients across the studies ranged from 36 to 62 years. The population of the meta-analysis included 1,632 (76%) who had undergone video-assisted thoracic surgery (VATS) and 268 (12.5%) who had open-lung biopsy.

Slightly more than one third (33.5%) of diagnoses involved idiopathic pulmonary fibrosis, followed by nonspecific interstitial pneumonia (12%), hypersensitivity pneumonitis (9.6%), cryptogenic organizing pneumonia (7.5%), sarcoidosis (6.8%), and connective tissue disease related to interstitial lung disease (4%).

The median diagnostic yield across all studies was 95%, ranging from 42% to 100% depending on the study. One study showed a diagnostic yield below 70%. Eight studies showed that the biopsy influenced a change in the treatment plan 42%-90% of the time. In the entire meta-analysis, treatment plans were altered for 59.5% of patients who received a specific diagnosis and in 55.2% of those without a definitive diagnosis.

“These results suggested that an alteration in treatment may not be directed by a definitive histological diagnosis and nonspecific histological results could also be useful in clinical practice,” Dr. Han said.

Eleven of the studies used CT guidance to obtain biopsies without a preference to lobe, but two studies predisposed to the right lobes had diagnostic yields of 84% and 94%. One study avoided the lingual or middle lobe, with a diagnostic yield of 97%, and another focused on the lingular lobe only, with a 100% yield. Two studies showed that biopsy samples from lingual or middle lobes had the same diagnostic yield as did those from other lobes.

With regard to diagnostic performance based on biopsy numbers, one study showed that multiple biopsies may increase the diagnostic yield. Twelve studies obtained one to three samples, and among them eight studies suggested one sample containing both lesion and normal tissue was sufficient to represent pathological changes. One study showed that multiple biopsies may increase diagnostic yield.

Of the 16 studies that provided sufficient data on mortality rates, the pooled 30- and 90-day mortality rates were 2.2% (95% CI 1.0-4.0%) and 3.4% (95% CI 1.8-5.5%), respectively. The composite postoperative mortality rate was 3.6% (95% CI 2.1%-5.5%).

In their discussion, Dr. Han and colleagues addressed the controversy surrounding lingual vs. middle lobe biopsy by noting that high-resolution CT (HRCT) can be valuable in identifying the appropriate biopsy location. While multiple studies supported the effectiveness of only one biopsy as long as it contained both normal and abnormal tissue, the researchers pointed out that future studies evaluating biopsy samples would do well to evaluate biopsy number combined with sample size.

HRCT, while highly specific, may be less sensitive than SLB in the diagnosis of idiopathic pulmonary fibrosis, they found. Two studies the meta-analysis looked at compared the diagnostic yield between SLB and HRCT; SLB finally diagnosed idiopathic pulmonary fibrosis in 75%-91% of suspected cases and in 19%-74% of cases when HRCT did not raise suspicion of the disease. “These findings suggested that HRCT, albeit highly specific, is less sensitive in the diagnosis of IPF, therefore necessitating the utility of SLB in the diagnosis of these HRCT-omitted cases,” Dr. Han said.

On the safety issue, while studies that excluded patients on mechanical ventilation reported lower mortality rates and two studies identified ventilator dependence as an independent risk factor for mortality, the investigators reported that the higher mortality rates were probably the result of a sicker patient population rather than the SLB procedure itself. They wrote that to “indiscreetly refuse” to perform SLB in these patients is “overcautious and inappropriate” given the benefits of SLB in validating diagnoses and influencing treatment plans.

Dr. Han and his colleagues reported having no relevant disclosures.

Surgical lung biopsy performs well and is relatively safe for evaluating suspected interstitial lung diseases, but may be especially helpful in confirming the diagnosis and directing the treatment of patients with idiopathic pulmonary fibrosis with atypical signs and symptoms, researchers have found.

In patients with immune disorders or severe respiratory dysfunction, or on mechanical ventilation, clinicians should weigh the diagnostic benefits of surgical lung biopsy (SLB) against its potential risks, according to a systematic review and meta-analysis of 23 studies published between 2000 and 2014, comprising 2,148 patients. Dr. Qian Han of the Guangzhou Institute of Respiratory Disease in China led the investigative team. The findings were published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

The meta-analysis focused on diagnostic yield of biopsy samples and postbiopsy mortality within 90 days of surgery (J. Thorac. Cardiovasc. Surg. 2014 [doi:10.1016/j.jtcvs.2014.12.057). The mean age of patients across the studies ranged from 36 to 62 years. The population of the meta-analysis included 1,632 (76%) who had undergone video-assisted thoracic surgery (VATS) and 268 (12.5%) who had open-lung biopsy.

Slightly more than one third (33.5%) of diagnoses involved idiopathic pulmonary fibrosis, followed by nonspecific interstitial pneumonia (12%), hypersensitivity pneumonitis (9.6%), cryptogenic organizing pneumonia (7.5%), sarcoidosis (6.8%), and connective tissue disease related to interstitial lung disease (4%).

The median diagnostic yield across all studies was 95%, ranging from 42% to 100% depending on the study. One study showed a diagnostic yield below 70%. Eight studies showed that the biopsy influenced a change in the treatment plan 42%-90% of the time. In the entire meta-analysis, treatment plans were altered for 59.5% of patients who received a specific diagnosis and in 55.2% of those without a definitive diagnosis.

“These results suggested that an alteration in treatment may not be directed by a definitive histological diagnosis and nonspecific histological results could also be useful in clinical practice,” Dr. Han said.

Eleven of the studies used CT guidance to obtain biopsies without a preference to lobe, but two studies predisposed to the right lobes had diagnostic yields of 84% and 94%. One study avoided the lingual or middle lobe, with a diagnostic yield of 97%, and another focused on the lingular lobe only, with a 100% yield. Two studies showed that biopsy samples from lingual or middle lobes had the same diagnostic yield as did those from other lobes.

With regard to diagnostic performance based on biopsy numbers, one study showed that multiple biopsies may increase the diagnostic yield. Twelve studies obtained one to three samples, and among them eight studies suggested one sample containing both lesion and normal tissue was sufficient to represent pathological changes. One study showed that multiple biopsies may increase diagnostic yield.

Of the 16 studies that provided sufficient data on mortality rates, the pooled 30- and 90-day mortality rates were 2.2% (95% CI 1.0-4.0%) and 3.4% (95% CI 1.8-5.5%), respectively. The composite postoperative mortality rate was 3.6% (95% CI 2.1%-5.5%).

In their discussion, Dr. Han and colleagues addressed the controversy surrounding lingual vs. middle lobe biopsy by noting that high-resolution CT (HRCT) can be valuable in identifying the appropriate biopsy location. While multiple studies supported the effectiveness of only one biopsy as long as it contained both normal and abnormal tissue, the researchers pointed out that future studies evaluating biopsy samples would do well to evaluate biopsy number combined with sample size.

HRCT, while highly specific, may be less sensitive than SLB in the diagnosis of idiopathic pulmonary fibrosis, they found. Two studies the meta-analysis looked at compared the diagnostic yield between SLB and HRCT; SLB finally diagnosed idiopathic pulmonary fibrosis in 75%-91% of suspected cases and in 19%-74% of cases when HRCT did not raise suspicion of the disease. “These findings suggested that HRCT, albeit highly specific, is less sensitive in the diagnosis of IPF, therefore necessitating the utility of SLB in the diagnosis of these HRCT-omitted cases,” Dr. Han said.

On the safety issue, while studies that excluded patients on mechanical ventilation reported lower mortality rates and two studies identified ventilator dependence as an independent risk factor for mortality, the investigators reported that the higher mortality rates were probably the result of a sicker patient population rather than the SLB procedure itself. They wrote that to “indiscreetly refuse” to perform SLB in these patients is “overcautious and inappropriate” given the benefits of SLB in validating diagnoses and influencing treatment plans.

Dr. Han and his colleagues reported having no relevant disclosures.

New recommendations from the American Heart Association focus on the treatment of people older than age 40 years with congenital heart disease (CHD), a population that was believed to number about 850,000 in the year 2000 and is estimated to increase 5% each year.

“This improved longevity is leading to increased use of the medical system for both routine and episodic care, and caregivers need to be prepared to diagnose, follow-up, and treat the older adult with congenital heart disease,” authors led by Dr. Ami B. Bhatt wrote in a scientific statement published online April 20, 2015 in Circulation. “The predictable natural progression of CHD entities and sequelae of previous interventions must now be treated in the setting of late complications, acquired cardiac disease, multiorgan effects of lifelong processes, and the unrelenting process of aging. Despite the advances in this field, death rates in the population from 20 to [more than] 70 years of age may be twice to 7 times higher for the [adults] with CHD population than for their peers.”

Intended as a complement to the 2008 American College of Cardiology/AHA guidelines for ACHD (Circulation 2008;118:e714-833), the new recommendations cover the diagnosis and management of CHD in adults over the age of 40 years to summarize what is currently known “and to outline areas in which additional knowledge is critical to their care.” The scientific statement is limited to structural CHD, including coronary artery anomalies and aortopathy associated with bicuspid aortic valve disease (Circulation 2015 April 20; doi:10.1161/CIR.0000000000000204).

Working on behalf of the American Heart Association Council on Clinical Cardiology, Dr. Bhatt, who directs the adult congenital heart disease program at Massachusetts General Hospital, Boston, and her coauthors emphasized that the exposure to cardiovascular risk factors among ACHD patients is “no less problematic than with the non-CHD population. The ACHD individual may have abnormal myocardial substrate, abnormal cardiovascular physiology, abnormal anatomy, or any combination of the 3. The adverse impact of superimposed cardiovascular risk factors may well be amplified in this group, who also may already be at risk for systemic ventricular dysfunction, rhythm disturbances, and heart failure.”

In an interview, Dr. Bhatt noted that the ACHD population is distinct from both the pediatric and young adult populations with CHD and has many interactions with the health care system outside of adult congenital cardiac visits. “Therefore, this statement is written to serve as a reference for the many caregivers who will increasingly come across this population in their practice,” she said. “This includes general adult and pediatric cardiologists, electrophysiologists, interventionalists (percutaneous and surgical), cardiac imagers, as well as primary care physicians, hospitalists, and emergency medicine colleagues who need to understand and easily reference the issues and clinical challenges pertinent to this segment of the CHD population.”

The statement addresses diagnosis and management of late presentation of native disease, evolving long-term complications in disease diagnosed and/or intervened upon in childhood, and the additional burden of multiorgan dysfunction and acquired cardiovascular disease with age. Special attention is given to noncardiac involvement, including hepatic and renal disease screening and management, issues of aging including cognitive decline and sexual dysfunction, and challenging populations including those with coronary artery anomalies or superimposed pulmonary hypertension. The statement includes thorough discussions of diagnostic imaging, arrhythmia management, and surgical options in the older adult.

Among the issues addressed in the statement:

• Patient medical records, especially cardiac catheterization reports, should be obtained from primary sources. “This allow[s] comprehensive evaluation of these patients,” the authors wrote. They also emphasized the importance of multidisciplinary care when needed, in a medical center where other illnesses can be managed in a setting that also is knowledgeable about CHD.

• Psychosocial screening should be part of routine care of ACHD patients. This includes a team approach involving physicians, advanced practice nurses, physician assistants, psychologists, and social workers.

• Physical activity is encouraged. Sedentary lifestyle is a risk factor for many older adults with CHD. Cardiopulmonary exercise testing can be used in ACHD patients to help physicians create an individualized exercise plan. Research demonstrates that a structured regimen can improve exercise tolerance in this population.

• Sexual activity is reasonable for most ACHD patients. Exceptions include those who have decompensated or advanced heart failure, severe and/or significantly symptomatic valvular disease, or uncontrolled arrhythmias. Counseling must be provided by health care providers and “is useful to assist in resumption of sexual activity [especially] after an acute cardiac event, new cardiovascular disease diagnosis, or [implantable cardioverter defibrillator] implantation.”

• Many men with ACHD can take erectile dysfunction drugs as long as they are not taking nitrates and as long as their condition does not preclude sexual activity. However, “the effectiveness of phosphodiesterase type 5 inhibitors has not been established in the presence of severe ventricular outflow tract obstruction.”

• The use of hormone replacement therapy by women with ACHD must consider the risk for thromboembolic disease as well as the severity of menopausal symptoms. “For example, women with Fontan surgery have a high risk of venous thromboembolism and should avoid HRT, whereas women with [tetralogy of Fallot] repair and good RV function have a low risk and could probably receive HRT for symptoms,” the authors wrote.

The statement also includes recommendations for clinicians treating ACHD patients regarding screening for and management of concomitant lung, kidney, or liver disease. For example, it recommends serial evaluation of liver function for all patients with a history of previous palliation with the Fontan procedure and routine assessment of renal function for all adults with moderate-to-complex CHD.

The information provided in the AHA statement is based on scientific research and combined clinical experience from longitudinal care, Dr. Bhatt said in the interview. “The authors engaged in a truly multidisciplinary effort as pediatric and adult cardiologists, cardiac subspecialists, radiologists, and surgeons worked together to create a document to assist caregivers in meeting the needs of this challenging and growing population,” she said. “Importantly, by sharing the clinical trajectory of the older adult with CHD, the authors hope this statement and future versions will inform pediatric and young adult care and research as we strive to together improve lifelong care in congenital heart disease.”

Five of the coauthors disclosed relevant financial relationships. Dr. Michael C. Earing has received honoraria from Actelion Pharmaceuticals. Dr. Elyse Foster has received a research grant from Abbott Vascular and is a consultant or advisory board member for Gilead. Dr. Brian B. Ghoshhajra is a consultant or advisory board member for Siemens Healthcare. Dr. Seema Mital is a consultant or advisory board member for Novartis. Dr. Zian H. Tseng has received honoraria from Biotronik. The remaining authors reported having no relevant financial disclosures.

[email protected]


On Twitter @dougbrunk

New recommendations from the American Heart Association focus on the treatment of people older than age 40 years with congenital heart disease (CHD), a population that was believed to number about 850,000 in the year 2000 and is estimated to increase 5% each year.

“This improved longevity is leading to increased use of the medical system for both routine and episodic care, and caregivers need to be prepared to diagnose, follow-up, and treat the older adult with congenital heart disease,” authors led by Dr. Ami B. Bhatt wrote in a scientific statement published online April 20, 2015 in Circulation. “The predictable natural progression of CHD entities and sequelae of previous interventions must now be treated in the setting of late complications, acquired cardiac disease, multiorgan effects of lifelong processes, and the unrelenting process of aging. Despite the advances in this field, death rates in the population from 20 to [more than] 70 years of age may be twice to 7 times higher for the [adults] with CHD population than for their peers.”

Intended as a complement to the 2008 American College of Cardiology/AHA guidelines for ACHD (Circulation 2008;118:e714-833), the new recommendations cover the diagnosis and management of CHD in adults over the age of 40 years to summarize what is currently known “and to outline areas in which additional knowledge is critical to their care.” The scientific statement is limited to structural CHD, including coronary artery anomalies and aortopathy associated with bicuspid aortic valve disease (Circulation 2015 April 20; doi:10.1161/CIR.0000000000000204).

Working on behalf of the American Heart Association Council on Clinical Cardiology, Dr. Bhatt, who directs the adult congenital heart disease program at Massachusetts General Hospital, Boston, and her coauthors emphasized that the exposure to cardiovascular risk factors among ACHD patients is “no less problematic than with the non-CHD population. The ACHD individual may have abnormal myocardial substrate, abnormal cardiovascular physiology, abnormal anatomy, or any combination of the 3. The adverse impact of superimposed cardiovascular risk factors may well be amplified in this group, who also may already be at risk for systemic ventricular dysfunction, rhythm disturbances, and heart failure.”

In an interview, Dr. Bhatt noted that the ACHD population is distinct from both the pediatric and young adult populations with CHD and has many interactions with the health care system outside of adult congenital cardiac visits. “Therefore, this statement is written to serve as a reference for the many caregivers who will increasingly come across this population in their practice,” she said. “This includes general adult and pediatric cardiologists, electrophysiologists, interventionalists (percutaneous and surgical), cardiac imagers, as well as primary care physicians, hospitalists, and emergency medicine colleagues who need to understand and easily reference the issues and clinical challenges pertinent to this segment of the CHD population.”

The statement addresses diagnosis and management of late presentation of native disease, evolving long-term complications in disease diagnosed and/or intervened upon in childhood, and the additional burden of multiorgan dysfunction and acquired cardiovascular disease with age. Special attention is given to noncardiac involvement, including hepatic and renal disease screening and management, issues of aging including cognitive decline and sexual dysfunction, and challenging populations including those with coronary artery anomalies or superimposed pulmonary hypertension. The statement includes thorough discussions of diagnostic imaging, arrhythmia management, and surgical options in the older adult.

Among the issues addressed in the statement:

• Patient medical records, especially cardiac catheterization reports, should be obtained from primary sources. “This allow[s] comprehensive evaluation of these patients,” the authors wrote. They also emphasized the importance of multidisciplinary care when needed, in a medical center where other illnesses can be managed in a setting that also is knowledgeable about CHD.

• Psychosocial screening should be part of routine care of ACHD patients. This includes a team approach involving physicians, advanced practice nurses, physician assistants, psychologists, and social workers.

• Physical activity is encouraged. Sedentary lifestyle is a risk factor for many older adults with CHD. Cardiopulmonary exercise testing can be used in ACHD patients to help physicians create an individualized exercise plan. Research demonstrates that a structured regimen can improve exercise tolerance in this population.

• Sexual activity is reasonable for most ACHD patients. Exceptions include those who have decompensated or advanced heart failure, severe and/or significantly symptomatic valvular disease, or uncontrolled arrhythmias. Counseling must be provided by health care providers and “is useful to assist in resumption of sexual activity [especially] after an acute cardiac event, new cardiovascular disease diagnosis, or [implantable cardioverter defibrillator] implantation.”

• Many men with ACHD can take erectile dysfunction drugs as long as they are not taking nitrates and as long as their condition does not preclude sexual activity. However, “the effectiveness of phosphodiesterase type 5 inhibitors has not been established in the presence of severe ventricular outflow tract obstruction.”

• The use of hormone replacement therapy by women with ACHD must consider the risk for thromboembolic disease as well as the severity of menopausal symptoms. “For example, women with Fontan surgery have a high risk of venous thromboembolism and should avoid HRT, whereas women with [tetralogy of Fallot] repair and good RV function have a low risk and could probably receive HRT for symptoms,” the authors wrote.

The statement also includes recommendations for clinicians treating ACHD patients regarding screening for and management of concomitant lung, kidney, or liver disease. For example, it recommends serial evaluation of liver function for all patients with a history of previous palliation with the Fontan procedure and routine assessment of renal function for all adults with moderate-to-complex CHD.

The information provided in the AHA statement is based on scientific research and combined clinical experience from longitudinal care, Dr. Bhatt said in the interview. “The authors engaged in a truly multidisciplinary effort as pediatric and adult cardiologists, cardiac subspecialists, radiologists, and surgeons worked together to create a document to assist caregivers in meeting the needs of this challenging and growing population,” she said. “Importantly, by sharing the clinical trajectory of the older adult with CHD, the authors hope this statement and future versions will inform pediatric and young adult care and research as we strive to together improve lifelong care in congenital heart disease.”

Five of the coauthors disclosed relevant financial relationships. Dr. Michael C. Earing has received honoraria from Actelion Pharmaceuticals. Dr. Elyse Foster has received a research grant from Abbott Vascular and is a consultant or advisory board member for Gilead. Dr. Brian B. Ghoshhajra is a consultant or advisory board member for Siemens Healthcare. Dr. Seema Mital is a consultant or advisory board member for Novartis. Dr. Zian H. Tseng has received honoraria from Biotronik. The remaining authors reported having no relevant financial disclosures.

[email protected]


On Twitter @dougbrunk

New recommendations from the American Heart Association focus on the treatment of people older than age 40 years with congenital heart disease (CHD), a population that was believed to number about 850,000 in the year 2000 and is estimated to increase 5% each year.

“This improved longevity is leading to increased use of the medical system for both routine and episodic care, and caregivers need to be prepared to diagnose, follow-up, and treat the older adult with congenital heart disease,” authors led by Dr. Ami B. Bhatt wrote in a scientific statement published online April 20, 2015 in Circulation. “The predictable natural progression of CHD entities and sequelae of previous interventions must now be treated in the setting of late complications, acquired cardiac disease, multiorgan effects of lifelong processes, and the unrelenting process of aging. Despite the advances in this field, death rates in the population from 20 to [more than] 70 years of age may be twice to 7 times higher for the [adults] with CHD population than for their peers.”

Intended as a complement to the 2008 American College of Cardiology/AHA guidelines for ACHD (Circulation 2008;118:e714-833), the new recommendations cover the diagnosis and management of CHD in adults over the age of 40 years to summarize what is currently known “and to outline areas in which additional knowledge is critical to their care.” The scientific statement is limited to structural CHD, including coronary artery anomalies and aortopathy associated with bicuspid aortic valve disease (Circulation 2015 April 20; doi:10.1161/CIR.0000000000000204).

Working on behalf of the American Heart Association Council on Clinical Cardiology, Dr. Bhatt, who directs the adult congenital heart disease program at Massachusetts General Hospital, Boston, and her coauthors emphasized that the exposure to cardiovascular risk factors among ACHD patients is “no less problematic than with the non-CHD population. The ACHD individual may have abnormal myocardial substrate, abnormal cardiovascular physiology, abnormal anatomy, or any combination of the 3. The adverse impact of superimposed cardiovascular risk factors may well be amplified in this group, who also may already be at risk for systemic ventricular dysfunction, rhythm disturbances, and heart failure.”

In an interview, Dr. Bhatt noted that the ACHD population is distinct from both the pediatric and young adult populations with CHD and has many interactions with the health care system outside of adult congenital cardiac visits. “Therefore, this statement is written to serve as a reference for the many caregivers who will increasingly come across this population in their practice,” she said. “This includes general adult and pediatric cardiologists, electrophysiologists, interventionalists (percutaneous and surgical), cardiac imagers, as well as primary care physicians, hospitalists, and emergency medicine colleagues who need to understand and easily reference the issues and clinical challenges pertinent to this segment of the CHD population.”

The statement addresses diagnosis and management of late presentation of native disease, evolving long-term complications in disease diagnosed and/or intervened upon in childhood, and the additional burden of multiorgan dysfunction and acquired cardiovascular disease with age. Special attention is given to noncardiac involvement, including hepatic and renal disease screening and management, issues of aging including cognitive decline and sexual dysfunction, and challenging populations including those with coronary artery anomalies or superimposed pulmonary hypertension. The statement includes thorough discussions of diagnostic imaging, arrhythmia management, and surgical options in the older adult.

Among the issues addressed in the statement:

• Patient medical records, especially cardiac catheterization reports, should be obtained from primary sources. “This allow[s] comprehensive evaluation of these patients,” the authors wrote. They also emphasized the importance of multidisciplinary care when needed, in a medical center where other illnesses can be managed in a setting that also is knowledgeable about CHD.

• Psychosocial screening should be part of routine care of ACHD patients. This includes a team approach involving physicians, advanced practice nurses, physician assistants, psychologists, and social workers.

• Physical activity is encouraged. Sedentary lifestyle is a risk factor for many older adults with CHD. Cardiopulmonary exercise testing can be used in ACHD patients to help physicians create an individualized exercise plan. Research demonstrates that a structured regimen can improve exercise tolerance in this population.

• Sexual activity is reasonable for most ACHD patients. Exceptions include those who have decompensated or advanced heart failure, severe and/or significantly symptomatic valvular disease, or uncontrolled arrhythmias. Counseling must be provided by health care providers and “is useful to assist in resumption of sexual activity [especially] after an acute cardiac event, new cardiovascular disease diagnosis, or [implantable cardioverter defibrillator] implantation.”

• Many men with ACHD can take erectile dysfunction drugs as long as they are not taking nitrates and as long as their condition does not preclude sexual activity. However, “the effectiveness of phosphodiesterase type 5 inhibitors has not been established in the presence of severe ventricular outflow tract obstruction.”

• The use of hormone replacement therapy by women with ACHD must consider the risk for thromboembolic disease as well as the severity of menopausal symptoms. “For example, women with Fontan surgery have a high risk of venous thromboembolism and should avoid HRT, whereas women with [tetralogy of Fallot] repair and good RV function have a low risk and could probably receive HRT for symptoms,” the authors wrote.

The statement also includes recommendations for clinicians treating ACHD patients regarding screening for and management of concomitant lung, kidney, or liver disease. For example, it recommends serial evaluation of liver function for all patients with a history of previous palliation with the Fontan procedure and routine assessment of renal function for all adults with moderate-to-complex CHD.

The information provided in the AHA statement is based on scientific research and combined clinical experience from longitudinal care, Dr. Bhatt said in the interview. “The authors engaged in a truly multidisciplinary effort as pediatric and adult cardiologists, cardiac subspecialists, radiologists, and surgeons worked together to create a document to assist caregivers in meeting the needs of this challenging and growing population,” she said. “Importantly, by sharing the clinical trajectory of the older adult with CHD, the authors hope this statement and future versions will inform pediatric and young adult care and research as we strive to together improve lifelong care in congenital heart disease.”

Five of the coauthors disclosed relevant financial relationships. Dr. Michael C. Earing has received honoraria from Actelion Pharmaceuticals. Dr. Elyse Foster has received a research grant from Abbott Vascular and is a consultant or advisory board member for Gilead. Dr. Brian B. Ghoshhajra is a consultant or advisory board member for Siemens Healthcare. Dr. Seema Mital is a consultant or advisory board member for Novartis. Dr. Zian H. Tseng has received honoraria from Biotronik. The remaining authors reported having no relevant financial disclosures.

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