"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford

As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?

There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:

• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.

Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.

Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.

• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.

• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.

For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.

• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.

Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.

To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.

• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.

• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.

According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."

• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.

• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.

Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.

For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.

"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford

As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?

There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:

• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.

Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.

Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.

• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.

• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.

For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.

• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.

Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.

To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.

• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.

• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.

According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."

• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.

• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.

Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.

For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.

"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford

As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?

There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:

• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.

Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.

Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.

• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.

• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.

For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.

• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.

Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.

To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.

• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.

• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.

According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."

• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.

• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.

Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.

For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.

Click here to listen to the Teach-Back team

Click here to listen to the Teach-Back team

Click here to listen to the Teach-Back team

The Centers for Medicare & Medicaid Services' (CMS) recently announced final rule [PDF] on Stage 2 compliance for "meaningful use" of electronic health records (EHR) has been met with mixed reactions among most providers and trade groups, including SHM which voiced its concerns back in July.

"It's the classic government mixed bag," says Brenda Pawlak, director of Manatt Health Solutions, a division of New York City law firm Manatt, Phelps & Phillips.

Physician groups, including SHM and the Medical Group Management Association (MGMA), have lauded CMS for pushing back the implementation of Stage 2 meaningful-use requirements to 2014 from 2013. They also praised the agency for halving to 5% the percentage of a practice's patients who interact with an online portal. But for some providers, even the 5% threshold will be difficult to meet. And because physicians have to meet all requirements to qualify for incentive bonuses, the issue could loom large for specific groups.

"I don't think the 10% to 5% is a substantive change," Pawlak says.

Although most hospitalists are not directly subject to "meaningful use" requirements, many are heavily involved with assisting their institutions with implementation. SHM, which voiced its concerns in a July letter to CMS, is following this topic closely.

Some physician groups also lamented that the deadline for Stage 1 compliance remains unchanged at 2015. As physicians and provider groups attempt to comply with myriad rules, Pawlak says, meeting the 5% threshold will emerge as more burdensome as the deadline approaches. Still, CMS and federal officials say, the final rule will help nudge the healthcare system further into the digital age.

"The big message here is the push on standards-based interoperability of information," says Farzad Mostashari, MD, ScM, of the U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology. "We are staying on course with the road map that we set in Stage 1."

The Centers for Medicare & Medicaid Services' (CMS) recently announced final rule [PDF] on Stage 2 compliance for "meaningful use" of electronic health records (EHR) has been met with mixed reactions among most providers and trade groups, including SHM which voiced its concerns back in July.

"It's the classic government mixed bag," says Brenda Pawlak, director of Manatt Health Solutions, a division of New York City law firm Manatt, Phelps & Phillips.

Physician groups, including SHM and the Medical Group Management Association (MGMA), have lauded CMS for pushing back the implementation of Stage 2 meaningful-use requirements to 2014 from 2013. They also praised the agency for halving to 5% the percentage of a practice's patients who interact with an online portal. But for some providers, even the 5% threshold will be difficult to meet. And because physicians have to meet all requirements to qualify for incentive bonuses, the issue could loom large for specific groups.

"I don't think the 10% to 5% is a substantive change," Pawlak says.

Although most hospitalists are not directly subject to "meaningful use" requirements, many are heavily involved with assisting their institutions with implementation. SHM, which voiced its concerns in a July letter to CMS, is following this topic closely.

Some physician groups also lamented that the deadline for Stage 1 compliance remains unchanged at 2015. As physicians and provider groups attempt to comply with myriad rules, Pawlak says, meeting the 5% threshold will emerge as more burdensome as the deadline approaches. Still, CMS and federal officials say, the final rule will help nudge the healthcare system further into the digital age.

"The big message here is the push on standards-based interoperability of information," says Farzad Mostashari, MD, ScM, of the U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology. "We are staying on course with the road map that we set in Stage 1."

The Centers for Medicare & Medicaid Services' (CMS) recently announced final rule [PDF] on Stage 2 compliance for "meaningful use" of electronic health records (EHR) has been met with mixed reactions among most providers and trade groups, including SHM which voiced its concerns back in July.

"It's the classic government mixed bag," says Brenda Pawlak, director of Manatt Health Solutions, a division of New York City law firm Manatt, Phelps & Phillips.

Physician groups, including SHM and the Medical Group Management Association (MGMA), have lauded CMS for pushing back the implementation of Stage 2 meaningful-use requirements to 2014 from 2013. They also praised the agency for halving to 5% the percentage of a practice's patients who interact with an online portal. But for some providers, even the 5% threshold will be difficult to meet. And because physicians have to meet all requirements to qualify for incentive bonuses, the issue could loom large for specific groups.

"I don't think the 10% to 5% is a substantive change," Pawlak says.

Although most hospitalists are not directly subject to "meaningful use" requirements, many are heavily involved with assisting their institutions with implementation. SHM, which voiced its concerns in a July letter to CMS, is following this topic closely.

Some physician groups also lamented that the deadline for Stage 1 compliance remains unchanged at 2015. As physicians and provider groups attempt to comply with myriad rules, Pawlak says, meeting the 5% threshold will emerge as more burdensome as the deadline approaches. Still, CMS and federal officials say, the final rule will help nudge the healthcare system further into the digital age.

"The big message here is the push on standards-based interoperability of information," says Farzad Mostashari, MD, ScM, of the U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology. "We are staying on course with the road map that we set in Stage 1."

Kerry Weiner, MD, acknowledges gaps in the continuity of care for many hospitalized patients, with the critical time being the first few days, or even hours, after leaving the hospital. The only provider who "really understands" what needs to happen next for the patient "is the hospitalist,” says Dr. Weiner, chief clinical officer for IPC The Hospitalist Co.

For the past decade, IPC has staffed a care-transitions call center at its corporate headquarters in North Hollywood, Calif. Twenty nurses, case managers, and patient representatives attempt to contact all patients discharged to home by IPC hospitalists within 48 to 72 hours.

According to data presented last December at an Institute for Healthcare Improvement national quality forum, IPC call centers reached out to nearly 350,000 patients discharged between October 2010 and September 2011. The calls were successful 30% of the time, and a fifth of the contacted patients needed an intervention. IPC calculates that those interventions prevented 1,782 avoidable readmissions.

According to Dr. Weiner, call center staff follow discharge instructions from the hospitalists using brief, customized, technology-driven reports. They focus on key points that could become health issues in the first few days after discharge.

IPC hopes to expand its care-transitions continuum, in part by prioritizing those patients who need to be called and reaching more of them, he adds.

Kerry Weiner, MD, acknowledges gaps in the continuity of care for many hospitalized patients, with the critical time being the first few days, or even hours, after leaving the hospital. The only provider who "really understands" what needs to happen next for the patient "is the hospitalist,” says Dr. Weiner, chief clinical officer for IPC The Hospitalist Co.

For the past decade, IPC has staffed a care-transitions call center at its corporate headquarters in North Hollywood, Calif. Twenty nurses, case managers, and patient representatives attempt to contact all patients discharged to home by IPC hospitalists within 48 to 72 hours.

According to data presented last December at an Institute for Healthcare Improvement national quality forum, IPC call centers reached out to nearly 350,000 patients discharged between October 2010 and September 2011. The calls were successful 30% of the time, and a fifth of the contacted patients needed an intervention. IPC calculates that those interventions prevented 1,782 avoidable readmissions.

According to Dr. Weiner, call center staff follow discharge instructions from the hospitalists using brief, customized, technology-driven reports. They focus on key points that could become health issues in the first few days after discharge.

IPC hopes to expand its care-transitions continuum, in part by prioritizing those patients who need to be called and reaching more of them, he adds.

Kerry Weiner, MD, acknowledges gaps in the continuity of care for many hospitalized patients, with the critical time being the first few days, or even hours, after leaving the hospital. The only provider who "really understands" what needs to happen next for the patient "is the hospitalist,” says Dr. Weiner, chief clinical officer for IPC The Hospitalist Co.

For the past decade, IPC has staffed a care-transitions call center at its corporate headquarters in North Hollywood, Calif. Twenty nurses, case managers, and patient representatives attempt to contact all patients discharged to home by IPC hospitalists within 48 to 72 hours.

According to data presented last December at an Institute for Healthcare Improvement national quality forum, IPC call centers reached out to nearly 350,000 patients discharged between October 2010 and September 2011. The calls were successful 30% of the time, and a fifth of the contacted patients needed an intervention. IPC calculates that those interventions prevented 1,782 avoidable readmissions.

According to Dr. Weiner, call center staff follow discharge instructions from the hospitalists using brief, customized, technology-driven reports. They focus on key points that could become health issues in the first few days after discharge.

IPC hopes to expand its care-transitions continuum, in part by prioritizing those patients who need to be called and reaching more of them, he adds.

Click here to listen to Dr. Simone

Click here to listen to Dr. Simone

Click here to listen to Dr. Simone

Click here to listen to Dr. Scarpinato

Click here to listen to Dr. Scarpinato

Click here to listen to Dr. Scarpinato

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

Donna Van Bogaert, PhD

Donna Van Bogaert, PhD

Donna Van Bogaert, PhD

Fiona Naumann, PhD

*For a PDF of the full article, click on the link to the left of this introduction.

Fiona Naumann, PhD

*For a PDF of the full article, click on the link to the left of this introduction.

Fiona Naumann, PhD

*For a PDF of the full article, click on the link to the left of this introduction.