Cover Story

Failure Is Not an Option

More interventional techniques are being used to improve outcomes for patients with HF.

The development of new percutaneous approaches for HF in recent years has boosted the involvement of interventional cardiologists in the treatment and management of these patients. Further, it is expected that the use of interventional techniques for HF will continue to grow.

“Contemporary interventional cardiologists are now a critical component of the HF team. This recent development is primarily driven by the fact that the HF patient population is growing exponentially,” Navin K. Kapur, MD, director of the interventional heart failure (IHF) training program, director of the acute circulatory support program, and associate professor of medicine in the division of interventional cardiolgy and advanced HF at Tufts Medical Center, told Cardiology Today’s Intervention. “Interventionalists used to primarily focus on patients referred to the cath lab for coronary intervention who had not yet experienced HF. Now, we are seeing that the majority of patients referred to the cath lab have some form of pre-existing HF, whether that is HF with reduced ejection fraction, HF with preserved ejection fraction or HF due to valvular heart disease.”

As a result, the interventional cardiologist’s involvement is moving beyond simply referring patients with advanced HF that have been treated with PCI or transcatheter valve repair or replacement to HF specialists and performing procedures with percutaneous circulatory support devices. It now also includes joining and forming teams with expertise from other subspecialties to comprehensively manage patients with HF; more advanced understanding of HF syndromes and the related hemodynamic issues, helping determine which technologies are best suited for which patients; and thinking about HF prevention after handling its precursors such as CHD and valvular heart disease.

Increased Cross-Collaboration

Cover image

Cover illustration © Lisa Clark

These changing dynamics to the treatment of HF create a need for comprehensive understanding about the structure and function of the heart, experts told Cardiology Today’s Intervention.

As part of that effort, the Society for Cardiovascular Angiography and Interventions and the Heart Failure Society of America have created the Interventional HF Working Group.

“HF is becoming an increasing epidemic and we are being held to a higher standard in terms of readmissions and more comprehensive care for our patients,” Srihari S. Naidu, MD, FACC, FSCAI, FAHA, chair of the Interventional HF Working Group, said in an interview. “In addition, it is becoming very clear that most of the technologies that are being used today — at least the ones that are most meaningful now — deal with HF.”

Therefore, a goal of the working group is to “re-envision everything we are doing under the guise of repairing structural anomalies of the heart into a more practical desire to improve overall heart function safely and effectively ... so that patients can go on living much more higher-quality and able lives in addition to adding quantity of life,” said Naidu, associate professor of medicine at SUNY Stony Brook School of Medicine and director of the cardiac catheterization laboratory, interventional cardiology fellowship program and hypertrophic cardiomyopathy treatment center at Winthrop University Hospital in Mineola, New York.

James B. Young, MD
James B. Young

According to James B. Young, MD, professor of medicine and executive dean, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, it is crucial for interventional cardiologists to have a “broad and deep understanding of how cath lab-based interventions can improve patients with certain types of ventricular dysfunction and HF.” Young is also chairman of the Cleveland Clinic Endocrinology and Metabolism Institute and medical director of the Kaufman Center for Heart Failure.

Young also suggested increasing awareness of how valvular heart disease relates to HF and left ventricular dysfunction, how interventions can help treat tricuspid valve disease and when temporary mechanical circulatory support devices should be employed.

An Essential Partnership

To optimize treatment of patients with HF, interventional cardiologists are collaborating more with HF specialists, cardiac surgeons and other specialties, similar to the heart team approach pioneered in the treatment of valvular heart disease.

“In this day and age, this is not just a proposed partnership; it is an essential partnership,” Mandeep R. Mehra, MD, FRCP, FESC, FACC, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center at Brigham and Women’s Hospital, told Cardiology Today’s Intervention. “We have HF specialists who are now embedded in cath labs, we have interventionalists who are embedded in HF programs and, more importantly, we now have training portals where our fellows tend to train in aspects of interventional HF.”

The idea, according to Naidu, is to have “more of a HF team approach, where there are specialists in HF and specialists in interventional cardiology who finally speak the same language, learning it from the national organizations down, taking it to the hospitals and putting the most complicated patients into this heart team portal. The reality is, by creating these networks locally at the hospitals, the patient receives better and more comprehensive care that makes a meaningful difference in their organic substrate that has led to HF.”

On the macro level, societies such as SCAI, HFSA and the International Society for Heart and Lung Transplantation have started to increase collaboration to share knowledge and determine how teams should interact at the hospital level, experts said. “It’s a practical approach to real-world management of the complex patient whose time has come,” Naidu said.

Srihari S. Naidu

“We would ultimately like to see HF doctors look at these patients with a better understanding of what interventional cardiology could provide,” Naidu said. “That way, they know when to consult us, they know when to perform a comprehensive invasive evaluation and they know much more about the intricacies of the various interventional technologies at their disposal. Vice versa, we need to be better involved from the interventional standpoint so that when we get consulted about HF, we have a better assessment of what the clinical syndrome is and what types of solutions we can offer.”

Available Percutaneous Devices

As a step toward putting these principles into practice, a consensus statement written by representatives of SCAI, HFSA, the American College of Cardiology and the Society of Thoracic Surgeons offers recommendations for optimizing the use of percutaneous mechanical circulatory support devices (see Sidebar).

These include intra-aortic balloon pumps, left atrial–aortic assist devices, LV-to-aortic assist devices, extracorporeal membrane oxygenation (ECMO) systems and right-sided support devices.

Navin K. Kapur

Although intra-aortic balloon pumps have been around for nearly 50 years, “the data are unclear as to who would benefit most, and the hemodynamic effects on patients with advanced HF have not been studied,” Kapur said.

“A balloon pump is probably ideal for patients who need some ischemic protection but do not need substantial peripheral perfusion support,” Naidu said.

More sophisticated and powerful systems are needed for patients who have higher levels of LV dysfunction or clinical instability, recently decompensated HF or cardiogenic shock, he said.

Left atrial–aortic assist devices such as TandemHeart (CardiacAssist) are appropriate for patients who need ventricular unloading and circulatory support, Kapur said. “In our experience, this system is effective as an alternative to the LV-to-aortic systems for patients who have a LV thrombus, aortic regurgitation, a ventricular septal defect, or who require ventricular unloading as well as oxygenation,” he said. Implantation can be a challenge because a transseptal puncture using large-bore cannulas and femoral access is required.

According to Naidu, the simpler LV-to-aortic assist devices such as Impella 2.5 or CP (Abiomed) are appropriate for patients undergoing PCI who have complex anatomy and reduced LV function. Another (Percutaneous Heart Pump [PHP], St. Jude Medical) is being tested in the SHIELD 2 trial. Kapur, co-principal investigator of that trial, said “the promise of the PHP is the ability to deliver higher flow rates using a small vascular access sheath.”

Patients with a significant decline in LV function or cardiogenic shock can benefit from a larger-capacity LV-to-aortic assist device such as Impella 5.0 (Abiomed), a left atrial–aortic assist device or an ECMO system, Naidu said.

“In general, however, we try to stay away from ECMO unless there is significant biventricular failure and/or you have poor oxygenation,” he said. Kapur further noted that VA-ECMO does not effectively unload the LV compared with other support systems such as the Impella and TandemHeart devices.

Percutaneous right-sided support devices are also growing in use, including offerings from the Tandem and Impella platforms. The growing awareness of right-sided HF has led to an increase in patients being evaluated for right-sided support devices, Kapur said.

Kapur and colleagues in September published a case report in Circulation: Heart Failure in which a patient received Impella devices for left-sided support (Impella 5.0) and right-sided support (Impella RP). “We can essentially take over complete function of the heart with two small incisions — one in the artery and one in the vein — in the cath lab,” Kapur said. “Full biventricular support will advance our ability to stabilize patients with cardiogenic shock.”

Young noted, however, that “perhaps the most challenging decision-making process is where to go after the device has been put in. These devices are short-term bridges to outcomes, which can be futility and death, enough recovery of the heart and circulatory system for the device to be weaned and removed, or bridges to a more permanent device or transplantation.” The science of myocardial recovery remains poorly understood and requires more investigation, Kapur said.

Understanding the Clinical Scenarios

Mandeep R. Mehra

It is imperative for interventional cardiologists and the HF team to understand each possible clinical scenario and clinical opportunity to best determine which patients should receive which interventional mechanical circulatory support procedures, Mehra said.

One scenario can be described as acute temporary percutaneous circulatory support. He described this scenario as patients who need “a device to serve as a temporizing bridge even as more durable decisions for device therapy can be entertained,” possibly due to cardiogenic or precardiogenic shock. Depending on patient characteristics, this may call for an intra-aortic balloon pump, a left atrial–aortic assist device such as TandemHeart, a LV-to-aortic assist device such as Impella or an ECMO device, he said.

The number of HF-related deaths declined since 2000, but increased in recent years, according to a report from the CDC’s National Center for Health Statistics.

The number of HF-related deaths declined since 2000, but increased in recent years, according to a report from the CDC’s National Center for Health Statistics.

Source: Ni H, Xu J. NCHS Data Brief. 2015;231:1-7.

Another scenario, Mehra said, is where it makes sense for interventional cardiologists and HF specialists to discuss the best options for myocardial or coronary repair in patients with or at risk for HF. “We can do high-risk PCI in some patients, we can provide treatments for hypertrophic cardiomyopathy in the cardiac cath lab, and we can reconstruct the aortic or mitral valves in those who have underlying valvular disease,” he said.

Sometimes, solutions implemented by interventional cardiologists in collaboration with HF specialists and others will be needed to reshape the LV. Mehra noted that research is being conducted in this area, from the development of a ventricular partitioning device (Parachute, CardioKinetix) to restore ventricular function to the testing of gene-therapy systems.

In addition, interventional cardiologists and HF specialists have been working together to implement intracardiac or intravascular shunts to help patients with different forms of HF, according to Mehra.

Finally, he said, interventionalists have helped HF specialists by using interventional techniques to implant biosensors to monitor pulmonary artery pressure in patients with HF (CardioMEMS HF System, CardioMEMS/St. Jude Medical).

Once those scenarios are understood, interventional cardiologists can become part of “very closely knitted heart teams within the HF group,” Mehra said. “For example, at Brigham and Women’s Hospital, we have a shock team. If a patient comes in with cardiogenic shock, an interventionalist, a HF specialist, a surgeon and a critical care specialist meet to decide the right treatment, whether that is medication, the cath lab, ECMO implantation or surgery. These decisions are made in a rapid decision tree collectively through a multidisciplinary team approach.”

Efforts for Prevention

With consideration of the growing epidemic of HF, interventional cardiologists should also focus on what they can do to prevent HF, experts said.

“The three primary causes of HF are hypertension, ischemic heart disease/multivessel coronary disease and valvular heart disease,” Kapur said. “In each of those three buckets, interventionalists have an opportunity to prevent the onset of advanced HF.”

They can combat hypertension through renal denervation once issues with that technology are sorted out; they can perform multivessel revascularization to “allow myocardium that you might have thought was not viable to become viable by restoring blood flow,” sometimes with the assistance of a support device; and they can use transcatheter aortic and mitral valve therapies to prevent onset of end-stage HF, he said.

Interventional cardiologists have a role to play in identifying signs of HF before it gets to the advanced stage, Naidu said.

“In general, once we find HF, we find congestion — and that’s the latest stage of the disease,” he said. “We need to find a way of assessing preclinical disease, which manifests mainly as fatigue, a drop in cardiac output at rest or a failure to increase cardiac output on exertion. I would like to see our field move in the direction of teasing out when that happens, which typically will be 5 to 10 years before overt HF. Once that’s determined, then we do what we need to do to correct that underlying state to ultimately delay or avoid the progression to HF. We need to have a plan before the point of no return. It might take 5 to 10 years to figure out the science of how to catch it and intervene earlier, which means taking some upfront risk to get a longer-term benefit.” — by Erik Swain

Disclosures: Kapur reports receiving consultant/speaker’s honoraria from HeartWare and consultant/speaker’s honoraria/institutional research support from Abiomed, CardiacAssist, Maquet and Thoratec/St. Jude Medical. Mehra reports consulting for Boston Scientific and Medtronic, serving on the steering committee for trials sponsored by Janssen Pharmaceuticals and Thoratec/St. Jude Medical, and serving on the data safety monitoring board for a trial sponsored by Teva. Naidu reports consulting for Abbott Vascular, Abiomed and Maquet. Young reports no relevant financial disclosures.

The development of new percutaneous approaches for HF in recent years has boosted the involvement of interventional cardiologists in the treatment and management of these patients. Further, it is expected that the use of interventional techniques for HF will continue to grow.

“Contemporary interventional cardiologists are now a critical component of the HF team. This recent development is primarily driven by the fact that the HF patient population is growing exponentially,” Navin K. Kapur, MD, director of the interventional heart failure (IHF) training program, director of the acute circulatory support program, and associate professor of medicine in the division of interventional cardiolgy and advanced HF at Tufts Medical Center, told Cardiology Today’s Intervention. “Interventionalists used to primarily focus on patients referred to the cath lab for coronary intervention who had not yet experienced HF. Now, we are seeing that the majority of patients referred to the cath lab have some form of pre-existing HF, whether that is HF with reduced ejection fraction, HF with preserved ejection fraction or HF due to valvular heart disease.”

As a result, the interventional cardiologist’s involvement is moving beyond simply referring patients with advanced HF that have been treated with PCI or transcatheter valve repair or replacement to HF specialists and performing procedures with percutaneous circulatory support devices. It now also includes joining and forming teams with expertise from other subspecialties to comprehensively manage patients with HF; more advanced understanding of HF syndromes and the related hemodynamic issues, helping determine which technologies are best suited for which patients; and thinking about HF prevention after handling its precursors such as CHD and valvular heart disease.

Increased Cross-Collaboration

Cover image

Cover illustration © Lisa Clark

These changing dynamics to the treatment of HF create a need for comprehensive understanding about the structure and function of the heart, experts told Cardiology Today’s Intervention.

As part of that effort, the Society for Cardiovascular Angiography and Interventions and the Heart Failure Society of America have created the Interventional HF Working Group.

“HF is becoming an increasing epidemic and we are being held to a higher standard in terms of readmissions and more comprehensive care for our patients,” Srihari S. Naidu, MD, FACC, FSCAI, FAHA, chair of the Interventional HF Working Group, said in an interview. “In addition, it is becoming very clear that most of the technologies that are being used today — at least the ones that are most meaningful now — deal with HF.”

Therefore, a goal of the working group is to “re-envision everything we are doing under the guise of repairing structural anomalies of the heart into a more practical desire to improve overall heart function safely and effectively ... so that patients can go on living much more higher-quality and able lives in addition to adding quantity of life,” said Naidu, associate professor of medicine at SUNY Stony Brook School of Medicine and director of the cardiac catheterization laboratory, interventional cardiology fellowship program and hypertrophic cardiomyopathy treatment center at Winthrop University Hospital in Mineola, New York.

James B. Young, MD
James B. Young

According to James B. Young, MD, professor of medicine and executive dean, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, it is crucial for interventional cardiologists to have a “broad and deep understanding of how cath lab-based interventions can improve patients with certain types of ventricular dysfunction and HF.” Young is also chairman of the Cleveland Clinic Endocrinology and Metabolism Institute and medical director of the Kaufman Center for Heart Failure.

Young also suggested increasing awareness of how valvular heart disease relates to HF and left ventricular dysfunction, how interventions can help treat tricuspid valve disease and when temporary mechanical circulatory support devices should be employed.

PAGE BREAK

An Essential Partnership

To optimize treatment of patients with HF, interventional cardiologists are collaborating more with HF specialists, cardiac surgeons and other specialties, similar to the heart team approach pioneered in the treatment of valvular heart disease.

“In this day and age, this is not just a proposed partnership; it is an essential partnership,” Mandeep R. Mehra, MD, FRCP, FESC, FACC, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center at Brigham and Women’s Hospital, told Cardiology Today’s Intervention. “We have HF specialists who are now embedded in cath labs, we have interventionalists who are embedded in HF programs and, more importantly, we now have training portals where our fellows tend to train in aspects of interventional HF.”

The idea, according to Naidu, is to have “more of a HF team approach, where there are specialists in HF and specialists in interventional cardiology who finally speak the same language, learning it from the national organizations down, taking it to the hospitals and putting the most complicated patients into this heart team portal. The reality is, by creating these networks locally at the hospitals, the patient receives better and more comprehensive care that makes a meaningful difference in their organic substrate that has led to HF.”

On the macro level, societies such as SCAI, HFSA and the International Society for Heart and Lung Transplantation have started to increase collaboration to share knowledge and determine how teams should interact at the hospital level, experts said. “It’s a practical approach to real-world management of the complex patient whose time has come,” Naidu said.

Srihari S. Naidu

“We would ultimately like to see HF doctors look at these patients with a better understanding of what interventional cardiology could provide,” Naidu said. “That way, they know when to consult us, they know when to perform a comprehensive invasive evaluation and they know much more about the intricacies of the various interventional technologies at their disposal. Vice versa, we need to be better involved from the interventional standpoint so that when we get consulted about HF, we have a better assessment of what the clinical syndrome is and what types of solutions we can offer.”

Available Percutaneous Devices

As a step toward putting these principles into practice, a consensus statement written by representatives of SCAI, HFSA, the American College of Cardiology and the Society of Thoracic Surgeons offers recommendations for optimizing the use of percutaneous mechanical circulatory support devices (see Sidebar).

These include intra-aortic balloon pumps, left atrial–aortic assist devices, LV-to-aortic assist devices, extracorporeal membrane oxygenation (ECMO) systems and right-sided support devices.

Navin K. Kapur

Although intra-aortic balloon pumps have been around for nearly 50 years, “the data are unclear as to who would benefit most, and the hemodynamic effects on patients with advanced HF have not been studied,” Kapur said.

“A balloon pump is probably ideal for patients who need some ischemic protection but do not need substantial peripheral perfusion support,” Naidu said.

More sophisticated and powerful systems are needed for patients who have higher levels of LV dysfunction or clinical instability, recently decompensated HF or cardiogenic shock, he said.

Left atrial–aortic assist devices such as TandemHeart (CardiacAssist) are appropriate for patients who need ventricular unloading and circulatory support, Kapur said. “In our experience, this system is effective as an alternative to the LV-to-aortic systems for patients who have a LV thrombus, aortic regurgitation, a ventricular septal defect, or who require ventricular unloading as well as oxygenation,” he said. Implantation can be a challenge because a transseptal puncture using large-bore cannulas and femoral access is required.

According to Naidu, the simpler LV-to-aortic assist devices such as Impella 2.5 or CP (Abiomed) are appropriate for patients undergoing PCI who have complex anatomy and reduced LV function. Another (Percutaneous Heart Pump [PHP], St. Jude Medical) is being tested in the SHIELD 2 trial. Kapur, co-principal investigator of that trial, said “the promise of the PHP is the ability to deliver higher flow rates using a small vascular access sheath.”

PAGE BREAK

Patients with a significant decline in LV function or cardiogenic shock can benefit from a larger-capacity LV-to-aortic assist device such as Impella 5.0 (Abiomed), a left atrial–aortic assist device or an ECMO system, Naidu said.

“In general, however, we try to stay away from ECMO unless there is significant biventricular failure and/or you have poor oxygenation,” he said. Kapur further noted that VA-ECMO does not effectively unload the LV compared with other support systems such as the Impella and TandemHeart devices.

Percutaneous right-sided support devices are also growing in use, including offerings from the Tandem and Impella platforms. The growing awareness of right-sided HF has led to an increase in patients being evaluated for right-sided support devices, Kapur said.

Kapur and colleagues in September published a case report in Circulation: Heart Failure in which a patient received Impella devices for left-sided support (Impella 5.0) and right-sided support (Impella RP). “We can essentially take over complete function of the heart with two small incisions — one in the artery and one in the vein — in the cath lab,” Kapur said. “Full biventricular support will advance our ability to stabilize patients with cardiogenic shock.”

Young noted, however, that “perhaps the most challenging decision-making process is where to go after the device has been put in. These devices are short-term bridges to outcomes, which can be futility and death, enough recovery of the heart and circulatory system for the device to be weaned and removed, or bridges to a more permanent device or transplantation.” The science of myocardial recovery remains poorly understood and requires more investigation, Kapur said.

Understanding the Clinical Scenarios

Mandeep R. Mehra

It is imperative for interventional cardiologists and the HF team to understand each possible clinical scenario and clinical opportunity to best determine which patients should receive which interventional mechanical circulatory support procedures, Mehra said.

One scenario can be described as acute temporary percutaneous circulatory support. He described this scenario as patients who need “a device to serve as a temporizing bridge even as more durable decisions for device therapy can be entertained,” possibly due to cardiogenic or precardiogenic shock. Depending on patient characteristics, this may call for an intra-aortic balloon pump, a left atrial–aortic assist device such as TandemHeart, a LV-to-aortic assist device such as Impella or an ECMO device, he said.

The number of HF-related deaths declined since 2000, but increased in recent years, according to a report from the CDC’s National Center for Health Statistics.

The number of HF-related deaths declined since 2000, but increased in recent years, according to a report from the CDC’s National Center for Health Statistics.

Source: Ni H, Xu J. NCHS Data Brief. 2015;231:1-7.

Another scenario, Mehra said, is where it makes sense for interventional cardiologists and HF specialists to discuss the best options for myocardial or coronary repair in patients with or at risk for HF. “We can do high-risk PCI in some patients, we can provide treatments for hypertrophic cardiomyopathy in the cardiac cath lab, and we can reconstruct the aortic or mitral valves in those who have underlying valvular disease,” he said.

Sometimes, solutions implemented by interventional cardiologists in collaboration with HF specialists and others will be needed to reshape the LV. Mehra noted that research is being conducted in this area, from the development of a ventricular partitioning device (Parachute, CardioKinetix) to restore ventricular function to the testing of gene-therapy systems.

In addition, interventional cardiologists and HF specialists have been working together to implement intracardiac or intravascular shunts to help patients with different forms of HF, according to Mehra.

Finally, he said, interventionalists have helped HF specialists by using interventional techniques to implant biosensors to monitor pulmonary artery pressure in patients with HF (CardioMEMS HF System, CardioMEMS/St. Jude Medical).

Once those scenarios are understood, interventional cardiologists can become part of “very closely knitted heart teams within the HF group,” Mehra said. “For example, at Brigham and Women’s Hospital, we have a shock team. If a patient comes in with cardiogenic shock, an interventionalist, a HF specialist, a surgeon and a critical care specialist meet to decide the right treatment, whether that is medication, the cath lab, ECMO implantation or surgery. These decisions are made in a rapid decision tree collectively through a multidisciplinary team approach.”

PAGE BREAK

Efforts for Prevention

With consideration of the growing epidemic of HF, interventional cardiologists should also focus on what they can do to prevent HF, experts said.

“The three primary causes of HF are hypertension, ischemic heart disease/multivessel coronary disease and valvular heart disease,” Kapur said. “In each of those three buckets, interventionalists have an opportunity to prevent the onset of advanced HF.”

They can combat hypertension through renal denervation once issues with that technology are sorted out; they can perform multivessel revascularization to “allow myocardium that you might have thought was not viable to become viable by restoring blood flow,” sometimes with the assistance of a support device; and they can use transcatheter aortic and mitral valve therapies to prevent onset of end-stage HF, he said.

Interventional cardiologists have a role to play in identifying signs of HF before it gets to the advanced stage, Naidu said.

“In general, once we find HF, we find congestion — and that’s the latest stage of the disease,” he said. “We need to find a way of assessing preclinical disease, which manifests mainly as fatigue, a drop in cardiac output at rest or a failure to increase cardiac output on exertion. I would like to see our field move in the direction of teasing out when that happens, which typically will be 5 to 10 years before overt HF. Once that’s determined, then we do what we need to do to correct that underlying state to ultimately delay or avoid the progression to HF. We need to have a plan before the point of no return. It might take 5 to 10 years to figure out the science of how to catch it and intervene earlier, which means taking some upfront risk to get a longer-term benefit.” — by Erik Swain

Disclosures: Kapur reports receiving consultant/speaker’s honoraria from HeartWare and consultant/speaker’s honoraria/institutional research support from Abiomed, CardiacAssist, Maquet and Thoratec/St. Jude Medical. Mehra reports consulting for Boston Scientific and Medtronic, serving on the steering committee for trials sponsored by Janssen Pharmaceuticals and Thoratec/St. Jude Medical, and serving on the data safety monitoring board for a trial sponsored by Teva. Naidu reports consulting for Abbott Vascular, Abiomed and Maquet. Young reports no relevant financial disclosures.