THIS MONTH'S FOCUS:

MECHANICAL CIRCULATORY SUPPORT
PHARMACY & PHARMACOLOGY

(PDF VERSION)

Many thanks to Evgenij Potapov & Ed Horn for coordinating the content for this month's issue.




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VINCENT'S TWO SENSE

This issue closes out the Summer or Winter of 2016, depending on your point of view. Manreet Kanwar, Claudius Mahr and Evgenij Potapov representing Cardiology and Mechanical Circulatory Support Council along with Ed Horn and Kyle Dawson representing the Pharmacy and Pharmacology Council have compiled an insightful and practical compendium of material the ISHLT and her patients that will arguably set a new standard for the road ahead in the Links. These articles stretch the boundaries of our society and provide useful bits of information applicable to everyone. In the spotlight, we are reminded of the importance of hoping for the best and preparing for the best from the outstanding article by Jill Steiner, Jennifer Beckman, Stephanie Cooper, Jason Smith, James Kirkpatrick and Claudius Mahr. This exemplary team of specialists emphasize the imperative of caring for patients requiring mechanical circulatory support who have been simultaneously nearing the brink of death. The early involvement of a palliative care specialist is the "moral imperative" message - these two carefully chosen words were drawn from the 1985 comedic flick Real Genius starring Val Kilmer. Other summaries from the Mechanical Circulatory Support Council include: Wheels of Fortune or Walking Dead? by Felix Schonrath and Evgenij Potapov, The Challenges and Early Successes of an MCS Program at The Fortis Memorial Research Institute (Gurgaon, India) by Sandeep Attawar and The Art of Decision Making in Patient Selection for Durable MCS: Goldilocks by Manreet Kanwar. Next from the Pharmacy and Pharmacology Council, we have Laura Lourenco Jenkins and Lisa Potter with Navigating the Quagmire of Immunosuppressant Drug Coverage and Affordability in the United States, Jennifer Day with Meds For My Pump: Common Medication Insurance Encounters in MCS, and Teshia Sorensen, John Ryan and Erin Michaelis with Insurance Considerations for Initiating Parenteral or Inhaled Prostacyclins in the Hospital for Pulmonary Arterial Hypertension. In addition, the PHARM Council further educates us on the Clinical Considerations for the Use of GLP-1 Agonists Post Lung Transplantation by Robin Klasek and Kyle Dawson, and Eight Years Later: How Comfortable Are We Really With Target Specific Oral Anticoagulants (TSOACs) After Cardiothoracic Transplant by Derek Owen and Kyle Dawson. Also, the ISHLT announces that Monograph Volume 9 is now available as an eBook. As Special Interest pieces, we have Stefania Paolillo's Change Your Mind, Think Differently, a report from an ISHLT International Traveling Scholarship Award Winner, and another poem by Maryanne Chrisant. Finally, you have been spared of Vincent Valentine's rants and raves usually thrown in the Editor's Corner. The Valentine Family is in the final stages of "the move" from League City, TX to Birmingham, AL in order to be part of an outstanding Lung Transplantation Team at the University of Alabama at Birmingham.

Vincent Valentine, MD
Links Editor-in-Chief



IN THE SPOTLIGHT:


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Hope for the Best, Plan for the Worst: Integrating Palliative Care in Mechanical Circulatory Support

Jill Steiner, MD
Jennifer Beckman, ARNP
Stephanie Cooper, MD
Jason W. Smith, MD
James N. Kirkpatrick, MD
Claudius Mahr, DO

Many patients who have received ventricular assist devices (VAD) will die with their devices. This difficult reality continues to cause distress for patients, families, and care teams. Over a third of patients with destination therapy (DT) VADs will die within three years [1]. To complicate matters further, according to INTERMACS data, 40% of patients cross over between bridge-to-transplant (BTT) and DT strategies. Despite clear improvements in longevity, patients with VADs remain severely, often tenuously, ill and may die unexpectedly, not infrequently as a complication of VAD support. As many as 70% of patients with VADs experience complications ranging from infection and bleeding to device malfunction and stroke [2]. Quality of life is still markedly better than without these devices, [3] but this speaks mostly to the challenges of living with end stage heart failure. As the risks of VAD therapy may not truly be appreciated until they become catastrophic realities, patients and family members may feel ill-prepared to confront the realities of life "on pump." [4] Read more →



FOCUSING ON MECHANICAL CIRCULATORY SUPPORT:



Wheels of Fortune or Walking Dead?

Felix Schönrath, MD
Evgenij V. Potapov, MD, PhD

Is sacubitril valsartan the future of heart failure medicine or simply futile medicine in end-stage heart failure patients? Since the PARADIGM HF study in 2014 showed remarkable improvements in outcome of heart failure patients with sacubitril valsartan, an angiotensin receptor neprylisin inhibitor (ARNI), this combined drug therapy has been at the center stage of heart failure medicine. Therefore, heart failure guidelines from both the US and from Europe launched in 2016 recommend this drug combination for the treatment of symptomatic heart failure patients. Many promises and desires were associated with the first new heart failure drug therapy for fifteen years. But is it really possible to improve outcome in such a way that other end-stage heart failure treatment strategies will step back and be useless in comparison? Read more →



The Challenges and Early Successes of an MCS Program at The Fortis Memorial Research Institute (Gurgaon, India)

Sandeep Attawar, MD

links imageI was a late adopter of mechanical assist devices as far as heart failure or thoracic organ transplantation was concerned. Given the available modalities of practicing cardiac surgery in India, I have felt a longstanding, personal frustration at the inability to support failing hearts, both post-cardiotomy and following acute heart failure. I do not believe I am alone as this has been a source of contention for my contemporaries across India. The origin of this issue may stem from out-of-pocket payor system. Our nation's private healthcare infrastructure presents patients with a host of obstacles, most notably that patients must pay (mostly) upfront money for all major surgeries and hospitalizations. Private medical expenses are a source of financial ruin to individuals in middle- and lower-income groups, especially given the patchy coverage and inconsistent quality of the nationalized health service. Read more →



The Art of Decision Making in Patient Selection for Durable MCS: Goldilocks

Manreet Kanwar, MD

links imageWith an ever increasing use of durable LVADs in end stage heart failure, the need for appropriate patient selection has never been more critical. The determination of who is an 'ideal' candidate remains challenging, given the complexity and multi-dimensional nature of this disease. There are various factors that go into this determination - those related to the disease and its impact on various aspects of the patient's health, their nutritional, financial and psycho-social status, input from caregivers and ability of their health care team to assess and prioritize these issues. As a result, heart failure physicians are constantly debating the need and timing for durable VADs - with both a VAD done 'too soon' or 'too late' in the course of disease presenting their unique downfalls. Read more →




FOCUSING ON PHARMACY & PHARMACOLOGY:



Navigating the Quagmire of Immunosuppressant Drug Coverage and Affordability in the United States

Laura Lourenço Jenkins, PharmD, BCPS
Lisa Potter, PharmD, BCPS, FAST, FCCP

The Quagmire
Immunosuppressive medications are essential for the prevention of organ transplant rejection. Transplant recipients occasionally encounter barriers in obtaining appropriate insurance coverage. Additionally, even with appropriate insurance that includes coverage for medications, high or unaffordable copays can prevent patients from obtaining their lifesaving medications. Initial concerns were addressed in 1985 by the Task Force on Organ Transplantation following the approval of cyclosporine in 1983 [1,2]. Subsequently, between 1986 and 2000, changes were made in Medicare coverage and reimbursement policies to enhance access to these life-sustaining therapies [3-8]. Those changes led to immunosuppressive coverage under the Medicare Part B benefit. In 2006, Medicare expanded coverage to include prescription drugs through the Medicare Part D program. Despite these changes in legislation, and regardless of whether a patient carries Medicare or some other type of insurance, many patients remain unable to afford their immunosuppressive medications. Missing these medications can lead to premature and avoidable graft loss [1,2,6,7,9-12]. Read more →



Meds For My Pump: Common Medication Insurance Encounters in MCS

Jennifer Day, PharmD

links imageAs insurance companies continue to increase the regulation of health plan formularies, in an attempt to control costs, the use of any 'off-label' medication therapies is under scrutiny like never before. As practitioners who care for such a unique patient population, we frequently encounter the use of newly approved or investigational devices. We are familiar with the medical management of complex patients with countless co-morbidities. Not unexpectedly then, we sometimes find it beneficial to use even "old" drugs in new ways or for indications not yet approved by the FDA. I'll highlight a couple of my favorites from experience in our VAD clinic. Dipyridamole initially received approval by the FDA in 1961 for use in the treatment of angina and later in 1986 as an anti-platelet agent [1]. Although it had largely fallen out of fashion, dipyridamole has found resurgence as part of the anticoagulation regimen recommended for patients implanted with many of the current left ventricular assist devices (LVADs). Read more →



Insurance Considerations for Initiating Parenteral or Inhaled Prostacyclins in the Hospital for Pulmonary Arterial Hypertension

Teshia Sorensen, PharmD, BCPS
John J. Ryan, MD, FACC, FAHA
Erin Michaelis, APRN

Current pulmonary arterial hypertension (PAH) guidelines recommend parenteral prostacyclins (e.g., epoprostenol, treprostinil) and inhaled prostacyclins (e.g., iloprost, treprostinil) for patients with WHO Group 1 PAH and Functional Class III or IV symptoms. Initiating prostacyclins in an acutely decompensated patient in the hospital requires a substantial amount of effort and coordination from the Pulmonary Hypertension team and pharmacy team to ensure therapy can be continued at home following hospital discharge. Developing an institutional process for initiating prostacyclins can help ensure that a safe and timely discharge is not delayed due to issues with insurance approval for continued outpatient use. Potential obstacles include obtaining insurance approval through prior authorization processes, applying for patient assistance programs for individuals with limited resources, and scheduling comprehensive education and delivery of outpatient medication, equipment, and supplies prior to discharge through the specialty pharmacy. This article will describe some experience with these challenges as well as methods that can be developed to reduce the burden on the Pulmonary Hypertension team, and ultimately, the patient. Read more →



Clinical Considerations for the Use of GLP-1 Agonists Post Lung Transplantation

Robin Klasek, PharmD
Kyle Dawson, PharmD, MBA, BCPS

Hyperglycemia post transplantation is a relatively common complication, either due to pre-existing diabetes or new-onset diabetes after transplant (NODAT). The estimated rates of NODAT 12 months post-transplant are 28-30% in heart transplant and 6-45% for lung transplants [1-3]. This article aims to discuss pharmacotherapy considerations for a newer class of incretin mimetics, the glucagon-like peptide-1 (GLP-1) agonists, used in the management of hyperglycemia in thoracic transplant patients with focus on risk vs. benefit in lung transplant recipients. Exposure to immunosuppressive agents, such as glucocorticoids and calcineurin inhibitors, in combination with other risk factors including older age, obesity (BMI>30), and frequent acute rejection episodes requiring treatment with high-dose steroids further increase the risk of NODAT. NODAT is associated with an increased risk of rejection, infections, and cardiovascular complications [4]. Many patients will require pharmacotherapy to manage hyperglycemia post transplantation, and this often includes insulin. Read more →



Eight Years Later: How Comfortable Are We Really With Target Specific Oral Anticoagulants (TSOACs) After Cardiothoracic Transplant

Derek Owen, PharmD
Kyle Dawson, PharmD, MBA, BCPS

Following dabigatran's approval by the European Medicines Agency in 2008 and by the US Food and Drug Administration in 2010, TSOACs are being prescribed with increasing frequency in the general population to reduce the risk of stroke in patients with atrial fibrillation and to treat venous thromboembolism (VTE) [1]. Three other TSOACs have since been approved including rivaroxaban, apixaban, and edoxaban. Without listing all of the potential benefits of these medications, the ease of use around biopsies and procedures due to their rapid onset/elimination may be appealing for clinicians. While these newer agents are now recommended ahead of warfarin for the treatment of VTE in the general population, comfort with their use in solid organ transplant patients is still growing amongst clinicians [2]. There are many reasons for a potential lack of comfort in using these agents in the transplant population. First and foremost, therapeutic drug monitoring recommendations are not available for the TSOACs. While laboratory monitoring tests do exist, there are not universally accepted therapeutic ranges for these assays. Read more →




ISHLT NEWS AND ANNOUNCEMENTS:



Monograph Volume 9 eBook is Now Available

links imageMonograph Volume 9: Pulmonary Hypertension and Right Heart Failure is now available as an eBook for purchase through iBook, Amazon, Barnes & Noble, and many other eBook retailers. This monograph offers a comprehensive, contemporary state of the art review of key aspects in the recognition, investigation and management of pulmonary hypertension which has attracted considerable interest throughout the world in recent years. Written by an invited global faculty of contributors, it focuses on important areas of debate within the field and reflects the unique expertise of the International Society for Heart and Lung Transplantation comprising views from Cardiology, Respiratory Medicine, Basic Science and Surgery. The monograph is directed towards all health care professionals with an interest in pulmonary hypertension and seeks to provide a critical commentary on the various subgroups of conditions that lead to pulmonary hypertension together with an evidence based approach to investigation and management. The formatting of the monograph is aimed to provide a logical pathway through this fascinating subject and we trust will facilitate its recognition as a valuable source of reference.



Annual Southeast Pediatric Cardiovascular Society Conference

Please join us for the 49th Annual Southeast Pediatric Cardiovascular Society Conference, sponsored by Joe DiMaggio Children's Hospital and held in Fort Lauderdale, FL on September 15 through 17th. The 49th Annual SEPCS Conference will provide an overview of current practice in the diagnosis and treatment of congenital and acquired heart disease in children and young adults. Discussions will include interactive sessions with both individual speakers and panels. The conference will offer learning opportunities for the entire spectrum of healthcare providers caring for children with acquired and congenital heart diseases. The themes for the meeting are: The Right Ventricle, and The Science of Innovation. Guest Faculty include William Norwood, Ed Bove, Andrew Redington, Beth Kaufman and Gil Wernovsky. Program and registration are available via the following link: www.jdch.com/sepcs




SPECIAL INTEREST:



Change Your Mind, Think Differently

Stefania Paolillo, MD, PhD

Change your mind, start thinking differently. This the main message instilled in me during my ISHLT International Traveling Scholarship at Brigham and Women's Hospital (BWH) and Harvard Medical School in Boston, USA. After I completed my Postgraduate Course in Heart Failure and acquired my Certificate in Advanced Studies from the University of Zurich in 2015, I applied for the ISHLT award to further enhance my skills in the management of advanced heart failure (HF) and develop a more comprehensive worldwide view. Two short weeks of a visiting fellowship at the Center for Advanced Heart Disease at BWH with Dr. Mandeep R. Mehra and his outstanding colleagues has been nothing short of an indelible and unique clinical experience. Read more →



The Weight of Angels

Maryanne Chrisant, MD

I walk through the hospital halls
weeping at the dying rows
of hot house children. I call
their names- "Jenny, Sam..." The list grows
each day. In small words I explain
how the body can't undo the damage
that the illness has done. I watch the pain
become mouth lines, eye lines. This age Read more →





Contact

Vincent G Valentine, MD
Editor-in-Chief
vvalentine@uabmc.edu


Editorial Staff


"Good decisions come from experience, and experience comes from bad decisions."
— Anonymous

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Disclaimer: Any opinion, conclusion or recommendation published by the Links is the sole expression of the writer(s) and does not necessarily reflect the views of the ISHLT.