Mechanical circulatory support guidelines issued

The International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.

"Traditionally, management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment," said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.

Massachusetts General Hospital

"We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham, said in an interview.

"These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD (ventricular assist device), and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and a cochair of the guidelines committee.

The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients."

But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.

The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-187).

The fourth of the five task forces addressed inpatient management of patients with MCSDs and was cochaired by Dr. Pamboukian and Dr. Stephanie A. Moore. Select recommendations may be of interest to hospitalists.

According to this task force, a multidisciplinary team led cooperatively by cardiac surgeons and cardiologists and composed of subspecialists (palliative care, psychiatry, and others as needed), MCS coordinators, and other ancillary specialties (social worker, psychologist, pharmacist, dietitian, physical therapist, occupational therapist, and rehabilitation services) is indicated for the in-hospital management of MCS patients.

For patients who develop right heart dysfunction in the non-ICU postoperative period, the task force said, inotropic support may need to be continued beyond 2 weeks if there is elevated jugular venous pressure, signs of venous congestion, decreased VAD flows (or low pulsatility in continuous flow MCSD), or end-organ dysfunction. Once euvolemic, inotropes should be weaned cautiously, with ongoing examination for recurrent signs and symptoms of RV dysfunction.

Diuretics and renal replacement therapy, such as continuous venovenous hemofiltration, should be used early and continued as needed to maintain optimal volume status.

Cardiac glycosides may be used to support RV function. For patients with persistent pulmonary hypertension who exhibit signs of RV dysfunction, pulmonary hypertension-specific therapies, such as phosphodiesterase-5 inhibitors, should be considered.

Recommendations for neurohormonal blockade and the treatment of hypertension post-MCS implant include pharmacotherapy with heart failure medications for blood pressure management.

Echocardiography is an integral part of determining the revolutions per minute of continuous-flow pumps. Common goals include adequate LV unloading while maintaining the LV septum in the midline and minimizing mitral regurgitation. Postoperatively, the revolutions per minute of continuous-flow pumps should be set low enough to allow for intermittent aortic valve opening which may reduce the risk of aortic valve fusion and the risk of late aortic valve insufficiency.

Anticoagulation and antiplatelet therapy initiated post operatively in the ICU setting should be continued with the aim of achieving device-specific recommended INR for warfarin and desired antiplatelet effects, according to the task force.

Bleeding in the early postoperative period during the index hospitalization should be urgently evaluated with lowering, discontinuation, and/or reversal of anticoagulation and antiplatelet medications.

To reduce risk for infection after MCS placement, the driveline should be stabilized immediately after the device is placed and throughout the duration of support. A dressing change protocol should be immediately initiated post operatively. Secondary antibiotic prophylaxis for prevention of endocarditis has not been studied in the MCS population but would be considered reasonable due to the risk of bacteremia in this group.

Recommendations for optimal nutritional status include consultation with nutritional services at the time of implantation with ongoing follow-up post operatively to ensure nutrition goals are being met. For those unable to meet nutritional goals orally, feeding should be started early and preferably through an enteral feeding tube. Parenteral nutrition should only be started if enteral nutrition is not possible and under the guidance of nutritional consultation.

Prealbumin and C-reactive protein levels can be monitored weekly to track the nutritional status of the postoperative patient. As nutrition improves, prealbumin should rise and C-reactive protein should decrease.

Patient and caregiver education should be initiated shortly after surgery and reinforced by the nursing staff. Educational strategies should use written, verbal, and practical methods.

MCS parameters should be written in the medical record at regular intervals with established criteria for parameters that require physician notification.

The patient and family members should be taught to track their device parameters and alert staff when changes are observed. Changes in parameters outside of normal ranges should be thoroughly evaluated and treated appropriately.

Routine support should be available from social workers, psychologists, or psychiatrists as patients and families adjust to life changes after MCS. Routine surveillance for psychiatric symptoms should be performed. If symptoms develop, consultation with specialists (including social work, psychology, and/or psychiatry) for diagnosis, treatment, and follow-up is recommended.

Assessment of specific problems that are related to domains of health-related quality of life (depression, anxiety, or pain) based on symptoms should help guide an action plan for these patients.

Successful discharge should include patient, caregiver and community provider education with written discharge instructions and preemptive home preparation regarding the safe management of the device and the MCS patient.

Recommendations for management of anticoagulation and antiplatelet therapy for patients who present with gastrointestinal bleeding include holding back anticoagulation and antiplatelet therapy in the setting of clinically significant bleeding and reversing anticoagulation in the setting of an elevated INR and clinically significant bleeding.

Anticoagulation and antiplatelet therapy should continue to be held until clinically significant bleeding resolves in the absence of evidence of pump dysfunction. The patient, device parameters, and the pump housing (if applicable) should be carefully monitored while anticoagulation and antiplatelet therapy is being withheld or the dose reduced.

Patients who present with a first episode of gastrointestinal bleeding should be managed in consultation with gastroenterology. Patients should at least have a colonoscopy and/or upper endoscopic evaluation. If the results are negative, evaluation of the small bowel, particularly in those with continuous-flow devices, should be considered.

In patients with persistent bleeding and a negative endoscopic evaluation, a tagged red blood scan or angiography should be considered.

Once the gastrointestinal bleeding has resolved, anticoagulation and antiplatelet therapy can be reintroduced with careful monitoring.

For patients with recurrent episodes of gastrointestinal bleeding, repeated endoscopic evaluation should take place in conjunction with gastroenterology consultation. When no source of bleeding can be detected or the source is not amenable to therapy, the type and intensity or even the use of antiplatelet therapy should be reevaluated in the context of the bleeding severity and pump type. Further, the goal INR or even the continued use of warfarin should be reevaluated in the context of the bleeding severity and pump type.

The patient and device parameters should be carefully monitored when anticoagulation and antiplatelet therapy have been reduced or discontinued because of recurrent gastrointestinal bleeding.

Reducing the pump speed for continuous-flow pumps in the setting of recurrent gastrointestinal bleeding due to arteriovenous malformations may be considered.

When patients present with a new neurologic deficit, assess the current INR and review the recent INR. Prompt consultation with neurology is recommended, as is CT and angiography of the head and neck.

Review the pump parameters for signs of device thrombosis or malfunction, and inspect the pump housing for clots in extracorporeal pumps. Discontinuation or reversal of anticoagulation in the setting of hemorrhagic stroke is recommended.

Assessing for the source of the thrombus should be considered in embolic stroke patients. Selective use of an interventional radiologic approach to thrombotic strokes or selective use of thrombolytic agents in the setting of thrombotic stroke without CT scan evidence of hemorrhage may be considered.

Chronic management of patients after presentation with a new neurologic deficit may include formal stroke rehabilitation in consultation with neurology, close monitoring of anticoagulation in the setting of an embolic event to ensure adequate levels of anticoagulation, long-term control of blood pressure, administration of the National Institutes of Health (NIH) stroke scale at 30 and 60 days, and resumption of anticoagulation in consultation with neurology or neurosurgery in the setting of hemorrhagic stroke.

Recommendations for assessment of neurocognitive deficits include routine neurocognitive assessment at 3, 6, 12, and 18 months after implant.

Recommendations for evaluation of MCS patients with a suspected infection include a complete blood count, chest radiographic imaging, and blood cultures.

At least three sets of blood cultures over 24 hours should be drawn, with at least one culture from any indwelling central venous catheters.

For those with a suspected cannula or driveline infection, obtaining a sample for Gram stain, KOH, and routine bacterial and fungal cultures is recommended.

When clinically indicated, aspirate from other potential sources, as dictated by presenting symptoms and examination.

Directed radiographic studies based on presenting symptoms and examination are recommended.

MCS patients with incessant ventricular arrhythmias require prompt admission for further management because hemodynamic compromise may occur. Patients with ongoing VT refractory to medical therapy may require catheter ablation, which should be performed by an electrophysiologist with expertise in treating patients with MCS.

When an MCS patient is undergoing a noncardiac procedure, the MCS and surgical teams need to collaborate. For nonemergency procedures, warfarin and antiplatelet therapy may be continued if the risk of bleeding associated with the procedure is low. If therapy needs to be stopped, warfarin and antiplatelet therapy should be held for an appropriate period of time as determined by the type of procedure being undertaken and risk of bleeding. Bridging with heparin or a heparin alternative while a patient is off warfarin may be considered.

For emergency procedures, warfarin may need to be rapidly reversed with fresh frozen plasma or prothrombin protein concentrate. Vitamin K can be administered with caution, but has slower onset of action. Post procedure, warfarin and antiplatelet therapy may be resumed when risk of surgical bleeding is deemed acceptable. Patients may be bridged with heparin or a heparin alternative while waiting for the INR to reach the target range.

Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.

"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.

Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.

The International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.

"Traditionally, management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment," said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.

Massachusetts General Hospital

"We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham, said in an interview.

"These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD (ventricular assist device), and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and a cochair of the guidelines committee.

The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients."

But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.

The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-187).

The fourth of the five task forces addressed inpatient management of patients with MCSDs and was cochaired by Dr. Pamboukian and Dr. Stephanie A. Moore. Select recommendations may be of interest to hospitalists.

According to this task force, a multidisciplinary team led cooperatively by cardiac surgeons and cardiologists and composed of subspecialists (palliative care, psychiatry, and others as needed), MCS coordinators, and other ancillary specialties (social worker, psychologist, pharmacist, dietitian, physical therapist, occupational therapist, and rehabilitation services) is indicated for the in-hospital management of MCS patients.

For patients who develop right heart dysfunction in the non-ICU postoperative period, the task force said, inotropic support may need to be continued beyond 2 weeks if there is elevated jugular venous pressure, signs of venous congestion, decreased VAD flows (or low pulsatility in continuous flow MCSD), or end-organ dysfunction. Once euvolemic, inotropes should be weaned cautiously, with ongoing examination for recurrent signs and symptoms of RV dysfunction.

Diuretics and renal replacement therapy, such as continuous venovenous hemofiltration, should be used early and continued as needed to maintain optimal volume status.

Cardiac glycosides may be used to support RV function. For patients with persistent pulmonary hypertension who exhibit signs of RV dysfunction, pulmonary hypertension-specific therapies, such as phosphodiesterase-5 inhibitors, should be considered.

Recommendations for neurohormonal blockade and the treatment of hypertension post-MCS implant include pharmacotherapy with heart failure medications for blood pressure management.

Echocardiography is an integral part of determining the revolutions per minute of continuous-flow pumps. Common goals include adequate LV unloading while maintaining the LV septum in the midline and minimizing mitral regurgitation. Postoperatively, the revolutions per minute of continuous-flow pumps should be set low enough to allow for intermittent aortic valve opening which may reduce the risk of aortic valve fusion and the risk of late aortic valve insufficiency.

Anticoagulation and antiplatelet therapy initiated post operatively in the ICU setting should be continued with the aim of achieving device-specific recommended INR for warfarin and desired antiplatelet effects, according to the task force.

Bleeding in the early postoperative period during the index hospitalization should be urgently evaluated with lowering, discontinuation, and/or reversal of anticoagulation and antiplatelet medications.

To reduce risk for infection after MCS placement, the driveline should be stabilized immediately after the device is placed and throughout the duration of support. A dressing change protocol should be immediately initiated post operatively. Secondary antibiotic prophylaxis for prevention of endocarditis has not been studied in the MCS population but would be considered reasonable due to the risk of bacteremia in this group.

Recommendations for optimal nutritional status include consultation with nutritional services at the time of implantation with ongoing follow-up post operatively to ensure nutrition goals are being met. For those unable to meet nutritional goals orally, feeding should be started early and preferably through an enteral feeding tube. Parenteral nutrition should only be started if enteral nutrition is not possible and under the guidance of nutritional consultation.

Prealbumin and C-reactive protein levels can be monitored weekly to track the nutritional status of the postoperative patient. As nutrition improves, prealbumin should rise and C-reactive protein should decrease.

Patient and caregiver education should be initiated shortly after surgery and reinforced by the nursing staff. Educational strategies should use written, verbal, and practical methods.

MCS parameters should be written in the medical record at regular intervals with established criteria for parameters that require physician notification.

The patient and family members should be taught to track their device parameters and alert staff when changes are observed. Changes in parameters outside of normal ranges should be thoroughly evaluated and treated appropriately.

Routine support should be available from social workers, psychologists, or psychiatrists as patients and families adjust to life changes after MCS. Routine surveillance for psychiatric symptoms should be performed. If symptoms develop, consultation with specialists (including social work, psychology, and/or psychiatry) for diagnosis, treatment, and follow-up is recommended.

Assessment of specific problems that are related to domains of health-related quality of life (depression, anxiety, or pain) based on symptoms should help guide an action plan for these patients.

Successful discharge should include patient, caregiver and community provider education with written discharge instructions and preemptive home preparation regarding the safe management of the device and the MCS patient.

Recommendations for management of anticoagulation and antiplatelet therapy for patients who present with gastrointestinal bleeding include holding back anticoagulation and antiplatelet therapy in the setting of clinically significant bleeding and reversing anticoagulation in the setting of an elevated INR and clinically significant bleeding.

Anticoagulation and antiplatelet therapy should continue to be held until clinically significant bleeding resolves in the absence of evidence of pump dysfunction. The patient, device parameters, and the pump housing (if applicable) should be carefully monitored while anticoagulation and antiplatelet therapy is being withheld or the dose reduced.

Patients who present with a first episode of gastrointestinal bleeding should be managed in consultation with gastroenterology. Patients should at least have a colonoscopy and/or upper endoscopic evaluation. If the results are negative, evaluation of the small bowel, particularly in those with continuous-flow devices, should be considered.

In patients with persistent bleeding and a negative endoscopic evaluation, a tagged red blood scan or angiography should be considered.

Once the gastrointestinal bleeding has resolved, anticoagulation and antiplatelet therapy can be reintroduced with careful monitoring.

For patients with recurrent episodes of gastrointestinal bleeding, repeated endoscopic evaluation should take place in conjunction with gastroenterology consultation. When no source of bleeding can be detected or the source is not amenable to therapy, the type and intensity or even the use of antiplatelet therapy should be reevaluated in the context of the bleeding severity and pump type. Further, the goal INR or even the continued use of warfarin should be reevaluated in the context of the bleeding severity and pump type.

The patient and device parameters should be carefully monitored when anticoagulation and antiplatelet therapy have been reduced or discontinued because of recurrent gastrointestinal bleeding.

Reducing the pump speed for continuous-flow pumps in the setting of recurrent gastrointestinal bleeding due to arteriovenous malformations may be considered.

When patients present with a new neurologic deficit, assess the current INR and review the recent INR. Prompt consultation with neurology is recommended, as is CT and angiography of the head and neck.

Review the pump parameters for signs of device thrombosis or malfunction, and inspect the pump housing for clots in extracorporeal pumps. Discontinuation or reversal of anticoagulation in the setting of hemorrhagic stroke is recommended.

Assessing for the source of the thrombus should be considered in embolic stroke patients. Selective use of an interventional radiologic approach to thrombotic strokes or selective use of thrombolytic agents in the setting of thrombotic stroke without CT scan evidence of hemorrhage may be considered.

Chronic management of patients after presentation with a new neurologic deficit may include formal stroke rehabilitation in consultation with neurology, close monitoring of anticoagulation in the setting of an embolic event to ensure adequate levels of anticoagulation, long-term control of blood pressure, administration of the National Institutes of Health (NIH) stroke scale at 30 and 60 days, and resumption of anticoagulation in consultation with neurology or neurosurgery in the setting of hemorrhagic stroke.

Recommendations for assessment of neurocognitive deficits include routine neurocognitive assessment at 3, 6, 12, and 18 months after implant.

Recommendations for evaluation of MCS patients with a suspected infection include a complete blood count, chest radiographic imaging, and blood cultures.

At least three sets of blood cultures over 24 hours should be drawn, with at least one culture from any indwelling central venous catheters.

For those with a suspected cannula or driveline infection, obtaining a sample for Gram stain, KOH, and routine bacterial and fungal cultures is recommended.

When clinically indicated, aspirate from other potential sources, as dictated by presenting symptoms and examination.

Directed radiographic studies based on presenting symptoms and examination are recommended.

MCS patients with incessant ventricular arrhythmias require prompt admission for further management because hemodynamic compromise may occur. Patients with ongoing VT refractory to medical therapy may require catheter ablation, which should be performed by an electrophysiologist with expertise in treating patients with MCS.

When an MCS patient is undergoing a noncardiac procedure, the MCS and surgical teams need to collaborate. For nonemergency procedures, warfarin and antiplatelet therapy may be continued if the risk of bleeding associated with the procedure is low. If therapy needs to be stopped, warfarin and antiplatelet therapy should be held for an appropriate period of time as determined by the type of procedure being undertaken and risk of bleeding. Bridging with heparin or a heparin alternative while a patient is off warfarin may be considered.

For emergency procedures, warfarin may need to be rapidly reversed with fresh frozen plasma or prothrombin protein concentrate. Vitamin K can be administered with caution, but has slower onset of action. Post procedure, warfarin and antiplatelet therapy may be resumed when risk of surgical bleeding is deemed acceptable. Patients may be bridged with heparin or a heparin alternative while waiting for the INR to reach the target range.

Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.

"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.

Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.

The International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.

"Traditionally, management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment," said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.

Massachusetts General Hospital

"We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham, said in an interview.

"These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD (ventricular assist device), and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and a cochair of the guidelines committee.

The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients."

But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.

The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-187).

The fourth of the five task forces addressed inpatient management of patients with MCSDs and was cochaired by Dr. Pamboukian and Dr. Stephanie A. Moore. Select recommendations may be of interest to hospitalists.

According to this task force, a multidisciplinary team led cooperatively by cardiac surgeons and cardiologists and composed of subspecialists (palliative care, psychiatry, and others as needed), MCS coordinators, and other ancillary specialties (social worker, psychologist, pharmacist, dietitian, physical therapist, occupational therapist, and rehabilitation services) is indicated for the in-hospital management of MCS patients.

For patients who develop right heart dysfunction in the non-ICU postoperative period, the task force said, inotropic support may need to be continued beyond 2 weeks if there is elevated jugular venous pressure, signs of venous congestion, decreased VAD flows (or low pulsatility in continuous flow MCSD), or end-organ dysfunction. Once euvolemic, inotropes should be weaned cautiously, with ongoing examination for recurrent signs and symptoms of RV dysfunction.

Diuretics and renal replacement therapy, such as continuous venovenous hemofiltration, should be used early and continued as needed to maintain optimal volume status.

Cardiac glycosides may be used to support RV function. For patients with persistent pulmonary hypertension who exhibit signs of RV dysfunction, pulmonary hypertension-specific therapies, such as phosphodiesterase-5 inhibitors, should be considered.

Recommendations for neurohormonal blockade and the treatment of hypertension post-MCS implant include pharmacotherapy with heart failure medications for blood pressure management.

Echocardiography is an integral part of determining the revolutions per minute of continuous-flow pumps. Common goals include adequate LV unloading while maintaining the LV septum in the midline and minimizing mitral regurgitation. Postoperatively, the revolutions per minute of continuous-flow pumps should be set low enough to allow for intermittent aortic valve opening which may reduce the risk of aortic valve fusion and the risk of late aortic valve insufficiency.

Anticoagulation and antiplatelet therapy initiated post operatively in the ICU setting should be continued with the aim of achieving device-specific recommended INR for warfarin and desired antiplatelet effects, according to the task force.

Bleeding in the early postoperative period during the index hospitalization should be urgently evaluated with lowering, discontinuation, and/or reversal of anticoagulation and antiplatelet medications.

To reduce risk for infection after MCS placement, the driveline should be stabilized immediately after the device is placed and throughout the duration of support. A dressing change protocol should be immediately initiated post operatively. Secondary antibiotic prophylaxis for prevention of endocarditis has not been studied in the MCS population but would be considered reasonable due to the risk of bacteremia in this group.

Recommendations for optimal nutritional status include consultation with nutritional services at the time of implantation with ongoing follow-up post operatively to ensure nutrition goals are being met. For those unable to meet nutritional goals orally, feeding should be started early and preferably through an enteral feeding tube. Parenteral nutrition should only be started if enteral nutrition is not possible and under the guidance of nutritional consultation.

Prealbumin and C-reactive protein levels can be monitored weekly to track the nutritional status of the postoperative patient. As nutrition improves, prealbumin should rise and C-reactive protein should decrease.

Patient and caregiver education should be initiated shortly after surgery and reinforced by the nursing staff. Educational strategies should use written, verbal, and practical methods.

MCS parameters should be written in the medical record at regular intervals with established criteria for parameters that require physician notification.

The patient and family members should be taught to track their device parameters and alert staff when changes are observed. Changes in parameters outside of normal ranges should be thoroughly evaluated and treated appropriately.

Routine support should be available from social workers, psychologists, or psychiatrists as patients and families adjust to life changes after MCS. Routine surveillance for psychiatric symptoms should be performed. If symptoms develop, consultation with specialists (including social work, psychology, and/or psychiatry) for diagnosis, treatment, and follow-up is recommended.

Assessment of specific problems that are related to domains of health-related quality of life (depression, anxiety, or pain) based on symptoms should help guide an action plan for these patients.

Successful discharge should include patient, caregiver and community provider education with written discharge instructions and preemptive home preparation regarding the safe management of the device and the MCS patient.

Recommendations for management of anticoagulation and antiplatelet therapy for patients who present with gastrointestinal bleeding include holding back anticoagulation and antiplatelet therapy in the setting of clinically significant bleeding and reversing anticoagulation in the setting of an elevated INR and clinically significant bleeding.

Anticoagulation and antiplatelet therapy should continue to be held until clinically significant bleeding resolves in the absence of evidence of pump dysfunction. The patient, device parameters, and the pump housing (if applicable) should be carefully monitored while anticoagulation and antiplatelet therapy is being withheld or the dose reduced.

Patients who present with a first episode of gastrointestinal bleeding should be managed in consultation with gastroenterology. Patients should at least have a colonoscopy and/or upper endoscopic evaluation. If the results are negative, evaluation of the small bowel, particularly in those with continuous-flow devices, should be considered.

In patients with persistent bleeding and a negative endoscopic evaluation, a tagged red blood scan or angiography should be considered.

Once the gastrointestinal bleeding has resolved, anticoagulation and antiplatelet therapy can be reintroduced with careful monitoring.

For patients with recurrent episodes of gastrointestinal bleeding, repeated endoscopic evaluation should take place in conjunction with gastroenterology consultation. When no source of bleeding can be detected or the source is not amenable to therapy, the type and intensity or even the use of antiplatelet therapy should be reevaluated in the context of the bleeding severity and pump type. Further, the goal INR or even the continued use of warfarin should be reevaluated in the context of the bleeding severity and pump type.

The patient and device parameters should be carefully monitored when anticoagulation and antiplatelet therapy have been reduced or discontinued because of recurrent gastrointestinal bleeding.

Reducing the pump speed for continuous-flow pumps in the setting of recurrent gastrointestinal bleeding due to arteriovenous malformations may be considered.

When patients present with a new neurologic deficit, assess the current INR and review the recent INR. Prompt consultation with neurology is recommended, as is CT and angiography of the head and neck.

Review the pump parameters for signs of device thrombosis or malfunction, and inspect the pump housing for clots in extracorporeal pumps. Discontinuation or reversal of anticoagulation in the setting of hemorrhagic stroke is recommended.

Assessing for the source of the thrombus should be considered in embolic stroke patients. Selective use of an interventional radiologic approach to thrombotic strokes or selective use of thrombolytic agents in the setting of thrombotic stroke without CT scan evidence of hemorrhage may be considered.

Chronic management of patients after presentation with a new neurologic deficit may include formal stroke rehabilitation in consultation with neurology, close monitoring of anticoagulation in the setting of an embolic event to ensure adequate levels of anticoagulation, long-term control of blood pressure, administration of the National Institutes of Health (NIH) stroke scale at 30 and 60 days, and resumption of anticoagulation in consultation with neurology or neurosurgery in the setting of hemorrhagic stroke.

Recommendations for assessment of neurocognitive deficits include routine neurocognitive assessment at 3, 6, 12, and 18 months after implant.

Recommendations for evaluation of MCS patients with a suspected infection include a complete blood count, chest radiographic imaging, and blood cultures.

At least three sets of blood cultures over 24 hours should be drawn, with at least one culture from any indwelling central venous catheters.

For those with a suspected cannula or driveline infection, obtaining a sample for Gram stain, KOH, and routine bacterial and fungal cultures is recommended.

When clinically indicated, aspirate from other potential sources, as dictated by presenting symptoms and examination.

Directed radiographic studies based on presenting symptoms and examination are recommended.

MCS patients with incessant ventricular arrhythmias require prompt admission for further management because hemodynamic compromise may occur. Patients with ongoing VT refractory to medical therapy may require catheter ablation, which should be performed by an electrophysiologist with expertise in treating patients with MCS.

When an MCS patient is undergoing a noncardiac procedure, the MCS and surgical teams need to collaborate. For nonemergency procedures, warfarin and antiplatelet therapy may be continued if the risk of bleeding associated with the procedure is low. If therapy needs to be stopped, warfarin and antiplatelet therapy should be held for an appropriate period of time as determined by the type of procedure being undertaken and risk of bleeding. Bridging with heparin or a heparin alternative while a patient is off warfarin may be considered.

For emergency procedures, warfarin may need to be rapidly reversed with fresh frozen plasma or prothrombin protein concentrate. Vitamin K can be administered with caution, but has slower onset of action. Post procedure, warfarin and antiplatelet therapy may be resumed when risk of surgical bleeding is deemed acceptable. Patients may be bridged with heparin or a heparin alternative while waiting for the INR to reach the target range.

Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.

"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.

Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.