J Artif Organs DOI 10.1007/s10047-014-0797-6
CASE REPORT
Artificial Heart (Clinical)
Seventeen-month-long paracorporeal biventricular mechanical support as a bridge to transplantation for severe dilated cardiomyopathy Tadashi Kitamura • Shinzo Torii • Norihiko Oka • Tetsuya Horai • Keiichi Itatani • Takeshi Yoshii • Yuki Nakamura • Miyuki Shibata • Tomoki Tamura • Haruna Araki • Yoshikiyo Matsunaga • Kagami Miyaji
Received: 11 July 2014 / Accepted: 5 October 2014 Ó The Japanese Society for Artificial Organs 2014
Abstract The long-term management of paracorporeal biventricular assist devices (BiVAD) is difficult because of significant risks of bleeding, thrombosis, and infection. Here we report the case of a 41-year-old woman with severe dilated cardiomyopathy who developed serious cerebral bleeding after receiving a paracorporeal BiVAD but recovered well after treatment. She eventually underwent cardiac transplantation 17 months after implantation of the paracorporeal BiVAD. Keywords Biventricular assist device Paracorporeal pulsatile pump Bridge to transplantation
Introduction It is often difficult to manage paracorporeal ventricular assist devices (VAD) for a long time because of critical complications such as bleeding, embolism, and infection. Long-term management of paracorporeal biventricular VADs (BiVADs) is even more difficult because the risks are doubled. In Japan, however, the waiting time for cardiac transplantation is considerably long because of a shortage of donors. We report on the use of a paracorporeal BiVAD for 17 months as a bridge to cardiac transplantation in a patient with severe dilated cardiomyopathy.
T. Kitamura (&) S. Torii N. Oka T. Horai K. Itatani T. Yoshii Y. Nakamura M. Shibata T. Tamura H. Araki Y. Matsunaga K. Miyaji Department of Cardiovascular Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara 252-0374, Japan e-mail: [email protected]
Case report A 41-year-old petite woman with a body surface area of 1.2 m2 presented with severe biventricular failure due to dilated cardiomyopathy. She was registered for heart transplantation after becoming dependent on intravenous inotropes despite receiving optimal pharmacological treatment and cardiac resynchronization therapy. Transthoracic echocardiography showed moderate mitral regurgitation and massive tricuspid regurgitation, with a systolic transtricuspid pressure gradient of only 4 mmHg. Right heart catheterization revealed normal right heart pressure, suggesting profound right heart failure. Her liver and renal function deteriorated, and she subsequently underwent surgery. We first performed tricuspid annuloplasty (Edwards MC3, Edwards Lifesciences, Irvine, CA, USA) and inserted a paracorporeal left ventricular assist device (LVAD) (Nipro Corporation, Tokyo, Japan). We were not able to wean the patient off cardiopulmonary bypass as we had anticipated; therefore, we performed mitral valve plasty using artificial chordae and an annuloplasty ring (Carpentier-Edwards Physio II, Edwards Lifesciences) and inserted an extracorporeal centrifugal right ventricular assist device (RVAD) (MERA, Tokyo Japan). After surgery, the patient was given 100 mg oral aspirin and intravenous heparin, which was later replaced by oral warfarin. Serum bilirubin and creatinine levels improved within 2 weeks. The international normalized ratio (INR) was adjusted between 3 and 4. The centrifugal RVAD pump was switched to a pulsatile pump (Nipro Corporation) on postoperative day 35 [1]. The initial setting of the BiVAD was as follows. LVAD: Systolic positive pressure, 200 mmHg; diastolic negative pressure, 50 mmHg; rate, 77 bpm; systolic duration, 36 %. RVAD: Systolic positive pressure, 130 mmHg, diastolic negative pressure, 46 mmHg; rate, 67 bpm; systolic duration, 32 %.
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0.2 L/min most of the time. The VAD cannula insertion sites were routinely swabbed for surveillance culture and, when the patient had pyrexia or elevated inflammatory parameters, oral or intravenous antibiotics were administered according to the culture results. The patient gradually became depressed and attempted to cut her air tube herself using eyebrow scissors 9 months after surgery; this necessitated an exchange of the LVAD system. Depression led to appetite loss, leading to fluctuation of the INR and an increase in thrombosis in the blood chamber. At 13 and 14 months after the initial surgery, the pump was changed 3 times (LVAD 2, RVAD 1). The VAD flow also dropped down to 3 L/min and the patient developed hypotension due to appetite loss, but her liver and renal function remained normal with intravenous fluid therapy. The INR was stabilized with supplementary enteral feeding, which was discontinued once the depression was well controlled with oral mirtazapine and sodium valproate. After 17 months of biventricular mechanical support, the patient was able to walk for 1200 m and the LVAD flow plateaued at approximately 4 L/min. The patient eventually received a cardiac transplant and was discharged from the hospital 7 weeks after transplantation. She is currently living a satisfactory life with no restrictions on her daily activities as a housewife. Fig. 1 A computed tomography image showing cerebral bleeding in the left frontal lobe
The LVAD and RVAD flows were 3.0 and 3.2 L/min, respectively. The patient received oral heart failure medications including carvedilol, angiotensin-converting enzyme inhibitor, sildenafil, isosorbide, amiodarone, and spironolactone. She underwent uneventful rehabilitation and was able to walk for 200 m 3 months after surgery, when she developed severe cerebral bleeding (Fig. 1). The INR was neutralized from 4.1 using fresh frozen plasma and factor IX (Novact M, Astellas Pharma Inc., Tokyo, Japan), and the patient underwent craniotomy for hemostasis. She fully recovered consciousness and was extubated 3 days after the craniotomy. Intravenous heparin and oral warfarin were resumed and heparin was ceased when the INR reached 2.5. The INR was controlled between 2.8 and 3.5. Oral aspirin was not resumed because of the prior critical cerebral bleeding. Thereafter, the patient continued the rehabilitation program and the VAD flow gradually increased. The LVAD pump was changed 6 months after the initial insertion because of increased thrombosis in the blood chamber. Transthoracic echocardiography at that time revealed mildly dilated left ventricle with the diastolic dimension of 50 mm, a left ventricular ejection fraction of 30 %, moderate to severe tricuspid regurgitation and moderately dilated and akinetic right ventricle with the diastolic dimension of 46 mm. The RVAD flow was greater than the LVAD flow by
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Discussion Management of severe dilated cardiomyopathy with profound right heart failure is challenging. Some patients require only LVADs, but it is not uncommon for such patients to receive a BiVAD. BiVADs are associated with a higher risk compared with LVADs alone in both the short and long term [2]. This is partly because of the delicate balance that must be achieved between right and left ventricular support and partly because the risks of serious complications related to VADs, including bleeding, thrombosis, and infection, are doubled. Therefore, patients with BiVAD have a lower chance of being successfully bridged to transplantation compared with patients with LVAD. According to a 2013 report by the Japanese Ministry of Health and Welfare, the average waiting time for heart transplantation in Japan is 961.4 ± 520.2 days, which is over 2.5 years (http://www.jotnw.or.jp/datafile/pdf/report. pdf). However, implantable RVAD is not reimbursed by medical insurance in Japan. Therefore, patients with BiVAD in Japan have to survive for the potentially long waiting period with at least one paracorporeal pump [3]. In addition, there is no commercially available implantable BiVAD system suitable for a small patient with a body surface area of only 1.2 m2.
J Artif Organs
There have been a few reports of long-term management of paracorporeal BiVAD [4–7]. To our knowledge, however, the reported duration of successful paracorporeal BiVAD support has been the longest till date in our case. Needless to say, optimal anticoagulation and infection control are crucial factors for successful long-term management of VADs. Our patient unfortunately developed critical cerebral bleeding 3 months after implantation, which required emergency craniotomy for hemostasis. Blood-thinning medication other than warfarin was not recommenced after this event because it was considered that another cerebral hemorrhage would be fatal. Therefore, INR control became extremely important for this patient. Meticulous INR control is provided only by dosage adjustment based on frequent blood tests and stable diet intake enabled by sufficient exercise, with the latter known to play a role in infection prevention [8]. The patient suffered from depression for a significant period of time because she was confined to the hospital on a leash of the VAD. Depression caused appetite loss and a fluctuation in the INR. Therefore, the patient required frequent VAD pump exchanges. Initially, antidepressant and psychiatric liaison nursing were not enough to stabilize the depression. After discussion with the patient, supplementary enteral feeding via a nasogastric tube was commenced to relieve her stress and resume normal feeding. Gradually she was able to eat on her own, and enteral feeding was ceased. Multidisciplinary treatment by the entire VAD team stabilized the patient’s general condition, and she eventually underwent transplantation 516 days after BiVAD implantation. In summary, a paracorporeal BiVAD sustained a patient with severe dilated cardiomyopathy for 17 months before transplantation. Multidisciplinary treatment enabled the patient to survive the long waiting period before heart transplantation.
Conflict of interest of interest.
The authors declare that they have no conflict
References 1. Inoue T, Kitamura T, Torii S, Hanayama N, Oka N, Itatani K, Tomoyasu T, Irisawa Y, Shibata M, Hayashi H, Ono M, Miyaji K. Five-week use of a monopivot centrifugal blood pump as a right ventricular assist device in severe dilated cardiomyopathy. J Artif Organs. 2014;17:95–8. 2. Farrar DJ, Hill JD, Pennington DG, McBride LR, Holman WL, Kormos RL, Esmore D, Gray LA Jr, Seifert PE, Schoettle GP, Moore CH, Hendry PJ, Bhayana JN. Preoperative and postoperative comparison of patients with univentricular and biventricular support with the thoratec ventricular assist device as a bridge to cardiac transplantation. J Thorac Cardiovasc Surg. 1997;113:202–9. 3. Nishimura T. Current status of extracorporeal ventricular assist devices in Japan. J Artif Organs. 2014. (epub ahead of print). doi: 10.1007/s10047-014-0779-8. 4. Kurihara C, Ono M, Nishimura T, Nawata K, Kinoshita O, Hisagi M, Motomura N, Kyo S. Prolonged biventricular assist device support as a bridge to heart transplantation. J Artif Organs. 2011;14:367–70. 5. Saito S, Sakaguchi T, Miyagawa S, Nishi H, Yoshikawa Y, Fukushima S, Daimon T, Sawa Y. Recovery of right heart function with temporary right ventricular assist using a centrifugal pump in patients with severe biventricular failure. J Heart Lung Transpl. 2012;31:858–64. 6. Oto O, Albayrak G, Ugurlu B, Kuserli Y, Ozpelit E, Guneri S. A mandatory modification in extracorporeal biventricular assist device (BIVAD) implantation: intercostal tunnel application: a case report. J Cardiothorac Surg. 2013;8:229. 7. Sakaguchi T, Saito S, Yoshioka D, Sawa Y. Long-term biventricular support with rotary blood pumps in a patient with a noncontractile heart. J Thorac Cardiovasc Surg. 2013;146:e29–30. 8. Moore FA, Feliciano DV, Andrassy RJ, McArdle AH, Booth FV, Morgenstein-Wagner TB, Kellum JM Jr, Welling RE, Moore EE. Early enteral feeding, compared with parenteral, reduces postoperative septic complications. The results of a meta-analysis. Ann Surg. 1992;216:172–83.
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CASE REPORT
Artificial Heart (Clinical)
Seventeen-month-long paracorporeal biventricular mechanical support as a bridge to transplantation for severe dilated cardiomyopathy Tadashi Kitamura • Shinzo Torii • Norihiko Oka • Tetsuya Horai • Keiichi Itatani • Takeshi Yoshii • Yuki Nakamura • Miyuki Shibata • Tomoki Tamura • Haruna Araki • Yoshikiyo Matsunaga • Kagami Miyaji
Received: 11 July 2014 / Accepted: 5 October 2014 Ó The Japanese Society for Artificial Organs 2014
Abstract The long-term management of paracorporeal biventricular assist devices (BiVAD) is difficult because of significant risks of bleeding, thrombosis, and infection. Here we report the case of a 41-year-old woman with severe dilated cardiomyopathy who developed serious cerebral bleeding after receiving a paracorporeal BiVAD but recovered well after treatment. She eventually underwent cardiac transplantation 17 months after implantation of the paracorporeal BiVAD. Keywords Biventricular assist device Paracorporeal pulsatile pump Bridge to transplantation
Introduction It is often difficult to manage paracorporeal ventricular assist devices (VAD) for a long time because of critical complications such as bleeding, embolism, and infection. Long-term management of paracorporeal biventricular VADs (BiVADs) is even more difficult because the risks are doubled. In Japan, however, the waiting time for cardiac transplantation is considerably long because of a shortage of donors. We report on the use of a paracorporeal BiVAD for 17 months as a bridge to cardiac transplantation in a patient with severe dilated cardiomyopathy.
T. Kitamura (&) S. Torii N. Oka T. Horai K. Itatani T. Yoshii Y. Nakamura M. Shibata T. Tamura H. Araki Y. Matsunaga K. Miyaji Department of Cardiovascular Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara 252-0374, Japan e-mail: [email protected]
Case report A 41-year-old petite woman with a body surface area of 1.2 m2 presented with severe biventricular failure due to dilated cardiomyopathy. She was registered for heart transplantation after becoming dependent on intravenous inotropes despite receiving optimal pharmacological treatment and cardiac resynchronization therapy. Transthoracic echocardiography showed moderate mitral regurgitation and massive tricuspid regurgitation, with a systolic transtricuspid pressure gradient of only 4 mmHg. Right heart catheterization revealed normal right heart pressure, suggesting profound right heart failure. Her liver and renal function deteriorated, and she subsequently underwent surgery. We first performed tricuspid annuloplasty (Edwards MC3, Edwards Lifesciences, Irvine, CA, USA) and inserted a paracorporeal left ventricular assist device (LVAD) (Nipro Corporation, Tokyo, Japan). We were not able to wean the patient off cardiopulmonary bypass as we had anticipated; therefore, we performed mitral valve plasty using artificial chordae and an annuloplasty ring (Carpentier-Edwards Physio II, Edwards Lifesciences) and inserted an extracorporeal centrifugal right ventricular assist device (RVAD) (MERA, Tokyo Japan). After surgery, the patient was given 100 mg oral aspirin and intravenous heparin, which was later replaced by oral warfarin. Serum bilirubin and creatinine levels improved within 2 weeks. The international normalized ratio (INR) was adjusted between 3 and 4. The centrifugal RVAD pump was switched to a pulsatile pump (Nipro Corporation) on postoperative day 35 [1]. The initial setting of the BiVAD was as follows. LVAD: Systolic positive pressure, 200 mmHg; diastolic negative pressure, 50 mmHg; rate, 77 bpm; systolic duration, 36 %. RVAD: Systolic positive pressure, 130 mmHg, diastolic negative pressure, 46 mmHg; rate, 67 bpm; systolic duration, 32 %.
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0.2 L/min most of the time. The VAD cannula insertion sites were routinely swabbed for surveillance culture and, when the patient had pyrexia or elevated inflammatory parameters, oral or intravenous antibiotics were administered according to the culture results. The patient gradually became depressed and attempted to cut her air tube herself using eyebrow scissors 9 months after surgery; this necessitated an exchange of the LVAD system. Depression led to appetite loss, leading to fluctuation of the INR and an increase in thrombosis in the blood chamber. At 13 and 14 months after the initial surgery, the pump was changed 3 times (LVAD 2, RVAD 1). The VAD flow also dropped down to 3 L/min and the patient developed hypotension due to appetite loss, but her liver and renal function remained normal with intravenous fluid therapy. The INR was stabilized with supplementary enteral feeding, which was discontinued once the depression was well controlled with oral mirtazapine and sodium valproate. After 17 months of biventricular mechanical support, the patient was able to walk for 1200 m and the LVAD flow plateaued at approximately 4 L/min. The patient eventually received a cardiac transplant and was discharged from the hospital 7 weeks after transplantation. She is currently living a satisfactory life with no restrictions on her daily activities as a housewife. Fig. 1 A computed tomography image showing cerebral bleeding in the left frontal lobe
The LVAD and RVAD flows were 3.0 and 3.2 L/min, respectively. The patient received oral heart failure medications including carvedilol, angiotensin-converting enzyme inhibitor, sildenafil, isosorbide, amiodarone, and spironolactone. She underwent uneventful rehabilitation and was able to walk for 200 m 3 months after surgery, when she developed severe cerebral bleeding (Fig. 1). The INR was neutralized from 4.1 using fresh frozen plasma and factor IX (Novact M, Astellas Pharma Inc., Tokyo, Japan), and the patient underwent craniotomy for hemostasis. She fully recovered consciousness and was extubated 3 days after the craniotomy. Intravenous heparin and oral warfarin were resumed and heparin was ceased when the INR reached 2.5. The INR was controlled between 2.8 and 3.5. Oral aspirin was not resumed because of the prior critical cerebral bleeding. Thereafter, the patient continued the rehabilitation program and the VAD flow gradually increased. The LVAD pump was changed 6 months after the initial insertion because of increased thrombosis in the blood chamber. Transthoracic echocardiography at that time revealed mildly dilated left ventricle with the diastolic dimension of 50 mm, a left ventricular ejection fraction of 30 %, moderate to severe tricuspid regurgitation and moderately dilated and akinetic right ventricle with the diastolic dimension of 46 mm. The RVAD flow was greater than the LVAD flow by
123
Discussion Management of severe dilated cardiomyopathy with profound right heart failure is challenging. Some patients require only LVADs, but it is not uncommon for such patients to receive a BiVAD. BiVADs are associated with a higher risk compared with LVADs alone in both the short and long term [2]. This is partly because of the delicate balance that must be achieved between right and left ventricular support and partly because the risks of serious complications related to VADs, including bleeding, thrombosis, and infection, are doubled. Therefore, patients with BiVAD have a lower chance of being successfully bridged to transplantation compared with patients with LVAD. According to a 2013 report by the Japanese Ministry of Health and Welfare, the average waiting time for heart transplantation in Japan is 961.4 ± 520.2 days, which is over 2.5 years (http://www.jotnw.or.jp/datafile/pdf/report. pdf). However, implantable RVAD is not reimbursed by medical insurance in Japan. Therefore, patients with BiVAD in Japan have to survive for the potentially long waiting period with at least one paracorporeal pump [3]. In addition, there is no commercially available implantable BiVAD system suitable for a small patient with a body surface area of only 1.2 m2.
J Artif Organs
There have been a few reports of long-term management of paracorporeal BiVAD [4–7]. To our knowledge, however, the reported duration of successful paracorporeal BiVAD support has been the longest till date in our case. Needless to say, optimal anticoagulation and infection control are crucial factors for successful long-term management of VADs. Our patient unfortunately developed critical cerebral bleeding 3 months after implantation, which required emergency craniotomy for hemostasis. Blood-thinning medication other than warfarin was not recommenced after this event because it was considered that another cerebral hemorrhage would be fatal. Therefore, INR control became extremely important for this patient. Meticulous INR control is provided only by dosage adjustment based on frequent blood tests and stable diet intake enabled by sufficient exercise, with the latter known to play a role in infection prevention [8]. The patient suffered from depression for a significant period of time because she was confined to the hospital on a leash of the VAD. Depression caused appetite loss and a fluctuation in the INR. Therefore, the patient required frequent VAD pump exchanges. Initially, antidepressant and psychiatric liaison nursing were not enough to stabilize the depression. After discussion with the patient, supplementary enteral feeding via a nasogastric tube was commenced to relieve her stress and resume normal feeding. Gradually she was able to eat on her own, and enteral feeding was ceased. Multidisciplinary treatment by the entire VAD team stabilized the patient’s general condition, and she eventually underwent transplantation 516 days after BiVAD implantation. In summary, a paracorporeal BiVAD sustained a patient with severe dilated cardiomyopathy for 17 months before transplantation. Multidisciplinary treatment enabled the patient to survive the long waiting period before heart transplantation.
Conflict of interest of interest.
The authors declare that they have no conflict
References 1. Inoue T, Kitamura T, Torii S, Hanayama N, Oka N, Itatani K, Tomoyasu T, Irisawa Y, Shibata M, Hayashi H, Ono M, Miyaji K. Five-week use of a monopivot centrifugal blood pump as a right ventricular assist device in severe dilated cardiomyopathy. J Artif Organs. 2014;17:95–8. 2. Farrar DJ, Hill JD, Pennington DG, McBride LR, Holman WL, Kormos RL, Esmore D, Gray LA Jr, Seifert PE, Schoettle GP, Moore CH, Hendry PJ, Bhayana JN. Preoperative and postoperative comparison of patients with univentricular and biventricular support with the thoratec ventricular assist device as a bridge to cardiac transplantation. J Thorac Cardiovasc Surg. 1997;113:202–9. 3. Nishimura T. Current status of extracorporeal ventricular assist devices in Japan. J Artif Organs. 2014. (epub ahead of print). doi: 10.1007/s10047-014-0779-8. 4. Kurihara C, Ono M, Nishimura T, Nawata K, Kinoshita O, Hisagi M, Motomura N, Kyo S. Prolonged biventricular assist device support as a bridge to heart transplantation. J Artif Organs. 2011;14:367–70. 5. Saito S, Sakaguchi T, Miyagawa S, Nishi H, Yoshikawa Y, Fukushima S, Daimon T, Sawa Y. Recovery of right heart function with temporary right ventricular assist using a centrifugal pump in patients with severe biventricular failure. J Heart Lung Transpl. 2012;31:858–64. 6. Oto O, Albayrak G, Ugurlu B, Kuserli Y, Ozpelit E, Guneri S. A mandatory modification in extracorporeal biventricular assist device (BIVAD) implantation: intercostal tunnel application: a case report. J Cardiothorac Surg. 2013;8:229. 7. Sakaguchi T, Saito S, Yoshioka D, Sawa Y. Long-term biventricular support with rotary blood pumps in a patient with a noncontractile heart. J Thorac Cardiovasc Surg. 2013;146:e29–30. 8. Moore FA, Feliciano DV, Andrassy RJ, McArdle AH, Booth FV, Morgenstein-Wagner TB, Kellum JM Jr, Welling RE, Moore EE. Early enteral feeding, compared with parenteral, reduces postoperative septic complications. The results of a meta-analysis. Ann Surg. 1992;216:172–83.
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