[Heart Transplantation for Older Patients].

The number of older donors is increasing in the limited number of donors in Japan. The number of older donors is increasing, and recipients are also ageing as the waiting period for transplantation becomes longer. The age of 60 years is one of the most important criteria for heart transplantation in Japan. Forty-two heart transplantations performed in our institution, and 12 cases were from donors aged over 60 years and seven recipients were older than 60 years at the time of transplantation. In four cases, both donor and recipient were over 60 years of age. All of these patients were discharged home after transplantation. As the number of older donors and recipients is expected to increase in the future, the number of marginal cases based on the status of not only the donor but also the recipient is expected to increase. The evaluation of coronary lesions and the identification of comorbid diseases, including malignant diseases, will become more important. A positive and careful overall decision at the time of transplantation is essential.

Investigating the cause of hemolysis in patients supported by a pulsatile ventricular assist device.

A survey conducted by Abiomed, Inc. revealed that 10 of 60 patients who received ventricular assistance via the AB5000 ventricular assist device (VAD) experienced hemolysis. The present study was conducted to investigate which factors influence hemolysis under pulsatile-flow VADs such as the AB5000. We compared the specificity of the AB5000 and its driving console with those of the NIPRO-VAD and VCT50χ under severe heart failure conditions using a mock circulatory system with a glycerol water solution. We used the mock circuit with bovine blood to confirm which pump conditions were most likely to cause hemolysis. In addition, we measured the shear velocity using particle image velocimetry by analyzing the seeding particle motion for both the AB5000 and NIPRO-VAD under the same conditions as those indicated in the initial experiment. Finally, we analyzed the correlation between negative pressure, exposure time, and hemolysis by continuously exposing fixed vacuum pressures for fixed times in a sealed device injected with bovine blood. Applying higher vacuum pressure to the AB5000 pump yielded a larger minimum inlet pressure and a longer exposure time when the negative pressure was under - 10 mmHg. The plasma-free hemoglobin increased as more negative pressure was driven into the AB5000 pump. Moreover, the negative pressure interacted with the exposure time, inducing hemolysis. This study revealed that negative pressure and exposure time were both associated with hemolysis.

Determinants of Changes in Arterial Stiffness after Thoracic Endovascular Aortic Repair.

BACKGROUND: Aortic stent grafting can cause aortic stiffening and increase pulse wave velocity (PWV), which can potentially affect long-term cardiovascular outcomes. The aim of this study was to clarify the factors contributing to increases in PWV after thoracic endovascular aortic repair (TEVAR). METHODS: We included 64 patients with thoracic aortic pathology (51 men; mean age, 73 years) who underwent elective TEVAR, in this study. TEVAR was performed for degenerative aortic aneurysm (n = 43) or aortic dissection (n = 21), and the treatment length was 175 ± 52 mm. Brachial-ankle PWV (baPWV) was obtained before and 1 week after TEVAR. Univariable and multivariable logistic regression analyses were used to determine the predictors of increases in baPWV of ≥100 cm/sec after TEVAR. RESULTS: baPWV increased from 1,851 ± 392 cm/sec to 2,047 ± 479 cm/sec, and the change in baPWV (ΔbaPWV) was 195 ± 339 cm/sec (95% confidence interval, 111-280). Thirty-seven patients (58%) had ΔbaPWV ≥100 cm/sec after TEVAR. In the multivariable analysis, in addition to Δheart rate and Δsystolic blood pressure, age (odds ratio, 1.21/year; 95% confidence interval, 1.05-1.40) and coronary artery disease (odds ratio, 12.0; 95% confidence interval, 1.20-121) were independent determinants of ΔbaPWV ≥100 cm/sec after TEVAR, whereas ΔbaPWV ≥100 cm/sec was not associated with treatment length or device type. CONCLUSIONS: TEVAR was associated with PWV progression, especially in older patients with coronary artery disease, whereas treatment length or device type was not a predictor of PWV progression after TEVAR.

Successful papillary muscle approximation for severe mitral regurgitation via apical cuff hole in HeartMate 3 implantation via left anterior thoracotomy.

We herein report a case of successful papillary muscle approximation for severe mitral regurgitation and HeartMate 3 left ventricular assist device implantation via left anterior thoracotomy in a 39-year-old man diagnosed with dilated cardiomyopathy. He underwent papillary muscle approximation in the mitral valve for severe functional regurgitation via the apical cuff hole. The postoperative course was uneventful. Echocardiography revealed that mitral regurgitation has disappeared. He was awaiting heart transplantation while working.

A therapeutic concept to resolve a possible coronary desaturation under Ecpella support and maximize the potential for myocardial recovery: combination of veno-arteriovenous extracorporeal membrane oxygenation and Impella (VAVEcpella).

INTRODUCTION: Ecpella, a combination of veno-arterial (V-A) extracorporeal membrane oxygenation (ECMO) and Impella, may result in the differential hypoxia in patients with cardiogenic shock and severe lung dysfunction. Here, we report a solution of this Ecpella-induced unfavorable phenomenon. CASE REPORT: A 70-year-old man developed cardiogenic shock from fulminant myocarditis. As we established Ecpella but immediately significant differential hypoxia became apparent, the ECMO configuration was switched from V-A to veno-arteriovenous (V-AV): a combination of V-AV ECMO and Impella, newly termed VAVEcpella, was instituted. The differential hypoxia resolved, and he was successfully weaned from mechanical circulatory support. DISCUSSION AND CONCLUSION: VAVEcpella is an effective configuration to resolve Ecpella-induced differential hypoxia and may contribute to restoration of normal cardiac function.

Fatal Pulmonary Hemorrhagic Infarction Caused by Pulmonary Vein Thrombotic Occlusion During Venoarterial Extracorporeal Membrane Oxygenation.

A 20-year-old man with arrhythmogenic right ventricular cardiomyopathy (ARVC) was resuscitated from ventricular fibrillation. He was transferred to our hospital because of progressive multiorgan dysfunction despite mechanical circulatory support with peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP). At admission to our hospital, chest X-ray showed bilateral complete lung opacification, and echocardiography revealed a massive thrombus occupying the left atrium (LA) and left ventricle (LV). Conversion to central ECMO with transapical LV venting and thrombectomy were performed. The huge LA thrombus occluded all pulmonary veins (PVs). Despite the surgery and intensive care, complete lung opacity remained, and he died of multiorgan failure associated with sepsis. Autopsy demonstrated bilateral pulmonary multiple red infarctions, and histopathology showed alveolar wall necrosis with extensive hemorrhage, confirming a diagnosis of pulmonary hemorrhagic infarction. Extensive pulmonary infarction was attributable to PV occlusion due to massive LA thrombus. PV thrombosis should be considered when refractory lung opacities are encountered during VA-ECMO and necessitates early intervention.

Pneumopericardium suggesting left ventricular assist device-related gastrointestinal complication.

We report an uncommon case of ventricular assist device-related infection and resultant fistula formation into the gastrointestinal tract. A 69-year-old man, who had undergone implantation of a HeartMate II 1 year earlier secondary to ischemic cardiomyopathy, presented to our hospital with a high fever. Computed tomography showed unusual gas collection around the heart apex (i.e., pneumopericardium), which had not been detected before. The patient developed sudden melena with fresh blood without abdominal symptoms 1 month after beginning antibiotic therapy. Emergent colonoscopy showed that the HeartMate II strain relief of the inflow conduit had penetrated the transverse colon. We immediately performed laparoscopy-assisted left-sided hemicolectomy and found intraoperatively that a fistula had formed between the splenic flexure and the pericardial cavity. Subsequently, the HeartMate II system was totally explanted and replaced with an Impella 5.0 for alternative hemodynamic support. In our patient, pneumopericardium might have been an early sign of a hidden gastrointestinal complication. Our experience is a caution for clinicians who manage patients with ventricular assist device support via the apex.

Single-stage hybrid total arch replacement for extended arch aneurysms.

OBJECTIVE: The therapeutic strategy for extended aortic arch aneurysms remains controversial and has changed substantially since thoracic endovascular aortic repair was introduced. We applied single-stage hybrid (s-hybrid) total arch replacement (TAR), which involved ascending aorta replacement and debranching of arch vessels, consecutively performed with thoracic endovascular aortic repair for extended arch aneurysms. The aim of this study was to investigate the short-term results of s-hybrid TAR and to clarify the benefit of this method. METHODS: We reviewed the operative results of 62 patients who underwent elective s-hybrid TAR or conventional TAR (c-TAR) through the median approach from 2008 to 2017. We used the s-hybrid approach in 15 patients and the c-TAR approach in 47 patients. In both groups, axillary arterial perfusion and selective antegrade cerebral perfusion under moderate hypothermia were applied for brain protection. We compared the perioperative outcomes of the two groups. RESULTS: We completed s-hybrid TAR in all 15 patients with extended aneurysms. The s-hybrid group required shorter times for myocardial ischemia, selective antegrade cerebral perfusion, and circulatory arrest of the lower body compared with the c-TAR group. The patients with complicated recurrent laryngeal nerve palsy and long ventilation support times were fewer in the s-hybrid group. No patient had substantial endoleaks or permanent paraplegia. The in-hospital mortality rates were 6.7% in the s-hybrid group and 0% in the c-TAR group. CONCLUSIONS: The s-hybrid TAR has the same or better perioperative outcomes compared with the c-TAR approach. For extended aneurysms, this technique could resolve the problem of respiratory failure induced by left thoracotomy and also resolve the problem of rupture during the waiting period in staged surgery.

Jarvik 2000 axial flow ventricular assist device in right single ventricle after Fontan operation.

We present a case of successful ventricular assist device support in a 13-year-old female diagnosed with right single ventricle, asplenia, dextrocardia, who had undergone a Fontan operation at 4 years old in an associated children hospital. She underwent placement of Jarvik 2000 axial flow ventricular assist device to the morphologic right ventricle which worked as systemic ventricle. The postoperative course was not eventful. She was waiting for heart transplantation attending high school 3 years after implantation.

Omental and deep inferior epigastric artery perforator flap coverage after heart transplantation to manage wide left ventricular assist device exposure with pocket infection.

Infection is a serious potential complication after left ventricular assist device (LVAD) implantation. In general, infection of the device pocket, with device exposure, should be managed by early device removal and heart transplantation. However, because of the small number of donors in Japan, accelerating access to heart transplantation is often difficult and the LVAD can be widely exposed during the waiting period. We report our experience of successful heart transplantation in a patient with a widely exposed LVAD with pocket infection. A 48-year-old man suffered from heart failure due to idiopathic dilated cardiomyopathy. An LVAD was implanted, but postoperative infection led to blood pump exposure. Heart transplantation was performed 4 months after LVAD exposure, at which time the epigastric skin defect measured 14 × 8 cm. The skin defect could not be closed after heart transplantation, so it was covered by an omental flap with split-thickness skin grafts. 7 days postoperatively, the peritoneal suture broke and the intestinal tract prolapsed outside the body. Reintroduction of the prolapsed intestinal tract and deep inferior epigastric artery perforator (DIEP) flap coverage of the omental flap were performed. The postoperative course was uneventful. There have been no reports of the management of wide skin defects in the presence of infection when heart transplantation is performed. Omental flap placement was useful for controlling long-lasting infection. An omental flap placed in a patient with a wide epigastric skin defect should be covered by durable skin flap, such as a DIEP flap, to avoid intestinal prolapse.

Jarvik 2000 axial-flow ventricular assist device placement to a systemic morphologic right ventricle in congenitally corrected transposition of the great arteries.

Few descriptions of the implantation and management of an implantable ventricular assist device in patients with complex congenital heart disease exist in the literature. The Jarvik 2000 axial-flow ventricular assist device (Jarvik Heart, Inc., NYC, NY, USA) can be placed in either the left or the right ventricle. We present the case of a 60-year-old man with congenitally corrected transposition of the great arteries who underwent successful placement of a Jarvik 2000 axial-flow ventricular assist device in a systemic morphologic right ventricle.

Preliminary report on the cost effectiveness of ventricular assist devices.

The aim of the present study was to perform a cost-effectiveness analysis (CEA) of ventricular assist devices (VAD) implantation surgery in the Japanese medical reimbursement system. The study group consisted of thirty-seven patients who had undergone VAD implantation surgery for dilated cardiomyopathy (n = 25; 67.6 %) or hypertrophic cardiomyopathy (n = 4; 10.8 %), and others (n = 8; 21.6 %). Quality-adjusted life years (QALYs) were calculated using the utility score and years of life. Medical reimbursement bills were chosen as cost indices. The observation period was the 12-month period after surgery. Then, the incremental cost-effectiveness ratio was calculated according to the VAD type. In addition, the prognosis after 36 months was estimated on the basis of the results obtained using the Markov chain model. The mean preoperative INTERMACS profile score was 2.35 ± 0.77. Our results showed that the utility score, which indicates the effectiveness of VAD implantation surgery, improved by 0.279 ± 0.188 (ΔQALY, p < 0.05). The cost of VAD implantation surgery was 313,282 ± 25,275 (ΔUS$/year) on the basis of medical reimbursement bills associated with therapeutic interventions. The calculated result of CEA was 364,501 ± 190,599 (ΔUS$/QALY). The improvement in the utility score was greater for implantable versus extracorporeal VADs (0.233 ± 0.534 vs. 0.371 ± 0.238) and ICER was 303,104 (ΔUS$/ΔQALY). Furthermore, when we estimated CEA for 36 months, the expected baseline value was 102,712 (US$/QALY). Therefore, VAD implantation surgery was cost effective considering the disease specificities.

The Present Situation and Clinical Topics of Ventricular Assist Device and Heart Transplantation in Japan.

Surgical treatment for heart failure includes coronary artery bypass grafting to ischemic heart disease, valvular disease surgery such as mitral valvuloplasty, left ventricular restoration, ventricular assist device (VAD), and heart transplantation. In addition, HeartSheet which is regenerative medicine using autologous skeletal myoblast sheets has been started from the spring of 2016. Formal insurance reimbursement of implantable LVAD was obtained in April 2011, and the life prognosis of patients with severe heart failure improved markedly. However, the indication for implantable LVAD is limited to bridge use for heart transplantation. Implantable LVAD cannot be implanted in patients over 65 years old under health insurance because the adaptive age of heart transplantation in Japan is under 65 years old. It is a problem that the indication of implantable LVAD is identical to that of heart transplantation. Clinical trial of destination therapy is in progress for the purpose of optimizing the implantable LVAD indication. I strongly pray that VAD treatment including destination therapy (DT) and transplant medical treatment based on good intentions will be accepted socially as general treatment.

Long-Term Comparison of Three Types of Aortic St. Jude Medical Mechanical Prosthesis in Japanese Patients.

BACKGROUND: The long-term results achieved with aortic St. Jude Medical (SJM) mechanical prostheses in various age groups of Japanese patients have not been previously compared or reported. METHODS AND RESULTS: Since 1981, a total of 240 SJM valves were implanted in 79 patients using the Standard model, in 58 patients with the Hemodynamic Plus model, and in 103 patients with the Regent model for aortic valve replacement (AVR). Follow-up was completed for 2,397 patient-years in 97.5% of the patients, among whom the effect of age was compared, and the subjects were divided into younger (<65 years) and older (≥65 years) groups. Hospital mortality rate was 2.5%. No structural valve deterioration was observed during the follow-up period. In addition, no significant differences were observed in long-term survival between the 3 models. In contrast, significantly better rates of freedom from all-cause death (P<0.0001), valve-related death (P=0.0018) and valve-related morbidity (P=0.0021), including bleeding events (P=0.0007), were observed in the younger group (n=157, 50.6±1.0 years old) than in the older group (n=83, 72.5±0.7 years old). CONCLUSIONS: All types of SJM valve used for single AVR achieved satisfactory early and long-term results in each age group even 25 years after surgery. When selecting this prosthesis for elderly patients, however, relatively worse performance may be expected compared with that observed in younger patients.

Long-term results of aortic valve replacement with mechanical prosthesis or carpentier-edwards perimount bioprosthesis in Japanese patients according to age.

BACKGROUND: The long-term results of aortic valve replacement (AVR; n=737) with bileaflet mechanical prosthesis (MP) or Carpentier-Edwards Perimount bioprostheses (BP) were evaluated in different age groups. METHODS AND RESULTS: Since 1981, a total of 737 prostheses (424 bileaflet MP vs. 313 BP) were implanted for AVR in 278 patients aged ≥70 years (79 MP vs. 199 BP), in 191 patients aged 60-69 years (128 MP vs. 63 BP) and in 268 patients aged <60 years (217 MP vs. 51 BP). Follow-up was completed for 6,523 patient-years in 98.5% of cases. Among the patients ≥70 years, both the actuarial survival rate (P=0.0434) and freedom from valve-related morbidity (P=0.0205) were better in the BP group than in the MP group without any difference in occurrence of structural valve deterioration in both groups. Among the patients aged 60-69, anticoagulant-related complications occurred less often in the BP group (P=0.0134) without any difference in long-term survival. Among the patients aged <60, long-term survival was significantly better in the MP group, whereas freedom from anticoagulant-related events did not differ. CONCLUSIONS: The use of BP is suitable in patients aged ≥70 years, while the use of bileaflet MP is preferable in patients aged <60 years. Among patients aged 60-69 years, the use of BP is acceptable because of the lower incidence of anticoagulant-related events and the equivalent long-term survival.

Cardiac energetics analysis after aortic valve replacement with 16-mm ATS mechanical valve.

The 16-mm ATS mechanical valve is one of the smallest prosthetic valves used for aortic valve replacement (AVR) in patients with a very small aortic annulus, and its clinical outcomes are reportedly satisfactory. Here, we analyzed the left ventricular (LV) performance after AVR with the 16-mm ATS mechanical valve, based on the concept of cardiac energetics analysis. Eleven patients who underwent AVR with the 16-mm ATS mechanical valve were enrolled in this study. All underwent echocardiographic examination at three time points: before AVR, approximately 1 month after AVR, and approximately 1 year after AVR. LV contractility (end-systolic elastance [Ees]), afterload (effective arterial elastance [Ea]), and efficiency (ventriculoarterial coupling [Ea/Ees] and the stroke work to pressure-volume area ratio [SW/PVA]) were noninvasively measured by echocardiographic data and blood pressure measurement. Ees transiently decreased after AVR and then recovered to the pre-AVR level at the one-year follow-up. Ea significantly decreased in a stepwise manner. Consequently, Ea/Ees and SW/PVA were also significantly improved at the one-year follow-up compared with those before AVR. The midterm LV performance after AVR with the 16-mm ATS mechanical valve was satisfactory. AVR with the 16-mm ATS mechanical valve is validated as an effective treatment for patients with a very small aortic annulus. The cardiac energetics variables, coupling with the conventional hemodynamic variables, can contribute to a better understanding of the patients' clinical conditions, and those may serve as promising indices of the cardiac function.

Operative modification for the prevention of device-related infection during NIPRO extracorporeal left ventricular assist device implantation.

An operative modification in which the NIPRO left ventricular assist device (LVAD) cannulas are passed through the intraperitoneal cavity is performed as the first-choice standard technique in our institution. Eighteen consecutive patients who underwent NIPRO LVAD implantation as heart transplantation candidates were enrolled in this study. The cannulas were passed through the intraperitoneal cavity in 11 patients (Group IP) and the extraperitoneal space in 7 patients (Group EP). A device-related major infection was defined as bloodstream infection and/or abscess formation in the deep tissue space. Device-related major infection occurred in 6 patients in Group IP and in 6 patients in Group EP. Of these patients, 3 patients in Group IP and 5 patients in Group EP suffered from uncontrollable bloodstream infection and finally died of development into multiple organ failure and/or cerebrovascular accidents. The actuarial rates of freedom from device-related major infection at 6 months after LVAD implantation were 100 % in Group IP and 38 % in Group EP, respectively (p = 0.02). Moreover, the actuarial survival rates after the initial device-related major infection in Group IP could be significantly higher than in Group EP (83 and 67 % at 6 months, p = 0.03). We demonstrated that this operative modification can contribute to prevention of progression of superficial skin infection to critical infection and to extension of the survival duration after the initial device-related major infection.

[Intraaortic balloon pumping( IABP) in Japan].

The intraaortic balloon pumping (IABP) is the most widely used circulatory assist device. IABP increases coronary perfusion in diastolic phase by the inflation of the balloon in the descending aorta (diastolic augmentation) and reduces afterload in systolic phase by the deflation of the balloon( systolic unloading). IABP improves the hemodynamic condition of patients who fall into acute heart failure and/or cardiogenic shock. Six-type IABP system can be used in Japan. The IABP-SHOCK II trial shows that there is no significant difference in mortality between optimal medical treatment with IABP and without IABP in addition to early revascularization. Clinical backgrounds in Japan are different from those in IABP-SHOCK II trial, and the further prospective studies of IABP in Japan thus called for.

Ventricular energetics early after surgery for chronic mitral regurgitation: repair versus replacement.

BACKGROUND AND AIM OF THE STUDY: The study aim was to compare the effects of mitral valve (MV) repair and replacement with partial (posterior leaflet only) chordal preservation on left ventricular (LV) performance in chronic degenerative mitral regurgitation (MR) by assessing ventricular energetics. METHODS: Contractility (end-systolic elastance), afterload (effective arterial elastance), and ventricular efficiency (ventriculoarterial coupling and the ratio of stroke work to pressure-volume area were determined using transthoracic echocardiography data obtained before and at one month after surgery in 29 patients undergoing MV repair, and in 12 patients undergoing partial chordal-sparing MV replacement. A two-way analysis of variance with repeated measures was used for comparisons among patients who underwent MV surgery (valve repair versus valve replacement). RESULTS: The LV diastolic volume index was decreased significantly in both groups (p<0.0001), whereas the LV systolic volume index did not change significantly (p=0.956). Despite the similar remarkable decrease in ejection fraction (p<0.0001) in both groups, end-systolic elastance remained unchanged (p=0.312). Effective arterial elastance was increased significantly in both groups (p<0.0001). Ventriculoarterial coupling and the ratio of stroke work to pressure-volume area deteriorated similarly in both groups (p<0.0001 and p<0.0001). CONCLUSION: Compensation of LV geometry after correction of chronic MR preserved ventricular contractility. Furthermore, the results of MV repair were not superior to those of MV replacement with partial chordal preservation in the early postoperative period. This suggested that partial chordal-sparing MV replacement is an effective method for the treatment of chronic MR in selected patients.