Survival After Septal Reduction in Patients >65 Years Old With Obstructive Hypertrophic Cardiomyopathy.

BACKGROUND: Obstructive hypertrophic cardiomyopathy (oHCM) is increasingly being diagnosed in elderly patients. OBJECTIVES: The authors sought to study long-term outcomes of septal reduction therapies (SRT) in Medicare patients with oHCM, and hospital volume-outcome relation. METHODS: Medicare beneficiaries aged >65 years who underwent SRT, septal myectomy (SM) or alcohol septal ablation (ASA), from 2013 through 2019 were identified. Primary outcome was all-cause mortality, and secondary outcomes included heart failure (HF) readmission and need for redo SRT in follow-up. Overlap propensity score weighting was used to adjust for differences between both groups. Relation between hospital SRT volume and short-term and long-term mortality was studied. RESULTS: The study included 5,679 oHCM patients (SM = 3,680 and ASA = 1,999, mean age 72.9 vs 74.8 years, women 67.2% vs 71.1%; P < 0.01). SM patients had fewer comorbidities, but after adjustment, both groups were well balanced. At 4 years (IQR: 2-6 years), although there was no difference in long-term mortality between SM and ASA (HR: 0.87; 95% CI: 0.74-1.03; P = 0.1), on landmark analysis, SM was associated with lower mortality after 2 years of follow-up (HR: 0.72; 95% CI: 0.60-0.87; P < 0.001) and had lower need for redo SRT. Both reduced HF readmissions in follow-up vs 1 year pre-SRT. Higher-volume centers had better outcomes vs lower-volume centers, but 70% of SRT were performed in low-volume centers. CONCLUSIONS: SRT reduced HF readmission in Medicare patients with oHCM. SM is associated with lower redo and better long-term survival compared with ASA. Despite better outcomes in high-volume centers, 70% of SRT are performed in low-volume U.S. centers.

Costs and Healthcare Resource Utilization for Obstructive Hypertrophic Cardiomyopathy With Septal Reduction Therapy.

BACKGROUND: Patients with obstructive hypertrophic cardiomyopathy (oHCM) and severe refractory symptoms may require invasive septal reduction therapies (SRTs), either surgical septal myectomy (SM) or transcatheter alcohol septal ablation (ASA). The main objective of this study was to quantify all-cause and oHCM-related healthcare resource utilization (HCRU) and costs for patients receiving SM or ASA. METHODS: This retrospective study utilized medical and pharmacy claims submitted during 2012-2020. HCRU and costs for 119 adults with oHCM who had at least 1 SM (n = 95) or ASA (n = 24) were compared for baseline and follow-up periods. RESULTS: The mean inpatient hospitalization stay was longer for SM (8.3 days) than ASA (6.0 days). Postprocedure HCM-related medication usage was greater following SM (98%) than ASA (88%). The mean number of HCM-related outpatient visits increased from pre- to post procedure (12.2 vs 15.9 in the SM group; 7.2 vs 9.5 in the ASA group), with most patients having at least 1 cardiology visit post procedure (86% of the SM group; 83% of the ASA group). Total mean HCM-related costs (reported in United States currency) increased with both procedures ($27,045 vs $119,772 in the SM group; $11,278 vs $54,351 in the ASA group), driven by increased inpatient hospitalization ($10,325 vs $112,923 in the SM group; $5509 vs $47,450 in the ASA group) and surgical costs ($6665 vs $92,031 in the SM group; $52 vs $44,815 in the ASA group). CONCLUSIONS: Our results indicate increasing costs for patients undergoing SRT, driven by inpatient hospitalizations and surgical costs. Commercially insured and Medicare Advantage patients with oHCM experience high healthcare costs and economic burden attributable to SRT.

Longitudinal Cost of Septal Myectomy Versus Alcohol Septal Ablation for Hypertrophic Cardiomyopathy.

OBJECTIVE: To compare the postprocedural health care utilization and cost of septal myectomy (SM) and alcohol septal ablation (ASA). PATIENTS AND METHODS: Using the OptumLabs Data Warehouse, we analyzed de-identified claims data of adult patients undergoing SM and ASA for obstructive hypertrophic cardiomyopathy from January 1, 2006, through December 31, 2018. We used propensity score weighting to compare the 2-year incidence rates of emergency department visits and rehospitalizations after SM and ASA. RESULTS: We identified 953 patients in total: 660 underwent SM and 293 underwent ASA. There was no difference in the risk (odds ratio, 1.1; 95% CI, 0.6 to 1.8) or frequency (incidence rate ratio, 1.1; 95% CI, 0.8 to 1.5) of emergency department visits, but the annual risk of hospital readmission was 10.8% after SM and 25.9% after ASA during the second postoperative year (P=.004). In those who were ever readmitted, the average length of hospital stay within the first 2 years after ASA was 1.6 times as long as that after SM (incidence rate ratio, 1.6; 95% CI, 1.0 to 2.4). Overall, the 2-year cumulative postprocedural cost was significantly higher after ASA (P<.001). CONCLUSION: Compared with ASA, SM is associated with fewer hospital readmissions and lower 2-year postprocedural health care cost.

Myocardial contrast echocardiography assessment of perfusion abnormalities in hypertrophic cardiomyopathy.

BACKGROUND: Perfusion defects during stress can occur in hypertrophic cardiomyopathy (HCM) from either structural or functional abnormalities of the coronary microcirculation. In this study, vasodilator stress myocardial contrast echocardiography (MCE) was used to quantify and spatially characterize hyperemic myocardial blood flow (MBF) deficits in HCM. METHODS: Regadenoson stress MCE was performed in patients with septal-variant HCM (n = 17) and healthy control subjects (n = 15). The presence and spatial distribution (transmural diffuse, patchy, subendocardial) of perfusion defects was determined by semiquantitative analysis. Kinetic analysis of time-intensity data was used to quantify MBF, microvascular flux rate (ß), and microvascular blood volume. In patients undergoing septal myectomy (n = 3), MCE was repeated > 1 years after surgery.  RESULTS: In HCM subjects, perfusion defects during stress occurred in the septum in 80%, and in non-hypertrophied regions in 40%. The majority of septal defects (83%) were patchy or subendocardial, while 67% of non-hypertrophied defects were transmural and diffuse. On quantitative analysis, hyperemic MBF was approximately 50% lower (p < 0.001) in the hypertrophied and non-hypertrophied regions of those with HCM compared to controls, largely based on an inability to augment ß, although hypertrophic regions also had blood volume deficits. There was no correlation between hyperemic MBF and either percent fibrosis on magnetic resonance imaging or outflow gradient, yet those with higher degrees of fibrosis (≥ 5%) or severe gradients all had low septal MBF during regadenoson. Substantial improvement in hyperemic MBF was observed in two of the three subjects undergoing myectomy, both of whom had severe pre-surgical outflow gradients at rest. CONCLUSION: Perfusion defects on vasodilator MCE are common in HCM, particularly in those with extensive fibrosis, but have a different spatial pattern for the hypertrophied and non-hypertrophied segments, likely reflecting different contributions of functional and structural abnormalities. Improvement in hyperemic perfusion is possible in those undergoing septal myectomy to relieve obstruction.  TRIAL REGISTRATION: ClinicalTrials.gov NCT02560467.

Intraoperative accurate assessment of septal myectomy for hypertrophic obstructive cardiomyopathy (HOCM).

Surgical restoration of the left ventricular outflow tract (LVOT) is necessary for patients suffering from hypertrophic obstructive cardiomyopathy (HOCM), when symptoms are present despite the administration of medical treatment. One point of great significance during the procedure is the evaluation of the LVOT gradient after completion of septal myectomy. Most physicians choose to measure this value by transesophageal echocardiography (TEE) in combination with the direct measurement with the use of needles inserted into the aorta and left ventricle. In this article, we present the implementation of a new technique to estimate the peak-to-peak pressure gradient between the left ventricle and the aorta intraoperatively using a single double lumen central venous catheter inserted through the antegrade cardioplegia cannulation site across the aortic valve into the left ventricle.

Intraoperative post-resection assessment of septal myectomy.

Intraoperative assessment of all cardiac structures and their function is critical to the operative planning and post-intervention assessment of septal myectomy and all operations on the left ventricular outflow tract. Using a single case study, I will share my approach to both pre- and post-intervention transesophageal echocardiography assessment and how it guides decision making.

Cost-Effectiveness of Implantable Cardioverter-Defibrillators in Children with Cardiac Conditions Associated with Risk for Sudden Cardiac Death.

Children at high risk for sudden cardiac death (SCD) receive implantable cardioverter-defibrillators (ICD) for prevention, but the cost effectiveness of ICDs in children at intermediate risk is unclear. Our objective was to create a cost-effectiveness model to compare costs and outcomes in children at risk of SCD, with and without ICD. Utilizing hypertrophic cardiomyopathy as the proxy disease, a theoretical cohort of 8150 children was followed for 69 years. Model inputs were derived from the literature, with an incremental cost-effectiveness ratio (ICER) willingness-to-pay threshold of $100,000/quality-adjusted life year (QALY) used to delineate cost effectiveness. Outcomes included prevalence of severe neurological morbidity (SNM), SCD, cost, and QALYs. In children at intermediate risk of SCD (4-6% over 5 years), ICD resulted in 56 fewer cases of SNM, 2686 fewer deaths. In children at high risk (> 6% over 5 years), ICD placement resulted in 74 fewer cases of SNM and 3663 fewer deaths from cardiac causes. The costs of ICD were higher, but placement was cost effective with an ICER of $3009 per QALY in intermediate risk children, but ICD therapy was a dominant strategy in high-risk children. Sensitivity analysis demonstrated ICD placement was cost-effective until the annual probability of SCD was < 0.22%. The model was robust over a wide range of values. For children at risk of SCD, prophylactic ICD implantation is cost effective, resulting in improved outcomes and increased QALYs, despite increased costs. These findings highlight the economic benefits of ICD utilization in this population.

Living with hypertrophic cardiomyopathy and an implantable defibrillator.

BACKGROUND: ICDs efficiently terminate life-threatening arrhythmias, but complications occur during long-term follow-up. Patients' own perspective is largely unknown. The aim of the study was to describe experiences of hypertrophic cardiomyopathy (HCM) patients with implantable defibrillators (ICDs). METHODS: We analyzed 26 Swedish patient interviews using hermeneutics and latent content analysis. RESULTS: Patients (aged 27-76 years) were limited by HCM especially if it deteriorates into heart failure. The ICD implies safety, gratitude, and is accepted as a part of the body even when inappropriate ICD shocks are encountered. Nobody regretted the implant. Both the disease and the ICD affected professional life and leisure time activities, especially at younger ages. Family support was usually strong, but sometimes resulted in overprotection, whereas health care focused on medical issues. Despite limitations, patients adapted, accepted, and managed challenges. CONCLUSION: HCM patients with ICDs reported good spirit and hope even though they had to adapt and accept limitations over time.

An assessment of left atrial function in patients with hypertrophic obstructive cardiomyopathy before and 1 year after septal ablation by two-dimensional speckle tracking echocardiography.

OBJECTIVE: The objective of this study was to assess left atrial (LA) function with two-dimensional speckle tracking echocardiography (2DSTE) in addition to standard echocardiographic assessments in patients with hypertrophic obstructive cardiomyopathy (HOCM) before and 1 year after septal ablation (SA). METHODS: The study included 31 patients with HOCM, who underwent SA. Each patient with HOCM underwent a complete two-dimensional transthoracic echocardiography before and 1 year after the SA. The measurements included basal septal thickness, left ventricular outflow trace (LVOT) gradient, mitral regurgitation (MR) grade, LA dimensions, left ventricular (LV) ejection fraction, and tissue Doppler parameters of lateral mitral annular e' and septal mitral annular e'. The LA wall was tracked on a frame-by-frame basis using 2DSTE, and LA volume waveforms were generated. The maximum LA volume (LAVmax ), minimal LA volume (LAVmin ), and the LA volume before atrial contraction (LAVpre-a ) were measured. The LA reservoir function was calculated as the expansion index and diastolic emptying index. The LA conduit function was calculated as the passive emptying percentage of total emptying (PE) and the passive emptying index (PEI). The LA booster function was calculated as the active emptying percentage of total emptying (AE) and the active emptying index (AEI). RESULTS: The LVOT gradient, end-diastolic septal base thickness, the grade of MR, and LA end-diastolic size were significantly decreased in patients with HOCM before and 1 year after the SA (All P<.05). The lateral mitral annular e' was significantly increased (P<.05), and the E/lateral e' ratio was significantly decreased (P<.05), whereas septal mitral annular e' was significantly decreased (P<.05), and the E/septal e' ratio was significantly increased (P<.05). LAVImax , LAVImin , and LAVIpre-a were significantly decreased 1 year after the SA (All P<.05). The expansion and diastolic emptying indices were significantly increased (All P<.05) at 1 year after the SA. PE and PEI were significantly increased (All P<.05). The AE and AEI were significantly decreased (All P<.05). LAVImax , LAVImin , and LAVIpre-a of the responders group were significantly lower than those of the nonresponders group (All P<.05). The expansion and diastolic emptying indices of the responders group were significantly higher than those of the nonresponders group (All P<.05). The PE and PEI of the responders were significantly higher than those of the nonresponders group (All P<.05). The AE and AEI of the responders were significantly lower than those of the nonresponders group (All P<.05). CONCLUSIONS: We found an improvement in the LA reservoir and conduit function but a reduction in LA booster pump function 1 year after the SA in the responders.

Septal Ablation and Hypertrophic Obstructive Cardiomyopathy: 7 Years US Experience.

BACKGROUND: Septal ablation (SA) is a key modality for left ventricular outflow tract gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM) patients with refractory symptoms. The primary objective of our study was to evaluate post-procedural mortality, complications, length of stay (LOS), and cost of hospitalization following SA. METHODS: We queried the Nationwide Inpatient Sample (NIS) between 2005 and 2011 using the ICD9 procedure code of 37.34 for ablation of heart tissue. Only adult patients with HOCM (ICD-9-CM: 425.1) were included. Patients with any arrhythmia diagnosis or open surgical ablation procedure code were excluded. Hierarchical mixed effects models were generated in order to identify the independent multivariate predictors of outcomes. RESULTS: A total of 358 SAs were available for analysis. There was no reported mortality during the study period; permanent pacemaker implantation rate was 8.7%. Highest hospital volume tertile (OR, 95%CI, P- value) predicted significantly lower post-procedural complications (0.51, 0.26-0.98, P = 0.04). Univariate analysis of highest versus lowest tertile of hospital volume showed significant decrease in LOS (2.6 days vs. 3.8 days, P<0.01) and non-significant decrease hospitalization costs (16,800$ vs. 19,500$, P = 0.29). CONCLUSIONS: SA is a safe procedure and associated with low peri- procedural mortality rate. A higher burden of baseline comorbidities is associated with worse outcomes while higher annual hospital volume is associated with lower rate of post-procedural complications, length of stay, and cost of care following SA.

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.

Contrast-enhanced Steady-state Free Precession in the Assessment of Hypertrophic Obstructive Cardiomyopathy after Alcohol Septal Ablation.

PURPOSE: We evaluated the feasibility of contrast-enhanced steady-state free precession (ceSSFP) in the assessment of myocardial injury and obstruction of the left ventricular outflow tract (LVOT) in patients with hypertrophic obstructive cardiomyopathy (HOCM) after alcohol septal ablation (ASA). METHODS: Twelve patients with HOCM underwent 16 magnetic resonance (MR) examinations following ASA. Precontrast SSFP, ceSSFP and late gadolinium enhancement (LGE) imaging were performed with a 1.5-tesla imager. ceSSFP was performed 3 to 7 min after gadolinium injection. We visually and quantitatively evaluated the signal patterns of the myocardium after ASA on SSFP and LGE MR imaging. We observed the LVOT using ceSSFP in the 3-chamber view. RESULTS: We could visualize ASA-induced myocardial infarction (MI) in all 16 studies by LGE and ceSSFP but in only 6 studies (37.5%) by precontrast SSFP. Contrast was higher between MI and remote myocardium with LGE than ceSSFP (P < 0.01). ASA-induced hypointense regions were well visualized by the 2 sequences after contrast in the 7 patients who underwent MR imaging within 7 weeks of ASA and in a few patients after 80 weeks from ASA. The ceSSFP allowed comparable visualization of the jet flow crossing the LVOT to that derived from echocardiographic data. CONCLUSION: Contrast-enhanced steady-state free precession allows assessment of myocardial injury as well as of the left ventricular outflow tract after alcohol septal ablation in a single scan without penalty in scan time and cine imaging contrast.

Noninvasive assessment of myocardial fibrosis in patients with obstructive hypertrophic cardiomyopathy.

OBJECTIVE: Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) imaging is the reference standard for non-invasive assessment of fibrosis. In hypertrophic cardiomyopathy (HCM) patients the histological substrate for LGE is still unknown. The aim of this study was to assess the ability of LGE and strain echocardiography to detect type and extent of myocardial fibrosis in obstructive HCM patients undergoing septal myectomy. METHODS: Thirty-two HCM patients (age 60±10) were included in this cross-sectional study and preoperatively examined by speckle-tracking strain echocardiography and LGE-CMR (n=21). Histological fibrosis was classified as interstitial, replacement and total. RESULTS: Histological fibrosis was present in 31 patients. The percentage of total, interstitial and replacement fibrosis was 15(7, 31)%, 11(5, 24)% and 3(1, 6)%, respectively. Reduced longitudinal septal strain correlated with total (r=0.50, p=0.01) and interstitial (r=0.40, p=0.03), but not with replacement fibrosis (r=0.28, p=0.14). Septal LGE was detected in 13/21 (62%), but percentage LGE did not correlate with total fibrosis (r=0.25, p=0.28). Extent of fibrosis did not differ between patients with and without septal LGE (20(9, 58)% versus 14(5, 19)% p=0.41). Patients with ventricular arrhythmias (n=8) had lower septal longitudinal strain and increased extent total and interstitial fibrosis in myectomy specimens, but no differences were demonstrated in LGE. Reduced longitudinal septal strain and increased extent of interstitial fibrosis predicted ventricular arrhythmias independently of age and gender. CONCLUSIONS: In myectomised HCM patients, reduced longitudinal septal strain correlated better with interstitial and total fibrosis in myectomy specimens, and was a more powerful tool to predict arrhythmias than LGE.

Live/real time three-dimensional transesophageal echocardiographic assessment of ventricular septal volume and mass before and after myectomy in hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common genetically transmitted cardiomyopathy. In patients resistant to medical management, myectomy is the surgical procedure of choice to reduce the symptoms of left ventricular outflow obstruction. Two-dimensional transesophageal echocardiography (2DTEE) has become part of the operative procedure by decreasing the incidence of postoperative complications. However, because of the three-dimensional geometry of left ventricular outflow tract, it is unable to comprehensively assess the location and severity of the obstruction and to provide accurate guidance during myectomy. In this study, 10 patients with HCM underwent live/real time three-dimensional transesophageal echocardiography (3DTEE) intra-operatively to measure the volume of the resected septum. This volume correlated well with the volume of the resected septal muscle directly obtained using a graduating cylinder containing water (r = 0.9, P < 0.000). 3DTEE may be potentially used as an adjunct to guide the surgeon in performing an adequate myectomy with a lower incidence of residual obstruction and complications such as an iatrogenic ventricular septal defect.

Is multidetector computed tomography a suitable alternative to MR imaging for the assessment of myocardial necrosis after alcohol septal ablation?

BACKGROUND: To compare magnetic resonance (MR) imaging and multidetector computed tomography (MDCT) for the assessment of myocardial infarction (MI) after alcohol septal ablation (ASA). METHODS: Ten patients (mean age, 60 years ± 16) were examined with both MDCT and 1.5-T MR imaging performed 10 minutes after injection, within 3 days after ASA. Half of them had a temporary pacemaker (PM) during MDCT examination. Global image quality (IQ) and localization of MI were noticed on both MDCT and MR images. Volumes of MI, contrast-to-noise ratios (CNR) and signal-to-noise ratios (SNR) were also calculated. ASA effectiveness was evaluated by echocardiography immediately and 3 months after procedure. RESULTS: Global IQ was considered adequate for both procedures. In 8 patients, MI reached the basal part of the septum on both MDCT and MR images. The 2 remaining patients exhibited sparing of the basal septum on MDCT and MR images. Volumes of MI were within the same range with the 2 techniques (MDCT: 22.1 ± 8.8 mL; MR imaging: 23.8 ± 9.4 mL) and correlated well each other (R(2)=0.85, p<0.002). The 2 patients with sparing of the basal interventricular septum had persistent gradient on echocardiography 3 months after ASA, suggesting failure of the procedure. The volumes of MI didn't correlate with the reduction of pressure gradient on echocardiography 3 months after ASA (R(2)=0.02, p<0.05). CONCLUSIONS: Evaluation of post ASA MI is feasible with MDCT by comparison with MR imaging. MDCT might serve as an alternative imaging method in case of PM implantation.

Assessment of atrial conduction abnormalities in patients with hypertrophic cardiomyopathy before and one year after alcohol septal ablation.

OBJECTIVES: Intra- and interatrial electromechanical delay (AEMD) can be used to evaluate the development of atrial fibrillation (AF). Percutaneous transluminal septal myocardial ablation (PTSMA) is an alternative therapy for patients with hypertrophic obstructive cardiomyopathy (HOCM) that results in sustained improvements in atrial structure and function. We investigated the effects of PTSMA on the intra- and inter-AEMD of HOCM patients using tissue Doppler imaging. METHODS: Conventional echocardiographic and AEMD parameters were obtained in 25 healthy controls and 31 HOCM patients before and 1 year after septal ablation procedures. RESULTS: Compared with the healthy controls, the left atrial volumes indexed by body surface area (LAVI) and the intra- and inter-AEMD were significantly higher in the HOCM patients. At 1 year after PTSMA, the LAVI was decreased (37.2 ± 11.4 to 27.0 ± 8.5 ml/m(2), p < 0.001). The intra- and inter-AEMD were also significantly decreased (22.7 ± 9.2 to 16.6 ± 7.7 ms, p < 0.001 and 37.0 ± 8.4 to 26.6 ± 8.0 ms, p < 0.001, respectively). These changes correlated well with the reductions in LAVI (r = 0.83, p < 0.001; r = 0.66, p < 0.001). CONCLUSIONS: Both the intra- and inter-AEMD were significantly prolonged in the HOCM patients. PTSMA can improve the prolonged and inhomogeneous propagation of sinus impulses in atria.

Successful launch of cardiac transplantation in Japan. Osaka University Cardiac Transplant Program.

Cardiac transplantation has been established as a therapeutic strategy for patients with end-stage heart failure. In Japan, however, cardiac transplantation has not been performed since the first case in 1968, and even now, after legislation for the approval of brain death was passed in 1997, it is still not performed regularly. Following long and steady efforts to enlighten Japanese society about the concept of brain death and the importance of organ transplantation, the first cardiac transplantation under the new legislation was successfully performed at Osaka University Hospital on February 1999. The patient was 47-year-old male in the dilated phase of hypertrophic cardiomyopathy who had been supported with an implantable left ventricular assist device. This article briefly reviews the situation prior to the first case of cardiac transplantation under the new legislation and discusses the current status of the therapy in Japan.