Significant impact of left ventricular assist device models on the value of flow-mediated dilation: effects of LVAD on endothelial function.

The precise physiological changes associated with the use of left ventricular assist device (LVAD) are not well characterized. We examined the impact of changes in hemodynamic state using LVAD on endothelial function. We measured flow-mediated vasodilation (FMD) to evaluate endothelial vasodilator function of the brachial artery in 53 patients (dilated cardiomyopathy: 39, ischemic cardiomyopathy: 4, and others: 10) with an implanted LVAD (DuraHeart, EVAHEART, or HeartMate II). We found that FMD value in the HeartMateII LVAD group (9.3% ± 2.9%) was significantly higher than those in the other two groups (EVAHEART: 6.7% ± 2.8% and DuraHeart: 6.2% ± 4.0%). Other factors that affected the FMD value were age (r = - 0.31, p = 0.026), Brinkman index (r = - 0.30, p = 0.029); however, aortic opening, aortic regurgitation, and other hemodynamic parameters such as cardiac index or pulmonary capillary wedge pressure did not correlate with FMD. Multivariate analyses revealed that the difference among the LVAD models most significantly affected the FMD values after adjusting for age and smoking status (t = 2.6, p = 0.014). Event free survival rate of death and cerebral infarction was not significantly different according to the value of FMD. The difference among the LVAD groups most significantly affected the state of endothelial function and it had more impact than other clinical factors.

Clinical impact of newly developed atrial fibrillation complicated with longstanding ventricular fibrillation during left ventricular assist device support: A case report.

BACKGROUND: Continuous-flow left ventricular assist devices (LVADs) improve survival and morbidity in patients with stage D heart failure. Management of LVADs for longer durations is necessary in some clinical settings, and a better understanding of the hemodynamics of patients using LVADs is warranted. Arrhythmia, including atrial (AA) and ventricular (VAs) arrhythmias, is a modifying factor of hemodynamics that is highly prevalent among patients with LVADs. However, the clinical impact of arrhythmias in various clinical settings in patients with LVAD, in which the hemodynamic load is likely to present as worsening of right heart failure, remains to be completely elucidated. CASE PRESENTATION: We describe the case of a patient under sustained ventricular fibrillation for extraordinarily long duration who was stabilized using LVAD support and in whom newly developed atrial fibrillation led to a significant worsening of right heart failure while using an LVAD. CONCLUSION: This case demonstrates the substantial clinical impact of AAs in the management of right heart failure using an LVAD.

Long-term support by left ventricular assist device for arrhythmogenic right ventricular cardiomyopathy.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heart muscle disorder characterized by right ventricular enlargement, right heart failure (HF), and ventricular arrhythmias which lead to sudden death especially in young adults. Current recommendations for management of patients with ARVC are antiarrhythmic medications, catheter ablation, and implantable cardioverter defibrillator therapy to prevent sudden cardiac death. However, despite these treatments, few patients suffer from recurrent ventricular arrhythmias or HF unresponsive to conventional management. Heart transplantation (HTx) is a preferred treatment for these cases, but because of a persistent donor heart shortage in Japan, ventricular assist device (VAD) support has become an important option for a management of the end-stage ARVC. Previous articles reported 4 cases of a successful management by left ventricular assist device (LVAD), but the longest interval of LVAD support was only 333 days. We present 3 cases of ARVC patients who were successfully managed by LVAD implantation for more than a year. These 3 cases are unconventional examples of ARVC patients, considering the nature of the disease. The novelty of these cases should be taken in the context of the extremely long waiting period for HTx in Japan.

Single-center experience of the bridge-to-bridge strategy using the Nipro paracorporeal ventricular assist device.

Currently, we use the Nipro paracorporeal VAD (p-VAD) for initial short-term ventricular support, as a bridge to decision (BTD) or a bridge to candidacy (BTC) treatment, in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels 1 and 2 patients. However, it is possible that compared to patients with primary implantable-VADs (P-iVAD), the bridge-to-bridge (BTB) patients are more likely to develop complications. This retrospective study used data from 24 consecutive BTB patients who were initially implanted with Nipro p-VAD as BTD or BTC treatments between April 2011 and March 2016, and subsequently underwent conversion to an i-VAD. The data from 72 patients who underwent a primary i-VAD (P-iVAD) procedure were used for comparison. Between the two groups, there was no significant difference in the incidence of infectious events (p = 0.72) or stroke (p = 0.44). Orthotropic heart transplantation was performed in 6 of the 24 patients in the BTB group and in 21 of the 72 patients in the P-iVAD group. The 1- and 2-year survival rates were 95.8% and 95.8% in the BTB group and 91% and 85.8% in the P-iVAD group; these values were not significantly different between groups (p = 0.91). Based on these results we conclude that BTB using Nipro p-VAD is a reasonable strategy for treating patients with severe decompensated end-stage heart failure.

A Useful Scoring System For Predicting Right Ventricular Assist Device Requirement Among Patients with a Paracorporeal Left Ventricular Assist Device.

Ventricular assist devices (VADs) have become an important therapy for advanced heart failure, however, the prognosis of those who receive a biventricular assist device (BiVAD) is still poor. We enrolled 70 patients who underwent paracorporeal VAD (Nipro-VAD®) implantation between 2004 and 2015 and studied the preoperative risk factors, including hemodynamic parameters for RVAD requirement. Furthermore, 2-year survival was compared between the BiVAD group and LVAD only group. Fourteen patients (20%) required RVAD. The BiVAD group had a significantly smaller left ventricular diastolic/systolic dimension, lower mean pulmonary artery wedge pressure (PAWP), lower cardiac index (CI), higher pulmonary vascular resistance (PVR), higher mean right atrial pressure (RAP), lower pulmonary artery pulsatility index (PAPi), lower right ventricular stroke work index (RVSWI), and higher mean RAP/mean PAWP ratio preoperatively. After multivariate analysis, only PVR > 4.5 Wood units: WU (P = 0.013, odds ratio: OR 7.9) and mean RAP/mean PAWP > 0.8 (P < 0.001, OR 14.4) were significant predictors for RVAD requirement. From these odds ratios, we assigned 1 point to PVR > 4.5 WU and 2 points to mean RAP/mean PAWP > 0.8. This simple scoring method adequately stratified the incidence of RVAD implantation (score 0: 4.4%, score 1: 28.6%, score 2: 41.7%, score 3: 83.3%). The cumulative survival rate at 2-year after VAD implantation was significantly worse among patients who required RVAD support compared to the LVAD only group (28.5% versus 74.4%, P = 0.009). RVAD requirement is associated with poor long-term survival, and this simple scoring system using PVR and mean RAP/mean PAWP may be useful for predicting RVAD requirement in such patients.

Coronary Artery Aneurysm Caused by a Stent Fracture.

Coronary stent fracture (SF) is rare as a complication of percutaneous coronary intervention (PCI), and its adverse events are increasingly being recognized with the development in devices of PCI. The major adverse events caused by SFs are in-stent restenosis due to neointimal overgrowth caused by poor drug delivery.1,2) A coronary artery aneurysm (CAA) is a rare complication of SF, but may lead to lethal events such as acute coronary syndrome or rupture of the CAA further leading to cardiac tamponade.3-5) However, the management of CAAs is controversial with or without SF.6) Herein, we report a case of a CAA caused by an SF and discuss the management of CAA complicated with SF, along with a literature review. We suggest that surgical treatment should be considered the higher-priority strategy in the cases of CAA with SF as compared to CAA without SF.

[Implantable Ventricular Assist Device].

For patients with "stage D refractory heart failure" as stated by the The Japanese Circulation Society (JCS) 2017/The Japanese Heart Failure Society (JHFS) 2017 Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure, extensive therapeutic methods including implantation of ventricular assist device (VAD) and/or heart transplantation, as well as terminal care. An implantable VAD is a device designed to support patients for a long term of several years. This device has its most part buried in the body with its driveline penetrated out through the skin to connect with a controller and butteries. In Japan, implantable VADs started to be used in 2011, and now 3 devices are available in a commercial basis, that is, EVAHEART 2, HeartMate II and Jarvik 2000. They are available when a patient has been listed as a candidate for heart transplantation, and recently the usage of implantable VAD as destination therapy that is applied for patients who are not eligible for heart transplantation but would get benefit from circulatory support, enough to be free from hospital-bound status and enjoy high quality of life. If this device can prove to improve heart failure patients' symptoms, resulting in decreasing medical expense, surely it would be widely accepted as a promising therapy to treat heart failure.

Central aortic valve closure successfully treated aortic insufficiency of the patient with Jarvik 2000 continuous flow left ventricular assist device: a case report.

Aortic insufficiency (AI) is a significant complication of long-term support of continuous flow left ventricular assist device (CF-LVAD) for patients with end-stage heart failure. A 26-year-old female with osteogenesis imperfecta (OI) was diagnosed with dilated phase hypertrophic cardiomyopathy (d-HCM)) and was implanted with Jarvik 2000, for bridge to transplantation. AI gradually developed and surgical intervention was indicated. We performed central aortic valve closure (CAVC) instead of valve replacement 20 months after CF-LVAD implantation. Patient's symptoms dramatically improved postoperatively. This is the first report of CAVC for a patient supported with Jarvik 2000.

Correlation between driveline features and driveline infection in left ventricular assist device selection.

Although the survival rate for left ventricular assist device (LVAD) therapy has improved, device-related complications are an unpredictable threat to the patient's quality of life. We focused on driveline infection, and aimed to determine whether specific features of drivelines affect the frequency of infection. We enrolled patients who underwent LVAD implantation and were followed-up at our institute between 2007 and 2015. We counted the occurrences of driveline infection requiring any antibiotic therapy over a 2-year study period. Furthermore, we experimentally measured and compared the outer diameters and stiffness of three devices. Of all, 72 patients received an LVAD during the enrollment period. LVADs were HeartMate II (n = 32), EVAHEART (n = 22), and DuraHeart (n = 18). The outer diameters and stiffness were measured in five of each device. HeartMate II group had the highest driveline infection-free rate among all three devices during the study period (p = 0.042). The driveline of the HeartMate II LVAD had a significantly smaller outer diameter and lower stiffness than that of the other two devices (p < 0.05 for both). In conclusion, device-specific driveline features may affect the development of driveline infection during LVAD therapy.

Readmissions after continuous flow left ventricular assist device implantation.

Continuous flow left ventricular assist device (CF-LVAD) therapy has improved the survival of patients with advanced heart failure. However, the readmission rate of CF-LVAD patients is still relatively high. A total of 90 patients who received CF-LVADs between April 2011 and March 2016 at our institute and were discharged home were analyzed retrospectively. They were followed up through March 2017. Clinical data, including frequency, length and etiology of readmission, were obtained from medical records. The mean observation period after initial discharge was 713 ± 322 days. In total, 73 patients (81%) had 236 readmissions, 214 unplanned and 22 planned. The overall and unplanned readmission rates were 1.34 and 1.22 per patient-year, respectively. The rate of freedom from unplanned first readmission at 1 year after initial discharge was 39%. The median interval between the previous hospital discharge and first and second readmissions was 311 and 213 days, respectively (log-rank test, p = 0.117). The rate of readmission after more than three readmissions was significantly higher than that of first or second readmission (log-rank test, p < 0.001). The most common etiology of readmission was driveline infection (DLI) (36%), followed by stroke (9%). The median length of hospital stay due to DLI was 23 days. The patients with repeated unplanned readmissions had significantly lower EuroQol 5 dimensions questionnaire utility score than those with no or just one readmission. Readmission was common in CF-LVAD patients, and the most common etiology of readmissions was DLI. The interval to the next readmission seemed shorter for patients with repeated readmissions.

Cardiac Sarcoidosis Diagnosed by Incidental Lymph Node Biopsy.

Cardiac involvement in systemic sarcoidosis sometimes provokes life-threatening ventricular tachyarrhythmia. Steroid administration is one of the fundamental anti-arrhythmia therapies. For an indication of steroid therapy, a definitive diagnosis of sarcoidosis is required.1) However, cases that are clearly suspected of cardiac sarcoidosis based on their clinical courses sometimes do not meet the current diagnostic criteria and result in the loss of an appropriate opportunity to perform steroid therapy.Here we report a case that was diagnosed as sarcoidosis by incidental biopsy of an inguinal lymph node during cardiac resuscitation for cardiac tamponade.2) While the inguinal lymph node was not swollen on computed tomography, a specimen obtained from an incidental biopsy during the exposure of a femoral vessel for the establishment of extracorporeal cardio-pulmonary resuscitation showed a non-caseating granuloma.This findings suggest a non-swelling lymph node biopsy might be an alternative strategy for the diagnosis for sarcoidosis if other standard strategies do not result in a diagnosis of sarcoidosis.

Novel Scoring System to Predict Ineligibility for Bridge to Implantable Left Ventricular Assist Device as Destination Therapy Before Extracorporeal Ventricular Assist Device Implantation - For the Coming Era of Destination Therapy in Japan.

BACKGROUND: Although destination therapy (DT) is now expected to be a promising strategy for those who are not suitable for heart transplantation in Japan, there has not been any investigation into ineligibility for bridging to implantable left ventricular assist device (I-LVAD) as DT among patients with extracorporeal LVAD. METHODS AND RESULTS: We retrospectively studied 85 patients who had received an extracorporeal LVAD. To assess ineligibility for a bridge to I-LVAD for DT, we defined DT ineligibility (DTI) as BiVAD requirement, death within 6 months, and persistent end-organ dysfunction (medium or high J-VAD risk score) at 6 months after extracorporeal LVAD implantation. DTI was recorded for 32 patients. Uni/multivariate analysis showed that smaller left ventricular diastolic dimension (<64 mm; [odds ratio (OR) 4.522]), continuous hemodiafiltration (OR 4.862), past history of cardiac surgery (OR 6.522), and low serum albumin level (<3.1 g/dl; OR 10.064) were significant predictors of DTI. By scoring 2, 2, 3, 4 points, respectively, considering each OR, we constructed a novel scoring system for DTI (DTI score), which stratified patients into 3 risk strata: low (0-3 points), medium (4-6 points), and high (7-11 points), from the view point of DTI risk (low 8%, medium 46%, high 93%, respectively). CONCLUSIONS: DTI score is a promising tool for predicting ineligibility for I-LVAD as DT before extracorporeal VAD implantation.

Reversible decline in pulmonary function during left ventricular assist device therapy.

Cardiac replacement therapy, consisting of left ventricular assist device (LVAD) implant surgery and heart transplantation, has considerably reduced the mortality and morbidity of patients with stage D heart failure. However, its impact on pulmonary function remains unclear. We retrospectively evaluated 22 consecutive patients (16 men; 42 ± 13 years old) who had undergone pulmonary function tests during the heart failure, LVAD, and heart transplantation periods. The LVAD therapy lasted an average of 871 ± 267 days. The % vital capacity and forced expiratory volume in 1 s decreased significantly after LVAD implantation and returned to baseline levels after heart transplantation. Correlation analysis indicated that a shorter duration of LVAD support was associated with a more significant improvement in % vital capacity in heart transplantation recipients, compared to the pre-LVAD period and the LVAD period. In conclusion, we provide evidence that a decrease in pulmonary function occurs during LVAD support but it may be reversible. Limited LVAD duration may be a key for the recovery of pulmonary dysfunction.

High pulmonary vascular resistance in addition to low right ventricular stroke work index effectively predicts biventricular assist device requirement.

Although the right ventricular stroke work index (RVSWI) is a good index for RV function, a low RVSWI is not necessarily an indicator for the need for a right ventricular assist device at the time of left VAD implantation. We here aimed to determine a more precise indicator for the need for a biventricular assist device (BiVAD). In total, 116 patients (mean age, 38 ± 14 years), who underwent hemodynamic assessments preoperatively including 12 BiVAD patients, and had been followed at our institute from 2003 to 2015, were included. Multivariate logistic regression analysis indicated that RVSWI and pulmonary vascular resistance (PVR) were independent predictors of BiVAD requirement (P < 0.05 for both). In addition, all patients were classified into 4 groups: (1) normal (RVSWI > 5 g/m, PVR < 3.7 WU), (2) pulmonary hypertension (RVSWI > 5, PVR > 3.7), (3) RV failure (RVSWI < 5, PVR < 3.7), and (4) both pulmonary hypertension and RV failure (RVSWI < 5, PVR > 3.7), and examined. Most of the patients in Group 4 (75 %), with acutely depressed hemodynamics and inflammatory responses in the myocardium, required BiVAD. Overall, patients with BiVAD had a worse survival rate as compared with those with LVAD alone. In conclusion, high PVR in addition to low RVSWI effectively predicts BiVAD requirement.

Is cardiopulmonary exercise testing essential to indicate ventricular assist device implantation in patients with INTERMACS profile 4-7?

Cardiopulmonary exercise testing (CPXT) is a promising tool for predicting 2-year cardiac death or ventricular assist device (VAD) implantation in patients assigned to INTERMACS profile 4-7. However, CPXT is not available in all hospitals. We evaluated 130 patients <65 years old with advanced heart failure assigned to INTERMACS profile 4-7 who underwent CPXT. CPXT scores (0-8 points), which we created recently, and the Seattle HF Model (SHFM) scores were both significant predictors of 2-year cardiac death or VAD implantation (14 events) by Cox-regression analysis (P < 0.05 for both) and had comparable areas under the curve (AUCs) in receiver operating characteristic analyses (0.811 vs. 0.737, P > 0.05). The combination score: age <46 years and serum sodium concentration <137 mEq/L, both of which were significant predictors of cardiac death or VAD implantation by uni/multivariate Cox-regression analyses, had a significantly higher AUC than did CPXT scores (0.909, P < 0.05). In a validation study, the AUC of the combination score was comparable with that of SHFM among 52 patients <65 years old receiving adaptive servo-ventilator treatment (0.753 vs. 0.794, P > 0.05). In conclusion, VAD indication may be discussed without CPXT in patients <65 years old with INTERMACS profile 4-7 at least in the current Japanese situation.

Preoperative iodine-123 meta-iodobenzylguanidine imaging is a novel predictor of left ventricular reverse remodeling during treatment with a left ventricular assist device.

Although left ventricular reverse remodeling (LVRR) is accompanied with an improved clinical course during LV assist device (LVAD) treatment, its preoperative prediction remains uncertain. Twenty-seven heart failure patients with dilated cardiomyopathy were enrolled in this study. Patients underwent (123)I-meta-iodobenzylguanidine (MIBG) scintigraphy before LVAD implantation, and were monitored at our institute from 2010 to 2014. This study investigated the prognostic value of preoperative (123)I-MIBG parameters for predicting postoperative LVRR. Of the preoperative variables studied, including (123)I-MIBG data, washout rate (WR) ≤ 39 % was the only significant, independent predictor of LVRR (defined as LV ejection fraction ≥35 % at 6 months post-LVAD implant using univariate and multivariate logistic regression analyses) (p = 0.036, odds ratio [OR]:14.45). Improved exercise capacity and more frequent opening of the native aortic valve, as well as lower B-type natriuretic peptide plasma levels, were observed in LVRR patients (p < 0.05 for all), although ß-blocker doses were comparable with those of non-LVRR patients throughout the 6-month LVAD support period. In conclusion, preoperative (123)I-MIBG is a novel predictive tool of LVRR during LVAD support.

A delayed splenic rupture after transcatheter arterial embolization required total splenectomy in a patient with an implantable left ventricular assist device.

We successfully managed a splenic injury and delayed splenic rupture in a patient with an implantable left ventricular assist device (iLVAD). A 42-year-old man with an iLVAD for idiopathic dilated cardiomyopathy was admitted to our department complaining of dizziness. Laboratory data showed severe anemia, and computed tomography demonstrated a traumatic splenic injury. Following conservative treatment, partial splenic embolization was performed. Fifteen days after the intervention, the patient went into hemorrhagic shock due to delayed splenic rupture. Emergency total splenic embolization was performed, and total splenectomy was conducted later to prevent re-bleeding or abscess formation. His postoperative course was uneventful, and he was discharged on postoperative day 22. Finally, he underwent orthotropic heart transplantation without post-splenectomy sepsis or thrombotic complications 472 days after splenectomy. Splenic injury should be considered as a possible complication of iLVAD. In addition, careful follow-up after transcatheter arterial embolization for splenic injury is essential for managing delayed splenic rupture.

A successful management of infection of the left ventricular assist device by pump exchange: conversion from DuraHeart to Jarvik 2000.

We successfully controlled infection of a left ventricular assist device by performing pump exchange. A 53-year-old man was implanted with DuraHeart for ischemic cardiomyopathy as a bridge to transplantation. Two years later, he was hospitalized with the diagnosis of driveline infection. The blood cultures detected Pseudomonas aeruginosa. During the admission, he developed brain hemorrhage perhaps due to septic emboli. The chest computed tomography scan revealed a small defect inside the outflow graft of the DuraHeart, which was highly suspected of vegetation. He underwent pump exchange, from DuraHeart to Jarvik 2000 with concomitant omentopexy. His postoperative course was uneventful, and he was discharged with no sequela of the brain hemorrhage. Four months after the pump exchange, he successfully underwent heart transplantation. No infectious tissue was observed in the pericardial space at the time of heart transplantation. Pump exchange is an effective way to manage refractory left ventricular assist device infection, and the timing of surgical intervention is of great importance.

Successful management of apical abscess after Nipro left ventricular assisted device explantation by removal of apical cuff and omentopexy.

Nipro-Toyobo-paracorporeal pulsatile flow VAD (Nipro VAD; Nipro, Osaka, Japan) has been used most commonly as a paracorporeal VAD (p-VAD) in Japan. There are few reports describing clinical course of post LVAD explantation and its complication. We herein present two cases of apical abscess after the explantation of the device. SSI is a main risk factor of formation of the apical abscess at the time of LVAD explantation. It is mandatory to perform sufficient debridement and closure of the layers including abdominal muscle and anterior abdominal fascia at exit sites in the explantation surgery. Omentopexy is also helpful for prevention from infection. Routine removal of apical cuff and outflow graft could be considered as one of the options when LVAD is explanted as bridge to recovery.