Perforation of the right atrial appendage during implantation of a leadless pacemaker.

We report a case of perforation of the right atrial appendage during implantation of a leadless pacemaker in a 94 years old woman. We performed emergency surgery to repair the perforation site. To our konwledge, there are few reports of right atrial perforation during a leadless pacemaker indwelling.

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.

Effects of Preoperative ß-Blocker Use on Clinical Outcomes after Coronary Artery Bypass Grafting: A Report from the Japanese Cardiovascular Surgery Database.

BACKGROUND: The authors evaluated the effect of preoperative ß-blocker use on early outcomes in patients undergoing coronary artery bypass grafting (CABG) in Japan. METHODS: The authors analyzed 34,980 cases of isolated CABGs, performed between 2008 and 2011, at the 333 sites recorded in the Japanese Cardiovascular Surgical Database. In addition to the use of multivariate models, a one-to-one matched analysis, based on estimated propensity scores for patients with or without preoperative ß-blocker use, was performed. RESULTS: The study population (mean age, 68 yr) comprised 20% women, and ß-blockers were used in 10,496 patients (30%), who were more likely to have risk factors and comorbidities than patients in whom ß-blockers were not used. In the ß-blocker and non-ß-blocker groups, the crude in-hospital mortality rate was 1.7 versus 2.5%, whereas the composite complication rate was 9.7 versus 11.6%, respectively. However, after adjustment, preoperative ß-blocker use was not a predictor of in-hospital mortality (odds ratio, 1.00; 95% CI, 0.82 to 1.21) or complications (odds ratio, 0.99; 95% CI, 0.91 to 1.08). When the outcomes of the two propensity-matched patient groups were compared, differences were not seen in the 30-day operative mortality (1.6 vs. 1.5%, respectively; P = 0.49) or postoperative complication (9.8 vs. 9.7%; P = 1.00) rates. The main findings were broadly consistent in a subgroup analysis of low-risk and high-risk groups. CONCLUSION: In this nationwide registry, the use of preoperative ß-blockers did not affect short-term mortality or morbidity in patients undergoing CABG.

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.

Two Case Reports of Group B Streptococcal Infective Endocarditis Complicated by Embolism.

Streptococcus agalactiae (Group B streptococcus, GBS) is the major pathogen encountered in the perinatal period, although the incidence of GBS infection has recently increased among non-pregnant adults. Nevertheless, GBS infective endocarditis (IE) is uncommon and often accompanies aortic embolism. We experienced two cases of GBS IE. In Case 1, mobile vegetation of the aortic valve caused an infective cerebral aneurysm. In Case 2, the patient experienced an acute aortic embolic episode. Generally, early surgery for large mobile sites of vegetation is recommended as a class IIb therapy in the guidelines. GBS IE often exhibits a severe clinical course and specificity of vegetation. Therefore, early surgery should be considered in such cases.

Prophylactic Intra-Aortic Balloon Pump Before Ventricular Assist Device Implantation Reduces Perioperative Medical Expenses and Improves Postoperative Clinical Course in INTERMACS Profile 2 Patients.

BACKGROUND: Although intra-aortic balloon pump (IABP) is sometimes used before cardiac surgery to achieve better outcome in high-risk patients, the clinical impact of prophylactic IABP support before left ventricular assist device (LVAD) implantation in patients with worsening hemodynamics was unknown. METHODS AND RESULTS: We enrolled 22 patients with worsening hemodynamics who had received IABP support before LVAD (IABP group), and also enrolled 22 patients receiving neither IABP nor extracorporeal membrane oxygenation before LVAD, who were selected on propensity score matching (non-IABP group). Although both groups had similar preoperative background, the IABP group had shorter postoperative intensive care unit (ICU) stay, and more improved hemodynamics (P<0.05 for all). Serum total bilirubin and creatinine decreased significantly in the IABP group compared with the non-IABP group during 1 month after LVAD implantation (P<0.05 for both). Medical expenses during perioperative ICU stay were significantly lower in the IABP group compared with the non-IABP group, even including the cost of preoperative IABP support (P<0.05). CONCLUSIONS: Prophylactic IABP support in heart failure patients with worsening hemodynamics improves post-LVAD clinical course and reduces perioperative medical expenses.

Plasma neutrophil gelatinase-associated lipocalin and worsening renal function during everolimus therapy after heart transplantation.

Recently, the mammalian target of rapamycin inhibitor everolimus (EVL) has been introduced as a novel immunosuppressant for heart transplant (HTx) recipients, and is expected to preserve renal function compared to conventional calcineurin inhibitors (CNIs). However, a considerable number of recipients treated with EVL were not free from worsening renal function regardless of CNI reduction. Data were collected retrospectively from 27 HTx recipients who had received EVL (trough concentration, 3.1-9.2 ng/mL) along with reduced CNIs (%decreases in trough concentration, 27.3 ± 13.0%) because of switching from mycophenolate mophetil due to digestive symptoms or neutropenia, progressive coronary artery vasculopathy, or persistent renal dysfunction, and had been followed over 1 year between August 2008 and January 2013. Estimated glomerular filtration rate (eGFR) decreased in 5 recipients (18.5%) during the study period. Univariate logistic regression analysis demonstrated that a higher plasma neutrophil gelatinase-associated lipocalin (P-NGAL) level was the only significant predictor for a decrease in eGFR over a 1-year EVL treatment period among all baseline parameters (P = 0.008). eGFR and proteinuria worsened almost exclusively in patients with baseline P-NGAL ≥ 85 ng/mL, which was the cutoff value calculated by an ROC analysis (area under the curve, 0.955; sensitivity, 1.000; specificity, 0.955). In conclusion, higher P-NGAL may be a novel predictor for the worsening of renal function after EVL treatment that is resistant to CNI reduction in HTx recipients.

Late rejection occurred in recipients who experienced acute cellular rejection within the first year after heart transplantation.

Serial endomyocardial biopsies (EMBs) are scheduled even several years after heart transplantation (HTx) to monitor for late rejection (LR). However, repeated EMBs are associated with an increased risk for fatal complications and decrease the quality of life of the recipient. We retrospectively analyzed clinical data from 42 adult recipients who had received HTx and were followed > 1 year at the University of Tokyo Hospital. Five recipients experienced LR at 1130 ± 157 days after HTx, and all 5 had experienced acute cellular rejection (ACR) with ISHLT grade ≥ 2R within the first year, which was treated with methylprednisolone pulse therapy (sensitivity, 1.000; specificity, 0.7027). Logistic regression analyses demonstrated that positive panel reactive antibody (PRA) was the only significant predictor for LR among all parameters at 1 year after HTx (P = 0.020, odds ratio 24.00). Among the 5 recipients with LR, LR occurred earlier in the two PRA positive recipients than in those with a negative PRA (981 ± 12 versus 1230 ± 110 days, P = 0.042). Among the perioperative parameters, gender mismatch [n = 13 (31%)] was the only significant predictor for ACR within the first year in logistic regression analyses (P = 0.042, odds ratio 4.200). In conclusion, the current schedule of serial EMBs should perhaps be reconsidered for recipients without any history of ACR within the first year due to their lower risk of LR.

Readmission due to driveline infection can be predicted by new score by using serum albumin and body mass index during long-term left ventricular assist device support.

Survival in patients with continuous flow left ventricular assist device (CF LVAD) had been increased owing to improved perioperative management procedures. The second target for successful long-term LVAD treatment was to reduce readmission especially due to device-specific infection, which was one of the major unsolved complications. Among 57 enrolled patients who had received CF LVAD and been followed for 530 days on median at our institute between 2008 and 2014, 21 patients experienced readmission due to driveline infection (DLI) at 190 days after the surgery on median. Considering the result of Uni/Multivariate Cox regression analyses demonstrating lower serum albumin concentration (S-ALB) (hazard ratio 0.144) and body mass index (BMI) (hazard ratio 0.843) both obtained at discharge were independent predictors of readmission due to DLI, we constructed a New Score "7 × [S-ALB (g/dL)] + [BMI]", which significantly stratified readmission-free rate into 3 groups [low (>50 Pt), intermediate (44-50 Pt), and high risk group (<44 Pt)] during 2-year study period (p = 0.008). Survival remained unchanged irrespective of DLI, whereas those with DLI needed longer in-hospital treatment (p < 0.05). In conclusion, readmission due to DLI could be predicted by using two simple nutrition parameters at discharge. Early nutrition assessment and intervention may reduce readmission and improve patients' quality of life during long-term LVAD support.

Is the internal jugular vein or femoral vein a better approach site for endomyocardial biopsy in heart transplant recipients?

Scheduled serial endomyocardial biopsies are executed by an internal jugular vein (IJV) or femoral vein (FV) approach to survey acute rejection after heart transplantation (HTx). However, a better approach site is needed. A total of 379 sessions consisting of 329 IJV approaches and 50 FV approaches in 48 HTx recipients executed at 75 ± 127 days (41182 days) after HTx between September 2007 and April 2014 at University of Tokyo Hospital were retrospectively analyzed. The IJV approach had shorter operation and radiation exposure times, and a lower dose of radiation exposure and lower usage of contrast agents than the FV approach (all P < 0.001). There were no fatal complications requiring surgical management or resulting in death during all sessions. The IJV approach had less complications than the FV approach (2.7% versus 10.0%, P = 0.011). Among the complications, atrial tachyarrhythmia occurred only with the IJV approach (0.9%), whereas transient ventricular tachyarrhythmia and bundle branch block were more frequently observed in the FV approach (8.0% versus 0.9%, P = 0.042). In conclusion, endomyocardial biopsy from the IJV approach was safer and less invasive than that of the FV approach if we only consider the incidence of atrial tachyarrhythmia.

Low cardiac output stimulates vasopressin release in patients with stage d heart failure.

BACKGROUND: Depressed hemodynamics stimulates arginine vasopressin (AVP) release, but the relationship between plasma AVP levels (P-AVP) and cardiac parameters, especially in patients with stage D heart failure (HF) receiving guideline-directed medical therapy, has not examined. METHODS AND RESULTS: Data including P-AVP were obtained from 162 in-hospital patients with stage D HF and from 80 patients receiving ventricular assist device (VAD, n=46) or heart transplantation (HTx, n=34) at 3 months after surgery. In the HF group, considerably high P-AVP (5.9±6.1 pg/ml) negatively correlated with serum sodium concentration (S-Na, 135.3±5.8 mEq/L, r=-0.548 [P<0.01]) and cardiac index (CI, 2.2±0.5 L·min(-1)·m(-2), r=-0.458 [P<0.01]). After VAD/HTx treatment, improvement in the CI (2.7±0.5 L·min(-1)·m(-2)[P<0.01] vs. HF) was accompanied by normalization of serum sodium concentration (S-Na; 138.2±2.0 mEq/L [P<0.01] vs. HF) and suppressed release of AVP (1.7±3.4 pg/ml [P<0.01] vs. HF). P-AVP positively correlated with only S-Na (r=0.454 [P<0.01]), whereas no correlation was observed with CI after VAD/HTx treatment. P-AVP ≥5.3 pg/ml well predicted poor 2-year survival in HF group (60% [P<0.01] vs. 90%). CONCLUSIONS: Low cardiac output stimulates AVP release via a non-osmotic process that results in hyponatremia and poor prognosis in patients with stage D HF. After sufficient recovery of cardiac output by cardiac replacement therapy, AVP release is suppressed and is mainly regulated by serum osmolality.

Simultaneous evaluation of wall motion and blood perfusion of a beating heart using stereoscopic fluorescence camera system.

In this study, we aimed to develop a stereoscopic fluorescence camera system for simultaneous evaluation of wall motion and tissue perfusion using indocyanine green (ICG) fluorescence imaging. The system consists of two high-speed stereo cameras, an excitation lamp, and a computer for image processing. Evaluation experiments demonstrated that the stereoscopic fluorescence camera system successfully performed the simultaneous measurement of wall motion and tissue perfusion based on ICG fluorescence imaging. Our system can be applied to intraoperative evaluation of cardiac status, leading to an improvement in surgical outcomes.

Endovascular treatment of cerebral hemorrhage in a patient with a left ventricular assist device: report of a case.

Cerebral hemorrhage is a common lethal complication associated with left ventricular assist device (LVAD) management. We performed cerebral angiography on patients with LVAD who developed cerebral hemorrhage and determined that ruptured aneurysms were the cause in some cases. Endovascular management of patients with LVAD can be a therapeutically useful approach for cerebral hemorrhage caused by aneurysm rupture.

Successful treatment of pump pocket infection after left ventricular assist device implantation by negative pressure wound therapy and omental transposition.

A 52-year-old man suffering from dilated cardiomyopathy underwent implantable left ventricular assist device (LVAD) insertion as a bridge to transplantation. He presented with evidence of LVAD-related mediastinitis and pump pocket infection 57 days after the LVAD implantation. The mediastinum was reopened and irrigated. A large amount of pus was observed around the outflow and inflow conduits and in the pump pocket. Negative pressure wound therapy (NPWT) was initiated. Methicillin-resistant Staphylococcus aureus (MRSA) was isolated from blood and mediastinal pus. Enterobacter cloacae was also isolated by mediastinal pus culture after the beginning of the NPWT. Three weeks after the start of the NPWT, the pus culture became negative, and omental transposition and sternal closure were performed. Intravenous antibiotics were administered until day 42, with the treatment subsequently switched to oral antibiotics. He was discharged from the hospital on day 57 and followed up at the outpatient clinic. Our findings suggest that NPWT followed by omental transposition be useful to treat mediastinitis or pump pocket infection after implantable LVAD insertion.

Everolimus-incorporated immunosuppressant strategy improves renal dysfunction while maintaining low rejection rates after heart transplantation in Japanese patients.

The long-term survival of heart transplantation (HTx) recipients has increased significantly in recent years, however, the nephrotoxic adverse effects of calcineurin inhibitors (CNIs) are still a major concern. Recently, an inhibitor of mammalian target of rapamycin, everolimus (EVL), has emerged as an alternative immunosuppressant drug that may allow CNI dosage reduction and thereby spare renal function. Data were collected from 20 HTx recipients who had received EVL (target trough level 3-8 ng/mL) along with a dose reduction of CNIs and/or mycophenolate mophetil (MMF) and had been followed for 1 year. Estimated glomerular filtration rate increased significantly with a reduction in the CNI dosage in a dose-dependent manner (P < 0.001, r = -0.807). Neutrophil count increased significantly (P < 0.05) with a reduction in the dosage of MMF (P = 0.009, r = -0.671). Cytomegalovirus antigenemia remained negative after EVL administration among all candidates without any antiviral agents (P = 0.001). There were no significant increases in the acute rejection rates among recipients with EVL compared to those without EVL (P = 0.132). An immunosuppressant strategy incorporating EVL could reduce the CNI and MMF dosages, which resulted in improvements in renal dysfunction and neutropenia while maintaining low rejection rates among HTx recipients.

[Mid-long term result of implantable ventricular assist device treatment for end-stage heart failure in the University of Tokyo Hospital].

Two implantable left ventricular assist devices(I-LVADs)were approved in Japan in 2011. I-LVADs were used for end-stage heart failure of 20 patients in our institute until March 2012. We examine the clinical course of these 20 patients who were treated with I-LVADs. End points are transplantation, death, or weaning from I-LVADs. Mean hospital days after I-LVAD implantation were 58.1 days, and all 20 patients could discharge from hospital alive. Until September 2012, mean follow up interval was 515 days. Five patients reached heart transplantation, 2 died, weaning from an I-LVAD could be done in 1 patient, and 12 continued to wait for heart transplantation. Survival rate was 100% at 1 month, 95% at 3 months, and 89% at 1 year, respectively. Mean follow up duration after discharge were 457 days, and 16 patients(80%)needed a total of 41 times of readmission in this period. Freedom from readmission was 75% at 1 month, 60% at 3 months, and 25% at 1 year, respectively. In conclusion, prognosis of I-LVAD treatment was good, but many patients needed readmission after I-LVAD implantation and follow up system for I-LVAD treatment should be improved immediately.

Deep sternal wound infection after cardiac surgery.

BACKGROUND: Deep sternal wound infection (DSWI) is a serious postoperative complication of cardiac surgery. In this study we investigated the incidence of DSWI and effect of re-exploration for bleeding on DSWI mortality. METHODS: We reviewed 73,700 cases registered in the Japan Adult Cardiovascular Surgery Database (JACVSD) during the period from 2004 to 2009 and divided them into five groups: 26,597 of isolated coronary artery bypass graft (CABG) cases, 23,136 valvular surgery cases, 17,441 thoracic aortic surgery cases, 4,726 valvular surgery plus CABG cases, and 1,800 thoracic aortic surgery plus CABG cases. We calculated the overall incidence of postoperative DSWI, incidence of postoperative DSWI according to operative procedure, 30-day mortality and operative mortality of postoperative DSWI cases according to operative procedure, 30-day mortality and operative mortality of postoperative DSWI according to whether re-exploration for bleeding, and the intervals between the operation and deaths according to whether re-exploration for bleeding were investigated. Operative mortality is defined as in-hospital or 30-day mortality. Risk factors for DSWI were also examined. RESULTS: The overall incidence of postoperative DSWI was 1.8%. The incidence of postoperative DSWI was 1.8% after isolated CABG, 1.3% after valve surgery, 2.8% after valve surgery plus CABG, 1.9% after thoracic aortic surgery, and 3.4% after thoracic aortic surgery plus CABG. The 30-day and operative mortality in patients with DSWI was higher after more complicated operative procedures. The incidence of re-exploration for bleeding in DSWI cases was 11.1%. The overall 30-day/operative mortality after DSWI with re-exploration for bleeding was 23.0%/48.0%, and it was significantly higher than in the absence of re-exploration for bleeding (8.1%/22.0%). The difference between the intervals between the operation and death according to whether re-exploration for bleeding had been performed was not significant. Age and cardiogenic shock were significant risk factors related to re-exploration for bleeding, and diabetes control was a significant risk factor related to DSWI for all surgical groups. Previous CABG was a significant risk factor related to both re-exploration for bleeding and DSWI for all surgical groups. CONCLUSIONS: The incidence of DSWI after cardiac surgery according to the data entered in the JACVSD registry during the period from 2004 to 2009 was 1.8%, and more complicated procedures were followed by higher incidence and mortality. When re-exploration for bleeding was performed, mortality was significantly higher than when it was not performed. Prevention of DSWI and establishment of an effective appropriate treatment for DSWI may improve the outcome of cardiac surgery.

Subacute presentation of right ventricular perforation after pacemaker implantation.

We report an 87-year-old woman with right ventricular perforation due to a permanent pacemaker lead detected 4-days after implantation. The pacemaker lead was seen to perforate through the myocardium and pericardium and to reach the left pleural cavity. We removed the wire surgically by median sternotomy. The pericardial effusion was cloudy and yellowish, suggesting infection. However, no bacteria were detected by bacterial cultures of the pericardial effusion and pacing wire. The patient developed neither mediastinitis nor sepsis after the operation, and a new pacemaker was implanted safely one month later.