Mid-term outcomes of surgical aortic valve replacement using a mosaic porcine bioprosthesis with concomitant mitral valve repair.

This study retrospectively evaluated the mid-term outcomes of surgical aortic valve replacement (SAVR) using a stented porcine aortic valve bioprosthesis (Mosaic; Medtronic Inc., Minneapolis, MN, USA) with concomitant mitral valve (MV) repair. From 1999 to 2014, 157 patients (median [interquartile range] age, 75 [70-79] years; 47% women) underwent SAVR with concomitant MV repair (SAVR + MV repair), and 1045 patients (median [interquartile range] age, 76 [70-80] years; 54% women) underwent SAVR only at 10 centers in Japan as part of the long-term multicenter Japan Mosaic valve (J-MOVE) study. The 5-year overall survival rate was 81.5% ± 4.1% in the SAVR + MV repair group and 85.1% ± 1.4% in the SAVR only group, and the 8-year overall survival rates were 75.2% ± 5.7% and 78.1% ± 2.1%, respectively. Cox proportional hazards analysis showed no significant difference in the survival rates between the two groups (hazard ratio, 0.87; 95% confidence interval, 0.54-1.40; P = 0.576). Among women with mild or moderate mitral regurgitation who were not receiving dialysis, those who underwent SAVR + MV repair, were aged > 75 years, and had a preoperative left ventricular ejection fraction of 30-75% tended to have a lower mortality risk. In conclusion, this subgroup analysis of the J-MOVE cohort showed relevant mid-term outcomes after SAVR + MV repair.

Clinical practice guidelines for telesurgery 2022 : Committee for the promotion of remote surgery implementation, Japan Surgical Society.

Telesurgery is expected to improve medical access in areas with limited resources, facilitate the rapid dissemination of new surgical procedures, and advance surgical education. While previously hindered by communication delays and costs, recent advancements in information technology and the emergence of new surgical robots have created an environment conducive to societal implementation. In Japan, the legal framework established in 2019 allows for remote surgical support under the supervision of an actual surgeon. The Japan Surgical Society led a collaborative effort, involving various stakeholders, to conduct social verification experiments using telesurgery, resulting in the development of a Japanese version of the "Telesurgery Guidelines" in June 2022. These guidelines outline requirements for medical teams, communication environments, robotic systems, and security measures for communication lines, as well as responsibility allocation, cost burden, and the handling of adverse events during telesurgery. In addition, they address telementoring and full telesurgery. The guidelines are expected to be revised as needed, based on the utilization of telesurgery, advancements in surgical robots, and improvements in information technology.

Long-Term Outcomes of the Mosaic Mitral Porcine Bioprosthesis in Japan　- Results From the Japan Mosaic Valve Long-Term Multicenter Study.

BACKGROUND: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic mitral porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study.Methods and Results:The medical records of 390 patients who underwent mitral valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014) were reviewed. Patient data were collected using the Research Electronic Data Capture software. Patient survival was determined using the Kaplan-Meier method. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined using actuarial methods. The median (interquartile range [IQR]) age of the cohort was 73 (69-77) years. The median (IQR) follow-up period was 4.83 (1.84-8.26) years. The longest follow-up period was 15.8 years. The 30-day mortality rate was 5.4%. The 12-year actuarial survival rate was 54.1±4.5%, and the freedom from valve-related death was 85.3±3.4%. The freedom from reoperation at 12 years was 74.3±5.7%. The freedom from SVD at 12 years was 81.4±6.6% for patients aged ≥65 years and 71.6±11.1% for those aged <65 years. The median (IQR) mean pressure gradient was 4.1 (3.0-6.0) and 5.6 (4.0-6.7) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.7 (1.4-2.0) and 1.4 (1.2-1.6) cm2at 1 and 10 years, respectively. CONCLUSIONS: The Mosaic porcine bioprosthesis offered satisfactory long-term outcomes for up to 12 years.

Impact of sleep-disordered breathing on ventricular tachyarrhythmias after left ventricular assist device implantation.

Sleep-disordered breathing (SDB) is associated with an increased risk of adverse events in patients with heart failure (HF); however, its impact in patients implanted with a left ventricular assist device (LVAD) remains unclear. We aimed to investigate the prevalence of SDB in patients with LVAD and its impact on their clinical outcomes. Fifty consecutive patients with LVAD who underwent portable sleep monitoring between September 2017 and April 2018 were prospectively enrolled, and they were followed up for 170 ± 36 days. According to their respiratory disturbance indexes (RDIs), they were categorized into the SDB group (RDI ≥ 15, n = 12) and the non-SDB group (RDI < 15, n = 38). The incidence of adverse events during the follow-up period was investigated after enrollment. Multivariate logistic regression analysis revealed significant differences in SDB in LVAD-implanted patients in terms of the logarithmic transformation brain natriuretic peptide (BNP) values (p = 0.005). The optimal BNP cut-off value for SDB prediction in LVAD-implanted patients was 300 pg/mL (sensitivity: 58.3%, specificity: 94.7%). During follow-up, ventricular tachyarrhythmias (VTas) occurred significantly more frequently in the SDB group (4 [33%] vs. 2 [5%] patients, p = 0.02); Atrial tachyarrhythmia (ATa) also tended to occur more frequently in the SDB group (2 [25%] vs. 2 [2%] patients, p = 0.07). SBD was prevalent in 24% of the LVAD-implanted patients with advanced HF. Furthermore, SDB was significantly associated with high BNP levels and was also potentially associated with subsequent incidence of VTa in patients with LVAD.

Efficacy of Off-Pump Coronary Artery Bypass Grafting With Concomitant Transcatheter Aortic Valve Replacement.

AIM: This study aimed to evaluate the early and intermediate-term outcomes of patients who underwent concomitant off-pump coronary artery bypass grafting (CABG) and transcatheter aortic valve replacement (TAVR). METHOD: Between January 2014 and June 2021, 49 patients underwent concomitant off-pump CABG and TAVR via median sternotomy (TAVRCAB group) and 143 underwent concomitant on-pump CABG and surgical aortic replacement. Of the 143 patients who underwent on-pump surgery, 80 (SAVRCAB group) were eligible for comparison. The composite event included all-cause death, heart failure rehospitalisation, repeat revascularisation, brain infarction, and repeat aortic valve replacement. RESULTS: The Society of Thoracic Surgeons' predicted risk for mortality and age were higher in the TAVRCAB group than in the SAVRCAB group (7.1% vs 3.1% [p<0.001]; 81 yrs vs 75 years [p<0.001], respectively), while the surgical time was shorter (289 min vs 352 min; p<0.001). There was no conversion to on-pump surgery in the TAVRCAB group. The postoperative maximum creatinine kinase-MB value was lower in the TAVRCAB group. There was no deep sternal wound infection or repeat revascularisation in either group. Hospital death and brain infarction developed in one patient (1.3%) each in the SAVRCAB group, but in no patients in the TAVRCAB group. The rates of freedom from the composite event were similar between the two groups during the follow-up period. CONCLUSIONS: Concomitant off-pump CABG and TAVR would be a less-invasive alternative procedure for treating intermediate or high surgical risk patients with aortic stenosis and coronary artery disease unsuitable for percutaneous coronary intervention.

[Robot-assisted Cardiac Surgery Council and Current Status and Future Prospect of Robotic Mitral Valve Surgery in Japan].

The Robot-assisted Cardiac Surgery Council (RACSC) was established in 2015, and consists of the members of three closely related surgical societies and associations. The RACSC conducts the review and approval of applicant surgeons and institutions. A registry system has also been established through the Japan Cardiovascular Surgery Database-National Clinical Database( JCVSD-NCD). For the last five years, including the time when robotic mitral valve surgery was first approved as a procedure covered by the Japanese social insurance system in 2018, a total of 1,161 patients were enrolled in the JCVSDNCD, with an increase of nearly 500 cases per year. These cases underwent operations in 25 approved hospitals. The mean patient age was 59±13 years( range:20-90 years), and the male to female patient ratio was 1.8 male dominant. The most common procedure was mitral valve reconstruction, and 79% of all patients underwent annuloplasty. The mean operative time was 238±100 min, the mean cardiopulmonary bypass (CPB) time was 158±69 min, and the mean aortic cross-clamp (AXC) time was 102±49 min. When these results were compared with those of the Cleveland Clinic, which treated more than 1,000 cases as an initial institutional experience, both CPB and AXC times were nearly the same. It is believed that 200 cases are needed to stabilize the CPB and AXC time. Currently in Japan, only 3 or 4 out of the 25 approved hospitals have performed more than 200 cases over the past 5 years. The 30-day hospital mortality and redo operation rate for persisting mitral regurgitation was 0.3% and 0.6%, respectively, almost equivalent to that of the Cleveland Clinic. We believe that the 5-year result for robotic mitral surgery in Japan is acceptable. It is of note, however, that the length of hospital stay was 10.8±7.6 days, much longer than that of patients at the Cleveland Clinic( 5.2±2.8 days), and the homologous blood transfusion rate was 40.3%, twofold higher than that of the Cleveland Clinic( 20.5%). Therefore, the full benefits of less invasive robotic mitral repair surgery have not yet been achieved. Further improvements in results are both essential and anticipated.

Clinical potential of hemodynamic ramp test by simultaneous echocardiography and right heart catheterization for aortic insufficiency in a patient with continuous-flow left ventricular assist device.

Aortic insufficiency (AI) is an important adverse event in patients with continuous-flow (CF) left ventricular assist device (LVAD) support. AI is often progressive, resulting in elevated 2-year morbidity and mortality. The effectiveness of echocardiographic ramp studies in patients with AI has been unclear. Here, we describe a patient with a CF-LVAD implant who underwent aortic valve replacement (AVR), following assessment of AI using a hemodynamic ramp test with simultaneous echocardiography and right heart catheterization (RHC). The patient was a 21-year-old man with cardiogenic shock due to acute myocarditis, who underwent HeartWare CF-LVAD (HVAD) implantation. Heart failure persisted despite increased doses of diuretics and inotrope, as well as an increased HVAD pump rate. HVAD monitoring revealed a correlation between increased HVAD pump rate and flow at each speed step. A hemodynamic ramp test with simultaneous transthoracic echocardiography and RHC revealed a significant discrepancy between HVAD pump flow and cardiac output (CO) at each speed step; moreover, pulmonary capillary wedge pressure remained high. Therefore, the patient underwent AVR. Subsequently, his low CO symptoms disappeared and inotropes were successfully discontinued. A postoperative hemodynamic ramp test revealed that AVR had successfully closed the loop of blood flow and reduced the discrepancy between HVAD pump flow and CO, thereby increasing CO. The patient was then discharged uneventfully. In conclusion, a hemodynamic ramp test with simultaneous echocardiography and RHC was useful for the evaluation of the causal relationship between AI and low CO, and for selection of surgical treatment for AI in a patient with CF-LVAD.

Surgical Aortic Valve Replacement for Aortic Stenosis in Dialysis Patients　- Analysis of Japan Cardiovascular Surgery Database.

BACKGROUND: Perioperative risk during surgical aortic valve replacement (SAVR) is reportedly high in dialysis patients. We aimed to determine the postoperative mortality and morbidity and identify the perioperative risk factors of mortality during SAVR in dialysis-dependent patients.Methods and Results:From the Japan Adult Cardiovascular Surgery Database, we compared 2,875 dialysis-dependent patients with 18,839 non-dialysis patients who all underwent SAVR between January 2013 and December 2016. The operative mortality was 8.7% vs. 2.0% in the dialysis and non-dialysis groups, respectively. Multivariate stepwise logistic regression analysis for operative mortality revealed 8 independent risk factors including age (odds ratio [OR]=1.2), concomitant coronary artery bypass grafting (OR=1.5), peripheral arterial disease (OR=1.9), atrial fibrillation (OR=2.5), New York Heart Association class IV (OR=2.5), liver dysfunction (OR=5.8), reduced left ventricular function (OR=1.4), and history of previous cardiac surgery (OR=2.1). In addition, 8 postoperative predictors of operative mortality were identified including bleeding deep sternal infection (OR=3.4), prolonged ventilation (OR=5.4) and gastrointestinal complications (OR=10.3). CONCLUSIONS: Compared with non-dialysis patients, SAVR in dialysis patients was associated with high rates of mortality and morbidity. An appropriate surgical strategy and careful perioperative assessment and management for prevention of infection, and respiratory and gastrointestinal complications might contribute to improved clinical outcomes after SAVR in these patients.

Long-Term Outcomes of the Mosaic Aortic Porcine Bioprosthesis in Japan　- Results From the Japan Mosaic Valve Long-Term Multicenter Study.

BACKGROUND: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic aortic porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study.Methods and Results:We reviewed the records of 1,202 patients who underwent aortic valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014). Patient data were collected using Research Electronic Data Capture. Patient survival was determined by Kaplan-Meier methodology. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined by actuarial methods. The median (interquartile range [IQR]) age of the cohort was 76 (70-80) years. The median (IQR) follow-up period was 3.52 (1.71-5.35) years. The longest follow-up was 15.8 years. The 30-day mortality rate was 2.3%. The 12-year actuarial survival rate was 59.9±7.5%, and the freedom from valve-related death was 81.1±7.9%. The freedom from reoperation was 86.4±2.6% at 12 years. The freedom from SVD at 12 years was 93.5±2.9% for patients aged ≥65 years and 98.2±1.8% for those aged <65 years. The median (IQR) systolic pressure gradient was 17 (12-23) and 19 (12-25) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.2 (1.1-1.5) and 1.1 (1-1.5) cm2at 1 and 10 years, respectively. CONCLUSIONS: The Mosaic porcine bioprosthesis showed satisfactory long-term outcomes over 12 years.

Incidence, Factors, and Prognostic Impact of Re-Exploration for Bleeding After Continuous-Flow Left Ventricular Assist Device Implantation　- A Japanese Single-Center Study.

BACKGROUND: Continuous-flow left ventricular assist device (CF-LVAD) substantially improves survival in endstage heart failure patients. However, bleeding complications are common after CF-LVAD implantation and in some cases, re-exploration for bleeding is needed. We aimed to investigate the incidence, timing, and risk factors of bleeding requiring re-exploration after CF-LVAD implantation.Methods and Results:We retrospectively reviewed 162 consecutive patients (age 43±13 years, 71% men) who underwent CF-LVAD implantation (HeartMateII 119, Jarvik2000 15, HVAD 13, EVAHEART 10, DuraHeart 5) from January 2012 to June 2019. During follow-up [median 662 days, interquartile range (IQR) 364-1,116 days], 35 (21.6%) experienced re-exploration for bleeding. The median timing of re-exploration was 6 (IQR 1-10) days. In the multivariate logistic regression analysis, postoperative platelet count was an independent predictor for re-exploration for bleeding after CF-LVAD implantation (per 104/µL: odds ratio 0.83, 95% confidence interval 0.74-0.93, P=0.002). Patients who experienced re-exploration for bleeding had a significantly worse survival rate than patients who did not (at 4 years, 73.6% vs. 90.1%, P=0.039). CONCLUSIONS: Re-exploration for bleeding is prevalent after CF-LVAD implantation, especially in patients with low postoperative platelet counts. As bleeding requiring re-exploration is associated with poor prognosis, risk stratification using the postoperative platelet count may be beneficial for these patients.

A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failure　- Initial Clinical Experience.

BACKGROUND: Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died. CONCLUSIONS: This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.

Effect of Therapeutic Modification on Outcomes in Heart Transplantation Over the Past Two Decades　- A Single-Center Experience in Japan.

BACKGROUND: During these 2 decades (1999-2019), many therapeutic strategies have been developed in the field of heart transplant (HTx) to improve post-HTx outcomes. In the present study, 116 consecutive HTx adults between 1999 and 2019 were retrospectively reviewed to evaluate the influences of a therapeutic modification on post HTx outcomes.Methods and Results:Patient survival, functional status and hemodynamics after HTx and modification of therapeutic strategies were reviewed. The overall cumulative survival rate at 10 and 20 years post-HTx was 96.4 and 76.7%, respectively. There were no significant differences in survival rate or exercise tolerance after HTx between extracorporeal and implantable continuous flow-LVAD. Post-HTx patient survival in patients, irrespective of the donor risk factors such as donor age, low LVEF, history of cardiac arrest, was equivalent across cohorts, while longer TIT and higher inotrope dosage prior to procurement surgery were significant risk factors for survival. In 21 patients given everolimus (EVL) due to renal dysfunction, serum creatinine significantly decreased 1 year after initiation. In 22 patients given EVL due to transplant coronary vasculopathy (TCAV), maximum intimal thickness significantly decreased 3 years after initiation. CONCLUSIONS: The analysis of a 20-year single-center experience with HTx in Japan shows encouraging improved results when several therapeutic modifications were made; for example, proactive use of donor hearts declined by other centers and the use of EVL in patients with renal dysfunction and TCAV.

Mechanical Circulatory Support Combined With Immunosuppression for the Treatment of Giant Cell Myocarditis　- A Single-Center Experience in Japan.

BACKGROUND: The therapeutic strategy for giant cell myocarditis (GCM) remains controversial, so we reviewed the clinical status of Japanese patients with GCM.Methods and Results:We retrospectively reviewed 6 consecutive patients with GCM requiring percutaneous mechanical circulatory support (p-MCS), with 3 further requiring ventricular assist devices. One patient died during p-MCS. Cardiac function improved in the other 5 with immunosuppressive therapy, but only 3 patients treated with dual immunosuppressants, including cyclosporine (CyA), achieved >1-year survival. CONCLUSIONS: The prognosis of patients with fulminant GCM is poor, but a treatment that combines MCS and early administration of CyA-based immunosuppressants will be useful.

Effect of the Creatinine Excretion Rate Index, a Marker of Sarcopenia, on Prediction of Intracranial Hemorrhage in Patients With Advanced Heart Failure and a Continuous-Flow Left Ventricular Assist Device.

BACKGROUND: Sarcopenia is characterized by progressive loss of skeletal muscle and has frequently been associated with poor clinical outcomes in patients with advanced heart failure (HF). The urinary creatinine excretion rate (CER) index is an easily measured marker of muscle mass, but its predictive capacity for mortality and cerebrovascular events has not been investigated in patients with a continuous-flow implantable left ventricular assist device (CF-iLVAD).Methods and Results:We retrospectively reviewed 147 patients (mean [±SD] age 43.7±12.5 years, 106 male) who underwent CF-iLVAD implantation between April 2011 and June 2019. CER indices in 24-h urine samples before CF-iLVAD implantation were determined. Over a median follow-up of 2.3 years, there were 10 (6.8%) deaths and 43 (29.3%) cerebrovascular events. Patients were divided into 2 groups (low and high CER index) according to the median CER index in men and women (i.e., 13.71 and 12.06 mg·kg-1·day-1, respectively). Mortality and intracranial hemorrhage rates after CF-iLVAD implantation were significantly higher in the low than high CER index group (mortality 12.3% vs. 1.4% [P<0.01]; intracranial hemorrhage 23.3% vs. 8.1% [P=0.01]). Multivariate Cox proportional hazard models revealed that a low CER index was an independent predictor of intracranial hemorrhage in patients receiving a CF-iLVAD (hazard ratio 3.63; 95% confidence interval 1.43-9.24; P<0.01). CONCLUSIONS: A low preoperative CER index is an independent, non-invasive predictor of intracranial hemorrhage after CF-iLVAD implantation.

Influence of Induction Therapy Using Basiliximab With Delayed Tacrolimus Administration in Heart Transplant Recipients　- Comparison With Standard Tacrolimus-Based Triple Immunosuppression.

BACKGROUND: Appropriate indications and protocols for induction therapy using basiliximab have not been fully established in heart transplant (HTx) recipients. This study elucidated the influence of induction therapy using basiliximab along with delayed tacrolimus (Tac) initiation on the outcomes of high-risk HTx recipients.Methods and Results:A total of 86 HTx recipients treated with Tac-based immunosuppression were retrospectively reviewed. Induction therapy was administered to 46 recipients (53.5%) with impaired renal function, pre-transplant sensitization, and recipient- and donor-related risk factors (Induction group). Tac administration was delayed in the Induction group. Induction group subjects showed a lower cumulative incidence of acute cellular rejection grade ≥1R after propensity score adjustment, but this was not significantly different (hazard ratio [HR]: 0.63, 95% confidence interval [CI]: 0.37-1.08, P=0.093). Renal dysfunction in the Induction group significantly improved 6 months post-transplantation (P=0.029). The cumulative incidence of bacterial or fungal infections was significantly higher in the Induction group (HR: 10.6, 95% CI: 1.28-88.2, P=0.029). CONCLUSIONS: These results suggest that basiliximab-based induction therapy with delayed Tac initiation may suppress mild acute cellular rejection and improve renal function in recipients with renal dysfunction, resulting in its non-inferior outcome, even in high-risk patients, when applied to the appropriate recipients. However, it should be carefully considered in recipients at a high risk of bacterial and fungal infections.

Central conversion from peripheral extracorporeal life support for patients with refractory congestive heart failure.

Conversion from peripheral extracorporeal life support (ECLS) to the central one can improve and stabilize hemodynamics in patients with refractory congestive heart failure-related multiorgan failure, whereas indication and selection of the type of the central ECLS have not been fully established. Institutional outcome of the conversion therapy was herein reviewed to verify indication and selection of three types of central ECLS. This study enrolled an institutional consecutive surgical series of 24 patients with refractory congestive heart failure under peripheral ECLS, related to fulminant myocarditis (n = 15), dilated cardiomyopathy (n = 5), or acute myocardial infarction (n = 4). They were converted to central Y-extracorporeal membrane oxygenation (ECMO, n = 6), extracorporeal ventricular assist device (EC-VAD, n = 12), or pump catheter (n = 6), dependent upon the degree of multiorgan failure. Despite the different degree of multiorgan failure prior to the conversion, improvement in end-organ perfusion and reduction in right atrial and pulmonary artery pressure were promptly achieved regardless of the type of the central ECLS. There were five in-hospital mortalities (21%) during the central ECLS, whereas mechanical support was weaned-off in 11 cases (46%) and durable LVAD was subsequently implanted for bridge to transplantation in eight cases (33%). Conversion from the peripheral ECLS to the central ones, such as central Y-ECMO, EC-VAD or pump catheter, promptly established a sufficient support with heart and lung unloading in patients with refractory congestive heart failure.

Early postoperative heparinization reduce hemolysis in patients with HeartMate II devices.

Hemolysis is closely related with pump thrombosis and thromboembolic events in patients with continuous flow left ventricular assist devices. We retrospectively investigated the impact of early postoperative heparinization on hemolysis in patients with HeartMate II devices. From April 2013 to August 2017, 83 patients (age 45 ± 12 years; 20 females; body surface area 1.6 ± 0.2 m2) underwent HeartMate II implantation. Postoperative heparinization was started when hemostasis was achieved and continued until full warfarinization. Hemolysis was defined in accordance with the Interagency Registry for Mechanically Assisted Circulatory Support definitions. The average support period was 22 ± 14 months. The 6-, 12-, and 24-month freedoms from hemolysis were 72%, 70%, and 67%, respectively. Pump thrombosis developed in five (6%) patients and four (5%) required pump exchanges. Heparin start time was significantly later in patients with hemolysis (43 ± 23 h after implantation) versus those without (29 ± 14 h after implantation; p = 0.01). Receiver operating characteristic analysis determined the cut-off point of heparin start time as 29 h. The patients were divided into the early group (heparin start time < 29 h; n = 29), and the late group (heparin start time > 29 h; n = 54). The respective 6-, 12-, and 24-month freedoms from hemolysis for the early group (86%, 86%, and 86%, respectively) were significantly higher than those for the late group (49%, 47%, and 44%, respectively; p = 0.002). Being in the late group was an independent risk factor for hemolysis (hazard ratio 4.09). Early postoperative heparinization (within 29 h after implantation) reduces hemolysis in patients with HeartMate II devices.

Role of Gallium-SPECT-CT in the Management of Patients With Ventricular Assist Device-Specific Percutaneous Driveline Infection.

BACKGROUND: Percutaneous driveline infection is a major complication of left ventricular assist device (LVAD). This study evaluated the role of gallium-67 single-photon emission computed tomography (Ga-SPECT)-CT in LVAD-specific percutaneous driveline infection. METHODS: Thirty-six patients with implantable continuous-flow LVAD, who underwent Ga-SPECT-CT to evaluate percutaneous driveline infections, were enrolled and divided into uptake and no-uptake groups based on tracer concentration uptake on Ga-SPECT-CT. Primary outcomes were surgical intervention and readmission for driveline infection. RESULTS: Twenty-two patients had uptake on Ga-SPECT-CT. No significant differences were noted in patient characteristics, wound appearance, or laboratory results. The prevalence of positive skin culture at the driveline exit site (DLES), and usage and duration of antibiotics did not differ. However, the uptake group had higher 1-year event rates (surgical intervention: 39% vs 0%, P = .019; readmission: 74% vs 6.9%, P = .0016). In addition to positive skin culture at DLES and short duration of antibiotic therapy, uptake on Ga-SPECT-CT was a risk factor for surgical intervention (odds ratio 9.00; P = .018) and readmission (odds ratio 7.86; P = .0051). CONCLUSIONS: Ga-SPECT-CT could be one of the clinical modalities for guiding the treatment of driveline infection in patients with a LVAD.

Benefits of the Modified Bicaval Anastomosis Technique for Orthotopic Heart Transplantation From a Size-Mismatched Marginal Donor.

BACKGROUND: Size-mismatched heart transplantation (HTx) is associated with a risk of stenosis of the caval anastomosis site or low cardiac output syndrome. We developed a modified bicaval anastomosis technique (mBCAT) that achieved an adjustable caval anastomosis to compensate for size mismatch. This study was performed to validate the rationale of the mBCAT for size-mismatched HTx.Methods and Results:This institutional consecutive series involved 106 patients who underwent HTx with the mBCAT during an 18-year period. The cohort was divided into 3 groups according to the donor-to-recipient body weight ratio: <0.8, undersized group (n=17); 0.8-1.3, size-matched group (n=68); and >1.3, oversized group (n=21); outcomes were compared. The undersized, size-matched, and oversized groups showed no significant differences in the rate of mild or worse echocardiographic tricuspid regurgitation at 1 month [1 (5.8%), 7 (10.2%), and 1 (4.8%), respectively; P=0.87] or the survival rate at 10 years [100%, 93.9%, and 100%, respectively; P=0.25]. The right heart catheter study revealed no pressure gradient across the orifices of both cavae in any patient. Additionally, the cardiac index immediately post-HTx was significantly low in the undersized group (P=0.008), but was similar to the other groups at 6 months post-HTx (P=0.16). CONCLUSIONS: The mBCAT prevented caval anastomosis-related complications in size-mismatched HTx and achieved excellent hemodynamics regardless of donor size.

Surgery for a Late Type IIIb Endoleak From a Fabric Tear of an Excluder Stent Graft.

An 85-year-old male patient, who had undergone endovascular abdominal aortic aneurysm repair (EVAR) using the Gore Excluder stent graft 10 years ago, was referred for intermittent abdominal pain. He also received coil embolization of the lumbar arteries for a persistent type II endoleak, resulting in continued aneurysmal dilation at 4, 6, and 8 years after the EVAR. The maximum size of the aneurysm sac was dilated from the initial size of 49 mm × 55 mm to 78 mm × 90 mm, and the contrast medium was observed around the proximal portion of the stent graft, suggesting the presence of a type Ia or II endoleak. Because the definite cause of the dilation was unclear and adequate proximal landing zone was not available to deploy an aortic cuff, emergent laparotomy was indicated to treat this symptomatic aneurysm dilation. A type IIIb endoleak due to fabric disruption of the main body was diagnosed, and the bleeding was controlled using a fibrin sealant patch. To reinforce the hemostasis site from the inside of the stent graft, a 28 mm × 3-cm Excluder aortic cuff was deployed inside the main trunk next day. At 1-year follow-up, his condition was stable without evidence of reexpansion of the aneurysmal sac.