SWENOTECA has since 1998 offered patients with clinical stage I (CS I) nonseminoma, adjuvant chemotherapy with one course of bleomycin, etoposide and cisplatin (BEP). The aim has been to reduce the ...risk of relapse, sparing patients the need of toxic salvage treatment. Initial results on 312 patients treated with one course of adjuvant BEP, with a median follow-up of 4.5 years, have been previously published. We now report mature and expanded results.
In a prospective, binational, population-based risk-adapted treatment protocol, 517 Norwegian and Swedish patients with CS I nonseminoma received one course of adjuvant BEP. Patients with lymphovascular invasion (LVI) in the primary testicular tumor were recommended one course of adjuvant BEP. Patients without LVI could choose between surveillance and one course of adjuvant BEP. Data for patients receiving one course of BEP are presented in this study.
At a median follow-up of 7.9 years, 12 relapses have occurred, all with IGCCC good prognosis. The latest relapse occurred 3.3 years after adjuvant treatment. The relapse rate at 5 years was 3.2% for patients with LVI and 1.6% for patients without LVI. Five-year cause-specific survival was 100%.
The updated and expanded results confirm a low relapse rate following one course of adjuvant BEP in CS I nonseminoma. One course of adjuvant BEP should be considered a standard treatment in CS I nonseminoma with LVI. For patients with CS I nonseminoma without LVI, one course of adjuvant BEP is also a treatment option.
A practical artificial heart has been sought for >50 years. An increasing number of people succumb to heart disease each year, but the number of hearts available for transplantation remains small. ...Early total artificial hearts mimicked the pumping action of the native heart. These positive-displacement pumps could provide adequate haemodynamic support and maintain the human circulation for short periods, but large size and limited durability adversely affected recipients' quality of life. Subsequent research into left ventricular assist devices led to the use of continuous-flow blood pumps with rotating impellers. Researchers have attempted to integrate this technology into modern total artificial hearts with moderate clinical success. The importance of pulsatile circulation remains unclear. Future research is, therefore, needed into positive-displacement and rotary total artificial hearts.
The potential for myocardial reconditioning and device explantation after long-term continuous-flow left ventricular assist device (LVAD) support presents an opportunity to delay or avoid ...transplantation in select patients.
Thirty of 657 patients with end-stage heart failure supported with continuous-flow LVADs were assessed for device explantation. Each patient underwent an individualized process of weaning focused on principles of ventricular unloading, gradual reconditioning, and transition to medical therapy.
After varying reconditioning periods, 27 patients (16 men, 11 women; age, 39 ± 12 years) underwent LVAD explant, and 3 patients (2 men, 1 woman; age, 22 ± 6 years) were evaluated for explantation but could not be weaned. The duration of LVAD support was 533 ± 424 days (range, 42-1,937 days) for the explant cohort and 1,097 ± 424 days (range, 643-1,483) for the non-explant cohort. The LV end-diastolic dimension, LV ejection fraction, systolic pulmonary artery pressure, cardiac output, and cardiac index in the explant cohort were significantly improved at explantation (all, p < 0.05). Two late deaths occurred after LVAD explantation despite satisfactory native cardiac function, and 1 patient required resumption of LVAD support 2.7 years after device removal. The remaining explant patients remain in New York Heart Association classes I to II with medical management alone (mean survival post-explant, 1,172 ± 948 days). The 3 candidates who could not be weaned ultimately underwent transplantation.
The potential for recovery of native LV function after long-term continuous-flow LVAD support should encourage a more aggressive approach to ventricular reconditioning with the goal of device explantation and a return to medical management, particularly in young patients with dilated cardiomyopathy.
Left ventricular assist devices (LVADs) are increasingly used to treat heart failure patients. These devices’ impeller blades and diffuser vanes must be designed for hydraulic performance and ...hemocompatibility. The traditional design method, applying mean-line theory, is not applicable to the design of small-scale pumps such as miniature LVADs. Furthermore, iterative experimental testing to determine how each geometric variable affects hydraulic performance is time and labor intensive. In this study, we tested a design method wherein empirical hydraulic results are used to establish a statistical model to predict pump hydraulic performance. This method was used to design an intra-atrial blood pump. Five geometric variables were chosen, and each was assigned two values to define the variable space. The experimental results were then analyzed with both correlation analysis and linear regression modeling. To validate the linear regression models, 2 test pumps were designed: mean value of each geometric variable within the boundaries, and random value of each geometric variable within the boundaries. The statistical model accurately predicted the hydraulic performance of both pump designs within the boundary space. This method could be expanded to include more geometric variables and broader boundary conditions, thus accelerating the design process for miniature LVADs.
Introduction:
Implementation of continuous flow (CF) technology in modern ventricular assist devices (VAD) has afforded a wealth of engineering and design advantages in the development of a total ...artificial heart (TAH). However, clinical application of CF has created a unique physiologic state, the consequences of which remain largely unknown. We sought to evaluate clinical and biochemical markers of end-organ function in calves supported with biventricular CF VADs for more than 30 days.
Methods:
Eight calves survived longer than 30 days following biventriculectomy and implantation of dual CF VADs. Four types of CF pumps were utilized for the study. Serial hematologic and biochemical profiles were drawn as markers for end-organ function, and hemodynamic data—including pump flows and intravascular pressures—were continuously monitored.
Results:
The eight calves survived an average of 58.8 days (range 30–92 days). Two of the calves were electively terminated at the conclusion of the study period, while the remaining animals were euthanized as a result of respiratory distress (n = 2) or impaired pump flows (n = 4). In each case, serial biochemical and hematologic values were suggestive of preserved end-organ function. Six animals successfully participated in treadmill exercise evaluations. No evidence of end-organ damage was encountered upon necropsy or histologic tissue analysis.
Conclusion:
Biventricular CF VAD implantation permits a viable bovine CFTAH model capable of demonstrating long-term survival. After 30 days of completely nonpulsatile flow, cumulative hemodynamic, clinical, biochemical, and histological analyses were consistent with preserved end-organ function, suggesting previously unreported long-term feasibility of a CFTAH design.
Epicardial VT Ablation During LVAD Implantation
Introduction
Patients undergoing catheter ablation for ventricular tachycardia (VT) may require epicardial mapping. In patients with end‐stage heart ...failure, hybrid surgical epicardial mapping and ablation during the period of left ventricular assist device (LVAD) implantation may be considered in select patients to reduce post‐LVAD ventricular tachycardia.
Methods and Results
From March 2009 to October 2012, 5 patients (4 men and 1 woman, age range 52–73 years) underwent open chest electrophysiology study and epicardial mapping for recurrent ventricular tachycardia while the heart was exposed during the period of LVAD implantation. Epicardial mapping was considered if patients had recurrent VT despite failed prior endocardial ablation and/or electrocardiogram (EKG) features of an epicardial exit. Activation and/or a substrate mapping approach were employed during all procedures. Three of 5 patients (60%) had acute procedural success. In all patients, VT was either eliminated or significantly reduced with epicardial ablation. One patient had mediastinal bleeding delaying sternal closure. During a follow‐up period of 363 ± 368 days, 4 patients died due to nonarrhythmic causes.
Conclusions
Open‐chest hybrid epicardial mapping and ablation for recurrent VT is feasible and can be considered in select patients during the period of LVAD implantation.
Abstract Objective Ventricular reconditioning and device weaning in select patients with continuous-flow left ventricular assist devices (CF LVADs) has been shown to be feasible. However, little is ...known regarding the outcomes associated with different surgical methods of device removal. We examined the effect of surgical explantation approach on early and late outcomes. Methods We retrospectively reviewed data from all patients who underwent successful ventricular weaning and CF LVAD explantation at our center. Patients were stratified by surgical approach. Descriptive univariate statistics, multivariate regression, and survival analyses were performed. Patients were censored by transplant, device reimplantation, or end of follow-up. Results Twenty-seven patients were identified who underwent successful removal of a CF LVAD (25 HeartMate II, 2 HeartWare) after 532 ± 424 days of support (range, 42-1937 days). Four approaches were used that vary primarily in the degree of retained pump material: complete pump removal with plug ventriculotomy closure (n = 13; 48%), pump housing explant with ligation of the inflow and outflow grafts (n = 7; 26%), ligation of the outflow graft and driveline transection (n = 5; 19%), and driveline transection alone (n = 2; 7%). Mean overall postexplant survival was 1286 ± 947 days (range, 143-3072 days). Overall time-to-event and survival analyses showed no significant association between surgical approach and postoperative length of stay ( P = .7), stroke ( P = .12), reoperation ( P = .4), or survival ( P = .12). Conclusions For patients who receive device therapy, pump deactivation and removal represents a favorable outcome. All methods are feasible and produce similar early and late survival and clinical outcomes.
Implanting short‐term mechanical circulatory support (MCS) devices as a bridge‐to‐decision is increasingly popular. However, outcomes have not been well studied in patients who receive short‐term MCS ...before receiving long‐term left ventricular assist device (LVAD) support. We analyzed outcomes in our single‐center experience with long‐term continuous‐flow (CF)‐LVAD recipients with pre‐implantation short‐term MCS. From November 2003 through March 2016, 526 patients (mean age, 54.7 ± 13.5 years) with chronic heart failure (mean ejection fraction, 21.7 ± 3.6%) underwent implantation of either the HeartMate II (n = 403) or the HeartWare device (n = 123). Before implantation, 269 patients received short‐term MCS with the TandemHeart, the Impella 2.5/5.0, an intra‐aortic balloon pump (IABP), venoarterial extracorporeal membrane oxygenation (VA‐ECMO), or the CentriMag. The short‐term MCS patients were compared with the CF‐LVAD–only patients regarding preoperative demographics, incidence of postoperative complications, and long‐term survival. The 269 patients received the following short‐term MCS devices: 57 TandemHeart, 27 Impella, 172 IABP, 12 VA‐ECMO, and 1 CentriMag. Survival at 30 days, 6 months, 1 year, and 2 years was 94.2, 87.2, 79.4, and 72.4%, respectively, for CF‐LVAD–only patients versus 91.0, 78.1, 73.4, and 65.6%, respectively, for short‐term MCS + CF‐LVAD patients (P = 0.17). Within the short‐term MCS group, survival at 24 months was poorest for patients supported with VA‐ECMO or the TandemHeart (P = 0.03 for both), and survival across all four time points was poorest for patients supported with VA‐ECMO (P = 0.02). Short‐term MCS was not an independent predictor of mortality in multivariate Cox regression models (hazard ratio = 1.12, 95% confidence interval = 0.84–1.49, P = 0.43). In conclusion, we found that using short‐term MCS therapy—except for VA‐ECMO—as a bridge to long‐term CF‐LVAD support was not associated with poorer survival.
PDF
