Technology and technique for left ventricular assist device optimization: A Bi-Tech solution.

BACKGROUND: We investigated the synergistic effect of the new cone-bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally-invasive approach to outcomes of LVAD patients. METHODS: We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin-bearing design and conventional approach (Group 1); cone-bearing and conventional approach (Group 2); cone-bearing and minimally-invasive implantation (Group 3). RESULTS: A total of 150 adult patients with end-stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow-up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1-year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing-risks-adjusted cumulative incidence rate for adverse events was 42.1 [27-62.7] per 100 patient-years in Group 1, 35.4 [25.3-48.2] in Group 2, and 22.1 [12.4-36.4] in Group 3 (p = 0.046 for Group 1 vs. 3). CONCLUSIONS: The association of the modern cone-bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique.

From bench to bedside: Impact of left ventricular assist device outflow conduit anastomosis position on outcome.

Continuous flow left ventricular assist devices (LVADs) have become a valuable therapy for end-stage heart failure. In vitro research highlighted a role of outflow cannula position on the pattern of blood flow in the aorta. However, the clinical effects of the alterations of flow remain unclear. We investigate short- and long-term outcomes of patients implanted with Jarvik 2000 LVAD, according to the ascending (Group 1) versus descending (Group 2) outflow graft connection to the aorta in a multicenter study. From May 2008 to October 2014, 140 consecutive end-stage heart failure patients underwent Jarvik 2000 LVAD implantation in 17 Italian centers. According with a preliminary multivariate analysis, we selected the 90 patients implanted in the four high-volume centers to avoid bias (Group 1 n = 39, Group 2 n = 51). Among the groups, no differences were recorded in the hospital mortality and the main complications occurring after LVAD implantation were similar. In multivariable analysis, the ascending aorta outflow cannula position and higher creatinine at discharge were significant predictors for long-term survival. Postimplant hemolysis was more pronounced in descending aorta outflow graft anastomosis. Outflow graft anastomosis to the ascending aorta is associated with better long-term survival, independent of age and perfusion techniques, reflecting the previous in vitro results.

The Coagulative Profile of Cyanotic Children Undergoing Cardiac Surgery: The Role of Whole Blood Preoperative Thromboelastometry on Postoperative Transfusion Requirement.

The objective of this study is to evaluate the preoperative coagulation pattern and its association to postoperative blood products transfusion in children with congenital heart disease (CHD), focusing on cyanotic patients (oxygen saturation, SATO 2 < 85%). From January to August 2014, preoperative standard coagulation tests and rotational thromboelastometry assays were performed on 81 pediatric patients (<16 years old) who underwent surgery for CHD with the aid of cardiopulmonary bypass. Sixty patients (74%) were acyanotic and 21 (26%) cyanotic. Mean age at time of surgery was 7.9 months (interquartile range 2.9-43.6 months). Cyanotic patients had a significantly higher hematocrit (P < 0.001), a reduced prothrombin activity (PT) (P = 0.01) level, and a lower platelet count (P = 0.02) than acyanotic patients. An inverse linear association was found between patient's SATO2 and clot formation time (CFT) (INTEM, P = 0.001, and EXTEM, P < 0.0001). A direct linear association was found between patient's SATO2 and maximum clot firmness (MCF) (INTEM, P = 0.04, and EXTEM, P = 0.05). Preoperative cyanosis was also associated with a lower median MCF in FIBTEM (P = 0.02). Cyanotic patients required more frequent postoperative transfusions of fibrinogen (7/21 patients, 33% vs. 4/60 patients, 6.7%, P = 0.01) and fresh frozen plasma (14/21, 67% vs. 25/60, 42%, P = 0.08). Patients with a lower presurgery PT and platelet count subsequently required more fibrinogen transfusion P = 0.02 and P = 0.003, respectively); the same goes for patients with a longer CFT (INTEM, P = 0.01 and EXTEM, P = 0.03) and a reduced MCF (INTEM, P = 0.02 and FIBTEM, P = 0.01) as well. Cyanotic patients showed significant preoperative coagulation anomalies and required a higher postoperative fibrinogen supplementation. The preoperative MCF FIBTEM has become an important factor in our postoperative thromboelastometry-guided transfusion protocols.

Cardiopulmonary exercise testing responses to different external portable drivers in a patient with a CardioWest Total Artificial Heart.

Management of patients treated with CardioWest Total Artificial Heart (CW-TAH) as a bridge to heart transplantation (HTx) is complicated by difficulties in determining the optimal timing of transplantation. We present a case of a 53-year-old man supported as an outpatient with a CW-TAH, whose condition deteriorated following exchange of the portable driver. The patient was followed-up with serial cardiopulmonary exercise testing (CPET) which demonstrated a fall of peak VO2 to below 12 ml/kg/min following driver substitution, and the patient was subsequently treated with urgent orthotopic HTx. This case highlights the potential utility of CPET as a means for monitoring and indicating timing of HTx in patients with CW-TAH, as well as the potential for clinical deterioration following portable driver substitution.

Evaluation of prosthetic valve thrombosis by 64-row multi-detector computed tomography. .

BACKGROUND AND AIM OF THE STUDY: Multi-detector computed tomography (MDCT), combined with retrospective electrocardiographic gating, permits cardiac imaging with high accuracy. Recent advances in MDCT have seemed to respond adequately to the need for a non-invasive and reliable assessment of the coronary artery lumen. METHODS: Two patients with prosthetic aortic valves (one bioprosthetic, one mechanical) presented at the authors' institution with dyspnea and syncopal episodes. MDCT was performed to evaluate thrombus characteristics and exclude coronary artery disease (CAD). RESULTS: Based on the MDCT coronary artery assessment, neither patient underwent preoperative invasive coronary angiography, abolishing the risk of any iatrogenic thrombus fragmentation and subsequent embolization. One patient underwent surgical treatment without complications, while medical therapy was successful in the other case. CONCLUSION: MDCT can be used for the accurate imaging of thrombi on prosthetic aortic valves, and to correctly assess possible CAD.

The danger of using a sledgehammer to crack a nut: ROTEM-guided administration of recombinant activated factor VII in a patient with refractory bleeding post-ventricular assist device implantation.

Recombinant activated factor VII (rFVIIa) is currently approved for treating or preventing hemorrhage in patients with hemophilia, Glanzmann's thrombasthenia, or congenital FVII deficiency. Its "off-label" use for massive bleeding in the setting of trauma or surgery has been increasing because of demonstrated efficacy. However, the use of rFVIIa also carries a high thrombo-embolic risk. This is particularly true in cardiac surgery patients, especially those treated with mechanical circulatory support. We describe the case of a patient treated with a biventricular assist device in our center, in whom severe bleeding was treated in a targeted manner, using rotational thromboelastometry to guide administration and dosing of rFVIIa. A comprehensive review of the emerging literature on the use of rFVIIa postventricular assist device implantation accompanies the case to highlight the need for careful selection of prohemostatic agents in this high-risk group.

HeartWare ventricular assist device as bridge to transplant in children and adolescents.

Limited options do exist for mechanical circulatory support as a bridge to transplantation in the pediatric population. This is especially true when it comes to intracorporeal technologies. We describe our successful experience with the use of HeartWare ventricular assist devices (HeartWare, Inc., Framingham, MA, USA) in three patients <16 years of age, as a successful and feasible bridge to transplant in patients weighing greater than 20 kg.

Less-invasive off-pump ventricular assist device implantation in regional paravertebral analgesia.

We describe the clinical course and treatment of a 58-year-old male with a primary cardiogenic shock, who underwent a minimally invasive off-pump ventricular-assist-device (VAD) implantation with the aid of paravertebral regional analgesia. He was extubated soon after the procedure, in the operating room, with the aim to reduce the right ventricle impairment. We illustrate how a minimally invasive implant may improve the clinical outcomes of VAD patients shortening their return time to active life.

Prognosticating Mortality of Primary Cardiogenic Shock Requiring Extracorporeal Life Support: The RESCUE Score.

We aimed to identify prognostic laboratory markers during extracorporeal life support (ECLS) in patients with primary refractory cardiogenic shock (RCS) and to create a preliminary specific mortality score. All 208 consecutive subjects admitted for primary RCS and treated with ECLS between January-2009 and December-2018 were retrospectively analyzed. Multivariate regression analysis on laboratory markers during the first nine days of ECLS was used to develop a "Refractory End-stage Shock CUred with Ecls" (RESCUE) score. Serum creatinine (OR = 3.72, 95%CI: 2.01-6.88), direct bilirubin (OR = 1.40, 95%CI: 1.05-1.8), and platelet count (OR = 0.62, 95%CI: 0.42-0.94) were independent predictors of in-hospital mortality and were included in the score. The mean AUC was 0.763 (95%CI: 0.698-0.828) in the development cohort and 0.729 (95%CI: 0.664-0.794) in the bootstrap internal validation cohort. The RESCUE score represents a novel promising instrument to predict early mortality during the first critical days of ECLS and to help in properly guiding the therapeutic decision-making process.

Percutaneous coronary intervention versus coronary artery bypass graft for left main coronary artery disease: A meta-analysis.

BACKGROUND: The optimal revascularization strategy for patients with left main coronary artery disease is still controversial. This is systematic review and meta-analysis aims to evaluate the outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents compared with coronary artery bypass graft (CABG) for LM disease. METHODS: Online electronic databases were systematically reviewed until January 2020 for randomized trials comparing PCI with drug-eluting stents and CABG. Primary outcomes were: all-cause mortality, myocardial infarction (MI), stroke, and repeated revascularization. Secondary outcomes included periprocedural and nonperiprocedural MI. The period of follow-up included 30 days, 1 year, and 5 years. Odds ratio and 95% confidence interval were calculated with a fixed-effects model. RESULTS: A total of 4595 patients (5 randomized trials) with left main coronary artery disease were included. At 30 days and 1 year, PCI was associated with lower incidence of stroke, higher repeated revascularization, and similar odds of mortality and MI compared with CABG. At 5 years, PCI was associated with higher rates of MI (odds ratio, 1.43; 95% confidence interval, 1.13-1.79; P = .003) and repeat revascularization (odds ratio, 1.89; 95% CI, 1.58-2.26; P < .001) than CABG. PCI was associated with lower periprocedural MI at 30 days, whereas at 5 years PCI was associated with higher nonperiprocedural MI (odds ratio, 2.32; 95% confidence interval, 1.62-3.31; P < .001). Mortality and stroke rate did not differ at 5-year follow-up. CONCLUSIONS: Patients with left main coronary artery disease treated with either PCI or CABG do not show significant difference in early or 5-year mortality. Although CABG was associated with higher stroke rates at 30 days and 1 year, PCI was associated with an increase in MI and need for repeat revascularization at 5 years.

How to Optimize ECLS Results beyond Ventricular Unloading: From ECMO to CentriMag® eVAD.

CentriMag® extracorporeal VAD support could represent a more physiological choice than conventional ECMO in primary cardiogenic shock. We therefore evaluated the outcome of patients with primary cardiogenic shock who were supported with CentriMag® extracorporeal VAD implantation versus conventional ECMO. We retrospectively reviewed all extracorporeal life supports implanted for primary cardiogenic shock between January 2009 and December 2018 at our institution. Among 212 patients, 143 cases (67%) were treated exclusively with ECMO (Group 1) and 69 cases (33%) with extracorporeal VAD implantation (Group 2, 48 of whom as conversion of ECMO). ECLS mean duration was 8.37 ± 8.43 days in Group 1 and 14.25 ± 10.84 days in Group 2 (p = 0.001), while the mean rates of the highest predicted flow were 61.21 ± 16.01% and 79.49 ± 18.42% (p = 0.001), respectively. Increasing mechanical support flow was related to in-hospital mortality and overall mortality in Group 1 (HR 11.36, CI 95%: 2.19-44.20), but not in Group 2 (HR 1.48, CI 95%: 0.32-6.80). High-flow ECMO patients had lower survival with respect to high-flow extracorporeal VAD patients (p = 0.027). In the setting of high-flow mechanical circulatory support, CentriMag® extracorporeal VAD optimized patient survival, granting long-term assistance and physiological circulation patterns.

Consolidated quality improvements following benchmarking with cardiothoracic surgery registries-a systematic review.

The influence of registries in medicine is large. However, there has been no systematic assessment conducted to quantify the impact of benchmarking with registries focused on cardiothoracic surgery. Numerous publications conclude that registry participation leads to improvement of outcomes for patients. A large number of registries provide evidence sub-structured by statistics that show decreases in morbidity and mortality in the participants' clinical units. Many authors praise the benchmarking method making use of databases of registries as having a positive effect on outcome of care. However, studies proving the direct causal relation between the use of cardiothoracic surgery-oriented registries and improvement of clinical in-hospital outcomes are extremely scarce. We aimed to analyse the causal relation between the use of cardiothoracic surgery-oriented registries and improvement of clinical outcomes. In a systematic literature review, publications demonstrating the use of registry data to obtain consolidated quality improvements were selected. After analysis of 2990 scientific publications, 6 studies filled the inclusion criteria. The selected studies acknowledged that benchmarking of data against registries was used for a focused and methodologically organized improvement in cardiothoracic departments. In conjunction with the impact of the applied methods on healthcare, their results demonstrate quantifiable enhanced local outcomes over time.

Identifying cardiac surgery operations in hospital episode statistics administrative database, with an OPCS-based classification of procedures, validated against clinical data.

OBJECTIVES: Administrative databases with dedicated coding systems in healthcare systems where providers are funded based on services recorded have been shown to be useful for clinical research, although their reliability is still questioned. We devised a custom classification of procedures and algorithms based on OPCS, enabling us to identify open heart surgeries from the English administrative database, Hospital Episode Statistics, with the objective of comparing the incidence of cardiac procedures in administrative and clinical databases. DESIGN: A comparative study of the incidence of cardiac procedures in administrative and clinical databases. SETTING: Data from all National Health Service Trusts in England, performing cardiac surgery. PARTICIPANTS: Patients classified as having cardiac surgery across England between 2004 and 2015, using a combination of procedure codes, age >18 and consultant specialty, where the classification was validated against internal and external benchmarks. RESULTS: We identified a total of 296 426 cardiac surgery procedures, of which majority of the procedures were coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral repair and aortic surgery. The matching at local level was 100% for CABG and transplant, >90% for aortic valve and major aortic procedures and >80% for mitral. At national level, results were similar for CABG (IQR 98.6%-104%), AVR (IQR 105%-118%) and mitral valve replacement (IQR 86.2%-111%). CONCLUSIONS: We set up a process which can identify cardiac surgeries in England from administrative data. This will lead to the development of a risk model to predict early and late postoperative mortality, useful for risk stratification, risk prediction, benchmarking and real-time monitoring. Once appropriately adjusted, the system can be applied to other specialties, proving especially useful in those areas where clinical databases are not fully established.

Predictors of postoperative bleeding in children undergoing cardiopulmonary bypass: A preliminary Italian study.

BACKGROUND: Several characteristics such as demographics, pre-existing conditions, surgical procedure, perioperative coagulopathy may predispose children undergoing cardiopulmonary bypass (CPB) to bleeding complications. As yet, studies on risk factors for postoperative bleeding have brought mixed results. The purpose of our study was therefore to retrospectively evaluate the parameters able to predict postoperative bleeding in a group of consecutive children undergoing cardiac surgery involving CPB. METHODS: We collected demographic and perioperative laboratory data, as well as intraoperative transfusion requirements and blood loss during the first 24h after surgery in a group of consecutive children (aged ≥1month) scheduled for cardiac surgery with CPB at Padua University Hospital between June 2014 and April 2015. Cases were patients who experienced a 24-h postoperative blood loss ≥80th percentile. Univariate and multivariate logistic regression analyses were performed to determine the independent parameters associated with a high 24-h postoperative chest tube drainage volume. RESULTS: Eighty-three children (M:F 38:45; age range 1-168months) were enrolled. Age<7.7months (p 0.015), postoperative platelets <109×109/L (p 0.003) and postoperative D-dimer ≥2350µg/L (p 0.007) were the variables most significantly and independently associated with excessive 24-h postoperative blood loss. CONCLUSIONS: Although preliminary, our study identified younger age, lower postoperative platelet count and higher D-dimer plasma levels as possible risk factors for postoperative bleeding. As for coagulation parameters, our results suggested consumptive coagulopathy might cause a strong predisposition to postoperative bleeding in children. Large-scale prospective studies would provide insight into the early diagnosis and treatment of CPB-related coagulopathies.

How to remove the retroauricular driveline in the Jarvik 2000 after heart transplantation.

The Jarvik 2000 is a left ventricular assist device (LVAD) used as either a bridge-to-transplant or destination therapy with the possibility of retroauricular percutaneous power delivery (pedestal). Percutaneous driveline infection in LVAD is a life-threatening complication that affects both the quality and length of life in patients. With its rigid fixation to the bone, the pedestal and the vascularity of scalp skin promote healing and reduce the risk of driveline infection. We describe a technique to remove the skull-mounted percutaneous pedestal of the Jarvik 2000 after heart transplantation.

Coronary Artery Bypass Grafting in Elderly Patients: Insights from a Comparative Analysis of Total Arterial and Conventional Revascularization.

The benefits of total arterial (TAR) versus conventional (CR) revascularization are controversial in the higher-risk cohort of elderly patients. Taking for granted its benefit on long-term survival, we evaluated the effect of TAR on safety (death, myocardial infarction, and stroke) of patients undergoing CABG. Between 2000 and 2009, 487 patients >75 years underwent isolated CABG at our institution (150 TAR and 337 CR). Patients with arterial free-grafts were excluded. After propensity matching, the outcomes of 131 TAR and 127 CR patients were compared. TAR patients had lower incidence of post-operative myocardial infarction (p = 0.025) and stroke (p = 0.005). They also experienced shorter intensive care unit (p = 0.046) and ward stay (p = 0.028), lower output of TnI (p = 0.035), and less wound complications (leg included) (p = 0.0001), while mortality was comparable (p = 0.57). In our cohort of elderly patients with multivessel disease, TAR was associated with lower rates of myocardial infarction, stroke, and shorter hospital stay.

From bench to bedside: Can the improvements in left ventricular assist device design mitigate adverse events and increase survival?

OBJECTIVE: In vitro tests demonstrated that the new cone-bearing configuration of the Jarvik 2000 (Jarvik Heart Inc, New York, NY) left ventricular assist device exhibits better hydraulic efficiency than the previous pin-bearing design. We investigated the long-term outcomes of patients who received the Jarvik 2000 left ventricular assist device, depending on bearing design. METHODS: A retrospective review of prospectively collected data from 18 centers included in the Italian Registry was performed. From May 2008 to September 2013, 99 patients with end-stage heart failure were enrolled. Patients were divided into 2 groups according to their Jarvik 2000 suspending mechanism: Group pin included patients with pin bearings (May 2008 to June 2010), and group cone included patients with newer cone bearings (July 2010 to September 2013). The 2 groups did not differ significantly in terms of baseline characteristics. RESULTS: A total of 30 of 39 patients (group pin) and 46 of 60 patients (group cone) were discharged. During follow-up, 6 patients underwent transplantation, and in 1 patient the left ventricular assist device was explanted. The cumulative incidence competing risk of the entire cohort for noncardiovascular-related death was 28% (20%-40%); the cumulative incidence competing risk for cardiovascular-related death was 56% (42%-73%): 71% in group pin versus 26% in group cone (P = .034). The multivariate analyses confirmed that the pin-bearing design was a risk factor for cardiovascular death, along with Interagency Registry for Mechanically Assisted Circulatory Support class. Right ventricular failures and ischemic and hemorrhagic strokes were significantly higher in group pin. CONCLUSIONS: Patients with the new pump configuration showed a better freedom from cardiovascular death and lower incidence of fatal stroke and right ventricular failure. Further studies are needed to prove the favorable impact of pump-enhanced fluid dynamics on long-term results.

Surgery for Semilunar Valve Regurgitation During Ventricular Assist Device Support in Children.

Semilunar valve regurgitation (SVR) in children on ventricular assist device (VAD) support is a difficult task. Three children with SVR prior or during VAD support, underwent uneventful semilunar valve surgery, and 2 patients were successfully bridged to heart transplantation. We conclude that surgical management of SVR during VAD support in children is feasible with low operative risk, and is mandatory to optimize VAD support while on waiting list.

Pulmonary embolism and LVAD: is there compatibility?

A 41-year-old-male with diagnosis of dilated cardiomyopathy was referred to our hospital for heart failure, despite standard medical therapy, to evaluate indications for heart transplantation or mechanical cardiac support. Preoperative contrast computer tomography (CT) scan diagnosed pulmonary thrombosis of the left branch of the pulmonary artery. Treatment with low molecular weight heparin was established and the next day a thrombus-arteriectomy and Heartware (Heartware, Framingham, MA, USA) left ventricular assist device (LVAD) implantation were performed simultaneously. The patient was discharged home with oral anticoagulant and antiplatelet therapy, according to our center's VAD protocol. Currently, the patient has been assisted with the LVAD for the past 24 months. The CT scan confirmed the absence of pulmonary artery thrombosis.