Human Clinical Fitting Study of the DexAide Right Ventricular Assist Device

The DexAide right ventricular assist device (RVAD) has been developed as an implantable RVAD. The purpose of this study was to determine the final design and optimal anatomical placement of the DexAide RVAD when implanted simultaneously with either of two commercially available left ventricular assist devices (LVADs) in patients. A mock-up DexAide RVAD was used to assess configuration with each of two types of commercially available LVADs at the time of LVAD implantation in three human clinical cases. The pump body of the DexAide RVAD was placed either in the preperitoneal space or in the right thoracic cavity. The DexAide RVAD placed into the right thoracic cavity is suitable for use with the Novacor or HeartMate II LVADs. The results of this study will guide the finalization of the inflow cannula and optimal placement of the DexAide RVAD for human clinical trials.     

Cleveland Clinic PediPump lamb cadaver fitting studies

We are developing the PediPump, a magnetically suspended, mixed-flow pump, as an implantable pediatric ventricular assist device (VAD). Lamb cadaver fitting studies were performed to determine the optimal pump location and optimal design of the inflow and outflow conduits for chronic in vivo studies. A prototype of the PediPump right and left ventricular assist devices (RVAD and LVAD, respectively) were implanted via a sternotomy or left thoracotomy in four lamb cadavers (3.7-34.2 kg). Via a sternotomy, the RVAD and LVAD required long inflow cannulas when placed into the right or left thoracic cavities, respectively. Via a left thoracotomy, with both pumps implanted in the left thoracic cavity, the RVAD required a 70 degrees inflow cannula and a bent outflow graft while the LVAD required a 130 degrees inflow cannula and a straight outflow graft. In conclusion, left thoracotomy provided optimal fitting for both LVAD and RVAD for the small lamb model.     

Implantable continuous-flow right ventricular assist device: lessons learned in the development of a cleveland clinic device

Although the need for right ventricular assist device (RVAD) support for right ventricular failure after the implantation of a continuous-flow left ventricular assist device has decreased, right ventricular failure still occurs in as many as 44% of patients after continuous-flow left ventricular assist device insertion. Cleveland Clinic's DexAide continuous-flow RVAD was implanted in 34 calves during the course of its development. This review discusses lessons learned in the design and development of an implantable continuous-flow RVAD that are drawn from the results of these in vivo studies, our clinical experience with RVAD support, and a review of previously published reports on clinical RVAD use.     

Optimal cannula positioning of HeartMate 3 left ventricular assist device

Cannula position in HeartMate II and HeartWare left ventricular assist devices (LVADs) is associated with clinical outcome. This study aimed to investigate the clinical implication of the device positioning in HeartMate 3 LVAD cohort. Consecutive patients who underwent HeartMate 3 LVAD implantation were followed for one year from index discharge. At index discharge, chest X-ray parameters were measured: (a) cannula coronal angle, (b) height of pump bottom, (c) cannula sagittal angle, and (d) cannula lumen area. The association of each measurement of cannula position with one-year clinical outcomes was investigated. Sixty-four HeartMate 3 LVAD patients (58 years old, 64% male) were enrolled. In the multivariable Cox regression model, the cannula coronal angle was a significant predictor of death or heart failure readmission (hazard ratio 1.27 [1.01-1.60], P = .045). Patients with a cannula coronal angle ≤28° had lower central venous pressure (P = .030), lower pulmonary capillary wedge pressure (P = .027), and smaller left ventricular size (P = .019) compared to those with the angle >28°. Right ventricular size and parameters of right ventricular function were also better in the narrow angle group, as was one-year cumulative incidence of death or heart failure readmission (10% vs. 50%, P = .008). Narrow cannula coronal angle in patients with HeartMate 3 LVADs was associated with improved cardiac unloading and lower incidence of death or heart failure readmission. Larger studies to confirm the implication of optimal device positioning are warranted.     

Aorto-pulmonary bypass shunt for intraoperative right ventricular support during LVAD implantation

We describe a simple modification of the cardiopulmonary bypass (CPB) circuit that allows selective intraoperative circulatory support of the right ventricle during left ventricular assist device (LVAD) implantation. The addition of a side branch to the arterial line and an intermediate line connector allows selective venting and perfusion through a cannula inserted in the main pulmonary artery. This modification of the CPB circuit allows for selective evaluation of right ventricular function, titration of inotropic support, and early identification of patients that require right ventricular assist device (RVAD) support.     

Assessment of right pump outflow banding and speed changes on pulmonary hemodynamics during biventricular support with two rotary left ventricular assist devices

The absence of an effective, easily implantable right ventricular assist device (RVAD) significantly diminishes long‐term treatment options for patients with biventricular heart failure. The implantation of a second rotary left ventricular assist device (LVAD) for right heart support is therefore being considered; however, this approach exhibits technical challenges when adapting current devices to produce the lower pressures required of the pulmonary circulation. Hemodynamic adaptation may be achieved by either reducing the rotational speed of the right pump impeller or reducing the diameter of the right outflow cannula by the placement of a restricting band; however, the optimal value and influence of changes to each parameter are not well understood. Hemodynamics were therefore investigated using different banding diameters of the right outflow cannula (3–6.5 mm) and pump speeds (500–4500 rpm), using two identical rotary blood pumps coupled to a pulsatile mock circulation loop. Reducing the speed of the right pump from 4900 rpm (for left ventricle support) to 3500 rpm, or banding the Ø10 mm (area 78.5 mm²) right outflow graft to Ø5.4 mm (22.9 mm²) produced suitable hemodynamics. Pulmonary pressures were most sensitive to banding diameters, especially when RVAD flow exceeded LVAD flow. This occurred between Ø5.3 and Ø6.5 mm (22.05–38.5 mm²) and speeds between 3200 and 4400 rpm, with the flow imbalance potentially leading to pulmonary congestion. Total flow was not affected by banding diameters and speeds below this range, and only increased slightly at higher values. Both right outflow banding or right pump speed reduction were found to be effective techniques to allow a rotary LVAD to be used directly for right heart support. However, the observed sensitivity to diameter and speed indicate that challenges may be presented when setting appropriate values for each patient, and control over these parameters is desirable.     

Preoperative risk factors for right ventricular failure after implantable left ventricular assist device insertion

Background. Implantable left ventricular assist device (LVAD) insertion complicated by early right ventricular (RV) failure has a poor prognosis and is generally unpredictable.

Methods. To determine preoperative risk factors for perioperative RV failure after LVAD insertion, patient characteristics and preoperative hemodynamics were analyzed in 100 patients with the HeartMate LVAD (Thermo Cardiosystems, Inc, Woburn, MA) at the Cleveland Clinic.

Results. RV assist device support was required for 11 patients (RVAD group). RVAD use was significantly higher in younger patients, female patients, smaller patients, and myocarditis patients. There was no significant difference in the cardiac index, RV ejection fraction, or right atrial pressure between the two groups preoperatively. The preoperative mean pulmonary arterial pressure (PAP) and RV stroke work index (RV SWI) were significantly lower in the RVAD group (p = 0.015 and p = 0.011, respectively). Survival to transplant was poor in the RVAD group (27%) and was 83% in the no-RVAD group.

Conclusions. The need for perioperative RVAD support was low, only 11%. Preoperative low PAP and low RV SWI were significant risk factors for RVAD use.     

Rechtsventrikuläre Funktion bei Implantation eines linksventrikulären Unterstützungssystems

Right ventricular function is from the outset the Achilles heel of left ventricular assist device (LVAD) therapy. Predicting right ventricular failure can be difficult and consideration of various factors is necessary including the right ventricular end-diastolic dimension (RVEDD) LVEDD ratio which seems to be a suitable preoperative predictive parameter in conjunction with the clinical symptoms. If the patient is in cardiogenic shock with imminent multiorgan failure the implantation of a LVAD alone will not be sufficient to assist the whole organism. The implantation of a biventricular assist device (BVAD) or veno-arterial extracorporeal membrane oxygenation (ECMO) is needed. Should there be any delay in the recovery of the patient after LVAD implantation right ventricular dysfunction must be excluded. If the RV dysfunction is clinically significant the implantation of an RVAD should be taken into consideration before the sequelae of venous congestion and impaired perfusion evolve. A secondary implantation in an intensive care unit (ICU) has a worse prognosis. To which degree a secondary tricuspid insufficiency should be corrected at the time of LVAD implantation is matter of debate and research.     

Banding the Right Ventricular Assist Device Outflow Conduit: Is It Really Necessary With Current Devices?

Implantable left ventricular assist devices (LVADs) have been adapted clinically for right‐sided mechanical circulatory support (RVAD). Previous studies on RVAD support have established the benefits of outflow cannula restriction and rotational speed reduction, and recent literature has focused on assessing either the degree of outflow cannula restriction required to simulate left‐sided afterload, or the limitation of RVAD rotational speeds. Anecdotally, the utility of outflow cannula restriction has been questioned, with suggestion that banding may be unnecessary and may be replaced simply by varying the outflow conduit length. Furthermore, many patients have a high pulmonary vascular resistance (PVR) at the time of ventricular assist device (VAD) insertion that reduces with pulmonary vascular bed remodeling. It is therefore important to assess the potential changes in flow through an RVAD as PVR changes. In this in vitro study, we observed the use of dual HeartWare HVAD devices (HeartWare Inc., Framingham, MA, USA) in biventricular support (BiVAD) configuration. We assessed the pumps' ability to maintain hemodynamic stability with and without banding; and with varying outflow cannulae length (20, 40, and 60 cm). Increased length of the outflow conduit was found to produce significantly increased afterload to the device, but this was not found to be necessary to maintain the device within the manufacturer's recommended operational parameters under a simulated normal physiological setting of mild and severe right ventricular (RV) failure. We hypothesize that 40 cm of outflow conduit, laid down along the diaphragm and then up over the RV to reach the pulmonary trunk, will generate sufficient resistance to maintain normal pump function.     

Mechanical support for biventricular failure using the HeartWare (HVAD) pump

The limited availability of organs for transplant has vastly popularized implantation of left ventricular assist devices. Right ventricular failure is a continued problem with an incidence as high as 44 %, significantly decreasing survival after left ventricular assist devices (LVAD) implantation. Survival is significantly better when LVAD patients at high risk for right ventricular failure (RVF) are converted directly to biventricular assist device (BiVAD) therapy instead of LVAD with subsequent right ventricular assist device (RVAD) implantation. The options available for biventricular assistance entail a total artificial heart (TAH) or additional right-sided placement of a continuous flow/pulsatile device which could be para-corporeal or implantable. The HeartWare HVAD (HeartWare International, Framingham, MA) device in a biventricular configuration is a very attractive option. This report details experiences and techniques for implantation of the HVAD in such a configuration.     

A novel,highly discriminatory risk model predicting acute severe right ventricular failure in patients undergoing continuous‐flow left ventricular assist device implant

Various risk models with differing discriminatory power and predictive accuracy have been used to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. There remains an unmet need for a contemporary risk score for continuous flow (CF)‐LVADs. We sought to independently validate and compare existing risk models in a large cohort of patients and develop a simple, yet highly predictive risk score for acute, severe RVF. Data from the Mechanical Circulatory Support Research Network (MCSRN) registry, consisting of patients who underwent CF‐LVAD implantation, were randomly divided into equal‐sized derivation and validation samples. RVF scores were calculated for the entire sample, and the need for a right ventricular assist device (RVAD) was the primary endpoint. Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified. A risk score was developed based on the identified variables and their respective regression coefficients. Between May 2004 and September 2014, 734 patients underwent implantation of CF‐LVADs [HeartMate II LVAD, 76% (n = 560), HeartWare HVAD, 24% (n = 174)]. A RVAD was required in 4.5% (n = 33) of the patients [Derivation cohort, n = 15 (4.3%); Validation cohort, n = 18 (5.2%); P = 0.68)]. 19.5% of the patients (n = 143) were female, median age at implant was 59 years (IQR, 49.4–65.3), and median INTERMACS profile was 3 (IQR, 2–3). RVAD was required in 4.5% (n = 33) of the patients. Correlates of acute, severe RVF in the final model included heart rate, albumin, BUN, WBC, cardiac index, and TR severity. Areas under the curves (AUC) for most commonly used risk predictors ranged from 0.61 to 0.78. The AUC for the new model was 0.89 in the derivation and 0.92 in the validation cohort. Proposed risk model provides very high discriminatory power predicting acute severe right ventricular failure and can be reliably applied to patients undergoing placement of contemporary continuous flow left ventricular assist devices.     

Transesophageal echocardiographic evaluation in mechanically assisted circulation

Transesophageal echocardiography (TEE) has assumed an increasing importance in cardiothoracic surgery, but its use in patients with mechanically assisted circulation is unclear. We performed TEE in 11 patients: total artificial heart (TAH) 2, right ventricular assist device (RVAD) 2, left ventricular assist device (LVAD) 6, biventricular assist device (BVAD) 1. TEE was helpful in three areas. (1) selection of the assist device (AD): evaluation of left and right ventricular function allows differentiation of left, right or biventricular failure. (2) management of patient and optimization of pump performance: in all patients, correct cannula position and pump flow could be identified. Right ventricular failure in the presence of LVAD was found to cause hemodynamic instability in 4 patients. In 1 patient with repeated RV dilation and hypotension despite RVAD, TEE allowed optimal pump settings to be determined. (3) weaning from AD: Recovery of ventricular function can be assessed prior to weaning and repeatedly monitored during weaning. TEE in TAH is limited to problems such as identification of atrial thrombus or inflow valve dysfunction. We conclude that TEE is useful in the setting of mechanically assisted circulation for AD selection, improvement of patient management, optimization of pump performance and during weaning from AD.     

Experimental study of optimal driving mode in biventricular assist device

It has been known that the ventricular assist device (VAD) is effective in profound ventricular failure refractory to conventional drugs and the intra-aortic balloon pumping. The patients with biventricular failure required biventricular mechanical support for survival. Until recently, biventricular assist device (BVAD) were applied in a few instances unfortunately. In this experimental study biventricular failure was induced by pulmonary artery banding and ligation of left anterior descending coronary artery in 20 pigs, and the BVAD was operated and the optimal driving mode was examined on the flow ratio of the right and left pumps. Group I animals were treated with BVAD, in the condition pump flow ratio right ventricular assist device (RVAD): left ventricular assist device (LVAD) = 1: less than 0.5 (4 pigs), group II were RVAD:LVAD = 1:0.5 less than or equal to less than 1 (8 pigs), and group III were RVAD:LVAD = 1:1 less than or equal to (8 pigs). CVP and RVEDP were decreased by operating the BVAD in all groups. In the group I, the flow of LVAD was less than a half of that of RVAD and the condition of excess left ventricular preload was elicited, and left ventricular failure was accelerated and it was difficult to maintain the systemic circulation. In contrast, in group II and III, the left ventricular preload was decreased, and left ventricular failure improved, and it was maintain the systemic circulation. PCWP/CVP was calculated as a method to determine clinically the right and left pump flow.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical Outcomes of Patients Treated With Pulmonary Vasodilators Early and in High Dose After Left Ventricular Assist Device Implantation

Right ventricular failure (RVF) is common after left ventricular assist device (LVAD) implantation and a major determinant of adverse outcomes. Optimal perioperative right ventricular (RV) management is not well defined. We evaluated the use of pulmonary vasodilator therapy during LVAD implantation. We performed a retrospective analysis of continuous‐flow LVAD implants and pulmonary vasodilator use at our institution between September 2004 and June 2013. Preoperative RVF risk was assessed using recognized variables. Sixty‐five patients (80% men, 50 ± 14 years) were included: 52% HeartWare ventricular assist device (HVAD), 11% HeartMate II (HMII), 17% VentrAssist, 20% Jarvik. Predicted RVF risk was comparable with contemporary LVAD populations: 8% ventilated, 14% mechanical support, 86% inotropes, 25% BUN >39 mg/dL, 23% bilirubin ≥2 mg/dL, 31% RV : LV (left ventricular) diameter ≥0.75, 27% RA : PCWP (right atrium : pulmonary capillary wedge pressure) >0.63, 36% RV stroke work index <6 gm‐m/m²/beat. The majority (91%) received pulmonary vasodilators early and in high dose: 72% nitric oxide, 77% sildenafil (max 200 ± 79 mg/day), 66% iloprost (max 126 ± 37 μg/day). Median hospital stay was 26 (21) days. No patient required RV mechanical support. Of six (9%) patients meeting RVF criteria based on prolonged need for inotropes, four were transplanted, one is alive with an LVAD at 3 years, and one died on day 35 of intracranial hemorrhage. Two‐year survival was 77% (92% for HMII/HVAD): transplanted 54%, alive with LVAD 21%, recovery/explanted 2%. A low incidence of RVF and excellent outcomes were observed for patients treated early during LVAD implantation with combination, high‐dose pulmonary vasodilators. The results warrant further investigation in a randomized controlled study.     

In Vivo Evaluation of the Miniaturized Gyro Centrifugal Pump as an Implantable Ventricular Assist Device

A miniaturized Gyro centrifugal pump has been developed to be incorporated into a totally implantable artificial heart. The Gyro PI (permanently implantable) model is a pivot bearing supported centrifugal pump with a priming volume of 20 ml. With the miniaturized actuator, the pump-actuator package has a height of 53 mm, a diameter of 65 mm, and a displacement volume of 145 ml. To evaluate the hemocompatibility and efficiency of the Gyro PI pump system, a plastic prototype (Gyro PI-601) was implanted into a bovine model as a left or right ventricular assist device (LVAD or RVAD), bypassing from the left ventricular apex to the descending aorta or from the right ventricular infundibulum to the main pulmonary artery. The calves were anticoagulated with heparin to maintain activated clotting times from 150 to 200 s. Four calves were supported for 23, 24, and 50 days in the LVAD studies, and 40 days in the RVAD study. The first calf died due to intrathoracic bleeding associated with sepsis. The second calf was euthanized for a low flow rate less than 2 L/min due to an obstructed inflow with growing pannus. The third and fourth calves were euthanized as scheduled. Renal and hepatic functions remained normal, and plasma free hemoglobin values were less than 8 mg/dL throughout the experiments. The fourth case showed flow rates of 4.83 ± 0.57 L/min, and input power of 6.16 ± 0.49 W, and the inside temperature of the actuator of 43.5 ± 0.52°C. The pumps implanted in the fourth calf demonstrated no thrombus formation at the autopsy. These in vivo experiments revealed that the Gyro PI pump can provide adequate flow as an easily implantable, efficient, antithrombogenic, and nonhemolytic centrifugal LVAD or RVAD with miniaturized actuators.     

Impact of Residual Mitral Regurgitation on Right Ventricular Systolic Function After Left Ventricular Assist Device Implantation

Significant mitral regurgitation (MR) is thought to decrease after left ventricular assist device (LVAD) implantation, and therefore repair of mitral valve is not indicated in current practice. However, residual moderate and severe MR leads to pulmonary artery pressure increase, thereby resulting in right ventricular (RV) dysfunction during follow‐up. We examined the impact of residual MR on systolic function of the right ventricle by echocardiography after LVAD implantation. This study included 90 patients (mean age: 51.7 ± 10.9 years, 14.4% female) who underwent LVAD implantation (HeartMate II = 21, HeartWare = 69) in a single center between December 2010 and June 2014. Echocardiograms obtained at 3–6 months and over after implantation were analyzed retrospectively. RV systolic function was graded as normal, mild, moderate, and severely depressed. MR (≥moderate) was observed in 43 and 44% of patients at early and late period, respectively. Systolic function of the RV was severely depressed in 16 and 9% of all patients. Initial analysis (mean duration of support 174.3 ± 42.5 days) showed a statistically significant correlation between less MR and improved systolic function of RV (P = 0.01). Secondary echocardiographic analysis (following a mean duration of support of 435.1 ± 203 days) was also statistically significant for MR degree and RV systolic dysfunction (P = 0.008). Residual MR after LVAD implantation may cause deterioration of RV systolic function and cause right‐sided heart failure symptoms. Repair of severe MR, in selected patients such as those with severe pulmonary hypertension and depressed RV, may be considered to improve the patient's clinical course during pump support.     

Minimal invasive temporary percutaneous right ventricular circulatory support after left ventricular assist device implantation

 Open in a separate windowOBJECTIVESCardiogenic shock is a life-threatening situation with high mortality rates. Mechanical unloading of the left ventricle may be achieved via left ventricular assist device (LVAD) implantation. Postoperative right ventricular (RV) failure, however, has very limited therapeutic options and is associated with increased postoperative mortality. In this paper, we describe a percutaneous right heart bypass for temporary postoperative RV support.METHODSWe retrospectively examined all patients receiving percutaneous RV mechanical support after LVAD implantation. All patients receiving trans-jugular mechanical right heart bypass during or after LVAD implantation in our tertiary medical centre between November 2014 and December 2019 were examined retrospectively. The venous draining cannula was placed in the femoral vein; the pulmonary cannula was placed in the pulmonary artery using fluoroscopy.RESULTSIn total, 14 patients received RV support using the trans-jugular technique. Mean age was 48.4 ± 14.9 years. Nine patients were treated with mechanical circulatory support before LVAD implantation. Biventricular support was done in 7 patients. All patients were treated with an Heartware HVAD . Mean postoperative intensive care unit stay was 46.3 ± 32.4 days. Mean right heart bypass support time was 10.6 ± 4.3 days. Twelve patients (86%) could be bridged to RV recovery, RV assist device implantation or heart transplantation.CONCLUSIONSPercutaneous RV mechanical support is feasible, safe and shows acceptable outcome. Early implantation of RV support may contribute to successful outcome after LVAD implantation.     

Is severe right ventricular failure in left ventricular assist device recipients a risk factor for unsuccessful bridging to transplant and post-transplant mortality

BACKGROUND: Bridging to transplant with a left ventricular assist device (LVAD) can be limited by severe right ventricular failure (RVF). The focus of this study was to ascertain whether early implantation (< 24 hours) of a right ventricular assist device (RVAD) in patients with severe RVF improved survival and whether severe RVF adversely affected post-transplant survival. METHODS: We conducted a 10-year review of our bridge to transplant experience using the Heartmate device (Thoratec, Pleasanton, CA, USA), studying patients who required an Abiomed RVAD (Abiomed, Danvers, MA, USA). RESULTS: There were 243 patients who underwent LVAD implantation, of which 17 (7.0%) required an RVAD. Ten patients underwent early RVAD insertion (< 24 hours) while 7 underwent delayed insertion (> 24 hours). Bridging to transplant was successful in 11 (64.7%) RVAD patients versus 163 (72.1%) non-RVAD patients (p = 0.046). Of the 10 patients who underwent early RVAD insertion, 7 (70.0%) were successfully bridged. Of the 7 patients who underwent delayed RVAD insertion, 4 (57.1%) were successfully bridged (p < 0.001). There was no significant difference in post-transplant 1, 5, and 10-year survival between RVAD and non-RVAD patients (71.4%, 71.4%, and 71.4% for RVAD patients, vs 90.5%, 80.4%, and 78.5%, respectively, for non-RVAD patients; p = 0.366). Pretransplant RVAD support was not a risk factor for post-transplant mortality (p = 0.864). CONCLUSIONS: Severe RVF adversely impacted bridging to transplant, although survival was improved with early RVAD insertion. The trend toward worse post-transplant survival in the RVAD cohort raises the possibility that if additional patients were evaluated, a difference in survival might be observed, suggesting the need for a multicenter analysis.     

A modified implantation technique for temporary right ventricular assist device: Enabling ambulation and less invasive decannulation

This report describes our unique temporary right ventricular assist device (RVAD) implantation technique, which enables early mobilization even during biventricular support and subsequent less invasive RVAD removal without needing resternotomy upon recovery.