Left Ventricular Assist Device Exchange Research Articles

Abstract 16276: Complex Corynebacterium Case: Management of Recurrent Corynebacterium Bacteremia in a Patient With Cardiac Implanted Electronic Device and Left Ventricular Assist Device

Background Cardiac implantable electronic device (CIED) infections are morbid and costly. Atypical organisms are increasingly recognized as a cause of CIED infections. We present a case of recurrent Corynebacterium striatum bacteremia requiring CIED and left ventricular assist device (LVAD) extraction. Case Presentation A 54-year-old female dialysis patient with diabetes, ischemic cardiomyopathy, primary prevention single chamber transvenous defibrillator (ICD) 8 years prior, and destination LVAD presented with chronic C. striatum driveline site infection and relapsing and remitting bacteremia. Over the prior two years, she suffered from chronic driveline infections requiring wound care, driveline washouts, and antibiotics, although not seen by the electrophysiology (EP) team. After a fourth episode of bacteremia, she underwent ICD extraction and LVAD pump exchange, followed by 6 weeks of vancomycin and 3 months of rifampin. She then remained free of bacteremia for 19 months, though continued to demonstrate evidence of driveline infection despite pump exchange. Ultimately, C. striatum bacteremia recurred. Given unrelenting soft tissue infection and recurrent bacteremia, redo LVAD exchange was deferred and she was treated with lifelong suppressive antibiotics. Discussion Corynebacterium species have historically been considered skin flora, but more recently have been identified as pathogens, both as a cause of endocarditis, and a common organism in LVAD associated soft tissue infections. There are few reports of CIED infection. Source control is difficult in bacteremia patients with both CIED and LVAD. In this case, recurrent bacteremia could be attributed to recurrent driveline-soft tissue infection. However, the prolonged freedom from bacteremia off antibiotics after CIED extraction, despite ongoing soft tissue and driveline infection, argues that her transvenous ICD may have been seeded. This case highlights the growing spectrum of bacteria implicated in CIED-related infection, that early extraction may be a critical intervention regardless of infectious source, and importance of multidisciplinary discussions including heart failure, surgery, infectious disease, and EP to improve outcomes in this complex population.

Clinical Outcomes of Left Ventricular Assist Device Pump Infection.

Few studies have focused on the clinical outcomes and risk factors of left ventricular assist device (LVAD) pump infection, and no standard treatment for LVAD pump infection has been established. Therefore, we used a therapeutic flowchart to manage LVAD pump infections. We retrospectively evaluated 220 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2021 at Osaka University, Japan. First, we performed wound debridement, negative-pressure wound therapy, antibiotic treatment, and omental flap transposition. Subsequently, we administered conservative treatment, scheduled implantable LVAD exchange, or emergent removal of the implantable LVAD and exchange for extracorporeal LVAD or percutaneous LVAD (IMPELLA). Pump infections occurred in 32 patients. The survival rates of patients with pump infections during LVAD support were 93%, 74%, and 61% at 180 days, 1 year, and 2 years after LVAD pump infection, respectively. Fifteen patients underwent successful heart transplantation. Bridge-to-bridge surgery, preoperative use of venoarterial extracorporeal membrane oxygenation or percutaneous LVAD, high lactate dehydrogenase levels, and driveline infection were significantly associated with pump infection. Our study reveals that poor preoperative condition and driveline infection were significant risk factors for LVAD pump infection.

CARC3: Simultaneous Transvalvular Percutaneous Left Ventricular Assist Device (LVAD) Exchange: A Reliable Method for Uninterrupted Mechanical Circulatory Support

Background: Impella CP and Impella 5.5 are commonly used catheter-based percutaneous transvalvular LVADs with differing flow support capacities and sites of placement. Impella exchanges are indicated for escalation of therapy, in cases of vascular or renal complications, and for mobility enhancement and improvement of physical conditioning. During conventional exchange, flow interruption occurs as the old device is pulled into the thoracic aorta prior to advancing the new device into the left ventricle (LV), threatening hemodynamic collapse in device-dependent cardiogenic shock patients. While “double device” uninterrupted Impella exchange has been reported, concerns remain with respect to valve damage, stroke, and entanglement with two devices concurrently in the LV. We present the largest institutional experience of simultaneous transvalvular Impella placement reported to date, demonstrating the feasibility, reproducibility and safety of the uninterrupted percutaneous LVAD exchange. Methods: 22 consecutive cardiogenic shock patients supported by an Impella (CP, 5.0 or 5.5) and requiring LVAD device replacement underwent a simultaneous transvalvular exchange procedure. The new device was advanced into the LV under transesophageal echocardiographic (TEE) and fluoroscopic guidance with the old device still in position. Flow was started on the new device as the old device was weaned, powered down and removed from the ventricle. Demographic data, etiology of illness, indication for device exchange, details of that exchange, and any postoperative complications were analyzed. Results: 95.5% (21/22) of patients were male, with average age of 54 years (32-71). 68.2% (15/22) had ischemic, whereas 31.8% (7/22) had nonischemic cardiomyopathy. Initial Impella location was the femoral artery in 90.9% (20/22) of patients. Replacement device was inserted via the right axillary artery in 90.9% (20/22) of patients. Using intraoperative TEE, 95.5% (21/22) showed no postoperative aortic insufficiency (AI), whereas 4.5% (1/22) had trace AI. No patients suffered vascular complications or suffered cardiac arrest during device exchange. One patient (4.5%) developed a hemorrhagic stroke 3 days post exchange. 59.1% (13/22) survived, with 3 patients recovering, 8 progressing to heart transplant, and 2 to durable LVAD. The ECMO-Impella patients had a survival rate of 35.7% (5/14), while the Impella-only survival was 100% (8/8). Conclusion: Based on our institutional experience, this technique is safe and reliable for escalating percutaneous LVAD device support in patients who are critically ill and cannot tolerate flow interruption. The severity of illness in this cohort is reflected in the incidence of pre-existing end-organ injury and overall mortality. By our evaluation, this “double barrel” exchange technique carries a significant advantage and minimal risk; however, larger studies will be needed to demonstrate statistical equivalency of this approach.Figure 1. Fluoroscopy demonstrating both percutaneous LVAD devices within the LV simultaneouslyFigure 2. Simultaneous Transvalvular Percutaneous LVAD Exchange

Device Exchange to HeartMate 3 LVAD: Impact of Previous Pump Model on Clinical Outcomes

BackgroundWe describe our clinical experience performing device exchange from a HeartMate II (HM2) or HVAD to a HeartMate 3 (HM3) left ventricular assist device. MethodsA single-center retrospective study was performed of all patients (N = 14) who underwent a left ventricular assist device exchange from HM2 (n = 7) or HVAD (n = 7) to HM3 between October 2018 and October 2021. The primary outcome was 1-year overall survival, and secondary outcomes included adverse events through discharge. ResultsAll patients (median age, 59 years; 29% female) were destination therapy and required urgent device exchange because of pump failure. Although statistically insignificant, the 1-year overall survival was worse in the HVAD to HM3 group compared with the HM2 to HM3 cohort (57% vs 100%, respectively; P = .19). The HVAD to HM3 group also experienced significantly more acute right-sided heart failure requiring right ventricular assist device support (71% vs 0%; P = .02), ventilator days (11 days vs 1 day; P = .001), and reoperation (100% vs 14%; P = .004). ConclusionsPatients being considered for device exchange from HVAD to HM3 may have a more complicated clinical course compared with HM2 to HM3 patients.

Our Single Center Experiences with Left Ventricular Assist Device Exchange

Mechanical circulatory support technology continues to evolve to satisfy the needs of advanced heart failure patients. Despite improvements, various problems occur frequently, and surgical exchange of the pump can be a feasible treatment option. Optimal patient selection is key to success in exchange operations. Using a retrospective observational cohort design, this study aims to evaluate preoperative profiles and clinical courses of patients' undergoing a device exchange operation and identified possible contributors to in-hospital mortality. Currently, 155 left ventricular assist device (LVAD) patients are being followed up in our program. In total, 15 of 155 patients underwent a pump exchange operation. Baseline characteristics, clinical features, and laboratory results were evaluated. The primary outcome was all-cause in-hospital mortality. Of the 15 patients who underwent a pump exchange operation, thrombosis was the primary cause in 12. Five patients experienced in-hospital mortality within 30 days of LVAD exchange. The international normalized ratio (INR) was higher in patients who experienced in-hospital mortality (2.4 [±0.6] vs 1.2 [±0.4], P=.005) than in patients who survived to discharge. In addition, preoperative lactate levels were significantly higher in patients who died within 30 days (2.9 [±2.6] vs 0.9 [±0.4], P=.019). Higher INR and lactate levels could possibly contribute to in-hospital mortality, which underlines the importance of right ventricular function in this patient population. Careful evaluation of the right heart function is of great importance before exchange operations, and preoperative hemodynamic stability is crucial for better postoperative outcomes.

Left ventricular assist device exchange from HeartMate II to HeartMate 3 in an Asian patient—a case report and literature review

BackgroundPump exchange surgery of left ventricular assist device (LVAD) has been demonstrated in several studies; however, information for Asian patients was limited.Case presentationA 63-year-old man underwent a pump upgrade from HeartMate II to HeartMate 3 for driveline damage through limited left anterior thoracotomy and lower partial sternotomy. He did not experience any hemodynamic adverse events or device malfunction during postoperative follow-ups of 12 months. We also reviewed all published cases with HeartMate II exchange to HeartMate 3.ConclusionsThe case demonstrated that it was safe and feasible to perform HMII LVAD exchange to HM3 through a limited approach for Asian patients.

Left ventricular assist device exchange: a review of indications, operative procedure, and outcomes.

The use of left ventricular assist devices (LVADs) is intended to treat patients with end-stage heart failure. Owing to technological advances, these devices are becoming more durable. However, LVADs may need to be exchanged when complications arise and heart transplantation is not possible. Indications for LVAD exchange (LVADE) include device thrombosis, device infections, and pump component failure. LVADE has historically been associated with a high risk of morbidity and mortality. In this review, we discuss the indications of LVADE, the decisional and technical aspects during surgery, and outcomes.

P53: Postoperative Leukocytosis Trends in Ventricular Assist Device Implantation and Coronary Artery Bypass Graft Surgery

Background and Objective: Leukocytosis is a marker of inflammation due to infectious or non-infectious etiologies and is seen after coronary artery bypass graft surgery (CABG) and left ventricular assist device (LVAD) placement. Differentiating reactive postoperative leukocytosis from post-operative infection can drive antimicrobial stewardship initiatives. In this study, we aimed to describe the expected temporal trend of white blood cell (WBC) counts after LVAD placement compared to CABG. Methods and Analysis: We conducted a retrospective chart review of adult patients who underwent durable LVAD implantation or on-pump CABG between 2017-2019 at a single university-affiliated tertiary care hospital in Washington, DC. We excluded patients who were undergoing LVAD exchange, percutaneous VAD placement, had kidney failure requiring renal replacement therapy or transplant, had thromboembolism <14 days before the procedure, clinical or microbiological evidence of systemic infection <7 days before the procedure, were on steroids ≥5 mg prednisone daily, had a history of hematologic malignancy or acquired immunodeficiency syndrome. We compared the WBC count trend postoperatively after LVAD placement vs. CABG until day 24 or discharge, whichever was earlier. Secondary outcomes included comparing number of patients with bacteremia or clinical evidence of infection requiring antimicrobial therapy among the two groups. Results: We reviewed the charts of 116 LVAD patients and 134 CABG patients with median age 61 years [Interquartile Range (IQR) 53.0, 67.0] and BMI 28.4 kg/m2 [IQR 25.5, 32.8]. In the LVAD group, there was a peak in median WBC count to 14.2 (x103/ μL) [IQR 11.3, 17.6] on Day 2 post-operatively and another peak on Day 10 post-operatively to 14.1 [IQR 10.6, 18.4]. In the CABG group, median WBC peak was observed at Day 2 post-operatively at 11.8 [9.1, 14.2] (Fig. 1). There were 10 (8.6%) LVAD patients with clinical or microbiological evidence of infection compared to 2 (1.5%) CABG patients (p = 0.01). After excluding patients with infections there was no change observed in the trend of the postoperative WBC counts. Conclusion: Post-operative leukocytosis is common in cardiopulmonary bypass and peak WBC are higher in LVAD patients than CABG patients. WBC counts peak in LVAD patients at day 2 and 10 postoperatively. This expected peak should be taken into consideration while evaluating patients for infections and antimicrobial therapy.

Flow dynamics during the HeartWare HVAD to HeartMate 3 exchange: A computational study assessing differential graft lengths and surgical techniques.

Flow dynamics during the HeartWare HVAD to HeartMate 3 exchange: A computational study assessing differential graft lengths and surgical techniques.

CT Derived Three Dimensional Modeling to Facilitate Minimally Invasive HVAD to HeartMate3 Left Ventricular Assist Device Exchange

<h3>Introduction</h3> The optimal surgical technique for HVAD to HeartMate 3 left ventricular assist device (LVAD) exchange will be patient dependent. We report a successful minimally invasive approach. <h3>Case Report</h3> Case: A 33-year-old woman with Adriamycin induced cardiomyopathy status post destination therapy HVAD in 2006 developed progressive alarms. Imaging revealed a large left ventricular (LV) thrombus attached to the inflow cannula. An elective HVAD to HeartMate 3 exchange was considered. Pre-operative planning: CT imaging was used to generate a three dimensional (3D) model of the heart and HVAD (A). To aid in planning both new device placement and the anastomosis between the HVAD and HeartMate 3 outflow grafts, a 3D model was generated (B). Surgical description: A left thoracotomy and 5th rib resection was used to access the HVAD and LV apex (C). The femoral vessels were cannulated for cardiopulmonary bypass and the heart was minimally manipulated. The HVAD pump, apical cuff, and exposed driveline were removed and LV clot evacuated. The HeartMate 3 apical cuff was secured to the LV apex and the pump placed in standard position (D). The HeartMate 3 (14mm) outflow graft was anastomosed to the retained HVAD (10mm) outflow graft by beveling the HVAD outflow graft (E, F). The HeartMate 3 driveline was then tunneled out of the left upper abdominal quadrant using a double tunnel technique. The thoracotomy was then closed in a standard fashion. <h3>Summary</h3> Outcome: The total bypass time was 1 hour and 20 minutes. She arrived to the intensive care unit on low dose epinephrine and vasopressin, which were rapidly weaned off. She required a total of 2 packed red blood cell transfusions. She was extubated on post-operative day 3 with normal hemodynamics and intact end organ function. She was eventually discharged in stable condition. 3D modeling was invaluable in preprocedural planning and final outcomes.

HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1-8).

Graft Resistance Difference after HVAD to HeartMate 3 Left Ventricular Assist Device Exchange

A likely consequence of the discontinued distribution and sale of the HVAD System (Medtronic, Minneapolis, MN) will be an increase in replacement with the HeartMate 3 (Abbott, Chicago, IL) left ventricular assist device when device exchange is necessary. If part or all of the HVAD 10-mm-diameter outflow graft is retained during replacement, the HeartMate 3 will have to run at a higher speed than it would with its 14-mm-diameter graft. A steady-state, invitro study was run with 250-mm-long samples of HVAD, HeartMate 3, and half-HVAD/half-HeartMate 3 grafts and additionally 125- and 375-mm-long samples of the HVAD graft. Flows of 3.0, 3.9, 4.3, 4.7, and 6.0 L/min were applied to encompass expected clinical conditions. At typical and high flow rates of 4.3 and 6.0 L/min, HeartMate 3 rotor speeds with the full HVAD graft had to be increased relative to those with the HeartMate 3 graft from 5350 to 5700 and 6350 to 6900 rpm, respectively, with power consumption increases from 3.7 to 4.3 W (16%) and 5.5 to 6.8 W (24%), respectively. The study did not elucidate a severe consequence of using a remnant HVAD graft during pump exchange, but the incremental risks of a higher rotor speed, disadvantage to the patient in battery runtime, and the general benefit of complete conversion to the HeartMate 3 graft should be balanced against other procedural considerations. Complete graft replacement during HVAD-to-HeartMate 3 conversion remains the preferred approach from an engineering point of view.

Left ventricular assist device therapy improves severe secondary mitral regurgitation without mitral valve repair

Abstract Background Severe secondary mitral regurgitation (MR) worsens prognosis in patients with medically managed heart failure (HF). In patients treated by left ventricular assist device (LVAD), it is unclear whether severe MR should be corrected at time of LVAD implantation. Purpose To evaluate impact of LVAD therapy on severe and non-severe secondary MR over 1 year. Methods Retrospective single centre study of consecutive patients who underwent HeartMate (HM)2 or HM3 LVAD implantation between January 2011 and March 2020. Results Of 155 patients, 20 were excluded due to LVAD exchange (n=10), mitral valve repair (n=1), or inaccessible pre-LVAD echocardiography (n=9). Based on multiparametric grading, 29/135 patients had severe secondary MR and 106/135 had non-severe secondary MR (including none). Severe MR patients were more often female [10/29 (34%) vs 11/106 (10%); p=0.002] but were of similar age (54±12 vs 55±9 years; p=0.624), size (27±5 vs 27±4 kg/m2; p=1.0), with equivalent renal function (53±22 vs 55±20 ml/min/1.73m2; p=0.641) and median pre-operative NT-proBNP [4076 (IQR 206–5438) vs 4914 (IQR 2706–7518) ng/L; p=0.488]. There were similar proportions of patients with ischaemic aetiology [16/29 (55%) vs 66/106 (62%); p=0.488) and those receiving HM2 [11/29 (38%) vs 32/106 (30%)] and HM3 [18/29 (62%) vs 74/106 (70%); p=0.575] LVAD. Echocardiography before LVAD implantation demonstrated similar left ventricular (LV) size (LV end-diastolic volume: 133±44 vs 118±50ml/m2; p=0.145, end-systolic volume: 107±41 vs 96±59ml/m2; p=0.348) and LV ejection fraction (17±9 vs 17±7%; p=1.0). Severe MR patients had significantly greater (p&amp;lt;0.001) MR by proximal isovolumetric surface area (0.93±0.27 vs 0.60±0.16cm), vena contracta (0.79±0.32 vs 0.57±0.18cm), regurgitant volume (47±25 vs 24±12ml), and fraction (54±15 vs 37±13%). Follow-up (f/u) echocardiography was performed at a median 222 days (range 356 days). Patients who received cardiac transplantation before f/u echocardiography were excluded. Relative severities of MR at f/u were: none = 12 (46%), mild = 8 (31%), moderate = 5 (19%), severe = 1 (4%) amongst patients with severe MR pre-LVAD, and none = 55 (58%), mild = 26 (27%), moderate = 13 (14%), severe = 1 (1%) amongst patients with non-severe MR pre-LVAD. At 1-year, after excluding all patients who underwent cardiac transplantation (severe MR n=4; non-severe MR n=2), rates of HF hospitalisation [5/25 (20%) vs 16/104 (15%); p=0.575] and all-cause mortality [2/25 (18%) vs 22/104 (21%); p=0.129)] were similar, irrespective of pre-LVAD MR severity. No patient who died during follow-up had severe MR prior to death. Conclusion LVAD improves severe secondary MR in 96% of cases, resulting in 1-year rates of HF hospitalisation and mortality similar to patients without severe MR pre-LVAD. These data suggest mitral valve surgery at time of LVAD implantation is not warranted. Funding Acknowledgement Type of funding sources: None.

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™.

Device exchange to a newer generation left ventricular assist device (LVAD) offers the opportunity to benefit from improved adverse events profiles. We present the three-year results of a patient cohort undergoing VAD upgrades to a new generation device focusing on outcomes and adverse events. We present the first series of patients who underwent LVAD upgrade to HeartMate 3™ (Abbott Laboratories; Abbott Park, IL, USA). All operations were performed less invasively. Follow-up time was three years after LVAD exchange. Overall four HeartMate II™ (Abbott Laboratories; Abbott Park, IL, USA) and two HVAD patients underwent LVAD upgrade. In five cases severe infection of the VAD led to device exchange (83%, 5/6). Three-year survival after LVAD exchange was 100% (6/6). In the follow-up examinations one patient showed a single syncope and several low flow alarms (1/6). The remaining five patients showed no technical malfunctions of the LVAD or hemodynamic adverse events (5/6). Four out of five patients whose devices had to be changed due to an infection suffered a local re-infection (4/5), which did not require any further surgical intervention. Four patients were successfully transplanted, and two patients were still on device support at three years after LVAD exchange. Three-year outcomes and adverse events after LVAD exchange to HeartMate 3™ (Abbott Laboratories). show excellent results. The superior hemocompatibility in terms of pump thrombosis makes the HM3 a favored choice in case of LVAD exchange due previous pump thrombosis. However, in cases of exchange due to device infection the risk of re-infection remains high.

Left Ventricular Assist Device Exchange to HeartMate III Using Minimally Invasive Approach

<h3>Purpose</h3> Pump thrombosis, infection or device malfunction are major complications of LVAD that may need to be treated with pump exchange. There is limited data on exchanges to HMIII. Our purpose was to review outcomes of patients undergoing any LVAD to HMIII exchange at our center using minimally invasive approach (subcostal and/or left anterolateral thoracotomy). <h3>Methods</h3> We retrospectively reviewed records of patients undergoing any LVAD to HMIII exchange from January 2016 to October 2020. Pre-operative characteristics, indication, hospitalization course and post discharge data was collected. <h3>Results</h3> Ten patients underwent LVAD (7 HMII, 2 HMIII, 1 HeartWare) to HMIII exchange. Baseline characteristics are described in Table 1. Indications for exchange were pump thrombosis (3), infection + thrombosis (2), malposition (1), malposition + thrombosis (1), outflow graft obstruction from external compression (1), outflow graft twisting and thrombosis (1) and drive line injury (1). All patients underwent minimally invasive approach but 5 needed additional sternotomy to clear abscess collection or due to anatomical complexity. Post exchange, 1 patient needed pericardial window, 1 needed short term hemodialysis, 1 had recurrence of GI bleeding, 1 had CVA on POD 1 and 3 patients needed washout and debridement or hematoma evacuation. There was no change in RV function. Mean length of stay was 20.8 ±2 days. There was only 1 re-admission (sternal wound drainage needing debridement) within 30 days of discharge. There were a total of 8 other admissions (2 for MSSA Bacteremia, 1 for HF exacerbation, 1 for GI bleeding, 1 repeat debridement of sternal wound, 1 for renal failure and 2 for unrelated reasons) within 1 year post discharge. There was no recurrence of thrombosis. Mortality was 0% at 30 days and 0% at 1 year for 5/10 patients (others are alive and less than 1 year from exchange). <h3>Conclusion</h3> LVAD to HMIII exchange with a minimally invasive approach has low surgical mortality and acceptable intermediate- term outcomes.

Continuous-Flow Left Ventricular Assist Device Support for Patients with Hypertrophic Cardiomyopathy: A Single Centre Experience

<h3>Purpose</h3> There is controversy over the use of durable left ventricular assist devices (LVADs) in supporting patients with hypertrophic cardiomyopathy (HCM) and advanced heart failure. HCM patients have smaller left ventricular (LV) dimensions and are at higher risk of LVAD inflow cannula occlusion from ventricular decompression. Right ventricular (RV) failure is also a concern in these patients. This study describes a single-centre experience of LVAD implantation in patients with heart failure due to HCM. <h3>Methods</h3> Cases were reviewed from a prospective registry of all LVAD implants at the University Health Network (Toronto, Canada) between 2006 and 2020 to identify patients with HCM. We determined baseline characteristics, peri-operative course and outcomes, including requirement for RV support, ICU and hospital length of stay and eventual outcome from LVAD support. <h3>Results</h3> We identified 15 patients with LVAD implantation for HCM with a history of heart failure of 6 (interquartile range: 4-12) years and peak VO₂ of 9.6 (9.2-10.4) ml/kg/min. Median age was 57 (46-60) years, 1 (7%) patient was female (Table). During the index admission for LVAD implant, 5 (33%) patients required renal replacement therapy and 3 (20%) died due to ischemic bowel, tracheobronchitis and liver failure/sepsis, respectively. No patients required RV support. ICU stay was 8 (6-11) days and hospital stay 33 (16-65) days in those discharged from hospital. Overall, patients were supported for 5153 patient-days; 9 (60%) patients underwent heart transplant after LVAD support of 206 (110-458) days, 2 (13%) are currently supported and 1 died after 1671 days from presumed pump thrombosis. One patient required LVAD exchange for late pump thrombosis. <h3>Conclusion</h3> This single-centre experience demonstrated that LVAD support in patients with HCM is safe and effective as a bridge to transplant or destination therapy. Further work should explore patient characteristics favourable to LVAD therapy in HCM patients.

Off-Pump Implant Strategy for the Jarvik 2000 LVAD

Purpose Median sternotomy and cardiopulmonary bypass (CPB) represent the gold standard for the left ventricular assist device (LVAD) implantation. Long-term survival rates in LVAD patients are highly dependent on the immediate peri- and post-operative course. The CPB deleterious effects in this fragile population include right ventricular dysfunction, bleeding, and end-organ injury. Minimally invasive strategies, with off-pump implantation and alternative access rather than sternotomy, have been recently reported for contemporary continuous-flow LVAD placement.We sought to assess the safety, feasibility, and short-term outcomes of minimally invasive off-pump LVAD implantation. Methods We retrospectively reviewed data of 19 patients who underwent off-pump Jarvik 2000 LVAD implantation, as destination therapy, from December 2010 to April 2019, at our center. The surgical access was: J-ministernotomy + left minithoracotomy in 89.5%, and anterolateral thoracotomy in 10.5% of the patients. Study endpoints were perioperative outcomes and long-term survival. Results Mean age was 67.1±5.2 years, 89.5 % were male and the underlying disease was ischemic cardiomyopathy in 42.1%. INTERMACS class was: II: 10.5%, III: 31.6%, IV: 57.9%. There were no on-pump conversions; a major bleeding required a surgical access conversion in 2 cases. Mean mechanical ventilation time was 17±7 hours, median of blood transfusion units was 6 (interquartile range 3-15). Perioperative stroke, bleeding requiring surgical re-entry and severe right ventricular failure were 5.2%, 21.1%, and zero, respectively. Median postoperative hospital stay was 30 days (interquartile range 21.5-45) with a 5.2% 30-day mortality rate. Mean duration of support was 1034.7 days (range 8-1981 days). Three patients had LVAD-related complications leading to device explant, after a mean time of 983±310 days: two patients underwent a re-do LVAD exchange, one was successfully transplanted. One- and 2-year overall survival were 77.8% ± 9.8% and 70% ± 11.5%, respectively. Conclusion Our preliminary experience shows that off-pump Jarvik 2000 LVAD implantation is feasible and safe alternative to the standard implantation technique. Good peri-operative outcomes and long-term survival rates could encourage an extended use of this strategy. However, additional implants and comparison of outcomes in larger populations are needed.

Complex HeartWare left ventricular assist device infection treated with pump exchange: clinical alert for the driveline location.

Infection is a major complication in patients with a left ventricular assist device (LVAD). Once a driveline exit-site infection (DLI) reaches the LVAD component, LVAD exchange may become necessary for radical treatment, although clinical results are not satisfactory. In this report, we describe two cases of LVAD infection successfully treated with pump exchange. During LVAD support, the DLI extended into the pump pocket and the outflow graft despite aggressive surgical debridement and negative pressure wound therapy. These two patients required LVAD exchange for radical treatment, because the estimated waiting period for heart transplantation was at least more than 1year. The LVAD exchange was performed through median re-sternotomy, and the infected HeartWare ventricular assist device (HVAD) was completely removed under cardiopulmonary bypass. Then, a new LVAD covered with the omentum flap was implanted. These two patients were successfully bridged to heart transplantation after 10months and 2years of support without recurrence of infection. These two cases may suggest that the driveline of the HVAD needs to be kept away from the outflow graft to prevent refractory outflow graft infection.

Off-pump HeartMate II Exchange in a Patient with Severe Lower Extremity Peripheral Artery Disease: A Case Report

Thrombosis of left ventricular assist device (LVAD) pumps is a serious complication that often requires exchange of the device. A 66-year-old man with severe peripheral vascular disease presented with pump thrombosis of the HeartMate II (HMII) LVAD 1.5 years after implantation. The HMII was exchanged to another HMII through a subcostal incision and without the use of cardiopulmonary bypass. For safety, the patient was prepared for cardiopulmonary bypass by exposing the right subclavian artery and insertion of a 5 FR cannula in the left common femoral vein. The pump was exchanged through a subcostal incision made over the LVAD pump pocket perpendicular to the costal margin. After deairing the pump and graft, LVAD support was resumed, postoperative course was uneventful, and the patient was discharged from the hospital four days later. Re-thrombosis, stroke, and right heart failure are frequent complications after LVAD exchange. Exchange through a subcostal incision with cardiopulmonary bypass backup appears to be safe.

Outcomes Following Left Ventricular Assist Device Exchange: Focus on the Impacts of Device Infection.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.