Successful Left Ventricular Assist Device Research Articles

Development of a Hub-and-Spoke Durable Left Ventricular Assist Device Program in Brazil, a Middle-Income Country

ObjectivesTo describe the experience of a left ventricular assist device (LVAD) program in a middle-income country in a hub-and-spoke model. MethodsPatients fulfilling strict inclusion and exclusion criteria were referred from different centers in Brazil for LVAD implantation through a philanthropy program financed via a Brazilian Federal Government tax exemption structure. LVAD implantation was performed in hub-and-spoke model with a single implanting center. Data was collected retrospectively using hospital records and telephone contact with other centers. Patients that received LVAD implants external to the philanthropic program, either at this or other Brazilian centers, were not included. ResultsBetween January 1st, 2013, and December 31st, 2020, 20 adult patients underwent long-term continuous flow LVAD implantation with decentralization of post-implant patient care in regional centers. Patients were referred from 11 centers from 7 states in Brazil and underwent LVAD implantation through a philanthropy program. The median age was 52.5 years and 85% were INTERMACS profile 3 patients. Two patients had Chagas cardiomyopathy. The overall survival censored for competing risks at 1 year and 2 years were 90% and 84% respectively. Three patients (15%) underwent heart transplantation in the first 2 years after LVAD implantation. Twelve patients returned to their original centers and were followed remotely. ConclusionsThis study presents a successful LVAD implantation program in a hub-and-spoke model in Brazil. Centralization of LVAD implantation with decentralization of post-implant patient care in regional centers is feasible and safe, enabling optimal allocation of resources in middle-income countries.

Myocardial Recovery With HeartMate 3 Left Ventricular Assist Device: An Attainable Goal That Needs Better Precision.

Despite advances in our understanding of myocardial recovery among left ventricular assist device (LVAD) patients, with 10-30% of patients achieving substantial myocardial improvement, the rates of LVAD support cessation remain extremely low (1-2%). These numbers are in stark contrast to clinical trial data where successful LVAD cessation is reported in up to 47% of patients. The majority of LVAD programs lack structured recovery programs and targeted protocols, likely underscoring the heterogeneity that exists among LVAD patients with myocardial recovery. This perspective summarizes the current medical and surgical challenges with respect to 1) identifying the appropriate candidates for LVAD cessation; 2) methods to wean LVAD support; 3) reviewing surgical techniques for cessation of current generation HeartMate 3 LVAD; and 4) approaching shared decision making for LVAD cessation between patients and providers given the uncertainties that remain in the field.

Long-term predictors of morbidity and mortality in patients following LVAD replacement.

As heart transplant guidelines evolve, the clinical indication for 73% of durable left ventricular assist device (LVAD) implants is now destination therapy. Although completely magnetically levitated LVAD devices have demonstrated improved durability relative to previous models, LVAD replacement procedures are still required for a variety of indications. Thus, the population of patients with a replaced LVAD is growing. There is a paucity of data regarding the outcomes and risk factors for those patients receiving first-time LVAD replacements. The study cohort consisted of all consecutive patients between 2006 and 2020 that received a first-time LVAD replacement at a single institution. Preoperative clinical and laboratory variables were collected retrospectively. The primary endpoint was death or need for an additional LVAD replacement. Data were subjected to Kaplan-Meier, univariate, and multivariate Cox hazard ratio analyses. In total, 152 patients were included in the study, of which 101 experienced the primary endpoint. On multivariate analysis, patients receiving HeartMate 3 (HM3) LVADs as the replacement device showed superior outcomes (HR 0.15, 95% CI 0.065-0.35, p < 0.0001). Independent risk factors for death or need for additional replacement included preoperative extracorporeal membrane oxygenation (ECMO) (HR 4.44, 95% CI 1.87-14.45, and p = 0.00042), increased number of sternotomies (HR 5.20, 95% CI 1.87-14.45, and p = 0.0016), and preoperative mechanical ventilation (HR 1.98, 95% CI 1.01-3.86, and p = 0.045). Replacement with HM3 showed superior outcomes compared to all other pump types when controlling for both initial pump type and other independent predictors of death or LVAD replacement. Preoperative ECMO, mechanical ventilation, and multiple sternotomies also increased the odds for death or the need for subsequent replacement.

Left ventricular assist device implantation combined with hemiarch replacement for severe aortic atherosclerosis.

Implantation of the left ventricular assist device (LVAD) has emerged as a widely employed therapeutic approach for specifically chosen individuals suffering from severe heart failure. Stroke is a well-known complication of LVAD implantation. Concomitant aortic surgeries in patients requiring LVAD implantation to avoid outflow graft anastomosis to a severe atherosclerotic aorta are unknown. We illustrate a successful LVAD implantation with hemiarch replacement for severe aortic atherosclerosis to decrease the risk of postoperative stroke. A 72-year-old male patient with advanced heart failure has chosen to undergo LVAD treatment. Preoperative examinations detected severe atherosclerosis in the ascending aorta. It was determined that clamping the ascending aorta and directly connecting the outflow graft could increase the risk of stroke after surgery. Therefore, it was decided to replace the diseased ascending aorta entirely. The HeartMate 3 was implanted under cardiopulmonary bypass (CPB) using right axillary artery cannulation. And moderate hypothermia and bilateral antegrade cerebral perfusion were utilized to perform hemiarch replacement. Subsequently, the outflow graft was connected to an artificial ascending aortic graft. The patient did not exhibit any specific complications, such as neurological abnormalities, after the surgery. Based on our observations, it appears that LVAD implantation combined with aortic replacement could be a viable option for specific patients, particularly those who have a perioperative stroke risk due to aortic atherosclerosis.

SHOCK5: Utilization of an RP Flex Impella to support Right Ventricular Dysfunction post Left Ventricular Assist Device Placement

Background: Right ventricular dysfunction (RVD) during Left Ventricular Assist Device (LVAD) placement is associated with increased morbidity and mortality. Right Ventricular Assist Device (RVAD) implantation has been shown to reduce the severity of RVD and can improve overall outcomes. We describe the first use of the RP Flex Impella (Abiomed, Danvers MA) RVAD to support RVD during durable LVAD HeartMate 3 implantation(Abbott, Chicago, IL). Case: A 68 year old female with a history of postpartum cardiomyopathy on home inotropic support for 4 years presented with acute exacerbation of heart failure in the setting of sustained ventricular tachycardia. She was evaluated for LVAD however preoperatively there were concerns for risk of RVD due to pulmonary artery pressure index (PAPI) 1.5 and echocardiogram with moderate right ventricular (RV) dilation and significantly reduced function which had progressed as compared to prior assessments. It was decided during the pre implant meeting to support the RV given borderline parameters despite high dose inotropic support. The RP flex impella was placed via the right internal jugular vein and provided 2.8L support. A sodium bicarbonate purge was utilized instead of heparin due to bleeding concerns. By postoperative day (POD) 1 epinephrine and inhaled nitric oxide were successfully titrated down to facilitate early extubation and systemic heparin was started with a goal PTT 50-60 along with aspirin 81mg. Central venous pressure (CVP) remained 8-12mmHg with PAPI 1.2-1.9 over the next few days. RV function on echo remained mildly reduced and LVAD parameters and hemodynamics were stable. Based on the ability to wean inotropes with stable hemodynamics, formal wean occurred on POD4 with reduction to 1.5L flow. Hemodynamics remained unchanged with CVP 10, PA 30/15, PAPI 1.5. Low dose milrinone remained for RV support and the Impella was removed POD 5 at bedside without complication. Post removal RV dilation and drop in PIs resulted in iNO therapy, which was quickly transitioned to sildenafil. Inotropes were fully weaned off POD 12 and the patient was discharged to acute rehab on POD 16 off inotropes and on sildenafil. Throughout this course, renal function remained within the patient’s normal range and the patient was ambulatory from POD 6. Conclusion: This experience describes the first use of RP flex impella to support RVD during durable LVAD placement. The RP flex impella offers a small, percutaneous option for RV support with ease of use and easy bedside removal due to small sheath size. Early use of the RP flex, preventing further sequelae of RVD allowed for adequate support, bypassing the need for surgical RVAD and thus a shorter recovery than traditionally required. Additionally this case adds to the growing literature of RVAD utilization to improve outcomes in patients with marginal RV function for a successful durable LVAD.

Prospective Phenotyping of Right Ventricle Function Following Intra-Aortic Balloon Pump Counterpulsation in Left Ventricular Assist Device Candidates: Outcomes and Predictors of Response.

Intra-aortic balloon pump (IABP) may be applied to optimize advanced heart failure (AHF) patients and improve right ventricular (RV) function before left ventricular assist device (LVAD) implantation. We aimed to evaluate the outcome of this intervention and define RV response predictors. Decompensated AHF patients, not eligible for LVAD because of poor RV function, who required IABP for stabilization were enrolled. Echocardiography and invasive hemodynamics were serially applied to determine fulfillment of prespecified "LVAD eligibility RV function" criteria (right atrium pressure [RA] <12 mm Hg, pulmonary artery pulsatility index [PAPi] >2.00, RA/pulmonary capillary wedge pressure [PCWP] <0.67, RV strain <-14.0%). Right ventricular-free wall tissue was harvested to assess interstitial fibrosis. Eighteen patients (12 male), aged 38 ± 14 years were supported with IABP for 55 ± 51 (3-180) days. In 11 (61.1%), RV improved and fulfilled the prespecified criteria, while seven (38.9%) showed no substantial improvement. Histopathology revealed an inverse correlation between RV interstitial fibrosis and functional benefit following IABP: interstitial fibrosis correlated with post-IABP RA ( r = 0.63, p = 0.037), RA/PCWP ( r = 0.87, p = 0.001), PAPi ( r = -0.83, p = 0.003). Conclusively, IABP improves RV function in certain AHF patients facilitating successful LVAD implantation. Right ventricular interstitial fibrosis quantification may be applied to predict response and guide preoperative patient selection and optimization. http://links.lww.com/ASAIO/A995.

Prophylactic LVAD for high-risk patients undergoing cardiac surgery.

Postcardiotomy cardiogenic shock (PCS) is associated with poor prognosis. Medical therapy with afterload reduction, contractility optimization and systemic vasopressors often fails, and mechanical support is required. The aim of this study was to propose a strategy of prophylactic left ventricular assist device (LVAD) for high-risk patients undergoing cardiac surgery. Between 2013 and 2019, 12 consecutive patients at high risk for PCS underwent cardiac surgery (valve surgery and/or coronary artery bypass grafting) with preplanned, prophylactic implantation of LVAD (CentriMag or Rotaflow). We reviewed patient characteristics and outcomes. Eight patients underwent a valve corrective surgery and sevenpatients underwent coronary artery bypass grafting. Eleven of 12 patients had successful LVAD insertion, support and wean, and survival to hospital discharge. Left ventricular function was stable perioperatively and improved at follow-up. Patients required low doses of inotropic support and no patients required extracorporeal membranous oxygenation. Major complications included, prolonged mechanical ventilation (n = 7), intra-aortic balloon pump (n = 1), temporary dialysis (n = 2), stroke (n = 1), bleeding requiring reoperation (n = 3), infection requiring mediastinal washout (n = 1). At a mean follow-up of, 660 ± 460.6 days all patients had either NYHA Class 1 (n = 6) or 2 (n = 4). There were two late mortalities (after 1 year). Prophylactic LVAD is a viable technique in select cardiac surgery patients who are high-risk for postcardiotomy shock. Further prospective study is warranted.

Pulmonary Vascular Reverse Remodeling After Left Ventricular Assist Device Implantation in Patients With Pulmonary Hypertension.

Prevalence of combined pre- and post-capillary (Cpc) pulmonary hypertension (PH) in patients with PH due to left heart disease (PH-LHD) and the long-term impact of left ventricular assist device (LVAD) implantation in patients with Cpc-PH are not fully elucidated. Eighty-nine patients with PH-LHD who underwent LVAD implantation were retrospectively analyzed. Patients were divided into two groups according to their preoperative pulmonary vascular resistance (PVR) and diastolic pressure gradient (DPG) values (Cpc-PH group, PVR >3 wood units [WU], or DPG ≥7 mmHg; isolated postcapillary [Ipc]-PH group, PVR ≤3 WU, and DPG <7 mmHg). There were 50 patients with Cpc-PH (PVR >3 WU [group A, n = 41]; PVR >3 WU and DPG ≥7 mmHg [group B, n = 8]; DPG ≥7 mmHg [group C, n = 1]), and 39 patients with Ipc-PH. Despite a successful LVAD implantation in all participants, 13 and two patients remained in groups A and B, respectively, early after LVAD implantation, whereas two patients each remained in groups A and B 1 year postoperatively. Values of PVR and DPG in the Cpc-PH group returned to normal levels by 3 years postoperatively. Over 50% of patients with PH-LHD had Cpc-PH, and PVR and DPG normalized in all participants within 3 years after LVAD implantation.

Transcatheter Edge-to-Edge Repair in Patients with Left Ventricular Assist Device Support

<h3>Introduction</h3> Reverse remodeling and myocardial recovery may occur during left ventricular assist device (LVAD) support. Persistent or recurrent mitral regurgitation (MR) might prevent successful LVAD weaning and should therefore be ruled out before LVAD explantation can be considered. We present a case series of transcatheter edge-to-edge repair (TEER) performed in 5 patients on LVAD support at our institution between January 1^st, 2016 and December 1^st, 2020. <h3>Case Report</h3> At the time of the procedure, patient age ranged from 30 to 71 years and patients were on LVAD support because of dilated cardiomyopathy or fulminant myocarditis for 1 to 4 years. All patients had shown signs of myocardial recovery and pump-stop echocardiography unmasked severe MR (Carpentier type II). The procedures were performed to assess the potential of LVAD weaning with a competent mitral valve. TEER was performed via femoral/transseptal access in general anesthesia and under transesophageal echocardiographic and fluoroscopic guidance. A reduction of MR from severe to mild was achieved by placing 1 or 2 clips. No postinterventional mitral stenosis was seen. All patients were transferred from the recovery room directly to normal ward and discharged after oral anticoagulation was restarted and INR was within the therapeutic range. In one patient, the hospital stay was prolonged due to management of a local driveline infection, which was unrelated to the procedure. In the further course, no complications according to Mitral Valve Academic Research Consortium criteria were observed. Subsequently, one patient met the LVAD weaning criteria and underwent successful LVAD explantation. <h3>Summary</h3> Transcatheter edge-to-edge repair post LVAD implantation is a safe alternative to concomitant MV surgery during LVAD implantation and may help to stratify patients with myocardial recovery for device explantation.

Shared Care to Destination Therapy Left Ventricular Assist Device Site: a Novel Strategy to Start a Successful Mechanical Circulatory Support Program.

Heart failure is an important healthcare issue because of its high prevalence, mortality, and morbidity. Advanced heart failure therapies have improved significantly over the years with improved outcomes. Heart transplantation remains an elusive treatment option for most patients; hence, the need for alternative therapy has given rise to the use of mechanical circulatory support (MCS) devices, initially as bridge to transplantation, but with more recent use as destination therapy. This review focuses on the intricacies of establishing a successful left ventricular assist device (LVAD) program for destination therapy in the setting of a growing anticipated need for wider availability of such treatment options. Guidelines have established the role of MCS in patients with advanced HF refractory to optimal guideline-directed medical therapy (GDMT) and cardiac device interventions. Multiple studies have shown generational improvement in the overall safety profile of MCS devices with the use of newer devices for destination therapy showing improved outcomes. Heart failure is a growing cardiovascular problem with an anticipated growing need for advanced HF therapies including MCS devices. A model of shared care LVAD to destination therapy implanting site should be considered as a strategy to start a successful LVAD program.

Right heart failure considerations in pediatric ventricular assist devices.

Right heart failure (RHF) is a vexing problem in children after left ventricular assist device (LVAD) implantation that can negatively impact transplant candidacy and survival. Anticipation, prevention, early identification and appropriate medical and device management of RHF are important to successful LVAD outcomes. However, there is limited pediatric evidence to guide practice. This pediatric-focused review summarizes the relevant literature and describes the harmonized approach to RHF from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). This review seeks to improve RHF outcomes through the sharing of best practices and experience across the pediatric VAD community.

Ineffective implantable cardioverter-defibrillator shocks among patients on continuous left ventricular assist device support: Clinical characteristics and management.

BackgroundPlacement of a left ventricular assist device (LVAD) has been described to compromise implantable cardioverter-defibrillator (ICD) defibrillation threshold (DFT). Elevated DFT will have negative consequences and increases the risk of ineffective ICD shocks, morbidity, and mortality. DFT testing is not routinely performed in clinical practice, despite this fact.ObjectiveWe describe the clinical characteristics of 7 LVAD patients who presented with multiple ineffective ICD shocks, along with the management strategy in such patients.MethodsSeven patients (5 male, mean age 52.2 ± 9 years, 85.7% nonischemic cardiomyopathy) with an ICD in situ who progressed to NYHA class IV, ACC/AHA stage D chronic systolic congestive heart failure who underwent successful LVAD implantation presented to our institution in the setting of ventricular tachyarrhythmia and ineffective ICD shocks. Six patients underwent implantation of azygos and subclavian coils with subsequent DFT testing. The remaining patient was made comfort care.ResultsFive patients had successful DFT testing with azygos (n = 4) and subclavian (n = 1) defibrillation coil implantation. One patient had unsuccessful DFT testing despite evaluation of multiple shock vectors. There were no major or minor vascular complications in any of the cases. There were no procedural-related deaths.ConclusionThis case series highlights the need for a systematic approach to management of ICDs and DFT testing in LVAD patients. The addition of new shock vectors with azygos and subclavian coil implantation may reduce DFT, shock burden, morbidity, and mortality.

Recovery From Exhaustion of the Frank-Starling Mechanism by Mechanical Unloading With a Continuous-Flow Ventricular Assist Device.

We describe our original left ventricular assist device (LVAD) speed ramp and volume loading test designed to evaluate native heart function under continuous-flow LVAD support.Methods and Results:LVAD speed was decreased in 4 stages from the patient's optimal speed to the minimum setting for each device. Under minimal LVAD support, patients were subjected to saline loading (body weight [kg]×10 mL in 15 min). Echocardiographic and hemodynamic data were obtained at each stage of the LVAD speed ramp and every 3 min during saline loading. Patients were divided into Recovery (with successful LVAD removal; n=8) and Non-recovery (others; n=31) groups. During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173). Increased cardiac output from volume loading was significantly higher in the Recovery than Non-recovery group (group effect, P=0.0124; time effect, P<0.0001; interaction effect, P=0.0091). Therefore, the Frank-Starling curve of the Recovery group was located upward and to the left of that of the Non-recovery group. The LVAD speed ramp and volume loading test facilitates the precise evaluation of native heart function during continuous-flow LVAD support.

How to Achieve Successful Left Ventricular Assist Device Implantation.

How to Achieve Successful Left Ventricular Assist Device Implantation.

Percutaneous Ventricular Assist Device Exclusion: Institutional Case Series and Review of Literature

Surgical left ventricular assist device (LVAD) explantation is associated with increased risk of perioperative mortality (9.2%), myocardial infarction (10.8%), stroke (4.9%), and postexplant infections (4.3%).1 Minimally invasive surgical strategies have been explored, but still expose patients to risks associated with blood transfusion and myocardial trauma during dissection of adhesions.2 Percutaneous LVAD exclusion can potentially avoid perioperative complications associated with surgical exclusion. In this case series, we examined our institutional experience and reviewed published data for risks and benefits associated with percutaneous LVAD exclusion. A total of four patients underwent percutaneous LVAD exclusion between 2011 and 2018 at our institution. Subsequently, we performed a systematic review of all reported cases of percutaneous LVAD exclusion published in Pubmed/Medline between the years 2011 and 2018 and identified seven additional cases. The cumulative results (n = 11) are presented in Supplemental Table 1 https://links.lww.com/ASAIO/A436. The average age of all patients was 44 ± 17 years, 7 (64%) were men, and 9 (82%) had non-ischemic cardiomyopathy. The average time between LVAD implantation and percutaneous LVAD exclusion was 16 ± 9 months. Majority of the patients underwent percutaneous LVAD exclusion for myocardial recovery (n = 7, 64%); four patients had LVAD-related complications (mainly, pump thrombosis) and were deemed poor surgical candidates for exchange or explant and were not suitable for transplant listing. Either an Amplatzer Vascular Plug II (St. Jude Medical, St. Paul, Minnesota) (n = 8, 73%) or an Amplatzer Septal Occluder (St. Jude Medical, St. Paul, Minnesota) (n = 3, 27%) were used to occlude the VAD outflow or inflow grafts. The type of Amplatzer device used to occlude the grafts was mainly based on operator’s preference. The average disc diameter of Amplatzer device used to occlude the outflow graft of HeartMate II device was 19 ± 2 mm and HeartWare LVAD was 13 ± 1 mm. The majority of implantations occluded the outflow graft (n = 9, 82%), while two cases reported occluding only the inflow graft (n = 2, 18%). The occlusion device was deployed at both proximal and distal portions of the outflow graft in the majority of the cases (n = 7, 64%). All cases reported successful LVAD exclusion. Following implantation, the driveline was excised followed by closing the open end with either Gore-Tex or BioGlue Surgical Adhesive (CryoLife Inc, Kennesaw, Georgia) in most cases. None of the cases reported any procedure related direct complications or death. The average reported postprocedure follow-up was 18 ± 11 months. For postexclusion stroke prophylaxis; majority of patients received warfarin with an INR goal range between 1.5 and 3. Nonetheless, one patient was discharged on daily Aspirin 100 mg only,3 while another did not receive any anticoagulation.4 The reason for using only Aspirin was not clarified by the authors while the patient without anticoagulation had percutaneous LVAD exclusion as a palliative option. However, both patients were reported to be alive without any cerebrovascular complications on long-term follow-up. These two cases suggest that warfarin might not be needed postexclusion for stroke prophylaxis, and further studies are required to validate this observation. Two of the four patients who underwent exclusion due to LVAD-related complications died within 2 weeks of the procedure, whereas the remaining seven patients who underwent exclusion for myocardial recovery were still alive at last reported follow-up. In summary, percutaneous LVAD exclusion appears to be associated with high procedural success and minimal procedural complications, and is potentially, an attractive alternative to conventional surgical exclusion. However, it is worth mentioning a few limitations of our study. First, percutaneous LVAD exclusion can theoretically be associated with higher risk of thromboembolic complications and therefore, necessitates lifelong anticoagulation. Second, the presence of retained LVAD hardware with direct endovascular access also carries the risk of endocarditis. However, neither of the abovementioned complications were reported in our review of these patients. A larger sample size or a longer follow-up period of these cases will be necessary to establish the incidence of the abovementioned potential long-term complications. Lastly, the publication bias also needs to be kept in mind which may have resulted in overestimation of the success rate of percutaneous LVAD exclusion. Prospective studies with larger sample size and longer duration of follow-up are necessary to accurately understand the risk and benefit associated with percutaneous LVAD exclusion. Acknowledgement The authors thank Balsara K., Brinkley M., Wigger M., Menachem J., Punnoose L., and Brown Sacks S. for their valuable clinical contribution.

Outflow Cannula Systolic Slope as a Predictor of Myocardial Recovery Leading to Successful LVAD Decommission: A Case Series

In patients implanted with durable left ventricular assist device (LVAD), the incidence of myocardial recovery leading to device explant or decommission is low, and reliable predictors of myocardial recovery remain lacking. Here, we investigate the potential of outflow cannula systolic slope as a non-invasive predictor of successful LVAD liberation amongst select cohort of patients with high recovery potential. We first identified a cohort of patients with high recovery likelihood by querying all LVAD patients at our institution who underwent reverse ramp test, a protocol developed to assess native myocardial contractility with sequential LVAD turn-down to minimal support. We then queried all echocardiographic studies of these patients within one year of the reverse ramp tests. In the subset of patients with adequate Doppler images of the outflow cannula, the systolic slope, a load-independent marker of contractility, was measured as previously described, and the clinical outcomes were correlated. Between September 1, 2015 and August 23, 2019, a total of 10 patients underwent reverse ramp test at our institution per published protocol. Of these, 4 patients had adequate echocardiographic window of the LVAD outflow cannula, and the systolic slope was calculated. 3 of the 4 patients had outflow cannula systolic slope of <1200 cm/s2 (813 ±148 cm/s2, range 651-1010 cm/s2; top figure), and none was able to achieve sustainable recovery (1 was bridged to transplant, 1 remains on LVAD support, and 1 was deceased). 1 out of the 4 patients had outflow cannula systolic slope >1200 cm/s2 (1788 cm/s2), and she underwent successful percutaneous decommission of her LVAD device (bottom figure). In a small case series of 4 patients from reverse ramp database with available echocardiographic images of the outflow cannula, high systolic slope value (>1200 cm/s2) identified the patient with clinical recovery leading to successful LVAD decommission.

Outcomes of patients after successful left ventricular assist device explantation: a EUROMACS study.

AimsSufficient myocardial recovery with the subsequent explantation of a left ventricular assist device (LVAD) occurs in approximately 1–2% of the cases. However, follow‐up data about this condition are scarcely available in the literature. This study aimed to report the long‐term outcomes and clinical management following LVAD explantation.Methods and resultsAn analysis of the European Registry for Patients with Mechanical Circulatory Support was performed to identify all adult patients with myocardial recovery and successful explantation. Pre‐implant characteristics were retrieved and compared with the non‐recovery patients. The follow‐up data after explantation were collected via a questionnaire. A Kaplan–Meier analysis for freedom of the composite endpoint of death, heart transplantation, LVAD reimplantion, or heart failure (HF) relapse was conducted. A total of 45 (1.4%) cases with myocardial recovery resulting in successful LVAD explantation were identified. Compared with those who did not experience myocardial recovery, the explanted patients were younger (44 vs. 56 years, P < 0.001), had a shorter duration of cardiac disease (P < 0.001), and were less likely to have ischaemic cardiomyopathy (9% vs. 41.8%, P < 0.001). Follow‐up after explantation could be acquired in 28 (62%) cases. The median age at LVAD implantation was 43 years (inter‐quartile range: 29–52), and 23 (82%) were male. Baseline left ventricular ejection fraction was 18% (inter‐quartile range: 10–20%), and 60.7% of the patients had Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2. Aetiologies of HF were dilated cardiomyopathy in 36%, myocarditis in 32%, and ischaemic in 14% of the patients, and 18% had miscellaneous aetiologies. The devices implanted were HeartMate II in 14 (50%), HVAD in 11 (39%), HeartMate 3 in 2 (7%), and 1 unknown with a median duration of support of 410 days (range: 59–1286). The median follow‐up after explantation was 26 months (range 0.3–73 months), and 82% of the patients were in New York Heart Association Class I or II. Beta‐blockers were prescribed to 85%, angiotensin‐converting enzyme inhibitors to 71%, and loop diuretics to 50% of the patients, respectively. Freedom from the composite endpoint was 100% after 30 days and 88% after 2 years.ConclusionsThe survival after LVAD explantation is excellent without the need for heart transplantation or LVAD reimplantation. Only a minority of the patients suffer from a relapse of significant HF.

Early outcomes with durable left ventricular assist device replacement using the HeartMate 3

BackgroundThe HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement. MethodsAn institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery. ResultsThere was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3. ConclusionsLVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.

Phrenic Nerve Stimulation in an LVAD Patient with Severe Sleep Apnea

Introduction Central sleep apnea (CSA) occurs in approximately 35% of patients with heart failure, thought to be an acquired pattern of respiratory control instability related in part to elevated sympathetic nervous system activation. Studies show that CSA is an independent risk factor for morbidity and mortality in these patients. A newer approach to treatment involves implantation of a unilateral, transvenous phrenic nerve stimulator to restore a physiological breathing pattern during sleep. We present a case of a patient with heart failure and CSA who underwent placement of a phrenic nerve stimulator and subsequently a left ventricular assist device (LVAD). Case A 62 year-old male with NYHA III, ACC/AHA C heart failure (EF 15%), paroxysmal ventricular tachycardia with biventricular pacing and ICD placement who had polysomnography (PSG) that revealed severe CSA. He underwent placement of a transvenous phrenic nerve stimulation system. He subsequently reported improved symptoms, with less daytime sleeping and increased duration of daily exercise. His apnea hypopnea index decreased from 46.3 events/hour at baseline to 6.9 events/hour 18 months post-therapy, and his central apnea index decreased from 42.6 events/hour to 0.2 events/hour. Two years after device implant he underwent placement of an LVAD in the setting of worsening heart failure symptoms and refractory ventricular arrhythmias. Prior to surgery his device was placed in monitor mode. After successful LVAD implantation, despite normalization of cardiac output, he reported return of excessive daytime fatigue; PSG confirmed severe CSA. With device adjustment, the biventricular pacing leads, phrenic nerve stimulator system, and LVAD were able to run concurrently without artifact or interference. Subsequent PSG confirmed successful treatment of CSA along with improvement in symptoms. Discussion CSA is common in patients with heart failure, thought to be related to elevated sympathetic nervous system activation and hemodynamic perturbations. Medical treatment of heart failure has shown limited success in improving CSA, and small studies have shown that optimization of hemodynamics and end-organ function with LVAD implantation does not reverse CSA. We report the first case of a patient with successful implantation of both a transvenous phrenic nerve stimulator and an LVAD. Despite normalization of cardiac output after LVAD implantation, severe CSA persisted, consistent with prior case reports. Conclusion Phrenic nerve stimulation is an option for patients with heart failure and moderate to severe CSA, including LVAD patients.

Left Ventricular Assist Devices: How Do We Define Success?

Despite the growing acceptance of left ventricular assist device (LVAD) therapy to improve survival and quality of life in heart failure (HF) patients, uncertainties persist regarding the definition of a successful implant. We sought to define an innovative approach to assess success and subsequently compare preoperative variables affecting outcomes. From January 2007 to 2015, 278 patients underwent LVAD implantation. Median age at implant was 62 years and 81% patients were males. Indication for support was bridge-to-transplantation in 36% patients and the etiology of HF was ischemic in 49% patients. Based on clinically relevant and accepted standards, we defined successful LVAD implant as someone who was alive or transplanted at 2 years, had two or less readmissions in the first year, had no major adverse events in the first year, and had a New York Heart Association class of ≤ II at 6 months. Follow-up was obtained for a median of 1.7 years for a total of 605 patient-years-of-support. Based on our criteria, 81/278 (29%) patients were defined as having a successful implant. Univariate predictors of LVAD failure included destination therapy indication (hazard ratio [HR] = 2.11 [1.24, 3.58]), ischemic cardiomyopathy (HR = 1.73 [1.02, 2.94]), and a higher left ventricular ejection fraction (HR = 1.54 [1.07, 2.22]). After multivariable analysis, only destination therapy indication (HR = 2.2 [1.28, 3.78]) was found to be independently predictive of success failure. Despite an overall trend toward improved outcomes on device therapy, our criteria classified only one-third of patients as successful. Continued improvements in adverse event profiles, appropriate patient selection, and optimal time of implantation, together hold the key to improve outcomes after LVAD therapy.