Continuous-Flow Left Ventricular Assist Device Support in Patients with Ischemic Versus Nonischemic Cardiomyopathy.

To determine whether the cause of cardiomyopathy affects outcomes in patients who undergo continuous-flow left ventricular assist device support, we compared postimplant adverse events and survival between patients with ischemic and nonischemic cardiomyopathy. The inclusion criteria for the ischemic group were a history of myocardial infarction or revascularization (coronary artery bypass grafting or percutaneous coronary intervention), ≥75% stenosis of the left main or proximal left anterior descending coronary artery, or ≥75% stenosis of ≥2 epicardial vessels. From November 2003 through March 2016, 526 patients underwent device support: 256 (48.7%) in the ischemic group and 270 (51.3%) in the nonischemic group. The ischemic group was older (60.0 vs 50.0 yr), included more men than women (84.0% vs 72.6%), and had more comorbidities. More patients in the nonischemic group were able to have their devices explanted after left ventricular recovery (5.9% vs 2.0%; P=0.02). More patients in the ischemic group had gastrointestinal bleeding (31.2% vs 22.6%; P=0.03), particularly from arteriovenous malformations (20.7% vs 11.9%; P=0.006) and ulcers (16.4% vs 9.3%; P=0.01). Kaplan-Meier analysis revealed no difference in overall survival between groups (P=0.24). Older age, previous sternotomy, higher total bilirubin level, and concomitant procedures during device implantation independently predicted death (P ≤0.03), whereas cause of heart failure did not (P=0.08). Despite the similarity in overall survival between groups, ischemic cardiomyopathy was associated with more frequent gastrointestinal bleeding. This information may help guide the care of patients with ischemic cardiomyopathy who receive continuous-flow left ventricular assist device support.

Factor Xa inhibitors in patients with continuous-flow left ventricular assist devices.

OBJECTIVE: Warfarin is standard anticoagulation therapy for patients with a continuous-flow left ventricular assist device (CF-LVAD). However, warfarin requires regular monitoring and dosage adjustments and fails for many patients, causing thromboembolic and bleeding events. Factor Xa inhibitors have been shown to be noninferior to warfarin in preventing strokes and are associated with less intracranial hemorrhage in patients with atrial fibrillation. We evaluated treatment safety and effectiveness in CF-LVAD patients who switched from warfarin to a factor Xa inhibitor (apixaban or rivaroxaban) after warfarin failure. METHODS: This was a retrospective, single-center study of patients treated between 2008 and 2018. We assessed the occurrence of stroke, non-central nervous system (CNS) embolism, pump thrombosis, and major gastrointestinal bleeding and intracranial hemorrhage during therapy. RESULTS: We identified seven patients: five were male, the average body mass index was 30 kg/m2, and average age was 56 years. Preimplantation comorbidities included hypertension (all patients) and diabetes mellitus, ischemic cardiomyopathy, atrial fibrillation, and previous myocardial infarction (four patients each). Overall, patients received warfarin for 3968 days and apixaban/rivaroxaban for 1459 days. The warfarin group was within the therapeutic INR range (2.0-3.0) 30% of the time. Complication rates did not differ between warfarin and apixaban/rivaroxaban: strokes, 0.20 vs none, non-CNS embolism, 0.54 vs none; pump thrombosis, 0.27 vs none; major gastrointestinal bleeding, 0.20 vs 0.50; intracranial hemorrhage, 0.13 vs none. CONCLUSIONS: Factor Xa inhibitors may be viable treatment options for CF-LVAD patients for whom warfarin therapy has failed. Large prospective studies are necessary to confirm these results.

Ten-Year Survival With a Continuous-Flow Left Ventricular Assist Device and Aortic Valve Closure.

We report the long-term survival of a 46-year-old man supported with a HeartMate II continuous-flow left ventricular assist device after complex repair of a bicuspid aortic valve, anomalous left main coronary artery, and dilated aorta. He has been maintained on an anticoagulation regimen of warfarin and low-dose aspirin without problems for 10 years, during which he has worked continuously and productively. Device flow has been kept at 10,000 rpm. Possible contributors to this long-term success include proper alignment of the device inflow cannula, pericardial patch closure of the left ventricular outflow tract, and, notably, the remarkable freedom from mechanical failure of the continuous-flow left ventricular assist device. Whether the higher flow rate produced by the pericardial patch closure contributes to pump longevity is unknown and merits further investigation.

Accuracy of Postoperative Risk Scores for Survival Prediction in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 Continuous-Flow Left Ventricular Assist Device Recipients.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

Outcomes of Repeat Left Ventricular Assist Device Exchange.

Implantable continuous-flow left ventricular assist devices (CF-LVADs) are used for long-term LV support in bridging patients to heart transplantation or as destination therapy. With prolonged support times, some patients will have repeat complications necessitating multiple device exchanges. To elucidate the safety and efficacy of repeat device exchange, we retrospectively reviewed data from 25 patients who underwent two or more CF-LVAD implantations between July 2005 and August 2017. Indications for exchange were thrombus/hemolysis (n = 8, 32%), electromechanical device malfunction (n = 14, 56%), and infection (n = 3, 12%). The implanted devices were the HeartMate II (n = 13, 52%), the HeartWare HVAD (n = 11, 44%), and the Jarvik 2000 (n = 1, 4%). Average hospital length of stay was 44 days (range 4-221 days), and 17 patients (68%) survived to discharge. Average duration of support after the most recent LVAD implantation was 802 days (range 1-3,229 days). Overall survival was 72% at 1 year and 60% at 2 years. Postoperative complications included respiratory failure in five patients (20%), device infection in five (20%), bleeding requiring reoperation in four (16%), neurologic dysfunction in four (16%), and acute renal failure in two (8%). Overall, our data suggest that repeat LVAD exchange is a feasible option for patients with recurrent device-related complications.

Acute kidney injury after implantation of a left ventricular assist device: a comparison of axial-flow (HeartMate II) and centrifugal-flow (HeartWare HVAD) devices.

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly being used to treat advanced, refractory chronic heart failure. Herein, we sought to determine the incidence of postoperative acute kidney injury (AKI) in axial-flow (HeartMate II; HM-II) and centrifugal-flow (HVAD) CF-LVAD recipients, as well as the effect of AKI on mortality. The study cohort comprised 520 patients who received a HM-II (n = 398) or HVAD (n = 122) at our center between November 2003 and March 2016. Their records were reviewed to determine the incidence of RIFLE-defined AKI after LVAD implantation. We compared the perioperative characteristics, postoperative complications, and survival rates of the patients with and without AKI and differentiated the outcomes based on device type (HM-II or HVAD). Seventy-five patients (14.4%) developed AKI postoperatively. Patients with AKI after LVAD implantation had significantly reduced survival compared to patients without AKI (p = 0.01). Cox proportional hazards models showed that AKI was a significant independent predictor of mortality (HR = 1.54, p = 0.03). Preoperative mechanical circulatory support and prolonged cardiopulmonary bypass time were independent predictors of AKI. The incidence of AKI was similar for HM-II and HVAD recipients (p = 0.25). There was no significant difference in AKI rates for the HM-II and HVAD recipients. Developing AKI adversely affected survival.

Improved systemic saturation after ventricular assist device implantation in a patient with decompensated dextro-transposition of the great arteries after the Fontan procedure.

We report the successful implantation of a HeartMate II left ventricular assist device after a failed Fontan procedure in a patient with dextro-transposition of the great arteries. The patient had developed significant intrapulmonary arteriovenous shunting. Despite the theoretical risk of worsening intrapulmonary shunting due to the decrease in systemic vascular resistance after device implantation, our patient did well. He was discharged from the hospital in stable condition and had better oxygen saturation than before the device was implanted. To our knowledge, ours is the 2nd report of the use of a ventricular assist device after the failure of a Fontan procedure, and the first report concerning the effect of ventricular assist device implantation on intrapulmonary shunting.

Association between cell-derived microparticles and adverse events in patients with nonpulsatile left ventricular assist devices.

BACKGROUND: Continuous-flow left ventricular assist devices (LVADs) expose blood cells to high shear stress, potentially resulting in the production of microparticles that express phosphatidylserine (PS+) and promote coagulation and inflammation. In this prospective study, we attempted to determine whether PS+ microparticle levels correlate with clinical outcomes in LVAD-supported patients. METHODS: We enrolled 20 patients undergoing implantation of the HeartMate II LVAD (Thoratec Corp, Pleasanton, CA) and 10 healthy controls who provided reference values for the microparticle assays. Plasma was collected before LVAD implantation, at discharge, at the 3-month follow-up, and when an adverse clinical event occurred. We quantified PS+ microparticles in the plasma using flow cytometry. RESULTS: During the study period, 8 patients developed adverse clinical events: ventricular tachycardia storm in 1, non-ST-elevation myocardial infarction in 2, arterial thrombosis in 2, gastrointestinal bleeding in 2, and stroke in 3. Levels of PS+ microparticles were higher in patients at baseline than in healthy controls (2.11% ± 1.26% vs 0.69% ± 0.46%, p = 0.007). After LVAD implantation, patient PS+ microparticle levels increased to 2.39% ± 1.22% at discharge and then leveled to 1.97% ± 1.25% at the 3-month follow-up. Importantly, levels of PS+ microparticles were significantly higher in patients who developed an adverse event than in patients with no events (3.82% ± 1.17% vs 1.57% ± 0.59%, p < 0.001), even though the 2 patient groups did not markedly differ in other clinical and hematologic parameters. CONCLUSIONS: Our results suggest that an elevation of PS+ microparticle levels may be associated with adverse clinical events. Thus, measuring PS+ microparticle levels in LVAD-supported patients may help identify patients at increased risk for adverse events.

Weight loss caused by visceral artery disease.

Dramatic unintentional weight loss can be caused by a spectrum of diseases ranging from very serious to benign and treatable. We describe the case of a 70-year-old woman with an extensive history of cardiovascular disease who presented with unintentional weight loss. Although she was diagnosed and treated for colitis, the patient continued to lose 50 pounds over 8 months, which prompted an angiogram. The angiogram revealed occlusion of her superior and inferior mesenteric arteries just distal to their origins, together with high-grade (80%-90%) stenosis at the origin of the celiac axis. After a stent was placed in the ostium of the celiac axis, the patient immediately began to regain weight. We suggest that clinicians consider chronic mesenteric ischemia when treating patients with undiagnosed unintentional weight loss and a history of atherosclerotic disease.

Bivalirudin for treatment of aortic valve thrombosis after left ventricular assist device implantation.

Ventricular assist devices are increasingly being used for mechanical support in patients with advanced heart failure. However, thromboembolism remains a leading cause of mortality in this population. We describe the successful treatment of native aortic valve thrombosis with bivalirudin in a patient with factor V Leiden mutation, who had undergone left ventricular assist device implantation, preventing the need for further surgical intervention.

Transcatheter aortic valve replacement in a nonagenarian.

Approximately 30% to 40% of elderly patients with severe, symptomatic aortic valve stenosis are deemed ineligible for surgery because of high perioperative risk. We describe the use of an alternative transfemoral approach known as transcatheter aortic valve implantation in a nonagenarian patient with severe aortic stenosis. Our patient recovered successfully, and by the time of her most recent follow-up visit, 7 months after the procedure, she had regained a substantial degree of function. This result suggests that transcatheter aortic valve implantation can enable some high-risk patients who are ineligible for surgery to undergo valve replacement, thereby regaining both quality and length of life.

Adenocarcinoma of the parotid gland metastatic to the ventricular septum and right ventricular wall.

Adenocarcinoma of the parotid gland metastatic to the right ventricle has rarely been reported in the medical literature. We describe the case of a 51-year-old man who had a right ventricular adenocarcinoma that metastasized from his right parotid gland. He had undergone incomplete resection of the parotid tumor, followed by radiotherapy, 5 years earlier. After resecting the cardiac adenocarcinoma with tumor-free margins, we reconstructed the ventricular septum and right ventricle, then performed coronary artery bypass grafting. At the patient's most recent follow-up examination 6 months later, he continued to do well and had a good quality of life.

Snake heart: a case of atavism in a human being.

Atavism is the rare reappearance, in a modern organism, of a trait from a distant evolutionary ancestor. We describe an apparent case of atavism involving a 59-year-old man with chest pain whose coronary circulation and myocardial architecture resembled those of the reptilian heart. The chest pain was attributed to a coronary steal phenomenon. The patient was discharged from the hospital on a heightened regimen of ß-blockers, and his symptoms improved significantly. To our knowledge, this is only the 2nd reported clinical case of a human coronary circulation similar to that of reptiles.

Advanced heart failure treated with continuous-flow left ventricular assist device.

BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups. CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)

Significance of anaemia in patients with advanced heart failure receiving long-term mechanical circulatory support.

AIMS: The aim of this study was to analyse the prognostic impact of anaemia in patients receiving long-term left ventricular assist device (LVAD) support. METHODS AND RESULTS: We reviewed the data of 65 consecutive patients who underwent LVAD support for at least 6 months. Anaemia was defined as haemoglobin levels <12.0 g/dL. Follow-up was performed 15 months after implantation. Anaemia was present in 30/65 patients (46%) after 6 months of LVAD support. Anaemic patients had higher levels of pre-implant creatinine (1.8 +/- 0.8 vs. 1.4 +/- 0.5 mg/dL; P = 0.04). The presence of anaemia after 6 months correlated with higher levels of creatinine and blood urea nitrogen and lower levels of albumin. Multivariate Cox proportional hazards regression analysis revealed that levels of haemoglobin <12 g/dL [risk ratio (RR), 8.94; 95% confidence interval (CI), 1.09-73.01; P = 0.04], creatinine >1.4 mg/dL (RR, 5.39; 95% CI, 1.78-16.30; P = 0.003), and albumin <1.5 g/L (RR, 3.23; 95% CI, 1.10-9.51; P = 0.03) were associated with all-cause mortality at 15 months. Long-term survival evaluated by Kaplan-Meier analysis was two times higher in non-anaemic patients after 6 months of LVAD support than in anaemic patients (P = 0.01). CONCLUSION: Anaemia is related to adverse outcomes in patients receiving prolonged LVAD support.

PleurX catheter for the management of refractory pleural effusions in congestive heart failure.

Pleural effusions that are caused by congestive heart failure and refractory to medical management are rare, and the options for treating them are few and sometimes ineffective. We report here our experience, over a 2-year period, with a novel device, the Denver Biomedical PleurX pleural catheter, in treating a series of 5 patients who had chronic, refractory, heart-failure-associated pleural effusions. The PleurX catheter is a small-bore chest tube designed to remain in place for prolonged periods, through which drainage of pleural fluid can be performed easily on a daily or less frequent outpatient basis. Placement of the catheter, in our series, was associated with no complications. In all patients, the catheter effectively drained the pleural space initially, thereby controlling the effusions and alleviating New York Heart Association functional class IV symptoms. The catheters remained in place for a period of 1 to 15 months. In 2 of the patients, the catheter was associated with no complications during the time that it remained in place. One of these patients had the catheter removed at heart transplantation, and 1 retained the catheter until death from underlying heart disease. For 1 patient, the catheter resulted in a partially loculated pleural space, and it was removed. In 2 patients, after prolonged use, it was associated with empyema, for which it was removed. We conclude that the PleurX catheter can effectively control refractory congestive-heart-failure-associated pleural effusions temporarily, but that its prolonged use can cause significant complications, most importantly empyema.

Effects of continuous aortic flow augmentation in patients with exacerbation of heart failure inadequately responsive to medical therapy: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM).

BACKGROUND: Prior investigations suggest that superimposing continuous flow on aortic flow (continuous aortic flow augmentation) produces vasodilation, cardiac unloading, and improved cardiac performance. METHODS AND RESULTS: We compared percutaneous continuous aortic flow augmentation (flow

Devices in heart failure: potential methods for device-based monitoring of congestive heart failure.

Congestive heart failure has long been one of the most serious medical conditions in the United States; in fact, in the United States alone, heart failure accounts for 6.5 million days of hospitalization each year. One important goal of heart-failure therapy is to inhibit the progression of congestive heart failure through pharmacologic and device-based therapies. Therefore, there have been efforts to develop device-based therapies aimed at improving cardiac reserve and optimizing pump function to meet metabolic requirements. The course of congestive heart failure is often worsened by other conditions, including new-onset arrhythmias, ischemia and infarction, valvulopathy, decompensation, end-organ damage, and therapeutic refractoriness, that have an impact on outcomes. The onset of such conditions is sometimes heralded by subtle pathophysiologic changes, and the timely identification of these changes may promote the use of preventive measures. Consequently, device-based methods could in the future have an important role in the timely identification of the subtle pathophysiologic changes associated with congestive heart failure.