Right ventricular function and residual mitral regurgitation after left ventricular assist device implantation determines the incidence of right heart failure.

BACKGROUND: The effect of significant mitral regurgitation (MR) on outcomes after continuous flow left ventricular assist device (cfLVAD) implantation remains unclear. METHODS: We performed a retrospective review of prospectively collected data from 159 patients with preoperative severe MR who underwent cfLVAD implantation (2003-2017). Two-step cluster analysis using the log-likelihood distance for post-cfLVAD implantation parameters, which included right ventricular (RV) dysfunction, MR severity, and tricuspid regurgitation (TR) severity. Post-cfLVAD implantation echocardiographic parameters were obtained within the first month. RESULTS: Cluster analysis resulted in 3 groups. Group 1 (n = 67) had mild or less MR with moderate-severe RV dysfunction (RVD). Group 2 (n = 43) had moderate-severe MR with moderate-severe RVD. Group 3 (n = 49) had moderate MR with mild RVD. Group 2 had the largest proportion with Interagency Registry for Mechanically Assisted Circulatory Support score of 1 (30.2%) and 2 (41.9%). They were more likely to undergo temporary mechanical circulatory support (18.6%) and tricuspid valve procedure (62.8%). Group 2 had the highest rate of stroke (30.2%; P = .02), hemolysis (39.5%; P = .01), device thrombosis (30%; P = .01), and worst survival (46.5%; P = .01). Survival at 5 years for groups 1, 2, and 3 were 56.0%, 17.6%, and 55.8%. Regression analysis of the entire population showed that greater MR severity after cfLVAD was associated with RV failure (P < .05; odds ratio, 1.6) and RV assist device use (P = .09; odds ratio, 1.6). After excluding tricuspid valve repairs, MR severity had a positive correlation with TR severity (R = 0.33; P < .01). CONCLUSIONS: After cfLVAD implantation, moderate-severe MR and RVD predicted RV failure. Patients with preoperative moderate-severe MR and TR coupled with moderate-severe RVD might benefit the most from mitral and tricuspid valve intervention.

Sex-related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high-risk percutaneous coronary intervention: Insight from the cVAD registry.

OBJECTIVE: To assess the in-hospital and short-term outcome differences between males and females who underwent high-risk PCI with mechanical circulatory support (MCS). BACKGROUND: Sex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high-risk PCI with MCS is scarce. METHODS: Using the cVAD Registry, we identified 1,053 high-risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow-up of 81.5 days. RESULTS: Females were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in-hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019). CONCLUSION: Female patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.

Impella-Induced Incessant Ventricular Tachycardia.

Background: The Impella 2.5 and Impella Cardiac Power (CP) devices (ABIOMED) are used to provide mechanical circulatory support for high-risk percutaneous coronary interventions or cardiogenic shock as a bridge to recovery or destination therapy. The Impella device has shown both efficacy and safety in patients presenting with cardiogenic shock. Performing clinical and hemodynamic assessments of patients presenting with cardiogenic shock is an important step to determine if mechanical circulatory support with an Impella device is indicated. Case Report: A 62-year-old male presented with cardiogenic shock requiring Impella device support. Two days later, the patient developed incessant ventricular tachycardia. Transthoracic echocardiography showed that the Impella device had migrated out of the ventricular cavity. Once the position of the Impella device was adjusted, ventricular tachycardia immediately resolved. Conclusion: Our case emphasizes the importance of using imaging modalities such as transthoracic echocardiography to ensure correct positioning of an Impella device in the left ventricle to avoid complications.

Right ventricular failure following left ventricular assist device implantation is associated with a preoperative pro-inflammatory response.

BACKGROUND: Systemic inflammation during implant of a durable left ventricular assist device (LVAD) may contribute to adverse outcomes. We investigated the association of the preoperative inflammatory markers with subsequent right ventricular failure (RVF). MATERIALS AND METHODS: Prospective data was collected on 489 patients from 2003 through 2017 who underwent implantation of a durable LVAD. Uni- and multivariable correlation with leukocytosis was determined using linear and binary logistic regression. The population was also separated into low (< 10.5 K/ul, n = 362) and high (> 10.5 K/ul, n = 127) white blood cell count (WBC) groups. Mantel-Cox statistics was used to analyze survival data. RESULTS: Postop RVF was associated with a higher preop WBC (11.3 + 5.7 vs 8.7 + 3.1) and C-reactive protein (CRP, 5.6 + 4.4 vs 3.3 + 4.7) levels. Multivariable analysis identified an independent association between increased WBC preoperatively with increased lactate dehydrogenase (LDH, P < 0.001), heart rate (P < 0.001), CRP (P = 0.006), creatinine (P = 0.048), and INR (P = 0.049). The high WBC group was more likely to be on preoperative temporary circulatory support (17.3% vs 6.4%, P < 0.001) with a trend towards greater use of an intra-aortic balloon pump (55.9% vs 47.2%, P = 0.093). The high WBC group had poorer mid-term survival (P = 0.042). CONCLUSIONS: Postop RVF is associated with a preoperative pro-inflammatory environment. This may be secondary to the increased systemic stress of decompensated heart failure. Systemic inflammation in the decompensated heart failure may contribute to RVF after LVAD implant.

Axillary Artery Access for Mechanical Circulatory Support Devices in Patients With Prohibitive Peripheral Arterial Disease Presenting With Cardiogenic Shock.

In patients with severe peripheral vascular disease, the common femoral artery may be so diseased as to not allow for deployment of mechanical circulatory support (MCS) such as in the setting of cardiogenic shock (CS). We sought to study the feasibility of axillary artery as alternative access for MCS in CS patients with severe occlusive peripheral artery disease (PAD). Records of all patients who presented with CS requiring MCS through axillary artery access from January 2016 to October 2017 were examined. Demographics, clinical, procedural, and outcomes data were collected on all patients. A total of 17 patients (mean age 68 ± 14years, 95% men) were identified. This was due to severe PAD in the iliac and/or common femoral arteries prohibiting large bore sheath access in allcases. Of the 17 patients, 9 required percutaneous coronary intervention. Time from axillary access to activation of Impella was 14.8 ± 4 minutes. Three patients required concomitant Impella RP for right ventricular support due to biventricular CS. Twelve patients died before Impella was explanted due to multiorgan failure, stroke, and infection. None of the patients who died had vascular complications related to axillary access. All 5 patients who survived to Impella explant were discharged from the hospital without major complication. Axillary artery is a safe and feasible alternative access for large bore devices in patients with prohibitive PAD. The meticulous technique described assures a very low rate of access related complications.

Cluster analysis of preoperative echocardiographic findings and outcomes following left ventricular device implantation.

OBJECTIVE: To investigate whether preoperative echocardiography findings determine postoperative continuous-flow left ventricular assist device outcomes. METHODS: From January 2003 to June 2017, 490 patients received a durable, continuous-flow left ventricular assist device. Two-step clustering of parameters including heart rate and preoperative echocardiographic findings (ie, left ventricular [LV] ejection fraction, right ventricular [RV] function, aortic insufficiency, mitral regurgitation [MR], tricuspid regurgitation [TR]) was performed and identified 5 distinct clusters associated with LV failure: group 1: moderate right ventricular dysfunction (RVD), severe MR and mild TR (n = 110); group 2: severe RVD, severe MR and TR (n = 64); group 3: moderate RVD and severe aortic insufficiency (n = 16); group 4: mild RVD and mild valvular pathology (n = 163); and group 5: moderate-severe RVD and mild valvular pathology (n = 137). Silhouette measure of cohesion and separation demonstrated satisfactory separation at 0.6. RESULTS: Group 2 had the greatest Interagency Registry for Mechanically Assisted Circulatory Support Level 1 (25%, P = .010), preoperative right atrial pressure (11 ± 5 mm Hg, P < .001), incidence of postoperative right ventricular failure (RVF; 20%, P = .001), delayed closure of the sternum (61%, P = .002), postoperative permanent dialysis (6%, P = .04), rate of tricuspid valve repair (n = 52; 81%, P < .001), and lowest RV stroke work index (489 ± 228 cc mm Hg/m2/beat, P < .001). RVF in groups 1, 3, 4, and 5 was 6%, 0%, 4%, and 9%, respectively. No differences in incidence of heart transplantation (P = .400) or survival (P = .535) were found. Severe TR predicted RVF in those with moderate-severe preoperative RVD (P = .001, odds ratio 3.9). CONCLUSIONS: Clustering demonstrated the importance of preoperative TR in predicting RVF. Combined severe LV and RV failure with severe MR and TR portends the worse prognosis.

Access and closure management of large bore femoral arterial access.

Femoral and radial artery access continue to be the standard of care for percutaneous coronary interventions. Cardiac catheterization has progressed to encompass a wide range of diagnostic and interventional procedures including coronary, peripheral, endovascular, and structural heart disease interventions. Despite advanced technology to make these procedures safe, bleeding, and vascular complications continue to be a substantial source of morbidity, especially in patients undergoing large-bore access procedures. New variations of percutaneous devices have reduced complications associated with these procedures. However, safe vascular access with effective hemostasis requires special techniques which have not been well described in the literature. Large-bore femoral artery access is feasible, safe, and associated with low complication rates when a protocol is implemented. Wayne State University, Detroit Medical Center Heart Hospital is a tertiary care, high-volume center for endovascular, structural heart and complex high risk indicated procedures with more 150 procedures involving mechanical circulatory support (MCS) devices per year. In this manuscript, we describe our approach to femoral artery large-bore sheath insertion and management. Our protocol includes proper identification of the puncture site, device selection, insertion, assessment of limb perfusion while on prolong MCS support, and hemostasis techniques after sheath removal.

Mechanical circulatory support for acute right ventricular failure in the setting of pulmonary embolism.

BACKGROUND: Right ventricular (RV) failure due to pulmonary embolism (PE) increases morbidity and mortality and contributes to prolonged hospital length of stay and higher costs of care. RV mechanical circulatory support (MCS) including Impella RP devices have been increasingly used in hemodynamically compromised PE patients who are refractory to intravascular volume expansion and inotropic therapy. However, effectiveness and safety of Impella RP, in hemodynamically unstable PE patients is unknown. METHODS: We included consecutive patients who presented to Detroit Medical Center between November 3, 2015 and October 2, 2017 with acute PE and had evidence of hemodynamic compromise indicating Impella RP. RESULTS: Total of five cases were identified. All patients met the shock definition due to massive or submassive PE and therefore received Impella RP on admission. Cardiac index was improved from mean of 1.69/min/m2, (0.88-2.15 L/min/m2 ), to 2.5 L/min/m2 (range 1.88-3.4), after 24 h of treatment. Similarly, mean heart rate reduced to 92 beats per minute (79-105), and mean systolic blood pressure increased to 140 mmHg (115-179). No significant changes were found in renal function, hemoglobin and platelets level during device use. One patient experienced hemoglobin drop from 13.7 to 7.3 g/dL but did not require blood transfusion. All patients survived to discharge. CONCLUSION: In patients with PE and RV shock, Impella RP device resulted in immediate hemodynamic benefit with reversal of shock and favorable survival to discharge.

Innovations in cardiac transplantation.

PURPOSE OF REVIEW: As the number of people living with heart failure continues to grow, future treatments will focus on efficient donor organ donation and ensuring safe and durable outcomes. This review will focus on organ procurement, graft surveillance and emerging therapies. RECENT FINDINGS: Preliminary studies into donation after cardiac death have indicated that this may be an effective means to increase the donor pool. Novel preservation techniques that include ex-vivo perfusion to improve donor metabolic stabilization prior to implantation may also expand the donor pool. Biomarkers, including circulating-free DNA, are emerging that could replace the endomyocardial biopsy for acute graft rejection, but we lack a risk predictive biomarker in heart transplantation. Novel immune suppressants are being investigated. Emerging therapeutics to reduce the development of chronic allograft vasculopathy are yet to be found. SUMMARY: This review highlights the most recent studies and future possible therapies that will improve outcomes in cardiac transplantation. Larger clinical trials are currently taking place and will be needed in the future to develop and sustain current trends toward better survival rates with cardiac transplantation.

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

INTRODUCTION: Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. METHODS: Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. RESULTS: Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. CONCLUSIONS: Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology.

Imaging modalities in cardiac electrophysiology.

Cardiac imaging, both noninvasive and invasive, has become a crucial part of evaluating patients during the electrophysiology procedure experience. These anatomical data allow electrophysiologists to not only assess who is an appropriate candidate for each procedure, but also to determine the rate of success from these procedures. This article incorporates a review of the various cardiac imaging techniques available today, with a focus on atrial arrhythmias, ventricular arrhythmias and device therapy.

Effectiveness of implantable cardioverter-defibrillators for the primary prevention of sudden cardiac death in women with advanced heart failure: a meta-analysis of randomized controlled trials.

BACKGROUND: Numerous clinical trials have established a role for implantable cardioverter-defibrillators in the prevention of sudden cardiac death in patients with heart failure. However, questions remain that regard the clinical benefit of these therapies in different patient subgroups. Specifically, the role of implantable cardioverter-defibrillators in women with heart failure for the primary prevention of sudden cardiac death has not been well established. Our objective is to determine whether implantable cardioverter-defibrillators reduce mortality in women with advanced heart failure. METHODS: We searched MEDLINE (1950-2008), EMBASE (1988-2008, week 24), the Cochrane Controlled Trials Register (third quarter, 2008), the National Institute of Health ClinicalTrials.gov database, the Food and Drug Administration Web site, and various reports presented at scientific meetings (1994-2007). Eligible studies were randomized controlled trials of implantable cardioverter/defibrillators for the primary prevention of sudden cardiac death in patients with heart failure that reported all-cause mortality as an outcome for the female population. Of the 2619 reports identified, 5 trials that enroll 934 women were included in the meta-analysis. RESULTS: Pooled data from the 5 trials revealed no statistically significant decrease in all-cause mortality in women with heart failure who receive implantable cardioverter-defibrillators (hazard ratio, 1.01; 95% confidence interval, 0.76-1.33). CONCLUSIONS: Implantable cardioverter-defibrillator therapy for the primary prevention of sudden cardiac death in women does not reduce all-cause mortality. Further studies are needed to investigate the reasons for this ob servation and to define the population of women who may benefit most from implantable cardioverter-defibrillator therapy.

Short term effects of milrinone on biomarkers of necrosis, apoptosis, and inflammation in patients with severe heart failure.

INTRODUCTION: Inotropes are associated with adverse outcomes in heart failure (HF), raising concern they may accelerate myocardial injury. Whether biomarkers of myocardial necrosis, inflammation and apoptosis change in response to acute milrinone administration is not well established. METHODS: Ten patients with severe HF and reduced cardiac output who were to receive milrinone were studied. Blood samples were taken just before initiation of milrinone and after 24 hours of infusion. Dosing was at the discretion of the patient's attending physician (range 0.25-0.5 mcg/kg/min). Plasma measurements of troponin, myoglobin, N-terminal-pro-BNP, interleukin-6, tumor necrosis factor-alpha, soluble Fas, and soluble Fas-ligand were performed at both time points. RESULTS: Troponin was elevated at baseline in all patients (mean 0.1259 +/- 0.17 ng/ml), but there was no significant change after 24 hours of milrinone (mean 0.1345 +/- 0.16 ng/ml, p = 0.44). There were significant improvements in interleukin-6, tumor necrosis factor-alpha, soluble Fas, and soluble Fas-ligand (all p < 0.05) indicative of reduced inflammatory and apoptotic signaling compared to baseline. CONCLUSION: In conclusion, among patients with severe HF and low cardiac output, ongoing myocardial injury is common, and initiation of milrinone did not result in exacerbation of myocardial injury but instead was associated with salutary effects on other biomarkers.