The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.

OBJECTIVES: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead. BACKGROUND: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability. METHODS: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed. RESULTS: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment. CONCLUSION: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.

An overview of left atrial appendage occlusion devices.

Atrial fibrillation (AF) places patients at increased risk of thromboembolic events that can be devastating. The left atrial appendage (LAA) has been identified as the source of thrombus formation in nonvalvular AF. Traditionally, systemic anticoagulation has been used to reduce the risk of stroke and systemic embolism. However, anticoagulation is not well tolerated in all patients and is underutilized. As a potential alternative to anticoagulation, novel therapies have been developed to remove the LAA. Three main techniques are being utilized to accomplish LAA exclusion: percutaneous intracardiac, percutaneous epicardial, and surgical approaches. Emerging evidence suggests that LAA exclusion may be an effective means of reducing the risk of stroke in patients with nonvalvular AF.

Case report: large left ventricular aneurysm with contained rupture and haemopericardium.

Background: Recent advancements in cardiology have significantly decreased the incidence of post-myocardial infarction mechanical complications. When these sequelae occur, they can have high morbidity and mortality and may require aggressive intervention. Case summary: We describe a case of contained rupture of a large left ventricular aneurysm (LVA) presenting with syncope in a 60-year-old male with late presentation myocardial infarction (MI) 6 weeks prior on home triple antithrombotic therapy (TAT). Urgent pericardiocentesis along with imaging techniques including ultrasound, computed tomography angiography (CTA), and cardiac magnetic resonance imaging (MRI) were used for initial diagnosis. Definitive treatment was achieved with excision and repair of the LVA with return to prior functional status 1 month after intervention. Discussion: Highlights of this report emphasize the importance of differential diagnosis consideration of LVA with contained rupture in patient populations with prior late presentation MI and TAT. High clinical suspicion and thorough diagnostic workup with appropriate imaging are important to guide appropriate treatment interventions.

Left Atrial Appendage Closure: Technical Considerations of Endocardial Closure.

Left atrial appendage closure (LAAC) is a safe and effective therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation and high bleeding risk with oral anticoagulants. Multimodality imaging with transesophageal echocardiography and computed tomography angiography to define the anatomy and its implications on endocardial exclusion is becoming increasingly important. The only LAAC device currently approved for clinical use in the United States is the WATCHMAN device. Systematic assessment of the transseptal crossing site, left atrial appendage anatomy, adequate device size selection, and device postdeployment evaluation is essential for the safety and efficacy of the procedure.

Overcoming the transcatheter aortic valve replacement Achilles heel: coronary re-access.

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for the treatment of symptomatic severe aortic stenosis (AS). Coronary artery disease (CAD) is common in patients with severe AS. As the indications for TAVR extend to lower risk patients with longer life expectancy and as CAD is a progressive condition, coronary angiography will become increasingly common in patients who have had a previous TAVR. Coronary artery re-access after TAVR may be challenging but is possible in most cases. Commissural alignment of the prosthesis with the native coronary ostia plays an important role in successful coronary re-access. Coronary artery obstruction is a potentially devastating complication of TAVR, particularly in valve-in-valve procedures. In the present keynote lecture, we review techniques used to mitigate the risk of coronary obstruction, as well as catheter selection and strategies for selective coronary artery engagement for specific transcatheter aortic valve (TAV) bioprostheses.

Predictors and Risk Calculator of Early Unplanned Hospital Readmission Following Contemporary Self-Expanding Transcatheter Aortic Valve Replacement from the STS/ACC TVT Registry.

BACKGROUND: Predictors of hospital readmissions and tools to predict readmissions after TAVR are scarce. Our objective was to identify predictors of early hospital readmission following TAVR in contemporary clinical practice and develop a risk calculator. METHODS: Patients with a contemporary self-expanding TAVR between 2015 and 2017 in the STS/ACC/TVT Registry™ database were included. Patients were divided into a derivation and validation cohort (2:1). A risk score was calculated using the derivation cohort based on multivariable predictors of 30-day unplanned readmissions and applied to the validation cohort. RESULTS: A total of 10,345 TAVR patients at 350 centers were included. Unplanned 30-day hospital readmission was 9.2%. Patients with an early readmission had higher 30-day rates for mortality (2.3% vs. 0.8%, p ≪ 0.001), stroke (4.1% vs. 2.7% p = 0.009), major vascular complications (2.0% vs. 1.0%, p = 0.003) and new pacemaker implantation (25.7% vs. 18.6%, p ≪ 0.001). Multivariable predictors of 30-day readmission included diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, decreased 5-m gait speed or the inability to walk, serum creatinine ≫1.6 mg/dL, index hospitalization length of stay ≫5 days, major vascular complication and ≥ moderate post-procedure aortic or mitral valve regurgitation. Based on these predictors, we stratified 30-day readmission risk into low-, moderate- and high-risk subsets. There was a 2.5× difference in readmission rates between the low- (5.8%) and high-risk subsets (14.6%). CONCLUSION: We stratified the risk of early hospital readmission after TAVR based on a simple scoring system. This score may improve discharge planning centered on the individual's readmission risk. SUMMARY: Unplanned readmissions in the United States are prevalent and costly accounting for $41.3 billion in annual hospital payments and are associated with adverse clinical outcomes. We found that diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, frailty, acute kidney injury, prolonged hospitalization, major vascular complications, and moderate or worse post-procedure aortic or mitral valve regurgitation predicted of 30-day readmission following self-expanding TAVR. This information may improve discharge planning centered on each patient's readmission risk.

Innovations in Transcatheter Valve Technology: What the Next Five Years Hold.

Transcatheter aortic valve replacement is indicated for the treatment of symptomatic severe aortic stenosis in patients at intermediate or greater risk for surgery. Future indications may include low-risk patients, asymptomatic patients, bicuspid valves, moderate aortic stenosis, and pure native aortic valve regurgitation. Key hurdles to overcome include pacemaker risk, vascular injury, paravalvular regurgitation, coronary artery reaccess, durability, and embolic risk. New valve designs include synthetic polymeric valves that may allow for greater durability, in addition to advances in terms of precise positioning and repositioning to reduce the complication rate.

Flow cytometric measurement of circulating endothelial cells: the effect of age and peripheral arterial disease on baseline levels of mature and progenitor populations.

BACKGROUND: Age and cardiovascular disease status appear to alter numbers and function of circulating endothelial progenitor cells (EPCs). Despite no universal phenotypic definition, numerous studies have implicated progenitors with apparent endothelial potential in local responses to vascular injury and with cardiovascular disease in general. To further define the role of this lineage in peripheral artery disease (PAD), we developed a multiparameter flow cytometry assay to analyze multiple phenotypic definitions of progenitor cells (PCs), EPCs, and mature endothelial cells (ECs) and evaluate effects of age and PAD on baseline levels of each subset. METHODS: Blood was collected from young healthy subjects (N = 9, mean age 33 +/- 8 years), older healthy subjects (N = 13, mean age 66 +/- 8 years), and older subjects with PAD (N = 15, mean age 69 +/- 8 years). After ammonium chloride lysis, cells were stained and analyzed on a Becton-Dickinson LSR II with a 5-color antibody panel: FITC-anti-CD31, PE-anti-CD146, PE-anti-CD133, PerCP-Cy5.5-anti-CD3,-CD19,-CD33 (lineage panel), PE-Cy7-anti-CD34, and APC-anti-VEGF-R2. Viability was assessed by propidium iodide exclusion, and only viable, low to medium side scatter lineage-negative singlets were analyzed. In some studies, cells were sorted for morphological studies. Subsets were defined as indicated later. RESULTS: Our results, using a comprehensive flow cytometric panel, indicate that CD133+, CD34+, and CD133+/CD34+ PCs are elevated in younger healthy individuals compared to older individuals, both healthy and with PAD. However, the number of EPCs and mature ECs did not significantly differ among the three groups. Assessment of endothelial colony forming units and dual acLDL-lectin staining supported the flow cytometric findings. CONCLUSIONS: We describe a comprehensive flow cytometric method to detect circulating mature and progenitor endothelial populations confirmed by conventional morphological and functional assays. Our findings suggest that aging may influence circulating levels of PCs, but not EPCs or ECs; PAD had no effect on baseline levels of any populations investigated. This study provides the basis for evaluating the potential effects of acute stress and therapeutic intervention on circulating progenitor and endothelial populations as a biomarker for cardiovascular status.

Low levels of Her2/neu expressed by Ewing's family tumor cell lines can redirect cytokine-induced killer cells.

PURPOSE: To identify novel treatments for pediatric solid tumors and/or for malignancies with low-level Her2/neu expression. EXPERIMENTAL DESIGN: Using fluorescence-activated cell sorting and immunohistochemistry, Her2/neu expression was determined on cell lines derived vfrom Ewing's family tumors (EFT) and neuroblastoma. Sensitivity to trastuzumab treatment was investigated using an in vitro proliferation assay. Cytotoxicity against EFT cell lines was done with either freshly isolated or ex vivo activated and expanded T cells (cytokine-induced killer cells, CIK cells), with or without addition of a CD3xHer2/neu bispecific antibody. The effects of either trastuzumab, CIK cells alone, or CD3xHer2/neu bispecific antibody redirected CIK cells was determined using a SCID/hu model of EFTs and serial, noninvasive bioluminescent imaging. RESULTS: EFT cell lines express 5- to 10-fold lower levels of her2/neu than either breast (BT-474) or ovarian (SK-OV-3) cell lines. Treatment of EFT cell lines with trastuzumab did not induce growth inhibition either in vitro or in vivo. In contrast, Her2/neu could be used to redirect CIK cell to mediate cytotoxicity against EFTs both in vitro and in vivo (using two different treatment schemas). CONCLUSIONS: CD3xHer2/neu bispecific antibody and CIK cells may be a suitable approach to treat malignancies with low-level Her2/neu expression not responsive to trastuzumab.

Effect of acute exercise on endothelial progenitor cells in patients with peripheral arterial disease.

To determine whether exercise increases endothelial progenitor cells (EPCs) in patients with peripheral vascular disease, we developed a multi-parameter flow cytometry assay to rigorously assess EPCs and mature endothelial cells (ECs) in control subjects and patients with peripheral artery disease (PAD) subjected to graded exercise. Blood was collected from young healthy subjects (n = 9, mean age 33 years), older healthy subjects (n = 13, mean age 66 years), and older subjects with PAD (n = 15, mean age 69 years) before and 10 minutes after exercise. White blood cells were isolated and stained with a five-color antibody panel: FITC-anti-CD31, PE-anti-CD146, PE-anti-CD133, PerCP-Cy5.5-anti-CD3,-CD19,-CD33, PE-Cy7-anti-CD34, and APC-anti-VEGF-R2. Viability was assessed by propidium iodide exclusion. Viable, low, side scatter singlets that were CD3-, 19-, and 33-negative were counted. While baseline levels of EPCs and ECs were similar among all subjects, young healthy subjects demonstrated significantly greater (p < 0.05) levels of progenitor cells (PCs) than older healthy and PAD subjects. Levels of EPCs and ECs tended to increase in all subjects after exercise; however, increases in PCs were only observed in young healthy and PAD subjects. Further, trends in the magnitude of change of subsets with exercise were most similar between young and PAD subjects. Our findings suggest that aging may reduce baseline circulating levels of PCs, but not EPCs or ECs, and that exercise-induced mobilization of subsets may differ depending on age and presence of PAD.