Heart transplantation (HTx) candidates supported by Impella (Abiomed, Danvers, MA) or intraaortic balloon pump (IABP), who demonstrate evidence of cardiogenic shock, may qualify for waitlist status 2 ...without exception under the new donor heart allocation system. However limited data comparing Impella versus IABP as a bridge to HTx exist.
The United Network for Organ Sharing database was queried for adults listed and/or transplanted between January 2014 and February 2020. Temporal trends regarding Impella and IABP use were analyzed using the Royston trend test and χ
test. Waitlist mortality was examined using Fine-Gray competing risks analysis. Post-HTx 180-day survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models.
Impella use increased from 0.2% in 2014 to 2.6% in 2020 (P < .01) and from 0.4% to 2.2% (P < .01) under the new allocation system. IABP use increased from 4.9% in 2014 to 27.6% in 2020 (P < .01) and from 6.7% to 26.6% (P < .01) under the new allocation system. Post-HTx survival was similar between groups (adjusted hazard ratio, 0.82; 95% CI, 0.38-1.78) despite more preoperative ventilation (3.6% vs 1.1%, P = .01) and higher model for end-stage liver disease excluding international normalized ratio scores (12.4 vs 9.5, P < .01) among Impella-supported recipients. Under the new system Impella-supported candidates were at higher risk of waitlist delisting compared with IABP-supported candidates (subhazard ratio, 2.42; 95% CI, 1.19-4.92).
Post-HTx survival is comparable between Impella-supported and IABP-supported recipients despite worse preoperative profiles among Impella-supported recipients. Higher risk of waitlist delisting among Impella-supported candidates under the new allocation system requires close attention.
Prolonged mechanical circulatory support (MCS) for severe left ventricular dysfunction in cardiogenic shock as a bridge to heart transplantation (HTx) generally requires a surgical procedure. ...Typically, a surgically implanted temporary extracorporeal left ventricular assist device (LVAD) is chosen because of superior flow and durability compared with a percutaneously delivered endovascular LVAD (pVAD). However, compared with its predecessors, the Impella 5.5 trans-valvular pVAD provides higher hemodynamic support and features improved durability. Here, we present four successful cases with prolonged Impella 5.5 support as a bridge to HTx, with a mean support duration of 70 days (maximum 83 days). These cases highlight several potential benefits of Impella 5.5. The minimally invasive implantation procedure of the device reduces bleeding, decreases the postoperative recovery period, and enables early patient ambulation to reduce physical deconditioning before HTx surgery. Furthermore, Impella 5.5 adequately unloads the left ventricle and provides hemodynamic support to maintain end-organ function to further optimize hemodynamics before HTx. The evolution of Impella 5.5 technology may provide an alternative bridging strategy to traditional surgically implanted temporary MCS in select cases.
Treatments for high-risk essential thrombocythemia (ET) address thrombocytosis, disease-related symptoms, as well as risks of thrombosis, hemorrhage, transformation to myelofibrosis, and leukemia. ...Patients resistant/intolerant to hydroxycarbamide (HC) have a poor outlook. MAJIC (ISRCTN61925716) is a randomized phase 2 trial of ruxolitinib (JAK1/2 inhibitor) vs best available therapy (BAT) in ET and polycythemia vera patients resistant or intolerant to HC. Here, findings of MAJIC-ET are reported, where the modified intention-to-treat population included 58 and 52 patients randomized to receive ruxolitinib or BAT, respectively. There was no evidence of improvement in complete response within 1 year reported in 27 (46.6%) patients treated with ruxolitinib vs 23 (44.2%) with BAT (P = .40). At 2 years, rates of thrombosis, hemorrhage, and transformation were not significantly different; however, some disease-related symptoms improved in patients receiving ruxolitinib relative to BAT. Molecular responses were uncommon; there were 2 complete molecular responses (CMR) and 1 partial molecular response in CALR-positive ruxolitinib-treated patients. Transformation to myelofibrosis occurred in 1 CMR patient, presumably because of the emergence of a different clone, raising questions about the relevance of CMR in ET patients. Grade 3 and 4 anemia occurred in 19% and 0% of ruxolitinib vs 0% (both grades) in the BAT arm, and grade 3 and 4 thrombocytopenia in 5.2% and 1.7% of ruxolitinib vs 0% (both grades) of BAT-treated patients. Rates of discontinuation or treatment switching did not differ between the 2 trial arms. The MAJIC-ET trial suggests that ruxolitinib is not superior to current second-line treatments for ET. This trial was registered at www.isrctn.com as #ISRCTN61925716.
•After hydroxycarbamide therapy in high-risk ET, ruxolitinib showed no improvement for complete or partial response rates compared with BAT.•Ruxolitinib significantly improved some disease-related symptoms, but rates of thrombosis, hemorrhage, or transformation were not different.
Right transaxillary transcatheter aortic valve replacement (TAx-TAVR) is rarely performed due to challenging vascular tortuosity and unfavorable implantation angles. We explored this procedure using ...the newer-generation balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA) valve and our novel "flip-n-flex" technique. The safety and effectiveness of the procedure and the learning curve of our early experiences were investigated.
The first 10 consecutive patients undergoing right TAx-TAVR performed at our center from June 2016 to May 2018 were included in the study. Patients' preoperative characteristics, procedural outcomes, and clinical outcomes were studied. Intraoperative fluoroscopy times were also reviewed to analyze the procedural learning curve.
The 10 patients were a mean age of 81.8 ± 8.7 years, and 5 patients (50%) were women. Mean Society of Thoracic Surgeons Predicted Risk of Mortality was 12.0% ± 9.5%. Procedural success was achieved in all cases without vascular complications. Paravalvular leak was absent or mild in all patients. Two patients (20%) required permanent pacemaker implantation. The median postoperative length of stay was 4 days (range, 2-13 days). The 30-day mortality was 0%. Mean transvalvular gradient improved from 38.4 ± 12.6 mm Hg to 9 ± 4.4 mm Hg postoperatively. New York Heart Association Functional Classification improved in all patients. The fluoroscopy time showed marked reduction from 44.1 ± 8.2 minutes to 17.4 ± 2.9 minutes with the use of the flip-n-flex technique.
Our early experience of right TAx-TAVR with the SAPIEN 3 valve demonstrated satisfactory outcomes and a quick learning as facilitated by the flip-n-flex technique. This could be a beneficial TAVR approach to suitable patients.
Objective Uncorrected functional tricuspid regurgitation has serious long-term morbidity and mortality. We reviewed our experience with tricuspid posterior annular bicuspidization versus ring ...tricuspid annuloplasty for treatment of functional tricuspid regurgitation. Methods From 1999 to 2003, 237 patients underwent tricuspid annuloplasty for functional tricuspid regurgitation as part of their cardiac surgical procedure. Bicuspidization was performed in 157 patients and ring annuloplasty in 80 patients. Preoperatively, 227 (96%) patients had moderate or greater tricuspid regurgitation with a median regurgitation of 3+. Follow-up information was obtained for 234 (99%) patients with a mean follow-up time of 3 years. Postoperative transthoracic echocardiograms were assessed for severity of tricuspid regurgitation. Moderate or greater tricuspid regurgitation was considered significant. Survival and development of recurrent tricuspid regurgitation were evaluated by Kaplan–Meier analysis. Tricuspid regurgitation and risk factors for recurrent regurgitation were identified and analyzed by multivariable ordinal longitudinal methods. Results At 3 years postoperatively, tricuspid regurgitation in patients treated by bicuspidization annuloplasty was zero to mild in 75%, moderate in 11%, moderate to severe in 6%, and severe in 8% of patients. In those undergoing ring annuloplasty, tricuspid regurgitation was zero to mild in 69%, moderate in 14%, moderate to severe in 7%, and severe in 10%. There was no significant difference between the two groups ( P = .18). Risk factors for recurrent tricuspid regurgitation included higher preoperative regurgitation grade, preoperative tricuspid regurgitation without concomitant mitral regurgitation, and higher pulmonary artery systolic pressure. Conclusions Bicuspidization annuloplasty and ring annuloplasty were effective at eliminating tricuspid regurgitation at 3 years postoperatively. Bicuspidization annuloplasty is a simple, inexpensive option for addressing functional tricuspid regurgitation. All patients with moderate-to-severe functional tricuspid regurgitation should undergo tricuspid annuloplasty regardless of the technique used.
Primary graft dysfunction is a feared complication and cause of mortality post-heart transplant. Primary graft dysfunction may require mechanical circulatory support, such as venoarterial ...extracorporeal membrane oxygenation, which carries its own risk for complications. We developed a new mechanical circulatory support method for patients who underwent heart transplant bridged with Impella 5.5, which was then placed into the donor heart. Among 12 heart transplants, four required Impella 5.5 support. The average age was 55.8 years. The mean duration for postoperative mechanical circulatory support was 3.8 days, ranging from 2 to 5 days. No patients developed severe right ventricular dysfunction. In our limited study, complications and mortality associated with the replanted Impella 5.5 were both 0%.
Hypertrophic cardiomyopathy (HCM) is considered a primary disorder of the sarcomere resulting in unexplained left ventricular hypertrophy but the paradoxical association of nonmyocyte phenotypes such ...as fibrosis, mitral valve anomalies and microvascular occlusion is unexplained. To understand the interplay between cardiomyocyte and nonmyocyte cell types in human HCM, single nuclei RNA-sequencing was performed on myectomy specimens from HCM patients with left ventricular outflow tract obstruction and control samples from donor hearts free of cardiovascular disease. Clustering analysis based on gene expression patterns identified a total of 34 distinct cell populations, which were classified into 10 different cell types based on marker gene expression. Differential gene expression analysis comparing HCM to Normal datasets revealed differences in sarcomere and extracellular matrix gene expression. Analysis of expressed ligand-receptor pairs across multiple cell types indicated profound alteration in HCM intercellular communication, particularly between cardiomyocytes and fibroblasts, fibroblasts and lymphocytes and involving integrin β1 and its multiple extracellular matrix (ECM) cognate ligands. These findings provide a paradigm for how sarcomere dysfunction is associated with reduced cardiomyocyte secretion of ECM ligands, altered fibroblast ligand-receptor interactions with other cell types and increased fibroblast to lymphocyte signaling, which can further alter the ECM composition and promote nonmyocyte phenotypes.
An susceptible-infected epidemic model with endogenous behavioral changes is presented to analyze the impact of a prophylactic vaccine on disease prevalence. It is shown that, with voluntary ...vaccination, whether an endemic equilibrium exists or not does not depend on vaccine efficacy or the distribution of agent-types. Although an endemic equilibrium is unique in the absence of a vaccine, the availability of a vaccine can lead to multiple endemic equilibria that differ in disease prevalence and vaccine coverage. Depending on the distribution of agent-types, the introduction of a vaccine or, if one is available, a subsidy for vaccination can increase disease prevalence by inducing more risky behavior.
Current donor-recipient size matching guidelines rely primarily on body weight, with no specified oversizing cutoff values. Recent literature has explored predicted total ventricular mass matching ...over body weight matching. We aim to explore the impact of total ventricular mass oversizing on heart transplant outcomes.
The United Network for Organ Sharing database was queried for adults who underwent primary heart transplant from 1997 to 2017. By using validated equations, donor-recipient total ventricular mass mismatch was calculated. Donor-recipient pairs were divided into 3 groups by total ventricular mass mismatch. Post–heart transplant 1-year survival was analyzed using the Kaplan–Meier method and Cox proportional hazards models. We also investigated post–heart transplant complications, independent predictors for mortality, donor-recipient sex mismatch, and donor-recipient body habitus in total ventricular mass mismatch greater than +50%.
A total of 34,455 donor-recipient pairs were included. Fractional polynomial regression demonstrated increased the risk of mortality with higher total ventricular mass mismatch. Total ventricular mass mismatch of +48.3% maximized the Youden Index. Donor-recipient pairs were subsequently grouped by total ventricular mass mismatch as −20% to +30%, +30% to +50%, and greater than +50%. Total ventricular mass mismatch greater than +50% was an independent risk factor for 1-year mortality (hazard ratio, 1.40, P = .004) and was associated with increased postoperative stroke (P = .002). Some 80.3% of these recipients were smaller female patients with male donors. Total ventricular mass mismatch from +30% to +50% was not associated with worse survival (P = .17).
Total ventricular mass mismatch greater than +50% is associated with worse 1-year survival, although this group comprises a small portion of heart transplant. total ventricular mass mismatch from +30% to +50% is not associated with worse survival. These outcomes should be considered in selecting donors and in efforts to expand the potential donor pool.
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