Balloon-Expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid Versus Tricuspid Aortic Stenosis.

BACKGROUND: Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS). METHODS: The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS. RESULTS: A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year. CONCLUSION: Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies. TRIAL REGISTRY: NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899.

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear. METHODS: In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm2, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack. RESULTS: Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (P=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (P=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (P=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]). CONCLUSIONS: In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.

Left Ventricular Mechanical Support with the Impella during Extracorporeal Membrane Oxygenation.

Background: Venoarterial extracorporeal membrane oxygenation (ECMO) provides systemic arterial support without directly unloading the left heart, which causes an elevated left ventricular (LV) pressure. The aim of the present study was to investigate the adjunctive application of the Impella device for LV unloading in patients during ECMO. Methods: This retrospective cohort study included patients who received Impella support in addition to venoarterial ECMO between April 2012 and December 2015. ECMO cannulation was performed peripherally or centrally, while the Impella device was surgically inserted into the femoral artery or the right axillary artery. Results: Among 62 patients, 10 (16.1%) received an Impella device during ECMO support. Following Impella support, right atrial pressure improved from a median of 18 (IQR, 14-24) mmHg to 13 (IQR, 10-15) mmHg and pulmonary wedge pressure improved from 30 (IQR, 26-35) mmHg to 16 (IQR, 12-19) mmHg in all the patients (p value < 0.001). Follow-up transthoracic echocardiograms (n = 6) showed a median decrease of 0.8 cm in LV end-diastolic volume (p value = 0.021). There were 5 (50%) in-hospital deaths due to sustained brain injury (n = 3) and refractory cardiogenic shock (n = 2). The remaining 5 patients were discharged and successfully bridged to more permanent LV assist device (n = 2) or heart transplantation (n = 3). Conclusion: The findings of the present study indicate that the application of the Impella device during ECMO support is effective in LV unloading and confers optimal hemodynamic support.

Extracorporeal Membrane Oxygenation in Massive Pulmonary Embolism.

BACKGROUND: Extracorporeal Membrane Oxygenation (ECMO) has been suggested for cardiopulmonary support in patients with massive pulmonary embolism (PE) refractory to other treatment or as bridging to embolectomy. The survival benefit from ECMO in patients with massive PE remains unclear. METHODS: Here, we describe 5 cases in which ECMO was used as cardiopulmonary support following massive near-fatal pulmonary embolism. RESULTS: The overall mortality in patients with massive PE that received ECMO support was 40%. Death occurred secondary to ECMO-related complication in one case and due to inability to maintain adequate cerebral perfusion despite ECMO support in the second case. CONCLUSIONS: ECMO can be considered as a treatment modality for patients with massive PE.

Extracorporeal membrane oxygenation in transcatheter aortic valve replacement.

Background Patients undergoing transcatheter aortic valve replacement can experience severe perioperative complications leading to hemodynamic instability and death. Venoarterial extracorporeal membrane oxygenation can be used to provide cardiorespiratory support during this time. Methods From 2012 to 2015, of 247 patients who underwent transcatheter aortic valve replacement, 6 (2.42%) required extracorporeal membrane oxygenation support. Their mean age was 82 ± 7.4 years, mean Society of Thoracic Surgeons score was 9.4 ± 6.6, and mean aortic gradient was 28.3 ± 12 mm Hg. Rescue extracorporeal membrane oxygenation was required for hemodynamic instability due to ventricular fibrillation ( n = 1), respiratory failure ( n = 1), left ventricular wall rupture ( n = 2), and aortic annulus rupture ( n = 1). In one patient, prophylactic extracorporeal membrane oxygenation was required due to advanced heart failure. Additional procedures included valve-in-valve implantation ( n = 1), conversion to an open procedure ( n = 3), and intraaortic balloon pump insertion ( n = 1). Results The median hospital stay was 20 days. There were 2 hospital deaths in patients whose hospital course was complicated by left ventricular wall rupture or aortic annulus rupture with resulting tamponade. Among the 4 survivors, one required continuous ventilator support following discharge, and 3 experienced no major complications during the first month after discharge. Conclusions Extracorporeal membrane oxygenation can be considered a viable option for high-risk patients undergoing transcatheter aortic valve replacement and those who develop cardiac complications following this procedure and require cardiorespiratory support.