Large-bore Vascular Closure: New Devices and Techniques

Endovascular aneurysm repair, transcatheter aortic valve implantation and percutaneous mechanical circulatory support systems have become valuable alternatives to conventional surgery and even preferred strategies for a wide array of clinical entities. Their adoption in everyday practice is growing. These procedures require large-bore access into the femoral artery. Their use is thus associated with clinically significant vascular bleeding complications. Meticulous access site management is crucial for safe implementation of large-bore technologies and includes accurate puncture technique and reliable percutaneous closure devices. This article reviews different strategies for obtaining femoral access and contemporary percutaneous closure technologies

Referring hospital involvement in early discharge post transcatheter aortic valve implantation: the TAVI (R-) EXPRES program

Aim: Over the past decade, transcatheter aortic valve implantation (TAVI) has matured into a valid treatment strategy for elderly patients with severe aortic stenosis. TAVI programs will grow with its adoption in low-risk patients. The aim of this study was to evaluate safety and feasibility of early discharge protocols, either home or back to a referring hospital.Methods: Consecutive patients undergoing TAVI between July 2017 and July 2019 were stratified into three discharge pathways from TAVI center: (1) early home (EXPRES); (2) early transfer to referring hospital (R-EXPRES); and (3) routine discharge (standard). Baseline, procedural, and 30-day outcomes were prospectively collected and compared per discharge pathway.Results: In total, 22 (5%) patients were enrolled in the EXPRES cohort [median age 78 (IQR: 73-81); mean Society of Thoracic Surgeons (STS) 2.4% ± 1.5%], 121 (29%) in the R-EXPRES cohort [median age 81 (IQR: 77-84); mean STS 4.3% ± 2.8%], and 269 (65%) in the routine discharge cohort [median age 80 (IQR: 75-85); mean STS 4.4% ± 3.1%]. EXPRES patients trended to be younger (P = 0.13) and had lower STS (P = 0.02). Early clinical outcome was similar through the different pathways including re-hospitalization rate. Median length of stay was one day longer for R-EXPRES vs. routine discharge patients [5 (IQR: 4-7) vs. 4 (IQR: 3-6); P < 0.01]. Median length of stay (LOS) was two days (IQR: 1-3 days) for EXPRES patients.Conclusion: Early discharge pathways home and to referral hospitals are safe and help streamline TAVI programs. LOS in referring hospitals may be further reduced

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs

Background: The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking. Aim: To evaluate MANTA in a real-world population and identify predictors for vascular complications. Methods: All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication. Results: The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75–85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4–29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28–98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53–0.93]), low- (OR 3.47 [1.21–10.00]) and high (OR 2.43 [1.16–5.10]) arteriotomies were independent predictors for vascular complications. Conclusion: In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors

Sildenafil treatment in established right ventricular dysfunction improves diastolic function and attenuates interstitial fibrosis independent from afterload

Right ventricular (RV) function is an important determinant of prognosis in congenital heart diseases, pulmonary hypertension, and heart failure. Preventive sildenafil treatment has been shown to enhance systolic RV function and improve exercise capacity in a model of fixed RV pressure load. However, it is unknown whether sildenafil has beneficial effects when treatment is started in established RV dysfunction, which is clinically more relevant. Our aim was to assess the effects of sildenafil treatment on RV function and fibrosis in a model of established RV dysfunction due to fixed afterload. Rats were subjected to pulmonary artery banding (PAB), which induced RV dysfunction after 4 wk, characterized by reduced exercise capacity, decreased tricuspid annular plane systolic excursion, and RV dilatation. From week 4 onward, 50% of rats were treated with sildenafil (100 mg.kg(-1).day(-1), n = 9; PAB-SIL group) or vehicle (n = 9; PAB-VEH group). At 8 wk, exercise capacity was assessed using cage wheels, and RV function was assessed using invasive RV pressure-volume measurements under anesthesia. Sildenafil treatment, compared with vehicle, improved RV ejection fraction (44 +/- 2% vs. 34 +/- 2%, P <0.05, PAB-SIL vs. PAB-VEH groups), reduced RV end-diastolic pressure (2.3 +/- 0.5 vs. 5.1 +/- 0.9 mmHg, P <0.05), and RV dilatation (end-systolic volume: 468 +/- 45 vs. 643 +/- 71 mu l, P = 0.05). Sildenafil treatment also attenuated RV fibrosis (30 +/- 6 vs. 17 +/- 3%, P <0.05) but did not affect end-systolic elastance, exercise capacity, or PKG or PKA activity. In conclusion, sildenafil improves RV diastolic function and attenuates interstitial fibrosis in rats with established RV dysfunction, independent from afterload. These results indicate that sildenafil treatment has therapeutic potential for established RV dysfunction

Left atrial appendage thrombus and cerebrovascular events post-transcatheter aortic valve implantation

AIMS: To elucidate the frequency and clinical impact of left atrial appendage thrombus (LAAT) in patients set for transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: All patients undergoing TAVI between January 2014 and June 2020 with analysable multislice computed tomography (MSCT) for LAAT were included. Baseline and procedural characteristics were collected, pre-procedural MSCT's were retrospectively analysed for LAAT presence. The primary endpoint was defined as the cumulative incidence of any cerebrovascular event (stroke or transient ischaemic attack) within the first year after TAVI. A Cox proportional hazards model was used to identify predictors.A total of 1050 cases had analysable MSCT. Median age was 80 [interquartile range (IQR) 74-84], median Society of Thoracic Surgeons' Predicted Risk Of Mortality (STS-PROM) was 3.4% (IQR 2.3-5.5). Thirty-six percent were on oral anticoagulant therapy for atrial fibrillation (AF). LAAT was present in 48 (4.6%) of cases. Patients with LAAT were at higher operative risk [STS-PROM: 4.9% (2.9-7.1) vs. 3.4% (2.3-5.5), P = 0.01], had worse systolic left ventricular function [EF 52% (35-60) vs. 55% (45-65), P = 0.01] and more permanent pacemakers at baseline (35% vs. 10%, P < 0.01). All patients with LAAT had a history of AF and patients with LAAT were more often on vitamin K antagonist-treatment than patients without LAAT [43/47 (91%) vs. 232/329 (71%), P < 0.01]. LAAT [hazard ratio (HR) 2.94 (1.39-6.22), P < 0.01] and the implantation of more than one valve [HR 4.52 (1.79-11.25), P < 0.01] were independent predictors for cerebrovascular events. CONCLUSION: Patients with MSCT-identified LAAT were at higher risk for cerebrovascular events during the first year after TAVI