Background . Monitored anesthesia care (MAC) may offer better outcomes than general anesthesia (GA) in transcatheter aortic valve implantation (TAVI). We compared TAVI outcomes between patients who received MAC versus GA. Methods . We retrospectively reviewed data from all patients ( N  = 659), as well as 216 propensity-matched patients, who underwent TAVI at our institution during 2014–2019. Results . MAC and GA did not differ significantly in mortality (1.6% MAC vs. 4.2% GA, p  = 0.05) or stroke (2.2% MAC vs. 2.4% GA, p  = 0.96); however, median length of stay (LOS) was shorter in the MAC group (2 d MAC vs. 7 d GA, p  < 0.0001). In propensity-matched patients, mortality (2.8% MAC vs. 4.6% GA, p  = 0.7) and stroke (3.7% MAC vs. 1.9% GA, p  = 0.7) did not differ significantly between groups. LOS remained shorter in the MAC group (2 d MAC vs. 7 d GA, p  < 0.0001). Conclusions . In this large, single-center, retrospective study, MAC was associated with shorter hospital stay after TAVI.

A 67-year-old man with a history of chest radiotherapy and severe aortic valve stenosis with calcification of the ascending aortic wall underwent implantation of an apicoaortic conduit from the left ventricular apex to the descending aorta. Eight years later, he presented with progressive exertional dyspnea. Imaging revealed severe native aortic valve insufficiency and calcification, with worsening left ventricular function. We decided to leave the apicoaortic conduit intact and perform transcatheter aortic valve replacement with a balloon-expandable prosthesis. Despite concerns that eliminating the obstruction across the native left ventricular outflow tract might decrease conduit flow and eventually cause graft thrombosis and peripheral embolization, we elected to move forward after a multidisciplinary discussion. The procedure resulted in angiographically and qualitatively similar forward flow across the newly implanted prosthesis and the existing apicoaortic conduit, with no hemodynamic or electrical dysfunction. The patient was discharged from the hospital the next day. At the 1-month follow-up visit, the patient felt well and reported marked functional improvement, with minimal symptoms during moderate to heavy exertion. The stroke volume index across the new bioprosthetic valve was low (13 mL/m2 at 1 mo and 18 mL/m2 at 1 y), suggesting that a substantial amount of blood was still exiting the ventricle through the left ventricle-to-aorta conduit. This report offers some guidance for treating patients with existing apicoaortic conduits and suggests that transcatheter aortic valve replacement is safe and effective if native aortic valve insufficiency develops.

BACKGROUND:Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) has emerged as a safe, effective alternative to redo aortic valve surgery in high-risk patients with degenerated surgical bioprosthetic valves. However, ViV-TAVR has been associated high postprocedural valvular gradients, compared with TAVR for native-valve aortic stenosis.METHODS:We performed a retrospective study of all patients who underwent ViV-TAVR for a degenerated aortic valve bioprosthesis between January 1, 2013 and March 31, 2019 at our center. The primary outcome was postprocedural mean aortic valve gradient. Outcomes were compared across surgical valve type (stented versus stentless), surgical valve internal diameter (≤19 versus >19 mm), and transcatheter aortic valve type (self-expanding vs. balloon-expandable).RESULTS:Overall, 89 patients underwent ViV-TAVR. Mean age was 69.0±12.6 years, 61% were male, and median Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.4 [interquartile range, 3.2-8.5]. Bioprosthesis mode of failure was stenotic (58% of patients), regurgitant (24%), or mixed (18%). The surgical valve was stented in 75% of patients and stentless in 25%. The surgical valve's internal diameter was ≤19 mm in 45% of cases. A balloon-expandable transcatheter valve was used in 53% of procedures. Baseline aortic valve area and mean gradients were 0.87±0.31 cm2 and 36±18 mmHg, respectively. These improved after ViV-TAVR to 1.38±0.55 cm2 and 18±11 mmHg at a median outpatient follow-up of 331 [67-394] days. Higher postprocedural mean gradients were associated with surgical valves having an internal diameter ≤19 mm (24±13 versus 16±8, P=0.002) and with stented surgical valves (22±11 versus 12±6, P<0.001).CONCLUSIONS:ViV-TAVR is an effective option for treating degenerated surgical aortic bioprostheses, with acceptable hemodynamic outcomes. Small surgical valves and stented surgical valves are associated with higher postprocedural gradients.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to open surgical replacement. Strictly selecting low-risk patients and using conscious sedation during TAVR has enabled hospital stays to be safely shortened. We evaluated the safety and effectiveness of a less rigorous patient-selection process involving multidisciplinary case discussions, percutaneous procedures with the use of conscious sedation, and postprocedural care outside an intensive care unit, with the goal of discharging patients from the hospital early. We call this "simple TAVR." We retrospectively reviewed the records of patients who underwent TAVR from March 2015 through February 2020 at our center. The procedures were performed by 2 high-volume operators. Of 524 total procedures, 344 (65.6%) qualified as simple TAVR. All 344 procedures were successful. The highest 30-day complication rate was associated with new permanent pacemaker implantation (7.3%, 25 patients); the rates of major vascular complications, stroke, and all-cause death were less than 3% each. Of note, 252 patients (73.3%) were discharged from the hospital the day after TAVR, and 307 (89.2%) within 48 hours. Simple TAVR is safe, economical, and feasible in real-world practice, and it does not necessitate a rigorous perioperative protocol or patient-selection process.

Background: Chest radiation therapy (CRT) for malignant thoracic neoplasms is associated with development of valvular heart disease years later. As previous radiation exposure can complicate surgical treatment, transcatheter aortic valve replacement (TAVR) has emerged as an alternative. However, outcomes data are lacking for TAVR patients with a history of CRT. Methods: We conducted a retrospective study of all patients who underwent a TAVR procedure at a single institution between September 2012 and November 2018. Among 1341 total patients, 50 had previous CRT. These were propensity-matched in a 1:2 ratio to 100 patients without history of CRT. Thirty-day adverse events were analyzed with generalized estimating equation models. Overall mortality was analyzed with stratified Cox regression modelling. Results: Median clinical follow-up was 24 months (interquartile range [8212], 12-44 months). There was no difference between CRT and non-CRT patients in overall mortality (hazard ratio [HR] 0.84 [0.37-1.90], P = 0.67), 30-day mortality (HR 3.1 [0.49-20.03], P = 0.23), or 30-day readmission rate (HR 1.0 [0.43-231],P = 1). There were no differences in the rates of most adverse events, but patients with CRT history had higher rates of postprocedural respiratory failure (HR 3.63 11.32-10.021, P = 0.01) and permanent pacemaker implantation (HR 2.84[1.15-7.01], P = 0.02). Conclusions: For patients with aortic valve stenosis and previous CRT, TAVR is safe and effective, with outcomes similar to those in the general aortic stenosis population. Patients with history of CRT are more likely to have postprocedural respiratory failure and to require permanent pacemaker implantation. (C) 2020 Elsevier B.V. All rights reserved.

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

Radiation treatment of thoracic malignancies is linked with development of valvular disease years after exposure. Given the challenges to surgical treatment related to previous radiation exposure, TAVR has emerged as an alternative. However, outcomes data for patients with history of mediastinal

BACKGROUND:Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device.METHODS AND RESULTS:A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%).CONCLUSIONS:In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices.CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Background. The primary treatment of symptomatic aortic stenosis is aortic valve replacement. Instead of open chest surgery, transcatheter aortic valve replacement (TAVR) is an alternative intervention for high-risk surgical candidates. Clinical Case. A 92-year-old male presented with progressive exertional dyspnea and recurrent syncopal attacks secondary to severe AS. The patient underwent successful transfemoral TAVR with 29mm Edwards SAPIEN XT valve. His postoperative course was complicated by aorto-right ventricular shunt. The patient's clinical course was followed up for one year. Conclusion. This case reports the incidence and clinical course of one of the rare complications of TAVR, aorto-right ventricular fistula. Conservative medical management is appropriate in hemodynamically stable patients with this specific complication.

Conclusions: Findings from ROCKET AF demonstrate that timing of trial stop- page for non-inferiority, especially in chronic disease conditions with accumulat-ing non-compliance, may affect the interpretation of trial findings. Further work is needed on understanding event-driven trial stoppage for non-inferiority trials. p-value LAAC an in left atrial volume. lariat p=0.004) at-least 10 mm 3 increase size. Identification of precursors of atrial fibrillation (AF) may lead to early detection and prevent associated morbidity and mortality. Atrial premature complexes (APCs) are commonly seen in healthy subjects. Results: Among 503 patients who underwent 24-hours holter monitoring, 121 (24.1%) patients had new-onset AF. There was no difference of the baseline characteristics between new-onset AF group and non AF group. In univariate analysis, hypertension (HTN), renal failure (CRF), high APC burdens, fastest APC running heart rate (HR), minimal HR, left ventricular ejection fraction (LVEF), left atrial volume index, peak mitral flow velocity of the early rapid filling wave and tricus-pid regurgitation grade were significantly associated with new-onset AF. In mul- tivariate analysis, higher APCs burden (P=0.047), higher fastest APCs running HR (P=0.034) and lower minimal HR (P=0.025) were independent risk factors for new-onset AF in asymptomatic patients with APCs. Conclusion: Higher APCs burden, higher fastest APCs HR and HR were associated with new-onset AF in asymptomatic patients with APCs in the long-term follow up. Purpose: Inflammatory activity is associated with increased mortality in atrial fibrillation (AF). We investigated if changes of interleukin-6 (IL-6) levels provided incremental prognostic value regarding cardiovascular events in anticoagulated patients with AF. Methods: In the ARISTOTLE trial 18,201 patients with AF and at least one ad- ditional risk factor for stroke were randomised to apixaban or warfarin. Blood samples were obtained at randomisation and at month 2 in 4,830 patients with a median follow-up of 1.8 years. Plasma concentrations of IL-6 were analysed with ELISA technique. Associations between clinical outcomes and IL-6 level at 2-months were analysed by Cox regression adjusting for baseline IL-6, clinical risk factors and other biomarkers. Results: IL-6 median level at entry was 2.0 ng/L (25th, 75th; 1.30, 3.20) and at 2-months 2.10 ng/L (1.40, 3.40), p < 0.05. At 2-months, the comparison between randomised treatment groups after adjusting for baseline IL-6 level, showed a slightly smaller increase in IL-6 level in patients assigned to apixaban than war- farin; geometric means 2.18 vs. 2.26 ng/L, respectively, ratio apixaban vs warfarin 0.96 ng/L (95% CI 0.93–1.00), p=0.0351. Cumulative hazard rates by group according to IL-6 level at baseline (below or above median) and IL-6 level at 2-months (below or above baseline median) are shown for mortality (Figure). Higher IL-6 level (continuous form) at 2-months was independently associated with a higher mortality (Table). Adding IL-6 at 2-months to baseline IL-6 level, clinical characteristics and other biomarkers improved the C-index from 0.74 to 0.76. There were no significant interactions between study treatment and the associa- tions between IL-6 level and outcomes. Higher IL-6 levels at 2-months are associated with higher mortality in AF patients on oral anticoagulation. Compared with baseline, there was less increase of IL-6 at 2-months in patients assigned to apixaban than warfarin. Background: Myocardial fibrosis plays a crucial role in structural heart remodel- ing in patients with atrial fibrillation and chronic heart failure, however association between an extent of electroanatomical substrate, circulating pro-fibrotic biomark- ers and myocardial tissue morphology still remains inconclusive. Methods: We prospectively analyzed electroanatomical high density bipolar maps (HDBM) in 38 patients with AF and CHF, who underwent circular pulmonary veins (PVs) isolation. LA areas outside PVs ostia with bipolar signals ≤ 0.75mV, associated with

Superior vena cava syndrome is a well-known disease entity that carries substantial rates of morbidity and mortality. Although most cases of superior vena cava syndrome are secondary to a malignant process, additional causes (such as mediastinal fibrosis, pacemaker lead implantation, or central venous catheter placement) have been reported. Multiple treatment options include percutaneous transluminal angioplasty, stent implantation, thrombolysis, mechanical thrombectomy, and venous grafting. We present a case of superior vena cava syndrome in a symptomatic 30-year-old woman who obtained complete relief of obstruction and marked symptomatic improvement through venoplasty and stenting, aided by our use of a balloon-in-balloon catheter system.

Exposing the heart to external beam radiotherapy (EBRT) increases the risk of heart disease sevenfold. We report 23 patients with previous EBRT and critical aortic stenosis (AS) who were treated with transcatheter aortic valve implantation (TAVI). Of the 424 consecutive patients who underwent TAVI

Objectives The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement.Background Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications.Methods ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement.Results The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported.Conclusions The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416) (C) 2014 by the American College of Cardiology Foundation

Aim. Totally percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) by using the "Pre-close" technique has been previously described. We retrospectively analyzed data, collected prospectively at our institution, regarding PEVAR via femoral artery access with local anesthesia and conscious sedation.Methods. Between January 2001 and May 2009, 1150 patients underwent PEVAR in the endovascular suite of the cardiac catheterization laboratory at our institution. Of those procedures, 915 (79%) were performed with local anesthesia and conscious sedation.Results. The majority of patients were male (87%). Their mean age was 72 +/- 10 years and 98% had a risk status of American Society of Anesthesiologists class III or IV. The PEVAR involved bilateral percutaneous femoral access with 12F to 24F sheaths (depending on the stent-graft system). The mean total procedure time was 149 minutes. Percutaneous closure of the arterial access sites with the Prostar XL was successful in 1727 (94.3%) of the 1830 femoral arteries in which PEVAR was attempted, whereas 103 femoral arteries (5.6%) required surgical repair because adequate hemostasis was not attained at the access site. There were no procedural deaths, but 6 patients (0.6%) died within 30 days of the procedure: 3 died of intestinal ischemia, 1 of stroke, 1 of refractory ventricular arrhythmia, and 1 of worsening renal failure. Mean length of hospital stay was 1.3 +/- 2 days.Conclusion. PEVAR with local anesthesia and intravenous sedation is safe and feasible and should be considered for patients for whom general anesthesia poses a high risk.

Symptomatic spontaneous celiac artery dissection is a rare condition that is being detected more often with the use of advanced imaging techniques. There is no consensus as to whether surgical or endovascular treatment is more appropriate.We describe the case of a 41-year-old hypertensive woman who presented with the sudden onset of sharp, persistent, right-upper-quadrant abdominal and epigastric pain. Magnetic resonance angiography of the abdomen revealed celiac artery dissection, with a flap compressing the lumen approximately 17 mm from the artery's origin at the aorta. Because of the patient's persistent epigastric pain, endovascular celiac artery stent implantation was performed with the use of 2 overlapping balloon-expandable stents. Twelve months after the procedure, the patient remained asymptomatic, and the stents were patent. This case and others in the medical literature suggest that endovascular treatment can be feasible in symptomatic patients with isolated spontaneous celiac artery dissection.

A 55-year-old woman presented with dyspnea on exertion due to a right internal mammary artery-to-superior vena cava arteriovenous fistula that occurred after pacemaker lead extraction with a laser sheath. The fistula was successfully repaired by placing a covered stent in the right internal mammary artery. In this unusual location, endovascular stenting is a reasonable alternative to coil embolization or surgical repair of an arteriovenous fistula resulting from laser lead extraction.

We sought to compare the efficacy of a low-permeability version of the Gore Excluder™ device with that of the original device. We used volumetric analysis and maximum transverse diameter measurements to examine abdominal aortic aneurysm size regression after endovascular aneurysm repair.From November 2002 through April 2007, 101 patients (82% men; mean age, 71.5 ± 8.9 yr) underwent endovascular aneurysm repair with the Excluder stent-graft: 34 with the original device, and 67 with the low-permeability device. Only patients without endoleak and with preprocedural and 1- and 2-year follow-up computed tomographic scans were included. Eight patients with type II endoleak and 2 with type I endoleak were excluded. Maximum abdominal aortic aneurysm diameter and volume were measured before endovascular aneurysm repair and annually thereafter. Postprocessing, multiplanar computed tomography, and 3-dimensional reconstructions were compared with baseline measurements. Diameter and volume changes that were greater than 5 mm or that exceeded 10% were considered significant.At 12 months, the mean maximum transverse diameter had decreased by -0.16 ± 12.1 mm in recipients of the original device and by -4.8 ± 5.9 mm in recipients of the low-permeability device (P = NS). In addition, mean reduction in volume had changed by -17 ± 16 mL in original-device recipients and by -36.1 ± 37.9 mL in low-permeability device recipients (P < 0.01).One-year follow-up revealed that the low-permeability stent-graft resulted in a greater decrease in abdominal aortic aneurysm volume than did the original stent-graft.

Carotid stenting has significantly evolved over the last decade as techniques and equipment have continued to improve. Several phases of waxing and waning enthusiasm have occurred that have started to settle in favour of carotid stenting in select patients. Carotid stenting is being performed more frequently in community hospitals with reasonable results, as seen in multiple registries. The most recent randomised trials that have compared carotid stenting versus carotid endarterectomy have shed considerable light on the safety and efficacy of stenting, but also have created controversy over the methods and design of many of these trials. The results of the most recent trial, Carotid revascularization endarterectomy versus stenting (CREST) and other registry studies have lifted considerable fog from the scene and confirmed the safety and efficacy of stenting. We are optimistic that future trials will involve better methods and equipment and will help to establish carotid stenting as a standard therapy for carotid artery stenosis.