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Background: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD)., Aims: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population., Methods: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry., Results: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction)., Conclusions: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.

Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65-75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

THV aortic embolization can be managed percutaneously by snaring the prosthesis in a stable position in ascending aorta. We report two cases of embolized Acurate NEO with extreme mobility of devices in ascending aorta in which a bailout supra-aortic trunk stenting with consistent aortic protrusion were performed stabilizing the devices., Competing Interests: Declaration of competing interest The performance of this study was supported exclusively by internal institutional funds. With regards to the present manuscript, Dr. F. Bedogni and Dr. F. De Marco are proctors and consultant for Boston Scientific. All other authors have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) has been a revolution in the treatment of severe aortic stenosis evolving to a high procedural success rate and low rate of complications. Embolization of the percutaneous device is a rare but potentially life-threatening complication. The spectrum of clinical manifestations ranges between incidental finding on cardiac imaging to cardiogenic shock or cardiac arrest. Data about predictors and management of transcatheter heart valve embolization are scarce and mostly anecdotical. Management strategies are related to the type, the size, the location of the embolized device, the timing of diagnosis, and the clinical presentation of the patient. According to recent data from TRAVEL registry, device embolization and migration occur in approximately 1% of the patients and is responsible for increased morbidity and mortality. However, in a considerable proportion of cases it could have been prevented, hence structural interventionalists should plan the procedures carefully and know thoroughly the risk factors for device embolization. Increased awareness of predisposing factors, preventive measures, and appropriate bail-out options and techniques are strongly advisable. This paper is a review of the incidence, and outcomes of percutaneous prosthesis embolization during TAVI. It also suggests an integrated algorithmic approach for the management of device embolization incorporating both percutaneous and surgical techniques.

Objectives: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS)., Background: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant., Methods: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up., Results: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%., Conclusions: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up., (© 2020 Wiley Periodicals LLC.)

Purpose of Review: In recent years, transcatheter aortic valve replacement (TAVR) and percutaneous mechanical circulatory support (MCS) systems have seen a widespread diffusion. These devices require the insertion of large femoral sheaths in a population of patients often presenting with calcific peripheral artery disease. Small and severely calcified iliac vessels are associated with increased risk of vascular complications or strategy changes such as the use of an alternative subclavian or transapical approach for TAVR or a conversion to surgery. Intravascular lithotripsy (IVL) technology applies mechanical pressure waves to modify vessel calcifications. It has been applied both in coronary and peripheral calcific disease with promising results. The use in vessel preparation before the insertion of large sheaths is an emerging application of this device., Recent Findings: After case reports and presentations of isolated cases, two multicenter registries collected 42 and 12 patients treated with peripheral IVL before TAVR and MCS insertion. In most cases, the largest balloons were used in the iliac arteries with success achieved directly or using a separate insertion sheath in all cases. Low-pressure dilatation during energy delivery avoided dissections or vessel ruptures with no need of postprocedural stent implantation or emergency surgical repair. IVL can successfully modify the arterial compliance and facilitate transfemoral delivery of TAVR or MCS in patients with calcified iliofemoral vessels, reducing the need for alternative TAVR access routes and allowing to perform high-risk coronary procedures with adequate support.

Background: Residual aortic regurgitation (AR) complicates a not negligible number of transcatheter aortic valve replacement (TAVR) procedures, and its entity is not always clear at intraprocedural angiographic and echocardiographic control. We applied a minimally invasive hemodynamic monitoring system (Pressure Recording Analytical Method, PRAM) in the setting of TAVR, with the aim of identifying parameters that may help in detection and quantification of residual AR., Methods: We performed hemodynamic monitoring with PRAM in 43 patients undergoing trans-femoral TAVR. Investigated parameters were systolic (Psys, mm Hg), diastolic (Pdia, mm Hg), mean (MAP, mm Hg) and dicrotic pressure (Pdic, mm Hg), cardiac output (CO, L/min), stroke volume (SV, mL), cardiac cycle efficiency (CCE, Units), dP/dt max&#95;rad (mm Hg/ms), MAP-Pdic (mm Hg)., Results: Procedural success was achieved in 86% of the patients; vascular complications occurred in 3 (6.9%), death in 2 (4.7%). Twenty (46.5%) patients had at least mild residual AR. CO, SV, CCE and dP/dt max&#95;rad changed significantly (p < 0.001) between baseline and end of procedure in the overall population, with more evident modifications in the subgroup without residual AR. MAP-Pdic variations were statistically significant only in the subgroup without AR (p = 0.05)., Conclusions: TAVR determined an improvement in hemodynamic parameters such as CO, SV, CCE, dP/dt max&#95;rad . MAP-Pdic was able to discriminate patients with significant residual AR. Hemodynamic monitoring with PRAM system during TAVR is easy and fast to obtain and may help in clinical decision-making in controversial cases., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m 2 stage 4 (S4), <15 ml/min/1.73 m 2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes., Methods and Results: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m 2 ) showed better survival than those without dilatation (HR 8.63, p=0.001)., Conclusions: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objectives: Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI., Methods: The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria., Results: One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS 2 and CHA 2 DS 2 -VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA 2 DS 2 -VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS 2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA 2 DS 2 -VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA 2 DS 2 -VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS 2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092)., Conclusions: In TAVI patients, CHA 2 DS 2 -VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)