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.
Summary
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.
Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of ...LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.
From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset.
AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.
In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.
A longtime aspiration of interventional cardiologists remains to improve the long-term impact of stent permanence in coronaries to restore original vessel patency and physiological endothelium ...response. Bioresorbable vascular scaffolds were considered revolutionary in coronary devices, but several trials were disappointing; thus, the challenge in this field remains. DESolve is a novolimus-eluting poly-L-lactide-based polymer scaffold that dissolves through a bio-reabsorption mechanism, vanishing completely in 2 years. Its ability to supply the necessary radial strength to support the vessel for the critical early months after delivery is an important feature showing a unique self-correction property, which reduces incomplete stent apposition. Overexpansion has a good, safe margin with DESolve. This review aims to provide an overview of this controversial topic.
There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of ...implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries.
This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety.
Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%).
Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
The Cardioband system is a transcatheter direct annuloplasty device that is implanted in patients with severe symptomatic functional mitral regurgitation (MR) due to annulus dilatation and high ...surgical risk. This device covers the posterior two‐thirds of the annulus, from the anterolateral to the posteromedial commissure, implanted in close proximity of the left circumflex artery, atrioventricular (AV) conduction system, and coronary sinus. We present the case of an 80‐year‐old‐gentleman with prohibitive surgical risk, treated with Cardioband implantation for functional MR with an evident P1–P2 cleft and P2–P3 indentation, a relative contraindication to MitraClip implantation. We achieved procedural success with significative mitral annulus reduction (30% anteroposterior reduction from 37 to 26 mm) and MR reduction (from grade 4 to grade 1–2). A late onset Mobitz 2 AV block developed after 26 hr and evolved to complete AV block in the following day, requiring definitive biventricular pacemaker (PM). Less than 200 Cardioband implantations have been performed but, to our knowledge, this is the first reported AV block, possibly facilitated by the pre‐existing bifascicular block, suggesting the opportunity of prolonged ECG monitoring after Cardioband like any other mechanical transcatheter structural intervention possibly affecting the AV conduction system.
Both cone-beam computed tomography (CBCT) and surface-guided radiotherapy (SGRT) are used for breast patient positioning verification before treatment delivery. SGRT may reduce treatment time and ...imaging dose by potentially reduce the number of CBCT needed. The aim of this study was to compare the displacements resulting in positioning from the Image Guided Radiation Therapy (IGRT) 3D and SGRT methods and to design a clinical workflow for SGRT implementation in breast radiotherapy to establish an imaging strategy based on the data obtained.
For this study 128 breast cancer patients treated with 42.5 Gy in 16 fractions using 3D conformal radiotherapy with free breathing technique were enroled. A total of 366 CBCT images were evaluated for patient setup verification and compared with SGRT. Image registrations between planning CT images and CBCT images were performed in mutual agreement and in online mode by three health professionals. Student's paired t-test was used to compare the absolute difference in vector shift, measured in mm, for each orthogonal axis (x, y, z) between SGRT and CBCT methods. The multidisciplinary team evaluated a review of the original clinical workflow for SGRT implementation and data about patients treated with the updated workflow were reported.
Comparison of the shifts obtained with IGRT and SGRT for each orthogonal axis (for the x-axes the average displacement was 0.9 ± 0.7 mm, y = 1.1 ± 0.8 mm and z = 1.0 ± 0.7 mm) revealed no significant statistical differences (p > 0.05). Using the updated workflow the difference between SGRT and IGRT displacements was <3 mm in 91.4 % of patients with a reduction in total treatment time of approximately 20 %, due to the reduce frequency of the CBCT images acquisition and matching.
This study has shown that IGRT and SGRT agree in positioning patients with breast cancer within a millimetre tolerance. SGRT can be used for patient positioning, with the advantages of reducing radiation exposure and shorter overall treatment time.
Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and ...feasibility and long-term follow-up are limited.
LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%.
LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.
Coronary and peripheral calcifications are associated with increased procedural complexity and suboptimal results in both coronary and peripheral percutaneous interventions. Intravascular lithotripsy ...(IVL) has recently entered the clinical scenario as a new technology for plaque modification, with promising results. We present a case of high risk left main (LM) percutaneous coronary intervention (PCI), in which peripheral Shockwave IVL was used to facilitate the delivery of an Impella CP via a 14 F sheath and coronary IVL was used to prepare a very calcific left main bifurcation lesion before stent deployment.
•Intravascular lithotripsy is a novel technique facilitating percutaneous interventions in the presence of calcific atherosclerotic disease.•Mechanical circulatory support during high risk PCI reduces the risk of adverse events.•In the presence of severe iliac calcifications, intravascular lithotripsy may be of help for Impella delivery.
: In recent years, three-dimensional modelling and printing techniques have improved diagnosis and preprocedural planning during percutaneous interventions or surgery in cardiovascular disease. The ...raw data for the whole process are obtained through medical imaging, where regions of interest, that is heart chambers, valves, aorta, coronary vessels etc., are segmented and converted into three-dimensional digital models, which are then reproduced in physical replica by a three-dimensional printer. In the current article, a freeware patient-specific three-dimensional modelling and printing step-by-step procedure for preprocedural planning for complex heart diseases is presented and applied on four patients. Finally, a general discussion on the potential and future developments of personalized three-dimensional modelling and rapid prototyping for preprocedural planning is also presented.
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