Access For Implantation Research Articles

Transcaval access for transcatheter aortic valve implantation: A meta-analysis and systematic review

BackgroundAnatomical factors may preclude transfemoral (TF) arterial access for transcatheter aortic valve implantation (TAVI). Transcaval (TCav) access has been utilized as an alternative access for these patients. We aimed to investigate the outcomes of TCav access in patients undergoing TAVI. MethodsWe performed a systematic review and meta-analysis including all published studies from 1996 to November 2023 that examined TCav access in patients undergoing TAVI. The main outcomes included all cause mortality, major vascular complications, major bleeding, stroke, and myocardial infarction (MI). Outcomes were reported at 30-day and 1-year follow-up. ResultsWe included 8 observational studies with a total of 517 patients (mean age 78.1±8 years, 56.6 % women, mean STS score 7 ± 4.5). Mean (SD) procedure time was 35 ± 9.8 mins and mean (SD) contrast volume was 136.3 ± 77.4 ml. Procedure success was achieved in 94.3 % of the patients. At 30-day follow-up, all-cause mortality occurred in 6.4 %, major bleeding in 12.2 %, blood transfusion in 23.3 %, retroperitoneal bleeding in 19 %, major vascular complications in 7.9 %, MI in 2.8 %, and AKI in 6.4 % of patients. At 1-year, all-cause mortality was 14.7 %. In a sub-group analysis including 3 studies comparing TCav (n = 316) to alternative accesses (including transcarotid, transaxillary, and transapical) (n = 303), there were no differences in all-cause mortality, major bleeding, major vascular complications, blood transfusion, or stroke at 30-day. ConclusionTranscaval approach is feasible and non-inferior to other alternative accesses in TAVI patients with prohibitive iliofemoral anatomy.

Single center experience of internal jugular vein as alternative access for implantation of a wireless pulmonary artery pressure sensor

Abstract This single-center study delves into the novel use of the internal jugular vein (IJ) as an alternative access pathway for the implantation of the CardioMEMS device, a wireless pulmonary artery pressure sensor. This approach is compared to the conventional femoral vein access in terms of procedural times, contrast volume, and patient outcomes. The study spans five years, from 2018 to 2023, evaluating the efficacy and safety of IJ access for CardioMEMS implantation. The analysis revealed a tendency towards shorter procedural times and reduced contrast volume with IJ access, although statistical significance was not reached due to the small sample size. Notably, IJ access provided a quicker needle-to-door time, suggesting benefits such as improved patient throughput and potentially shorter hospital stays, which are pivotal in a healthcare landscape that prioritizes efficiency and cost-effectiveness. In conclusion, this investigation offers initial evidence that IJ vein access is a feasible and potentially superior alternative for CardioMEMS device implantation. While the findings are preliminary due to the study's limited scale, they pave the way for future larger-scale, multicenter studies. Such research could confirm the benefits of IJ access and possibly influence clinical practices, enhancing the management of heart failure patients.

Single arterial access versus standard access in TAVI: results from a large multicenter registry

Abstract Background The transfemoral approach has become the gold standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional secondary access (ScA) is used for angiographic guidance of the procedure. Recently, small, single-center studies demonstrated feasibility of single-access for transfemoral TAVI without a secondary access. However, comparative and large-scale data are missing. Purpose We assessed vascular and bleeding complications of ScA and Single access (SA) approaches in a large multicenter registry to evaluate both strategies. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. In 9,457 patients who qualified for analysis ScA (80.7% femoral, 19.3% radial) were performed in 8709 (92%) and SA in 748 (8%). Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Median age was 81.9[IQR 78.2, 85.1] years and 48.9% of patients were female (median logistic EuroSCORE II: 3.3% [IQR 2.1, 5.6]). Peripheral artery disease was comparable between groups (13.5 vs. 14.0%, p=0.73). While overall major access-related vascular complications did not differ significantly (6.1% vs. 4.8%, p=0.20), there was a higher incidence of minor complications for ScA compared to SA (9.0% vs. 2.8%, p<0.001). Secondary access complications amounted to 2.7% in the ScA group and were mainly characterized as bleeding (1.2%) and pseudoaneurysms (1.2%) mostly treated conservatively (1.2%), yet in some cases surgical repair was needed (0.8%). No significant difference was observed regarding type III/IV bleeding (4.1% vs. 4.3%, p=0.91), stroke rate (2.4% vs. 3.6%, p=0.05), stage III/IV acute kidney injury (2.4% vs. 2.4%, p=1.00) or all-cause 30-day mortality (5.8% and 5.7%, p=0.99) for ScA compared to SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of minor access-related vascular complications without compromising overall outcomes, suggesting potential benefits of a minimally-invasive TAVI approach with the omission of additional vascular access.

TCT-897 Experience Using Brachiocephalic Transcatheter Aortic Valve Implantation Access as an Alternative Option for Patients Unsuitable for Transfemoral or Left Subclavian Approach: A Two-Center Series

TCT-897 Experience Using Brachiocephalic Transcatheter Aortic Valve Implantation Access as an Alternative Option for Patients Unsuitable for Transfemoral or Left Subclavian Approach: A Two-Center Series

Feasibility of ultrasound-guided axillary vein access for implantation of cardiac implantable electronic device leads

BackgroundThe axillary vein is preferred over the subclavian vein, and the cephalic vein for cardiac implantable electronic device (CIED) lead insertion. However, studies on ultrasound-guided axillary vein access (US-AVA) in Asia are scarce. This study aims to evaluate the feasibility of US-AVA for CIED lead implantation in Korean patients.MethodsFrom September 2021 to September 2023, we employed US-AVA for CIED lead implantation procedures. Patients’ demographic and procedural data were collected and analyzed retrospectively.ResultsUS-AVA was successful in 301 patients (97.7%). There were no occurrences of pneumothorax or severe hematoma due to inadvertent arterial puncture, nor were there any other significant vascular access-related acute complications. During the median 1.7 years of follow-up, no CIED infection or lead-related problems have occurred. Compared to a historical cohort of patients who underwent fluoroscopy-guided axillary vein access (FL-AVA), US-AVA significantly reduced procedure and fluoroscopy time and showed a trend toward reduced radiation doses.ConclusionUS-AVA is a safe and effective technique for CIED lead implantation in Korean patients, with advantages over FL-AVA in terms of procedural efficiency and patient safety.

Objective evaluation, using computed tomography, of round window access for cochlear implantation.

The aim of this study was to determine optimal radiological parameters for assessment of the round window approach in cochlear implantation surgery. Patients undergoing cochlear implantation at the Department of Otolaryngology in Szczecin, between 2015 and 2022 inclusive, were eligible for the study. Radiological assessments were performed according to eight parameters (seven proposed in the literature) and visibility clinical assessments were made intra-operatively on a scale of 1 to 5 (1 - not visible, 5 - fully visible). Visibility assessments of the round window niche (RWN) and round window membrane (RWM) allowed the difference (RWN minus RWM) to be used as a clinical assessment of the size of the overhang over the round window. Computed tomography images of 57 ears from 52 patients were analyzed in terms of round window access. The study group included 26 females and 26 males, ranging in age from 1 year to 80 years, with a median age of 41 years. In clinical assessment, round window visibility was rated as 5, after removal of the bone overhang, in 69% of patients. Cochlear access through the round window was achieved in 39 (68%) cases, extended access through the round window in 13 (23%) cases and cochleostomy was performed in 5 (9%) cases. Statistically significant ordinal correlations with round-window access were found using one parameter from the literature (Chen_Angle) and from our proposal (RWM_prediction). From parameters describing the bone overhang of the round window, positive correlations (using Kendall rank tests) were found using parameters from the literature (Sarafraz_OH and Mehanna_OH). Radiological measurements describing access to the round window which determine the angle based on the anatomy of the posterior wall of the auditory canal and the position of the facial nerve were found to be of the highest value. In the future, the use of algorithms for computed tomography evaluation and robot-assisted surgery will require parameters for assessing round window access, for surgery planning and choice of electrode. The parameters proposed by various authors are summarized, allowing researchers to assess their usefulness in further clinical practice.

Feasibility and outcomes of ultrasound-guided transcutaneous access to the axillary vein for implantation, revision, and upgrade of cardiac electronic devices

Abstract Background Implanting leads for cardiac implantable electronic devices (CIED) requires venous access. Venous access is commonly established through the cephalic and subclavian vein. For CIED upgrades or revisions, the preferred cephalic vein access is often not viable. Several reports suggest that fluoroscopy-guided axillary vein puncture may reduce thoracic complications. Purpose This study reports on procedural outcomes of ultrasound-guided axillary vein access for CIED implantation, revision, or upgrade in a large tertiary care centre. Outcomes were compared to the traditional subclavian vein approach. Methods This retrospective, single-center non-randomized study, conducted from January 2021 to August 2023, analyzed patients undergoing CIED implantation, revision, or upgrade. Axillary access, initially introduced by one operator, was increasingly adapted by additional operators. The axillary access was obtained by ultrasound-guided visualization of the axillary vein at the deltopectoral groove (Figure 1A and B). Subsequently, the wire(s) were transcutaneously inserted. An adjacent skin incision allowed for threading the wire(s) followed by standard lead implantation (Figure 1C). The study evaluated the acute success of each venous access method and the incidence of adverse events. Those were defined as pneumothorax, hemothorax, and pocket hematoma. An intention-to-treat analysis was performed. A p-value assessed the comparative outcomes between the axillary and subclavian access methods. Results In this study, 986 patients (mean age 74, IQR 64-82 years, 35% women) underwent CIED implantation, revision, or upgrade with 1636 lead implants. Axillary access was used in 578 patients with 532 (92%) successful implantations. Subclavian access yielded a higher success rate with 394/408 patients (97%) (p=0.003). For device upgrades or revisions specifically, axillary access was successful in 68/79 patients (86%), versus 44/47 patients (94%) with subclavian access (p=0.193). Acute complications were less frequent with axillary access (0.3%, 2/578 patients) and consisting of two cases of pneumothorax requiring intervention. In CIED implantations via subclavian access, complications occurred in 17/408 patients (4.2%) (p<0.001) including pneumothorax in 12 patients (2.9%, with 2% requiring intervention), hemothorax in three patients (0.7%), and pocket hematoma in two patients (0.5%). No additional complications were observed in the axillary group. Conclusion The implementation of transcutaneous, ultrasound-guided axillary access for CIED implantations, revisions and upgrades in a major CIED training centre is feasible. Complication rates were low compared to subclavian venous access.Figure 1

Application of Transcatheter Electrosurgery in Structural Heart Interventions: A Report of Three Different Techniques

Transcatheter electrosurgery is a novel technique to traverse or cut tissue, within blood-filled spaces, using alternating current directed by guidewires and catheters. We report the first series of transcatheter electrosurgery procedures in Asia including transcaval access for transcatheter aortic valve implantation, intentional aortic leaflet laceration to mitigate the risk of coronary occlusion in transcatheter aortic valve implantation and intentional laceration of anterior mitral valve leaflet to mitigate the risk of left ventricular outflow tract obstruction. These procedures are potentially valuable in Asian patients because of their smaller body build compared to Caucasians posing a higher risk of coronary or left ventricular outflow tract obstruction during transcatheter valve implantation. There is a need to adopt transcatheter electrosurgery in Asia to treat more surgically inoperable patients, including proper simulation training, bench training and clinical proctorship.

Transcarotid vascular access for transcatheter aortic valve implantation: is choosing the left side always right?

BackgroundThe transcarotid (TC) vascular access for transcatheter aortic valve implantation (TAVI) has emerged as the first-choice alternative to the transfemoral access, in patients unsuitable for the latter. The use of both the left and right common carotid arteries (CCAs) for TC-TAVI has been described, but the optimal side is subject to debate. We conducted this pilot study to compare the level of vessel tortuosity and plaque burden from either the left CCA to the aortic annulus, or the right CCA to the aortic annulus, considering them as surrogates for technical and procedural complexity.MethodsConsecutive patients who underwent TC-TAVI between 2018 and 2021 in our institution were included. Using three-dimensional reconstruction, pre-TAVI neck and chest computed tomography angiography exams were reviewed to assess the tortuosity index (TI), sum of angles metric, as well as plaque burden, between each CCA and the aortic annulus.ResultsWe included 46 patients who underwent TC-TAVI. No significant difference regarding the mean TIs between the left and right sides (respectively 1.20 and 1.19, p = 0.82), the mean sum of angles (left side: 396°, right side: 384°, p = 0.27), and arterial plaque burden (arterial plaque found in 30% of left CCAs and 45% of right CCAs, p = 0.19) was found.ConclusionsWe found no convincing data favoring the use of one particular access side over the other one. The choice of the CCA side in TC-TAVI should to be made on a case-by-case basis, in a multidisciplinary fashion, and may also depend on the operators’ experience.

Biomechanical Finite Element Simulation of Cochlear Implant Surgical Robot Drilling Through Direct Cochlear Access

AbstractRobotic drilling through direct cochlear access for cochlear implantation (CI) is currently a prominent area in the field of CI surgery. However, the safety of drilling remains an issue due to the limited space within the facial recess. Estimation and control of drilling force are critical to prevent drill‐bit breakthrough, excessive heat generation, and mechanical damage to the facial nerve. The bone drilling process presents a favorable application scenario for finite element (FE) analysis. In this study, a 3D FE model of temporal bone drilling is established for the first time to predict the drilling force. The self‐developed CI surgical robot validates these findings through experimental drilling. The experimental results show that the drilling process can be divided into three stages, and the corresponding force curve can be divided into six zones. The overall trend of temporal bone drilling is two force peaks and one trough in the middle. The drilling force is positively correlated with the feed rate. The FE results found to be in good agreement with the experimental results. Numerical simulation can be utilized as an invaluable tool for assisting in predicting the position of drilling tools and optimizing drilling parameters in the future.

Ultrasound-Guided Venous Axillary Access Versus Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI Randomized Trial

BackgroundAxillary vein puncture (AVP) and cephalic vein surgical cutdown are recommended in international guidelines because of their low risk of pneumothorax and chronic lead complications. Directly visualizing and puncturing the axillary vein under ultrasound guidance reduces radiation exposure, provides direct needle visualization, and lowers periprocedural complications. Our hypothesis is that ultrasound-guided axillary access is safer and more feasible than the standard fluoroscopic technique. ObjectivesThe purpose of this study was to assess the efficacy and safety of ultrasound-guided axillary venous access during cardiac lead implantation for pacemakers (PMs) and implantable cardioverter-defibrillator (ICD) implantations. MethodsPatients were randomized in a 1:1 fashion to either axillary venous access under fluoroscopic guidance or ultrasound-guided axillary venous access. The composite outcome, including pneumothorax, hemothorax, inadvertent arterial puncture, pocket hematoma, pocket infection, lead dislodgement, and death, was evaluated 30 days after implantation. ResultsWe randomized 270 patients into 2 groups: the standard group for fluoroguided AVP (n = 134) and the experimental group for ultrasound-guided AVP (n = 136). No disparities in baseline characteristics were observed between the groups. The median age of the patients was 81 years, with women comprising 41% of the population. The majority of patients received single- and dual-chamber PMs (87% vs 88%; P = 1.00), and slightly over 10% in both groups received ICDs (13% vs 12%; P = 0.85). In total, we placed 357 leads in PMs and 48 leads in ICDs. Among these, 295 leads were inserted via axillary vein access and 110 via cephalic vein access. Notably, the subclavian vein was never used as a vascular access. The composite outcome was lower in the ultrasound group according to intention-to-treat analysis (OR: 0.55; 95% CI: 0.31-0.99; P = 0.034). The main difference within the composite outcome was the lower incidence of inadvertent axillary arterial puncture in the experimental group (17% vs 6%; P = 0.004). The ultrasound group also exhibited lower total procedural x-ray exposure (10,344 μGy × cm2 vs 7,119 μGy × cm2; P = 0.002) while achieving the same rate of success at the first attempt (61% vs 69%; P = 0.375). ConclusionsUltrasound-guided AVP is safer than the fluoroscopy-guided approach because it achieves the same rate of acute success while maintaining low total procedural radiation exposure. Ultrasound AVP should be considered the optimal venous access method for cardiac lead implantation. (Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation [ZEROFLUOROAXI]; NCT05101720)

НАРУШЕНИЕ ПРОХОДИМОСТИ ВЕН ВЕРХНИХ КОНЕЧНОСТЕЙ У ПАЦИЕНТКИ С ПОКАЗАНИЯМИ К ИМПЛАНТАЦИИ ЭЛЕКТРОКАРДИОСТИМУЛЯТОРА (КЛИНИЧЕСКИЙ СЛУЧАЙ)

Today, permanent cardiac pacing is the most effective way to correct bradyarrhythmia. Most pacemaker leads are implanted through the veins of the upper extremities. Common vein access involves either a cephalic vein cutdown or a puncture of the subclavian or axillary veins. Implantation of leads may become technically difficult or unfeasible if there is an anomaly in the structure of the veins or, more often, occlusion/stenosis of the veins of the upper extremities after thrombosis. The article presents It is illustrated with the case of a 75-year-old patient with indications for pacemaker implantation presented by the article. The first implantation attempt was unsuccessful: extensive occlusion of the left subclavian vein (SCV) and stenosis of the right SCV were detected. The venous obstruction was asymptomatic. The patient underwent venography and was diagnosed with up to 90% luminal narrowing of the right SCV. Percutaneous transluminal angioplasty of the right SCV was performed; the residual stenosis was 50%. Subsequently, a dual-chamber pacemaker was successfully implanted into the patient; the postoperative period was uneventful. The vein obstruction could be related to a history of malignant neoplasm of the uterus. A brief literature review of various types of vascular access for pacemaker implantation and alternative implantation options complements the case report. Keywords: Pacemaker, venous thromboembolic complications, deep vein thrombosis, deep vein stenosis, angioplasty.

Transcatheter Aortic Valve Implantation Access Sites: Same Goals, Distinct Aspects, Various Merits and Demerits.

Transcatheter aortic valve implantation (TAVI) has been established as a safe and efficacious treatment for patients with severe symptomatic aortic stenosis (AS). Despite being initially developed and indicated for high-surgical-risk patients, it is now offered to low-risk populations based on the results of large randomized controlled trials. The most common access sites in the vast majority of patients undergoing TAVI are the common femoral arteries; however, 10-20% of the patients treated with TAVI require an alternative access route, mainly due to peripheral atherosclerotic disease or complex anatomy. Hence, to achieve successful delivery and implantation of the valve, several arterial approaches have been studied, including transcarotid (TCr), axillary/subclavian (A/Sc), transapical (TAp), transaortic (TAo), suprasternal-brachiocephalic (S-B), and transcaval (TCv). This review aims to concisely summarize the most recent literature data and current guidelines as well as evaluate the various access routes for TAVI, focusing on the indications, the various special patient groups, and the advantages and disadvantages of each technique, as well as their adverse events.

Complications according to intrathoracic versus extrathoracic venous access for cardiac device implantation: results from the PLACE (Planning Lead Access for Cardiac Electrostimulation) study

Abstract Background and Aims The choice of the vascular access for cardiac pacing devices (CIED) implant may impact on patients outcome. Recent studies and consensus documents encourage the use of an extra-thoracic access to prevent adverse events. In this large, multicenter, retrospective study we report the impact of leads access on post-procedural outcome. Methods Consecutive patients receiving a CIED from 2008 to 2019 in 4 high-volume Italian hospitals were enrolled. Short- and long-term complications (i.e. pneumothorax, cardiac tamponade, pocket decubitus, pocket hematoma, lead dislodgement, lead failure) were collected and their relationship with the type of vascular access (extra- vs intra-thoracic, i.e. cephalic vein/extra-thoracic axillary vein vs subclavian vein puncture) was analyzed. Primary endpoint was the occurrence of at least one complication during follow-up. Results A total of 4,443 patients were enrolled; 3,374 (75.9%) received a pacemaker (PM) and 1,069 (24.1%) an implantable cardioverter defibrillator (ICD). Mean follow-up was 1,630±1,010 days. At least one complication occurred in 7.6% of patients. At multivariate Cox regression analysis, adjusted for baseline confounders, the presence of structural heart disease (HR 1.59, 95%CI 1.21-2.10; p=0.001), anticoagulant therapy at implantation [HR 1.31, 95%CI 1.0004-1.71; p=0.05) and female gender (HR 0.78, 95%CI 0.63-0.98; p=0.03) were associated with the primary outcome measure. Extra-thoracic access did not reduce the risk of complications compared to intra-thoracic access (HR 0.97, 95%CI 0.76-1.25 p=0.81). The use of both accesses in the same patient conferred a significant increase in the risk of complications (HR vs single approach:1.95, 95%CI 1.41-2.69; p <0.001). Conclusions The choice of a different vascular access (intra- vs extra-thoracic) does not impact on post-procedural complications in patients receiving CIED. In particular, the intra-thoracic subclavian vein puncture by experienced operators is not related to a poorer outcome. The need for both types of access in the same patient (i.e. increased procedure complexity) increases the risk of post-procedural complications.Graphical abstract

Abstract 17876: Outcome of Ultrasound versus Fluroscopy Guided PPM Implantation

Introduction: Universal standard practice for venous access for implanting permanent pacemaker (PPM) is with fluoroscopy with venogram. Ultrasound (US) guided vascular access is increasingly encouraged to minimise radiation, contrast load and inadvertent injury to other structures. The incidence of US-guided vascular access related complications is unknown. Goals: To compare complications including radiation exposure with Ultrasound (US) guided vascular access, compared with fluoroscopy/venogram access. Method: Retrospective data of 205 consecutive patients implanted with PPM (elective and urgent) from August 2021 to August 2022 at single centre were collated for access-related complications and cumulative entire-procedure radiation dose. Result: 149/205 (73%) patients underwent fluoroscopy guided subclavian/axillary/cephalic vein versus access and 55/205 (27%) US-guided access. Fluoroscopy guided access was associated with complication rate of 6.8% (14/205), compared with 0.97% (2/205) for US-guided access (p=0.3602; Fisher exact test). There were no differences in radiation dosage between the two groups (p=0.1917). Conclusion: There were no statistically significant differences in vascular access-related complications or radiation dose between fluoroscopy guided and US-guided venous access for PPM implantation. US-guided access was however associated with lower complication rates. Larger robust randomized controlled trials would be required to validate these finding.

Temporal Trends in Early Pediatric Cochlear Implantations in California from 2018 to 2020.

To characterize the demographics of children receiving cochlear implantations, identify factors associated with delayed implantations, and trend these factors over time. Retrospective cross-sectional study. Healthcare Cost and Utilization Project California State Ambulatory Surgery Database for calendar years 2018-2020. Children 5 years or younger undergoing cochlear implantation. Cochlear implantation. The population-controlled number of cochlear implantations was calculated and stratified by race and insurance. Early implantation was defined as implantation at age 2 years or younger. A mixed-effects logistic regression model was generated to identify factors associated with early implantation and how that association changed from 2018 to 2020. The final cohort included 467 children. The number of implantations increased from 141 to 175 implants from 2018 to 2020 (24.1% increase); 229 (49.0%) children were implanted at 2 years or younger. Medicaid insurance was associated with decreased odds of early implantation (odds ratio, 0.18 [95% confidence interval, 0.15-0.23], p < 0.001); this association with Medicaid insurance was significant when stratified across all racial groups. The percentage of children with Medicaid who were implanted at 2 years or younger increased from 20.9 to 62.0% from 2018 to 2020. Among children in California, socioeconomic factors, in particular public insurance, are correlated with age of cochlear implantation. These disparities improved significantly from 2018 to 2020. Further investigation into changes and initiatives in California during this time frame may aid in directing national efforts to improve pediatric cochlear implantation access.

Handheld ultrasound device-guided axillary vein access for pacemaker and defibrillator implantation

While ultrasound assistance for accessing the axillary vein has been established as a reliable method for cardiac pacemaker and cardioverter-defibrillator leads implantation, there is a lack of information regarding the utilization of portable handheld ultrasound devices within this context. We describe our experience with the systematic use of a pocket-sized handheld ultrasound device during the implantation of transvenous cardiovascular implantable electronic devices.

The use of distal femoral venous access for pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation: randomized study design and preliminary results

Aim. This study aims to compare the results of the distal femoral access with the classic approach in patients undergoing pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation.Methods. The primary results of the 1:1 randomized single-center study are presented. The study group recruited 47 patients who underwent the catheter-based procedure using ultrasound-assisted distal femoral access. 38 patients with traditional ultrasound-guided proximal femoral access were involved in the control group.Results. Total 85 patients were included: 47 in the study group and 38 in the control group. The median age was 61 years, and pulmonary vein cryo-ablation was performed in 84%. 95% of patients were taking direct oral anticoagulants. In the study group, the most frequent topographic and anatomical variant was the location of the superficial femoral vein on the lateral side from the artery (81%), whereas in the control group it was on the medial side (81%). The median access time was 30 s in the study group for the right leg and 35 s for the left leg. In the control group, access time was 33 s and 39 s for the right and left leg respectively. Unintentional arterial puncture occurred more frequently in both groups when the vein was fully overlapped by the artery for both right and left legs, but the differences were statistical unsignificant (p&gt;0.05 and p=0.09 in the main group, p=0.24 and p=0.72 in the control group). In a correlation analysis, neither body mass index (p=0.19) nor femoral circumference (p=0.19 for right and p=0.06 for left legs) influenced the access time and did not increase the number of unintended arterial punctures. Two patients in the control group required additional manual hemostasis. There was no postprocedural venous thrombosis in both groups. Back pain was observed only in patients in the control group.Conclusion. The efficacy and safety of the distal femoral access approach are comparable to the traditional proximal approach. Earlier postprocedural activation of patients can help improve quality of life.

Transcatheter Aortic Valve Implantation Using the Transcervical Vascular Access (from a 7-Year Experience from a Swiss Tertiary Center)

The gold-standard transfemoral (TF) access for transcatheter aortic valve implantation (TAVI) is not suitable in 10% to 15% of patients, and alternative accesses are needed. Studies have suggested that the transcervical (TC) access might yield outcomes comparable to the TF access. In our center, TC-TAVI is the first-line alternative to TF-TAVI. We herein present our 7-year experience regarding the use of the TC access in TAVI. We included all consecutive patients referred for TC-TAVI between January 1, 2016 and December 31, 2022. Data regarding the patients' characteristics,perioperative and 30-day outcomes were prospectively collected. Patients were separated into 2 temporal groups (group 1: January 1, 2016 to June 30, 2019; group 2: July 1, 2019 to December 31, 2022) to assess the changes of their characteristics and outcomes over time. A total of 95 patients were included, with more belonging to group 2 (n=56 vs n=39 in group 1). Patients in group 2 were significantly younger (81.0 [interquartile range 77.0 to 87.0] vs 89.0 [interquartile range 83.0 to 92.0] years, p <0.001) and had a higher prevalence of hypertension (87.5% vs 66.7%, p=0.028) and chronic pulmonary disease (35.7% vs 15.4%, p=0.029). There was no significant difference regarding other co-morbidities or surgical scores. All-cause mortality and the risk of stroke at 30days were low and similar (group 2 vs group 1, 3.6% vs 2.5%, p=0.787 and 1.8% vs 0%, p=0.397, respectively), as were the risks of permanent pacemaker implantation, postoperative acute kidney injury, cardiac tamponade, life-threatening bleeding, and major vascular complications. In conclusion, the use of the TC access increased over time. The rates of adverse events did not change, despite patients from mid-2019 onward having slightly more co-morbidities.

PEDS11: Use of the CardioMEMSTM HF System in Pediatric Patients for Heart Failure Management

Background: The CardioMEMSTM HF system has been successfully used in adults for management of heart failure. Reports of use in pediatric patients are rare. In this case series, we aim to describe the novel use of this device in a large academic pediatric center. Methods: Retrospective, single center, descriptive case-series. Results: At time of abstract completion, our center has successfully implanted the CardioMEMSTM HF systems in four patients. The age at implantation ranged from 11 to 17 years, weight at implantation ranged from 27-73 kg. Vascular access for implantation was via a femoral vein in all patients. Three were implanted into the left lower pulmonary artery (PA) and one was implanted into the left pulmonary artery. The PA size ranged from 8.5-13.8 mm. There were no adverse events with implantation. The PA pressures reported by the device ranged from 14-20 mmHg and correlated with invasive monitoring. The pulmonary vascular resistance ranged from 2.3-8.7 iWu. Patient #1 had a diagnosis of Shone’s complex, and developed left ventricular diastolic dysfunction and resultant pulmonary artery hypertension (PAH). She was supported with a Berlin LVAD and subsequently underwent cardiac transplantation. Patient #2 had restrictive cardiomyopathy and paroxysmal junctional tachycardia with difficult to manage fluid status. This patient ultimately underwent cardiac transplant. Patient #3 had congenital aortic valve stenosis with concern of left atrial hypertension and ultimately underwent transplantation. Patient #4 had chemotherapy induced dilated cardiomyopathy and underwent Heartmate III LVAD implantation and is currently requiring milrinone for ongoing heart failure management. In all cases the CardioMEMSTM HF was successfully implanted and gave valuable diagnostic information in the management of PAH, fluid management and heart failure. Conclusions: This single center case series describes the early successful use of CardioMEMSTM HF system to aid management of PAH, fluid management and heart failure in a diverse pediatric population.