Device Success Research Articles

Abstract 4116639: Efficacy of Transcatheter Aortic Valve Replacement for Severe Pure Native Aortic Valve Regurgitation: A Meta-Analysis

Background: Surgical aortic valve replacement (SAVR) is the preferred treatment option for patients with severe aortic regurgitation (AR). Recently, several patients with mixed aortic valve disease, comprising severe aortic stenosis (AS) and at least moderate AR, have been successfully treated with TAVR. However, the treatment of severe native aortic valve regurgitation (NAVR) without AS remains a matter of contention, and the efficacy of TAVR remains uncertain. Aims: The primary outcomes were 30-day mortality and the incidence of device success. The secondary outcomes included incidence of myocardial infarction (MI), stroke, major bleeding, acute kidney injury (AKI) ≥ stage 2, moderate-to-severe paravalvular leak (PVL), permanent pacemaker implantation (PPM), and post-procedural moderate-to-severe AR. Methods: We systematically searched PubMed, Cochrane Library, Scopus and ClinicalTrials.gov for published articles from inception until 2nd April 2024 to evaluate clinical outcomes of TAVR in patients with NAVR. The statistical analysis was conducted using R-Studio 5.3.3. The rates of events with 95% confidence intervals (CI) and the heterogeneity was assessed using p-value and I 2 statistics. Results: A total of 23 published articles with 4,397 patients were included. All-cause mortality at 30 days was 12% (95% CI: 6% to 23%), while device success was 86% (95% CI: 81% to 92%). The incidence of complications such as MI (3%, 95% CI: 2% to 4%), stroke (3%, 95% CI: 2% to 3%), major bleeding (8%, 95% CI: 5% to 11%), AKI ≥ stage 2 (8%, 95% CI: 5% to 12%), and major vascular complications were relatively low (6%, 95% CI: 4% to 7%). PPM was required for 15% of patients (95% CI: 11% to 18%). PVL was observed in 10% of patients (95% CI: 2% to 41%) and post-procedural moderate-to-severe AR occurred in 9% of patients (95% CI: 4% to 20%). Conclusion: TAVR is a viable and reasonable option for a specific population with NAVR. Nevertheless, it is imperative to conduct larger studies with a longer duration of follow-up to obtain more robust evidence of the feasibility of TAVR in patients with NAVR. </div>

Successful Transcatheter Closure of an Iatrogenic Axillary Arteriovenous Fistula in a Young Girl: A Delayed Complication of Intervention in a Resource-limited Setup

Abstract Arteriovenous fistula (AVF) is a well-known complication in the adult population following cardiac interventions. Data on the pediatric age group are lacking. Furthermore, there are no guidelines for the management of the pediatric population. We present a case of successful endovascular device closure of iatrogenic axillary AVF in a limited resource setup. A 9-year-old girl had palliative ductal stenting through the left axillary artery for complex congenital cyanotic heart disease 6 months back. She presented with an iatrogenic axillary AVF. We planned to close the defect in catheterization laboratory. After successful device deployment, there was a complete occlusion of the arterial system. To maintain arterial patency stenting was performed subsequently. Successful device closure of complicated axillary AVF in the pediatric population can be achieved even in a recourse-limited setup.

Utilization of Alloplastic Prostheses in the Extended Reconstruction of the Temporomandibular Joint: A Review of the Literature

Extended temporomandibular joint reconstruction (eTMJR) can be described as a refined approach to conventional temporomandibular joint reconstruction (TMJR) designed to address both the articulating components of the TMJ and associated mandibular segmental defects or defects in the skull base. Extended temporomandibular joint reconstruction (eTMJR) combined with the advancement in VSP not only offers improved functional and esthetic outcomes but also signifies a significant leap forward in the realm of TMJR interventions. In comparison to autogenous grafts, alloplastic pro$stheses exhibit superior outcomes concerning MIO, pain management, and dietary functionality, underscoring their potential as the preferred treatment modality. This review article showcases an in-depth exploration of eTMJR, covering its classifications, indications, contraindications, advantages, disadvantages, complications, virtual surgical planning (VSP), criteria for successful alloplastic devices, and the surgical approach.

Sex Differences in a Real-World Registry Examining Coronary Lithotripsy for Calcified Lesions

Intravascular lithotripsy (IVL) has established as a safe and effective treatment for coronary artery calcification (CAC). This study aimed to evaluate sex-related differences in the treatment with IVL in a real-world, all-comers international registry. Patients undergoing IVL between May 2019 and February 2024 were enrolled from the BENELUX-IVL registry. Patients were divided into men and women groups. Efficacy endpoints included device success (delivery of the IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis and/or fluoroscopically) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints were IVL-related complications and MACE at one-year follow-up. 454 patients (73±9.0 years) were treated with IVL, comprising 342 (75%) men and 112 (25%) women. More women presented with acute coronary syndrome (41% in men vs 54% in women; p=0.014) and aorto-ostial lesions (17% in men vs. 29% in women; p=0.009), while the Syntax score (23.5±14.2 in men vs. 17.1±1.0 in women; p<0.001) was higher in men. Rates of device success (97% vs. 98%; p=1.000), technical success (90% vs. 91%; p=0.821) procedural success (90% vs. 88%; p=0.749), IVL-related complications (1% vs 2%; p=0.362) and one-year MACE rates (12% vs 17%; p=0.456) were comparable. In conclusion, despite differences in clinical presentation and lesion types, IVL seems to be safe and effective for both sexes across various clinical and anatomical scenarios.

Transcatheter Repair of Tricuspid Valve Regurgitation: A Systematic Review.

Introduction: Clinically significant severe tricuspid regurgitation (TR) is a common untreated pathology associated with increased mortality. Even though surgical valve replacement has been the mainstay option, transcatheter intervention is a novel and potentially effective tool. To the best of our knowledge, this is the first systematic review that assessed and compared clinical and echocardiographic outcomes of coaptation and annuloplasty devices in patients with clinically significant TR. Methods: PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until February 2023. Primary endpoints were technical and procedural successes. Secondary endpoints were TR grade, NYHA, change in 6 min walk distance (6MWD), and echocardiographic parameters at 30-day follow-up. Results: We included thirty-eight studies consisting of 2273 patients with severe symptomatic TR (NYHA III-IV 77% and severe/massive/torrential TR 83.3%) and high surgical risk (mean EUROSCORE of 7.54). The technical success for the annuloplasty devices was 96.7% and for the coaptation device was 94.8%. The procedural success for the annuloplasty devices was 64.6% and for the coaptation device was 81.4%. The 6MWD increased by 17 m for the coaptation devices and increased by 44 m after 30 days for the annuloplasty devices. A reduction in TR grade to <2 was seen in 70% of patients with coaptation and 59% of patients with annuloplasty devices. Conclusions: Transcatheter tricuspid valve intervention appears to be feasible and is associated with favorable outcomes.

Evolving use and clinical outcomes of coronary intravascular lithotripsy: insights from an international, multicentre registry

BackgroundIntravascular lithotripsy (IVL) is increasingly used for treatment of coronary artery calcification. This study aimed to evaluate contemporary utilisation patterns, safety and efficacy of IVL in an unselected real-world patient cohort.MethodsWe included 454 patients undergoing IVL from May 2019 to February 2024 across seven centres in two European countries. Key endpoints included device success, technical success, procedural success, IVL-related complications and major adverse cardiovascular events (MACE) at 1-year follow-up.ResultsThe cohort (mean age 73±9 years, 75% male) had a mean SYNTAX Score of 22.0±13.6. Device, technical and procedural success were achieved in 98%, 91% and 89% of patients, respectively. IVL-related complications occurred in six patients (1%). At 1-year follow-up, MACE was observed in 37 patients (13%). Over time, IVL use increased in patients with acute coronary syndrome (p=0.004) and in combination with intracoronary imaging (p=0.002), while use of other calcium modification devices decreased (p=0.034).ConclusionIn this real-world registry, IVL demonstrated efficacy across diverse clinical and anatomical settings. High success rates, low complication rates and MACE rates were observed acutely and at 1-year follow-up. Utilisation patterns evolved over time, with increased adoption in acute scenarios and alongside intracoronary imaging.

A sex-specific comparison of valve-in-valve transcatheter aortic valve implantation

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Since patients receiving initially a new bioprosthetic aortic valve are predominantly male, data on a sex-specific comparison of ViV-TAVI is scarce. Thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of female (F) versus male (M) patients with failing bioprosthetic aortic valves undergoing ViV-TAVI. Methods A total of 375 Patients at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 160 (42.6 %) women and 215 (57.4 %) men were included. Women were older (F 81 (77; 84), p &amp;lt; 0.001), had a greater surgical risk (STS PROM F: 9.1 (6.1; 13,9) %, p &amp;lt; 0.001) and a higher rate of previous coronary bypass surgery (F: 25.6 % vs M: 40 %, p = 0.004), while presenting mostly failed valve sizes &amp;lt; 20 mm (F: 59.4 % vs M: 33.4 %, p &amp;lt; 0.001) and therefore higher gradients (F: 40 (31; 50) mmHg vs M: 32 (25; 42) mmHg, p &amp;lt; 0.001). Aortic regurgitation was the mode of failure in 7.5 % of F vs. 14.4 % of M. The number of stentless valves was higher in men (F: 8,1 % vs M: 14 %, p = 0.08). Patients received a self-expanding TAVI prostheses in 79.4 % and 75.8 % respectively in F and M patients. The rates of technical success (F: 75.6 % vs M: 83.3 %, p =0.06), device success (F: 52.5 % vs M: 58.2 %, p = 0.27) and early safety (F: 67.5 % vs M: 67 %, p = 0.91) were comparable between genders. Residual mean gradients were higher in F (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.03), while the rates of residual regurgitations were greater in M patients (F: 1 (0.6 %) vs M: 11 (5.1 %), p = 0.04). The Kaplan-Meier estimated 30-day mortality rate (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality rates (F: 10 % vs M: 92.6 %, p = 0.37) were comparable between genders. Conclusion: F and M patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar mortality rates after 30 days and 1 year. The residual gradients in F and residual regurgitations in M could be explained by structural features of their failed valves. Further large scale studies are needed to determine, if such procedural outcomes are truly sex-specific.

Comparison of ridaforolimus-eluting and zotarolimus-eluting coronary stents: 5-Year outcomes from the BIONICS and NIREUS trials

Abstract Introduction Despite similarities between different modern drug eluting stents (DES), their comparative short and long-term safety and efficacy has generated much interest and yielded conflicting results. The BIONICS and the NIREUS randomized clinical trials showed non-inferiority of the Ridaforolimus eluting stent (RES) compared to the Zotarolimus-eluting stent (ZES) with respect to 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss. Aim To evaluate clinical outcomes between treatment groups over 5 years follow-up Methods BIONICS and NIREUS were prospective, randomized, single-blind multicenter trials comparing RES and ZES in patients undergoing PCI. Patients were blinded to treatment assignment and randomized to RES or ZES in a 1:1 fashion in BIONICS, and in 2:1 fashion in NIREUS. Clinical events were assessed during hospital stay, at 30 days, 1 year, and yearly thereafter, up to 5 years. The The primary endpoint in the current study was the 5-year rate of target lesion failure (TLF). Results The study population included 2221 patients enrolled in the BIONICS (n=1919) and NIREUS (n=302) studies. Median follow-up was 1822 days (interquartile range 1783 to 1847 days). Mean age was 63.2±10.3 years, and most patients were men (79.7%). Clinical presentation with ACS was similar between groups (38.9% versus 37.9%, RES versus ZES, respectively, p=0.38). Procedural characteristics were similar for patients treated with RES and ZES. A mean of 1.6±0.9 and 1.5±0.8 stents were implanted in RES and ZES patients, respectively, p=0.08. Post dilatation was performed more frequently in the RES group (63.3% versus 60.1%, p=0.02) and procedure duration was longer in RES versus ZES patients (47.0±31.8 minutes versus 44.6±29.2 minutes, p=0.01). Device success was high in both groups but slightly higher in the ZES group (98.2% versus 99.5% for RES and ZES, respectively, p=0.002) yet with similar procedural success (97.9% versus 97.3%, p=0.49). At 5 years, the primary endpoint of TLF was similar between treatment groups (12.2% RES versus 11.3% ZES, p=0.52). Rates of TLR (7.6% RES versus 6.8% ZES, p=0.42), target vessel-related MI (4.8% RES versus 4.9% ZES, p=0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, p=0.87), also did not differ between groups. Target vessel revascularization (TVR) and cardiac death were higher among the RES group (12.3% versus 9.5% p=0.037, and 3.6% versus 2.2 % p=0.042, respectively). However, after correction for baseline characteristics there was no significant difference in cardiac death between groups. Conclusions In a pooled analysis of two randomized trials, 5-year clinical outcomes were similar between patients undergoing PCI with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of patients with coronary artery disease.Central illustrationZES vs. RES

Current application and results of the combined use of intravascular lithotripsy and rotational atherectomy for the treatment of calcified coronary lesions

Abstract Background Intravascular lithotripsy (IVL) and rotational atherectomy (RA) might be used simultaneously (Rotatripsy) to treat calcified lesions during percutaneous coronary intervention (PCI), though data on the effectiveness and sequence of their use is limited. Purpose To identify indicators for the use of Rotatripsy and to assess its safety and success rates, both acutely as at one-year follow-up. Methods Patients undergoing PCI with IVL and RA across six centers in two European countries from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Angiographic and intracoronary imaging (ICI) data were analyzed centrally. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis &amp;lt;30% by quantitative coronary analysis) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised rotatripsy-related complications and MACE at one-year follow-up. Results A total of 114 patients (75±9 years, 78% male) underwent rotatripsy for 120 lesions. Patients presented with an ACS in 58(51%) cases and chronic coronary syndrome in 56(49%). The left anterior descending artery(n=66, 55%) was the most frequently treated target vessel, with diverse lesions being addressed, including bifurcations(30%), ostial(18%), CTO(7%) and in-stent(12%) lesions. The mean burr size was 1.5±0.2mm with a maximum rotational speed of 171±15k rpm and burr/vessel ratio of 0.46±0.2. IVL involved an average of 68±25 pulses and a balloon size of 3.5±0.5mm. The predominant used sequence of rotatripsy was RA followed by IVL(n=106, 88%). Among these cases, IVL was electively combined with RA in 68(57%) lesions, and used for balloon underexpansion(n=37, 31%) and stent crossing failure after RA(n=1, 1%). Additionally, IVL served as bail-out strategy after RA and stenting in 10(8%) and preceded RA in 4(3%) lesions, particularly when balloon/stent delivery failed after IVL. After rotatripsy, stents were implanted in 116(97%) lesions and drug-eluting balloon used in 3(3%). ICI was utilized in 69(58%) target lesions. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications occurred in 4 patients(4%), and included two(2%) coronary perforations, one(1%) dissection and one(1%) burr entrapment. At one-year follow-up (present in 77(67%)), MACE was observed in 7(6%). Conclusions Rotatripsy demonstrated efficacy across diverse clinical and anatomical settings, with the majority of procedures electively employing RA before IVL. High success rates and low complication rates were observed, with few patients experiencing MACE at one-year follow-up.

Mortality rates in patients undergoing urgent versus elective transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Background Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, leading frequently to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR to elective procedures. Methods We systematically screened three databases searching for studies comparing urgent versus elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-day stroke, 30-day acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage and 30-day bleedings. Results Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality (RR: 2.53, 95% CI: 1.81 – 3.54), in-hospital mortality (RR: 2.67, 95% CI: 1.94 – 3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28 – 2.85) and AKI (RR: 2.83, 95% CI: 1.93 – 4.14), compared to elective procedure. No differences were observed in the rest secondary endpoints. Conclusions Urgent TAVR was associated with higher in-hospital and 30-day mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

HFpEF is associated with a higher risk of hospitalization or death in men undergoing transcatheter edge-to-edge tricuspid valve repair

Abstract Aims There are fundamental differences between women and men regarding the pathophysiology and etiology of tricuspid regurgitation (TR) as well as underlying comorbidities. The aim of this study was to analyze differences between female and male patients undergoing transcatheter edge-to-edge tricuspid valve repair for TR (T-TEER) and to identify gender-specific predictors of adverse outcome. Methods and Results In this monocentric study 197 consecutive patients (96 women and 101 men) undergoing T-TEER at our university heart center were included. Prevalence of heart failure with preserved ejection (HFpEF) was higher in women than in men (63% vs. 37.3%; p=0.001) whereas men more often had heart failure with reduced ejection fraction (HFrEF; 62.7% vs. 37%; p=0.001). Women had more severe symptoms (86.2% in New York Heart Association (NYHA) class III-IV vs. 72.3% in men; p=0.022). Device success rates (p=0.64), procedural characteristics (e.g. number of clips, p=0.17) and postprocedural results (TR grade post clip, p=0.1) were comparable. One-year mortality did not differ between genders (5.9% in women, 8.6% in men; p=0.53). Likewise, no significant difference could be found with regard to heart failure hospitalizations within one year after T-TEER (20.3% in women, 18.8% in men, p=0.82). Strikingly, prevalence of HFpEF was substantially higher than of HFrEF in men that reached the combined endpoint of one-year mortality or rehospitalization for heart failure (61.5% vs. 38.5%; p = 0.08). In women, no relevant difference could be found (27.0% vs. 32.4%; p=0,623). To identify gender-specific predictors of the combined endpoint, a cox regression analysis was performed. In men, HFpEF emerged as an independent predictor (HR 2.703; 95% CI 1.069 – 6.837; p = 0.036). In women, NYHA functional class proved to be an independent risk factor (Hazard Ratio (HR) 3.362; 95% confidence interval (CI) 1.085 – 10.415; p=0.036) for the combined endpoint whereas HFpEF was not associated with adverse outcome (HR 0.865, 95% CI 0.259 – 2.885, p=0.81). Conclusions Women undergoing T-TEER were more symptomatic and had higher prevalence of HFpEF compared to men. Nevertheless, HFpEF emerged as an independent predictor of the combined endpoint of one-year mortality or rehospitalization for heart failure only in men. NYHA functional class independently predicted adverse outcome in women.

4-year follow-up results of percutaneous closure of atrial septal defect with the total biodegradable poly-L-lactic acid device: date from a prospective, single-center trial

Abstract Background The poly-L-lactic acid (PLLA) device is a novel, total biodegradable occluder dedicated to percutaneous closure of atrial septal defect (ASD) .Closure of ASD with the PLLA device has proven to be relatively safe and effective in our preclinical and first-in-human studies. Objective The aim of the study was to evaluate long-term safety and efficacy of the PLLA device in percutaneous closure of ASD in a large cohort of patients. Methods A prospective study enrolling patients who had a clinically significant ASD was conducted in our institution from May 2018 to August 2019. Percutaneous ASD closure was undertaken with the PLLA device. Evaluations were scheduled pre-hospital discharge and again at 1, 3, 6, 12, 24, 36 and 48 months post implantation. Primary endpoints were a composite of clinical success, including closure success and no major complications at the 48-month follow-up evaluation. Results A total of 52 patients (35 children, 55.8% females, median age 7.55 years, median weight 28.75Kg) underwent an attempt at percutaneous ASD closure with PLLA device. Successful device implantation was achieved in 50 (96.1%) of 52 patients with delivery attempts. All the 50 patients (100%) completed 4-year follow-up visit. Closure success at 4-year follow-up were 84% (42/50), with 8 patient (16%) reported to have clinically significant leaks, including 2 large residual leaks, 5 moderate residual leaks, and 1 small residual leak. 10 complications occurred, with 1 event of cardiac arrhythmia during procedure, and 9 follow-up events, consisting in cardiac arrhythmias (n=6), moderate or large mitral regurgitation (n=2), and headache (n=1). Conclusion Percutaneous ASD closure with PLLA device in human seems to be safe. However, increased occurrence of residual leaks overtime indicated that long-term efficacy of PLLA device in human was sub-optimal.TTE follow-up of a case with PLLA device

Impact of left atrial appendage occlusion in atrial flow evaluated through 4D flow cardiac magnetic resonance

Abstract Introduction Device-related thrombus (DRT) and peri-device leak constitute significant complications following left atrial appendage occlusion (LAAO), primarily due to its association with strokes and thromboembolic events. Patient-specific fluid simulations have been employed to explore this hypothesis(1). However, these simulations require detailed anatomical and physiological data, rely on certain assumptions when defining boundary conditions, and involve long computational times. Recently, there has been growing interest in the use of 4D flow cardiac magnetic resonance (CMR) imaging for various cardiovascular diseases, owing to its capability to reproduce blood flow. While its role in the LAAO scenario has been evaluated in silico(2), there are no reported cases of its application in patients undergoing LAAO. Purpose Our objective was to evaluate the impact of LAAO in atrial flow through 4D flow CMR. Methods Five patients undergone LAAO were included in the pilot study. A pre- and 90-days post-procedure 4D flow CMR scans were performed. One of the patients was excluded due to suboptimal image quality. To assess the impact of LAAO on atrial flow dynamics, three parameters were evaluated: a) mean velocity, b) stasis velocity ratio, and c) endothelial cell activation potential (ECAP) index — all associated with an elevated risk of thrombus formation(3,4). Results Baseline and procedural characteristics, along with imaging results, are presented in Table 1. Preprocedural 4D flow CMR for all patients revealed low velocities (Figure 1A) and a high ECAP index (Figure 2A) in the left atrial appendage, indicating flow stasis and an elevated risk of thrombus formation. Successful device implantation was performed in all cases, and no periprocedural complications were detected. Postprocedural 4D flow CMR was feasible in all cases, and no artifacts were detected despite the presence of the LAAO device. An objective increase in velocities and a decrease in the ECAP index were observed in all cases following LAAO. No DRT or ischemic events were reported during follow-up. Conclusions Our preliminary study demonstrates that 4D flow CMR provides valuable information on left atrial flow dynamics following the LAAO procedure. Further studies are warranted to evaluate this promising technique.Table 1.Patient characteristicsFigure 1 and 2.Representative example

Imaging characteristics and clinical outcomes of hemodialysis vs. non-hemodialysis patients undergoing transcatheter aortic valve replacement: a Japanese single-center experience.

In 2021, Japan approved transcatheter aortic valve replacement (TAVR) for end-stage renal disease patients on hemodialysis (ESRD-HD). Yet, clinical/anatomical differences and outcomes between patients with and without ESRD-HD remain underexplored. This single-center study enrolled consecutive patients who underwent TAVR with the SAPIEN 3 between 2021 and 2023. Baseline characteristics and outcomes up to 1year were compared. Inverse probability treatment weighting (IPTW) approach and Cox regression were used. Among 287 eligible patients, 59 had ESRD-HD. Patients with ESRD-HD were predominantly male (59.2% vs. 40.7%; p = 0.01), younger (78.0 [73.5-83.5] vs. 84.0 [79.8-88.0]; < 0.001), with lower body mass index (21.4 [19.6-23.3] vs. 22.9 [20.3-25.3]; p = 0.02], higher surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality ≧8%: 28 [47.5%] vs. 34 [14.9%]; p < 0.001), and more peripheral artery disease (25.4% vs. 4.8%; p < 0.001). Patients with ESRD-HD had a significantly higher prevalence of severely calcified femoral arteries (12.5% vs. 2.6%; p < 0.001). However, there were no differences in the computed-tomographic (CT) anatomical characteristics of the aortic valve complex (AVC), including the aortic valve calcium score (1995 [1372-3374] vs. 2195 [1380-3172]; p = 0.65) or the presence of moderate or severe left ventricular outflow tract calcification (4.3% vs. 5.2%; p > 0.99). Major vascular complications were rare, and technical (98.3% vs. 98.7%; p > 0.99) and device success (75.9% vs. 82.4%; p = 0.26) rates were high in both. At 1year, there were no significant differences in a composite endpoint of death, stroke, major bleeding, or myocardial infarction (32.4% vs. 33.2%; HR 1.12; 95% CI 0.45-2.80; p = 0.81), nor its components after baseline adjustment.

Factors associated with failure of intraosseous access in prehospital trauma treatment by military medical personnel

IntroductionIntraosseous devices have become an alternative to peripheral intravenous (PIV) access. Despite the established success of intraosseous devices in laboratory and simulator studies, there is a lack of data regarding...

Vía transapical para reemplazo percutáneo de válvula mitral por valvulopatía: una experiencia ibérica

Introduction and objectives: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure.Methods: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year.Results: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively.Conclusions: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry

ObjectiveWe evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary...

TCT-246 Device Success Algorithm of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Prospectively Applied to the All-Comer PIONEER IV Trial

TCT-246 Device Success Algorithm of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Prospectively Applied to the All-Comer PIONEER IV Trial

TCT-240 The Device Success Algorithm of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Prospectively Applied to Three-Vessel Coronary Artery Disease Patients Undergoing State-of-the-Art Percutaneous Coronary Intervention in the International Multivessel TALENT Randomized Trial

TCT-240 The Device Success Algorithm of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Prospectively Applied to Three-Vessel Coronary Artery Disease Patients Undergoing State-of-the-Art Percutaneous Coronary Intervention in the International Multivessel TALENT Randomized Trial

Evaluation of the Implementation of a Novel Fluid Resuscitation Device in the Prehospital Care of Sepsis Patients: Application of the Implementation Outcomes Framework

Objectives Early identification and fluid resuscitation are recognized performance measures within sepsis care. Despite fluid resuscitation, fluid goals are often not achieved in the prehospital environment. Furthermore, description of implementation process and evaluation of implementation success are historically underreported in prehospital research. The objective of this study was to contextualize and evaluate the system-wide implementation of a novel fluid resuscitation device, the LifeFlow PLUS®, in the treatment of prehospital sepsis patients. Methods A single urban emergency medical services (EMS) system internally decided to adopt a novel fluid resuscitation device. This EMS system added the device to the clinical care guidelines of suspected sepsis patients. Prior to and during implementation of the new guidelines, several strategies were undertaken to promote consistent, appropriate system-wide use of the device. A mixed methods study design was deployed. Surveys of EMS clinicians and leaders assessed perceptions of the device and sepsis education prior to field implementation of the device. Clinician and leader semi-structured interviews assessed implementation experience and device adoption. Document analysis evaluated deployment of implementation strategies. Data were triangulated to contextualize implementation and evaluate success. Results Clinician (88%) and leader (91%) confidence in appropriate clinician device use and device superiority for sepsis care (73 and 100%, respectively) were high. Clinicians (58%) were less likely to view the device as easy to implement compared to leaders (73%). Three themes were developed from semi-structured interviews, including “exposure” to the device, “reinforcing factors” to prompt device use, and “clinician buy-in.” Twenty unique implementation strategies (e.g., dynamic trainings, mandating change) were used to promote successful system-wide device adoption. Conclusions The overall implementation success of this novel fluid resuscitation device was moderate. Barriers to adoption included complexity of clinical decision-making and ease of device use. Facilitators to adoption included the use of multiple modes of education, clinical reminders, presenting evidence of device benefit, and prehospital culture. Prior to future prehospital implementation programs, EMS systems should focus on identifying and addressing key barriers and facilitators to improve adoption.