Early outcomes with a fully retrievable SinoCrown transcatheter heart valve in patients with severe aortic stenosis.

BACKGROUND: This study summarizes and analyzes data from patients suffering from symptomatic aortic stenosis who successfully underwent transcatheter aortic valve implantation (TAVI) using a novel, completely retrievable transcatheter heart valve. METHODS: We included patients who underwent a TAVI procedure with SinoCrown valves at our center between December 2021 and September 2022. We collected 1-year follow-up data on survival, complications, echocardiographic results, New York Heart Association functional class in heart failure, and patient-reported health-related quality of life outcomes. RESULTS: Eight successive patients (73.3 ± 4.3 years) were included in the study, with a median Society of Thoracic Surgery risk score of 4.26%. The procedure had a 100% success rate. Median postoperative discharge time was 7 days, with no 30-day hospital readmissions. Postoperative aortic valve hemodynamics improved, indicated by decreased transvalvular flow velocity compared with preoperative values (1.9 ± 0.2 vs. 4.9 ± 0.2 m/s, p < 0.0001). The median and maximum follow-up times were 8 and 12 months, respectively. During the follow-up period, there were no serious complications such as death, stroke, valve embolization, or high-grade atrioventricular block. CONCLUSIONS: The results from eight initial TAVI cases performed with the SinoCrown valve demonstrated promising safety and efficacy.

Left Ventricular Hypertrophy Regression Following Transcatheter Aortic Replacement: A Comparison of Self-Expanding Versus Balloon-Expandable Prostheses.

There are limited reports on the impact of prosthesis-patient mismatch (PPM) on regression of left ventricular hypertrophy (LVH) following transcatheter aortic valve replacement (TAVR). We compared the relative effects of supra-annular, self-expanding (SE) versus intra-annular, balloon-expandable (BE) prostheses on TAVR LVH regression. Regression of left ventricular mass index (LVMi) was evaluated in 168 consecutive TAVR patients, including 60 treated with SE valves (Evolut series) and 108 treated with BE valves (Sapien 3). All patients had LVH determined at baseline by echocardiography and had repeat LVMi measurements at a mean follow-up time of 707±528 days. SE patients were more likely female (68.3 vs 46.3%, p=0.007), but otherwise the two cohorts did not differ with respect to baseline demographics and STS Risk Score. SE patients had a higher effective orifice area indexed to body surface area (EOAi) following TAVR (0.98±0.29 vs 0.86±0.25 cm²/m², p=0.006), with lower mean aortic valve gradients (9.9±6.5 vs 12.8±5.8 mmHg, p=0.003) and a lower prevalence of moderate/severe PPM (33.3 vs. 49.1%, p=0.049). On follow-up, changes in LVMi were similar between the SE and BE groups, with similar absolute changes in LVMi (19.2±26.8 vs. 21.9±31.7 g/m2, p=0.578) and relative LVMi decrease (14.0±19.5 vs 16.2±24.2%, p=0.547). No difference in LVMi regression was also noted comparing combined SE/BE patients with moderate/severe PPM versus those without PPM. In conclusion, despite differences in EOAi, mean aortic valve gradient, and prosthesis-patient mismatch post TAVR, the degree of LVH regression during intermediate follow-up did not differ between patients receiving supra-annular SE and intra-annular BE prostheses.

Palliative procedures for advanced obstructive colorectal cancer: a systematic review and meta-analysis.

PURPOSE: Advanced obstructive colorectal cancer (AOCC) presents surgical challenges. Consideration must be given to alleviating symptoms and also quality of life and survival time. This study compared prognostic efficacies of palliative self-expanding metal stents (SEMSs) and surgery to provide insights into AOCC treatment. METHODS: PubMed, Web of Science, MEDLINE, and Cochrane Library were searched for studies that met inclusion criteria. Using a meta-analysis approach, postoperative complications, survival rates, and other prognostic indicators were compared between patients treated with SEMSs and those treated surgically. Network meta-analysis was performed to compare prognoses between SEMS, primary tumor resection (PTR), and stoma/bypass (S/B). RESULTS: Twenty-one studies were selected (1754 patients). The odds ratio (OR) of SEMS for clinical success compared with surgery was 0.32 (95% confidence interval [CI] 0.15, 0.65). The ORs for early and late complications were 0.34 (95% CI 0.19, 0.59) and 2.30 (95% CI 1.22, 4.36), respectively. The ORs for 30-day mortality and stoma formation were 0.65 (95% CI 0.42, 1.01) and 0.11 (95% CI 0.05, 0.22), respectively. Standardized mean difference in hospital stay was - 2.08 (95% CI - 3.56, 0.59). The hazard ratio for overall survival was 1.24 (95% CI 1.08, 1.42). Network meta-analysis revealed that SEMS had the lowest incidence of early complications and rate of stoma formation and the shortest hospital stay. PTR ranked first in clinical success rate and had the lowest late-complication rate. The S/B group exhibited the lowest 30-day mortality rate. CONCLUSION: Among palliative treatments for AOCC, SEMSs had lower early complication, stoma formation, and 30-day mortality rates and shorter hospital stays. Surgery had higher clinical success and overall survival rates and lower incidence of late complications. Patient condition/preferences should be considered when selecting AOCC treatment.

When Stents Go Astray, We Find a Way: A Case Report on Retrieving a Migrated Esophageal Stent.

Benign esophageal strictures are characterized by the narrowing of the esophageal passage due to fibrotic changes. These strictures can arise from various causes, including gastroesophageal reflux disease, which leads to peptic strictures; surgical procedures causing esophageal injury, resulting in anastomotic strictures; radiation therapy, ingestion of corrosive substances, or endoscopic resection. Approximately 10% of benign esophageal strictures do not respond to conventional dilation therapy, prompting the consideration of temporary stent insertion as an alternative treatment approach. However, only about one-third of patients with refractory benign esophageal strictures experience sustained relief from dysphagia following self-expanding stent placement. Challenges such as stent migration and hyperplastic tissue response pose limitations to the effectiveness of this intervention. The utilization of self-expanding metal stents (SEMSs) in benign esophageal diseases is not standard practice due to the associated risks of adverse events such as tissue ingrowth at the uncovered portions, migration, and bleeding. One of the major challenges encountered is the growth of hyperplastic tissue around the stent during retrieval and subsequent serial esophageal bougie dilations. Long-term self-bougie dilations, coupled with the patient's gained self-confidence, played a crucial role in the management. While most migrated esophageal metallic stents are typically left in the stomach, in this particular case, the patient's progressive dysphagia necessitated retrieval. This article discusses a 65-year-old female with a benign esophageal stricture treated with a self-expandable metallic stent. Eight months post-insertion by another doctor, she presented to us with worsening dysphagia. Endoscopy revealed a stent migrated into the antrum of the stomach with a proximal esophageal stricture. Endoscopic dilation and stent retrieval were performed, followed by serial esophageal bougie dilations. Subsequently, her dysphagia settled with self-insertion of a 9 mm esophageal dilator.

Challenges associated with low rectal malignant obstruction stenting: a case report.

An ongoing debate exists regarding the feasibility of placing self-expanding metallic stents (SEMS) within 5 cm of the anal verge. Traditionally, SEMS have been considered contraindicated for patients with a malignant rectal obstruction within this region due to potential impact on the anorectal ring or anal canal, which can cause incontinence, proctalgia, and tenesmus. However, in the case of a 63-year-old female who presented with distention, abdominal pain, and diminishing stool output, the rectal exam identified a bulky fixed mass. Imaging studies revealed large bowel obstruction and high-grade stricture, with a minuscule residual lumen. Endoscopy identified a bulky mass obscuring the lumen at 5 cm from the anal verge, and biopsy confirmed adenocarcinoma. Despite the traditionally held contraindication, a 2.5 cm × 9.0 cm colonic stent was successfully deployed, leading to brisk colonic decompression. This allowed the patient to promptly undergo chemoradiotherapy.

Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2.

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3-7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm2/m2 vs. 0.95 cm2/m2 vs. 0.92 cm2/m2, p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization.

Long-Term Preclinical Evaluation of a Permanent Stent Developed for the Human Eustachian Tube.

The Eustachian tube (ET) is a bottleneck when it comes to middle ear (ME) health. If its function is impaired, this can lead to serious consequences for the patient, such as hearing problems or deafness. Therefore, this study investigated a tapered nitinol stent (3-5 mm × 14 mm) for the human ET as a potential new permanent treatment for chronic Eustachian tube dysfunction (ETD) and thus ME ventilation disorders. The self-expanding stent was inserted unilaterally into the ET of 24 sheep with observation periods of 3, 6, and 12 months. Local tissue effects and the safety of the stent insertion were analyzed based on regular endoscopic checks, weekly tympanometry measurements, final imaging, and histological examinations. The animals showed no stent-related health restrictions. However, the individual anatomy and stenting procedure had an influence on the results. The tissue reaction in the endoscopic examinations was mild even though no concomitant antibiotics were administered. After all three monitoring periods, stented ETs had a significantly larger ET lumen than the non-stented contralateral ETs. However, tissue growth was detected in the stent. Overall, the first long-term study on an ET stent showed that the tapered ET stent could be a promising treatment option for ETD.

Outcomes of Transcatheter Aortic Valve Replacement Using Third-Generation Balloon-Expandable Versus Self-Expanding Valves: A Meta-analysis.

Background: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV). Methods: Electronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs). Results: The meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV. Conclusion: In this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV.

Successful Hemostasis Using Fully Covered Self-Expanding Metallic Stent for Spontaneous Hemobilia in a Child With Portal Cavernoma Cholangiopathy.

Portal cavernoma cholangiopathy refers to changes in the intrahepatic and extrahepatic biliary ducts in patients with extrahepatic portal venous obstruction. Spontaneous hemobilia in the setting of portal cavernoma cholangiopathy is extremely rare, and it poses diagnostic as well as therapeutic challenge. Here, we report the case of a 10-year-old girl with extrahepatic portal venous obstruction, who presented with hemobilia. Computed tomography angiography of abdomen and endoscopic ultrasound confirmed the presence of pericholedochal, paracholedochal, and intracholedochal varices. Hemostasis was achieved with the placement of a fully covered self-expanding metallic stent into the common bile duct. Fully covered self-expanding metallic stent is safe and effective for control of bleeding in children presenting with hemobilia.

Does Colorectal Stenting as a Bridge to Surgery for Obstructive Colorectal Cancer Increase Perineural Invasion?

Objectives: To clarify whether self-expandable metallic stent (SEMS) placement for obstructive colorectal cancer (CRC) increases perineural invasion (PNI), thereby worsening the prognosis. Methods: In total, 1022 patients with pathological T3 or T4 colon or rectosigmoid cancer who underwent resection were retrospectively reviewed. The study patients were divided into a no obstruction group (n=693), obstruction without stent group (n=251), and obstruction with stent group (n=78), and factors demonstrating an independent association with PNI, the difference in PNI incidence and severity between groups, and the association between PNI and the duration from SEMS placement to surgery were investigated. Survival analysis was performed for each group. Results: On multivariate analysis, SEMS placement (hazard ratio [HR]: 2.08) was independently associated with PNI whereas SEMS placement was not. PNI occurred in 39%, 45%, and 68% of the no obstruction, obstruction without stent, and obstruction with stent group, respectively. In the obstruction with stent group, the proportion of PNI was not associated with the duration from SEMS placement to surgery. Extramural PNI, an advanced form of PNI, demonstrated no increase with increasing interval. The five-year OS was 86.3%, 76.7%, and 73.1% in no obstruction, obstruction without stent, and obstruction with stent group, respectively. On multivariate analysis, obstruction was an independent risk factor of decreased OS (HR: 1.57) whereas SEMS placement was not. Conclusions: The prognosis was comparable between patients with SEMS placement and those with an obstruction who did not undergo SEMS placement, thus demonstrating that SEMS is a viable, therapeutic option for BTS.

Impact of self-expanding metal stents on long-term survival outcomes as a bridge to surgery in patients with colon cancer obstruction: Current state and future prospects.

Since self-expanding metal stents (SEMS) were first introduced in acute colon cancer obstruction, the increased rate of primary anastomosis and improved quality of life following SEMS placement have been clearly shown. However, it was demonstrated that SEMS are associated with higher recurrence rates. Although several trials have shown that overall and disease-free survival in patients following SEMS placement is similar with patients undergoing emergency surgery, obstruction and a high incidence of recurrence imposed many concerns. The optimal time interval from SEMS to surgery is still a matter of debate. Some studies have recommended a time interval of ~2 weeks between SEMS insertion and elective surgery. A prolonged interval of time from SEMS insertion to elective surgery and the administration of neoadjuvant chemotherapy (NAC) has been proposed. SEMS-NAC might have advantages for improving the surgical and long-term survival outcomes of patients with acute colon cancer obstruction, which is an optional approach in the management of acute colon cancer obstruction.

Shorter interval to surgery after self-expanding metallic stent may result in better oncologic outcomes in colon cancer obstruction.

INTRODUCTION: Colon cancer obstruction is one of the most serious conditions in colorectal surgery. However, the use of self-expanding metallic stent (SEMS) has made it possible to avoid emergency surgery and stoma creation, therefore enabling minimally invasive surgery and one-stage operation. In this study, we aimed to investigate whether there is an optimal interval from SEMS to surgery for the best long-term oncologic outcomes. METHODS: Obstructive colon cancer patients treated with SEMS insertion and received surgery were included in the study. Patient data were retrospectively reviewed in prospectively collected data. Using the ROC curve, the optimal interval to surgery after SEMS insertion was 10 days; the patients were divided into the early surgery group (≤10 days, ES) and the late surgery group (>10 days, LS). Factors contributing to the 5-year disease-free survival (DFS) and overall survival (OS) were analyzed. RESULTS: 83 patients were included in this study. Eight patients (9.6 %) had SEMS insertion failure, with 3 perforations and 5 failed expansions. There were no differences between the ES group and the LS group in terms of pathologic characteristics, incidence of stoma creation, and adjuvant chemotherapy. Twenty-six patients (31.3 %) had recurrences; local (Arnarson et al., 2023) [6], peritoneal seeding (Lee et al., 2013) [8], liver (Ho et al., 2017) [11], lung [7], bone (van Hooft et al., 2020) [2], and abdominal wall metastasis (Chen and Sheen-Chen, 2000) [1]. The 5-year DFS rate was significantly better in the ES group than the LS group (74.3 % vs. 55.01 %; p = 0.0394). The 5-year OS was slightly better in the ES group than the LS group (76.11 % vs. 58.75 %; p = 0.0901). In univariable analysis, the ES group showed a lower risk of recurrence than the LS group (OR: 0.447 [0.204-0.984], p = 0.0455), but this was not reproduced in the multivariable analysis. CONCLUSION: This study has shown that the long-term oncologic outcomes were better in patients who received surgery after SEMS within 10 days. Hence, we propose with caution that elective surgery might be suggested to take place within 10 days from SEMS insertion for better oncologic outcomes.

Impact of Small Aortic Annuli on the Performance of Transcatheter Aortic Valve Replacement Bioprostheses: An Updated Meta-Analysis of Recent Studies.

A metanalysis of available randomized controlled trials and observational studies comparing self-expanding (SE) and balloon-expandable (BE) bioprostheses in patients with small aortic annulus and aortic stenosis for short- and midterm hemodynamic and clinical outcomes was performed. A total of 21 studies with a total 8,647 patients (SE: n = 4,336 patients vs BE: n = 4,311 patients) were included. SE bioprostheses had a lower postoperative mean gradient at 30 days (Mean Difference [MD] -5.16, 95% confidence interval [CI] 4.7 to 5.5, p <0.001) and at 1 year (MD -6.6, 95%CI 6.1 to 7.03, p <0.001), with a larger indexed effective orifice area (0.17, 95% CI 0.13 to 0.22, p <0.001 and 0.17, 95% CI 0.08 to 0.27, p <0.001) at both time intervals. BE bioprostheses had a higher risk of 30-day and 1-year severe prosthesis-patient mismatch (risk ratio [RR] 1.07, 95% CI 1.04 to 1.09, p <0.001; RR 1.07, 95% CI 1.04 to 1.11, p <0.001). The 30-day and 1 year paravalvular leaks (RR 0.99, 95% CI 0.98 to 0.99, p <0.001; RR 0.89, 95% CI 0.82 to 0.95, p <0.001) and permanent pacemaker implantation (RR 0.97, 95% CI 0.94 to 0.99, p 0.01, I2 = 40%,) were lower in the BE group. BE bioprostheses were associated with a lower risk of in-hospital stroke (RR 0.99, 95% CI 0.98 to 1, p = 0.01). In conclusion, in patients with small aortic annulus and aortic stenosis, SE bioprostheses have superior hemodynamic performance but higher rates of paravalvular leak, permanent pacemaker implantation, and in-hospital stroke. BE bioprostheses were associated with a higher risk of severe prosthesis-patient mismatch.

Cardiac output in patients with small annuli undergoing transcatheter aortic valve implantation with self-expanding versus balloon expandable valve (COPS-TAVI).

BACKGROUND: There is limited data on cardiac output in patients with small aortic annuli undergoing trans-catheter aortic valve implantation (TAVI) according to the implanted platform of balloon-expandable (BEV) compared to self-expanding valves (SEV). METHODS: This is a retrospective analysis of consecutive patients with severe aortic stenosis and small annuli who underwent successful TAVI. Cardiac output was measured using echocardiography within 4 weeks following TAVI. Data were recorded and analysed by an experienced operator who was not aware of the type of the implanted valve. RESULTS: 138 patients were included in the analysis, of whom 57 % underwent TAVI with BEV. Clinical and echocardiographic characteristics were comparable between the two platforms, except for more frequent previous cardiac surgery and smaller indexed aortic valve in the BEV group. There was no relationship between computed tomography-derived aortic annulus area and cardiac output post TAVI. When compared to patients who underwent TAVI with BEV, those with SEV had larger cardiac output [mean difference - 0.50 l/min, 95 % CI (-0.99, -0.01)] and cardiac index [mean difference - 0.20 l/min/m2, 95 % CI (-0.47, 0.07)], although the latter did not reach statistical significance. Unlike patients with small body surface area, in those with large body surface area both cardiac output and cardiac index were statistically larger in patients who underwent SEV compared to BEV. CONCLUSION: Cardiac output, as measured by echocardiography, was larger in patients with small annuli who underwent TAVI procedure with SEV compared to BEV. Such difference was more evident in patients with large body surface area.

The use of self-expanding metallic stents in the management of benign colonic obstruction: a systematic review and meta-analysis.

INTRODUCTION: Patients presenting with large bowel obstruction (LBO) frequently undergo emergency surgery that is associated with significant morbidity. In malignant LBO, endoscopic approaches with placement is a self-expanding metal stent (SEMS), have been proposed to prevent emergency surgery and act as a bridge to an elective procedure-with the intention of avoiding a stoma and reducing morbidity. This systematic review aims to assess the quality and outcomes of data available on the use of SEMS in benign causes of colonic obstruction. METHODS: This systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the protocol was registered on Prospero (ID: CRD42021239363). PUBMED, MEDLINE, HMIC, CINAHL, AMED, EMBASE, APA and Cochrane databases were searched. Studies were assessed for quality utilising the MINORS criteria. Pooled odds ratios with 95% confidence intervals (95% CI) were calculated using random effects models. RESULTS: Sixteen studies were included for analysis. 300 patients were included with an average age of 68, and a male predominance of 57%. The quality of the papers included were at risk of bias. The pooled rate of technical success of procedure was 94.4% (95% CI 90.5-96.8%) The pooled rate of clinical success was 77.6% (95% CI: 66.6-85.7%). Adverse effects were low, with perforation 8.8% (4.5-16.6%), recurrence 26.5% (17.2-38.5%) and stent migration 22.5% (14.1-33.8%). DISCUSSION: This systematic review demonstrated that SEMS for benign colonic obstruction can be a safe and successful procedure. The utilisation of SEMS in malignant disease as a bridge to surgery has been well documented. Whilst the limitations of the data interpreted are appreciated, we postulate that SEMS could be utilised to decompress patients acutely and allow pre-operative optimisation, leading to a more elective surgery with less subsequent morbidity.

Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve.

Repositionable self-expanding valves allow for repositioning during deployment to achieve optimal valve placement. However, the risk of brain injury associated with repositioning, as detected by diffusion-weighted magnetic resonance imaging (DW-MRI), is unknown. Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with repositionable self-expanding valves and receiving DW-MRI before and within 7 days post-TAVR procedure were included. The primary outcomes were incidence, number, total volume, and volume per lesion of the cerebral ischemic lesion in DW-MRI after TAVR. Univariate and multivariate logistic regression assessed the association between repositioning and bigger total lesion volume (> 1 cm3 or > 0.5 cm3). Negative binomial regressions were performed to explore the association between repositioning and number of lesions. A propensity score matching was performed to adjust the potential confounders. Moreover, inverse probability of treatment weighted regression model with nonstabilized weights was used as sensitivity analysis. Among 243 included patients, repositioning was performed in 116 (47.7%) patients. The incidence of overt stroke (1.7% vs. 1.6%, p = 0.927) and silent stroke (86.2% vs. 85.8%, p = 0.932) were comparable between two groups. However, the number of new lesions (5.0 [2.0-9.0] vs. 3.0 [2.0-6.0], p = 0.048), and total lesion volume (275.0 [90.0-947.5] mm3 vs. 180.0 [50.0-440.0] mm3, p = 0.022) were significantly higher in the repositioned group. Moreover, the proportion of patients with lesion size greater than 0.5 cm3 was higher in the repositioned group (37.9% vs. 22.0%, p = 0.007). The similar results were observed after propensity score matching. In both multivariate regression model and sensitivity analysis, the repositioning was the independent predictor of number of lesions and bigger total lesion volume after TAVR. The utilization of the repositioning feature may increase the number and volume of silent brain infarcts in DW-MRI in patients who underwent TAVR. (Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population [TORCH]; NCT02803294).

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis.

Background: Aortic stenosis (AS) is a common heart condition categorized into congenital and acquired forms. Transcatheter aortic valve replacement (TAVR) is an innovative method for AS management, and two valve types, self-expanding valves (SEV) and balloon-expandable valves (BEV), are used in TAVR. The objective of this study is to compare the clinical outcomes associated with balloon-expandable and self-expandable valves in transcatheter aortic valve replacement. Methods: The researchers conducted a comprehensive meta-analysis following PRISMA guidelines and AMSTAR-2 tool. The methodology involved a systematic literature search, strict eligibility criteria, unbiased study selection, meticulous data extraction, quality assessment, and rigorous statistical analysis. Results: Our analysis included twenty-six papers and 26 553 patients. BEV exhibited significant advantages over SEV in overall mortality across 21 studies, particularly in perioperative and 30-day assessments. However, no substantial disparities emerged between the two valve types in stroke incidence. BEV demonstrated notable benefits in reducing hospitalization rates across 6 studies and significantly fewer instances of permanent pacemaker implantations across 19 studies, particularly evident in the perioperative setting. Other secondary outcomes like bleeding, acute kidney injury, and myocardial infarction showcased non-significant differences between BEV and SEV. Conclusion: The analysis indicates that BEV may offer benefits in specific aspects of TAVR outcomes, but further research is needed to fully understand the factors influencing patient outcomes and mortality in TAVR procedures.

German Experience with a Novel Balloon-Expandable Heart Valve Prosthesis for Transcatheter Aortic Valve Implantation-Outcomes of the MYLAND (MYvaL germAN stuDy) Study.

Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.

Balloon-Expandable Valve for the Treatment of Self-Expanding Valve Failure: The Need for a Tailored Approach.

An 82-year-old patient experienced symptomatic intra-prosthetic aortic regurgitation 5 years after self-expandable transcatheter heart valve (THV) implantation. Redo-transcatheter aortic valve replacement was initially considered at high risk of coronary obstruction. Using a systematic computed tomography-based approach planning a low implantation with a SAPIEN 3 Ultra THV, we effectively mitigated risks.

Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry.

BACKGROUND: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry. METHODS: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure. RESULTS: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus. CONCLUSION: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.