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Transcatheter heart valve embolization is a serious and rare complication of transcatheter aortic valve replacement. Having a strategy for promptly managing transcatheter heart valve embolization is crucial to avoid emergency conversion from transcatheter aortic valve replacement to open-heart surgery. Many cases of transcatheter heart valve embolization occurring with balloon-expandable prostheses such as the SAPIEN 3 (Edwards LifeSciences Corporation) valve and self-expandable prostheses such as the ACURATE neo (Boston Scientific Corporation) valve have been reported in the literature. Here, for the first time (to the authors' knowledge), the case of a Myval (Meril Life Sciences Pvt Ltd) transcatheter heart valve embolization during transcatheter aortic valve replacement, which was treated percutaneously with favorable outcomes, is reported., (© 2024 The Authors. Published by The Texas Heart Institute®.)

Background: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients., Aims: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness., Methods: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations., Results: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year., Conclusion: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL., (© 2024 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: The aim of this study was to describe the procedural and early outcomes of patients with mechanical mitral valve prosthesis (MVP) undergoing transcatheter aortic valve replacement (TAVR) with a novel self-expandable retrievable device., Background: TAVR in patients with prior MVP may have an increased risk of complications related to device positioning and interference between both prosthetic valves., Methods: An observational study was conducted, including eight patients with severe symptomatic aortic stenosis and prior mechanical MVP who underwent TAVR with the novel device Allegra TM (Biosensors). No transesophageal monitoring was used., Results: The mean age of the study population was 75 years. The mean distance between MVP and aortic annulus was 3.8 mm. Procedural success was achieved in all patients with no major intraprocedural, in-hospital, or follow-up complications., Conclusions: TAVR with Allegra TAVI system in patients with prior MVP offers good procedural and clinical outcomes., (© 2022 Wiley Periodicals LLC.)

Introduction and Objectives: Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios., Methods: All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area., Results: In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events., Conclusions: A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality., (Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device., Background: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients., Methods: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1)., Results: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke., Conclusions: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve., (© 2021 Wiley Periodicals LLC.)

Introduction and Objectives: To investigate the incidence and clinical relevance of the presence of mobile echogenic images (MEI) during transesophageal echocardiography (TEE) for monitoring of transcatheter aortic valve implantation (TAVI)., Methods: Consecutive patients referred to our center for transfemoral or transapical TAVI were included. The procedure was monitored by three-dimensional (3D) TEE and images were analyzed by two independent experts. In-hospital follow-up was carried out and correlated with imaging findings., Results: A total of 104 patients were included. MEI were visualized in 11 patients during the procedure (11%) and in over 50% of cases were identified as thrombi, however no differences in periprocedural stroke were found in follow-up., Conclusions: Visualization of MEI during 3D TEE monitoring of TAVI is relatively common (11%) and in over 50% of cases they are identified as thrombi. The clinical implications of this finding are uncertain, as despite their frequency, the incidence of clinical stroke in this patient population was no higher. 3D TEE is a useful tool for diagnosis of MEI and can alert the operator to their presence., (Copyright © 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.)

Introduction and Objectives: Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable. Two of the main areas of uncertainty in this field are valve durability and long-term survival., Methods: This prospective single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012. Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years. Valve Academic Research Consortium-2 definitions were used., Results: Seventy-nine patients were included, with an immediate success rate of 94.9%. The median survival was 47.6 months (95% confidence intervals, 37.4-57.9 months), ie, 4 years. One quarter of deaths occurred in the first month, and most were of cardiovascular cause. After the first month, most deaths were due to noncardiovascular causes. The mean values of valve gradients did not increase during follow-up. The cumulative rate of prosthetic valve dysfunction was 15.3%, with no cases of repeat valve replacement., Conclusions: Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure. There was a 15.3% prosthetic valve dysfunction rate in cumulative follow-up, with no cases of repeat valve replacement., (Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system., Objective: To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors., Methods: We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients., Results: A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013)., Conclusion: The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

Objective: To analyze long-term survival and predictors of mortality in patients evaluated for transcatheter aortic valve implantation (TAVI) depending on the decision taken by the heart team., Methods: All patients with severe aortic stenosis and high surgical risk evaluated for TAVI between June 2008 and June 2012 were included. Patients were grouped according to the therapeutic strategy decided by the heart team. Mean follow-up was 16.6 months (maximum 55.3)., Results: A total of 149 patients were evaluated: 79 were accepted for TAVI, 12 had no current indication for valve replacement and were deferred, 13 were redirected to conventional surgery and 45 received medical treatment. The evaluated patients had a mean age of 83.7 years and a mean EuroSCORE of 19.8±12.3. Median survival free from all-cause death was 34.7 months (95% CI 27.1-42.3) in the TAVI group, 47.4 months (95% CI 0-97.4) in the deferred intervention group, not available in the surgery group and 8.2 months (95% CI 5.6-10.9) in the medical treatment group (log-rank p<0.001). After multivariable adjustment, only treatment group remained as an independent predictor of mortality. Considering the TAVI group as the reference category, the adjusted hazard ratio for all-cause death was 0.70 (95% CI 0.24-2.04) for the deferred intervention group, 0.16 (95% CI 0.02-1.19) for the surgery group and 2.47 (95% CI 1.46-4.18) for the medical treatment group., Conclusion: The decision taken by the heart team on potential candidates for TAVI has a decisive prognostic significance, as those who are unsuitable for any kind of valve replacement have a significantly higher mortality., (Copyright © 2015 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.)

Background: In order to improve technique and to prevent serious procedural complications during transcatheter aortic valve implantation (TAVI), it is crucial to identify the causes of death of patients undergoing this procedure., Objective: The objective of this study was to identify the causes of death during the procedure and at 1 month in patients with severe aortic stenosis undergoing TAVI., Methods: 12 published studies with information about the causes of death in patients undergoing TAVI were selected. Overall, 1223 patients were included in these studies, and 249 deaths were reported (119 at 1 month and 130 at >1 month post-procedure). Mortality during the procedure and at 1 month was 2.3% and 9.7%, respectively. The proportion of cardiac deaths was higher at <1 month in comparison with >1 month (56% versus 34%, respectively; p = 0.001). At 1 month, the most frequent causes of death were cardiac failure/multi-organ failure (24%), sudden death/cardiac arrest (17%), vascular and bleeding complications (17%), stroke (11%), sepsis (11%), and cardiac tamponade (10%). During the procedure, the most frequent causes of death were cardiac tamponade (39%), cardiac failure (21%), cardiac arrest (18%), and vascular and/or bleeding complications (18%). In patients treated with the CoreValve system (Medtronic, Minneapolis, Minnesota) versus those treated with Edwards valves (Cribier-Edwards, Edwards-SAPIEN or SAPIEN XT valve, Edward Lifesciences, Irvine, California), deaths at 1 month due to vascular and bleeding complications were less frequent (3% versus 22%, respectively; p = 0.019), but those due to cardiac tamponade (26% versus 6%, respectively; p = 0.019), and because of aortic regurgitation (10% versus 0%, respectively; p = 0.03) were more frequent., Conclusion: In this pooled analysis, mortality at 1 month after TAVI was 9.7%. The causes of death were widely variable, and of both cardiac and non-cardiac origin. There were some important differences between both devices in the cause of mortality.

Background and Objective: In recent years, techniques for implantation of aortic prosthesis via catheter have been developed as a therapeutic alternative in patients with severe aortic stenosis rejected for surgery. The correct selection of candidates is one of the more complex aspects of this treatment. We analyzed the acceptance rate in our environment for transcatheter aortic valve implantation in patients referred to our hospital for evaluation as possible candidates, describing the exclusion reasons., Patients and Method: 30 patients with severe aortic stenosis and rejected for surgical aortic valve replacement were referred to our hospital to evaluate transcatheter aortic valve implantation. The patients first underwent clinical evaluation and were studied with echocardiography, angiography and computed tomography., Results: Of the 30 patients, 18 were rejected for the procedure (60%): 4 patients with non-severe aortic stenosis, 2 asymptomatic patients, 2 patients who finally underwent surgery because of a low-surgical-risk, 5 patients with contraindications for the procedure, 2 patients who finally did not want to undergo the procedure and 3 patients were further rejected because the vascular access was inappropriate. Of the remaining 12 patients initially accepted, 3 died before the procedure was performed. Finally, only 9 patients (30%) underwent transcatheter aortic valve implantation., Conclusions: Of the patients referred for transcatheter aortic valve implantation, only 40% were accepted. The mortality rate during the evaluation process of this procedure is high, showing that these patients are terminally ill.

Percutaneous implantation of aortic valve prostheses has recently emerged as a therapeutic option for patients with severe symptomatic aortic stenosis for whom surgical valve replacement is not suitable. We describe our initial experience with this technique at our institution. Percutaneous implantation of an Edwards Sapiens aortic prosthesis was performed using the transfemoral approach in four patients with severe symptomatic aortic stenosis for whom surgery was not suitable (mean EuroSCORE, 23%). The procedure was successful in all patients, with optimal implantation of the prosthesis and no complications. By 1 month of follow-up, no patient had experienced an event and all had improved their functional class.

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