Self-expanding Valve Prosthesis Research Articles

First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Post-Procedure Monocyte Count Levels Predict Major Adverse Cardiovascular Events (MACE) Following Transcatheter Aortic Valve Implantation (TAVI) for Aortic Stenosis

Aortic stenosis has recently been characterised as having an inflammatory aetiology, beyond the traditional degenerative model. Recruitment of monocytes has been associated with inflammation contributing to progression of calcific aortic-valve disease. Prior research has demonstrated that pre-procedure inflammatory biomarkers do not consistently discriminate poorer outcomes in those with aortic stenosis. It remains, however, unclear if postprocedure inflammatory biomarkers, which are influenced by intraprocedural pro-inflammatory insults, can predict major adverse cardiovascular events (MACE) post transcatheter aortic valve implantation (TAVI). All patients with postprocedure monocyte levels undergoing transcatheter aortic valve implantation at The Alfred Hospital, Melbourne, Australia (2008-2019) were included. The highest monocyte count from postprocedure days 1 to 3 was used. Patients were divided into "high" or "low" postprocedure monocyte count groups using the Youden Index. The incidence of 30-day MACE a composite of stroke, acute myocardial infarction, and death) was then compared. In total, 472 patients were included (54% men, median age 84 years). Fourteen (14) patients (3%) suffered a 30-day MACE. Those with high postprocedure monocyte count were more likely to: be hypertensive (p=0.049); have a higher Society of Thoracic Surgeons risk score (p=0.032); and, undergo non-transfemoral access (p=0.018). A high (≥0.975) postprocedure monocyte count was significantly associated with 30-day MACE (odds ratio [OR] 1.16 for each 0.1 increase in monocyte, p=0.025). This association remained present on multivariable analysis adjusted for age, sex, Society of Thoracic Surgeons risk score, and self-expanding valve prosthesis type (OR 1.17, p=0.028). The association between postprocedure monocytosis and 30-day MACE suggests that minimising peri-procedural inflammatory insults may improve outcomes. This inexpensive and readily available biomarker may also aid in tailored risk stratification for patients.

A comparison of neurological event and mortality rates between transcatheter aortic valve implantation and surgical aortic valve replacement.

Transcatheter aortic valve implantation (TAVI) is the treatment of choice for patients with symptomatic severe aortic stenosis. To evaluate the neurological event and mortality rates of TAVI in comparison with those of surgical aortic valve replacement (SAVR). A systematic literature search identified pertinent full-text journal articles published from 2000 to 2022 that were taken as the study materials. Patients were at the age of 79.3 ±2.8 years and 79.9 ±2.9 years at the time of intervention/open surgery in the TAVI and SAVR groups, respectively. Patients' age and preoperative comorbidity rates were similar in both groups. A self-expanding valve prosthesis and a percutaneous transfemoral route were the most commonly used in patients receiving TAVI. The duration of the procedure and the hospital stay were much shorter, and the number of transfused blood units was much lower in the TAVI group than in the SAVR group. No significant intergroup difference was found in the prevalence of postoperative stroke, 1-month all-cause mortality, and 1-month and 1-year cardiovascular mortality rates. However, 1-year all-cause mortality was much lower in the TAVI than the SAVR group. The subgroups of risk stratification showed better outcomes for non-high-risk patients compared with high-risk patients. Irrespective of other postoperative complications of TAVI, this study emphasizes the postoperative major neurological events and mortality. TAVI appears to be superior to SAVR with regard to 1-year all-cause mortality. TAVI is thus recommended for elderly patients with symptomatic severe aortic stenosis at very high surgical risk contraindicated for SAVR.

Balloon expandable vs. self-expandable transcatheter aortic valve prosthesis short-term results of retrospective study

Transcutaneous aortic valve implantation has been established as an effective method for the treatment of highgrade aortic stenosis in non-operative, high-risk for conventional surgery patients. According to the developed implantation technologies, the prostheses are divided into balloon-expandable valve prostheses (balloon-expandable valves, BEV) and self-expanding valve prostheses (self-expanding prostheses SEV). The two types of devices have different models for implantation, stratum architecture, cusps characteristics, leading to different hemodynamics, frequency of use and performance of normal prosthesis function. The research aims to monitor the short-term results, up to 1 month after discharge, in terms of mortality, the manifestation of heart failure, (para) prosthetic regurgitation, implantation of a pacemaker, and vascular complications. Materials and methods: the article presents a retrospective follow-up of a total of 230 high-risk for conventional cardiac surgery patients with high-grade aortic stenosis treated in a cardiology clinic at UMHAT St. Ekaterina Sofia until 2020, divided into two groups depending on the implanted type of prosthesis. Conclusions: The results obtained based on our experience prove the safety of new prostheses. When choosing between BEV and SEV, the best clinical outcome requires a good knowledge of the strengths and weaknesses of using medical devices with a personalized approach consistent with the clinical and anatomical characteristics of the patient.

Predictors of pacemaker implantation after transcatheter aortic valve implantation according to kind of prosthesis and risk profile: a systematic review and contemporary meta-analysis.

Permanent pacemaker implantation (PPI) may be required after transcatheter aortic valve implantation (TAVI). Evidence on PPI prediction has largely been gathered from high-risk patients receiving first-generation valve implants. We undertook a meta-analysis of the existing literature to examine the incidence and predictors of PPI after TAVI according to generation of valve, valve type, and surgical risk. We made a systematic literature search for studies with ≥100 patients reporting the incidence and adjusted predictors of PPI after TAVI. Subgroup analyses examined these features according to generation of valve, specific valve type, and surgical risk. We obtained data from 43 studies, encompassing 29 113 patients. Permanent pacemaker implantation rates ranged from 6.7% to 39.2% in individual studies with a pooled incidence of 19% (95% CI 16-21). Independent predictors for PPI were age [odds ratio (OR) 1.05, 95% confidence interval (CI) 1.01-1.09], left bundle branch block (LBBB) (OR 1.45, 95% CI 1.12-1.77), right bundle branch block (RBBB) (OR 4.15, 95% CI 3.23-4.88), implantation depth (OR 1.18, 95% CI 1.11-1.26), and self-expanding valve prosthesis (OR 2.99, 95% CI 1.39-4.59). Among subgroups analysed according to valve type, valve generation and surgical risk, independent predictors were RBBB, self-expanding valve type, first-degree atrioventricular block, and implantation depth. The principle independent predictors for PPI following TAVI are age, RBBB, LBBB, self-expanding valve type, and valve implantation depth. These characteristics should be taken into account in pre-procedural assessment to reduce PPI rates. PROSPERO ID CRD42020164043.

Surgical aortic valve replacement due to infective endocarditis after transcatheter aortic valve implantation with the self-expanding Portico valve prosthesis

Surgical aortic valve replacement due to infective endocarditis after transcatheter aortic valve implantation with the self-expanding Portico valve prosthesis

Aortic regurgitation after transcatheter aortic valve replacement

Abstract The assessment of hydrodynamic performance of transcatheter aortic valve prostheses in vitro is essential for the develosepment and approval of novel devices. Therefore, this study aims to investigate the correlation of target implantation depth and paravalvular regurgitation in a controlled in vitro test situation. We designed a test setup with retrograde steady flow conditions measuring paravalvular regurgitation as a function of increasing pressure on the closed valve ranging from 0 mmHg to 200 mmHg. Our future aim is to benchmark different valve prosthesis designs and describe the correlation between target implantation depth, paravalvular regurgitation and prosthesis design aspects. The current study describes the developed test setup, validation experiments as well as first results for a selfexpanding valve prosthesis. The highest regurgitation was measured at an implantation depth of 2 mm. In fact, regurgitation increases from 26.1 ± 8.2 ml/min at 0 mmHg to 1,490.7 ± 182.7 ml/min at 160 mmHg. The slightest regurgitation, however, was measured for an implantation depth of 6 mm ranging from 2.2 ± 0.6 ml/min at 0 mmHg to 605.8 ± 18.9 ml/min at 200 mmHg.

Bilateral branch pulmonary artery valve implantation in repaired tetralogy of fallot.

Transcatheter, bilateral branch pulmonary artery (PA) valve implantation is a novel treatment for patients with severe pulmonary insufficiency and oversized right ventricle (RV) outflow tract. There is scarce data on efficacy and safety of this approach. This was a retrospective study of 8 patients with repaired tetralogy of fallot (TOF) who underwent bilateral branch PA valve implantation. Demographics, echocardiography, cardiac catheterization, and axial imaging data were reviewed. Variables were compared by a paired sample t-test. All patients were adult sized (weight 43-99 kg) with oversized RV outflow tract not suitable for conventional transcatheter pulmonary valve implantation. Staged bare metal PA stenting followed by valve implantation (interval 3-5 months) was technically successful in 7 patients with one stent embolization. In another patient, proximal stent migration prevented placement of bilateral pulmonary valve stents. There were a total of 14 valved branch PA stents placed (Melody valve n = 9, Sapien XT n = 2, Sapien 3 n = 3). In the 7 patients undergoing successful branch pulmonary valve placement, at median follow up of 10 months (range 3 months to 6 years), 13 (93%) valves had none/trivial insufficiency on echocardiography. Prevalve and postvalve implantation cardiac magnetic resonance imaging in five patients showed significant reduction of indexed RV end-diastolic volume (152 ± 27 to 105 ± 15 mL/m2 , P < .001). Transcatheter, bilateral branch PA valve implantation was technically feasible with satisfactory efficacy and safety in patients with repaired TOF, severe pulmonary insufficiency, and oversized RV outflow tracts. Elimination of pulmonary insufficiency with this method resulted in reduced RV end-diastolic volume. This approach can be offered as an alternative to surgery, particularly in patients considered high risk for standard surgical placement and who are not candidates for the newer self-expanding valve prosthesis for placement in RV outflow tracts larger than 30 mm diameter.

Importance of imaging for transcatheter aortic valve replacement in dextrocardia with situs inversus totalis

We describe imaging utility for trans-femoral aortic valve replacement (TAVR) with 29-mm Core-Valve Evolut R self-expanding valve prosthesis in a singular case of an old man with symptomatic severe aortic stenosis (SAS), dextrocardia, and situs inversus totalis. Cardiac computed tomography plays a pivotal role from pre-procedural planning to TAVR by our heart-team. It gives crucial information to choice the appropriate valve sizing, to avoid paravalvular leak, coronaries obstructions, or serious aortic injuries. To the best of our knowledge, this is the first case of TAVR successfully performed in Italy in a patient with symptomatic SAS, dextrocardia and situs inversus totalis.

TCT-782 Effect of a Mechanical-Expanding vs. Self-Expanding Transcatheter Valve Prosthesis on Health Status in Patients with Severe Aortic Stenosis at High Surgical Risk: Results from the REPRISE III Trial

TCT-782 Effect of a Mechanical-Expanding vs. Self-Expanding Transcatheter Valve Prosthesis on Health Status in Patients with Severe Aortic Stenosis at High Surgical Risk: Results from the REPRISE III Trial

Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial

BackgroundSymptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. ObjectivesThis study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. MethodsPatients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. ResultsThirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. ConclusionsTMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514)

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Implante percutáneo de la válvula autoexpandible CoreValve® en pacientes con estenosis aórtica grave y aorta de porcelana: seguimiento a medio plazo

Introduction and objectivesThere is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve® implantation in patients with severe aortic stenosis, with and without porcelain aorta. MethodsIn this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. ResultsPatients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). ConclusionsIn patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve® self-expanding valve prosthesis is safe and feasible.Full English text available from: www.revespcardiol.org/en

Percutaneous Implantation of the CoreValve® Self-expanding Valve Prosthesis in Patients With Severe Aortic Stenosis and Porcelain Aorta: Medium-term Follow-up

Introduction and objectivesThere is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve® implantation in patients with severe aortic stenosis, with and without porcelain aorta. MethodsIn this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. ResultsPatients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). ConclusionsIn patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve® self-expanding valve prosthesis is safe and feasible.

Benefits and Complications of Direct Implantation of Self-Expandable Aortic Valve Prosthesis for Severe Aortic Stenosis

Objective To describe the initial experience with aortic valve implantation via a direct approach using a self-expanding CoreValve TM aortic valve prosthesis in a tertiary care center from Argentina. Material and methods From May to December 2010, 21 consecutive patients with severe aortic stenosis (SAS) and high surgical risk undergoing percutaneous aortic valve replacement with CoreValve TM prosthesis were included. The inclusion criteria were the following: aortic valve area 6 mm. Results Mean age was 79±8 years, mean aortic valve area was 0.7±0.2 cm 2 and mean logistic EuroSCORE was 26±15% (50% with logistic EuroSCORE ³ 20%). After valve implantation, peak transaortic pressure gradient measured by echocardiography decreased from 80±22 to 14±5 mm Hg. Two patients developed severe aortic regurgitation which improved with post-dilation. The success rate of the procedure was of 95% as a patient died immediately after valve implant. A definite pacemaker was implanted to six patients due to atrioventricular block. Cumulative survival was 75% after a mean follow-up of 5±2.8 months. Conclusion Our initial experience suggests that direct implantation of CoreValve TM prosthesis is a safe and feasible therapeutic option for patients with SAS and high surgical risk.

Fatal prosthetic valve endocarditis of the CoreValve ReValving System

Sirs: Since the first human case description in 2005, the CoreValve self-expanding valve prosthesis (Medtronic, Minneapolis, Minnesota) is available for interventional treatment of aortic valve stenosis in patients with high surgical risk [1]. In the last years, an increasing number of patients treated with transcatheter valve implantation (TAVI). We present a case of Staphylococcus lugdunensis prosthetic valve endocarditis of the CoreValve ReValving

Transcatheter percutaneous aortic valve implantation: The dream has become a reality

Transcatheter percutaneous aortic valve implantation: The dream has become a reality

Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation

The risk of stroke after transfemoral aortic valve implantation (TAVI) due to dislodgement and subsequent embolization of debris from aortic arch atheroma or from the calcified valve itself ranges between 2% and 10%. The rate of clinically silent cerebral ischemia is unknown but may be even higher. Thirty-two patients who underwent TAVI with the use of a balloon-expandable (n=22) or self-expandable (n=10) stent valve prosthesis were included in this descriptive study and compared with a historical control group of 21 patients undergoing open surgical aortic valve replacement. Periprocedural apparent and silent cerebral ischemia was assessed by neurological testing and serial cerebral diffusion-weighted magnetic resonance imaging at baseline, at 3.4 (2.5 to 4.4) days after the procedure, and at 3 months. TAVI was successful in all patients. After the procedure, new foci of restricted diffusion on cerebral diffusion-weighted magnetic resonance imaging were found in 27 of 32 TAVI patients (84%) and were more frequent than after open surgery (10 of 21 patients [48%]; P=0.011). These lesions were usually multiple (1 to 19 per patient) and dispersed in both hemispheres in a pattern suggesting cerebral embolization. Volumes of these lesions were significantly smaller after TAVI than after surgery (77 [59 to 94] versus 224 [111 to 338] mm(3); P<0.001). There were neither measurable impairments of neurocognitive function nor apparent neurological events during the in-hospital period among TAVI patients, but there was 1 stroke (5%) in the surgical patient group. On 3-month follow-up diffusion-weighted magnetic resonance imaging, there were no new foci of restricted diffusion, and there was no residual signal change associated with the majority (80%) of the foci detected in the periprocedural period. Clinically silent new foci of restricted diffusion on cerebral magnetic resonance imaging were detected in almost all patients (84%) undergoing TAVI. Although typically multiple, these foci were not associated with apparent neurological events or measurable deterioration of neurocognitive function during 3-month follow-up. Further work needs to be directed to determine the clinical significance of these findings in a larger patient population.

Function and Performance of Nitinol Vascular Implants

Nitinol, an intermetallic compound of Titanium and Nickel has found widespread use as material for vascular implants. Its unusual stress hysteresis and superelasticity makes these devices biomechanically compatible with the body's structures. Nitinol also exhibits excellent corrosion resistance, biocompatibility and MR compatibility. The paper focuses on the material specific properties of self expanding stents to treat peripheral vascular disease, like biased and temperature dependent stiffness, kink resistance, stent durability and fatigue, and describes the design aspects of different Nitinol stents. The function and performance of other Nitinol implants is also explained, like vena cava filters, cardiac septal re- pair devices, and self-expanding heart valve prosthesis. A separate section describes the performance of endovascular Nit- inol implants in Magnetic Resonance Imaging, MRI.

Successful Deployment of a Transcatheter Aortic Valve in Bicuspid Aortic Stenosis

Transcatheter aortic valve replacement (TAVR) has recently emerged as a therapeutic option for patients with severe aortic stenosis who are considered inoperable.1 To avoid potential complications related to this novel procedure (such as coronary artery obstruction or perivalvular leakage), detailed information on the aortic valve anatomy is critically important.1,2 Multislice computed tomography (MSCT) enables a comprehensive 3D assessment of aortic valve anatomy and, particularly, the extent and location of valve calcifications, one of the reasons for inappropriate deployment of the valved stent together with the bicuspid anatomy.3 After TAVR, the positioning and deployment of the valve prosthesis can be evaluated by this imaging technique. This report concerns a 54-year-old woman with symptomatic bicuspid aortic valve stenosis (aortic valve area, 0.9 cm2). Comorbidity included hypertension and hypercholesterolemia. Importantly, 2 years earlier, the patient experienced a cerebrovascular accident with severe consequences that determined a high risk for cardiac surgery. Consequently, the …