Severe Symptomatic Aortic Stenosis Research Articles

Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry.

Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.

LIFETIME MANAGEMENT OF AORTIC STENOSIS IN EXTREME SETTING

Abstract A 51–year–old male patient returned to our attention due to symptomatic severe aortic stenosis. Despite the severity of the aortic valve disease, he had been previously turned down from aortic valve replacement by us because of lack of symptoms and very unfavorable anatomy. Indeed he had been irradiated at the age of 3 due to Hodgkin’s Lymphoma and presented with porcelain aorta, small ascending aorta and aortic annulus. The patient returned to us with a 3–month history of progressive dyspnea (NYHA class IIa) and one episode of lipothymia during physical exercise. Physical examination, hematologic and biochemical investigations at admission were normal. Our trans–thoracic echocardiogram confirmed a trileaflet aortic valve (AV) that was severely stenotic and calcified with a mean gradient of 60 mmHg and an AV area of 0.5 cm2 (0.3 cm2/m2), in presence of good left ventricular systolic function with an ejection fraction (EF) of 60%. CT excluded coronary disease but, confirmed severe calcified aortic stenosis and porcelain aorta with small calcific sino–tubular junction and ascending aorta and protruding LVOT calcium. (Ascending aorta 19 mm; STJ 19 mm). The heart–team judged the patient not suitable for AVR and decided to perform a high–risk TAVI, leaving apical conduit as the last resort. From a technical standpoint, the LVOT calcium and the short and narrow STJ were high risk features for rupture with balloon expandable devices. On the other hand the short and narrow STJ with the narrow ascending aorta would represent a serious issue for the expansion of self–expanding devices and an even more troublesome feature for future coronary access and coronary occlusion in the setting of TAVI–in–TAVI down the road. Given the patient’s young age, a balloon expandable SAPIEN ultra 23 mm was chosen to be implanted with a two–step inflation to minimize the risk of STJ rupture. The prosthesis was partially expanded until anchoring was achieved on the aortic leaflets then, on continuous pacing, the balloon was rapidly collapsed, pushed down deeper under the STJ and fully inflated to achieve prosthesis’ inflow expansion. Intra–procedural and post–procedural course were uneventful and the patient was discharged home in 5th Day. Transthoracic echocardiogram at the dismission reveal a trans–aortic mean gradient of 18 mmhg, the absence of significant paravalvular leaks and a preserved ejection fraction. Pre–discharge CT scan confirmed feasibility of future TAVI–in–TAVI in case of need.

Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis: The NOTION-2 Trial.

Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤ 75 years of age, including both tricuspid and bicuspid AS. The NOTION-2 trial enrolled and 1:1 randomized low-risk patients aged ≤ 75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke or rehospitalization (related to the procedure, valve or heart failure) at 12 months. A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group (absolute risk difference 3.1%; 95% confidence interval [CI], -2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3). Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation and moderate-or-greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8, 95% CI: 0.8 to 18.5) treated with TAVI or surgery, respectively (P for interaction=0.1). Among low-risk patients aged ≤ 75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI and surgery. TAVI outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Valve-in-valve implantation to seal post-dilation-induced annular rupture in transcatheter aortic valve replacement.

An 85-year-old woman was admitted to our hospital with severe symptomatic aortic stenosis. Preoperative computed tomography and transesophageal echocardiography (TEE) revealed a type I bicuspid aortic valve.

TAVI in younger patients: is it a reliable option?

Abstract Funding Acknowledgements None. Background/Introduction Severe aortic stenosis is the most common valve disease requiring intervention. It has very poor prognosis, and early intervention is recommended. Either surgical or percutaneous transcatheter intervention is possible. According to European guidelines, surgical aortic valve replacement (SAVR) is usually indicated for patients younger than 75 years old. However, some patients are refused surgery, and transcatheter aortic valve implantation (TAVI) might be an option of treatment for these patients, however medium-long term results are still uncertain. Purpose This study intends to evaluate the efficacy and safety of TAVI in younger patients with severe symptomatic aortic stenosis. Methods Retrospective cohort of 224 patients were submitted to TAVI in the last 3 years, of which 21 patients were younger than 75 years old. The primary endpoints are mortality, major adverse cardiovascular events (MACE) and rehospitalization (related to the procedure, valve, or heart failure). Efficacy and safety were evaluated during a follow-up of at least 6 months, compared with the traditional group. Results A total of 224 patients underwent TAVI during the last 3 years at our center. Of these, 21 patients (9%) were younger than 75 years. The mean age was 72,1±3 [62-75] years old and 33% were female (n=7). 95% (n=20) of the TAVI procedures were due to degenerative severe aortic stenosis and 5% (n=1) due to degenerative aortic surgical valve prothesis. The mean euroscore risk value was 6,2±1,3%, and 18 patients were refused for surgery (86%) and 3 patients refused surgery (14%). All procedures were performed by transfemoral access, with 2 peripheral access complications (9,5%), 1 hemorrhagic (4%), solved with covered stent, and 1 closure device occlusion solved with wire crossing and balloon inflation (4%). It was necessary to implant 3 temporary pacemakers, however, only 2 patients required a definitive pacemaker implantation (9,5%). There were no cases intraprocedural death, MACE or aortic severe complications. There was a statistically significant reduction of risk of peripheral complications and pacemaker implantation on younger patients comparing with older patients (p=0,04 and p=0,05 respectively). Mean follow-up time was 14±8,3 months [6-39 months]. During follow-up there were no deaths, MACE or episodes of rehospitalization due to heart failure recorded. Regarding echocardiographic evaluation, there were no cases of significant valve degeneration, with mean aortic gradient of 13±4,1mmHg, no significant leakage or other echocardiographic findings. In younger patients, TAVI appears to be also valid therapeutic option, with less risk of peripheral access complication or need of permanent pacemaker implantation. During the follow-up there was no cases of prothesis degeneration, proving to be a reliable option for the medium to long term.

Urgent transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis is associated with increased 30-days mortality: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction In patients with severe symptomatic aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option; yet, 20% of these patients' hospitalizations are related to acute decompensation. The vast majority of TAVR procedures conducted across the US are elective procedures on patients who are hemodynamically stable. Despite that, according to recent research, urgent TAVR may be a feasible option for AS patients experiencing acutely decompensated heart failure or cardiogenic shock. Additionally, there is also a gap in the guidelines concerning the interventions in this acute setting, with only a brief recommendation for aortic balloon valvuloplasty as a bridge to TAVR or surgery in decompensated AS. Purpose The aim of this systematic review and meta-analysis is to assess 30-days mortality post-TAVR in patients submitted to an urgent procedure and compare them with the elective TAVR population. Methods We systematically searched three major databases (Medline, Cochrane Central Register of Controlled Trials and Scopus) for studies comparing patients submitted to urgent versus elective TAVR. Primary endpoint of our systematic review and meta-analysis is the 30-days mortality post-procedurally. Only studies provided data about our primary endpoint were considered in this analysis. Secondary endpoints comprised acute kidney injury (AKI), permanent pacemaker implantation (PPM) and stroke during the first 30-days post-TAVR. Risk ratio (RR) was calculated with 95% confidence intervals (CIs) and a random-effects model (Mantel-Haenzel) was used to estimate the pooled RR. Results This systematic review acquired 497 results. After duplicates removal, we screened 454 reports and we read full-text articles of 35 studies. Fourteen studies were included in our analysis. A total of 43,051 patients undergoing TAVR were included in our analysis; 3,607 patients submitted to an urgent TAVR, while the rest 39,444 had an elective procedure. Our analysis showed that patients undergoing urgent TAVR have 244% higher risk for mortality during the first 30-days post-procedurally (RR: 2.44, 95%CI: 1.49, 3.99) (Figure). Data about AKI, PPM and stroke during the first 30-days post-TAVR were available for 10 studies. The risk for AKI appeared to be significantly higher in patients undergone urgent TAVR (RR: 2.68, 95% CI: 1.60, 4.47). No significant differences were observed in stroke incidence (RR: 1.04, 95% CI: 0.89, 1.20) and PPM (RR: 1.08, 95%CI: 0.95, 1.22) during 30-days follow-up. Conclusion Compared to elective procedures, urgent TAVR seems to have increased 30-days mortality and AKI, and comparable PPM and stroke rates. These findings provide valuable insights offering potential updates to current guidelines in this field. Further studies on long-term outcomes and in a larger patient population are needed.

Surgical aortic valve replacement in a patient with severe scoliosis

Aortic valve replacement for severe symptomatic Aortic stenosis is a low-risk procedure, but when compounded with coexisting conditions, procedural risk may increase. We present the case of a middle-aged female patient presenting with a constellation of complexities, including oblique sternum, severe dextroscoliosis, severe symptomatic aortic stenosis with bicuspid aortic valve, aortic root distortion, and a relatively rare blood group. Despite multiple problems, she underwent successful surgical aortic valve replacement. This case highlights the importance of a multidisciplinary approach in complex cardiac patients with the utmost need for a heart team concept for patient-centric decision-making.

Management of an Iatrogenic Pulmonary Artery Rupture via Balloon Tamponade.

Pulmonary artery rupture is a rare complication of right heart catheterization characterized by a rapid clinical deterioration and high mortality rate. We present the case of an 89-year-old woman with severe symptomatic aortic stenosis who underwent cardiac catheterization prior to aortic valve replacement. The patient had acute cardiopulmonary deterioration due to pulmonary artery rupture at the time of right heart catheterization, that was successfully sealed by balloon tamponade.

The role of Matrix Metalloproteinase-2 and Galectin-3 as predictive biomarkers for all-cause mortality in patients undergoing transfemoral transcatheter aortic valve implantation

Background Currently available risk scores fail to accurately predict morbidity and mortality in patients with severe symptomatic aortic stenosis who undergo transcatheter aortic valve implantation (TAVI). In this context, biomarkers like matrix metalloproteinase-2 (MMP-2) and Galectin-3 (Gal-3) may provide additional prognostic information. Methods Patients with severe aortic stenosis undergoing consecutive, elective, transfemoral TAVI were included. Baseline demographic data, functional status, echocardiographic findings, clinical outcomes and biomarker levels were collected and analysed. Results The study cohort consisted of 89 patients (age 80.4 ± 5.1 years, EuroScore II 7.1 ± 5.8%). During a median follow-up period of 526 d, 28 patients (31.4%) died. Among those who died, median baseline MMP-2 (alive: 221.6 [170.4; 263] pg/mL vs. deceased: 272.1 [225; 308.8] pg/mL, p < 0.001) and Gal-3 levels (alive: 19.1 [13.5; 24.6] pg/mL vs. deceased: 25 [17.6; 29.5] pg/mL, p = 0.006) were higher than in survivors. In ROC analysis, MMP-2 reached an acceptable level of discrimination to predict mortality (AUC 0.733, 95% CI [0.62; 0.83], p < 0.001), but the predictive value of Gal-3 was poor (AUC 0.677, 95% CI [0.56; 0.79], p = 0.002). Kaplan–Meier and Cox regression analyses showed that patients with MMP-2 and Gal-3 concentrations above the median at baseline had significantly impaired long-term survival (p = 0.004 and p = 0.02, respectively). Conclusions In patients with severe aortic stenosis undergoing transfemoral TAVI, MMP-2 and to a lesser extent Gal-3, seem to have additive value in optimizing risk prediction and streamlining decision-making.

One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study.

The dry-pericardium Vienna transcatheter aortic valve system is repositionable and retrievable, already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. The VIVA first-in-human feasibility study, a prospective, nonrandomized, single-center trial, evaluated the Vienna aortic valve in 10 patients with severe symptomatic aortic stenosis, who were at intermediate or high surgical risk. This study, registered at ClinicalTrials.gov (NCT04861805), focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1-year follow-up. The mean patient age was 79 ± 5 years, 60% male. Valve sizes used: 26 mm (10%), 29 mm (30%), 31 mm (60%). Key hemodynamic improvements were significant: mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, aortic valve area (cm2) increased from 0.75 to 1.91, and maximum jet velocity through the aortic valve (m/s) decreased from 4.41 to 1.95 (p < 0.0001). No moderate/severe paravalvular leakage was observed, and computed tomography scans revealed no evidence of hypo-attenuated leaflet thickening. The study recorded one life-threatening bleeding event, two cases requiring postprocedural pacemaker implantation, and three ischemic events, with only one causing lasting neurological impairment. Importantly, there were no cases of cardiovascular mortality and only one noncardiovascular death, which was confirmed as unrelated to the device. The study indicates the Vienna valve as a potential option for severe symptomatic aortic stenosis, designed to streamline the procedure and potentially lower healthcare costs by reducing resource and equipment needs, also procedural errors. Further research is essential to thoroughly evaluate its safety and efficacy.

Predictors, clinical impact, and management strategies for conduction abnormalities after transcatheter aortic valve replacement: an updated review.

Transcatheter aortic valve replacement (TAVR) has increasingly become a safe, feasible, and widely accepted alternative surgical treatment for patients with severe symptomatic aortic stenosis. However, the incidence of conduction abnormalities associated with TAVR, including left bundle branch block (LBBB) and high-degree atrioventricular block (HAVB), remains high and is often correlated with risk factors such as the severity of valvular calcification, preexisting conditions in patients, and procedural factors. The existing research results on the impact of post-TAVR conduction abnormalities and permanent pacemaker (PPM) requirements on prognosis, including all-cause mortality and rehospitalization, remain contradictory, with varied management strategies for post-TAVR conduction system diseases across different institutions. This review integrates the latest research in the field, offering a comprehensive discussion of the mechanisms, risk factors, consequences, and management of post-TAVR conduction abnormalities. This study provides insights into optimizing patient prognosis and explores the potential of novel strategies, such as conduction system pacing, to minimize the risk of adverse clinical outcomes.

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Clinical Midterm Results of Surgical Aortic Valve Replacement with Sutureless Valves.

Sutureless aortic valves may enable shorter procedure times, which benefits patients with elevated surgical risk. We describe the outcomes of patients with aortic stenosis who underwent aortic valve replacement (AVR) using the sutureless Perceval aortic bioprosthesis. Data from a retrospective cohort were obtained from a clinical database. The study enrolled patients with symptomatic severe aortic stenosis who underwent surgical AVR with a sutureless bioprosthesis between August 2015 and December 2020. In total, 113 patients were included (mean age, 75.3±8.4 years; 57.5% women; median Society of Thoracic Surgeons score, 9.7%; mean follow-up period, 51.19±20.6 months). Of these patients, 41 were octogenarians (36.2%) and 3 were nonagenarians (2.6%). Transthoracic echocardiography was employed to assess changes in ejection fraction (EF), left ventricular mass index (LVMI), and mean pressure gradient (MPG). The in-hospital mortality rate was 2.6%, and 13 patients developed new-onset atrial fibrillation. A permanent pacemaker was implanted in 3 patients (2.6%). The median intensive care unit stay was 1 day (interquartile range [IQR], 1-2 days), and the median hospital stay was 12 days (IQR, 9.5-15 days). The overall survival rate at 5 years was 95.9%. LVMI and MPG were reduced postoperatively, while EF increased over the follow-up period. No structural valve deterioration was observed, and no meaningful paravalvular leakage developed during follow-up. The use of a sutureless valve in the aortic position is safe and feasible, even for high-risk elderly patients requiring surgical AVR. LVMI and MPG decreased postoperatively, while EF increased over the follow-up period.

Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands

BackgroundThere is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population.MethodsA two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses.ResultsTAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses.ConclusionsBased on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation - Insights From the International Transcatheter Aortic Valve Implantation Registry.

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Sex differences in the outcomes after transcatheter aortic valve replacement with newer generation devices: A meta-analysis.

Transcatheter aortic valve replacement (TAVR) is a reasonable therapeutic approach among patients with symptomatic severe aortic stenosis irrespective of surgical risk. Data regarding sex-specific differences in the outcomes with newer generation valves are limited. Electronic databases were searched for studies assessing sex differences in the outcomes of patients undergoing TAVR with newer generation valves (SAPIEN 3 or Evolut). Random effects model was constructed for summary estimates. Four observational studies with 4522 patients (44.8% women) were included in the meta-analysis. Women were older and had a lower prevalence of coronary artery disease and mean EuroScore. Women had a higher incidence of short-term mortality (up to 30 days) (risk ratio [RR]: 1.60, 95% confidence interval [CI]: 1.14-2.25), but no difference in 1-year mortality (RR: 0.92, 95% CI: 0.72-1.17). There was no significant difference in the incidence of major bleeding (RR: 1.16, 95% CI: 0.86-1.57), permanent pacemaker (PPM) (RR: 0.80, 95% CI: 0.62-1.04), or disabling stroke (RR: 1.16, 95% CI: 0.54-2.45). In this meta-analysis, we found that women undergoing TAVR with newer-generation devices were older but had a lower prevalence of comorbidities. Women had a higher incidence of short-term mortality but no difference in the 1-year mortality, bleeding, PPM, or stroke compared with men. Future studies are required to confirm these findings.

Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation in Patients with Severe Iliofemoral Calcifications: Expanding Transfemoral Indications.

(1) Background: Transfemoral transcatheter aortic valve implantation (TAVI) has become the standard treatment for most patients with severe symptomatic aortic stenosis. Intravascular lithotripsy may facilitate transfemoral TAVI (IVL-TAVI) even in patients with severely calcified iliofemoral disease. We assessed technical aspects and clinical outcomes of this novel approach compared to alternative transaxillary access (TAX-TAVI). (2) Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 30 patients from 2019 to 2022 at a single academic heart center. IVL was performed as part of the TAVI procedure in all cases. Results were compared to a control group of 44 TAX-TAVI procedures performed for the same indication from 2016 to 2021. The safety outcome was a composite of all-cause death, stroke, access-related bleeding ≥ type 2 within 24 h and major vascular access site complications at 30 days. The efficacy outcome was defined as a technical success according to VARC-3. (3) Results: Median age was 78.2 [74.3, 82.6] years, 45.9% were female and mean STS-PROM was 3.6% [2.3, 6.0]. Iliofemoral calcifications were more severe in the IVL-TAVI vs. TAX-TAVI groups (lesion length: 63.0 mm [48.6, 80.3] vs. 48.5 mm [33.1, 68.8]; p = 0.043, severe calcification at target lesion: 90.0% vs. 68.2%; p = 0.047, and median arc calcification 360.0° [297.5, 360.0] vs. 360.0° [180.0, 360.0]; p = 0.033). Technical success was achieved in 93.3% vs. 81.8% (p = 0.187) in IVL- and TAX-TAVI and the safety outcome occurred in 10.0% vs. 31.8% in IVL- and TAX-TAVI (p = 0.047), respectively. (4) Conclusions: IVL-assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.

Impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation using a self-expandable Evolut R valve

BackgroundTranscatheter Aortic Valve Implantation (TAVI) has a growing target population after being indicated even in low-surgical-risk patients with severe symptomatic aortic stenosis. However, postoperative outcomes can be compromised due to para-valvular leakage (PVL). A lot of procedural steps have been investigated to decrease this partially avoidable operational hazard. Oversizing is a main technique to decrease the PVL, despite being itself a risky step. Many studies have been conducted to identify the optimum degree of oversizing. However, studies about oversizing by more than 20% are scarce. We aimed to evaluate the safety and efficacy of oversizing equal to or more than 20%.Results209 patients who underwent TAVI using the self-expandable valve Evolut R were initially included. 66 patients were excluded because of the baseline conduction disturbance and lack of sufficient data, so 143 patients, 60 females and 83 males, were enrolled in our study as two groups based on the degree of oversizing: Group A included 97 patients with an oversizing index (OI) of less than 20%, and Group B included 46 patients with an OI of 20% or more. We conducted a new technique for more accurate measuring of the OI in the context of the implantation depth, and our patients were categorized using this technique. Our findings have met our primary end point in terms of the safety and efficacy of oversizing by 20% or more. There was no significant difference between both groups in terms of new-onset conduction disturbance (NOCD), with zero cases of annular rupture or coronary encroachment. In terms of efficacy, The incidence of significant PVL (grade 2 or more) in group B was less than in group A (P value 0.007). The ROC curve found that the minimum depth of implantation-derived oversizing (DIDO) to predict no significant PVL was less than 17%.ConclusionProsthesis oversizing by 20% using the self-expandable Evolut R valve is safe and effective, with no significant effect on the conduction system, coronary encroachment, or annular injury, and warrants a greater reduction in the incidence of significant PVL.

Transfemoral TAVR with Surgical Cut-down in a Patient with Aorto Bi-iliac Bypass Graft

Transcatheter aortic valve replacement (TAVR) has become the mainstream option for patients with symptomatic severe aortic valve stenosis and is preferably performed by the transfemoral route. However, a subset of patients requires alternative access with comorbidities associated with femoral access routes, and alternative access such as transapical, transaxillary, transcarotid, subclavian, and transcaval can be considered. However, access options are further limited by the presence of severe comorbidities. This case reports TAVR performed through a transfemoral approach in a patient with previous aorto bi-iliac bypass graft surgery.

Efficacy and safety of a minimalistic balloon aortic valvuloplasty strategy in a centre without heart surgery.

Balloon aortic valvuloplasty (BAV) is a palliative tool for patients with symptomatic severe aortic stenosis (AS) at prohibitive risk for surgery or as a bridge to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). BAV is traditionally performed in hospitals with onsite cardiac surgery due to its potential complications. The aim of this study was to evaluate the safety of BAV procedures performed by trained high-volume operators in a centre without onsite surgery and to assess the effect of a minimalistic approach to reduce periprocedural complications. From 2016 to 2021, 187 BAV procedures were performed in 174 patients. Patients were elderly (mean age: 85.0±5.4 years) and had high-risk (mean European System for Cardiac Operative Risk Evaluation score [EuroSCORE] II: 10.1±9.9) features. According to the indications, 4 cohorts were identified: 1) bridge to TAVR (n=98; 56%); 2) bridge to SAVR (n=8; 5%); 3) cardiogenic shock (n=11; 6%); and 4) palliation (n=57; 33%). BAV procedures were performed using the standard retrograde technique via femoral access in 165 patients (95%), although radial access was used in 9 patients (5%). Ultrasound-guided vascular puncture was performed in 118 patients (72%) and left ventricular pacing was administered through a stiff guidewire in 105 cases (60%). BAV safety was confirmed by 1 periprocedural death (0.6%), 1 intraprocedural stroke (0.6%), 2 major vascular complications (1%) and 9 minor vascular complications (5%). Nine cases of in-hospital mortality occurred (5%), predominantly in patients with cardiogenic shock. BAV is a safe procedure that can be performed in centres without onsite cardiac surgery using a minimalistic approach that can reduce periprocedural complications.