Search

Transcatheter heart valve technology has rapidly progressed since initial approval in the United States. There are currently two widely available transcatheter heart valve delivery systems approved in the US; however limited data exist on optimal device selection for various patient populations. This review explores the characteristics of currently approved transcatheter heart valve systems and scenarios where one valve system may be favored over others. We provide a simplified decision tree for selecting the optimal transcatheter valve system for specific patient-centered characteristics.

Objective Transcarotid access for transcatheter aortic valve replacement is emerging as an alternative to more traditional nonfemoral access options such as transapical or transaortic; however, comparative data are limited. The purpose of the study was to analyze outcomes after transcatheter aortic valve replacement using transcatheter compared with transthoracic (transapical/transaortic) access. Methods The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was queried for patients who underwent transcarotid, transapical, or transaortic transcatheter aortic valve replacement with the SAPIEN 3 (Edwards Lifesciences, Irvine, Calif) transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated, and propensity score matching and logistic regression were used to compare transcatheter access with transthoracic access. Results In the propensity-matched analysis, 667 transcarotid transcatheter aortic valve replacement procedures were compared with 1334 transthoracic procedures. Transcarotid transcatheter aortic valve replacement was associated with lower mortality (4.2% vs 7.7%, P = .004), less new-onset atrial fibrillation (2.2% vs 12.1%, P Conclusions Transcatheter aortic valve replacement using transcarotid access is associated with lower 30-day mortality, less atrial fibrillation, shorter intensive care unit and overall length of stay, fewer readmissions, greater improvement in Kansas City Cardiomyopathy Questionnaire scores, and no significant difference in stroke or major vascular complications compared with transthoracic access.

Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) is an appealing alternative to surgical intervention on failed aortic prosthesis with comparable safety and efficacy. ViV TAVR has proven to be a technical challenge in stentless bioprosthetic aortic valves like free style aortic valve prosthesis. In this case series of two patients we report the utility of transesophageal echocardiogram guidance to help visualize surgical annulus and TAVR deployment.

Preserving coronary artery access is a crucial goal during transcatheter aortic valve replacement (TAVR) procedures, especially in case of self-expandable transcatheter heart valve (SE-THV) implantation. In this light, a proper commissural alignment is needed to avoid the risk of coronary obstruction and to permit easy vessels re-cannulation for diagnostic and interventional purposes. New-generation SE-THVs have been furnished of different markers, able to guide operators to perform a correct commissural alignment. In this case series, we describe key procedural aspects of commissural alignment for the different available SE-THVs, providing a step-by-step tutorial for each device. Lastly, we illustrate a commissural alignment in a contrast-zero TAVR.

Introduction The Perceval Valve has been increasingly used in Surgical Aortic Valve Replacement (SAVR) recently due to ease of implantation. However, we have seen some cases of relatively early haemodynamic failure of the Perceval valve and these patients may then present for valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). Experience of ViV-TAVI in the Perceval valve is limited. Methods We report our experience of VIV-TAVI in four cases of early-failing Perceval valves, two with stenosis and two with regurgitation. We also review the literature with regard to ViV-TAVI for this indication. Results Four patients aged between 66 and 78 years presented with Perceval valve dysfunction an average of 4.6 years following SAVR. All cases underwent Heart Team discussion and a ViV-TAVI procedure was planned thereafter. Strategies to ensure crossing through the centre of the valve and not outside any portion of the frame were found to be essential. Three patients had self-expanding valves implanted and one had a balloon-expandable prosthesis. The average aortic valve area (AVA) improved from 0.8 cm 2 pre-procedure to 1.5 cm2 post-procedure*. The mean gradient (MG) improved from 35.5 mmHg (range 19.7–53 mmHg) pre-procedure to 14.8 mmHg (range 7–30 mmHg) post-procedure. In one patient a MG of 30 mmHg persisted following valve deployment. There were no significant peri-procedural complications. Conclusions ViV-TAVI is a useful option for failed Perceval prostheses and appears safe and effective in this small series. Crossing inside the whole frame of the Perceval valve is essential.

An 84-year-old woman with a history of hypertension, diabetes mellitus, dyslipidaemia and aortic stenosis (AS) was referred to our hospital for transcatheter aortic valve implantation (TAVI). She occasionally recognised dyspnoea on exertion for the last 2 years, but she had no symptoms of chest pain

Although established, transcatheter pulmonary valve replacement is in its infancy compared with surgical pulmonary valve replacement. Extended clinical experience and follow-up have identified new challenges; however, careful evaluation of data through clinical trials has facilitated effective evolution of responses to these challenges. The limited patient population has resulted in less interest in new valve design, but having been the older sibling to transcatheter aortic valve replacement, transcatheter pulmonary valve replacement is likely to benefit in the future from design modifications to the more popular and commercially viable transcatheter aortic valve revolution. Improving valve longevity and applying the technology to native outflow tracts remain the short-to-medium term goals.

The use of bioprosthetic valves for treating patients with severe valve disease has increased over the last 2 decades, and, as a consequence, a growing number of patients with failing surgical bioprosthesis is expected in the near future. In this setting, valve-in-valve (ViV) transcatheter aortic/mitral valve replacement (TAVR and TMVR) has emerged as an alternative to redo surgery. Despite the increasing experience in ViV procedures, the development of these techniques faces several specific challenges, mainly related to the unique anatomical and physiological characteristics presented in ViV-TAVR/TMVR. Subsequently, various approaches have been proposed to overcome ViV-related complications and pitfalls. A growing body of evidence is currently available concerning early- and long-term clinical outcomes of patients undergoing ViV-TAVR/TMVR. These data should be comprehensively evaluated by the Heart Team in the decision-making process involving patients with failing surgical bioprostheses. In this review, we aimed to delineate the technical challenges and risks associated with ViV-TAVR and ViV-TMVR, provide an updated overview of the main clinical results, and summarize the future perspectives of this evolving field.

Background The association between renal morphological findings and changes in renal function in patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. Aims We aimed to investigate the association between renal morphological findings and changes in renal function in patients undergoing TAVI. Methods Among 283 consecutive patients undergoing TAVI between 2018 and 2021, the study sample included 224 patients. Renal morphological measurements were performed by preoperative multi-detector computed tomography. Estimated glomerular filtration rate (eGFR) improvement and deterioration were defined as positive or negative changes in an eGFR of ≥10% one month after TAVI. The renal cortex thickness index was defined as the ratio of total renal cortex thickness to body surface area. Results The incidences of eGFR improvement and deterioration were 33.9% and 24.1%, respectively. The renal cortex thickness index had a significant correlation with changes in eGFR (r=0.34, pl0.01). The index of the area under the curve of renal cortex thickness for eGFR improvement and deterioration were 0.73 and 0.68, respectively. The cut-off values were 5.82 mm/m2 for eGFR improvement (odds ratio [OR]: 0.10; 95% confidence interval: 0.05-0.20; pl0.01) and 4.89 mm/m2 for eGFR deterioration (OR: 9.07; 95% confidence interval: 4.55-18.6; pl0.01). Conclusions The renal cortex thickness index was associated with changes in renal function in patients who underwent TAVI. Its measurements might be useful for predicting the renal function change in patients undergoing TAVI.

Objectives The clinical and cost-saving benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis who are at high or intermediate risk of surgical mortality are supported by a growing evidence base. The PARTNER 3 trial (Placement of AoRTic TraNscathetER Valve Trial) demonstrated clinical benefits with SAPIEN 3 TAVI compared with SAVR in selected patients at low risk of surgical mortality. This study uses PARTNER 3 outcomes in combination with a French national hospital claim database to inform a cost-utility model and examine the cost implications of TAVI over SAVR in a low-risk population. Methods A 2-stage cost-utility analysis was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured using the PARTNER 3 data set. These data fed into a Markov model that captured longer-term outcomes of patients, after TAVI or SAVR intervention. Results TAVI with SAPIEN 3 offers meaningful benefits over SAVR in providing both cost saving (€12 742 per patient) and generating greater quality-adjusted life-years (0.89 per patient). These results are robust with TAVI with SAPIEN 3 remaining dominant across several scenarios and deterministic and probabilistic sensitivity analyses. Conclusions This model demonstrated that TAVI with SAPIEN 3 was dominant compared with SAVR in the treatment of patients with severe symptomatic aortic stenosis who are at low risk of surgical mortality. These findings should help policy makers in developing informed approaches to intervention selection for this patient population.

Rationale and Objectives Aortic stenosis (AS) is one of the most common valvular heart disease. Symptomatic AS is associated with a high mortality rate which prompts fast intervention. The introduction of transcatheter aortic valve replacement (TAVR) has drastically improved the outcome of high surgical risk for mortality patients with severe AS. However, this procedure requires the employment of multimodality imaging in the pre-procedural planning, intra-procedural optimization, and post-procedural follow-up stages. This also requires an accurate understanding of the indications, measurements, strength, and limitations of each imaging modality during the different TAVR stages. Conclusion In this review, we aim to outline to radiologists the evidence-based approach and indications of different imaging modalities through the pre, peri, and post TAVR stages.

Background Noninvasive cardiac output (CO) measurement using ClearSight™ (Edwards Lifesciences, Irvine, CA, US) eliminates the need for intra-arterial catheter insertion. However, the accuracy and reliability of this system have not been evaluated in severe aortic valve stenosis (AS). Methods Thirty patients who underwent elective transcatheter aortic valve implantation (TAVI) were prospectively enrolled in this study. CO was simultaneously measured twice before and twice after valve deployment, for a total of four times per patient, and compared between the ClearSight (COClearSight) system and CO from the pulmonary artery catheter (PAC) thermodilution (COTD) as reference. Bland-Altman analysis was used to compare the percentage error between the measurement methods. Results A total of 112 paired data points were obtained. The percentage error between COClearSight and COTD was 43.1%. The paired datasets were divided into the following groups according to the systemic vascular resistance index (SVRI): low (

Background Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. Objective We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. Methods From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. Results Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022). Conclusions The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.

INTRODUCTION AND OBJECTIVES Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. METHODS The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. RESULTS The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P

Although cardiac computed tomography angiography (CCTA) assessment of right ventricular dysfunction (RVD) is feasible, the incremental prognostic value remains uncertain in patients undergoing transcatheter aortic valve replacement (TAVR) evaluation. This study sought to determine the incremental clinical utility of RVD identification by CCTA while accounting for clinical and echocardiographic parameters.Patients who underwent multiphasic ECG-gated functional CCTA using dual-source system for routine TAVR planning were evaluated. Biphasic contrast protocol injection allowed for biventricular contrast enhancement. CCTA-based RVD was defined as right ventricular ejection fraction (RVEF) ​ ​50%. The association of CCTA-RVD with all-cause mortality and the composite outcome of death or heart failure hospitalization after TAVR was evaluated and examined for its incremental utility beyond clinical risk assessment and echocardiographic parameters.A total of 502 patients were included (median [IQR] age, 82 [77 to 87] years; 56% men) with a median follow-up of 22 [16 to 32] months. Importantly, 126 (25%) patients were identified as having RVD by CCTA that was not identified by echocardiography. CCTA-defined RVD predicted death and the composite outcome in both univariate analyses (HR for mortality, 2.15; 95% CI, 1.44-3.22; p ​ ​0.001; HR for composite outcome, 2.11; 95% CI, 1.48-3.01; p ​ ​0.001) and in multivariate models that included clinical risk factors and echocardiographic findings (HR for mortality, 1.74; 95% CI, 1.11-2.74; p ​= ​0.02; HR for composite outcome, 1.63; 95% CI, 1.09-2.44; p ​= ​0.02).Functional CCTA assessment pre-TAVR correctly identified 25% of patients with RVD that was not evident on 2D echocardiography. The presence of RVD on CCTA independently associates with clinical outcomes post-TAVR.

Objectives: To study the safety and feasibility of a restrictive temporary-RV-pacemaker use and to evaluate the need for temporary pacemaker insertion for failed left ventricular (LV) pacing ability (no ventricular capture) or occurrence of high-degree AV-blocks mandating continuous pacing. Background: Ventricular pacing remains an essential part of contemporary transcatheter aortic valve implantation (TAVI). A temporary-right-ventricle (RV)-pacemaker lead is the standard approach for transient pacing during TAVI but requires central venous access. Methods: An observational registry including 672 patients who underwent TAVI between June 2018 and December 2020. Patients received pacing on the wire when necessary, unless there was a high-anticipated risk for conduction disturbances post-TAVI, based on the baseline-ECG. The follow-up period was 30 days. Results: A temporary-RV-pacemaker lead (RVP-cohort) was inserted in 45 patients, pacing on the wire (LVP-cohort) in 488 patients, and no pacing (NoP-cohort) in 139 patients. A bailout temporary pacemaker was implanted in 14 patients (10.1%) in the NoP-cohort and in 24 patients (4.9%) in the LVP-cohort. One patient in the LVP-cohort needed an RV-pacemaker for incomplete ventricular capture. Procedure time was significantly longer in the RVP-cohort (68 min [IQR 52–88.] vs. 55 min [IQR 44–72] in NoP-cohort and 55 min [IQR 43–71] in the LVP-cohort [p < 0.005]). Procedural high-degree AV-block occurred most often in the RVP-cohort (45% vs. 14% in the LVP and 16% in the NoP-cohort [p ≤ 0.001]). Need for new PPI occurred in 47% in the RVP-cohort, versus 20% in the NoP-cohort and 11% in the LVP-cohort (p ≤ 0.001). Conclusion: A restricted RV-pacemaker strategy is safe and shortens procedure time. The majority of TAVI-procedures do not require a temporary-RV-pacemaker.

To compare in-hospital outcome of Evolut-R 34 mm vs. smaller Evolut-R devices and to identify predictors of paravalvular leak (PVL) and deep implantation specific for Evolut-R 34 mm.This single-center retrospective study included 359 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with Evolut-R 34 mm (N = 84,23.4%) and Evolut-R 23/26/29 mm (N = 275,76.6%) between 2016 and 2019.Patients in Evolut-R 34 mm group were more frequently males, had lower STS score, ejection fraction, and mean aortic gradient compared to the Evolut-R 23/26/29 mm group. Horizontal aorta and large LVOT were more frequent findings in the Evolut-R 34 mm group, whereas calcium volume was comparable among the groups. During TAVR, mean implantation depth and contrast volume were greater in the Evolut-R 34 mm group, compared to the Evolut 23/26/29 mm group. Post-procedurally, 30-day mortality, ≥moderate PVL, device success and pacemaker implantation (PM) rates were comparable between groups. Among independent predictors of ≥moderate PVL, calcium volume (OR:1.04; p0.001) was predictive with different thresholds in both groups, whereas aortic angulation (OR:1.40; p = 0.005) was predictive only in Evolut-R 34 mm group at a cutoff of 60° (AUC:0.73; p = 0.043). Body weight (OR:1.03; p = 0.027), left ventricular outflow tract (LVOT) diameter (OR:1.34; p = 0.001), and mean aortic gradient (OR:0.96; p = 0.006) were independent predictors of deep implantation (mean depth ≥ 6 mm), with LVOT27 mm being predictive specifically for Evolut-R 34 mm (AUC:0.66; p = 0.024).TAVR with Evolut-R 34 mm and Evolut-R 23/26/29 mm showed comparable in-hospital outcome. Aortic angulation60° and LVOT27 mm were predictive respectively of ≥moderate PVL and deep implantation specifically in Evolut-R 34 mm patients.

The MacNew questionnaire is a disease-specific quality of life measure that has been used in patients with myocardial infarction and heart failure. We aimed to investigate the impact of transcatheter aortic valve implantation (TAVI) on health-related quality of life (HRQoL) using MacNew Questionnaire and identify predictors associated with a change in its score. This was a prospective multi-center study performed across 5 National Health Service hospitals in the United Kingdom performing TAVI between 2016 and 2018. HRQoL was assessed using MacNew Questionnaire, Euro Quality of Life-5D-5L, and Short Form 36 questionnaires collected at baseline, 3-, 6- and 12 months after the procedure. Out of 225 recruited patients, 19 did not have TAVI and 4 withdrew their consent, and hence 202 patients were included. HRQoL was assessed in 181, 161, and 147 patients at 3, 6, and 12 months, respectively. Using MacNew, there was a significant improvement in all domains of HRQoL as early as 3 months after TAVI which was sustained up to 12 months with improved discrimination of change in HRQoL compared with other scales. Poor mobility at baseline and history of myocardial infarction were independent predictors of reduced improvement in HRQoL at 3 months. HRQoL increased in all subgroups of patients including frail ones. In conclusion, the MacNew assessment tool performed well in a representative TAVI cohort and could be used as an alternative disease-specific method for assessing HRQoL change after TAVI.

Background Limited data are available regarding clinical outcomes of valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) following the United States Food and Drug Administration approval of ViV TAVI in 2015. Aims The aim of this study was to evaluate in-hospital, 30-day, and 6-month outcomes of ViV TAVI versus repeat surgical aortic valve replacement (SAVR) in patients with a failed aortic bioprosthetic valve. Methods This retrospective cohort study identified patients who underwent ViV TAVI or repeat SAVR utilising the Nationwide Readmission Database from 2016 to 2018. Primary outcomes were all-cause readmission (at 30 days and 6 months) and in-hospital death. Secondary outcomes were in-hospital stroke, pacemaker implantation, 30-day/6-month major adverse cardiac events (MACE), and mortality during readmission. Propensity score-matching (inverse probability of treatment weighting) analyses were implemented. Results Out of 6,769 procedures performed, 3,724 (55%) patients underwent ViV TAVI, and 3,045 (45%) underwent repeat SAVR. ViV TAVI was associated with lower in-hospital all-cause mortality (odds ratio [OR] 0.42, 95% confidence interval [CI]: 0.20-0.90, p=0.026) and a higher rate of 30-day (hazard ratio [HR] 1.46, 95% CI: 1.13-1.90, p=0.004) and 6-month all-cause readmission (HR 1.54, 95% CI: 1.14-2.10, p=0.006) compared with repeat SAVR. All secondary outcomes were comparable between the two groups. Conclusions ViV TAVI was associated with lower in-hospital mortality but higher 30-day and 6-month all-cause readmission. However, there was no difference in risk of in-hospital stroke, post-procedure pacemaker implantation, MACE, and mortality during 30-day and 6-month readmission compared with repeat SAVR, suggesting that ViV TAVI can be performed safely in carefully selected patients.

Background We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. Materials/methods We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. Results We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% ( p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99–1.02). Conclusions TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Background Transcatheter aortic valve replacement (TAVR) computed tomography (CTA) images can be used to evaluate coronary artery disease (CAD). Methods We conducted a prospective cohort study of consecutive TAVR patients from November 2019 to February 2021 to evaluate TAVR CTA assessment of CAD on the rate of pre-TAVR invasive angiography. Patients had CTA first or invasive angiography first at the discretion of their treating physician. TAVR CTA scans were categorized as normal/mild CAD, single vessel disease, high risk (multi-vessel or left main disease), or non-diagnostic in patients without prior coronary artery bypass grafting (CABG) and as low risk or high risk in patients with prior CABG. Invasive angiography was recommended pre-TAVR for high risk or non-diagnostic CTA findings. Results TAVR was performed on 354 patients and CTA first was performed in 273 patients and invasive angiography first in 81 patients. Among 231 patients without prior CABG who had CTA first, 22.1% (51/231) had pre-TAVR invasive angiography and 1.3% (3/231) had pre-TAVR revascularization. Normal/mild CAD or single vessel disease was found on CTA in 174 patients of whom, 0.5% (1/174) had high risk disease on invasive angiography. Among 42 patients with prior CABG who had CTA first, 14.3% (6/42) had pre-TAVR invasive angiography and 2.4% (1/42) had pre-TAVR revascularization. Conclusion TAVR CTA CAD evaluation can avoid pre-TAVR invasive angiography in over 70 % of patients while rarely missing high-risk findings. A CTA first strategy to assess CAD should be considered, especially among patients where conservative management of CAD is preferred.

New or preexisting atrial fibrillation (AF) is frequent in patients undergoing aortic valve replacement. We evaluated whether the presence of AF during transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) impacts the length of stay, healthcare adjusted costs, and inpatient mortality. The median length of stay in the patients with AF increased by 33.3% as compared with those without AF undergoing TAVI and SAVR (5 [3 to 8] days vs 3 [2 to 6] days, p

With continued growth of transcatheter aortic valve replacement (TAVR), safe alternative access remains important for patients without adequate transfemoral (TF) access. Registry-based outcomes with transcarotid (TC) TAVR are favorable compared to transapical or transaxillary/subclavian, but TC vs TF comparisons have not been made. Our objective was to compare outcomes between TF and TC access routes for TAVR at a high-volume United States center. Methods: We retrospectively evaluated all TF and TC TAVR procedures from June 11, 2014 (first TC case) through December 31, 2019. The primary outcomes were 30-day stroke and 30-day mortality. Secondary outcomes were 1-year stroke, 1-year survival, and 30-day and 1-year life-threatening/major bleeding, vascular complications, and myocardial infarction. Propensity score weighted (PSW) models were used to compare risk-adjusted TF and TC outcomes. Of 1,465 TAVR procedures, 1319 (90%) were TF and 146 (10%) were TC. Procedure time and length of stay did not differ between groups. Unadjusted 30-day stroke (TF = 2.0%, TC = 2.7%, P = 0.536) and mortality (TF = 2.1%, TC = 2.7%, P = 0.629) were similar between groups. PSW 30-day stroke (odds ratio (OR) (95% confidence interval (CI)) = 0.8 (0.2-2.8)) and mortality (OR (95% CI) = 0.8 (0.2-3.0)) were similar between groups. Unadjusted and PSW 30-day major/life threatening bleeding, major vascular complications, and myocardial infarction did not differ between groups. Survival at one year was 90% (88%-92%) for TF patients and 87% (81%-93%) for TC patients (unadjusted P = 0.28, PSW hazard ratio = 1.0 (0.6-1.7)). Transcarotid TAVR is associated with similar outcomes compared to transfemoral TAVR at an experienced, high-volume center.

Background: Recent data suggested that transcatheter aortic valve replacement (TAVR) may be indicated also for low-risk patients. However, robust evidence is still lacking, particularly regarding valve performance at follow-up that confers a limitation to its use in young patients. Moreover, a literature gap exists in terms of 'real-world' data analysis. The aim of this study is to compare the cost-effectiveness of sutureless aortic valve replacement (SuAVR) versus transfemoral TAVR.Methods: Prospectively collected data were retrieved from a centralized database of nine cardiac surgery centers between 2010 and 2018. Follow-up was completed in June 2019. A propensity score matching (PSM) analysis was performed.Results: Patients in the TAVR group (n = 1002) were older and with more comorbidities than SuAVR pa-tients (n = 443). The PSM analysis generated 172 pairs. No differences were recorded between groups in 30-day mortality [SuAVR vs TAVR: n = 7 (4%) vs n = 5 (2.9%); p = 0.7] and need for pacemaker implant [n = 10 (5.8%) vs n = 20 (11.6%); p = 0.1], but costs were lower in the SuAVR group (20486.6 +/- 4188 euro vs 24181.5 +/- 3632 euro ; p < 0.01). Mean follow-up was 1304 +/- 660 days. SuAVR patients had a significantly higher probability of survival than TAVR patients (no. of fatal events: 22 vs 74; p < 0.014). Median follow-up was 2231 days and 2394 days in the SuAVR and TAVR group, respectively.Conclusion: The treatment of aortic valve stenosis with surgical sutureless or transcatheter prostheses is safe and effective. By comparing the two approaches, patients who can undergo surgery after heart team evaluation show longer lasting results and a more favorable cost ratio. (C) 2021 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Transcatheter aortic valve replacement has substantially grown in volume over the years, and increasingly is being used in patients with longer life expectancy, including younger patients. With increasing implantation of transcatheter heart valves (THV) the need for explantation of these devices with replacement of the aortic valve will also go up. Bioprosthetic valve endocarditis, along with paravalvular leaks and structural valve degeneration will be the leading causes requiring THV explantation and redo-aortic valve replacement (AVR). Given the cascade of trials in different populations and the rapid development cycle for THV, the patients, design and composition of the bioprostheses being explanted will vary considerably. However, many of the preoperative considerations, imaging and technical considerations in patients with a failed THV will be the same. Here, we highlight the technical steps to achieve a safe THV explantation and redo-AVR.

Despite the rapid adoption of transcatheter aortic replacement (TAVR), surgical TAVR valve explantation (TAVR-explant) and the clinical impact of explanted TAVR device type are not well described.TAVR-explant from 2016 to 2019 was queried using the Society of Thoracic Surgeons (STS) National Database. A total of 483 patients with documented explanted valve type, consisting of 330 (68%) patients with balloon-expandable and 153 (32%) patients with self-expandable devices, were identified. The primary outcome was 30-day mortality. The secondary outcome was the need for any simultaneous procedures with TAVR-explant.The mean age was 72.8 years, 38% of the patients were female, and 51% demonstrated New York Heart Association functional class III to IV symptoms. During TAVR-explant, 63% of patients required other simultaneous procedures, including aortic repair (27%), mitral procedures (22%), coronary artery bypass grafting (15%), and tricuspid procedures (7%). Patients with a self-expandable device underwent more frequent ascending aortic replacement (22% vs 9%; P.001) than those with a balloon-expandable device, whereas the aortic root replacement rate was similar (19% vs 24%; P = .22). The overall 30-day mortality was 18% without differences in the mortality or other major complications between the groups. Of the 157 patients with isolated surgical aortic valve replacement and available STS predicted risk of mortality score, the observed-to-expected (O/E) mortality ratio was 2.2.The TAVR-explant outcomes were comparable between patients with balloon-expandable devices and patients with self-expandable devices, whereas ascending aortic replacement was observed more frequently in patients with self-expandable devices. Younger patients undergoing TAVR should be informed of the future TAVR-explant risk that may accompany a higher O/E ratio and frequent morbid concurrent procedures.

With wide expansion of transcatheter aortic valve replacement (TAVR) and dissemination of multidisciplinary-based approaches to care, societies are discussing the implementation of a tier system to valve centers. This study explores the impact of tier-based systems of care on surgical aortic valve replacement (SAVR) outcomes at institutions that perform SAVR only.Medicare beneficiaries undergoing SAVR procedures from 2012 to 2015 were included. The SAVR hospitals were stratified into either tier A, valve centers with a TAVR program; or tier B, valve centers without a TAVR program. Adjusted survival, assessed by multivariable Cox regression, controlled for program type and patient risk profile. Time-dependent analysis accounted for hospitals that initiated a TAVR program during the study period.Overall, there were 562 tier A and 485 tier B SAVR hospitals. Tier A hospitals had significantly higher comorbidity burden compared with tier B hospitals (all P.05) but had significantly lower rates of 30-day mortality (3.2% vs 4.1%) and 1-year mortality (8.1% vs 9.4%; both P.05). After risk stratification, tier B hospitals had significantly worse 30-day mortality compared with tier A hospitals for all patient risk-profiles, except for the low-risk patients (P.01). These findings persisted in the time-dependent analysis. Adjusted midterm survival was higher in tier A vs tier B hospitals.Low-risk patients can safely undergo SAVR in both tier level hospitals without compromising outcomes. Establishment of quality of care measures, especially in the SAVR-only hospitals, remains paramount and should be closely integrated when designing tier-based systems for aortic valve replacement care.

Background The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented. Methods Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak. Results Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak. Conclusions The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Comparative costing studies using real-world data stratified by patient case-mix, are valuable to decision makers for making reimbursement decisions of new interventions. This study evaluated real-world hospital admissions and short-term costs of transcatheter aortic valve implantation (TAVI) and isolated surgical aortic valve replacement (SAVR) for patients with aortic stenosis, stratified by the Society of Thoracic Surgeons (STS) risk scores.Retrospective analysis of consecutive patients with a principal diagnosis of aortic stenosis who underwent isolated valve replacement at a single tertiary hospital, January 2012-December 2017. Patients were followed-up for 30 days post-procedure or until hospital discharge if index hospitalisation was greater than 30 days. Intensive care unit (ICU) and hospital length of stay (days), and costs in 2018 Australian dollars for the index procedure and 30-day follow-up were assessed. Multivariable generalised linear and two-part models with gamma distribution and log link function adjusting for Society of Thoracic Surgeons (STS) risk group and key sociodemographic characteristics were used.Of 488 patients, 61% males, median age 78 years (IQR 14 years), 221 (45%) received transcatheter aortic valve replacement (TAVI) and 267 (55%) received surgical aortic valve replacement (SAVR). STS risk scores were low (28%), intermediate (46%) and high (26%) for TAVI patients, and low (85%), intermediate (12%) and high (3%) for SAVR patients. When adjusted, TAVI length of stay was 57% shorter than SAVR (95% CI 31-83%, p0.001) for intensive care unit (ICU) admission, and 64% shorter (95% CI 47-81%, p0.001) for hospital admissions. TAVI costs were 13% lower than SAVR (95% CI 4-22%, p=0.005).This data suggests short-term health care costs are lower for patients with aortic stenosis undergoing TAVI than SAVR. A further roll-out of the TAVI program in hospitals across Australia may result in savings to the health system.

The presence of a horizontal aorta in patients treated with transcatheter aortic valve replacement increases the difficulty of the procedure. We present 5 cases with aortic stenosis with a horizontal aorta who underwent transcatheter aortic valve replacement using a self-expanding prostheses, with the objective of describing the techniques used and obtaining success with a snare catheter. (Level of Difficulty: Intermediate.), Central Illustration

Objectives The aim of this study was to compare the incidence and prognostic significance of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) according to racial groups. Background PPM after TAVR may be of more concern in Asian populations considering their relatively small annular and valve sizes compared with Western populations. Methods TP-TAVR (Transpacific TAVR Registry) was an international multicenter cohort study of patients with severe aortic stenosis who underwent TAVR in the United States and South Korea from January 2015 to November 2019. PPM was defined as moderate (0.65-0.85 cm2/m2) or severe ( Results Among 1,101 eligible patients (533 Asian and 569 non-Asian), the incidence of PPM was significantly lower in the Asian population (33.6%; moderate, 26.5%; severe, 7.1%) than in the non-Asian population (54.5%; moderate, 29.8%; severe, 24.7%). The 1-year rate of the primary outcome was similar between the PPM and non-PPM groups (27.5% vs 28.1%; P = 0.69); this pattern was consistent between Asian (25.4% vs 25.2%; P = 0.31) and non-Asian (28.7% vs 32.1%; P = 0.97) patients. After multivariable adjustment, the risk for the primary outcome did not significantly differ between the PPM and non-PPM groups in the overall population (HR: 0.95; 95% CI: 0.74-1.21), in Asian patients (HR: 1.07; 95% CI: 0.74-1.55), and in non-Asian patients (HR: 0.86; 95% CI: 0.63-1.19). Conclusions In this study of patients with severe aortic stenosis who underwent TAVR, the incidence of PPM was significantly lower in Asian patients than in non-Asian patients. The 1-year risk for the primary composite outcome was similar between the PPM and non-PPM groups regardless of racial group. (Transpacific TAVR Registry [TP-TAVR]; NCT03826264 )

Conduction disturbances after transcatheter aortic valve implantation (TAVI) are common, heterogeneous, and frequently result in permanent pacemaker implantation (PPI). Pacemaker therapy with a high rate of right ventricular pacing is associated with heart failure, hospitalizations, and reduced quality of life.The purpose of this study was to compare medium-term outcomes between PPI implantation strategies, as choosing the right indication for PPI is still an area of uncertainty and information on outcomes of PPI regimens beyond 1 year is rare.We compared outcomes after 3 years between a restrictive PPI strategy, in which the lowest threshold for PPI was left bundle branch block (LBBB) (QRS120 ms) with the presence of new atrioventricular block (PQ200 ms), and a liberal PPI regimen, in which PPI already was performed in patients with new-onset LBBB.Between January 2014 and December 2016, TAVI was performed in 884 patients at our center. Of these, 383 consecutive, pacemaker-naive patients underwent TAVI with the liberal PPI strategy and subsequently 384 with the restrictive strategy. The restrictive strategy significantly reduced the percentage of patients undergoing PPI before discharge (17.2% vs 38.1%; P.001). The incidence of the primary endpoint (all-cause-mortality and hospitalization for heart failure) after 3 years was similar in both groups (30.7% vs 35.2%; P = .242), as was all-cause-mortality (26.6% vs 29.2%; P = .718). Overall, patients who required PPI post-TAVI had significantly more hospitalizations due to heart failure (14.8% vs 7.8%; P = .004).A restrictive PPI strategy after TAVI reduces PPI significantly and is safe in medium-term follow-up over 3 years.

A 69-year-old man with mediastinal radiation history underwent balloon valvuloplasty before transcatheter aortic valve replacement, which caused aortic leaflet rupture leading to unstable severe aortic regurgitation and subsequent left main ostial obstruction. A balloon-expanding valve was implanted to capture the ruptured leaflet and a left main stent was placed. (Level of Difficulty: Advanced.), Central Illustration

To compare short- and long-term outcomes after transcatheter aortic valve implantation (TAVI) in the public and private hospital setting.Propensity-matched, retrospective analysis of a prospective registry.Patients with severe aortic stenosis who underwent TAVI at a tertiary public hospital (n=507) and an experienced private hospital (n=436).The primary endpoint was all-cause mortality.Patients that underwent TAVI in the public hospital were younger than patients in the private hospital (82±8 years vs 84±6 years, p0.001), with lower estimated short-term mortality risk (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score4.0%: 43% vs 56%, p0.001). There was no difference between public and private hospitals in 30-day mortality (1.5% vs 1.2%, p=1.0), and the rate of complications was similar. Long-term survival was similar in propensity-matched public (n=344) and private (n=344) patient cohorts. The 1-year, 2-year, 5-year and 7-year survival rates were 95%, 90%, 67% and 47% in public patients, and 92%, 86%, 67% and 51% in private patients (p=0.94). In multivariable analysis, the hospital setting was not a predictor of mortality.Despite increased age and predicted mortality in private hospital patients, short- and long-term outcomes after TAVI were comparable between public and private hospital settings. This study demonstrates the feasibility of performing TAVI in a private hospital with a dedicated and experienced team and questions the current restricted access to TAVI in the private sector.

Bicuspid aortic insufficiency (BAI) patients with root aneurysm often require aortic valve and root replacement in a composite procedure. The valve-sparing root replacement (VSARR) procedure is aimed at preserving the native valve when possible. This case highlights a successful transcatheter aortic valve replacement procedure in a BAI patient previously treated with VSARR. (Level of Difficulty: Intermediate.), Central Illustration

Background Transcatheter aortic valve replacement (TAVR) procedural success relies heavily on volumetric reconstruction imaging, particularly ECG-gated multi-detector row computed tomography. We postulated that single examination using fast low-angle shot (FLASH) dual source CT scanning (DS-CTA) could provide lower dose than ECG-gated CTA while maintaining the image quality. Methods In this single-centre cohort study, all patients who underwent ECG-gated and FLASH DS-CTA were evaluated. Volumetric reconstructions were performed for both ECG-gated and FLASH DS-CTA to obtain nonsagittal views of the structures. ECG-gated cardiac CT was obtained to evaluate the aortic annular size while FLASH DS-CTA was obtained to examine the aortic and iliac vasculature as part of TAVR imaging protocol. We evaluated measures of aortic annulus, coronaries and sinus of Valsalva using ECG-gated and FLASH DS-CTA scanning protocols. Image quality assessments were performed using aortic root region-of-interest signal-to-noise ratio. Results A total of 130 patients (mean age 81.5 ± 9.2 years, 46.2% female, and 99.2% white) underwent both ECG-gated CT and FLASH DS-CTA. There were excellent correlations between aortic annular area (R2 = 0.934) and aortic annular perimeter (R2 = 0.923) measured by the two protocols. Only 2 (1.5%) patients had >10% difference between aortic annular measurements by ECG-gated and FLASH DS-CTA, while none of the patients had a >10% difference between aortic annular perimeter measured by ECG-gated and FLASH DS-CT scans. There was no significant difference in signal-to-noise ratio between the two methods (mean difference 13.4; 95% CI −2.1–28.8, p = 0.09). There was significantly lower radiation dose for FLASH DS-CTA than ECG-gated CT scan (mean dose-length product difference 404.38; 95% CI 328.9–479.87, p Conclusion Overall, FLASH DS-CTA and ECG-gated CT scans provided comparable image quality and aortic annular dimensions for pre-TAVR evaluation. DS-CTA additionally provided the necessary angiographic imaging of the aorta and peripheral access vessels while still maintaining a lower radiation dose. We propose that a single non-ECG gated FLASH DS-CTA could be utilized to provide all the necessary pre-TAVR imaging information without a gated CT scan.

The aim of this study was to compare the prevalence and real-world outcomes of patients who require peripheral vascular intervention during the same hospitalization as transcatheter aortic valve replacement (TAVR) compared with TAVR alone.There are limited data on the prevalence and outcomes of combined TAVR and percutaneous peripheral vascular intervention.All patients who underwent TAVR in 2016 and 2017 were identified using the Nationwide Readmissions Database. Outcomes of patients undergoing TAVR alone were compared with those of patients undergoing combined TAVR and peripheral intervention, TAVR and peripheral intervention with and without a history of peripheral artery disease, and alternative-access TAVR with transfemoral TAVR in individuals undergoing peripheral intervention. The primary outcome was in-hospital mortality.A total of 99,654 hospitalizations were identified, among which 4,397 patients (4.42%) underwent peripheral intervention during the same admission as TAVR. Patients who required peripheral intervention had increased mortality (4.2% vs 1.5%; P 0.001), stroke (3.5% vs 1.8%; P 0.001), acute kidney injury (17.6% vs 10.8%; P 0.001), blood transfusion (16.0% vs 11.3%; P 0.001), 30-day readmission (16.3% vs 12.1%; P 0.001), median length of stay (4 days [IQR: 2-8 days] vs 3 days [IQR: 2-5 days]; P 0.001), and hospitalization charges. Compared with patients undergoing peripheral intervention to facilitate transfemoral TAVR, alternative-access TAVR was associated with increased mortality (4.6% vs 3.0%; P = 0.036), acute kidney injury (22.7% vs 14.3%; P 0.001), median length of stay (5 days [IQR: 3-10 days] vs 4 days [IQR: 2-7 days]; P 0.001), and 30-day readmission (18.1% vs 15.5%; P = 0.012).Peripheral vascular intervention may be used to facilitate transfemoral access or as a bailout for vascular complications during TAVR. Combined TAVR and peripheral intervention is associated with an increased risk for adverse events, though outcomes are better compared with alternative-access TAVR using a nonfemoral approach.

Resumen Introduccion y objetivos La Asociacion de Cardiologia Intervencionista de la Sociedad Espanola de Cardiologia (ACI-SEC) presenta su informe anual de actividad de 2020, ano de la pandemia de la COVID-19. Metodos Se invito a participar a todos los centros espanoles con sala de hemodinamica. La recogida de datos se realizo por via telematica y una empresa externa, junto con los miembros de la ACI-SEC, llevo a cabo su analisis. Resultados Participaron 123 centros (4 mas que el ano previo), 83 publicos y 40 privados. Se observo una reduccion del 9,4% de coronariografias, el 10,1% de intervenciones coronarias percutaneas, el 4,1% de angioplastias primarias, el 0,9% de valvulas aorticas transcateter y el 8,3% de cierre de orejuelas. Los unicos procedimientos que se incrementaron con respecto a anos previos fueron la reparacion mitral con clips (13,8%) y el cierre del foramen oval permeable (19,4%). En cuanto a los dispositivos, disminuyeron las guias de presion (5,5%), la imagen intravascular y los dispositivos de preparacion de placa (a excepcion de la litotricia, que aumento un 62%). Conclusiones El registro en el ano de la pandemia de la COVID-19 demuestra una marcada caida en la actividad de todos los procedimientos a excepcion de la reparacion percutanea de la valvula mitral con clips y el cierre del foramen oval permeable. Dicha caida es menor que lo descrito previamente, lo cual indica un rebote de la actividad intervencionista tras la primera ola. Introduction and objectives The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) presents its annual activity report for 2020, the year of the coronavirus disease (COVID-19) pandemic. Methods All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company, together with the members of the ACI-SEC. Results A total of 123 centers participated (4 more than 2019), of which 83 were public and 40 were private. Diagnostic coronary angiograms decreased by 9.4%, percutaneous coronary interventions by 10.1%, primary percutaneous coronary interventions by 4.1%, transcatheter aortic valve replacements by 0.9%, and left atrial appendage closure by 8.3%. The only procedures that increased with respect to previous years were edge-to-edge mitral valve repair (13.8%) and patent foramen ovale closure (19.4%). The use of pressure wire (5.5%), intravascular imaging devices and plaque preparation devices decreased (with the exception of lithotripsy, which increased by 62%). Conclusions In the year of the COVID-19 pandemic, the registry showed a marked drop in activity in all procedures except for percutaneous mitral valve repair and patent foramen ovale closure. This decrease was less marked than previously described, suggesting a rebound in interventional activity after the first wave. Full English text available from:www.revespcardiol.org/en

Background Transfemoral access is the most common approach for transcatheter aortic valve replacement (TAVR). However, a subset of patients require alternative access. This study describes the evolution and outcomes of alternative-access TAVR at Cleveland Clinic. Methods From January 2006 to January 2019, 2446 patients underwent TAVR, 414 (17%) through alternative access (247 transapical, 95 transaortic, 56 transaxillary, 2 transcarotid, 10 transiliac, 4 transcaval). Patients undergoing alternative-access TAVR had high preoperative risk. Propensity-matched comparisons were targeted at comparing transfemoral versus transaxillary approaches since 2012. Results Over time, the favored alternative-access approach shifted from transapical and transaortic to transaxillary. Pacemaker requirement was similar for alternative-access and transfemoral approaches. Compared with transfemoral access, major vascular injuries were higher in the alternative-access group (12 [2.9%] vs 27 [1.3%], P = .02), but minor vascular injuries were lower (13 [3.1%] vs 198 [9.8%], P Conclusions The transaxillary approach has emerged as our preferred alternative-access strategy for TAVR. It is associated with superior operative outcomes compared with transthoracic approaches, and results are comparable with those of the transfemoral approach.

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving treatment option with an inherent risk of causing cerebral infarctions. The mechanism of cerebral infarction during TAVI mainly involves embolisms from the aortic wall and valve. Transoesophageal echocardiography (TEE) is useful for detecting aortic atheromas. We present the case of a patient in whom the dispersal of aortic atheromas was monitored by TEE during TAVI. This report demonstrates the importance of preoperatively predicting embolisms from aortic atheromas in patients with severe aortic stenosis.