Self-expanding Transcatheter Research Articles

Cusp overlap method for self-expanding transcatheter aortic valve replacement.

Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used. We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique. We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers. There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar. Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve.

Comparing balloon-expandable and self-expanding transfemoral transcatheter aortic valve replacement based on subgroups in Germany 2019/2020

BackgroundPreviously, overall comparable outcomes were seen for balloon-expandable (BE) or self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR). However, subgroup analyses based on large case numbers are still needed.MethodsGerman national data of all BE and SE transfemoral TAVR treating aortic valve stenosis in 2019 and 2020 were analysed. We then compared different outcomes and performed a subgroup analysis for the endpoint in-hospital mortality.ResultsOverall, 46,243 TAVR were analysed, 19,910 BE, and 26,333 SE. Patients in the SE group had a significantly higher logistic EuroSCORE (13.61 vs 12.66%, p < 0.001), age (81.55 vs 79.99a, p < 0.001), and proportion of women (54.82 vs 40.06%, p < 0.001). Both groups showed a similar in-hospital mortality with 2.37% in BE and 2.35% in SE (p = 0.916). In-hospital mortality also did not differ significantly after risk adjustment (OR = 0.98 [0.86, 1.13], p = 0.799). Patients in the SE group had a significantly lower risk of major bleeding (OR = 0.83 [0.73, 0.95], p = 0.006), but a significantly higher risk of stroke (OR = 1.38 [1.19, 1.59], p < 0.001), delirium (OR = 1.15 [1.06, 1.24], p = 0.001), and permanent pacemaker implantation (OR = 1.29 [1.21, 1.37], p < 0.001). In the subgroup analysis of in-hospital mortality, there were no significant differences in any of the observed subgroups (age < 75/75–79/80–84/ ≥ 85a, logistic EuroSCORE < 4/4– < 9/ ≥ 9, gender, NYHA III/IV, previous CABG, peripheral vascular disease, COPD, pulmonary hypertension, renal disease GFR < 30 ml/min, and diabetes mellitus).ConclusionIn the direct comparison of balloon-expandable and self-expanding TAVR, there are no differences for in-hospital mortality in subgroups.Graphical abstract

Self-expanding or balloon-expandable transcatheter aortic valve replacement in a German comparison

Abstract Background Studies demonstrated that results for self-expanding vs balloon-expandable transcatheter aortic valve replacement (TAVR) are similar, with larger subgroup analyzes missing. Methods We identified 46,243 self-expanding (SE) and balloon-expandable (BE) transfemoral TAVR for aortic stenosis in German hospitals in 2019 or 2020. Both in-hospital outcomes as well as subgroups for in-hospital mortality were analyzed. Results Regarding baseline characteristics, the logistic EuroSCORE was higher in SE (SE 13.6% - BE 12.7%; p&amp;lt;0.001), which also applied to age (SE 81.6a - BE 80.0a; p&amp;lt;0.001). There was a comparable in-hospital mortality rate in both groups (BE 2.37% - SE 2.35%; p=0.916). Risk adjusted in-hospital mortality was also not significantly different (OR=0.98, p=0.799). The SE group presented a significantly lower risk of major bleeding events (OR=0.83, p=0.006), however, there was a significantly higher risk of stroke (OR=1.38, p&amp;lt;0.001), risk of delirium (OR=1.15, p=0.001) as well as risk of permanent pacemaker implantation (OR=1.29, p&amp;lt;0.001). No difference has been found for acute kidney injury, mechanical ventilation &amp;gt;48h, length of hospital stay, and reimbursement. In addition, the subgroups showed no significant differences for in-hospital mortality regarding age, logistic EuroSCORE, gender, heart failure NYHA III/IV, previous coronary artery bypass graft, peripheral vascular disease, chronic obstructive pulmonary disease, pulmonary hypertension, renal disease GFR &amp;lt;30ml/min or diabetes mellitus. Conclusion Self-expanding or balloon-expandable TAVR did not show significant differences for in-hospital mortality in a subgroup analysis in Germany.

Abstract 15800: Evaluating the Correlation Between Right Ventricular Outflow Tract Dimensions and Arrhythmia Risk Following Self-Expanding Transcatheter Pulmonary Valve Replacement

Introduction: The introduction of self-expanding valves has allowed for an expanded range of patients who can be treated with transcutaneous pulmonary valve replacement (TPVR). Though major complications are rare, ventricular tachycardia has been reported following self-expanding valve placement prompting investigation of potential risk factors. Hypothesis: Significant variation in valve dimensions within the right ventricular outflow tract (RVOT) throughout the cardiac cycle is postulated as a cause for increased arrhythmia risk. We hypothesized that greater dynamic variation of the valve in the RVOT correlates to higher ventricular arrythmia risk. Methods: A single center review was performed of patients who underwent TPVR with either Harmony TPV or Alterra Pre-stent with subsequent placement of 29mm Sapien valve between 2019 and 2023. Using post-procedural 3D rotational angiography, minimum (systole) and maximum (diastole) diameters (mm), perimeter (mm) and cross-sectional area (mm 2 ) of the valve frame were measured in two locations: closest to the branch pulmonary artery bifurcation and the RV cavity. Results: Twenty-eight patients were included (14 Harmony TPV, 14 Alterra). Higher frequency of ventricular arrythmia was seen in patients with congenital pulmonary stenosis ( p =0.004). Higher ventricular arrythmia rate was associated with larger diastolic diameter (34.1 vs 33.2mm, p =0.04), mean perimeter (118.3 vs 108.6mm, p =0.03) and area (1124.5 vs 926.2mm 2 , p =0.03) of the valve frame closest to the RV cavity. Conclusions: Increased movement of the valve frame close to the RV cavity may correlate with a higher ventricular arrythmia risk due to increased contact with the native RVOT throughout the cardiac cycle. Future studies should focus on more accurate, mathematical methodology to better understand whether the complex interaction between self-expanding valves and the native RVOT is a determinant for post-procedural ventricular arrythmia.

Abstract 16590: Left Ventricular Remodelling Following Transcatheter Mitral Valve Replacement With the Innovalve System

Introduction: Transcatheter Mitral Valve Replacement (TMVR) using a trans-septal approach is a new therapeutic option for patients with severe mitral regurgitation (MR). However, both surgical as well as currently under-testing trans-catheter approach, are shown to cause decrease in LV function. The Innovalve TMVR is a novel self-expandable transcatheter mitral valve prosthesis, delivered trans-septally using femoral venous access. It is deployed in an intravalvular posterior position after subvalvular anchoring by rotation of 6 circumferential arms Hypothesis: TMVR procedure (Innovalve system) leads to LV anatomical and functional changes Methods: CT was performed before the Innovalve TMVR procedure, and after 3 to 6 months. CT protocol included retrospective ECG gating with full cardiac cycle coverage. LV end diastolic and end systolic diameters (LVEDD, LVESD) were measured in the left ventricular outflow tract orientation at the most basal level. Tip to tip papillary muscle distance was measured in the short axis orientation at the most basal slice demonstrating the papillary muscle tips. LV ejection fraction (LVEF) was calculated using the end systolic and end diastolic volumes. All measurements were performed at end systole and end diastole before MTVR and after 3-6 months using a dedicated platform (3Mensio). Results: Ten patients (7 males) average age 69+/-10 years, underwent the Innovalve TMVR procedure. Average LVESD decreased from 52±15 mm at baseline to 44±15mm (P=0.016) at 3-6 months. Similarly, LVEDD decreased from 60±14 mm at baseline, to 52±13mm at 3-6 months (P=0.039). Average papillary muscle tip to tip distance at end diastole (ED) decreased from 31.7±7mm at baseline to 28.4±6.5mm at 3-6 months (P=0.047).A trend of LVEF improvement was evident with an increase from 35%±12 average at baseline compared with 39%±12 average after 3-6 months (P=0.346). Conclusions: These preliminary results show that the TMVR procedure using the Innovalve system may result in favourable LV reverse remodelling changes including reduction of LVESD, LVEDD and ED papillary muscle distances, with improved LVEF. This encouraging data might suggest favourable postprocedural structural LV change.

Optimal Angiographic View for Implantation of Self-Expanding Transcatheter Aortic Valves

Background. Transcatheter aortic valve implantation is safe and effective alternative to surgical treatment of severe aortic valve stenosis among patients of all risk groups. Optimal implantation depth is key for successful hemodynamic and clinical&#x0D; Results. Despite the improvement of prostheses design and increasing experience of operators cardiac conduction abnormalities and paravalvular leak continue to be a significant complication of this procedure, directly affecting the long-term prognosis. Self-expanding valves require special approaches for optimal angiographic projection to assess the implantation depth of the prosthesis. &#x0D; Aims in this study we compared coplanar view and cusp overlap technique during self-expanding aortic valves implantation. &#x0D; Methods. We performed a retrospective analysis of 81 TAVI performed in Russian Research Center of Surgery. The patients were divided into two groups depending on the implantation projection: coplanar view (CV) and cusp overlap technique (COT). The incidence of cardiac conduction abnormalities (cumulative incidence of third degree AV block and left bundle branch block) depending on the implantation projection was analyzed. The procedural characteristics in the form of contrast agent volume, fluoroscopic time and operator comfort were also evaluated. &#x0D; Results. After TAVI 16 (51.6%) and 13 (26.0%) patients had cardiac conduction disturbances (cumulative incidence of third degree AV block and left bundle branch block) in the CV and COT respectively (p = 0.019). In the CV group, 2 (6.5%) patients, and in the COT group, 3 (6%) patients had third degree AV block (p = 0.935) and 14 (45.2%) и 10 (20%) left bundle branch block (p = 0,016). In the COT group, there was a significant decrease contrast media (181 66.4 mL vs. 158.9 50.8 mL, p = 0.032). Fluoroscopic time also decreased (23.2 7.7 min vs. 21.3 6.8 min), but without a significant difference (p = 0.678). According to the results of the operator survey, the COT projection was more comfortable. &#x0D; Conclusions. Optimal implantation depth is an important condition for achieving hemodynamic efficiency of the prosthesis and reducing the risk of conduction abnormalities. Operator comfort, better assessment of the implantation depth, safety and efficiency of the cusp overlap technique allow its use as the main implantation view for TAVI.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial

BackgroundData comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. ObjectivesThe authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. MethodsPatients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. ResultsA total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. ConclusionsIn patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Outcomes Following Transcatheter Aortic Valve Replacement for Aortic Stenosis in Patients With Type 0 Bicuspid, Type 1 Bicuspid, and Tricuspid Aortic Valves.

Data concerning the outcomes of transcatheter aortic valve replacement in type 0 bicuspid aortic stenosis (AS) are scarce. The study aims to compare the outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy. We enrolled consecutive patients undergoing transcatheter aortic valve replacement for severe AS between 2012 and 2022 in this single-center retrospective cohort study. The primary outcome was mortality, while secondary outcomes included in-hospital complications such as stroke and pacemaker implantation and transcatheter heart valve hemodynamic performance. The number of patients with AS with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy was 328, 302, and 642, respectively. Self-expanding transcatheter heart valves were used in the majority of patients (n=1160; 91.4%). In the matched population, differences in mortality (30 days: 4.2% versus 1.7% versus 1.7%, Poverall=0.522; 1 year: 10% versus 2.3% versus 6.2%, Poverall=0.099) and all stroke (30 days: 1.0% versus 0.9% versus 0.0%, Poverall=0.765; 1 year: 1.4% versus 1.6% versus 1.3%, Poverall=NS) were nonsignificant, and the incidence of overall in-hospital complications was comparable among groups. Ascending aortic diameter was the single predictor of 1-year mortality in type 0 bicuspid patients (hazard ratio, 1.59 [95% CI, 1.03-2.44]; P=0.035). The proportion of patients with a mean residual gradient ≥20 mm Hg was the highest in those with type 0 bicuspid anatomy, although the need for permanent pacemaker implantation was the lowest in this group. Major clinical outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy are equivalent at short- and mid-term follow-up. These observations merit further exploration in prospective international registries and randomized controlled trials.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40mm Hg, peak aortic velocity >3 and <4m/s, and aortic valve area >1.0 and <1.5cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30days and 1year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30days and 1year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Self-Expandable Transcatheter Heart Valve Embolization Caused by Sledding Phenomenon With a Pigtail Catheter

Self-Expandable Transcatheter Heart Valve Embolization Caused by Sledding Phenomenon With a Pigtail Catheter

Impact of different in vitro models on functional performance of the self-expanding transcatheter heart valve.

Transcatheter heart valves (THVs) are investigated according to International Organization for Standardization requirements using in vitro heart simulators to evaluate hydrodynamic performance. In contrast to surgical valves, a THV's performance heavily depends on the configuration and shape of the aortic anulus. In International Organization for Standardization regulations, there is no detailed definition for the construction of a compartment in which a THV has to be tested. Therefore, the aim of this in vitro study was to compare different in vitro models for functional testing of THVs. Porcine aortic conduits (23-mm diameter) were implanted in Dacron prostheses and calcified with double-distilled water and calcification buffer at 37°C over 83 million cycles in a Hi-Cycler (durability testing) mimicking nearly 3 patient-years. Hydrodynamic testing of Evolut PRO 26 mm was performed within 3 models (plexiglass, native conduit and calcified conduit; all 23-mm diameter) at a frequency of 64 bpm and different stroke volumes (55-105 ml). Calcified conduits showed significantly higher mean pressure gradients (MPG) and lower effective orifice areas (EOA) in comparison to native conduits (without THV; P < 0.001). EOA and MPG of Evolut PRO differed depending on the model tested. Calcified conduits resulted in the lowest EOA and highest MPG of the THV compared to plexiglass and the native conduit. Full expansion of the THV was least impaired in the native conduit, while lowest geometric orifice area, lowest minimal internal diameter and highest pin-wheeling index of Evolut PRO were seen in the calcified conduit. Full expansion and functional performance of the Evolut PRO THV depends on the configuration of the testing compartment in an in vitro setting.

Self-Expandable Prosthesis Valve Adaptation: Non-Uniform Expansion and Stent Frame Decoupling

The incidence of non-uniform expansion in the context of the self-expandable transcatheter heart valve (THV) is little investigated, along with stent-frame decoupling, which is a form of stent adaptation, in which the lower part of the THV stent conforms to both the ellipticity of the left ventricle outflow tract and the native annulus while maintaining the higher part of the valve more circular. We analyzed post-implant multi-detector computed tomography scans in 50 patients. Prosthesis non-uniform expansion was assessed by computing the prosthesis eccentricity on 6 prespecified levels: (1) frame inflow, (2) native annulus, (3) leaflet inflow, (4) prosthesis waist, (5) leaflet outflow, and (6) frame outflow. Stent-frame decoupling was assessed by comparing the mean eccentricity on 6 different prosthesis levels. Implantation depth, leaflet expansion and alignment, and residual anatomic sinus area ratios were also calculated. Subclinical leaflet thrombosis was defined as hypoattenuated lesion of a meniscal shape. At a 12-month follow-up, non-uniform expansion was consistently detected at each valvular level. Highest eccentricity was measured at the native annulus level (eccentricity: 0.54 ± 0.12), while the lowest index at the frame outflow level (0.23 ± 0.11). Similar results were observed in the subgroup analyses of sizes 23, 26, 29, and 34. Eccentricity significantly decreased from the annulus level to the prosthesis frame outflow (p <0.001). Notably, the incidence of mild-to-severe subclinical leaflet thrombosis was relevant (16%). In conclusion, prosthesis non-uniform expansion and stent frame decoupling frequently occur after self-expandable THV replacement. The clinical and hemodynamic implications remain uncertain.

Results of new-generation balloon vs. self-expandable transcatheter heart valves for bicuspid aortic valve stenosis.

Data comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV. A total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV. A 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109). Treatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.

Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.

Cusp overlap technique decreases paravalvular leakage in self-expandable transcatheter aortic valve replacement.

The cusp overlap technique allows greater visual separation between the basal annular plane and the conduction system and decreases the permanent pacemaker implantation rate. We assessed the impact of the cusp overlap technique on conduction disturbance and paravalvular leakage after transcatheter aortic valve replacement. A total of 97 patients underwent transfemoral transcatheter aortic valve replacement with self-expandable valves at our institution from November 2018 to January 2023. The mean age of the patients was 85years, and 23% were male. The patients were divided into two groups: the cusp overlap technique group and the non-cusp overlap technique group. We compared the clinical results between the two groups. The 30-day permanent pacemaker implantation rate was similar between the two groups (cusp overlap technique: 6.3% vs. non-cusp overlap technique: 10.2%, p = 0.48). The rate of new-onset conduction disturbance was slightly lower in the cusp overlap than non-cusp overlap technique group (18.8% vs. 34.7%, respectively; p = 0.08). The implanted valve function was similar between the two groups, but the rate of trivial or less paravalvular leakage (PVL) was significantly higher in the cusp overlap technique group on echocardiography (69% vs. 45%, p = 0.02). On multidetector computed tomography, the implantation depth at the membranous septum was significantly shorter in the cusp overlap technique group (2.0 ± 2.3 vs. 2.9 ± 1.5mm, p = 0.02). The degree of canting was slightly smaller in the cusp overlap technique group (1.0 ± 2.2 vs. 1.7 ± 1.9mm, p = 0.07). The relative risk of PVL equal to or greater than mild was 1.76 times higher for valve implantation without the cusp overlap technique (adjusted odds ratio, 3.74; 95% confidence interval, 1.45-9.69; p < 0.01). Transcatheter aortic valve replacement using the cusp overlap technique is associated with an optimized implantation depth, leading to fewer conduction disturbances. Optimal deployment may also maximize the radial force of self-expanding valves to reduce paravalvular leakage.

Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study

The purpose of this first-in-human (FIH) study was to determine the safety and feasibility of the transfemoral premounted dry-pericardium Vienna Self-Expandable Supra-Annular Aortic Valve System. This novel system is repositionable and retrievable and comes already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. This is a prospective, nonrandomized, single-arm, single-center, first-stage FIH feasibility study, which will be followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis. The first-stage FIH study evaluated the safety and feasibility of the device in 10 patients with severe aortic stenosis based on recommendations by the Valve Academic Research Consortium-2 for transcatheter aortic valve implantations. The mean patient age was 79±5years, 60% were male, and all patients were in New York Heart Association functional class II to III. The primary safety end point was successful when all patients were alive at 30-day follow-up. Device and technical success were observed in all patients. Two patients had a stroke, 1 of which occurred 5days after the procedure. New permanent pacemakers were implanted in 2 patients (22.2%), of which only 1 was because of complete heart block. Only 1 patient (10%) had moderate paravalvular leak at 30days. After the procedure, the mean aortic valve gradient decreased from 48.7±10.8mmHg to 8.8±4.3mmHg. In conclusion, this FIH feasibility study demonstrates successful procedural feasibility, with no 30-day mortality and favorable valve hemodynamic performance, leading to an improvement in quality of life. ClinicalTrials.gov identifier NCT04861805.

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

Assessment of Hemodynamics and Patient-Prosthesis Mismatch by Valve Size for an Intra-Annular Self-Expanding Transcatheter Heart Valve at 30 Days

Assessment of Hemodynamics and Patient-Prosthesis Mismatch by Valve Size for an Intra-Annular Self-Expanding Transcatheter Heart Valve at 30 Days

Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

The impact of cusp overlap on permanent pacemaker requirement following self-expanding transcatheter aortic valve replacement

Background/purposeThe cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center. MethodsWe conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve. ResultsOf the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve. ConclusionsThe cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates.