Project description:BackgroundThe need for permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve replacement (TAVR). Deep implantation position is a risk factor for PPM implantation. Thus, in the field of self-expandable (SE) transcatheter heart valves (THV) cusp overlap projection (COP) technique was implemented to reduce parallax, allowing a more precise guidance of implantation depth.AimsThis meta-analysis aims to report the outcome of patients undergoing TAVR with SE THV using COP versus conventional implantation technique (CIT).MethodsSystematical search in MEDLINE and EMBASE yielded five observational controlled studies comparing both implantation techniques for the SE Evolut prosthesis (Medtronic Intern. Ltd., CA, USA) and fulfilling the inclusion criteria for meta-analysis.ResultsTotally, 1227 patients were included, comprising 641 who underwent COP and 586 CIT TAVR. Incidence of post-procedural need for PPM implantation was significantly lower in COP group (9.8% vs 20.6%; OR = 0.43; p < 0.00001). This was accompanied by significantly higher implantation position in COP group (mean difference distance from distal end of the intraventricular portion of the THV to the non-coronary cusp (NCC): - 1.03 mm; p = 0.00001). Incidence of new-onset left bundle branch block did not differ. Regarding procedural and 30-day mortality, technical success, post-procedural aortic regurgitation, and rates of multiple device implantation, no difference between COP and CIT was found.ConclusionCOP is an effective and safe implantation technique to reduce the need for a permanent pacemaker implantation during TAVR with SE Evolut prosthesis.
Project description:IntroductionSince TAVR was approved for lower-risk aortic stenosis (AS) patients, managing post-implantation conduction disturbances has become crucial, especially with self-expanding heart valves (SEV). This study aims to identify risk factors for conduction disturbances in such patients using a specific fluoroscopic cusp overlap (COL) technique.MethodsThis retrospective study analyzed AS patients who underwent TAVR with SEV from 2019 to 2022, excluding those needing pacemakers or valve-in-valve procedures. Patients were grouped by conventional (CON) and COL techniques, with outcomes monitored using Valve Academic Research Consortium (VARC)-2 criteria.ResultsIn this cohort study of 114 patients, 17 were excluded due to pre-existing pacemakers. Forty-seven received SEVs using COL, and 50 with CON techniques. The COL group showed a significant reduction in new LBBB (27.7% vs. 46%, p = 0.006) and PPI rates (4.3% vs. 18%, p = 0.033) compared to the CON group. Deeper implantation depth below the non-coronary cusp (NCC) and left coronary cusp (LCC) was linked to an increased risk of conduction disturbances. Multivariate analysis identified smaller left ventricular outflow tract diameter, shorter membranous septum length, and greater pre-releasing implantation depth below the LCC as predictors of future PPI risk.ConclusionThe use of the COL technique significantly reduces the risk of newly developed conduction disturbances after SEV TAVR. Keeping SEV implantation depth within 1 mm of the membranous septum length and maintaining an implantation depth of <6 mm below the LCC before final release further minimizes the risk of PPI.
Project description:BackgroundThe implantation depth (ID) is a critical condition for optimal hemodynamic and clinical outcomes in transcatheter aortic valve replacement (TAVR). The recently recommended cusp-overlap technique (COT) offers optimized fluoroscopic projections facilitating a precise ID. This single-center observational study aimed to investigate short-term clinical performance, safety, and efficacy outcomes in patients undergoing TAVR with self-expandable prostheses and application of COT in a real-world setting.Materials and methodsFrom September 2020 to April 2021, a total of 170 patients underwent TAVR with self-expandable devices and the application of COT, while 589 patients were treated from January 2016 to August 2020 with a conventional three-cusp coplanar view approach. The final ID and 30-day outcomes were compared after 1:1 propensity score matching, resulting in 150 patients in both cohorts.ResultsThe mean ID was significantly reduced in the COT cohort (-4.2 ± 2.7 vs. -4.9 ± 2.3 mm; p = 0.007) with an improvement of ID symmetry of less than 2 mm difference below the annular plane (47.3 vs. 57.3%; p = 0.083). The rate of new permanent pacemaker implantation (PPI) following TAVR was effectively reduced (8.0 vs. 16.8%; p = 0.028). While the fluoroscopy time decreased (18.4 ± 7.6 vs. 19.8 ± 7.6 min; p = 0.023), the dose area product increased in the COT group (4951 ± 3662 vs. 3875 ± 2775 Gy × cm2; p = 0.005). Patients implanted with COT had a shorter length of in-hospital stay (8.4 ± 4.0 vs. 10.3 ± 6.7 days; p = 0.007).ConclusionTranscatheter aortic valve replacement using the cusp-overlap deployment technique is associated with an optimized implantation depth, leading to fewer permanent conduction disturbances. However, our in-depth analysis showed for the first time an increase of radiation dose due to extreme angulations of the gantry to obtain the cusp-overlap view.
Project description:BackgroundValve-in-valve transcatheter aortic valve implantation (TAVI) has emerged as a competent alternative for the treatment of degenerated bioprosthetic valves after surgical aortic valve replacement, or during TAVI procedure as a bailout option. Herein, we report a rare case of a self-expandable Medtronic Evolut R valve into a failing Medtronic CoreValve, with the use of modern pre-TAVI imaging screening, suggesting the proper procedural design steps for so complicated implantations.Case summaryA frail 78-year-old woman with a degenerated Medtronic Core Valve 26 mm bioprosthesis, implanted in 2011 due to severe aortic stenosis, was referred to our hospital due to worsening dyspnoea New York Heart Association III. The screening echocardiography documented severe aortic stenosis, while the classical risk scores were in favour of repeated TAVI (EuroSCORE II 5.67%). Computed tomography measurements and three-dimensional (3D) printing model were of great help for the proper valve selection (Medtronic Evolut R 26 mm), while the use of cerebral protection device (Claret Sentinel) was considered as a necessary part of the procedure. The simultaneous use of fluoroscopy and transoesophageal echocardiogram led to optimal haemodynamic result, confirmed by the discharge echocardiogram, with a significant clinical improvement during the first month follow-up.DiscussionThe main periprocedural concerns remain valve malpositioning, coronary artery obstruction, and high remaining transvalvular gradients. The multimodality pre-TAVI imaging screening may be helpful for precise procedural design. Despite the limited use of 3D models, it is necessary to adopt such tissue-mimicking phantoms to increase the possibility of optimal procedural result.
Project description:BackgroundSurgical implantation rates of bioprosthetic valves, especially the use of sutureless or rapid deployment valves, as well as the advent of transcatheter valve implantation (TAVR) have increased during the last decades mainly due to their excellent haemodynamic and clinical results. One common characteristic of all bioprosthetic types of surgical aortic valve replacement (SAVR) and TAVR is the risk of early degeneration, which leads to valve-dysfunction and is associated with higher rates of valve reinterventions. Recent studies have demonstrated that cusp thrombosis may play a role in early valve dysfunction. This case report is, to our knowledge, the first documentation on a successful treatment of early aortic valve (AV) degeneration of a sutureless AV thrombosis with a valve-in-valve (ViV) TAVR implantation.Case summaryA 77 years old woman was re-evaluated from the heart-team, which considered the following characteristics: severe impairment of mobility and frailty with an STS-score of 10.01% and a EuroSCORE II of 6.9%. Due to the high surgical risk for SAVR, we decided to perform a ViV-TAVR using a balloonexpandable bioprosthesis. The procedure was performed via transfemoral access under general anaesthesia using a 23 mm Edwards-Sapien 3 bioprosthesis without balloon-valvuloplasty and with nominal-volume dilation under rapid-pacing.DiscussionThe differentiation of bioprosthesis valve thrombosis, and hypoattenuating leaflet thickening vs. structural valve degeneration can be difficult, and a multimodality imaging approach, comprising trans-thoracic echocardiogram, transoesophageal echocardiography and computed tomography, useful. These investigations are very important to decide the right strategy of surgical valve replacement vs. TAVR.
Project description:Despite the rapid increase in experience and technological improvement, the incidence of conduction disturbances in patients undergoing transcatheter aortic valve replacement (TAVR) with the self-expandable CoreValve Evolut valve remains high. Recently, a cusp-overlap view (COP) implantation technique has been proposed for TAVR with self-expandable valves offering an improved visualization during valve expansion compared to the three-cusp view (TCV). This study aims to systematically analyze procedural outcomes of TAVR patients treated with the CoreValve Evolut valve using a COP compared to TCV in a high-volume center. The primary endpoint was technical success according the 2021 VARC-3 criteria. A total of 122 consecutive patients (61 pts. TCV: April 2019 to November 2020; 61 pts. COP: December 2020 to October 2021) that underwent TAVR with the CoreValve Evolut prosthesis were included in this analysis. Although there was no difference in the primary endpoint technical success between TCV and COP patients (93.4% vs. 90.2%, OR 0.65, 95% CI 0.16, 2.4, p = 0.51), we observed a significantly lower risk for permanent pacemaker implantation (PPI) among COP patients (TCV: 27.9% vs. COP: 13.1%, OR 0.39, 95% CI 0.15, 0.97, p = 0.047). Implantation of the CoreValve Evolut prosthesis using the COP might help to reduce the rate of PPI following TAVR.
Project description:BackgroundConduction disturbances demanding permanent pacemaker implantation (PPI) remain a common complication after transcatheter aortic valve replacement (TAVR). Optimization of the implantation depth (ID) by introducing the cusp-overlap projection (COP) technique led to a reduced rate of PPI when self-expanding valves were used.ObjectivesThe aim of the present study was to determine if using the novel COP view is applicable for all types of TAVR prosthesis and results in a higher ID and reduced incidence of new conduction disturbances and PPI.MethodsIn this prospective case-control study 586 consecutive patients undergoing TAVR with either balloon-expandable Edwards SAPIEN S3 (n = 280; 47.8%), or mechanically expandable Boston LOTUS Edge heart valve prostheses (n = 306; 52.2%) were included. ID as well as rates of periprocedural PPI and left bundle branch block (LBBB) were compared between the conventional three-cusp coplanar (TCC) projection and the COP view for implantation.ResultsOf 586 patients, 282 (48.1%) underwent TAVR using COP, whereas in 304 patients (51.9%) the TCC view was applied. Using COP a significantly higher ID was achieved in Edwards SAPIEN S3 TAVR procedures (ID mean difference -1.0 mm, 95%-CI -1.9 to -0.1 mm; P = 0.029), whereas the final platform position did not differ significantly between both techniques when a Boston LOTUS Edge valve was used (ID mean difference -0.1 mm, 95%-CI -1.1 to +0.9 mm; P = 0.890). In Edwards SAPIEN S3 valves, higher ID was associated with a numerically lower post-procedural PPI incidence (4.9% vs. 7.3%; P = 0.464). Moreover, ID was significantly deeper in patients requiring PPI post TAVR compared to those without PPI [8.7 mm (6.8-10.6 mm) vs. 6.5 mm (6.1-7.0 mm); P = 0.005]. In Boston LOTUS Edge devices, COP view significantly decreased the incidence of LBBB post procedure (28.1% vs. 47.9%; P < 0.001), while PPI rates were similar in both groups (21.6% vs. 25.7%; P = 0.396).ConclusionThe present study demonstrates the safety, efficacy and reproducibility of the cusp-overlap view even in balloon-expandable and mechanically-expandable TAVR procedures. Application of COP leads to significantly less LBBB in repositionable Boston LOTUS Edge valves and a numerically lower PPI rate in Edwards SAPIEN S3 valves post TAVR compared to the standard TCC projection. The results should encourage to apply the COP view more widely in clinical practice.
Project description:ObjectivesWe aimed to assess the procedural and clinical results of transcatheter aortic valve replacement (TAVR) for nonraphe bicuspid aortic stenosis (AS) with coronary vs mixed cusp fusion.BackgroundIt remains unclear whether cusp fusion morphology affects TAVR outcomes in patients with nonraphe bicuspid AS.MethodsThis retrospective study enrolled consecutive patients with severe symptomatic AS and type-0 bicuspid aortic valve, who underwent TAVR at our institution between 2012 and 2017. TAVR outcomes were defined based on the Valve Academic Research Consortium-2 recommendations.ResultsCompared to patients with mixed cusp fusion (44/71), those with coronary cusp fusion (27/71) had a larger ellipticity index for the aortic annulus (21.9% ± 9.0% vs 15.6% ± 9.3%, p=0.007) and increased left ventricular outflow tract obstruction (31.1% ± 9.4% vs 26.9% ± 7.5%, p=0.04) but comparable rates of second valve implantation (15.9% vs 14.8%), mild paravalvular leakage (PVL, 38.5% vs 30.2%), permanent pacemaker implantation (PPM, 25.9% vs 15.9%), and 30-day mortality (7.4% vs 6.8%). Use of a first-generation transcatheter heart valve was associated with higher risk for mild PVL (odds ratio (OR) = 4.37; 95% confidence interval (95% CI) = 1.14-16.75; p=0.03) but not PPM (OR = 0.77; 95% CI = 0.22-2.62; p=0.67), whereas a larger oversizing ratio tended to be associated with a higher PPM rate (OR = 1.49; 95% CI = 0.46-4.86; p=0.51) but lower incidence of mild PVL (OR = 0.51; 95% CI = 0.19-1.35; p=0.17).ConclusionsIn AS patients with type-0 bicuspid valves, cusp fusion morphology does not affect the procedural or clinical results of TAVR. Use of second-generation transcatheter heart valves may provide more favorable results in such patients. This trial is registered with NCT01683474.