Balloon-expandable Prosthesis Research Articles

German Experience with a Novel Balloon-Expandable Heart Valve Prosthesis for Transcatheter Aortic Valve Implantation-Outcomes of the MYLAND (MYvaL germAN stuDy) Study.

Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.

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

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

Open mitral valve replacement with a balloon-expandable prosthesis using the valve-in-valve technique: a case report

Mitral defects are the most common acquired heart disturbances. The only radical treatment for severe valve stenosis or its insufficiency is surgical correction of the defects. The main challenge of implanting a mechanical mitral prosthesis is associated to its thrombosis complication that demands repeated surgical intervention on re-replacement of the mitral prosthesis. Herein, a clinical case of patient P. (58 years old) is presented, who was admitted to the Federal Center for Cardiovascular Surgery (Penza, Russia) with thrombosis of the mitral valve prosthesis and its dysfunction. The patient has already been undergone repeated surgery to replace the mitral valve. The purpose of the clinical case description is to demonstrate the using of open mitral valve replacement method based on the valve-in-valve technique with a transcatheter balloon-expandable prosthesis, its efficacy and safety.The considered method of treatment can simplify the main stage of the surgical intervention; reduce the time of artificial circulation and aortic clamping as well as the number of intraoperative complications. This type of surgical treatment can be considered as an option for re-prosthesis in patients at high surgical risk who are indicated for re-intervention due to impaired function of previously implanted heart valve prosthesis. A clinical case attests the possibility, efficacy and safety of using a balloon-expandable prosthesis for mitral valve replacement with the valve-in-valve technique upon repeated surgical interventions. Received 12 January 2024. Revised 16 February 2024. Accepted 19 February 2024. Informed consent: The patient’s informed consent to use the records for medical purposes is obtained. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsLiterature review: M.A. DenisovDrafting the article: I.Ya. SenzhapovCritical revision of the article: A.I. MikulyakSurgical treatment: V.V. Bazylev, M.G. ShmatkovFinal approval of the version to be published: V.V. Bazylev, A.I. Mikulyak, M.G. Shmatkov, I.Ya. Senzhapov, M.A. Denisov

TAVR-in-TAVR with a balloon-expandable valve for paravalvular leak.

Paravalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR. We retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated. In total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01). Our findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.

Acquired Thrombocytopenia in Contemporary Transcatheter Aortic Valve Prosthesis.

Postprocedural thrombocytopenia is a known phenomenon following transcatheter aortic valve implantation (TAVI). The aim of this study is to evaluate whether postinterventional platelet kinetics differ when comparing the current generation of balloon-expandable valve (BEV) and self-expanding valve (SEV) prostheses. We performed a retrospective analysis of patients undergoing TAVI at our facility between 2017 and 2019. Patients were stratified according to the type of prosthesis used: BEV or SEV. Hematocrit-corrected platelet counts were calculated to account for dilution. Nadir platelet counts (lowest recorded platelet count), drop platelet counts (DPC; highest relative platelet drop from baseline), and severity of thrombocytopenia during the discourse and at discharge were assessed. Of the 277 included patients, 212 received SEV and 65 BEV. BEV patients were younger (81.8 ± 4.4 years vs 79.7 ± 6.8 years, p = 0.03). Further demographic characteristics were similar between groups. Implanted SEV were larger (p < 0.001) and had shorter procedural times (p < 0.01). There were no significant differences in postprocedural discourse. Postinterventional platelet drop was more pronounced in BEV patients in several evaluated metrics: mean DPC (24.3 ± 10.9% vs 18.8 ± 14.8%, p < 0.01), patients with DPC > 30% (n = 19, 29.2%, vs n = 33, 15.6%, p = 0.02), and also when comparing platelet kinetics. Despite improvements in outcome, the current generation of balloon-expandable TAVI prostheses carries a predisposition for postprocedural thrombocytopenia even when the effects of dilution are accounted for.

Abstract 12681: Sex-Specific Predictors of Pacemaker Implantation After Transcatheter Aortic Valve Implantation

Introduction: Permanent pacemaker (PPM) remains a common complication after transcatheter aortic valve implantation (TAVI). Despite recognition of sex-specific differences in the electrophysiological structure of the heart, there is a paucity of data examining whether predictors for PPM after TAVI differs among women and men to facilitate a precision medicine approach. Hypothesis: To examine incidence rates and predictors of PPM after TAVI according to sex. Methods: We retrospectively examined incidence rates and characteristics of women and men requiring PPM within 30-days after TAVI between 2012 to 2021. Predictors of PPM were identified using logistic regression. Results: A total of 3323 patients underwent TAVI, of which 407 (12.3%) required PPM within 30-days after TAVI. A PPM was required in 12.3% (170/1377) of women and in 12.2% (237/1946) of men (p=0.89). Baseline characteristics are shown in the Table. Compared to women, men requiring a PPM were more likely to have a history of myocardial infarction (MI), prior bypass surgery, reduced systolic function, first degree atrioventricular block (1 st AVB), normal renal function, balloon expandable prosthesis, and larger prosthesis size. In multivariable analysis, right bundle branch block and self-expandable prosthesis were significant predictors for both sexes (Figure). Men had relatively more exclusive predictors (age, prior MI, atrial fibrillation, 1 st AVB, left bundle branch block, prosthesis size) compared to women (Figure). Conclusions: PPM incidence rates after TAVI are similar for women and men however, sex-specific predictors for PPM exist and may be used guide pre- and post-procedural management.

Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

The Influence of the Learning Curve on Clinical Outcomes in Balloon-Expandable versus Self-Expandable Transfemoral Transcatheter Aortic Valve Implantation.

Balloon-expandable (BE) and self-expandable (SE) prostheses are the main types of devices currently used in transcatheter aortic valve implantation (TAVI). Despite the different designs, clinical practice guidelines do not make any specific recommendation on the selection of one device over the other. Most operators are trained in using both BE and SE prostheses, but operator experience with each of the two designs might influence patient outcomes. The aim of this study was to compare the immediate and mid-term clinical outcomes during the learning curve in BE versus SE TAVI. The transfemoral TAVI procedures performed in a single center between July 2017 and March 2021 were grouped according to the type of implanted prosthesis. The procedures in each group were ordered according to the case sequence number. For each patient, a minimum follow-up time of 12 months was required for inclusion in the analysis. The outcomes of the BE TAVI procedures were compared with the outcomes of the SE TAVI procedures. Clinical endpoints were defined according to the Valve Academic Research Consortium 3 (VARC-3). The median follow-up time was 28 months. Each device group included 128 patients. In the BE group, case sequence number predicted mid-term all-cause mortality at an optimal cutoff value ≤58 procedures (AUC 0.730; 95% CI: 0.644-0.805; p &lt; 0.001), while in the SE group, the cutoff value was ≤85 procedures (AUC 0.625; 95% CI: 0.535-0.710; p = 0.04). A direct comparison of the AUC showed that case sequence number was equally adequate in predicting mid-term mortality, irrespective of prosthesis type (p = 0.11). A low case sequence number was associated with an increased rate of VARC-3 major cardiac and vascular complications (OR 0.98 95% CI: 0.96-0.99; p = 0.03) in the BE device group, and with an increased rate of post-TAVI aortic regurgitation ≥ grade II (OR 0.98; 95% CI: 0.97-0.99; p = 0.03) in the SE device group. In transfemoral TAVI, case sequence number influenced mid-term mortality irrespective of prosthesis type, but the learning curve was longer in the case of SE devices.

Assessment of consistency in aortic valve sizing between surgical and transcatheter aortic valve replacement.

One of the crucial aspects of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) is the valve prosthesis selection. To assess the consistency of the aortic valve sizing in SAVR and TAVR by comparing the sizes of aortic prostheses selected based on the intraprocedural annulus measurements and simulation of the TAVR planning. The study comprised of 167 patients with aortic stenosis treated with SAVR. Simulation of the prosthesis sizing blinded to the SAVR results was performed based on the assessment of cardiac computed tomography (CCT) images. Based on the CCT images, the average value of the aortic annulus diameter was 25.4 ±3.0 mm. Aortic valve calcifications were mild in 29 cases, moderate in 78 cases, and severe in 53 cases. The sizes of the valves recommended by the simulations were larger than valves surgically implanted in 98.6% of patients for self-expanding and in 91.7% of patients for balloon-expandable prostheses. The average difference for self-expanding prostheses was 6.4 mm and 4.5 mm for balloon expandable valves. Additionally, a negative correlation was observed for the difference in prosthesis size and size of the valve used by surgeons. There is a systematic difference between sizes of aortic prostheses used in SAVR and TAVR. Further studies are needed to evaluate if the difference in prosthesis size selection contributes to the frequency of prosthesis-patient mismatch phenomenon and burden of high postoperative mean transaortic gradient.

Mid-term results of open transaortic implantation of the «MedLab-CT» prosthesis: prospective clinical study

Aim. To evaluate the mid-term clinical and hemodynamic results of open transaortic implantation of the balloon-expandable prosthesis MedLab-CT in patients with high surgical risk.&#x0D; Material and methods. The study included 41 patients (mean age 65.711.7 years) who underwent open implantation of the MedLab-CT (MedInzh, Russia) aortic valve (AV) prosthesis under cardiopulmonary bypass and cardioplegia, belonging to the cohort of high surgical risk according to the data EuroSCORE II scale, with critical symptomatic aortic stenosis, high functional class according to the classification of the New York Heart Association (NYHA). All studied patients had clinical indications for transcatheter AV replacement, however, given the concomitant surgical pathology of the heart (critical multivessel coronary artery disease unsuitable for endovascular treatment and/or damage to other valves), as well as the morphological features of the aortic root (low location coronary artery ostia relative to the annulus fibrosus of the AV, large calcifications of the coronary cusps according to computed tomography, with a high risk of ostium occlusion), they were denied a minimally invasive procedure. The incidence of adverse clinical events and hemodynamic parameters of the AV prosthesis in the medium-term period were assessed.&#x0D; Results. The average follow-up period was 13.1 months, the maximum was 3 years. Mortality 2.4% (n=1), there were no cases of stroke. The average gradient in the long-term period on AK MedLab-CT is 8.53.1 mm Hg. Paravalvular regurgitation above grade 2 and transvalvular regurgitation were not detected. Thus, no cases of dysfunction of the aortic prosthesis were noted.&#x0D; Conclusion. In the medium term, satisfactory clinical and hemodynamic results of open implantation of the MedLab-CT balloon-expandable prosthesis were obtained in high surgical risk patients.

Abstract 12852: Transcatheter Aortic Valve Replacement for Aortic Stenosis in Small Aortic Annulus: Medium-Term Follow-Up

Introduction: Small aortic annulus (SAA) is a clinical challenge in managing aortic stenosis (AS). The SAA has been associated with poorer outcomes after surgical AVR with an increased risk of perioperative and overall mortality, suboptimal valvular hemodynamics, and adverse cardiovascular events. Hypothesis: TAVI could be a therapeutic alternative in these patients. Methods: We performed a retrospective analysis of all patients with AS treated with TAVI from 2015 to 2021 in our center, with SAA defined as the aortic annulus of ≤22mm perimeter-derived diameter (PDD), measured by CT. Results: Sixty-eight patients were included (85.3% women, 83.2± 6.5 years) with a mean PDD of 20.7 ± 1.1 mm. The 14.7% had LVEF &lt;50% and 1.4% had bicuspid aortic valve. The Access route was transfemoral in 64 patients (94.2%) and 4 transapical (5.8%). Self-expanding prostheses were used in 78% of the cases, balloon-expandable prostheses in 17.6%, and mechanically-expandable prostheses in 4.4%. The size of the aortic prostheses was 23mm in 82.3% and &gt;23mm in 17.7%. The perioperative implant success rate was 100% defined as single prosthesis implantation with a mean gradient &lt;20mmhg and angiographic paravalvular leak &lt;2. The rate of new permanent pacemaker implantation was 13.2%. The in-hospital complications rate was 5.8% (4 patients): major vascular complication in 1 patient (1.4%), acute kidney injury stage ≥2 in 1 (1.4%), disabling stroke in 2 (2.9%). There were no deaths in the first 30 days of the procedure. At discharge, the TTE máximum gradient was 19.8 ± 9.2mmhg, the mean gradient 9 ± 4.8mmhg, and 4 patients had paravalvular leak grade ≥2 (5.9%). During a mean follow-up of 27.8 ±7.6 months, 45 patients were in NYHA functional class I (66.2%), 19 in NYHA 11 (27.9%), and 3 in NYHA III (4.4%). Eight patients (11.7%) were readmitted due to heart failure, 10 died (14.7%) due to all-cause mortality, and only 3 of them died due to cardiovascular causes (4.4%). Conclusions: Although the optimal approach for treating patients with AS and SAA remains controversial. TAVI is a very attractive option in these patients, allowing the implantation of prostheses with excellent immediate hemodynamic results, a low rate of complications, and significant clinical improvement in the follow-up.

Abstract 13416: Evaluation of Risk Factors for Pacemaker After Tavr Among Patients With a Pre-Existing Right Bundle Branch Block

Background : Pacemaker implantation (PMI) remains a common complication after TAVR. While a pre-existing right bundle branch block (RBBB) is consistently the strongest reported risk factor for PMI, most patients with a RBBB will not require PMI after TAVR. Objective : To identify factors associated with a higher risk of PMI after TAVR among patients with pre-existing RBBB. Methods : We identified all patients at a single institution undergoing first-time TAVR with a balloon-expandable prosthesis without a pre-existing pacemaker or ICD, and pre-existing RBBB (defined as RBBB morphology with QRS &gt;=110ms) from December 2013 to December 2020 (n=219). We evaluated the univariate association for numerous clinical, EKG, imaging, and procedural characteristics with PMI. We included all factors with p=&lt;0.10 in a logistic regression model to assess for independent associations with PMI in the original cohort and 1000 bootstrapped samples. Results : A history of syncope, body mass index, calcium channel blocker use, baseline PR interval, and prosthesis oversizing &gt;16% were associated with PMI on univariate analysis. When included in a logistic regression model, syncope (OR 3.2, 95%CI: 1.1-8.8, p=0.027) and oversizing (OR 3.1, 95% CI: 1.4-6.8, p=0.005) remained independently associated with PMI. These findings were consistent in the bootstrapped samples. Those with both factors (n=4) had a PMI rate of 75% which was higher compared to those with one or neither (43% and 22%, respectively; p&lt;0.001). Conclusion : Among those with pre-existing RBBB, a history of syncope and prosthesis oversizing &gt;16% were independently associated with a higher risk of PMI. These findings warrant external validation.

Radiation exposure during transcatheter aortic valve implantation (TAVI): comparison of balloon-expandable versus self-expandable prostheses

Abstract Transcatheter aortoc valve implantation (TAVI) is performed under fluoroscopic control and can be associated with the need for long fluoroscopy times and repeated cine acquisitions in angulated projections. The procedural steps for TAVI with balloon-expandable and self-expanding prostheses differ and may be associated with significant differences in radiation exposure. Published data regarding patient or operator radiation exposure in TAVI are limited to small series. We therefore analyzed the influence of prosthesis type on radiation exposure in a consecutive series of 1185 patients who underwent TAVI between 2016 and 2021. A cohort of 1185 consecutive patients undergoing TAVI between 2016 and 2021 was analyzed. Radiation exposure was determined by evaluating overall fluoroscopy time, the number of acquired cine sequences, and total dose-area product (DAP). After eliminating patients treated via a non-transfemoral approach, data between patients underging TAVI with self-expanding prostheses and patients undergoing TAVI with balloon-expandable prostheses were compared. Out of the total patient cohort, 46 patients were excluded due to treatment via a non-transfemoral approach. Of the remaining 1139 patients, 437 (38%) were treated with self-expandable prostheses and 702 (62%) were treated with balloon-expandable prostheses. Median age was 81 years, 45% of patients were female. Body weight was slightly but significantly higher in patients treated by balloon-expandable prostheses (median 73 kg vs. 79 kg, p&amp;lt;0.001). Median fluoroscopy time was 453 s (IQR 365–603 s) for self-expandable prostheses vs. 414 s (IQR 341–540 s) for balloon-expandable prostheses (p=0.002). Also, the number of cine acqusitions was significantly higher (median 12 vs. 7; p&amp;lt;0.001), and total DAP was 6442 mGy cm2 (IQR 4452–9669 mGy cm2) for self-expandable vs. 4798 (IQR 3353–6981 mGy cm2) for balloon-expandable prostheses (p&amp;lt;0.001, see Fig. 1). In multivariable analysis, male sex, higher body weight and use of a self-expandable prosthesis were independently associated with higher total DAP. Transcatheter aortic valve implantation using balloon-expandable prostheses is associated with significantly lower total dose-area product than treatment with self-expandable prostheses. This may be particularly relevant for operators who perform the procedure frequently. Funding Acknowledgement Type of funding sources: None.

Left bundle branch pacing after transcatheter aortic valve implantation. Initial experience of a center

Abstract Introduction Permanent pacing is often needed in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) due to new onset conduction disorders. Nevertheless, continuous right ventricular pacing may deteriorate left ventricular ejection fraction (LVEF) and lead to poor outcomes. Thus, in last years, more physiological forms of pacing, such as left bundle branch pacing (LBBP) have been developed to prevent pacing induced cardiomyopathy. Purpose The aim of our study is to describe the initial experience in our center, evaluate the safety and feasibility of LBBP after TAVI and describe electrophysiological outcomes in the first months of follow-up. Methods We designed a prospective registry that collected all patients from the TAVI program of our center who developed conduction abnormalities in the immediate postoperative and received LBBP. We analyzed baseline characteristics, complications and procedure time, electrophysiological parameters after the procedure and final QRS interval. During follow-up LVEF, electrophysiological parameters and adverse clinical events (readmissions for heart failure, cardiovascular mortality and all-cause of mortality) were also evaluated at 3rd, 6th and 12th month. Results Between January 2020 and January 2022, twenty patients who developed conduction abnormalities after TAVI underwent LBBP. Seven patients (35%) had a complete atrioventricular block, two patients (10%) alternating bundle branch block and 11 (55%) had a new left bundle branch block. HV electrophysiology study was performed in 8 patients, with a median value of 68ms (66–72). Of the 20 patients, 3 out of 4 patients were male and had history of hypertension. 40% had previous ischemic heart disease and one patient had transthyretin cardiac amyloidosis. Median age was 79 years-old (76–83.5). Balloon-expandable prosthesis was implanted in 11 patients while 9 received a self-expandable prosthesis. Median basal LVEF was 59% (41.5–60) and median NTproBNP was 1722pg/ml (535–5848). LBBP was successful in all of the 20 patients. The median time of the procedure was 60 minutes (45–80) without suffering any complications. The median QRS interval before the procedure was 155ms (140–158) and 116ms (105–125) post-implant. To date, two patients have died of non-cardiac cause 3 and 8 months after LBBP. There have been no readmissions for heart failure. LVEF (pre and post-LBBP) and electrophysiological parameters post-implant and three-month follow-up are shown in Table 1. Conclusions In our experience, LBBP after TAVI is a safe and feasible procedure. Despite the small sample size and short follow-up period, our first results indicate stability of LVEF and pacemaker parameters. Funding Acknowledgement Type of funding sources: None.

The Manchester experience – a novel technique for supra-annular placement of the Edwards SAPIEN 3 Ultra TVH prosthesis in severe bicuspid aortic valve stenosis

Abstract Background Bicuspid AV disease has been excluded from the seminal trials evaluating transcatheter heart valve (THV) placement in severe aortic stenosis. Although registry data has shown good results overall, case selection likely involves more challenging anatomical subsets being treated either surgically or medically in this very heterogenous condition. Conventional annular placement, as well as high annular placement in tapered anatomies remain the commonest deployment techniques. We reasoned that marked supra-annular placement with the mid-portion of the SAPIEN 3 Ultra (S3U) valve sealing skirt placed at the narrowest opening point at commissural level could be an alternative strategy allowing treatment of additional patient groups. This proposed technique takes advantage of elliptical expansion at commissural level with more circular expansion above and below this point to prevent embolisation, as well as sealing skirt positioning at the narrowest opening point to prevent paravalvular leak. Aims We examined the feasibility of marked supra-annular placement of the balloon-expandable S3U prosthesis with the mid-point of the sealing skirt placed at commissural level in patients with severe bicuspid aortic valve stenosis and relative contra-indications to annular placement. Methods We assessed patients with severe bicuspid aortic stenosis undergoing TAVI at our centre over a 9-month period and identified those with relative contra-indications to conventional annular placement. These included: (i) excessive annular size (ii) severe leaflet and raphe calcification with risk of rupture into the right ventricle (iii) excessive leaflet length with potential leaflet overhang. CT imaging was used to define the narrowest opening location at commissural level, typically 10–15mm supra-annular. The diameter at this level was used to select THV size. Calculations were made to approximate the mid skirt level to this supra-annular position. In most cases this involved supra-annular positioning with the lower THV border 5–8mm supra-annular. This was achieved in most cases by aligning the unexpanded border with the annulus. Results Out of 9 patients with biscupid AV, 4 had relative contra-indications for annular placement. In all 4 cases, excellent valvular expansion with only minimal paravaulvar leak was achieved with placement of the S3U prosthesis at 5–7mm above the annulus and with supra-annular sealing at commissural level. Annular dimensions of 35.5mm and 31.5mm were successfully treated with 29mm and 26mm valves due to significant tapering at commissural level in 2 patients. There were no procedural complications, incidences of AV blocks or valve embolisation. Conclusion As a proof of concept, we have demonstrated excellent outcomes with marked supra-annular TAVI placement in patients with severe bicuspid AV stenosis and anatomy unfavourable for conventional annular placement. This is the first description of this completely novel deployment technique. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Manchester Royal Infirmary

Technical features of a self-expandable prosthetic valve for the treatment of pulmonary valve disease

Background. Balloon-expandable prostheses authorized for transcatheter pulmonary valve replacement in the Russian Federation have a barrel-shaped frame, which requires pre-stenting of a native right ventricular outflow tract or a conduit. This increases procedure duration, complicates implantation technique, and increases operation costs. Aim. To develop a self-expandable pulmonary valve model for transcatheter replacement and prepare it for preclinical trials.Methods. The model of a self-expandable pulmonary valve bioprothesis for transcatheter replacement made of nitinol was developed. The leaflets and the lining of the frame were made of porcine pericardium and assembled manually. Radial force testing was performed; valve loading into the delivery system was also tested.Results. According to the results of the tests, the valve biomaterial and the suture sites were not damaged after compression. In 2022, initial preclinical tests are scheduled to determine viability of the implanted valves at 6 and 12 months after surgery, and the rate of calcification for this observation period is to be assessed as well.Conclusion. By optimizing the design of the support frame, we improved the transcatheter model of the biological valve with satisfactory results at the initial stage of preclinical trials. Received 22 April 2022. Revised 5 May 2022. Accepted 11 May 2022. Funding: This work is supported by a grant of the Russian Science Foundation (project No. 21-75-10041). Conflict of interest: Authors declare no conflict of interest. Contribution of the authorsConception and study design: K.A. Rzaeva, T.P. Timchenko, A.N. Arkhipov, N.R. NichayData collection and analysis: A.V. Voitov, N.R. NichayDrafting the article: K.A. Rzaeva, A.V. GorbatykhCritical revision of the article: I.Yu. Zhuravleva, I.A. Soynov, A.V. Bogachev-ProkophievFinal approval of the version to be published: K.A. Rzaeva, T.P. Timchenko, I.Yu. Zhuravleva, A.N. Arkhipov, A.V. Gorbatykh, A.V. Voitov, N.R. Nichay, A.V. Bogachev-Prokophiev, I.A. Soynov

Technical Aspects and Development of Transcatheter Aortic Valve Implantation.

Aortic stenosis is the most common valve disease requiring surgery or percutaneous treatment. Since the first-in-man implantation in 2002 we have witnessed incredible progress in transcatheter aortic valve implantation (TAVI). In this article, we review the technical aspects of TAVI development with a look at the future. Durability, low thrombogenicity, good hydrodynamics, biocompatibility, low catheter profile, and deployment stability are the attributes of an ideal TAVI device. Two main design types exist—balloon-expandable and self-expanding prostheses. Balloon-expandable prostheses use a cobalt-chromium alloy frame providing high radial strength and radiopacity, while the self-expanding prostheses use a nickel-titanium (Nitinol) alloy frame, which expands to its original shape once unsheathed and heated to the body temperature. The valve is sewn onto the frame and consists of the porcine or bovine pericardium, which is specially treated to prevent calcinations and prolong durability. The lower part of the frame can be covered by polyethylene terephthalate fabric or a pericardial skirt, providing better sealing between the frame and aortic annulus. The main future challenges lie in achieving lower rates of paravalvular leaks and new pacemaker implantations following the procedure, lower delivery system profiles, more precise positioning, longer durability, and a good hemodynamic profile. Patient-specific design and the use of autologous tissue might solve these issues.

Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study.

ObjectivesPatients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis.MethodsWe performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance.ResultsOf 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77–1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52–1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12–0.62).ConclusionPatients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.

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

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

P331 IMPLANT OF THE BALLOON EXPANDABLE BIOLOGICAL PROSTHESIS FOR TAVI (EDWARDS SAPIEN 3 ULTRA) PRE–ASSEMBLED ON EXPANSION BALLOON, IN “OPEN” SITUATION WITH PATIENT IN CEC

Abstract The biological valve prostheses malfunctioning often leads to severe forms of heart failure, whose treatment requires surgical or percutaneous re–intervention. We report the case of a 77–year–old man with a biological aortic prosthesis since 2009 (Elan stentless–21), hospitalized for acute cardiac decompensation related to severe aortic prosthetic insufficiency (likely infective endocarditis with periprosthesis abscess involving the perivalvular fibrous lamina) and coexistence of severe mitral insufficiency. After 25 days of therapy, in stable haemodynamic conditions, surgery was scheduled to replace the aortic prosthesis and the mitral valve, in CEC. The exposure of the aortic valve plane highlighted the rupture of the prosthetic coronary cusp in the absence of prosthetic detachment and perivalvular abscess. After removal of the degenerated cusps, the preparation and implantation of the new biological prosthesis (perimount–Magna–19) was hindered by the excessive presence of calcium–fibrosis in the suture site of the valve ring which did not allow adequate sealing, with multiple peri–prosthetics leaks; the possibility of sutureless prostheses implantation was made impossible by lack of adequate anatomical conditions. In these conditions, the possibility of implanting a biological prosthesis for TAVI, pre–mounted on the expansion balloon (Ewards–Sapien3–Ultra–23mm), in an “open” situation and in CEC, was considered. The implantation of the balloon–expandable prosthesis was performed with direct vision of the aortic annulus and coronary ostia; the insertion of the prosthesis was performed on a standard “J” guide wire positioned in the ventricle; the expansion of the prosthesis was performed in two balloon inflation steps. The intraoperative ecotransophageal echo demonstrated the correct positioning of the biological aortic prosthesis with minimal periprosthetic leak. The presence of severe residual mitral insufficiency suggested a replacement of the mitral valve with biological prosthesis. On day 4 the patient was clinically stable; the transesophageal echocardiogram showed normal functioning of the prostheses. The direct implantation of the expandable biological prosthesis in the cardiac surgery room, in “open” and CEC, after excluding active endocarditic processes and infectious complications, allowed the implantation of a larger prosthesis and to avoid significant perivalvular leaks.