Balloon-expandable Transcatheter Aortic Valve Research Articles

Early Structural Valve Deterioration of Balloon Expandable Transcatheter Aortic Valve Leaflets Due to Intrinsic and Extrinsic Nodular Calcification in a Hemodialysis Patient: A Case Report

Abstract Background Several reports have shown that transcatheter aortic valves are comparable in durability to surgical aortic valves. However, early structural valve deterioration (SVD) is rarely reported to occur, especially in hemodialysis patients. Case Summary We present a case of rapidly progressive bioprosthetic aortic valve stenosis in a patient with end-stage renal disease (ESRD) secondary to diabetic nephropathy in an 83-year-old female admitted due to progressive dyspnea and orthopnea. A 23-mm sized SAPIEN3 bioprosthetic aortic valve showed normal function for the first year after transcatheter aortic valve implantation (TAVI), but then rapidly developed stenosis and required acute hospitalization for heart failure a year and a half after surgery. Emergent surgical aortic valve replacement (SAVR) with a 19-mm On-X valve (CryoLife, Kennesaw, GA, USA) was performed. Pathological examination of the explanted SAPIEN 3 valve demonstrated severely degenerated bioprosthetic pericardial leaflets with severe intrinsic and extrinsic nodular calcification, which could limit the leaflet motion. Discussion There is a lack of reports on the long-term procedural outcomes of TAVI in hemodialysis patients. The development of SVD in patients undergoing dialysis is multifactorial and has yet to be fully elucidated. In the presented case, the removed TAVI valve had severe extrinsic calcified nodules alongside a fibrin thrombus. Considering these pathological findings, antithrombotic therapy to prevent fibrin thrombus from adhering to the TAVI valve may be important to avoid early SVD.

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

Improved Hemodynamics With Self-Expanding Compared to Balloon-Expandable Transcatheter Aortic Valve Implantation in Small Annulus Patients: A Propensity-Matched Analysis

Patients with small aortic annuli (SAA) pose a challenge in patients undergoing aortic valve replacement because of the potential for prosthesis-patient mismatch (PPM). This study aimed to compare the clinical and hemodynamic outcomes of self-expandable valve (SEV) versus balloon-expandable valve (BEV) transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and SAA. All patients who underwent TAVI for severe native aortic stenosis with a SAA between January 2018 and December 2022 were retrospectively included in the study from a single center. Propensity score matching was performed to balance the baseline characteristics. Bioprosthesis valve dysfunction was based on modified Valve Academic Research Consortium 3 criteria. A total of 1,170 TAVI procedures were performed between 2018 and 2022. After applying the exclusion criteria, 332 patients reported a SAA at computed tomography scan, and the matching created 109 balanced pairs. Echocardiographic data at discharge showed higher mean transvalvular gradients (p <0.001), higher grades of mitral regurgitation (p = 0.029), and lower ejection fraction (p <0.043) in BEVs than SEVs. At follow-up, significant differences favoring the SEV group regarding bioprosthesis valve dysfunction were observed (p = 0.002), especially in terms of severe PPM (p = 0.046) and at least moderate structural valve deterioration (p = 0.040). In conclusion, TAVI in patients with SAA using a BEV was associated with lower valve areas, higher mean pressure gradients, and PPM (including severe) than a SEV. Short- and midterm all-cause and cardiac-related mortality did not differ between the 2 groups. Future randomized studies with extended follow-ups are warranted to validate these outcomes.

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

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.

Assessing Potential Risks of Future Redo Transcatheter Aortic Valve Replacement in Asian Patients

BackgroundIn the Asian cohort, data are limited on the risk for coronary obstruction due to sinus of Valsalva (SOV) sequestration in redo transcatheter aortic valve replacement (TAVR) procedures. ObjectivesThe aim of this study was to assess the potential risk for coronary obstruction in simulated redo TAVR in Asian patients. MethodsPost-TAVR computed tomographic data from 788 patients who received balloon-expandable (BE) SAPIEN 3 transcatheter aortic valves (TAVs) and 334 patients who received self-expanding (SE) Evolut R or Evolut PRO TAVs were analyzed. The risk for coronary obstruction due to SOV sequestration in redo TAVR, defined as the TAV commissure level above the sinotubular junction (STJ) and a TAV-to-STJ distance <2.0 mm in each coronary sinus, was retrospectively evaluated. ResultsThe potential risks for coronary obstruction due to SOV sequestration at 1 or both coronary arteries were identified in 52.1% of the BE TAV group and 71.3% of the SE TAV group (P < 0.001). After adjusting for multiple covariates, STJ diameter, STJ height, TAV oversizing degree by area, and implantation depth were independently associated with SOV sequestration risk in the BE TAV group, whereas STJ diameter and implantation depth were independently associated with SOV sequestration risk in the SE TAV group. ConclusionsCoronary obstruction due to SOV sequestration in redo TAVR may occur in a substantial number of Asian patients. This finding suggests the importance of considering the structural feasibility of future redo TAVR when implanting the first TAV, especially in Asian patients with long life expectancy.

Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.

Native aortic leaflets and permanent pacemaker implantation risk following balloon-expandable transcatheter aortic valve implantation

ObjectivePermanent pacemaker implantation (PPI) risk is higher following transcatheter aortic valve implantation (TAVI) than surgical valve replacement. Native aortic leaflets are retained in patients undergoing TAVI, unlike in surgical valve replacement. Whether the retained leaflets influence PPI risk because of their proximity to the conduction system is unknown. The study sought to determine the association between infra-annular extension of native right coronary cusp/noncoronary cusp (RCC/NCC) post balloon-expandable TAVI and PPI risk. MethodsWe performed a retrospective analysis of 190 patients undergoing balloon-expandable TAVI at a single center. Manifestation of infra-annular extension of RCC/NCC was considered to be present when part of leaflet extended below aortic–annular plane on post-implantation aortic-root angiography. ResultsInfra-annular extension of RCC/NCC was observed in 33 patients (17.37%). PPI incidence post-TAVI was higher in patients with infra-annular extension of RCC/NCC than in those without (36.36% versus 8.92%, relative-risk: 4.08, p˂0.0001). On logistic-regression analysis, preexisting right bundle-branch block (RBBB) (odds-ratio: 12.73, 95% confidence-interval: 2.16–74.93, p = 0.005), and infra-annular extension of RCC/NCC (odds-ratio: 5.63, 95% confidence-interval: 2.17–14.58, p < 0.0001) were independently associated with PPI risk. Preexisting RBBB (φ = +0.25, p = 0.001) and infra-annular extension of RCC/NCC (φ = +0.30, p < 0.0001) showed a positive-correlation with PPI risk. Infra-annular extension of RCC/NCC was a significant predictor of PPI risk on receiver-operating-characteristic curve analysis (area under-the-curve 0.67; 95% confidence-interval: 0.54–0.79, p = 0.006). ConclusionThe retained native aortic leaflets play a significant role in PPI risk following balloon-expandable TAVI. Infra-annular extension of RCC/NCC is a novel predictor, and is associated with a four-fold higher risk of PPI.

Transcatheter Aortic Valve Implantation with balloon-expandable valve in low-flow low-gradient severe aortic stenosis in Nepal

Transcatheter aortic valve implantation is the most preferred treatment of aortic stenosis in elderly patients at high surgical risk; however, few data exist on the adoption of transcatheter aortic valve implantation for the management of low-flow, low-gradient severe aortic stenosis patients. We present a recent case experience with a 77-year-old man suffering from low-flow, low-gradient, symptomatic severe aortic stenosis with concomitant coronary artery lesions in the left anterior descending and right coronary arteries. He was treated successfully with balloon-expandable transcatheter aortic valve implantation after the percutaneous coronary intervention of the left anterior descending artery and right coronary artery lesion. Post-procedural and 30-day follow-ups showed good functional and hemodynamic improvements with the mean aortic gradient of 3 mmHg (baseline: 30 mmHg) without residual paravalvular leakage. Our first experience with a balloon-expandable transcatheter valve was satisfactory as we observed clinical efficacy and good performance of the balloon-expandable transcatheter aortic valve in low-flow, low-gradient, symptomatic severe AS patients.

Emergent transcatheter mitral valve implantation: Early and mid-term outcomes

BackgroundTranscatheter mitral valve implantation (TMVI) may be attractive to treat high-risk patients with mitral bioprosthesis or annuloplasty ring failure or severe mitral annular calcification. AimTo report the outcomes of patients after valve-in-valve/ring/mitral annular calcification TMVI using balloon expandable transcatheter aortic valves, according to the degree of urgency of the procedure. MethodsAll patients who underwent TMVI in our centre from 2010 to 2021 were classified into three groups: elective, urgent or emergent/salvage TMVI. ResultsA total of 157 patients were included: 129 (82.2%) had elective, 21 (13.4%) urgent and 7 (4.4%) had emergent/salvage TMVI. Patients with emergent/salvage TMVI had a higher EuroSCORE II: elective, 7.3%; urgent, 9.7%; emergent/salvage, 54.5% (P<0.0001). The indication for TMVI was bioprosthesis failure in all of the emergent/salvage group, in 13 of the urgent group (61.9%) and in 62 of the elective group (48.1%). Overall, the technical success rate of TMVI was 86%, and was similar in the three groups (elective, 86.1%; urgent, 95.2%; emergent/salvage, 71.4%). The cumulative survival rate at 2-year follow-up was lower in the emergent/salvage group than in the elective or urgent group (42.9% vs 71.2% for the elective group; 76.2% for the urgent group; log-rank test, P=0.012). The excess mortality in the emergent/salvage group occurred during the first month postprocedure. Thereafter, the 30-day landmark analysis did not show any more statistical difference between the three groups (log-rank test, P=0.94). ConclusionsEmergent/salvage TMVI was associated with high early mortality, but 1-month survivors had similar outcomes to patients with elective/urgent TMVI. The degree of urgency of the procedure should not prevent TMVI in high-risk patients.

TCTAP C-203 An Inoperable Non-calcified Severe Aortic Regurgitation Case Treated by Balloon Expandable Transcatheter Aortic Valve Replacement

TCTAP C-203 An Inoperable Non-calcified Severe Aortic Regurgitation Case Treated by Balloon Expandable Transcatheter Aortic Valve Replacement

Three-Year Outcomes of Balloon-Expandable Transcatheter Aortic Valve Implantation According to Annular Size

Data on the association between annular size and transcatheter aortic valve implantation (TAVI) outcomes beyond 1 year are limited. The present study assessed the association between the aortic annulus size and TAVI clinical and hemodynamic outcomes at 3years of follow-up. Patients were classified according to the aortic annulus size as having small, intermediate, and large annuli (size <400, 400 to 574, and ≥575mm2, respectively). The co-primary endpoints were all-cause mortality and heart failure hospitalization. Further, the changes in hemodynamic outcomes over the follow-up period (median 37, interquartile range: 26 to 45 months) were assessed. The present analysis included 850 patients, with 182 patients (21.4%), 538 patients (63.3%), and 130 patients (15.3%) in the small, intermediate, and large-sized aortic annulus groups, respectively. The groups had comparable age and pre-TAVI pressure gradients; however, patients with small annuli had higher Society of Thoracic Surgeons risk scores. Adjusted Cox regression analysis showed that compared to patients with intermediate-sized annuli, patients with small and large annuli had similar all-cause mortality (hazard ratio [HR]=1.11, 95% confidence interval [CI] 0.72 to 1.69 and HR=0.74, 95% CI 0.48 to 1.16, respectively) and heart failure hospitalization rates (HR=0.96, 95% CI 0.55 to 1.69 and HR=1.26, 95% CI 0.73 to 2.17, respectively). However, patients with small annuli had consistently higher mean and peak pressure gradients and a higher risk of patient-prosthesis mismatch. The risks of moderate-to-severe regurgitation and structural valve deterioration were similar between the three groups. In conclusion, although patients with small annuli had higher transvalvular gradients, there was no significant association between the aortic annulus size and TAVI clinical outcomes at 3years of follow-up. Future studies should compare the performance of transcatheter valve types in patients with different aortic annulus sizes.

5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli

BackgroundSelf-expanding transcatheter heart valves (THVs) are associated with better echocardiographic hemodynamic performance than balloon-expandable THVs and are considered preferable in patients with small annuli. ObjectivesThis study sought to compare 5-year outcomes between self-expanding vs balloon-expandable THVs in severe aortic stenosis (AS) patients with small annuli. MethodsConsecutive severe AS patients with an aortic valve annulus area <430 mm2 who underwent transcatheter aortic valve replacement (TAVR) with either the CoreValve Evolut (Medtronic) or SAPIEN (Edwards Lifesciences) THV between 2012 and 2021 were enrolled from the Bern TAVI registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups. ResultsA total of 723 patients were included, and propensity score matching resulted in 171 pairs. Technical success was achieved in over 85% of both groups with no significant difference. Self-expanding THVs were associated with a lower transvalvular gradient (8.0 ± 4.8 mm Hg vs 12.5 ± 4.5 mm Hg; P < 0.001), a larger effective orifice area (1.81 ± 0.46 cm2 vs 1.49 ± 0.42 cm2; P < 0.001), and a lower incidence of prosthesis-patient mismatch (19.7% vs 51.8%; P < 0.001) than balloon-expandable THVs. At 5 years, there were no significant differences in mortality (50.4% vs 39.6%; P = 0.269) between groups. Disabling stroke occurred more frequently in patients with a self-expanding THV than those with a balloon-expandable THV (6.6% vs 0.6%; P = 0.030). Similar results were obtained using inverse probability of treatment weighting in the Bern TAVI registry and the nationwide Swiss TAVI registry. ConclusionsThe echocardiographic hemodynamic advantage of self-expanding THVs was not associated with better clinical outcomes compared with balloon-expandable THVs up to 5 years in patients with small annuli. (Swiss TAVI Registry; NCT01368250)

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients

BackgroundData on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. MethodsBetween June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. ResultsThe rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. ConclusionsThe 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

BackgroundThe latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. ObjectivesThis study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. MethodsThe OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. ResultsAmong 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). ConclusionsThe OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

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.

Mid-term impact of underfilling and overfilling of the SAPIEN 3 balloon-expandable transcatheter aortic valve implantation on mortality and valve function.

At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 [IQR: 1.18-1.56] vs. 1.57 [IQR: 1.41-1.84] vs. 1.58 [IQR: 1.45-1.71] cm2, P = 0.02) and a higher mean transvalvular gradient (13.6 [IQR: 11.0-15.7] vs. 12.1 [IQR: 9.0-14.9] vs. 12.0 [IQR: 8.1-14.8] cm2, P = 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.

Transcatheter aortic valve-in-valve implantation to treat aortic para-valvular regurgitation after TAVI

BackgroundPara-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). MethodsPatients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. ResultsCore-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. ConclusionsThis study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation.

Comparison of performance of self-expanding and balloon-expandable transcatheter aortic valves

ObjectiveTo evaluate the flow dynamics of self-expanding and balloon-expandable transcatheter aortic valves pertaining to turbulence and pressure recovery. Transcatheter aortic valves are characterized by different designs that have different valve performance and outcomes. MethodsAssessment of transcatheter aortic valves was performed using self-expanding devices (26-mm Evolut [Medtronic], 23-mm Allegra [New Valve Technologies], and small Acurate neo [Boston Scientific]) and a balloon-expandable device (23-mm Sapien 3 [Edwards Lifesciences]). Particle image velocimetry assessed the flow downstream. A Millar catheter was used for pressure recovery calculation. Velocity, Reynolds shear stresses, viscous shear stress, and pressure gradients were calculated. ResultsThe maximal velocity at peak systole obtained with the Evolut R, Sapien 3, Acurate neo, and Allegra was 2.12 ± 0.19 m/sec, 2.41 ± 0.06 m/sec, 2.99 ± 0.10 m/sec, and 2.45 ± 0.08 m/sec, respectively (P < .001). Leaflet oscillations with the flow were clear with the Evolut R and Acurate neo. The Allegra shows the minimal range of Reynolds shear stress magnitudes (up to 320 Pa), and Sapien 3 the maximal (up to 650 Pa). The Evolut had the smallest viscous shear stress magnitude range (up to 3.5 Pa), and the Sapien 3 the largest (up to 6.2 Pa). The largest pressure drop at the vena contracta occurred with the Acurate neo transcatheter aortic valve with a pressure gradient of 13.96 ± 1.35 mm Hg. In the recovery zone, the smallest pressure gradient was obtained with the Allegra (3.32 ± 0.94 mm Hg). ConclusionsFlow dynamics downstream of different transcatheter aortic valves vary significantly depending on the valve type, despite not having a general trend depending on whether or not valves are self-expanding or balloon-expandable. Deployment design did not have an influence on flow dynamics.

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity‐matched analysis

In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.