Self-expanding Transcatheter Aortic Valve Replacement Research Articles

First-in-Man Experience of a Fully Retrievable Self-Expanding Dry-Tissue Transcatheter Aortic Valve Replacement System.

First-in-Man Experience of a Fully Retrievable Self-Expanding Dry-Tissue Transcatheter Aortic Valve Replacement System.

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

BackgroundA severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown.AimWe sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR.Materials and methodsThe TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria.ResultsAmong 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases.ConclusionAfter TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality.Clinical trial registration[https://clinicaltrials.gov], identifier [NCT04500964].

C-50 | Association of Aortoventricular Angulation and Clinical Outcomes After Self-Expanding TAVR

For patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEV), greater aortoventricular (AoV) angulation has been identified as a technical challenge. However, it remains unclear if AoV angle affects early clinical outcomes. The aim of this analysis was to evaluate outcomes of patients with complex anatomy treated with contemporary SEVs.

Temporal Trends in Self-Expandable Transcatheter Aortic Valve Replacement in South America: A Systematic Review and Meta-Analysis

ObjectivesThis study aimed to estimate temporal trends in clinical presentation and short-term outcomes of transcatheter aortic valve replacement (TAVR) with self-expandable prostheses in South America through a systematic review and meta-analysis of observational data. MethodsWe comprehensively searched for articles published in peer-reviewed medical journals and for abstracts presented in medical conferences of the region from September 1, 2008, to June 29, 2020. We included single-center studies on self-expandable TAVR populations with ≥ 10 patients from South America. ResultsA total of 28 cohorts from 6 countries pooling 1780 patients were included in a random-effects meta-analysis. Pooled estimates of age changed during time (period 2011-2015, 81.6 years; 95% confidence interval [CI] 80.7-82.4; period 2016-2018, 80.6 years; 95% CI 79.8-81.3; period 2019: 78.5 years; 95% CI 77.0-80.0; P = .0003); no other temporal trends in patient characteristics were ascertained. Temporal trends in short-term mortality pooled estimates were in-hospital mortality (11.8% [95% CI 8.2-16.7] for the period 2011-2015, 6.6% [95% CI 4.5-9.6] for the period 2016-2018, and 4.4% [95% CI 1.9-9.8] for the period 2019 [P = .007]) and 30-day mortality (12.8% [95% CI 7.7-20.4], 9.7% [95% CI 7.0-13.3], and 5.7% [95% CI 2.8-11.3], respectively [P =.044]). These associations between reporting year of the study and lower mortality remained after adjusting by age and surgical risk (multivariate meta-regression). ConclusionsIn studies reported between 2011 and 2019 in South America, we demonstrated a clear time trend toward reduction of short-term mortality after self-expandable TAVR, independently of age and surgical risk of populations. These findings are relevant to the local reassessment of cost-effectiveness of TAVR.

Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-YearAnalysisFrom the SURTAVI Trial.

This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery. Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden. The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers. Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30days (P< 0.001) and 1 year (P=0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30days and after both procedures at 1 and 2 years. In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Mechanisms of Death in Low-Risk Patients After Transcatheter or Surgical Aortic Valve Replacement

BackgroundDeath in high- and intermediate-risk patients after self-expanding transcatheter (TAVR) and surgical aortic valve replacement (surgery) differed in mechanisms and timing. In both risk groups, 1-year all-cause mortality was lower in TAVR than in surgery patients. The differences in mechanism and timing of death in low-risk patients has not been studied. This report explores the mechanisms of death during 3 time periods; 0 to 30 days (early), 31 to 120 days (recovery), and 121 to 365 days (late). MethodsWe retrospectively examined the mechanisms and timing of death following TAVR or surgery in the randomized Evolut Low Risk Trial. Patients were enrolled between March 2016 and November 2018 from 86 designated TAVR centers. Mechanisms of death were categorized as due to technical reasons, failure to repair, complications linked to death, failure to recover or other. ResultsAll-cause mortality at 1 year was 2.2% for TAVR and 2.8% for surgery, p = 0.44. Early deaths included 3 TAVR patients, all due to technical reasons, and 8 surgery patients (1 technical, 5 complications and 2 failed to recover). Recovery period deaths included 6 TAVR patients (4 complications, 1 failed to recover and 1 other), and 1 surgery patient from complications of valve endocarditis. Late period deaths included 6 TAVR patients and 9 surgery patients, primarily due to complications.Conclusions: In this low-risk study cohort, no patient died from failure to repair the valve; reduction in procedural complications in the TAVR and surgery groups remain opportunities for further improvement in outcomes.Clinical Trial Registrations (clinicaltrials.gov): NCT02701283 (Evolut Low Risk).

Self-Expanding Transcatheter Aortic Valve Replacement for Pure Aortic Regurgitation With Extremely Horizontal Aorta: A Case Series.

Transcatheter aortic valve replacement (TAVR) is not the preferred therapy for pure aortic regurgitation (AR). Extremely horizontal aorta (aorta root angle ≥70°) is regarded as an "off-label" use in self-expanding TAVR. This case series enrolled 7 consecutive pure AR patients who had extremely horizontal aorta and underwent self-expanding TAVR from the TORCH registry. To the best of our knowledge, this is the first study to report successful self-expanding TAVR for pure AR with extremely horizontal aorta, revealing the feasibility of both transapical and transfemoral TAVR in this challenging population.

Permanent Pacemaker Reduction Using Cusp-Overlapping Projection in TAVR: A Propensity Score Analysis.

The aim of this study was to determine if modifying the classical implantation technique for self-expanding (SE) transcatheter aortic valve replacement to a novel cusp-overlapping projection (COP) technique results in a higher implantation depth (ID) and subsequently reduces the rate of permanent pacemaker implantation (PPMI). The COP technique presents the potential benefit of an optimized ID to reduce the rate of PPMI. However, only a few studies have compared clinical outcomes with those achieved using the standard technique. Thisisthe first study to systematically evaluate this approach for SE transcatheter heart valves (THVs) in different populations METHODS: Beginning in February 2015, 444 patients were consecutively included. Propensity score matching was used to control baseline characteristics because of the observational nature of the study. In total, 161 pairs of patients were analyzed. Three methods were used to measure ID (noncoronary cusp [NCC] to the THV, mean of the NCC and the left coronary cusp [LCC] to the THV, and the deepest edge from the LCC and the NCC to the THV). ID was significantly higher in COP cases when measuring from the NCC (4.2mm vs 5.3mm; P< 0.001) and the mean from the NCC and the LCC (5.3mm vs 5.9mm; P=0.04), but not from the deepest edge. The PPMI rate was lower in the COP group: 19 (11.8%) vs 35 (21.7%) (P=0.03; relative risk: 0.54; 95% CI: 0.32-0.91). The present study showed that the COP technique significantly reduces PPMI in SE THV implantation compared with the classical implantation technique, with similar rates of complications.

Outcomes of Transcatheter Aortic Valve Replacement in Patients Treated With Systemic Steroids.

Chronic steroid therapy is associated with higher vascular complication rates in patients undergoing transcatheter aortic valve replacement (TAVR). The effect of corticosteroids on aortic annular complications has not been directly assessed in this population. A retrospective analysis of 1095 patients undergoing transfemoral TAVR was performed. Patients treated with chronic steroids at the time of the procedure (n = 99) were compared with those who received no steroids (n = 992). The primary outcome included a composite of aortic annular complications, defined as a combination of aortic annular rupture, aortic dissection/perforation, and left ventricular perforation. The primary outcome was significantly higher in the steroid group (4.0% vs 0.5%; P<.01). This finding was primarily driven by higher rates of acute annular rupture in the steroid group (2.0% vs 0.2%; P=.04). Steroid use was associated with higher rates of intraoperative cardiac arrest (5.1% vs 1.5%; P=.03), device capture/retrieval (4.0% vs 0.8%; P=.01), and emergent conversion to open heart surgery (4.0% vs 0.6%; P<.01). There were no differences with respect to in-hospital mortality, stroke, myocardial infarction, need for permanent pacemaker, bleeding complications, minor vascular complications, hospital length of stay, hospital 30-day readmission, or 30-day echocardiographic findings. Additionally, within the steroid group, there were no significant differences between balloon-expandable vs self-expanding TAVR prostheses with respect to composite aortic annular complications. Chronic steroid therapy increases the risk of aortic annular complications in patients undergoing TAVR, with detrimental consequences including intraoperative cardiac arrest and conversion to open heart surgery. Steroid use should be considered in patient selection and determination of procedural technique for TAVR.

Neosinus and Sinus Flow After Self-Expanding and Balloon-Expandable Transcatheter Aortic Valve Replacement.

The aim of this study was to evaluate flow dynamics in the aortic sinus and the neosinus (NS) after transcatheter heart valve (THV) implantation in valve-in-valve (ViV). Leaflet thrombosis may occur on THVs and affect performance and durability. Differences in flow dynamics may affect the risk for leaflet thrombosis. Hemodynamic assessment following THV implantation in a surgical aortic valve was performed in a left heart simulator under pulsatile physiological conditions. Assessment was performed using a 23-mm polymeric surgical aortic valve (not diseased) and multiple THV platforms, including self-expanding devices (26-mm Evolut, 23-mm Allegra, small ACURATE neo) and a balloon-expandable device (23-mm SAPIEN 3). Particle image velocimetry was performed to assess flow in the sinus and NS. Sinus and NS washout, shear stress, and velocity were calculated. Sinus and NS washout was fastest and approximately 1 cardiac cycle for each with the Evolut, ACURATE neo, and Allegra compared with the SAPIEN 3, with washout in 2 and 3 cardiac cycles, respectively. The Allegra showed the largest shear stress distribution in the sinus, followed by the SAPIEN 3. In the NS, all 4 valves showed equal likelihoods of occurrence of shear stress<1 Pa, but the Allegra showed the highest likelihoods of occurrence for shear stress >1 Pa. The velocities in the sinus and NS were 0.05, 0.078, 0.080, and 0.075m/s for Evolut, SAPIEN 3, ACURATE neo, and Allegra ViV, respectively. Sinus and NS flow dynamics differ substantially among THVs after ViV. Self-expanding supra-annular valves seem to have faster washouts compared with an equivalent-size balloon-expandable THV.

The Predictors of Conduction Disturbances Following Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve: A Multicenter Study.

Objective: To evaluate the predictors of new-onset conduction disturbances in bicuspid aortic valve patients using self-expanding valve and identify modifiable technical factors.Background: New-onset conduction disturbances (NOCDs), including complete left bundle branch block and high-grade atrioventricular block, remain the most common complication after transcatheter aortic valve replacement (TAVR).Methods: A total of 209 consecutive bicuspid patients who underwent self-expanding TAVR in 5 centers in China were enrolled from February 2016 to September 2020. The optimal cut-offs in this study were generated from receiver operator characteristic curve analyses. The infra-annular and coronal membranous septum (MS) length was measured in preoperative computed tomography. MSID was calculated by subtracting implantation depth measure on postoperative computed tomography from infra-annular MS or coronal MS length.Results: Forty-two (20.1%) patients developed complete left bundle branch block and 21 (10.0%) patients developed high-grade atrioventricular block after TAVR, while 61 (29.2%) patients developed NOCDs. Coronal MS <4.9 mm (OR: 3.08, 95% CI: 1.63–5.82, p = 0.001) or infra-annular MS <3.7 mm (OR: 2.18, 95% CI: 1.04–4.56, p = 0.038) and left ventricular outflow tract perimeter <66.8 mm (OR: 4.95 95% CI: 1.59–15.45, p = 0.006) were powerful predictors of NOCDs. The multivariate model including age >73 years (OR: 2.26, 95% CI: 1.17–4.36, p = 0.015), Δcoronal MSID <1.8 mm (OR: 7.87, 95% CI: 2.84–21.77, p < 0.001) and prosthesis oversizing ratio on left ventricular outflow tract >3.2% (OR: 3.42, 95% CI: 1.74–6.72, p < 0.001) showed best predictive value of NOCDs, with c-statistic = 0.768 (95% CI: 0.699–0.837, p < 0.001). The incidence of NOCDs was much lower (7.5 vs. 55.2%, p < 0.001) in patients without Δcoronal MSID <1.8 mm and prosthesis oversizing ratio on left ventricular outflow tract >3.2% compared with patients who had these two risk factors.Conclusion: The risk of NOCDs in bicuspid aortic stenosis patients could be evaluated based on MS length and prosthesis oversizing ratio. Implantation depth guided by MS length and reducing the oversizing ratio might be a feasible strategy for heavily calcified bicuspid patients with short MS.

TCT-476 Same-Day Discharge After Minimalist, Self-Expanding Transcatheter Aortic Valve Replacement in a Community Hospital During the COVID-19 Pandemic

TCT-476 Same-Day Discharge After Minimalist, Self-Expanding Transcatheter Aortic Valve Replacement in a Community Hospital During the COVID-19 Pandemic

Self-expanding and balloon-expandable transfemoral transcatheter aortic valve replacement: in-hospital outcomes in Germany

Abstract Background The impact of valve type used in transfemoral transcatheter aortic valve replacement (TF-TAVR) on outcomes is currently under discussion. Purpose We examine the in-hospital outcomes of balloon-expandable (BE) and self-expanding (SE) valves in a complete national cohort in Germany in 2018. Methods All 17,295 patients receiving TF-TAVR with BE (N=9,882) or SE (N=7,413) valves in Germany in 2018 were identified. Outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, mechanical ventilation &amp;gt;48h, length of hospital stay, and reimbursement. Since there was no randomization of patients to the two treatment options, logistic or linear regression models were carried out using 22 baseline patient characteristics and center-specific variables as potential confounders. Propensity score methods served as sensitivity analysis. Results Both valve types differed significantly in baseline characteristics with higher EuroSCORE (p&amp;lt;0.001), age (p&amp;lt;0.001) and rate of female sex (p&amp;lt;0.001) in patients treated with SE valves. After risk adjustment, there were no marked differences in outcomes for in-hospital mortality (risk adjusted odds ratio (aOR) for SE instead of BE: 0.94 [95% CI 0.76; 1.17], p=0.617), major bleeding (aOR 0.91 [0.73; 1.14], p=0.400), stroke (aOR 1.13 [0.88; 1.46], p=0.347), acute kidney injury (aOR 0.97 [0.85; 1.10], p=0.621), postoperative delirium (aOR 1.09 [0.96; 1.24], p=0.184), mechanical ventilation &amp;gt;48h (aOR 0.98 [0.77; 1.25], p=0.893), length of hospital stay (risk adjusted difference in days of hospitalization: −0.05 [−0.34; 0.25], p=0.762) and reimbursement (−€72 [−€291; €147], p=0.519). Similar results were found using propensity score methods. Conclusion Outcomes in contemporary TF-TAVR procedures are broadly equivalent regardless of the valve type used. Major complications rarely occur in both types of valve. Funding Acknowledgement Type of funding sources: None. Self- vs balloon-expanding TF-TAVR

BUDGET IMPACT ANALYSIS OF TRANSCATHETER AORTIC VALVE REPLACEMENT COMPARED TO SURGICAL AORTIC VALVE REPLACEMENT IN LOW-RISK AORTIC STENOSIS PATIENTS: A CANADIAN PERSPECTIVE

<h3>BACKGROUND</h3> In patients with severe symptomatic aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) is approved for use across the entire spectrum of risk, including low surgical risk patients. TAVR has been shown to provide rapid improvement in quality-of-life while being less invasive than surgical aortic valve replacement (SAVR). In Canada, TAVR funding is limited, and the perceived higher cost of TAVR may be a barrier to expanding the therapy to low-risk patients. While TAVR has been shown to be cost-effective, the affordability of implementing TAVR for low-risk AS patients from the hospital's payers' perspective is not known. <h3>METHODS AND RESULTS</h3> A budget impact analysis was conducted using a one-year time horizon to quantify the total cost of healthcare resource utilization to initially treat low-risk AS patients and the subsequent management of adverse events (AEs). Micro-costing was performed for both self-expandable TAVR and SAVR based on resource utilization (operating room time, supplies, intensive care unit (ICU) and total length of stay (LOS)) and complication event rates (heart failure (HF) hospitalization, pacemaker implantation, stroke, acute kidney injury) from the recently published Evolut Low-Risk CoreValve trial. Overall differences in cost between TAVR and SAVR were calculated for 100 patients for various scenarios of TAVR uptake (0% to 70%) in low-risk AS patients. Costs were obtained from provincial datasets and the published literature (reported in 2021 Canadian dollars). The mean procedural cost of SAVR and TAVR per patient was $41,405 and $44,061, respectively. The one-year cost of managing AEs for SAVR and TAVR were $4,883 and $4,398, respectively (difference = $485). Overall, the incremental difference in cost was $2,172 higher with TAVR at one year per patient. The total cost of care for a hypothetical cohort of 100 low-risk AS patients in the base-case scenario (10% TAVR, 90% SAVR) was $4,650,357. The proportion of TAVR/SAVR was increased incrementally to a final scenario (70% TAVR, 30% SAVR) where the total cost of care was $4,780,612 representing a 2.8% increase in cost. One-way sensitivity analysis on key variables showed that the main contributors to the cost difference were the ICU LOS (difference in cost: -3.1% to 3.2%) and HF hospitalization rates (2.8% to 3.9%). <h3>CONCLUSION</h3> Despite the higher upfront procedure cost, the incremental cost of implementing TAVR in low-risk severe symptomatic aortic stenosis patients was small due to relatively lower adverse events rates at one year. In severe aortic stenosis management, a shift from SAVR to TAVR is likely affordable.

Quantification of noncircular stent expansion after TAVR into a pathological annulus and its impact on paravalvular leakage

Abstract Patients undergoing transcatheter aortic valve replacement (TAVR) may suffer severe clinical complications, caused by paravalvular leakage (PVL) which is defined as leakage between TAVR and aortic annulus. PVL is often facilitated by a severely calcified annulus. This limits the expansion of a self-expandable TAVR stent. To assess TAVR performance in terms of leakage, measurement of regurgitation fraction in a pathophysiological annulus is recommended according to ISO 5840. For this purpose, a configuration of a circular annulus with a calcification nodule has been proposed in the recently published ISO 5840. The impact of the proposed pathophysiological annulus model on the expansion of self-expandable TAVR stents and on the regurgitation fraction was investigated in this study. For this purpose, two commercially available selfexpandable TAVRs (Evolut R and Portico) were implanted in a calcified annulus model. Circular expansion of the TAVR stents was investigated based on μCT scans of the implanted TAVR. The calcification-induced area in which retrograde flow can occur during diastole was detected. These results were then compared with the experimentally determined regurgitation fraction obtained from pulse duplicator tests. The results of the μCT scans showed a continuous leakage area in the region of the annulus for the Evolut R compared to a locally larger leakage area of the Portico, which, however, reattaches to the annulus in the distal inflow region. The hydrodynamic measurements confirmed a smaller leakage in the pathological annulus for the Portico. In summary, it can be assumed that a continuous leakage area in the TAVR stent inflow region encourages the PVL of TAVR.

Anatomical Predictors of Valve Malposition During Self-Expandable Transcatheter Aortic Valve Replacement.

Background: The consequence of valve malposition (VM) during transcatheter aortic valve replacement (TAVR) can be severe, but the determinants of VM with self-expandable TAVR have not been thoroughly evaluated. We aimed to investigate the anatomical predictors of VM during self-expandable TAVR.Methods: In this multicenter retrospective study, TAVR was performed using the Venus A-Valve. The baseline, computed tomography, and procedural characteristics along with clinical outcomes were collected. Multivariate logistic regression model and receiver operating characteristic (ROC) curve analyses were performed.Results: A total of 84 consecutive patients (23 with VM) were included. Stepwise regression showed that annulus perimeter/left ventricular outflow tract perimeter (AL ratio) and sinotubular junction (STJ) height were predictors of VM. The ROC curve indicated a moderate strength of AL ratio [area under the curve (AUC) 0.71, cutoff 0.96] and a weak strength of STJ height (AUC 0.69, cutoff 23.8 mm) to predict VM. The combination of both predictors revealed a higher predictive value of VM (AUC 0.77). In multivariate analysis, AL ratio <0.96 [odds ratio (OR) 3.98, p = 0.015] and STJ height ≥23.8 mm (OR 4.63, p = 0.008) were strong independent predictors of VM. The presence of both predictors was associated with a very high risk of VM (OR 10.67, p = 0.002). The rate of moderate-to-severe paravalvular regurgitation was higher in patients with VM at 30 days (26.1 vs. 4.9%, p = 0.011).Conclusions: A conical left ventricular outflow tract and tall aortic sinuses were strong anatomical predictors of VM during self-expandable TAVR.

PCV8 Balloon-expandable versus self-expandable transcatheter aortic valve replacement

to assess the financial consequences of choosing different transcatheter aortic valve replacement (TAVR) valves, namely balloon-expandable valves (BEV) or self-expandable valves (SEV) for the treatment of high risk severe aortic stenosis (SAS).

Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli.

The aim of this study was to define predictors of prosthesis-patient mismatch (PPM) and its impact on mortality after transcatheter aortic valve replacement (TAVR) with self-expandable valves (SEVs) in patients with small annuli. TAVR seems to reduce the risk for PPM compared with surgical aortic valve replacement, especially in patients with small aortic annuli. Nevertheless, predictors and impact of PPM in this population have not been clarified yet. Predictors of PPM and all-cause mortality were investigated using multivariable logistic regression analysis from the cohort of the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry, which included patients with severe aortic stenosis and small annuli (annular perimeter<72mm or area<400mm2 on computed tomography) treated with transcatheter SEVs: 445 patients with (n=129) and without (n = 316) PPM were enrolled. Intra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95%CI: 0.25-0.84) and valve oversizing (OR: 0.53; 95%CI: 0.28-1.00) seemed to protect against PPM occurrence. At a median follow-up of 354days, patients with severe PPM, but not those with moderate PPM, had a higher all-cause mortality rate compared with those without PPM (log-rank p=0.008). Multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio: 4.27; 95%CI: 1.34 to 13.6). Among patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM; conversely, post-dilation and valve oversizing protected against PPM occurrence. Severe PPM was independently associated with all-cause mortality.

Surgical Sutureless and Sutured Aortic Valve Replacement in Low-risk Patients

BackgroundRandomized clinical trials have shown that transcatheter aortic valve replacement is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial. MethodsThe Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding transcatheter aortic valve replacement or surgery. Use of sutureless or sutured valves was at the surgeons’ discretion. ResultsSix hundred eighty patients underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The Valve Academic Research Consortium-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P = .93). All-cause mortality between groups was similar at 30 days (0.5% vs 1.5%, P = .28) and 1 year (3.3% vs 2.6%, P = .74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P = .65) and 1 year (2.6% vs 2.2%, P = .76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P < .001). Aortic valve–related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P = .04). Mean gradients 1 year after sutureless and sutured aortic valve replacement were 9.9 ± 4.2 versus 11.7 ± 4.7 mm Hg (P < .001). ConclusionsAmong low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics but with an increased rate of pacemaker implantation and valve-related hospitalizations.

Pacemaker implantation after balloon- or self-expandable transcatheter aortic valve replacement in patients with aortic stenosis

Abstract Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with different devices available in recent years remains a matter of debate. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. Results A total of 49,201 patients with aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using the balloon-expandable (BE) Edwards SAPIEN valve or the self-expanding (SE) Medtronic CoreValve were found in the database. Patients treated with early BE or SE valves had higher Charlson comorbidity and frailty indexes than those treated with later BE or SE valves, and slightly higher EuroSCORE II. Patients treated with SE valves had higher rates of previous pacemaker or defibrillator than those treated with BE valves. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1–2.0] years). PPI after the procedure was reported in 13,289 patients, among whom 11,010 (22.4%) had implantation during the first 30 days (figure 1). In multivariable analysis, using early BE TAVR as reference, adjusted OR (95% CI) for PPI during the first 30 days was 0.88 (0.81–0.95) for latest BE TAVR, 1.40 (1.27–1.55) for early SE TAVR and 1.17 (1.07–1.27) for latest SE TAVR. Compared to early BE TAVR, adjusted HR for PPI during the whole follow-up was 1.01 (0.95–1.08) for latest BE TAVR, 1.30 (1.21–1.40) for early SE TAVR and 1.25 (1.18–1.34) for latest SE TAVR. Conclusion In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. However, this was less apparent than previously reported in this large analysis of unselected patients seen in “real life” practice. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up. Funding Acknowledgement Type of funding source: None