Balloon-expandable Valve Research Articles

Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients

BackgroundPrevious studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. ObjectivesThe aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. MethodsPropensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. ResultsA total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration–related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. ConclusionsIn this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration–related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i [PARTNER II Trial: Placement of Aortic Transcatheter Valves II – S3 Intermediate], NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II – XT Intermediate and High Risk], NCT01314313)

Distal Balloon Inflation Technique - A Bailout Method of Difficulty in Crossing Balloon-Expandable Valve Delivery System Due to Unfavorable Guidewire Position During Transcatheter Aortic Valve Replacement.

Distal Balloon Inflation Technique - A Bailout Method of Difficulty in Crossing Balloon-Expandable Valve Delivery System Due to Unfavorable Guidewire Position During Transcatheter Aortic Valve Replacement.

Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock.

The safety and efficacy of transcatheter aortic valve replacement (TAVR) with contemporary balloon expandable transcatheter valves in patients with cardiogenic shock (CS) remain largely unknown. In this study, the TAVRs performed for CS between June 2015 and September 2022 using SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were analysed. CS was defined as: (i) coding of CS within 24 h on Transcatheter Valve Therapy Registry form; and/or (ii) pre-procedural use of inotropes or mechanical circulatory support devices and/or (iii) cardiac arrest within 24 h prior to TAVR. The control group was comprised of all the other patients undergoing TAVR. Baseline characteristics, all-cause mortality, and major complications at 30-day and 1-year outcomes were reported. Landmark analysis was performed at 30 days post-TAVR. Cox-proportional multivariable analysis was performed to determine the predictors of all-cause mortality at 1 year. A total of 309 505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5006 patients presented with CS prior to TAVR (1.6%). The mean Society of Thoracic Surgeons score was 10.76 ± 10.4. The valve was successfully implanted in 97.9% of patients. Technical success according to Valve Academic Research Consortium-3 criteria was 94.5%. In a propensity-matched analysis, CS was associated with higher in-hospital (9.9% vs. 2.7%), 30-day (12.9% vs. 4.9%), and 1-year (29.7% vs. 22.6%) mortality compared to the patients undergoing TAVR without CS. In the landmark analysis after 30 days, the risk of 1-year mortality was similar between the two groups [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.95-1.21]. Patients who were alive at 1 year noted significant improvements in functional class (Class I/II 89%) and quality of life (ΔKCCQ score +50). In the multivariable analysis, older age (HR 1.02, 95% CI 1.02-1.03), peripheral artery disease (HR 1.25, 95% CI 1.06-1.47), prior implantation of an implantable cardioverter-defibrillator (HR 1.37, 95% CI 1.07-1.77), patients on dialysis (HR 2.07, 95% CI 1.69-2.53), immunocompromised status (HR 1.33, 95% CI 1.05-1.69), New York Heart Association class III/IV symptoms (HR 1.50, 95% CI 1.06-2.12), lower aortic valve mean gradient, lower albumin levels, lower haemoglobin levels, and lower Kansas City Cardiomyopathy Questionnaire scores were independently associated with 1-year mortality. This large observational real-world study demonstrates that the TAVR is a safe and effective treatment for aortic stenosis patients presenting with CS. Patients who survived the first 30 days after TAVR had similar mortality rates to those who were not in CS.

Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study.

The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve. In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days. Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, p = 0.56), stroke (2% vs. 4%, p = 0.41) and myocardial infarction (1% vs. 3%, p = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, p = 0.01). At 1 year, cardiac death (2% vs. 4%, p = 0.41) and the stroke rate (7% vs. 5%, p = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, p = 0.17). Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate-severe PVL in both groups.

Optimal stroke volume index cut off for survival of severe aortic stenosis patients undergoing TAVI - where should we draw the line?

Abstract Funding Acknowledgements Type of funding sources: None. Background Low-flow status in patients with severe aortic stenosis (SAS) is currently defined using stroke volume index (SVi), at a cut off below 35mL/m2. Low-flow has been associated with higher mortality in patients undergoing transcatheter aortic valve implantation (TAVI). However, different cut offs have been recently suggested to more accurately define a low-SVi associated with worse survival after valvular intervention. Purpose Determine the impact of SVi in mortality of SAS patients undergoing TAVI and define a prognostically relevant threshold in this context. Methods A database comprising all patients treated with TAVI between 2011 and 2019 in a single-centre was retrospectively analyzed, and cases with echocardiograms performed before intervention in our centre were included. Primary endpoint was defined as time to all-cause death or last follow-up over the five years after intervention. Surv_cutpoint from survival package in R was used to evaluate optimal low-SVi cutpoints associated with worse survival in SAS patients undergoing TAVI. Low-flow patients were compared with normal-flow counterparts using the determined low-SVi definition. The prognostic values of continuous and categorical SVi at a <35mL/m2 cut off and using the newly determined threshold were tested using Kaplan-Meier curves, log-rank test and Cox proportional hazard model adjusted for EuroSCORE II. Patients were further divided as having preserved or reduced ejection fraction (EF, <52%). p<0.05 was considered statistically significant. Results Of 657 TAVI performed, 488 (74.6%) patients were included in the present analysis, over a median follow-up of 56 months. A SVi<35ml/m2 was not associated with higher mortality after TAVI (p = 0.07). An optimal cutpoint of low-SVi was defined at <29mL/m2 (n=115, 24%), and these patients were on a more advanced NYHA class, were of higher estimated surgical risk, were more frequently hypertensive and anemic, and had a higher prevalence of atrial fibrillation. Echocardiographic data revealed lower EF, lower functional aortic valve area and lower transvalvular gradients in low-SVi patients. Regarding TAVI design, a balloon-expandable valve was more frequently used in this setting. SVi<29ml/m2 was associated with higher mortality after intervention [p = 0.003, hazard ratio (HR) 1.60 (1.18–2.17)], including after adjusting to EuroSCORE II, and in a reduced (but not preserved) EF context. When analyzed as a continuous variable, a higher SVi was associated with better survival after TAVI. Conclusions SVi is a prognostically relevant parameter in SAS patients undergoing TAVI. Contrary to a classically defined threshold of <35mL/m2, a SVi<29mL/m2 was associated with higher mortality after intervention in our population.

Extrapolation of CT aortic annulus derived diameter/CT aortic annulus area from 2D echocardiography aortic annulus diameter in TAVR: not a reliable tool

Abstract Funding Acknowledgements Type of funding sources: None. Background Computed tomography (CT) aortic annulus area, CT area derived diameter and two-dimensional echocardiography (2D ECHO) diameters are used for valvular sizing in transcutaneous aortic valve replacement (TAVR). According to our previous study, 2D ECHO annulus diameter was smaller in comparison to CT derived diameter (22.6±2.9 vs 25.0±5.5mm, p = 0.013), but both CT aortic annulus area derived diameter/CT aortic annulus and 2D ECHO diameter predicted correct valve size selection with the same accuracy of 79–80%. However, CT requires radiation and iodine contrast administration, which might be the limitation in patients with chronic kidney disease or history of iodine allergy. Purpose To determine if 2D ECHO diameter can be used for reliable estimation of CT area derived diameter/CT aortic annulus area. Methods 139 consecutive patients with favourable outcome of Sapien XT/Sapien S3 TAVR (no more than mild aortic regurgitation, only one valve implanted) were included in the study. 2D ECHO diameter was measured from mid oesophageal three-chamber view (110–135°) just below the anatomical aortic valve annulus. CT aortic annulus was obtained as double oblique plane by manual multiplanar reconstruction of CT dataset, defined by three lowest attachment points of valvular leaflets. Aortic annulus area was measured by manual tracking of lumen contours, area derived diameter as 2*√(area/π). Linear regression analysis between pre-implant CT area derived diameter and 2D ECHO diameter was performed; extrapolated CT annulus area diameter and CT aortic annulus area [π*(d/2)2] were calculated from 2D ECHO diameter. Concordance of valve size selection based on extrapolated CT area derived diameter vs original CT area derived diameter and extrapolated CT aortic annulus area vs original CT aortic annulus area was determined on patients where CT aortic annulus area/annulus derived diameter were falling outside the overlap of the manufacturer recommended ranges for neighbouring valve sizes. Results Significant relationship between CT aera derived diameter and 2D ECHO diameter was found (r=0.720, p<0.001, Fig 1,2). Extrapolated CT area derived diameter would have led to inappropriate size selection in 33/100 more cases (undersizing in 16%, oversizing in 17%), similar to extrapolated aortic annulus area, where both undersizing and oversizing was observed in 18/106 (17%) more cases in comparison to original CT based parameters. Conclusion Extrapolation of CT aortic annulus area/area derived diameter from 2D ECHO diameter is not a reliable tool in valvular sizing for balloon expandable Sapien valve. In patients with chronic kidney disease or history of iodine allergy, three-dimensional (3D) ECHO aortic annulus assessment remains the only viable alternative tool.

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.

Comparison of Outcomes Following Transcatheter Aortic Valve Replacement Requiring Peripheral Vascular Intervention or Alternative Access.

Background Peripheral vascular intervention (PVI) is occasionally required to facilitate delivery system insertion or to treat vascular complications during transfemoral transcatheter aortic valve replacement (TF-TAVR). However, the impact of PVI on outcomes is not well understood. Therefore, we aimed to compare outcomes between TF-TAVR with versus without PVI and between TF-TAVR with PVI versus non-TF-TAVR. Methods and Results We retrospectively reviewed 2386 patients who underwent TAVR with a balloon-expandable valve at a single institution from 2016 to 2020. The primary outcomes were death and major adverse cardiac/cerebrovascular event (MACCE), defined as death, myocardial infarction, or stroke. Of 2246 TF-TAVR recipients, 136 (6.1%) required PVI (89% bailout treatment). During follow-up (median 23.0 months), there were no significant differences between TF-TAVR with and without PVI in death (15.4% versus 20.7%; adjusted HR [aHR], 0.96 [95% CI, 0.58-1.58]) or MACCE (16.9% versus 23.0%; aHR, 0.84 [95% CI, 0.52-1.36]). However, compared with non-TF-TAVR (n=140), TF-TAVR with PVI carried significantly lower rates of death (15.4% versus 40.7%; aHR, 0.42 [95% CI, 0.24-0.75]) and MACCE (16.9% versus 45.0%; aHR, 0.40 [95% CI, 0.23-0.68]). Landmark analyses demonstrated lower outcome rates following TF-TAVR with PVI than non-TF-TAVR both within 60 days (death 0.7% versus 5.7%, P=0.019; MACCE 0.7% versus 9.3%; P=0.001) and thereafter (death 15.0% versus 38.9%, P=0.014; MACCE 16.5% versus 41.3%, P=0.013). Conclusions The need for PVI during TF-TAVR is not uncommon, mainly due to the bailout treatment for vascular complications. PVI is not associated with worse outcomes in TF-TAVR recipients. Even when PVI is required, TF-TAVR is associated with better short- and intermediate-term outcomes than non-TF-TAVR.

Intravenous thrombolysis for bioprosthetic valve thrombosis.

A 77-year-old woman experienced new-onset dyspnoea on exertion 1 year after alcohol septal ablation and transcatheter aortic valve implantation (TAVI) with a balloon-expandable valve for symptomatic severe aortic stenosis and basal septal hypertrophy. Transthoracic echocardiographic assessment (TTE) revealed an incremental transvalvular peak velocity from 2.9 m/s 3 days after TAVI to 4.3 m/s. Multislice computed tomography (MSCT) demonstrated hypoattenuated leaflet thickening (HALT) of all leaflets and reduced leaflet motion (RLM) of one leaflet (Panel A). Her antithrombotic regimen was changed from apixaban 5 mg bi-daily to acenocoumarol with a target international normalized ratio (INR) of 2.5–3.5. Six weeks later, symptoms persisted and the transvalvular peak velocity was 3.9 m/s (Panel B). A decision was made to attempt to resolve the thrombus with repeated intravenous infusions of alteplase.1,2 Four sequential infusions of 25 mg alteplase/25 h resulted in an uneventful but stepwise decrease of the transvalvular peak velocity to 2.8 m/s (Panel C–F). Multislice computed tomography confirmed normalization of leaflet motion with some residual remaining leaflet thickening (Panel F). MSCT cine images before and after alteplase infusion are available in the Supplementary data online (Videos S1 and S2).

Midterm Outcomes in Patients With Aortic Stenosis Treated With Contemporary Balloon-Expandable and Self-Expanding Valves: Does Valve Size Have an Impact on Outcome?

Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis.

Transfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR. We searched PubMed, EMBASE, Clinicaltrials.gov, Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31-0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32-0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07-0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17-0.48); p < 0.00001) were also lower in the BEV arm. BEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients. identifier, CRD42020181190.

Permanent pacemaker implantation following transcatheter aortic valve implantation: a systematic review and Bayesian network meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Permanent pacemaker implantation (PPI) remains a common complication after transcatheter aortic valve implantation (TAVI). Different transcatheter heart valves (THVs) exist, and newly approved devices are growing. A comparison according to the mechanisms of TAVI prosthesis with longer follow-up needs to be made. We address this issue using a systematic review and a Bayesian network meta-analysis (NMA). Methods A systematic literature review was carried out up to Oct 31, 2022, to identify studies reporting the use of balloon-expandable valves (BEVs), self-expandable valves (SEVs), and mechanically expandable valves (MEVs). We compared the various THVs, or standard medical treatment (STD), with a common comparator of surgical aortic valve replacement (SAVR) concerning PPI. Data at the most extended follow-up for each study were extracted. A random-effects Bayesian NMA was used to calculate odds ratios (OR) and 95% credible intervals (CrI) using MetInsight V4.0.0. The surface under the cumulative ranking area (SUCRA) probabilities was selected to calculate the ranking and hierarchy of the different treatments. The larger SUCRA indicates the greater likelihood of becoming the best intervention. Results We included 15 RCTs comprising 12.783 patients, among whom 8.585 underwent TAVI using various commercially available THVs, including BEVs (Sapien &amp; Sapien XT, Sapien 3), MEVs (Corevalve, Evolut &amp; Pro/R, Acurate Neo, Portico), and MEVs (Lotus). The median follow-up was 2.5 years (IQR 1-5). No significant differences in the risk of PPI were observed between STD: 1.70 [0.556, 5.39], Sapien &amp; Sapien XT: 1.39 [0.834, 2.41], Sapien 3: 1.70 [0.977, 2.88], and Acurate Neo: 1.68 [0.768, 3.789], compared with SARV. All the other THVs (Corevalve: 3.07 [1.99. 4.959]; Evolut &amp; Pro/R: 3.19 [1.80, 6.03]; Lotus: 5.22 [2.08, 13.7]; Portico: 7.22 [2.85, 19.4]) showed significant differences in the risk of PPI compared with SARV. In Bayesian ranking results, Sapien &amp; Sapien XT had the highest chance (77%) of providing a lower PPI rate. Meanwhile, Portico THV was ranked the worst (5%) regarding the likelihood of PPI rate (Figure 1). According to the mechanism, all the THVs showed a higher risk for PPI than SARV (BEVs: 1.60 [1.01, 2.54]; SEVs: 3.09 [1.97, 4.96]; and MEV: 5.30 [1.62, 17.7]). STD: 1.92 [0.518, 7.14] had a non-significant PPI rate compared with SARV. SUCRA plot showed that SARV was the intervention with the lowest (95%) probability of PPI, followed by BEVs (65%), STD (55%), SEVs (27%) and MEVs (7%) (Figure 2). In both analyses, the assessment of inconsistency between direct and indirect estimates was not significant (P &amp;gt; 0.05). Conclusions This NMA of RCTs includes a more significant number of patients with longer follow-up. We demonstrated that BEVs are associated with lower PPI rates than SEVs and MEVs. Some newer generations of THVs (Acurate Neo, Evolut R/Pro) performed better than the older ones, reducing the PPI rate.

Quantity and location of aortic valve calcification predicts paravalvular leakage after transcatheter aortic valve replacement: a systematic review and meta-analysis.

Transcatheter aortic valve replacement (TAVR) is the first-line treatment for patients with moderate-to-high surgical risk of severe aortic stenosis. Paravalvular leakage (PVL) is a serious complication of TAVR, and aortic valve calcification contributes to the occurrence of PVL. This study aimed to investigate the effect of location and quantity of calcification in the aortic valve complex (AVC) and left ventricular outflow tract (LVOT) on PVL after TAVR. We performed a systematic review and meta-analysis to evaluate the effect of quantity and location of aortic valve calcification on PVL after TAVR using observational studies from PubMed and EMBASE databases from inception to February 16, 2022. Twenty-four observational studies with 6,846 patients were included in the analysis. A high quantity of calcium was observed in 29.6% of the patients; they showed a higher risk of significant PVL. There was heterogeneity between studies (I2 = 15%). In the subgroup analysis, PVL after TAVR was associated with the quantity of aortic valve calcification, especially those located in the LVOT, valve leaflets, and the device landing zone. A high quantity of calcium was associated with PVL, regardless of expandable types or MDCT thresholds used. However, for valves with sealing skirt, the amount of calcium has no significant effect on the incidence of PVL. Our study elucidated the effect of aortic valve calcification on PVL and showed that the quantity and location of aortic valve calcification can help predict PVL. Furthermore, our results provide a reference for the selection of MDCT thresholds before TAVR. We also showed that balloon-expandable valves may not be effective in patients with high calcification, and valves with sealing skirts instead of those without sealing skirts should be applied more to prevent PVL from happening. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=354630, identifier: CRD42022354630.

Tick Tock timing of permanent pacemaker implantation after transcatheter aortic valve replacement. A single center review

Abstract Funding Acknowledgements Type of funding sources: None. Background Permanent pacemaker implantation (PPI) for high degree atrio-ventricular block (AVB) is common in patients after transcatheter aortic valve replacement (TAVR). There is still no clear recommendation regarding the optimal timing of PPI and programming of the pacemakers (PM) in these patients. Methods Data of all 1363 patients who underwent TAVR in our center between July 2019 and September 2022 was included in this retrospective study. In patients with high degree AVB a PPI was performed either in the same procedure or at least within 24 h after TAVR. All patients underwent a PM-interrogation before discharge. Results A permanent PM was implanted in 122 of 1363 (9%) patients with a mean age of 82 years. AVB that required PPI occurred in 9.2% (100/1087) of the patients with a self-expandable (SE) valve and in 8% (22/276) of the patients with a balloon expandable (BE) valve. In 34 patients PPI was performed in the same TAVR procedure, and 88 patients were treated in an average of 3.5 days after TAVR. Right-sided PM was implanted in 27 out of the 34 (79.4%) intra-procedural cases and in 3 of the 88 (3.4%) post-procedural cases. No major complications were reported. Two revision procedures were performed due to lead dislodgements in both groups respectively [(2/34 (5.9%); 2/88 (2.3%)]. Two pneumothoraces (2/88, 2.3%) were reported in the post-procedural PPI patients. The overall complication rate was 4.9 % (6/122). The AV-conduction showed recovery in 37 Patients (37/122, 30%) during the first interrogation in an average of 2.1 days after TAVR [(9/34(26.5%); 28/88 (31.8%)]. The AV-hysteresis was programmed in 48 out of the 94 implanted dual chamber pacemakers during the first interrogation. The average length of stay in hospital in patients with intra-procedural PPI and in those who underwent PPI in a second procedure was 13.7 and 14 days respectively with no significant difference between both groups (p&amp;gt;0.05). Conclusion Intra-procedural PPI was not associated with significant reduction of in hospital stay. The percentage of AV-conduction recovery after TAVR was high, even in short term follow up. Patients could benefit from a longer monitoring to avoid PPI and programming of AV-hysteresis during the first interrogation in these population should be recommended. Randomized and long-term follow up data are needed.

Discrepancy between invasive and echocardiographic transvalvular gradient after TAVI: Insights from the LAPLACE-TAVI registry

BackgroundEchocardiography-based transvalvular mean pressure gradient (ECHO-mPG) used to assess the forward valve function and structural valve deterioration could overestimate the true pressure gradient. This study evaluated the discrepancy between invasive and ECHO-mPG after transcatheter aortic valve implantation (TAVI) with respective valve type and size, its impact on a device success criterion, and predictors of a pressure discrepancy. MethodsWe analyzed 645 patients registered in a multicenter TAVI registry (balloon-expandable valve [BEV]: 500; self-expandable valve [SEV]: 145). The invasive transvalvular mPG was measured after valve implantation using two Pigtail catheters (CATH-mPG), while the ECHO-mPG was measured within 48 h after TAVI. Pressure recovery (PR) was calculated using the following formula: ECHO-mPG × effective orifice area (EOA)/ascending aortic area (AoA) × (1 − EOA/AoA). ResultsECHO-mPG was weakly correlated with (r = 0.29, p < 0.0001), and consistently overestimated CATH-mPG in both BEV and SEV, and respective valve sizes. The magnitude of the discrepancy was larger for BEV than SEV (p < 0.001) and smaller valves (p < 0.001). After the correction of PR using the above formula, the pressure discrepancy remained for BEV (p < 0.001) but not SEV (p = 0.10). The proportion of patients with an ECHO-mPG > 20 mmHg decreased from 7.0% to 1.6% after correction (p < 0.0001). Among the baseline and procedural variables, post-procedural ejection fraction, BEV versus SEV, and smaller valves were associated with a larger discrepancy in mPG. ConclusionsECHO-mPG could be overestimated after TAVI, especially in patients with a smaller BEV. A higher ejection fraction, BEV, and smaller valves were predictors of a pressure discrepancy between CATH- and ECHO-mPG.

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.

Long-Term Outcomes after Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedures.

Redo mitral valve surgery is the standard of care for failed mitral bioprostheses or recurrence of mitral regurgitation after repair. Nonetheless, catheter-based valve-in-valve (ViV) or valve-in-ring (ViR) procedures have increasingly become viable alternatives in high-risk subpopulations. Despite reported good initial results, little is known about longer-term outcomes. Here, we report the long-term outcomes of transcatheter mitral ViV and ViR procedures. All consecutive patients (n = 54) undergoing transcatheter mitral ViV or ViR procedures for failed bioprostheses or recurring regurgitation after mitral repair in the time period between 2011 and 2021 were retrospectively enrolled. The mean age was 76.5 ± 6.5 years, and 30 (55.6%) of the patients were male. The procedures were done using a commercially available balloon-expandable transcatheter heart valve. Clinical and echocardiographic follow-up data were obtained from the hospital's database and analyzed. Follow-up reached up to 9.9 years with a total of 164.3 patient-years. A total 25 patients received a ViV and 29 patients a ViR procedure. Both groups were at high surgical risk with an STS-PROM of 5.9 ± 3.7% in ViV and 8.7 ± 9.0% in ViR patients (p < 0.01). The procedures themselves were mainly uneventful with no intraoperative deaths and a low conversion rate (n = 2/54; 3.7%). VARC-2 procedural success was low (ViV 20.0% and ViR 10.3%; p = 0.45), which was either driven by high rates of transvalvular pressure gradients ">5 mmHg" (ViV 92.0% and ViR 27.6%; p < 0.01) or residual regurgitation ">trace" (ViV 28.0% and ViR 82.7%; p < 0.01). ICU-stay was prolonged in both groups (ViV 3.8 ± 6.8 days and ViR 4.3 ± 6.3 days; p = 0.96) with acceptable hospital stay (ViV 9.9 ± 5.9 days and ViR 13.5 ± 8.0 days; p = 0.13). Despite 30-day mortality being acceptable (ViV 4.0% and ViR 6.9%; p = 1.00), the mean posthospital survival time was disappointingly low (ViV 3.9 ± 2.6 years and ViR 2.3 ± 2.7 years; p < 0.01). Overall survival in the entire group was 33.3%. Cardiac reasons for death were frequent in both groups (ViV 38.5% and ViR 52.2%). Cox-regression analysis identified ViR procedures as a predictor of mortality (HR 2.36, CI 1.19-4.67, p = 0.01). Despite acceptable immediate outcomes in this high-risk subpopulation, long-term results are discouraging. Transvalvular pressure gradients as well as residual regurgitations remained drawbacks in this real-world population. The indication for catheter-based mitral ViV or ViR procedures rather than conventional redo-surgery or conservative treatment must be thoughtfully considered.

Balloon-Expandable Pulmonary Valves for Patched or Native Right Ventricular Outflow Tracts.

The implantation of percutaneous balloon expandable valves in native or patched right ventricular outflow tracts (nRVOT) is a challenging technique due to the diversity of anatomies and shapes, the large sizes, and the distensibility of the nRVOT, for which specific techniques have been developed. We present a single center experience with balloon expandable percutaneous pulmonary valves in nRVOT, describing the techniques used, complications observed, and a short-mid term follow-up.. This is a single center descriptive study of patients who underwent a percutaneous pulmonary valve implantation in a nRVOT with a balloon expandable pulmonary valve in our center between September 2012 and June 2022.. We implanted successfully 45 valves in 46 patients (20 Sapien and 25 Melody). Tetralogy of Fallot or pulmonary atresia with VSD were the main congenital heart disease (n = 32). All were pre-stented, 18 in a one step procedure. We used a Dryseal sheath in 13/21 Sapien. In 6 patients we used the anchoring technique, 5 with a very large nRVOT and one pyramidal nRVOT. In the 3.5year follow-up 7 patients developed endocarditis and 3 required a valve redilation, no fractures were observed. PPVI of native RVOT with balloon expandable valves is feasible in a number of selected anatomies, including large or pyramidal nRVOT, using specific techniques, (presenting, LPA anchoring).

PO-05-019 WHEN RIGHT IS WRONG: INCIDENCE AND OUTCOMES OF RIGHT BUNDLE BRANCH BLOCK FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT

Right bundle branch block (RBBB) following transcatheter aortic valve replacement (TAVR) for aortic stenosis is uncommon. However, its incidence and prognosis have not been well-described. To characterize the incidence of post-TAVR RBBB alongside its associated risk of permanent pacemaker (PPM) implantation and mortality. All patients ≥18 years who underwent TAVR at the Mayo Clinic Enterprise from June 2010 to May 2021 were considered; patients with pre-TAVR RBBB and/or PPM were excluded from the analysis. Clinical history, imaging variables, and electrocardiographic data were abstracted from the electronic medical records. Post-TAVR RBBB, defined as new onset RBBB in the postprocedure period, was manually verified by the study authors. The risks of PPM implantation (within 90-days post-TAVR) and mortality following TAVR were compared between patients with and without post-TAVR RBBB using the Kaplan-Meier method and Cox proportional hazards modeling. Out of 1992 patients included, 15 (0.75%) experienced new RBBB post-TAVR. There was a higher proportion of patients who had valve oversizing among patients with new RBBB post-TAVR versus not (17.9% versus 10.0%, p=0.034). There were no other significant differences in demographics or clinical characteristics between patients with and without post-TAVR RBBB including age at TAVR, sex, type of valve implanted, valve size, aortic valve calcium score, or left ventricular ejection fraction (Table 1). Ten patients (66.7%) with post-TAVR RBBB experienced high-grade atrioventricular block (≥2 consecutive blocked P waves) and subsequently underwent PPM implantation (median 4 days; interquartile range 1-90 days), compared to 268/1977 (13.6%) without RBBB (Figure 1). After adjustment for age, sex, balloon expandable valve, annulus diameter, and valve oversizing, post-TAVR RBBB was significantly associated with PPM implantation (hazard ratio [HR] 8.36, 95% confidence interval [CI] 4.19-16.7; p<0.001). No statistically significant increase in mortality was seen with post-TAVR RBBB (HR 0.83, 95% CI 0.33-2.11; p=0.69) following adjustment for age and sex. Although encountered rarely, post-TAVR RBBB was associated with an elevated risk of PPM implantation. The mechanisms for its development and its clinical prognosis require further study.Tabled 1Table 1: Baseline characteristics of study cohortMedian (IQR) or No. (%) of patientsVariableNNo RBBB (N=1977)New-Onset RBBB (N=15)P-valueAge at TAVR1,99281.3 (75.4, 86.0)82.6 (78.8, 87.4)0.45Sex (Males)1,9921,111 (56.2%)9 (60.0%)0.80Balloon Expandable Valve1,9921,744 (88.2%)12 (80.0%)0.41Valve size1,99226.0 (23.0, 29.0)26.0 (24.5, 29.0)0.49Annulus Area (cmˆ2) based on CT1,8504.7 (4.0, 5.4)4.6 (4.3, 5.1)0.81Annulus Diameter (mm)1,93027.0 (25.0, 29.1)26.0 (25.1, 28.8)0.87Valve Oversizing *1,85010.0 (3.0, 18.5)17.9 (15.4, 23.4)0.034LVEF (%)1,89762.0 (55.0, 66.0)61.5 (54.2, 67.8)0.97AV Peak Velocity1,8974.2 (4.0, 4.6)4.1 (4.0, 4.3)0.42AV Mean Gradient1,89743.0 (38.0, 51.0)41.5 (41.0, 44.8)0.76AV Area1,8970.8 (0.7, 0.9)0.9 (0.8, 1.0)0.33LVOT AV Velocity Ratio1,8970.2 (0.2, 0.2)0.2 (0.2, 0.3)0.47LVOT AV TVI Ratio1,8970.2 (0.2, 0.2)0.2 (0.2, 0.3)0.51LVOT Dimension1,7292.2 (2.1, 2.3)2.2 (2.1, 2.3)0.77LV Geometry9710.64Concentric Hypertrophy359 (37.4%)5 (45.5%)Concentric Remodeling264 (27.5%)2 (18.2%)Eccentric Hypertrophy158 (16.5%)3 (27.3%)Normal Geometry179 (18.6%)1 (9.1%)LVED Dimension1,55649.0 (45.0, 53.0)48.0 (43.0, 53.5)0.64Aortic Valve Calcium Score1,7302,281.0 (1,556.5, 3,169.5)2,729.0 (1,979.1, 3,480.5)0.31Myocardial Infarct1,987137 (6.9%)2 (13.3%)0.28Congestive Heart Failure1,987522 (26.5%)5 (33.3%)0.56Charlson Comorbidity Index1,9872.0 (0.0, 4.0)2.0 (1.0, 4.0)0.61STS Risk Score1,7304.8 (3.0, 8.0)4.0 (3.1, 9.2)0.86P-values result from a Wilcoxon rank sum test (continuous variables) or Fisher’s exact test (categorical variables). *Valve oversizing = (Nominal Area / Annulus area (mm)) -1) *100 AV – aortic valve; CT – computed tomography; IQR – interquartile range; LVEF – left ventricular ejection fraction; LVOT – left ventricular outflow tract; STS – Society of Thoracic Surgeons; TAVR – transcatheter aortic valve replacement; TVI - tissue velocity index Open table in a new tab

PO-04-043 ALTERNATING PR AND RP INTERVALS PRIOR TO COMPLETE AV BLOCK: THE CHICKEN OR THE EGG?

The incidence of permanent pacemaker implantation for high-degree AV block after transcatheter aortic valve replacement (TAVR) is approximately 6%, because of mechanical damage to the conduction system. We report a novel ECG marker, i.e. inverse decremental conduction (IDC), that heralds paroxysmal AV block. Case report and exploration of the electrophysiological mechanism. N/A A 73-year-old male with severe symptomatic aortic stenosis underwent TAVR with a balloon-expandable valve. On day 1 post-TAVR, his 12-lead ECG revealed sinus rhythm with a normal PR interval and unchanged RBBB with a left anterior fascicular block (LAFB). The patient was discharged with mobile cardiac outpatient telemetry. Although the patient was asymptomatic, he was asked to come to the emergency department (ED) after his monitor detected a 3.5-second pause during sleep. Shortly after a 12-lead ECG was obtained in the ED, he experienced two sudden cardiac arrests due to complete AV block and asystole requiring CPR and transcutaneous pacing. He underwent emergent implantation of a dual-chamber pacemaker. His ECG in the ED reveals alternating PR intervals (Figure). The first impression of the alternating PR intervals is a dual AV nodal physiology with a 2:1 block in the fast pathway, a relatively benign ECG sign. However, paroxysmal AV block and recent history of TAVR suggested a His-Purkinje injury with block at the subnodal level. More specifically, TAVR-related IDC in the left posterior fascicle (LPF) underlies alternating PR intervals in the setting of RBBB and LAFB. In other words, the PR length is proportional to the preceding RP length, i.e. a longer RP leads to a longer subsequent PR and vice versa due to IDC in LPF. The injured His-Purkinje fibers may lose their all-or-none conduction property and display IDC post-TAVR. This manifests as LBBB with a duration proportional to the preceding RP or RR interval or as prolongation of the PR interval with lengthening of the preceding RP interval in presence of RBBB. IDC in the His-Purkinje may be masked by decremental conduction in the AV node and is often under-recognized. Once the PR interval prolongs with lengthening of the preceding RP interval post-TAVR, unrelated to vagal stimulation, insertion of a temporary or permanent pacemaker is urgently indicated. Alternating PR intervals can be a benign finding, but in this case were linked with paroxysmal AV block secondary to IDC, with resultant cardiac arrest post-TAVR.