Diagnostic Value of Aortic Valve Calcification Levels in the Assessment of Low-Gradient Aortic Stenosis.

BACKGROUND: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines. OBJECTIVES: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm2 and peak aortic valve velocity <4.0 m/s. METHODS: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women. RESULTS: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women. CONCLUSIONS: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS.

Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial.

BACKGROUND: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device-host interactions. AIMS: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self-expanding supra-annular transcatheter heart valve. METHODS: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days. RESULTS: A total of 77 patients were included (median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th-75th percentile 12.0-21.0] vs. 3.5% [25th-75th percentile 0-11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7 (25th-75th percentile 5.5-19.1) in mild PVL and 17.7 (25th-75th percentile 3.6-19.4) in moderate PVL (p = 0.04). CONCLUSION: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies.

Changing haemodynamic status of patients referred for transcatheter aortic valve intervention during the COVID-19 pandemic.

INTRODUCTION: Delays in the diagnosis and referral of aortic stenosis (AS) during the coronavirus disease 2019 (COVID-19) pandemic may have affected the haemodynamic status of AS patients. We aimed to compare clinical and haemodynamic characteristics of severe AS patients referred for transcatheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) before the pandemic versus two subsequent periods. METHODS: This study compared three 1­year historical cohorts: a pre-COVID-19 group (PCOV), a 1st-year COVID-19 group (COV-Y1) and a 2nd-year COVID-19 group (COV-Y2). The main parameters were baseline New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic pressure (LVEDP). Demographics, procedural characteristics and 30-day clinical outcomes were assessed. The transition time between heart team decision and TAVI was examined. Pairwise group comparisons were performed (PCOV vs COV-1Y and COV-1Y vs COV-2Y). RESULTS: A total of 720 patients were included with 266, 249 and 205 patients in the PCOV, COV-Y1 and COV-Y2 groups, respectively. BAV was performed in 28 patients (4%). NYHA class did not differ across the cohorts. Compared to PCOV, LVEF was slightly lower in COV-Y1 (58% (49-60%) vs 57% (45-60%), p = 0.03); no difference was observed when comparing COV-Y1 and COV-Y2. LVEDP was higher in COV-Y1 than in PCOV (20 mm Hg (16-26 mm Hg) vs 17 mm Hg (13-24 mm Hg), p = 0.01). No difference was found when comparing LVEDP between COV-Y1 and COV-Y2. Thirty-day mortality did not differ between groups. Transition time was reduced in the COVID era. Duration of hospital stay declined over the study period. CONCLUSIONS: Patients undergoing TAVI during the COVID-19 pandemic had more advanced AS illustrated by lower LVEF and higher LVEDP, but there were no differences in clinical outcome. The TAVI pathway became more efficient.

Validation of a Three-Dimensional Computed Tomography Reconstruction Tool for Aortic Valve Calcium Quantification.

Background: Aortic valve calcification correlates with the severity of aortic valve stenosis and a high calcium score is associated with conduction disturbances and paravalvular leakage after transcatheter aortic valve replacement. The 3mensio Structural Heart is a semiautomated software package to facilitate aortic root analysis by multislice computed tomography.The aim of the contemporary study is to validate a semiautomated calcium quantification scoring tool with a conventional manual calcium quantification tool. Methods: Fifty randomly selected patients who underwent multislice computed tomography for preprocedural planning were retrospectively selected to compare the semiautomated aortic valve Agatston calcium score by 3mensio with the manually obtained score using IntelliSpace Portal as standard reference. Results: Patients had a mean age of 76.7 ± 7.4 years and 60% were male. The median Agatston score was 3390 [interquartile range 1877-4509] with 3mensio and 3434 [interquartile range 1839-4620] with IntelliSpace.The mean difference was -0.18 [95% confidence interval (CI) -53.8 to 53.4]. The intraclass correlation coefficient between the Agatston scores using IntelliSpace and 3mensio showed an excellent correlation of 0.995 [95% CI 0.992-0.997], p ≤ 0.001. The interobserver and intraobserver variability was 0.993 ([95% CI 0.961-0.998], p ≤ 0.001) and 0.995([95%CI 0.981-0.999], p = <0.001), respectively. Conclusions: The semiautomated calcium quantification module in 3mensio Structural Heart highly correlated with a conventional manual calcium scoring tool.

Sex-Specific Differences in Aortic Valve Calcification Between Bicuspid and Tricuspid Severe Aortic Stenosis.

Sex-specific thresholds of aortic valve calcification (AVC) correlate with aortic stenosis (AS) and may complement echocardiography to determine AS severity. Importantly, current guideline-recommended thresholds of AVC scores derived by multislice computed tomography do not distinguish between bicuspid and tricuspid aortic valves. The objective of this study was to evaluate the sex-specific differences in the amount of AVC in patients with severe AS and tricuspid (TAV) versus bicuspid (BAV) aortic valve morphologies, retrospectively evaluated by 2 tertiary care institutions. The inclusion criteria comprised patients with severe AS and a left ventricular ejection fraction ≥50% and suitable imaging examinations. The study included 1,450 patients (723 men; 49.9%) with severe AS, including 1,335 patients with TAV (92.1%) and 115 with BAV (17.9%). The calculated Agatston score was higher in BAV patients (men: BAV 4,358 [2,644 to 6,005] AU vs TAV 2,643 [1,727 to 3,794] AU, p <0.01; women: BAV 2,174 [1,330 to 4,378] AU vs TAV 1,703 [964 to 2,534] AU, p <0.01), also when indexed for valve dimensions and body surface area (men: BAV 2,227 [321 to 3,105] AU/m2 vs TAV 1,333 [872 to 1,913] AU/m2, p <0.01; women: BAV 1,326 [782 to 2,148] AU/m2 vs TAV 930 [546 to 1,456] AU/m2, p <0.01). Differences between the BAV- and TAV-derived Agatston score was more prominent in concordant severe AS. In conclusion, sex-specific Agatston scores in severe AS were approximately 1/3 higher in patients with BAV than in patients with TAV for both women and men. Optimal AVC thresholds should be adjusted for BAV, also respecting considerable prognostic implications.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry.

BACKGROUND: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. OBJECTIVES: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. METHODS: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. RESULTS: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). CONCLUSIONS: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry.

BACKGROUND: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM). AIMS: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli. METHODS: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL). RESULTS: The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001). CONCLUSIONS: In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.

Sex-specific aortic valve calcifications in patients undergoing transcatheter aortic valve implantation.

AIMS: To study sex-specific differences in the amount and distribution of aortic valve calcification (AVC) and to correlate the AVC load with paravalvular leakage (PVL) post-transcatheter aortic valve intervention (TAVI). METHODS AND RESULTS: This registry included 1801 patients undergoing TAVI with a Sapien3 or Evolut valve in two tertiary care institutions. Exclusion criteria encompassed prior aortic valve replacement, suboptimal multidetector computed tomography (MDCT) quality, and suboptimal transthoracic echocardiography images. Calcium content and distribution were derived from MDCT. In this study, the median age was 81.7 (25th-75th percentile 77.5-85.3) and 54% male. Men, compared to women, were significantly younger [81.2 (25th-75th percentile 76.5-84.5) vs. 82.4 (78.2-85.9), P ≤ 0.01] and had a larger annulus area [512 mm2 (25th-75th percentile 463-570) vs. 405 mm2 (365-454), P < 0.01] and higher Agatston score [2567 (25th-75th percentile 1657-3913) vs. 1615 (25th-75th percentile 905-2484), P < 0.01]. In total, 1104 patients (61%) had none-trace PVL, 648 (36%) mild PVL, and 49 (3%) moderate PVL post-TAVI. There was no difference in the occurrence of moderate PVL between men and women (3% vs. 3%, P = 0.63). Cut-off values for the Agatston score as predictor for moderate PVL based on the receiver-operating characteristic curve were 4070 (sensitivity 0.73, specificity 0.79) for men and 2341 (sensitivity 0.74, specificity 0.73) for women. CONCLUSION: AVC is a strong predictor for moderate PVL post-TAVI. Although the AVC load in men is higher compared to women, there is no difference in the incidence of moderate PVL. Sex-specific Agatston score cut-offs to predict moderate PVL were almost double as high in men vs. women.

Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.

BACKGROUND: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern. OBJECTIVES: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT. METHODS: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score. RESULTS: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days. CONCLUSIONS: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry.

BACKGROUND: New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. METHODS: We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. RESULTS: In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2-85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p â€‹< â€‹0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 â€‹mm [IQR 2.2-5.1] vs. 4.1 â€‹mm [IQR 2.8-6.0], p â€‹= â€‹<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79-0.96], p â€‹= â€‹<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84-0.98], p â€‹= â€‹0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79-1.21], p â€‹= â€‹0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35-3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21-13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83-0.97], p â€‹< â€‹0.01), annulus area (OR 1.003 [95% CI 1.001-1.005], p â€‹= â€‹0.04), NCC implantation depth (OR 1.13 [95% CI 1.07-1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03-2.27], p â€‹= â€‹0.04) were associated with new-PPI. CONCLUSION: MS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 â€‹mm defined a high-risk group for PPI (>20%), MS length 3-7 â€‹mm intermediate risk for PPI (10-20%) and MS length > 7 â€‹mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR.

Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: Design and Rationale of the Rotterdam Edoxaban Trial.

BACKGROUND: Multislice computed tomography (MSCT) may reveal hypo-attenuated leaflet thickening (HALT) and/or reduced leaflet motion (RELM) in approximately 15 % of patients after transcatheter aortic valve replacement (TAVR). These supposedly thrombogenic phenomena may be associated with neurological events and increased transprosthetic gradients. It is unclear whether oral anticoagulant therapy -specifically a factor Xa inhibitor- could affect the incidence of HALT/RELM. STUDY DESIGN: The Rotterdam EDOXaban (REDOX) trial is an investigator-initiated, single-center, prospective registry in which 100 patients with no formal indication for oral anticoagulant drugs or dual antiplatelet therapy, will receive a 3-month treatment with edoxaban, followed by a MSCT to detect HALT/RELM. The primary endpoint is the incidence of HALT at 3-months follow-up. Secondary endpoints include the incidence of RELM at 3 months; change in transprosthetic gradients at 1 year and the clinical composite endpoint of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) at 1 year follow up. The study is powered to demonstrate with 90 % statistical power and a 0.025 alpha a 4 % incidence of HALT with edoxaban as compared to the expected 15 % rate with an antiplatelet regimen and will enroll 100 patients to account for loss of follow-up or CT-drop out. CONCLUSION: The REDOX trial will investigate the short-term effect of an Xa-inhibitor on the incidence of HALT after TAVR. (ClinicalTrials.gov Identifier: NCT04171726).

Incidence and mechanisms of bioprosthetic dysfunction after transcatheter implantation of a mechanically-expandable heart valve.

BACKGROUND: The mechanically-expandable transcatheter valve is no longer commercially available, yet clinical and echocardiographic surveillance is imperative for thousands of patients who received transcatheter aortic valve implantation (TAVI) with this platform. AIMS: We aimed to determine the incidence and mechanism of bioprosthetic valve dysfunction (BVD) following TAVI with mechanically-expandable valves. METHODS: From 2013 to 2020, all 234 patients who underwent TAVI with the LOTUS valve were included. BVD was categorised as (i) structural valve deterioration (SVD), (ii) non-structural valve dysfunction (NSVD), (iii) clinical valve thrombosis and (iv) endocarditis, according to the Valve Academic Research Consortium-3 criteria. RESULTS: The mean age was 79±7 years, 60% were male, and the mean Society of Thoracic Surgeons score was 4.2±2.9%. The technical success rate was 94% and the 30-day device success rate was 78%. All-cause mortality at 1 year was 15%; median follow-up duration was 36 (IQR 18-60) months during which 47% of patients died. One hundred and three patients had ≥1 type of BVD (44%), which predominantly consisted of NSVD (39%, mostly because of ≥moderate patient-prosthesis mismatch). BVD during follow-up included endocarditis (3.4%), clinical valve thrombosis (3.4%) and SVD (1.3%). Both endocarditis and clinically apparent valve thrombosis occurred early and late after TAVI and resulted in valve-related deaths in 38% and 13% of patients, respectively. Overall, ≥moderate haemodynamic valve deterioration occurred in 5.5% and bioprosthetic failure in 7.3%, leading to valve-related deaths in 36% of cases. CONCLUSIONS: BVD represents a relevant health issue after TAVI with a mechanically-expandable valve. Serious but reversible causes of BVD include endocarditis and clinically apparent valve thrombosis, both carrying a time-independent hazard post-TAVI.

Left atrial appendage thrombus and cerebrovascular events post-transcatheter aortic valve implantation.

AIMS: To elucidate the frequency and clinical impact of left atrial appendage thrombus (LAAT) in patients set for transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: All patients undergoing TAVI between January 2014 and June 2020 with analysable multislice computed tomography (MSCT) for LAAT were included. Baseline and procedural characteristics were collected, pre-procedural MSCT's were retrospectively analysed for LAAT presence. The primary endpoint was defined as the cumulative incidence of any cerebrovascular event (stroke or transient ischaemic attack) within the first year after TAVI. A Cox proportional hazards model was used to identify predictors.A total of 1050 cases had analysable MSCT. Median age was 80 [interquartile range (IQR) 74-84], median Society of Thoracic Surgeons' Predicted Risk Of Mortality (STS-PROM) was 3.4% (IQR 2.3-5.5). Thirty-six percent were on oral anticoagulant therapy for atrial fibrillation (AF). LAAT was present in 48 (4.6%) of cases. Patients with LAAT were at higher operative risk [STS-PROM: 4.9% (2.9-7.1) vs. 3.4% (2.3-5.5), P = 0.01], had worse systolic left ventricular function [EF 52% (35-60) vs. 55% (45-65), P = 0.01] and more permanent pacemakers at baseline (35% vs. 10%, P < 0.01). All patients with LAAT had a history of AF and patients with LAAT were more often on vitamin K antagonist-treatment than patients without LAAT [43/47 (91%) vs. 232/329 (71%), P < 0.01]. LAAT [hazard ratio (HR) 2.94 (1.39-6.22), P < 0.01] and the implantation of more than one valve [HR 4.52 (1.79-11.25), P < 0.01] were independent predictors for cerebrovascular events. CONCLUSION: Patients with MSCT-identified LAAT were at higher risk for cerebrovascular events during the first year after TAVI.

Insights in a restricted temporary pacemaker strategy in a lean transcatheter aortic valve implantation program.

OBJECTIVES: To study the safety and feasibility of a restrictive temporary-RV-pacemaker use and to evaluate the need for temporary pacemaker insertion for failed left ventricular (LV) pacing ability (no ventricular capture) or occurrence of high-degree AV-blocks mandating continuous pacing. BACKGROUND: Ventricular pacing remains an essential part of contemporary transcatheter aortic valve implantation (TAVI). A temporary-right-ventricle (RV)-pacemaker lead is the standard approach for transient pacing during TAVI but requires central venous access. METHODS: An observational registry including 672 patients who underwent TAVI between June 2018 and December 2020. Patients received pacing on the wire when necessary, unless there was a high-anticipated risk for conduction disturbances post-TAVI, based on the baseline-ECG. The follow-up period was 30 days. RESULTS: A temporary-RV-pacemaker lead (RVP-cohort) was inserted in 45 patients, pacing on the wire (LVP-cohort) in 488 patients, and no pacing (NoP-cohort) in 139 patients. A bailout temporary pacemaker was implanted in 14 patients (10.1%) in the NoP-cohort and in 24 patients (4.9%) in the LVP-cohort. One patient in the LVP-cohort needed an RV-pacemaker for incomplete ventricular capture. Procedure time was significantly longer in the RVP-cohort (68 min [IQR 52-88.] vs. 55 min [IQR 44-72] in NoP-cohort and 55 min [IQR 43-71] in the LVP-cohort [p < 0.005]). Procedural high-degree AV-block occurred most often in the RVP-cohort (45% vs. 14% in the LVP and 16% in the NoP-cohort [p ≤ 0.001]). Need for new PPI occurred in 47% in the RVP-cohort, versus 20% in the NoP-cohort and 11% in the LVP-cohort (p ≤ 0.001). CONCLUSION: A restricted RV-pacemaker strategy is safe and shortens procedure time. The majority of TAVI-procedures do not require a temporary-RV-pacemaker.

Impact of different guidewires on the implantation depth using the largest self-expandable TAVI device.

Background: The deployment process of the largest self-expandable device (STHV-34) during transcatheter aortic valve implantation (TAVI) might be challenging due to stabilization issues. Whether the use of different TAVI-guidewires impact the procedural success and outcome is not well-known. Therefore, we sought to evaluate the impact of non-Lunderquist (NLu) vs. the Lunderquist (Lu) guidewires during TAVI using the STHV-34 on the procedural and 30-day outcomes. Methods: The primary study endpoint was defined as the final implantation depth (ID) depending on the selected guidewire strategy. Key secondary endpoints included VARC-3-defined complications. Results: The study cohort included 398 patients of four tertiary care institutions, of whom 79.6% (317/398) had undergone TAVI using NLu and 20.4% (81/398) using Lu guidewires. Baseline characteristics did not substantially differ between NLu and Lu patients. The average ID was higher in the Lu cohort (NLu vs. Lu: -5.2 [-7.0-(-3.5)] vs. -4.5 [-6.0-(-3.0)]; p = 0.022*). The optimal ID was reached in 45.0% of patients according to former and only in 20.1% according to nowadays best practice recommendations. There was no impact of the guidewire use on the 30-day outcomes, including conduction disturbances and pacemaker need (NLu vs. Lu: 15.1 vs. 18.5%; p = 0.706). Conclusion: The use of the LunderquistTM guidewire was associated with a higher ID during TAVI with the STHV-34 without measurable benefits in the 30-day course concerning conduction disturbances and associated pacemaker need. Whether using different guidewires might impact the outcome in challenging anatomies should be further investigated in randomized studies under standardized conditions.

Impact of Interventricular membranous septum length on pacemaker need with different Transcatheter aortic valve implantation systems.

Background The need for new permanent pacemaker implantation (PPI) after Transcatheter Aortic Valve Implantation (TAVI) remains a critical issue. Membranous Septum (MS) length is associated with PPI after TAVI. The aim of this study was to identify different MS thresholds for the contemporary THV-platforms. Methods This retrospective, case-control study enrolled all patients who underwent a successful TAVI procedure with contemporary THV-platforms in the Erasmus University Medical Center between January 2016 and March 2020. The follow-up period for new PPI was 30 days. MS-length was determined by Computed Tomography. Results The study consisted 653 TAVI patients with median age 80.6 years (IQR 74.7-84.8). New PPI occurred in 120 patients (18.4%). Patients with new PPI had a shorter MS-length (2.9 mm (IQR 2.3-4.3) vs. 4.2 mm (IQR 2.9-5.7), p < 0.001). MS-length < 3 mm identified a high-risk phenotype with 30.3% PPI-rate (OR 6.5 [95%CI 2.9-14.9]), MS-length 3-6 mm an intermediate-risk phenotype with 15.4% PPI-rate (OR 2.7 [95%CI 1.2-6.2]) and MS > 6 mm a low-risk phenotype with a 6.3% PPI-rate (reference). For the Lotus valve, there was no significant difference in PPI-rates between the high-risk (45.8%, OR 3.5 [95%CI 0.8-15.1]) and low-risk group (20%). By multivariate analysis MS-length, Agatston-score, use of Lotus valve, and ECG with first-degree AV block, RBBB or bifascular block were independent predictors for new PPI. Conclusion MS-length was an independent predictor for new PPI post-TAVI. Three phenotypes were found based on MS-length. MS < 3 mm was universally associated with a high risk for new PPI (>30%). MS > 6 mm represented a low-risk phenotype with PPI-rate < 10%. PPI-rate varied per THV type in the intermediate phenotype. PPI-rate with Lotus was high regardless of MS-length.

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.

BACKGROUND: The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking. AIM: To evaluate MANTA in a real-world population and identify predictors for vascular complications. METHODS: All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication. RESULTS: The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications. CONCLUSION: In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors.