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Background: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)., Objectives: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV., Methods: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR., Results: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02)., Conclusions: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth., Competing Interests: Funding Support and Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Dr R.T. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic and Philips Healthcare, Siemens Healthineers; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. P Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr George has received consulting fees from Edwards Lifesciences. Dr Zhao is an employee of Edwards Lifesciences. Dr Blanke has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI Cardia, and Conformal; he is a Consultant for Edwards Lifesciences and Laralab Imaging. Dr Babaliaros has received consulting fees from Abbott and Edwards Lifesciences. Dr Szeto has received grant support from Edwards Lifesciences and Medtronic; and is a consultant for MicroInterventional Devices. Dr Makkar has received research support from Edwards Lifesciences and Abbott; and consultant fees/honoraria from Abbott, Cordis Corporation, and Medtronic. Dr Thourani serves on advisory boards for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Webb is a consultant for Edwards Lifesciences. Michael Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (unpaid); has received institutional research grants from Abbott, Boston Scientific, and Medtronic; has been an unpaid advisor for Abbott, Boston Scientific, Sinomed, and Medtronic; and holds equity in Medinol. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Nazif has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves., Background: Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems., Methods: Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference., Results: Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO)., Conclusions: Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status., (Copyright © 2020. Published by Elsevier Inc.)

Introduction: In irregular heart rhythms, echocardiographic calculation of aortic effective orifice area (EOA) requires averaging measurements from multiple cardiac cycles. Whether a single cycle length method can be used to calculate aortic EOA in aortic stenosis with nonsinus rhythms is not known., Methods: Transthoracic echocardiograms of 100 patients with aortic stenosis and either atrial fibrillation (AF) or frequent ectopy (FE) were retrospectively reviewed. The aortic valve velocity time integral (VTI AV ) and the left ventricular outflow tract VTI (VTI LVOT ) were measured by two methods: the standard method (averaging multiple beats) and the single cycle length method. The latter matches the R-R intervals for VTI AV and VTI LVOT . Stroke volume, EOA, and Doppler velocity index were calculated by both methods in all patients. The single cycle length method was used for short and long R-R cycles in AF and for postectopic beats (long R-R cycles) in FE., Results: In AF, long R-R cycles resulted in larger stroke volumes (73 ± 21 vs 63 ± 18 mL; P ≤ .0001) but no difference in EOA (0.84 ± 0.27 vs 0.82 ± 0.27 cm 2 ; P = .11), whereas short R-R cycles resulted in smaller stroke volumes (55 ± 18 vs 63 ± 18 mL, P ≤ .0001) but a larger EOA (0.86 ± 0.28 vs 0.82 ± 0.27 cm 2 ; P = .01). In FE, the postectopic beat led to larger stroke volumes (96.1 ± 28 vs 78 ± 23 mL; P < .0001) and a larger EOA (0.99 ± 0.32 vs 0.94 ± 0.32 cm 2 ; P = .0006) and Doppler velocity index (0.24 ± 0.07 vs 0.23 ± 0.07; P < .001)., Conclusions: In AF patients, the single, long cycle length method of calculating EOA can be used instead of averaging multiple cardiac cycles. The single cycle length method used on a postextrasystolic beat results in a larger EOA than a normal sinus beat and may have utility in clinical decision-making., (Copyright © 2018 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients., Objectives: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries., Methods: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide. The questionnaire included 59 questions on patient selection, technical aspects of the procedure, and postprocedural management. The centers were divided into Spain (n = 41), rest of Europe (n = 105), and rest of the world (n = 104)., Results: The cumulative number of procedures (74; range, 40-122) and those performed in the last year (16.5; range, 15-29.5) in Spain, were significantly lower than the rest of Europe (P<.01) and the rest of the world (P<.01). The patient risk profile was higher, with an under-use of functional tests compared to the rest of the world. While the use of computed tomography to analyze the aortic annulus was lower in Spain (P<.001), general anesthesia and transesophageal echocardiography were more frequently used in Spain than in the rest of Europe (P<.001 for both). Dual-antiplatelet therapy is the most common post-TAVI antithrombotic therapy in the absence of an indication for anticoagulation, although its duration is longer in Spain (6 months) compared to European centers (3 months)., Conclusions: Routine TAVI practice in Spain differed in some key aspects of preprocedural, intraprocedural, and postprocedural management. Future studies will help to unify strategies and assess their impact on clinical results.

Background: The threshold for the optimal computed tomography (CT) number in Hounsfield Units (HU) to quantify aortic valvular calcium on contrast-enhanced scans has not been standardized. Our aim was to find the most accurate threshold to predict paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR)., Methods: 104 patients who underwent TAVR with the CoreValve prosthesis were studied retrospectively. Luminal attenuation (LA) in HU was measured at the level of the aortic annulus. Calcium volume score for the aortic valvular complex was measured using 6 threshold cutoffs (650 HU, 850 HU, LA × 1.25, LA × 1.5, LA+50, LA+100). Receiver-operating characteristic (ROC) analysis was performed to assess the predictive value for > mild PVR (n = 16). Multivariable analysis was performed to determine the accuracy to predict > mild PVR after adjustment for depth and perimeter oversizing., Results: ROC analysis showed lower area under the curve (AUC) values for fixed threshold cutoffs (650 or 850 HU) compared to thresholds relative to LA. The LA+100 threshold had the highest AUC (0.81), and AUC was higher than all studied protocols, other than the LA x 1.25 and LA + 50 protocols, where the difference approached statistical significance (p = 0.05, and 0.068, respectively). Multivariable analysis showed calcium volume determined by the LAx1.25, LAx1.5, LA+50, and LA+ 100 HU protocols to independently predict PVR., Conclusions: Calcium volume scoring thresholds which are relative to LA are more predictive of PVR post-TAVR than those which use fixed cutoffs. A threshold of LA+100 HU had the highest predictive value., (Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is performed frequently in patients with severe, symptomatic aortic stenosis who are at high risk or inoperable for open surgical aortic valve replacement. Computed tomography angiography (CTA) has become the gold standard imaging modality for pre-TAVR cardiac anatomic and vascular access assessment. Traditionally, cardiac CTA has been most frequently used for assessment of coronary artery stenosis, and scanning protocols have generally been tailored for this purpose. Pre-TAVR CTA has different goals than coronary CTA and the high prevalence of chronic kidney disease in the TAVR patient population creates a particular need to optimize protocols for a reduction in iodinated contrast volume. This document reviews details which allow the physician to tailor CTA examinations to maximize image quality and minimize harm, while factoring in multiple patient and scanner variables which must be considered in customizing a pre-TAVR protocol., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: Hybrid percutaneous coronary intervention offers an alternative method of revascularization for high-risk surgical populations. We report the outcomes of a single-stage hybrid strategy in valvular cardiac surgery and explore its effects on operative risk and bleeding., Methods: In a hybrid operating room, 26 patients underwent hybrid surgery consisting of femoral arterial access, then coronary stenting followed by valve surgery, with appropriate heparin dosing. Clopidogrel (300 mg) was given on anesthesia induction in nonreoperative cases, or at the time of cross clamping (after stenting) for reoperative cases., Results: Mean follow-up was 680 ± 277 days. The planned coronary stenting and surgery was successful in all patients. Major cardiovascular and cerebrovascular adverse events occurred in 1 patient, with no inhospital deaths observed. No vascular complication or stent thrombosis was observed with the described antiplatelet regimen. Outcomes were comparable to those of standard bypass valve replacement surgery., Conclusions: This study demonstrates the feasibility and early safety of a single-stage hybrid strategy with coronary stenting followed by valvular surgery in patients at increased surgical risk. Hybrid procedures may lower operative risk by eliminating or reducing the need for bypass grafting., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR)., Background: Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve., Methods: The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM., Results: Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year., Conclusions: PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR)., Background: The impact of AVC in different locations within the aortic valve complex is incompletely understood., Methods: This study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed., Results: Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index., Conclusions: Quantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Recently, transcatheter valve-in-valve implantation has emerged as a new alternative to surgical reoperation for degenerated bioprosthetic valves, either in the aortic or mitral position. The early experience and outcome of this strategy appears promising in highly selected patient groups. Here we report a case of early structural valve degeneration in the aortic and mitral position in a patient with chronic hemodialysis successfully treated with transthoracic transcatheter valve-in-valve implantation., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Previous studies have shown cross-sectional 3-dimensional (3D) transesophageal echocardiographic (TEE) measurements to severely underestimate multidetector row computed tomographic (MDCT) measurements for the assessment of aortic annulus before transcatheter aortic valve replacement. This study compares annulus measurements from 3D-TEE using off-label use of commercially available software with MDCT measurements and assesses their ability to predict paravalvular regurgitation., Methods and Results: One hundred patients with severe, symptomatic aortic stenosis who had both contrast MDCT and 3D-TEE for annulus assessment before balloon-expandable transcatheter aortic valve replacement were analyzed. Annulus area, perimeter, and orthogonal maximum and minimum diameters were measured. Receiver operating characteristic analysis was performed with mild or greater paravalvular regurgitation as the classification variable. Three-dimensional TEE and MDCT cross-sectional perimeter and area measurements were strongly correlated (r=0.93-0.94; P<0.0001); however, the small differences (≤1%) were statistically significant (P=0.0002 and 0.0074, respectively). Discriminatory ability for ≥ mild paravalvular regurgitation was good for both MDCT (area under the curve for perimeter and area cover index=0.715 and 0.709, respectively) and 3D-TEE (area under the curve for perimeter and area cover index=0.709 and 0.694, respectively). Differences in receiver operating characteristic analysis between MDCT and 3D-TEE perimeter and area cover indexes were not statistically significant (P=0.15 and 0.35, respectively)., Conclusions: Annulus measurements using a new method for analyzing 3D-TEE images closely approximate those of MDCT. Annulus measurements from both modalities predict mild or greater paravalvular regurgitation with equivalent accuracy.