Aug 2026· JACC: Advances· pp.
103219
· 0 citations· 25 references
Medicine
TL;DR
The fiberoptic guidewire effectively classified clinically relevant transvalvular gradients with limited bias post-TAVR, although it produced higher LVEDPs, possibly reflecting wire-induced leaflet interaction.
Abstract
Background
A novel fiberoptic transcatheter aortic valve replacement (TAVR) guidewire was developed that enables continuous hemodynamic monitoring, easy pacing over the wire, and guiding of the valve prosthesis.
Objectives
This study aimed to evaluate construct validity of hemodynamic measurements obtained with the fiberoptic TAVR guidewire compared to conventional fluid-filled pigtail catheters.
Methods
This prospective registry study included patients undergoing TAVR. Complete hemodynamic assessment was performed in-duplo with the fiberoptic TAVR guidewire and conventional pigtail catheters. Primary endpoint was the agreement between modalities for post-TAVR mean pressure gradient (PG). Secondary endpoints included agreement in assessing paravalvular regurgitation and in-depth signal analysis using a validated automated algorithm.
Results
This study included 150 patients (mean age 79.7 ± 5.8 years; 46.7% female). Comparison of invasive pressure measurements yielded moderate to excellent agreement (intraclass correlation coefficient [ICC]-range: 0.65 to 0.95). Bias was observed in left ventricular end-diastolic pressure (LVEDP), with the fiberoptic guidewire measuring higher LVEDPs (+3.5 mm Hg). Post-TAVR mean PG showed a mean absolute difference of 2.7 ± 2.1 mm Hg (ICC: 0.67), minimal bias (-0.45 mm Hg), and 87% concordance with a discrete cutoff (10 mm Hg). Good overall agreement was observed for most indices of paravalvular regurgitation (ICC-range: 0.81-0.87). Automated algorithm assessment revealed fewer artefacts and calibration errors for the fiberoptic guidewire (P = 0.048), repeat analysis improved mean PG agreement (ICC-range: 0.80-0.85).
Conclusions
The fiberoptic guidewire effectively classified clinically relevant transvalvular gradients with limited bias post-TAVR, although it produced higher LVEDPs, possibly reflecting wire-induced leaflet interaction. Algorithm-derived assessment revealed the fiberoptic guidewire producing measurements with fewer artefacts and calibration errors, supporting its proof-of-concept potential to complement current invasive assessment standards.
BACKGROUND
Conduction disturbances requiring permanent pacemaker (PPM) implantation remain a frequent complication of transcatheter aortic valve implantation (TAVI). This study aimed to evaluate the "Vectorial Angle"-a novel computed tomography (CT)-derived biomechanical parameter-alongside traditional anatomical and electrocardiographic predictors of PPM following balloon-expandable TAVI METHODS: This retrospective cohort study included 67 patients with severe symptomatic aortic stenosis undergoing TAVI with the balloon-expandable Myval system. The Vectorial Angle was defined on pre-procedural CT at the elliptical left ventricular outflow tract (e-LVOT) level as the angular deviation between the minor axis (representing the axis of maximal radial expansion force) and the midpoint of the right coronary to non-coronary (RCC-NCC) commissure (approximating the anatomical course of the conduction system).
RESULTS
PPM implantation was required in 12 patients (17.9%). In multivariate logistic regression analysis, a narrower Vectorial Angle (OR 0.935 per 1° increment, 95% CI 0.889-0.982; p=0.007) and a shorter membranous septal length (MSL) (OR 0.447 per 1 mm increment, 95% CI 0.241-0.831; p=0.011) emerged as the only independent predictors of PPM requirement. Valve oversizing index was not associated with PPM implantation (p=0.954). Implantation depth was numerically greater in the PPM group but did not reach independent predictor status (p=0.079). Pre-existing right bundle branch block (RBBB) lost independent predictive value after adjustment for these structural parameters. Receiver operating characteristic (ROC) curve analysis for the Vectorial Angle yielded an area under the curve of 0.806 (p=0.001), with an optimal cutoff of ≤52°.
CONCLUSIONS
The Vectorial Angle is a novel, independent pre-procedural predictor of PPM after balloon-expandable TAVI. This finding highlights that the spatial orientation of the valve's maximal radial force relative to the conduction tissue is a potential anatomical determinant associated with conduction-system vulnerability, complementing conventional anatomical assessments such as MSL.
M. Doğan, A. Kıvrak, U. Canpolat et al.· American Journal of Cardiolo...· 0 citations
BACKGROUND
Reliable catheter-tissue apposition is important for effective pulmonary vein isolation using pulsed field ablation. The contact index, derived from real-time impedance rise on the EnSite X mapping system, may provide an objective surrogate for catheter contact; however, its utility with the PulseSelect catheter remains insufficiently defined.
METHODS
In this single-center pilot study, patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the PulseSelect catheter under general anesthesia were evaluated. High-resolution transesophageal echocardiography was used as the reference standard to classify electrode-level catheter apposition as contact or non-contact. Contact index values from electrodes 3-7 were paired with transesophageal echocardiography findings, and receiver operating characteristic curve analysis was performed.
RESULTS
A total of 316 paired imaging-electrical data points were analyzed. Interobserver agreement for transesophageal echocardiography-based contact assessment was excellent (Cohen's κ = 0.86). Contact index values were higher at contact than non-contact segments. A contact index cutoff of 10% yielded an area under the curve of 0.864, with 76.1% sensitivity and 82.9% specificity. In the central electrodes 4-6, the area under the curve was 0.871, with 80.1% sensitivity and 81.2% specificity.
CONCLUSIONS
Contact index was associated with transesophageal echocardiography-confirmed catheter-tissue apposition during pulsed field ablation using the PulseSelect catheter. A 10% threshold may be a useful candidate reference for real-time apposition assessment, requiring validation in larger studies.
Gen Fujiwara, Y. Mizutani, Satoshi Yanagisawa et al.· Pacing and clinical electrop...· 0 citations
Fiber Optic RealShape has an acceptable technical success rate in visceral TV catheterization during cEVAR, which has improved following the 3D-Hub implementation, supporting initial FORS use in all catheterizations to minimize radiation.
Charlotte C. Lemmens, B. Mees, M. Vleugels et al.· Journal of Endovascular Ther...· 0 citations
BACKGROUND
The expansion of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy requires procedural optimization to enhance long-term valve durability.
OBJECTIVES
To evaluate the relationship between fluoroscopic determinants of optimal transcatheter heart valve (THV) implantation-coaxiality, implantation depth, and expansion-and clinical and valve-related outcomes.
METHODS
In this cohort study, consecutive patients undergoing transfemoral TAVR with balloon-expandable prostheses (Sapien S3, Sapien S3 Ultra) between February 2014 and June 2022 were included. THV coaxiality, implantation depth, and expansion were assessed in the 3-cusp view following deployment using standardized protocols. Suboptimal implantation was defined as ≥1 unfavorable determinants (coaxiality ≥4.8°, depth ≥6 mm, or underexpansion ≥20%). Outcomes included the modified early safety endpoint, moderate or severe hemodynamic valve deterioration, and stage 2 bioprosthetic valve failure.
RESULTS
Among 1,032 patients (mean age 81 ± 6 years, 35.1% female), suboptimal THV implantation occurred in 443 (42.9%) patients and was driven by noncoaxial deployment (n = 240, 23.3%), excessive implantation depth (n = 261, 25.3%), and underexpansion (n = 54, 5.2%). Suboptimal implantation was associated with a higher likelihood of the modified early safety endpoint at 30 days (43.3% vs 19.9%; adjusted odds ratio: 3.05; 95% CI: 2.30-4.04) and stage 2 bioprosthetic valve failure at 5 years (subHR: 4.40; 95% CI: 1.25-13.59). Patients with ≥2 determinants demonstrated higher rates of hemodynamic valve deterioration at 5 years (subHR: 3.48; 95% CI: 1.24-9.80).
CONCLUSIONS
Optimal THV implantation was associated with improved early procedural safety and long-term THV durability in balloon-expandable TAVR. Systematic fluoroscopic assessment of optimized valve implantation may enhance patient outcomes.
L. Vitez, D. Angellotti, D. Tomii et al.· JACC: Advances· 0 citations
BACKGROUND
Aortic angulation (AA), defined as the angle between the horizontal plane on the coronal plane and the plane of the aortic valve annulus, is an important anatomical factor in transcatheter aortic valve replacement (TAVR). Whether AA affects early clinical outcomes and complications in self-expanding (SE)-TAVR procedures is still controversial.
METHOD
We conducted a retrospective cohort study of 519 consecutive patients who underwent SE-TAVR at our centre from January 2016 to January 2021. Preoperative AA, technique success, and one-year postoperative survival rates were primarily analysed.
RESULTS
The AA of patients undergoing SE-TAVR ranged from 25° to 93°, with a mean value of 55.4°±9.7°. There was a statistically significant difference in technique success between AA≤55.5° and AA>55.5° groups (84.3% vs 75.1%, p=0.009), mainly driven by the higher proportion of second-valve implantation during TAVR (8.8% vs 19.6%, p<0.001). In valve-type subgroup analysis, larger AA demonstrated good predictive value for second-valve implantation (area under the curve 0.690; 95% confidence interval 0.617-0.763). However, AA showed limited predictive efficacy for technical success in patients with bicuspid aortic valve, and it was not associated with major complications or unplanned interventions in patients with tricuspid aortic valve.
CONCLUSIONS
A larger AA is associated with a lower rate of technical success of SE-TAVR, mainly due to an increased frequency of second-valve implantation. The impact of AA is more evident in patients with tricuspid aortic valve rather than in those with bicuspid aortic valve.
Qianbei He, Yuanyuan Yu, Ruitao Li et al.· Heart, Lung and Circulation· 0 citations
Using a high-pressure balloon to do bioprosthetic valve remodeling (BVR) for a failed surgical non-fracturable aortic valve is thought to improve the expansion of a transcatheter heart valve (THV) during valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). However, the risks and benefits of this approach remain under debate. We present two cases of failed bioprosthetic aortic valves (Trifecta 19 mm and 21 mm, Abbott Vascular) receiving ViV-TAVR using balloon-expandable valves (Sapien 3 20-mm, Edwards Lifesciences). In one patient, an ATLAS GOLD balloon catheter (20 mm, BD, Franklin Lakes, New Jersey, USA) was used to do BVR. In the other patient, a double-tap technique with the same volume balloon post-dilatation was performed without BVR. Both procedures were successful, with notable clinical improvement. The post-TAVR computed tomography and transthoracic echocardiogram were performed 1 month after the procedure which demonstrated comparable hemodynamic results; however, the THV deformation was more pronounced in the patient who underwent BVR. Importantly, the THV-to-coronary ostium distance in this patient decreased unexpectedly from 5 mm to near 0 mm over right coronary artery. These cases illustrate that using a high-pressure balloon to perform BVR in a non-fracturable surgical valve had limited impact on THV expansion at the annular level. Conversely, unpredictable over-expansion of the THV in the outflow portion may pose an increased risk to the coronaries, even when the valve-to-coronary distance is long prior to the valve-in-valve TAVR procedure.
Y. Tsai, Ching-Wei Lee, Su‐Chan Chen et al.· Catheterization and cardiova...· 0 citations