Laser ablation for preventing coronary obstruction and maintaining coronary access in redo-TAVR: A proof of concept.

BACKGROUND: Redo-transcatheter aortic valve replacement (TAVR) is a promising treatment for transcatheter aortic valve degeneration, becoming increasingly relevant with an aging population. In redo-TAVR, the leaflets of the initial (index) transcatheter aortic valve (TAV) are displaced vertically when the second TAV is implanted, creating a cylindrical cage that can impair coronary cannulation and flow. Preventing coronary obstruction and maintaining coronary access is essential, especially in young and low-risk patients undergoing TAVR. This study aimed to develop a new leaflet modification strategy using laser ablation to prevent coronary obstruction and facilitate coronary access after repeat TAVR. METHODS: To evaluate the feasibility of the leaflet modification technique using laser ablation, the initial phase of this study involved applying a medical-grade ultraviolet laser for ablation through pericardial tissue. Following this intervention, computational fluid dynamics simulations were utilized to assess the efficacy of the resulting perforations in promoting coronary flow. These simulations played a crucial role in understanding the impact of the modifications on blood flow patterns, ensuring these changes would facilitate the restoration of coronary circulation. RESULTS: Laser ablation of pericardium leaflets was successful, demonstrating the feasibility of creating openings in the TAV leaflets. Flow simulation results show that ablation of index valve leaflets can effectively mitigate the flow obstruction caused by sinus sequestration in redo-TAVR, with the extent of restoration dependent on the number and location of the ablated openings. CONCLUSIONS: Laser ablation could be a viable method for leaflet modification in redo-TAVR, serving as a new tool in interventional procedures.

Redo-TAVR for bioprosthetic valve degeneration with obvious neoplasm in a left cerebral infarction patient.

Key Clinical Message: In recent years, it is necessary to Redo-TAVR for the patients with bioprosthetic valve degeneration. This case report described a unique instance to successfully Redo-TAVR a patient with bioprosthetic valve degeneration, in addition, with left cerebral infarction and renal insufficiency. Abstract: Over time, more and more patients have bioprosthetic valve degeneration either used in SAVR or TAVR. In order to solve the produced problems due to the degenerated bioprosthetic valve, Redo-TAVR was increasingly popular due to its safe and efficiency especially for the high risk and complicated symptoms patients. In this case, the patient with left cerebral infarction and renal insufficiency has exhibited severe regurgitation and obvious neoplasm around the previous replaced aortic valve. For the patient with complicated symptoms, we did not image for this patient and only used CT to determine the position and angle for the Redo-TAVR on the base of metal stent for the previous replaced aortic valve. During the Redo-TAVR process, for fear of the obvious neoplasm slipping from the previous replaced aortic valve to embolism of important organs, before carrying out the Redo-TAVR, cerebral protection device, temporary pacemaker, and coronary artery protection device were utilized in order to avoid the damage for the important organs from the obvious neoplasm slipping from the previous replaced aortic valve. The surgery was successful and the patient recovered well. The patient's symptoms of chest tightness and suffocation have been greatly reduced.

Effects of implantation height on the performance of a redo transcatheter aortic valve replacement using a balloon-expandable valve.

Objective: The use of the transcatheter aortic valve in low-risk patients might lead to a second intervention due to the deterioration of the first 1. Understanding the implantation height is key to an effective redo transcatheter aortic valve replacement treatment. Methods: The effects of implantation height on the performance of a balloon-expandable valve within a self-expandable valve were assessed using hemodynamic testing and particle image velocimetry. The hemodynamic performances, leaflet kinematics, and turbulent shear stresses were measured and compared. Results: When a second balloon-expandable valve was positioned at varying heights relative to the first self-expandable valve, the leaflet motion of the first valve transitioned from free opening and closing to overhanging, and eventually to being entirely pinned to the stent, forming a neo-skirt. When the leaflets of the self-expandable valve could move freely, a decrease in regurgitation fraction was observed, but with an increased pressure gradient across the valve. Flow visualization indicated that the overhanging leaflets disrupted the flow, generating a higher level of turbulence. Conclusions: This study suggests that the overhanging leaflets should be avoided, whereas the other 2 scenarios should be carefully evaluated based on an individual patient's anatomy and the cause of failure of the first valve.

Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis.

BACKGROUND: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited. OBJECTIVES: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR. METHODS: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR. RESULTS: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41). CONCLUSIONS: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.

TAVR in TAVR: Where Are We in 2023 for Management of Failed TAVR Valves?

PURPOSE OF REVIEW: As TAVR is increasingly performed on younger patients with a longer life expectancy, the number of redo-TAVR procedures is likely to increase in the coming years. Limited data is currently available on this sometimes challenging procedure. We provide a summary of currently published literature on management of patients with a failed transcatheter aortic valve. RECENT FINDINGS: Recent registry data have increased the clinical knowledge on redo-TAVR. Additionally, numerous bench studies have provided valuable insights into the technical aspects of redo-TAVR with various combinations of valve types. Redo-TAVR can be performed safely in selected cases with a high procedural success and good short-term outcomes. However, at present, the procedure remains relatively infrequent and many patients are not eligible. Bench testing can be useful to understand important concepts such as valve expansion, neoskirt, leaflet overhang, and leaflet deflection as well as their potential clinical implications.

Redo transcatheter aortic valve replacement in degenerated transcatheter bioprosthesis (TAV-in-TAV).

INTRODUCTION: With the expanding indications of transcatheter aortic valve replacement (TAVR) to younger and low-risk patients, the life expectancy of patients currently undergoing TAVR will likely outlive the durability of transcatheter bioprosthesis. Consequently, the number of failed transcatheter bioprosthesis requiring surgical valve explant or redo TAVR is expected to increase. AREAS COVERED: The aim of this review is to provide an updated overview of redo TAVR for treating degenerated transcatheter bioprosthesis, focusing on pre-procedural planning, potential challenges of coronary reaccess during TAVR-in-TAVR and main outcomes of TAVR explant and redo TAVR. EXPERT OPINION: Patient-tailored device selection and individualized implantation height should be carefully assessed during the index TAVR procedure (weighting between pacemaker avoidance and the potential risk of coronary occlusion in future TAVR-in-TAVR). Future prospective studies comparing safety and clinical outcomes between redo TAVR vs TAVR explant are eagerly awaited.

Redo-TAVR: Essential Concepts, Updated Data and Current Gaps in Evidence.

Within the last two decades, transcatheter aortic valve replacement (TAVR) has transformed the treatment strategy for symptomatic severe aortic stenosis (AS), representing a less invasive alternative to traditional open-chest surgery. With time, advances in device features, imaging planning, and implantation techniques have contributed to an improvement in safety as well as a reduction in procedural complications. This has led to the expansion of TAVR to lower-risk patients, where TAVR has shown favorable outcomes compared to surgical aortic valve replacement (SAVR). As TAVR expands to younger and lower-risk patients with longer life expectancies, the need for reintervention for failing transcatheter heart valves is expected to increase. Redo-TAVR has gained increasing relevance in the lifetime management of AS as one of the treatment strategies available for structural valve dysfunction (SVD). However, some issues are associated with this approach, including coronary re-access and the risk of coronary obstruction. In this review, we provide essential concepts to properly select candidates for Redo-TAVR, updated data on clinical outcomes and complication rates, and current gaps in evidence.

Transcatheter heart valve commissural alignment: an updated review.

Transcatheter aortic valve replacement (TAVR) indications recently extended to lower surgical risk patients with longer life expectancy. Commissural alignment (CA) is one of the emerging concepts and is becoming one of the cornerstones of the TAVR procedure in a patient with increased longevity. Indeed, CA may improve transcatheter heart valve (THV) hemodynamics, future coronary access, and repeatability. The definition of CA has been recently standardized by the ALIGN-TAVR consortium using a four-tier scale based on CT analysis. Progress has been made during the index TAVR procedure to optimize CA, especially with self-expandable platforms. Indeed, specific delivery catheter orientation, THV rotation, and computed-tomography-derived views have been proposed to achieve a reasonable degree of CA. Recent data demonstrate feasibility, safety, and a significant reduction in coronary overlap using these techniques, especially with self-expandable platforms. This review provides an overview of THV CA including assessment methods, alignment techniques during the index TAVR procedure with different THV platforms, the clinical impact of commissural misalignment, and challenging situations for CA.

Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access.

BACKGROUND: Data regarding the impact of high transcatheter heart valve (THV) implantation on coronary access after transcatheter aortic valve replacement (TAVR) as assessed by postimplantation computed tomography (CT) are scarce. OBJECTIVES: The authors sought to assess the impact of high THV implantation on coronary access after TAVR. METHODS: We included 160 and 258 patients treated with Evolut R/PRO/PRO+ and SAPIEN 3 THVs, respectively. In the Evolut R/PRO/PRO+ group, the target implantation depth was 1 to 3 mm using the cusp overlap view with commissural alignment technique for the high implantation technique (HIT), whereas it was 3 to 5 mm using 3-cusp coplanar view for the conventional implantation technique (CIT). In the SAPIEN 3 group, the HIT employed the radiolucent line-guided implantation, whereas the central balloon marker-guided implantation was used for the CIT. Post-TAVR CT was performed to analyze coronary accessibility. RESULTS: HIT reduced the incidence of new conduction disturbances after TAVR for both THVs. In the Evolut R/PRO/PRO+ group, post-TAVR CT showed that the HIT group had a higher incidence of the interference of THV skirt (22.0% vs 9.1%; P = 0.03) and a lower incidence of the interference of THV commissural posts (26.0% vs 42.7%; P = 0.04) with access to 1 or both coronary ostia compared with the CIT group. These incidences were similar between the HIT and CIT groups in the SAPIEN 3 group (THV skirt: 0.9% vs 0.7%; P = 1.00; THV commissural tabs: 15.7% vs 15.3%; P = 0.93). In both THVs, CT-identified risk of sinus sequestration in TAVR-in-TAVR was significantly higher in the HIT group compared with the CIT group (Evolut R/PRO/PRO+ group: 64.0% vs 41.8%; P = 0.009; SAPIEN 3 group: 17.6% vs 5.3%; P = 0.002). CONCLUSIONS: High THV implantation substantially reduced conduction disturbances after TAVR. However, post-TAVR CT revealed that there is a risk for unfavorable future coronary access after TAVR and sinus sequestration in TAVR-in-TAVR. (Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access; UMIN000048336).

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.

Transcatheter Aortic Valve Replacement in Failed Transcatheter Bioprosthetic Valves.

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves.

Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium.

Given the expanding indications of transcatheter aortic valve replacement (TAVR) in younger patients with longer life expectancies, the ability to perform postprocedural coronary access represents a priority in their lifetime management. A growing body of evidence suggests that commissural (and perhaps coronary) alignment in TAVR impacts coronary access and valve hemodynamics as well as coronary flow and access after redo-TAVR. Recent studies have provided modified delivery system insertion and rotation techniques to obtain commissural alignment with available transcatheter heart valve devices. Moreover, patient-specific preprocedural planning and postprocedural imaging tools have been developed to facilitate and evaluate commissural alignment. Future efforts should aim to refine transcatheter heart valve and delivery system designs to make neocommissural alignment easier and more reproducible. The aim of this review is to present an in-depth insight of commissural alignment in TAVR, including its rationale, standardized definitions, technical steps, outcomes, and future directions.

Coronary Access Following Redo TAVR: Impact of THV Design, Implant Technique, and Cell Misalignment.

BACKGROUND: The implications and potential challenges of coronary access after redo transcatheter aortic valve replacement (TAVR) are unknown. OBJECTIVES: The authors sought to evaluate the impact of different transcatheter heart valve (THV) designs, neoskirt height, implant technique, and cell misalignment on coronary access after redo TAVR. METHODS: Different THV designs (Sapien 3 [Edwards Lifesciences LLC], Evolut Pro [Medtronic], ACURATE neo [Boston Scientific Corporation], and Portico [Abbott Structural Heart]) and sizes were implanted inside Sapien XT (Edwards Lifesciences LLC) and Evolut R (Medtronic) THVs, which were modeled as the "failed" THVs, at different implant depths. Valve combinations underwent micro-computed tomography to determine the neoskirt height and dimensions of the lowest accessible cell for potential coronary access. This was compared with dimensions of 6-F/7-F/8-F coronary guiding catheters. RESULTS: Redo TAVR combinations resulted in a wide range of neoskirt heights (15.4-31.6 mm) and a variable diameter of the lowest accessible cell (1.9-21.8 mm). An ACURATE neo implanted in a Sapien XT resulted in the largest accessible cells, whereas a Portico implanted in a Sapien XT resulted in the lowest neoskirt heights. The smallest accessible cell was observed in the Evolut Pro-in-Evolut R configuration with higher neoskirt heights. Redo TAVR in a tall frame valve with supra-annular leaflets caused a taller neoskirt height. In Evolut-in-Evolut combinations, misalignment of the cells of the 2 THVs reduced the cell area by 30% to 50% compared with an aligned configuration. CONCLUSIONS: This study demonstrates that different redo TAVR combinations are not equivalent in terms of future coronary access. Redo TAVR using a tall frame valve in a failed tall frame valve and misaligned cells may lead to potentially challenging coronary access.

Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type.

BACKGROUND: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. OBJECTIVES: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. METHODS: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]). RESULTS: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176). CONCLUSIONS: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.

Early Acurate Neo transcatheter heart valve degeneration in a haemodialysis patient successfully managed with Sapien 3 Ultra: a case report.

Background: Aortic valve disease is the most prevalent valvular abnormality in the developed world and carries a high risk of morbidity and mortality. Transcatheter aortic valve replacement (TAVR) is favoured over open-heart surgery in high-risk patient categories and is increasingly used in lower-risk groups. End stage kidney disease (ESKD) is associated with premature calcific degeneration of bioprosthetic heart valves. Redo-TAVR requires meticulous pre-procedural planning to avoid the important risks of sinus sequestration and impaired coronary access. Transcatheter aortic valve replacement with the Acurate Neo transcatheter heart valve (THV) has been clinically available for a short time only and there are limited reports describing redo-TAVR in the Acurate Neo. Case summary: We present a case of early, rapid onset, structural valve degeneration in a Acurate Neo, supra-annular, self-expanding THV in a dialysis patient. The patient presented with chest pain and breathlessness 4 years after TAVR with a Acurate Neo for severe stenosis of a bicuspid aortic valve. Echocardiogram now showed severe stenosis of the THV and computed tomography revealed severe THV leaflet calcification but no pannus or leaflet thrombus. After careful pre-procedural planning a S3 Ultra balloon-expandable valve was selected and positioned relatively high to pin the first THV leaflets in a fully open position without compromising coronary artery flow or coronary access. Discussion: End stage kidney disease may cause rapid, calcific degeneration of TAVR valves leading to presentation with severe aortic stenosis. Redo-TAVR in the Acurate Neo THV with a Sapien 3 Ultra is feasible with careful pre-procedural planning to mitigate the risks of sinus sequestration and impaired coronary access.