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1.
Eur Heart J ; 2024 May 31.
Article in English | MEDLINE | ID: mdl-38820201

ABSTRACT

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

2.
Struct Heart ; 8(3): 100276, 2024 May.
Article in English | MEDLINE | ID: mdl-38799806

ABSTRACT

Background: Bioprosthetic valve fracture (BVF) during valve-in-valve TAVR (transcatheter aortic valve replacement) is a procedural adjunct designed to optimize the expansion of the transcatheter heart valve and reduce patient-prosthesis mismatch by using a high-pressure balloon to intentionally fracture the surgical heart valve (SHV). Methods: We performed bench testing on 15 bioprosthetic SHV to examine the optimal balloon size and pressure for BVF. We assessed morphological changes and expansion of SHV by computed tomography angiography. Successful BVF was defined as balloon waist disappearance on fluoroscopy and/or sudden pressure drop during balloon inflation. Results: Nine valves met the definition of BVF, 3 of which were confirmed by disruption of the stent frame. We classified surgical valves into 3 subsets: 1) fracturable with metal stent frame (MSF), 2) fracturable with polymer stent frame (PSF) and 3) nonfracturable. In general, valves with MSF were fractured using a balloon size = true internal diameter plus 3-5 mm inflated at high pressure (16-20 ATM) whereas valves with PSF could be fractured with a balloon size = true internal diameter plus 3-5 mm and lower balloon pressure (6-14 ATM). Gains in computed tomography angiography derived inflow area after BVF were 12.3% for MSF and 3.6% for PSF SHV. Conclusions: Gains in CT-determined valve area after BVF depend on the physical properties of the SHV, which in turn influences pressure thresholds and balloon sizing strategy for optimal BVF. Elastic recoil of PSF valves limits the gains in inflow area after BVF.

3.
JACC Cardiovasc Interv ; 17(7): 874-886, 2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38599690

ABSTRACT

BACKGROUND: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients. OBJECTIVES: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves. METHODS: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed. RESULTS: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation. CONCLUSIONS: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763).


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Humans , Female , Middle Aged , Aged , Aged, 80 and over , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/etiology , Stroke Volume , Treatment Outcome , Ventricular Function, Left , Cardiac Catheterization/methods
5.
J Cardiol ; 83(6): 351-358, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38432474

ABSTRACT

Transcatheter aortic valve replacement (TAVR) has emerged as a preferred treatment modality for aortic stenosis, marking a significant advancement in cardiac interventions. Transcatheter heart valves (THVs) have also received approval for treating failed bioprosthetic valves and rings across aortic, mitral, tricuspid, and pulmonic positions. Unlike surgically implanted valves, which are sewn into the annulus, THVs are anchored through relative oversizing. Although THVs are designed to function optimally in a fully expanded state, they exhibit a certain degree of tolerance to underexpansion. However, significant deformation beyond this tolerance can adversely affect the valve's hemodynamics and durability, ultimately impacting patient outcomes. Such post-implantation deviations from the valve's intended three-dimensional design are influenced by a variety of physiological and anatomical factors unique to each patient and procedure, leading to underexpansion, eccentric expansion, and vertical deformation. These deformation patterns increase leaflet stress and strain, potentially causing fatigue and damage. This review article delves into the extent of THV deformation, its impact on leaflet function, hypoattenuating leaflet thickening, and structural valve degeneration. It provides an in-depth analysis of deformation specifics in different procedural contexts, including TAVR in native aortic stenosis, aortic and mitral valve-in-valve procedures, and redo-TAVR. Additionally, the review discusses strategies to mitigate THV deformation during the procedure, offering insights into potential solutions to these challenges.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve Stenosis/surgery , Treatment Outcome , Prosthesis Design
6.
Ann Thorac Surg ; 117(6): 1154-1162, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38382704

ABSTRACT

BACKGROUND: Selection of transcatheter valve size using preprocedural computed tomography (CT) is standardized and well established. However, valve sizing for surgical aortic valve replacement (SAVR) is currently performed intraoperatively by using sizers, which may result in variation among operators and risk for prosthesis-patient mismatch. This study evaluated the usefulness of CT annulus measurement for SAVR valve sizing. METHODS: This study included patients who underwent SAVR using Inspiris or Magna Ease and received preoperative electrocardiogram-gated CT imaging. Starting from June 2022, study investigators applied a CT sizing algorithm using CT-derived annulus size to guide minimum SAVR label size. The final decision of valve selection was left to the operating surgeon during SAVR. The study compared the appropriateness of valve selection (comparing implanted size with CT-predicted size) and prosthesis-patient mismatch rates without aortic root enlargement between 2 cohorts: 102 cases since June 2022 (CT sizing cohort) and 180 cases from 2020 to 2021 (conventional sizing cohort). RESULTS: Implanted size smaller than CT predicted size and severe prosthesis-patient mismatch were significantly lower by CT sizing than by conventional sizing (12% vs 31% [P = .001] and 0% vs 6% [P = .039], respectively). Interoperator variability was a factor associated with implanted size smaller than CT predicted with conventional sizing, whereas it became nonsignificant with CT sizing. CONCLUSIONS: Applying CT sizing to SAVR led to improved valve size selection, less prosthesis-patient mismatch, and less interoperator variability. CT sizing for SAVR could also be used to predict prosthesis-patient mismatch before SAVR and identify patients who need aortic root enlargement.


Subject(s)
Aortic Valve , Heart Valve Prosthesis , Tomography, X-Ray Computed , Humans , Female , Male , Tomography, X-Ray Computed/methods , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aged , Retrospective Studies , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Prosthesis Design , Aged, 80 and over , Preoperative Care/methods , Heart Valve Prosthesis Implantation/methods , Transcatheter Aortic Valve Replacement/methods
7.
EuroIntervention ; 20(2): e146-e157, 2024 Jan 15.
Article in English | MEDLINE | ID: mdl-38224255

ABSTRACT

BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.


Subject(s)
Transcatheter Aortic Valve Replacement , Humans , Female , Middle Aged , Aged , Aged, 80 and over , Male , Transcatheter Aortic Valve Replacement/adverse effects , Device Removal , Catheters , Heart Valves , Registries
8.
JACC Cardiovasc Imaging ; 17(1): 79-95, 2024 01.
Article in English | MEDLINE | ID: mdl-37731368

ABSTRACT

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.


Subject(s)
Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Humans , Diagnostic Imaging , Predictive Value of Tests , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery , Clinical Trials as Topic
9.
JACC Cardiovasc Imaging ; 17(4): 396-407, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37921717

ABSTRACT

BACKGROUND: Quantification of myocardial changes in severe aortic stenosis (AS) is prognostically important. The potential for comprehensive myocardial assessment pre-transcatheter aortic valve replacement (TAVR) by computed tomography angiography (CTA) is unknown. OBJECTIVES: This study sought to evaluate whether quantification of left ventricular (LV) extracellular volume-a marker of myocardial fibrosis-and global longitudinal strain-a marker of myocardial deformation-at baseline CTA associate with post-TAVR outcomes. METHODS: Consecutive patients with symptomatic severe AS between January 2021 and June 2022 who underwent pre-TAVR CTA were included. Computed tomography extracellular volume (CT-ECV) was derived from septum tracing after generating the 3-dimensional CT-ECV map. Computed tomography global longitudinal strain (CT-GLS) used semi-automated feature tracking analysis. The clinical endpoint was the composite outcome of all-cause mortality and heart failure hospitalization. RESULTS: Among the 300 patients (80.0 ± 9.4 years of age, 45% female, median Society of Thoracic Surgeons Predicted Risk of Mortality score 2.80%), the left ventricular ejection fraction (LVEF) was 58% ± 12%, the median CT-ECV was 28.5% (IQR: 26.2%-32.1%), and the median CT-GLS was -20.1% (IQR: -23.8% to -16.3%). Over a median follow-up of 16 months (IQR: 12-22 months), 38 deaths and 70 composite outcomes occurred. Multivariable Cox proportional hazards model, accounting for clinical and echocardiographic variables, demonstrated that CT-ECV (HR: 1.09 [95% CI: 1.02-1.16]; P = 0.008) and CT-GLS (HR: 1.07 [95% CI: 1.01-1.13]; P = 0.017) associated with the composite outcome. In combination, elevated CT-ECV and CT-GLS (above median for each) showed a stronger association with the outcome (HR: 7.14 [95% CI: 2.63-19.36]; P < 0.001). CONCLUSIONS: Comprehensive myocardial quantification of CT-ECV and CT-GLS associated with post-TAVR outcomes in a contemporary low-risk cohort with mostly preserved LVEF. Whether these imaging biomarkers can be potentially used for the decision making including timing of AS intervention and post-TAVR follow-up will require integration into future clinical trials.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Female , Male , Transcatheter Aortic Valve Replacement/adverse effects , Ventricular Function, Left , Stroke Volume , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Predictive Value of Tests , Tomography, X-Ray Computed , Treatment Outcome , Retrospective Studies
12.
Circ Cardiovasc Interv ; 16(11): e012966, 2023 11.
Article in English | MEDLINE | ID: mdl-37988437

ABSTRACT

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Reintervention for failed transcatheter heart valves will likely increase in the future as younger patients are expected to outlive the initial bioprosthesis. While redo-TAVR has emerged as an attractive and less invasive alternative to surgical explantation (TAVR-explant) to treat transcatheter heart valve failure, it may not be feasible in all patients due to the risk of coronary obstruction and impaired coronary access. Conversely, TAVR-explant can be offered to most patients who are surgical candidates, but the reported outcomes have shown high mortality and morbidity. This review provides the latest evidence, current challenges, and future directions on redo-TAVR and TAVR-explant for transcatheter heart valve failure, to guide aortic valve reintervention and facilitate patients' lifetime management of aortic stenosis.


Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/adverse effects , Risk Factors , Treatment Outcome , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Heart Valve Prosthesis Implantation/adverse effects
13.
Circ Cardiovasc Interv ; 16(11): e013497, 2023 11.
Article in English | MEDLINE | ID: mdl-37988440

ABSTRACT

BACKGROUND: Our aim was to assess the feasibility of repeat transcatheter aortic valve (TAV) replacement for degenerated Sapien3 (S3) prostheses by simulating subsequent implantation of S3 or Evolut, using in vivo computed tomography-based sizing and the impact on coronary and patient-prosthesis mismatch risks. METHODS: Computed tomography scans from 356 patients with prior S3 TAV replacement implantation were analyzed. The in vivo sizing for second TAV based on averaged area of 3 levels of outflow, mid (narrowest) and inflow, was compared with in vitro recommendations, that is, same size as index S3 for second S3 and 1 size larger for Evolut. Risks of coronary obstruction and patient-prosthesis mismatch were determined by valve-to-aorta distance and estimated effective orifice area, respectively. RESULTS: Overall, the majority of patients (n=328; 92.1%) had underexpanded index S3 with an expansion area of 94% (91%-97%), leading to significant differences in size selection of the second TAV between in vivo and in vitro sizing strategies. Expansion area <89% served as a threshold, resulting in 1 size smaller than the in vitro recommendations were selected in 45 patients (13%) for S3-in-S3 and 13 (4%) for Evolut-in-S3, while the remaining patients followed in vitro recommendations (P<0.01, in vivo versus in vitro sizing). Overall, 57% of total patients for S3-in-S3 simulation and 60% for Evolut-in-S3 were considered low risk for coronary complications. Deep index S3 implantation (odds ratio, 0.76 [interquartile range, 0.67-0.87]; P<0.001) and selecting Evolut as the second TAV (11% risk reduction in intermediate- or high-risk patients) reduced coronary risk. Estimated moderate or severe patient-prosthesis mismatch risk was 21% for S3-in-S3 and 1% for Evolut-in-S3, assuming optimal expansion of the second TAV. CONCLUSIONS: Redo-TAV replacement with S3-in-S3 and Evolut-in-S3 could be feasible with low risk to coronaries in ≈60% of patients, while the remaining 40% will be at intermediate or high risk. The feasibility of redo-TAV replacement is influenced by sizing strategy, type of second TAV, native annular anatomy, and implant depth.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Feasibility Studies , Treatment Outcome , Prosthesis Design , Tomography, X-Ray Computed
14.
EuroIntervention ; 19(11): e937-e947, 2023 Dec 18.
Article in English | MEDLINE | ID: mdl-37899719

ABSTRACT

BACKGROUND: The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for THV durability. AIMS: The objective of this study was to assess the extent and predictors of THV deformation in MViV procedures. METHODS: We examined 33 patients who underwent MViV with SAPIEN prostheses. The extent of THV deformation (deformation index, eccentricity, neosinus volume, asymmetric leaflet expansion and vertical deformation) and hypoattenuating leaflet thickening (HALT) were assessed using cardiac computed tomography (CT), performed prospectively at 30 days post-procedure. For descriptive purposes, the THV deformation index was calculated, with values >1.00 representing a more hourglass shape. RESULTS: Non-uniform underexpansion of THV was common after MViV implantation, with a median expansion area of 74.0% (interquartile range 68.1-84.1) at the narrowest level and a THV deformation index of 1.21 (1.13-1.29), but circularity was maintained with eccentricity ranging from 0.24 to 0.28. The degree of oversizing was a key factor associated with greater underexpansion and a higher deformation index (ß=-0.634; p<0.001; ß=0.594; p<0.001, respectively). Overall, the incidence of HALT on the 30-day postprocedural CT was 27.3% (9 of 33). Most patients (32 of 33) were on anticoagulation therapy, but the prothrombin time and international normalised ratio (PT-INR) at the time of the CT scan was <2.5 in 23 of 32 patients. Among patients with a PT-INR of <2.5, HALT was predominantly observed with a high THV deformation index of ≥1.18. CONCLUSIONS: THV deformation, i.e., underexpansion and an hourglass shape, commonly occurs after MViV implantation and is negatively affected by excessive oversizing. Optimising THV expansion during MViV could potentially prevent HALT.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve Stenosis/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Treatment Outcome , Prosthesis Design , Aortic Valve/surgery
16.
EuroIntervention ; 19(4): e352-e362, 2023 Jul 17.
Article in English | MEDLINE | ID: mdl-37334801

ABSTRACT

BACKGROUND: TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability. AIMS: We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS. METHODS: This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety. RESULTS: Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm2, and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm2, MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm. CONCLUSIONS: Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Female , Aged , Aged, 80 and over , Male , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Prospective Studies , Feasibility Studies , Biomimetics , Treatment Outcome , Prosthesis Design
17.
Ann Thorac Surg ; 116(5): 933-942, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37354965

ABSTRACT

BACKGROUND: Recent reports have demonstrated worse than expected outcomes of surgical explantation after transcatheter aortic valve replacement (TAVR). However in-depth analysis of the short- and mid-term risk of concomitant cardiac surgery at the time of TAVR explant is lacking. METHODS: Data from the multicenter EXPLANT-TAVR registry of patients undergoing TAVR-explant between November 2009 and September 2020 were retrospectively analyzed. Patients undergoing concomitant procedures were included, but explants performed during the same admission as the initial TAVR or concomitant procedures performed on the aortic root, ascending aorta, or arch were excluded. Outcomes were evaluated between the isolated surgical aortic valve replacement (SAVR) and concomitant SAVR groups. Median follow-up was 6.6 months. RESULTS: Among 199 patients, concomitant SAVR was performed in 94 patients (47.2%), primarily with mitral valve surgery (n = 45) followed by coronary artery bypass grafting (n = 23). Despite similar mean ages between groups (72.8 vs 73.4 years), concomitant SAVR had a higher median Society of Thoracic Surgeons Predicted Risk of Mortality score at the index TAVR (5.9% vs 3.7%, P = .001). There were no differences in median time-to-explant between groups (12.9 vs 8.7 months, P = .78). However concomitant SAVR had longer mean cardiopulmonary bypass (166 vs 114 minutes, P = .001) and cross-clamp times (123 vs 81 minutes, P = .001). Both 30-day (16.7% vs 9.9%) and 1-year mortality (36.1% vs 22.1%) were higher with concomitant SAVR but did not reach statistical significance (both P > .05). On Kaplan-Meier analysis, actuarial estimates of cumulative survival were significantly lower with concomitant SAVR at 3 years (56.8% vs 81.1%, P = .020). CONCLUSIONS: For surgical explantation after TAVR failure, concomitant SAVR is associated with increased mortality. Further studies with longer follow-up are warranted to examine the benefit from earlier intervention before concomitant disease develops.

18.
JACC Cardiovasc Interv ; 16(10): 1176-1188, 2023 05 22.
Article in English | MEDLINE | ID: mdl-37225288

ABSTRACT

BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.


Subject(s)
Mitral Valve Insufficiency , Humans , Middle Aged , Aged , Aged, 80 and over , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/surgery , Retrospective Studies , Treatment Outcome , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Registries
19.
J Cardiovasc Comput Tomogr ; 17(3): 222-225, 2023.
Article in English | MEDLINE | ID: mdl-36922309

ABSTRACT

BACKGROUND: Computed tomography angiography (CTA) assessment of myocardial extracellular volume fraction (CT-ECV) is feasible, although the protocols for imaging acquisition and post-processing methodology have varied. We aimed to identify a pragmatic protocol for CT-ECV assessment encompassing both imaging acquisition and post-processing methodologies to facilitate its clinical implementation. METHODS: We evaluated consecutive patients with severe aortic stenosis undergoing evaluation for transcatheter aortic valve replacement (TAVR). Pre-contrast and 3-min-delayed CTA were obtained in systole using either helical prospective-ECG-triggered (high-pitch) or axial sequential-ECG-gated acquisition, adding to standard TAVR CTA protocol. Using a dedicated software for co-registration of CTA datasets, three methodologies for ECV measurement were evaluated: (1) mid-septum region of interest (Septal ECV), (2) averaged-global ECV (Global ECV) encompassing 16-AHA segments, and (3) average of septal and lateral segments (Averaged ECVsep and Averaged ECVlat). RESULTS: Among the 142 patients enrolled (median â€‹= â€‹81 years, 44% females), 8 were excluded due to significant imaging artifacts precluding Global ECV assessment. High-pitch scan mode was performed in 68 patients (48%). Suboptimal image quality for Global ECV assessment was associated with high-pitch scan mode (odds ratio: OR â€‹= â€‹2.26, p â€‹= â€‹0.036), along with the presence of intracardiac leads (OR â€‹= â€‹4.91, p â€‹= â€‹0.002), and BMI≥35 â€‹kg/m2 (OR â€‹= â€‹2.80, p â€‹= â€‹0.026). Septal ECV [median â€‹= â€‹29.4%] and Averaged ECVsep [29.0%] were similar (p â€‹= â€‹0.108), while Averaged ECVlat [27.5%] was lower than Averaged ECVsep (p â€‹< â€‹0.001), resulting in lower Global ECV [28.6%]. CONCLUSIONS: Myocardial CT-ECV assessment is feasible using a systolic sequential acquisition pre-contrast, and similar additional 3-min delayed scan. Septal ECV measurement provides similar values to Global ECV and is equally reproducible.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Female , Humans , Male , Prospective Studies , Predictive Value of Tests , Tomography, X-Ray Computed , Computed Tomography Angiography/methods , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery
20.
JACC Cardiovasc Interv ; 16(5): 515-526, 2023 03 13.
Article in English | MEDLINE | ID: mdl-36922036

ABSTRACT

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) may be associated with adverse hemodynamics, which might affect clinical outcomes. OBJECTIVES: This study sought to evaluate the extent and predictors of transcatheter heart valve (THV) deformity in ViV TAVR and the relation to postprocedural hemodynamics. METHODS: We examined 53 patients who underwent ViV TAVR in surgical heart valves with self-expanding Evolut prostheses. THV deformation was examined using cardiac computed tomography prospectively performed 30 days after ViV TAVR, and correlated with 30-day echocardiographic hemodynamic data. RESULTS: Near complete expansion of the functional portion of the implanted ViV prostheses (ie, >90%) was observed in 16 (30.2%) patients. Factors related to greater expansion of the functional portion and consequently larger neosinus volume were absence of polymer surgical frame, higher implantation and use of balloon aortic valvuloplasty or bioprosthetic valve fracture during the procedure (all P < 0.05). Underexpansion of the functional portion, but not the valve inflow frame, was closely associated with mean gradient and effective orifice area at 30 days on echocardiography, with and without adjustment for the sizes of the THV and surgical heart valve. CONCLUSIONS: Underexpansion of the functional portion of THV prostheses is common during ViV TAVR, occurs more frequently with deep implantation and the presence of a polymer surgical stent frame, and is associated with worse postprocedural hemodynamics. Procedural techniques, such as higher implantation and balloon postdilatation, may be used to help overcome problems with THV underexpansion and improve clinical outcomes.


Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Treatment Outcome , Prosthesis Design , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Hemodynamics , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology
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