Abstract
Aims
There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to ...determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures.
Methods and results
A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P < 0.001). CT measurements were obtained in 20 (54%) and 90 (5.4%) of patients with and without coronary obstruction, respectively. VTC distance was shorter in coronary obstruction patients in relation to controls (3.24 ± 2.22 vs. 6.30 ± 2.34, respectively; P < 0.001). Using multivariable analysis, the use of a stentless or stented bioprosthesis with externally mounted leaflets odds ratio (OR): 7.67; 95% confidence interval (CI): 3.14–18.7; P < 0.001 associated with coronary obstruction for the global population. In a second model with CT data, a shorter VTC distance predicted this complication (OR: 0.22 per 1 mm increase; 95% CI: 0.09–0.51; P < 0.001), with an optimal cut-off level of 4 mm (area under the curve: 0.943; P < 0.001). Coronary obstruction was associated with a high 30-day mortality (52.9% vs. 3.9% in the controls, respectively; P < 0.001).
Conclusion
Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC.
Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the ...lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.
The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in ...part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).
Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation.
Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality.
Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg).
Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.
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A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.
Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an ...alternative to redo surgery for patients with a failing aortic bioprosthesis.
Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).
Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.
Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.
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Aortic valve-in-valve is a less invasive alternative to surgical redo in the treatment of failed bioprosthetic valves. While only inoperable patients underwent the procedure before, operators ...currently offer it to those at lower risk and worldwide experience is in the thousands. Early mortality has diminished in recent analyses and improvements in symptoms and quality of life have been documented. Main considerations with aortic valve-in-valve include elevated postprocedural gradients, coronary obstruction and leaflet thrombosis. Risk factors for each of these adverse events have been described at length. Aortic valve-in-valve offers a safe and effective option in the management of failed bioprosthetic valves.
Background Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Conclusion Transcatheter aortic valve replacement ...using the new Braile Inovare Proseal prosthesis is able to provide encouraging results with significant decrease in paravalvular leak.
To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage PVL) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively ...the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT).
Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL.
Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%.
Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.
We describe the endovascular management of a middle-aged woman who developed a bleeding suprasternal fistula after conventional aortic valve replacement. The patient’s condition was considered ...inoperable. A customized stent attached to a transcatheter valve was successfully used to treat the individual, this being the first-in-human case of the promising Endo-Bentall procedure. (Level of Difficulty: Advanced.)
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This paper describes the endovascular management of a middle-aged woman who developed a bleeding suprasternal fistula after conventional aortic valve…
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