The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic ...bioprostheses at high-risk for reoperation.
Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery.
VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve.
Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later.
Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298)
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The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear.
We sought to evaluate the incidence of, risk factors ...for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population.
All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality.
A total of 1139 patients (mean age 82.4±7.7years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio adjHR 1.62, 95% confidence interval CI 1.09–2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11–2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13–2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17–2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20–3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95–4.94), along with increased Society of Thoracic Surgeons’ score (adjHR 1.07, 95% CI 1.03–1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00–2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52–2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41–4.65).
Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI≤35% are the main risk factors for readmission for heart failure.
L’incidence et facteurs de risque (FdR) de réadmission pour insuffisance cardiaque après un remplacement valvulaire aortique percutané (TAVI) restent méconnus.
Décrire l’incidence, FdR, et l’impact clinique d’une réadmission pour insuffisance cardiaque après un TAVI dans un échantillon non sélectionné de patients.
Tous les patients traités par TAVI dans deux centres tertiaires français entre février 2010 et décembre 2016 ont été inclus de façon prospective et suivi pendant un an. Les FdR de réadmission pour insuffisance cardiaque et de mortalité ont été analysé via un modèle multivarié de Cox.
Un total de 1139 patients (âge moyen 82,4±7,7 ans ; 52,2 % de sexe masculin) ont été inclus. Une réadmission pour insuffisance cardiaque dans l’année post-TAVI a eu lieu chez 99 (9,2 %) patients. Les FdR de réadmission pour insuffisance cardiaque étaient un antécédent de fibrillation atrial (ratio de risque ajusté adjHR 1,62, intervalle de confiance à 95 % IC 95 % 1,09–2,40), un diabète (adjHR 1,67, IC 95 % 1,11–2,50), une insuffisance rénale chronique (adjHR 1,72, IC 95 % 1,13–2,62), une pneumopathie chronique (adjHR 1,81, IC 95 % 1,17–2,81) et une fraction d’éjection ventriculaire gauche post-TAVI≤35 % (adjHR 2,12, IC 95 % 1,20–3,75). Une réadmission pour insuffisance cardiaque était associée à un surcroît de mortalité (adjHR 3,11, IC 95 % 1,95–4,94), ainsi qu’un score STS élevé (adjHR 1,07, IC 95 % 1,03–1,12), une pneumopathie chronique (adjHR 1,45, IC 95 % 1,00–2,09), un antécédent de fibrillation atrial (adjHR 2,11, IC 95 % 1,52–2,93) et un choc durant l’hospitalisation initiale (adjHR 2,56, IC 95 % 1,41–4,65).
Après un TAVI, une réadmission pour insuffisance cardiaque survient chez un patient sur dix et est associée à un surcroît de la mortalité. Les comorbidités des patients et une fraction d’éjection ventriculaire gauche post-TAVI≤35 % sont les principaux FdR de réadmission pour insuffisance cardiaque.
Purpose
Interventional cardiology devices and especially stents are constantly evolving. A good radiopacity is essential to properly position the stent and to reduce the risk of complications during ...percutaneous coronary intervention (PCI). We wanted to assess the radiopacity of coronary stents.
Methods
9 stents were evaluated. Stents were deployed in a silicon bifurcation model and several pulsed fluoroscopy acquisitions (7.5 and 15 pulses/s) of each device were performed in a catheterization laboratory. Quantitative radiopacity assessment was performed using a radiopacity visual scale and qualitative radiopacity assessment was performed by showing the images to three experienced operators, single-blind.
Results
Our study showed statistically significant differences between stents regarding radiopacity assessed in a quantitative analysis (
p
< 0.000001) or a qualitative analysis (
p
< 0.000001), whether the acquisitions were made in 7.5 or 15 pulses/s. Resolute Onyx and Synergy were the most radio-opaque in both qualitative and qualitative analysis. Moreover, there was a statistically significant correlation between the radiopacity of stents, their strut thickness (
p
< 0.0001) and the presence of platinum in their metallic alloy (
p
< 0.0001).
Conclusion
This study highlighted significant differences in the radiopacity of coronary stents deployed in a bench test model. The strut thickness and the presence of platinum increased the radiopacity.
Background
Coronary angiography is more complex in patients with coronary artery bypass grafts (CABG). Image fusion is a new technology that allows the overlay of a computed tomography (CT) ...three‐dimension (3D) model with fluoroscopic images in real time.
Methods and Results
This single‐center prospective study included 66 previous CABG patients undergoing coronary and bypass graft angiography. Image fusion coronary angiographies (fusion group, 20 patients) were compared to conventional coronary angiographies (control group, 46 patients). The fusion group included patients for whom a previous chest CT scan with contrast was available. For patients in this group, aorta and CABG were reconstructed in 3D from CT acquisitions and merged in real time with fluoroscopic images. The following parameters were compared: time needed to localize the CABG; procedure duration; air kerma (AK); dose area product (DAP); and volume of contrast media injected. Results are expressed as median. There were no significant differences between the 2 groups in patient demographics and procedure characteristics (access site, number of bypass to be found, and interventional cardiologist's experience). The time to localize CABG was significantly shorter in the fusion group (7.3 versus 12.4 minutes; P=0.002), as well as the procedure duration (20.6 versus 25.6 minutes; P=0.002), AK (610 versus 814 mGy; P=0.02), DAP (4390 versus 5922.5 cGy·cm2; P=0.02), and volume of iodinated contrast media (85 versus 116 cc; P=0.002).
Conclusions
3D image fusion improves the CABG detection in coronary angiography and reduces the time necessary to localize CABG, total procedure time duration, radiation exposure, and volume of contrast media.
Transcatheter aortic valve replacement is currently used off-label for noncalcified aortic valve regurgitation and therefore is restricted to selected cases. In this setting we describe a rare ...complication of Sapien 3 (Edwards Lifesciences, Irvine, California) embolization from the left ventricle to the descending aorta. Given their technical challenges, such procedures require specific considerations and management. (Level of Difficulty: Advanced.)
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Background: Current scientific guidelines have extended the indication for transcatheter aortic valve replacement (TAVR) to patients who present an intermediate risk for surgery and have been so far ...considered for conventional surgery. We previously demonstrated that the TAVR procedure generated profits despite elevated costs, but comparison with surgery has not been performed. The objective of this study was to assess the profitability of the TAVR procedure compared with conventional surgery in a high-volume French hospital. Consecutive patients eligible for transfemoral TAVR or surgical aortic valve replacement (SAVR) were included retrospectively in this single-centre study between September 2014 and December 2015. The primary endpoint was the profitability of each procedure (defined as the ratio between the profit and total revenues), calculated for each patient. Secondary composite endpoints included major adverse events in the 30 days following procedure and breakdown of costs. Results: Two hundred and thirty-eight patients were included in the TAVR group and 341 in the SAVR group. TAVR patients presented higher operative risk scores and more comorbidities. Compared with SAVR, TAVR was associated with higher profits (€2732 ± 1768 per patient vs. €2177 ± 2437 per patient, P < 0.001) but also higher costs (€27,778 ± 4961 vs. €17,813 ± 6071, P < 0.001) resulting in lower profitability (9.3 ± 5.7% vs. 11.7 ± 10.1%, P < 0.001). The price of the bioprosthesis represented 70% of the TAVR total cost. Conclusions: TAVR performed in carefully selected patients was associated with higher profits than SAVR, but also higher costs resulting in lower profitability.
BACKGROUND:No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve ...replacement has been conducted to date.
METHODS:From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.
RESULTS:In propensity–matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 95% CI, 1.46–1.91; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 95% CI, 1.63–2.22; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 95% CI, 1.07–1.66; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 95% CI, 1.06–1.29; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.
CONCLUSION:The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.
CLINICAL TRIAL REGISTRATION:https://www.clinicaltrials.gov. Unique identifierNCT01777828.
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