Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bio prostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. METHODS: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. RESULTS: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. CONCLUSIONS: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials

Background The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. Methods Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. Results The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively ( p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups ( p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. Conclusion At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III

OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS: Mean patient age was 65.5 6 10.8 years and mean lesion reference diameter was 2.70 6 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P 5 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 6 0.31 mm in-segment and 0.396 0.34 mm in scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

The Role of Automated 3D Echocardiography for Left Ventricular Ejection Fraction Assessment.

Ejection fraction is one of the most powerful determinants of prognosis and is a crucial parameter for the determination of cardiovascular therapies in conditions such as heart failure, valvular conditions and ischaemic heart disease. Among echocardiographic methods, 3D echocardiography has been attributed as the preferred one for its assessment, given an increased accuracy and reproducibility. Full-volume multi-beat acquisitions are prone to stitching artefacts due to arrhythmias and require prolonged breath holds. Single-beat acquisitions exhibit a lower temporal resolution, but address the limitations of multi-beat acquisitions. If not fully automated, 3D echocardiography remains time-consuming and resource-intensive, with suboptimal observer variability, preventing its implementation in routine practice. Further developments in hardware and software, including fully automated knowledge-based algorithms for left ventricular quantification, may bring 3D echocardiography to a definite turning point.

Diferencias en geometría entre válvulas percutáneas expandibles con balón y autoexpandibles y su relación con la insuficiencia aórtica / Differences in frame geometry between balloon-expandable and self-expanding transcatheter heart valves and association with aortic regurgitation

Introducción y objetivos: Se sabe que los factores relacionados con el paciente y con la intervención se asocian con insuficiencia aórtica después de un implante percutáneo de válvula aórtica. No obstante, también puede causarla una interacción específica entre el dispositivo y el huésped como consecuencia de las propiedades biomecánicas de las válvulas, con independencia de los factores clínicos. El objetivo de este estudio es esclarecer el papel de la geometría de la válvula en la aparición de insuficiencia aórtica después del implante de las válvulas Medtronic CoreValve® y Edwards SAPIEN®. Métodos: Se llevó a cabo un estudio observacional que incluyó a 134 pacientes tratados con implante percutáneo de válvula aórtica empleando las válvulas Medtronic CoreValve® y Edwards SAPIEN®. El análisis geométrico se realizó en tres niveles predefinidos de ambas válvulas mediante angiografía rotacional con compensación de movimiento usando un programa informático específicamente desarrollado para este fin. Se estableció una distinción entre los pacientes con insuficiencia aórtica nula o leve y los pacientes con insuficiencia aórtica moderada o grave según la ecocardiografía. Resultados: Las características basales eran similares con ambas válvulas. A pesar del mayor uso de predilatación en el grupo de CoreValve® (el 95,2 frente al 82,0%; p = 0,012), el mayor exceso de tamaño de prótesis/anillo aórtico (perímetro, el 114 ± 7% frente al 103 ± 7%; p < 0,001) y la misma profundidad de implante (seno no coronario, 7 ± 4 frente a 8 ± 2 mm; seno coronario izquierdo, 8 ± 4 frente a 8 ± 2 mm), esta válvula tuvo menos expansión (el 83 ± 7% frente al 92 ± 4%; p < 0,001) y fue más excéntrica (el 82 ± 8% frente al 95 ± 3%; p < 0,001) que la válvula Edwards SAPIEN®, también tras introducir un ajuste de la excentricidad respecto a la excentricidad del anillo valvular del paciente (el 4 ± 13% frente al 21 ± 11%; p < 0,001). La excentricidad y la excentricidad ajustada se asociaron con insuficiencia aórtica moderada o grave. Conclusiones: Independientemente de los factores relacionados con el paciente y con la intervención, existe una interacción entre dispositivo y huésped que es específica del dispositivo y explica la insuficiencia aórtica existente después de un implante percutáneo de válvula aórtica (AU)

Introduction and objectives: Patient- and procedure-related factors are known to be associated with aortic regurgitation after transcatheter aortic valve implantation. Nevertheless, this entity may also be caused by a specific device-host interaction due to the biomechanical properties of the valves, independently of clinical factors. We sought to elucidate the role of frame geometry in the occurrence of aortic regurgitation after Medtronic CoreValve and Edwards SAPIEN valve implantation. Methods: We conducted an observational study encompassing 134 patients undergoing transcatheter aortic valve implantation with the Medtronic CoreValve and Edwards SAPIEN valve. Frame analysis was performed at 3 predefined levels of both valves by rotational angiography using dedicated motion compensation software. A distinction was made between patients with no-to-mild and moderate-to-severe aortic regurgitation by echocardiography. Results: Baseline characteristics were similar between the 2 valves. Despite greater use of predilation in the CoreValve (95.2% vs 82.0%; P = .012), more oversizing (perimeter, 114 ± 7% vs 103 ± 7%;P < .001), and the same depth of implantation (noncoronary sinus, 7 ± 4 vs 8 ± 2 mm; left coronary sinus, 8 ± 4 vs 8 ± 2 mm), it was less expanded and more eccentric than the Edwards SAPIEN (83 ± 7% vs 92 ± 4%; P < .001 and 82 ± 8% vs 95 ± 3%; P < .001, respectively) and when eccentricity was adjusted for the patient's annulus eccentricity (4 ± 13% vs 21 ± 11%;P < .001). Eccentricity and adjusted eccentricity were associated with moderate-to-severe aortic regurgitation. Conclusions: Independently of patient- and procedure-related factors, there is a device-specific device-host interaction that explains aortic regurgitation after transcatheter aortic valve implantation (AU)