Feasibility of the Engager™ aortic transcatheter valve system using a flexible over-the-wire design

OBJECTIVES The aim was to investigate the safety and feasibility of the redesigned Engager™ transcatheter aortic valve implantation (TAVI) system. METHODS Transapical aortic valve implantation with the Engager™ valve prosthesis was intended in 11 patients, and performed in 10. Endpoints were defined according to the valve academic research consortium recommendations for reporting outcomes of TAVI in clinical trials. RESULTS All 10 patients were implanted successfully. No devicerelated or delivery system complications like coronary obstruction or aortic dissection emerged. One patient (10%) died from non-device-related reasons at post-operative day 23 of multi-organ failure. The invasively measured peak-to-peak gradient after valve implantation was 7.1±3.5mmHg. In 90%, there was no or only trivial (≤grad I) aortic regurgitation due to paravalvular leakage. In 10% of the patients, aortic regurgitation grade I-II was observed. At 30-day follow up, the mean gradient was 15.6±4.9mmHg, and no more than a mild transvalvular and paravalvular aortic regurgitation was seen as assessed by transthoracic echocardiography. CONCLUSIONS Application of the Engager™ TAVI system is safe and feasible. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and was successful in all patients. No device or delivery-system-related complications emerged. Safety and feasibility endpoints were met. Good results concerning the aortic valve performance after implantation and at 30-day follow up were ascertained. These results encouraged the start of a European Pivotal trial including patients to dat

Transcatheter aortic valve implantation and its impact on mitral valve geometry and function

BACKGROUND The aim of this study was to evaluate the impact of transcatheter aortic valve implantation (TAVI) on mitral valve geometry and function. METHODS Eighty-four patients underwent TAVI. Forty-four (52%) patients received a balloon-expandable valve and 40 (48%) were implanted with a self-expandable valve. All patients underwent three-dimensional-volumetric transesophageal echocardiography of the mitral valve before and immediately after TAVI. A dedicated software was used for assisted semiautomatic measurement of mitral annular geometry. RESULTS During systole, the anterior to posterior (AP) diameter was significantly reduced after the procedure (3.4 ± 0.5 cm vs 3.2 ± 0.5 cm; P < .05). The mitral annular area (10.8 ± 2.8cm$^{2}$ vs 9.9 ± 2.6cm$^{2}$ ; P < .05) as well as the tenting area (1.6 ± 0.7 cm$^{2}$ vs 1.2 ± 0.6 cm$^{2}$ ; P < .001) measured at mid-systole were reduced after TAVI. Diastolic measures were similar. Patients treated with balloon-expandable valves showed a significantly larger reduction in the AP diameter compared to self-expandable valves (-0.25 cm vs -0.11 cm; P < .05). The reduction of the annular area was higher in the balloon-expandable group (-1.2 ± 1.59 vs -0.22 ± 1.41; P < .05). Grade of mitral regurgitation did improve or remained stable after TAVI. CONCLUSION TAVI significantly impacts the mitral valve and mitral annular geometry and morphology. The choice of the prosthesis (balloon- vs self-expandable) may be relevant for those changes

Outcome of patients treated with engager transapical aortic valve implantation: one-year results of the feasibility study

OBJECTIVE: The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation. METHODS: Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year. RESULTS: All patients underwent the implantation procedure successfully. No device-related or delivery system-related complications were observed. One patient died of non-device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up. CONCLUSIONS: Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system-related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation

Alternative minimally invasive surgical explantation techniques for failed transcatheter mitral valve repair devices

Objective: The use of transcatheter mitral valve repair (TMVr) devices is increasing in elderly and high-risk patients. However, the increasing number of patients with recurrent mitral regurgitation (MR) has confronted surgeons with the issue of how to explant the devices and whether the mitral valve should be repaired or replaced. The aim of the study is to summarize our clinical experience with the explantation of different TMVr devices and to provide alternative surgical techniques that can be performed in different clinical scenarios. Methods: A simulator system including a dummy valve representing native valves was used to create video documentation and to develop alternative surgical methods for clip explantation. Moreover, the clip explantation techniques were shown in 2 patients undergoing minimally-invasive mitral valve repair after a failed TMVr. Results: Alternative explantation techniques were described for each TMVr device; 2 techniques for MitraClip and 3 techniques for PASCAL (Precision Transcatheter Valve Repair System), which may be adjusted for each individual according to the underlying valve pathology and the degree of device encapsulation. The patients were discharged without residual MR and remained MR free at the follow-up. Conclusions: Transcatheter edge-to-edge repair devices can be surgically explanted without damaging the MV leaflets. Removal of each device may require a different technique tailored to the degree of device encapsulation and valve pathology. Increasing experience may facilitate repair in patients with recurrent MR after TMVr.ISSN:2666-250

Minimally invasive surgical aortic valve replacement: The RALT approach

Less-invasive techniques for cardiothoracic surgical procedures are designed to limit surgical trauma, but the technical requirements and preoperative planning are more demanding than those for conventional sternotomy. Patient selection, interdisciplinary collaboration, and surgical skills are key factors for procedural success. Aortic valve replacement is frequently performed through an upper hemisternotomy, but the right anterior minithoracotomy represents an even less traumatic, technical advancement. Preoperative assessment of the ascending aorta in relation to the sternum is mandatory to select patients and the intercostal access site. This description of the surgical technique focuses on the specific procedural details including the obligatory planning with computed tomography and our cannulation strategy. We also sought to define the anatomical ascending aorta-sternal relationship, as it is of utmost importance in preoperative computed tomographic planning.ISSN:0886-0440ISSN:1540-819

Reliability and Influence on Decision Making of fully-automated vs. semi-automated Software Packages for Procedural Planning in TAVI

Precise procedural planning is crucial to achieve excellent results in patients undergoing Transcatheter aortic valve implantation (TAVI). The aim of this study was to compare the semi-automated 3mensio (3 m) software to the fully-automated HeartNavigator3 (HN) software. We randomly selected 100 patients from our in-house TAVI-registry and compared aortic annulus and perimeter as well as coronary distances between 3m-measurements and post-hoc HN-measurements. Finally, we retrospectively simulated prosthesis choice based on HN-measurements and analyzed the differences compared to routinely used 3 m based strategy. We observed significant differences between the two software packages regarding area (3 m 464 ± 88 mm², HN 482 ± 96 mm², p < 0.001), perimeter (3 m 77 ± 7 mm, HN 79 ± 8 mm, p < 0.001) and coronary distances (LCA: 3 m 13 ± 3 mm, HN 12 ± 3 mm, p < 0.001; RCA: 3 m 16 ± 3 mm, HN 15 ± 3 mm, p < 0.001). Prosthesis choice simulation based on newly obtained HN-measurements would have led to a decision change in 18% of patients, with a further reduction to 4% following manual adjustment of HN-measurements. The fully-automatic HN-software provides higher values for annular metrics and lower annulus-to-coronary-ostia distances compared to 3m-software. Measurement differences did not influence clinical outcome. Both, the HN-software and the 3m-software are sophisticated, reliable and easy to use for the clinician. Manual adjustment of HN-measurements may increase precision in complex aortic annulus anatomy.ISSN:2045-232

Left atrial appendage occlusion techniques for open heart surgery and for minimally invasive thoracotomy

ISSN:2304-1021ISSN:2225-319

Computed Tomography-Based Assessment of Transvalvular Pressure Gradient in Aortic Stenosis

Background: In patients with aortic stenosis, computed tomography (CT) provides important information about cardiovascular anatomy for treatment planning but is limited in determining relevant hemodynamic parameters such as the transvalvular pressure gradient (TPG). Purpose: In the present study, we aimed to validate a reduced-order model method for assessing TPG in aortic stenosis using CT data. Methods: TPG(CT) was calculated using a reduced-order model requiring the patient-specific peak-systolic aortic flow rate (Q) and the aortic valve area (AVA). AVA was determined by segmentation of the aortic valve leaflets, whereas Q was quantified based on volumetric assessment of the left ventricle. For validation, invasively measured TPG(catheter) was calculated from pressure measurements in the left ventricle and the ascending aorta. Altogether, 84 data sets of patients with aortic stenosis were used to compare TPG(CT) against TPG(catheter). Results: TPG(catheter) and TPG(CT) were 50.6 ± 28.0 and 48.0 ± 26 mmHg, respectively (p = 0.56). A Bland-Altman analysis revealed good agreement between both methods with a mean difference in TPG of 2.6 mmHg and a standard deviation of 19.3 mmHg. Both methods showed good correlation with r = 0.72 (p < 0.001). Conclusions: The presented CT-based method allows assessment of TPG in patients with aortic stenosis, extending the current capabilities of cardiac CT for diagnosis and treatment planning