Three-dimensional EchoNavigator System Guided Transcatheter Closure of Paravalvular Leakage.
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SUBMITTER: Kim BH
PROVIDER: S-EPMC6669176 | biostudies-literature | 2019 Jul
REPOSITORIES: biostudies-literature
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Three-dimensional EchoNavigator System Guided Transcatheter Closure of Paravalvular Leakage.
Kim Byung Ho BH Koh Yoon Seok YS Lee Kwan Yong KY Chung Woo Baek WB
Journal of cardiovascular imaging 20190514 3
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Project description:BackgroundClosure of a percutaneous paravalvular leak (PVL) is a technically challenging procedure because of the specific anatomy postoperatively and the complex catheter techniques required. Transesophageal echocardiography (TEE) and three-dimensional (3D) printing might be helpful in identifying complex anatomical structures and the procedural design.ObjectivesThe purpose of this study was to review our experiences with transcatheter closure of PVL guided by TEE and 3D (TEE&3D) printing.MethodsA total of 166 patients with PVL after surgical valve replacement underwent transcatheter closure, from January 2015 through December 2020. Among these patients, 68 had preoperative guidance from TEE&3D printing. We reviewed the catheter techniques, perioperative characteristics, and prognosis. The median follow-up period was 36 (3-70) months.ResultsAcute procedural success was achieved in 154/166 (92.8%) patients; of these, 64/68 (94.1%) had TEE&3D guidance and 90/98 (91.8%) had transthoracic echocardiography (TTE) guidance. No hospital deaths occurred. All patients having percutaneous procedures were given local anesthesia, while 13 patients having transapical procedures were given general anesthesia. Multiple approaches were used, including transfemoral, transapical, and transseptal via the arteriovenous loop. We also deployed multiple devices, including the Amplatzer Vascular Plug II (AVP II), the Amplatzer duct occluder II, the patent ductus arteriosus (PDA) occluder, and the Amplatzer muscular ventricular septal defect occluder. Those cases guided by TEE&3D printing had shorter procedural times compared with those guided by TTE [(61.2 ± 23.4) vs. (105.7 ± 53.9) min, p < 0.05]. The fluoroscopic time was also shorter for operations guided by TEE&3D printing compared with those guided by TTE alone [(18.5 ± 11.4) vs. (27.3 ± 5.6) min, p < 0.05]. The complications included recurrent hemolysis, residual regurgitation, acute renal insufficiency, and anemia. There was no significant difference in the incidence of complications between the 2 groups.ConclusionTransesophageal echocardiography and 3D printing show advantages compared with standalone TTE in guiding the transcatheter closure of PVL with shorter procedural and fluoroscopic times. This minimally invasive treatment could provide reliable outcomes in selected patients.Clinical trial registration[www.ClinicalTrials.gov], identifier [NCT02917980].
| S-EPMC9163305 | biostudies-literature
Project description:Paravalvular leakage (PVL) is yet a potential and serious complication after transcatheter aortic valve replacement. Percutaneous PVL closure may be the treatment of choice upon failure of balloon postdilation in patients with excessive surgical risk. If the retrograde approach fails, an antegrade strategy might provide the solution.
| S-EPMC9969761 | biostudies-literature
Project description:BackgroundPostsurgical thoracic aortic pseudoaneurysms (PTAPs) are a potentially lethal complication after cardiac or aortic surgery. Surgical management can pose a challenge with high in-hospital mortality rates. Transcatheter closure is a less-invasive alternative treatment option for selected patients, although current experience is limited.AimsWe aimed to evaluate procedural and imaging outcomes of our first 11 cases of transcatheter PTAP closure with the use of closure devices.MethodsPatients with a high operative risk who underwent transcatheter PTAP closure at our centre from 2019 to 2021 were retrospectively included. Suitability was evaluated on preprocedural computed tomography (CT) scans and three-dimensional (3D) reconstructions. All procedures were performed in the catheterisation laboratory. Intraprocedural aortography and postprocedural CT scans with 3D reconstructions were used to evaluate PTAP occlusion.ResultsEleven consecutive patients with a high operative risk and a history of cardiac/aortic surgery who underwent transcatheter PTAP closure were included. PTAPs were predominantly located at the proximal or distal anastomosis of a supracoronary ascending aortic vascular graft or Bentall prosthesis (82%). Implanted closure devices included Amplatzer Valvular Plug III (82%), Amplatzer septal occluder (9%) and Occlutech atrial septal defect occluder (9%). No periprocedural complications occurred. After device deployment, residual flow was absent on aortography in 64% and minimal residual flow was present in 36% of patients. Subtotal or total occlusion of the PTAP on follow-up CT ranged between 45% and 73%.ConclusionsAlthough subtotal or total occlusion of the PTAP was found at follow-up in only 45-73% of cases, transcatheter PTAP closure guided by preprocedural 3D reconstructions can offer a valuable minimally invasive primary treatment option for patients who otherwise would face a high-risk reoperation.
| S-EPMC10516814 | biostudies-literature
Project description:BACKGROUND:Three-dimensional (3D) models have the unique ability to replicate individualized cardiac anatomy and may therefore provide clinical benefit. Transcatheter aortic valve implantation (TAVI) currently relies on preoperative imaging for accurate valve sizing, type of valve used, and avoidance of complications. Three-dimensional (3D) modelling may provide benefit for optimal preoperative TAVI planning. The goal of this study is to assess the utility of 3D modelling in the prediction of paravalvular leak (PVL) post TAVI. METHODS:Retrospective analysis of five patients who underwent TAVI at our center. Pre-operative cardiac gated CT images were utilized to create a 3D printed model with true size aortic root dimensions, including the coronary artery ostium location and left ventricular outflow tract. Deployment of the corresponding model and size TAVI valve into the created 3D model at a similar depth of implantation via fluoroscopy was performed for each patient. Degree of PVL was assessed using a closed system with water infusion under pressure over a duration of 5 s. Correlation was made between the volume obtained in the closed loop model during the pressurized period and the degree of PVL reported on the patients post TAVI placement on transthoracic echocardiogram. RESULTS:One female, and four males (age in years ranged from 68 to 87) underwent successful TAVI (0% 30-day mortality). PVL on post procedure TTE ranged from none to trivial. Successful deployment of TAVI valves inside the 3D model occurred in all cases. The average volume of water collected on three trials over 5 s ranged between 19.1-24.1?ml A multivariate linear regression showed significant association between the degree of PVL reported on post-operative transthoracic echocardiogram and the amount of volume detected in the 3D model (difference: -3.9657, 95% CI: (-?4.6761,-3.2554), p?<?0.001). CONCLUSIONS:Our experiments show that replicated 3D models have potential clinical utilization in predicting PVL in the TAVI population. Future research into the role of 3D modelling in the field of TAVI should continue to be explored.
| S-EPMC7405457 | biostudies-literature
Project description:BackgroundPercutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to select an appropriate device. We aim to explore the additional value of 3D printing in predicting device related adverse events including mechanical valve leaflet blockade, risk of device embolization and residual shunting.MethodsFrom the FFPP registries (NCT05089136 and NCT05117359), we included 11 transcatheter PVL closure procedures from three centers for which 3D printed models were produced. Cardiac CT was used for segmentation for 3D printed models (3D-heartmodeling, Caissargues, France). Technology used a laser to fuse very fine powders (TPU Thermoplastic polyurethane) into a final part-laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed using a set of occluders.ResultsPVLs were located around aortic prostheses in six cases, mitral prostheses in four cases and tricuspid ring in one case. The device chosen during the simulation on the 3D printed model matched the one implanted in eight cases. In the three other cases, a similar device type was chosen during the procedures but with a different size. A risk of prosthesis leaflet blockade was identified on 3D printed models in four cases. During the procedure, the occluder was removed before release in one case. In another case the device was successfully repositioned and released. In two patients, leaflet impingement was observed post-operatively and surgical device removal had to be performed.ConclusionIn a case-series of complex transcatheter PVL closure procedures, hands-on simulation testing on 3D printed models proved its usefulness to plan and facilitate these challenging procedures.
| S-EPMC9410469 | biostudies-literature
Project description:New interventional techniques have made transcatheter closure of aortic paravalvular leaks a viable therapeutic option to treat the sequelae of these defects, including congestive heart failure and hemolysis. We report the transcatheter closure of an aortic paravalvular leak via a combined retrograde/antegrade approach. This was necessary because of difficulty in crossing the defect with a sheath from the retrograde approach. This technique might be useful in application to other difficult structural heart interventions. To our knowledge, this is the first report of a treated paravalvular leak around a Mitroflow(®) Aortic Pericardial Heart Valve.
| S-EPMC4591883 | biostudies-literature
Project description:BackgroundThe optimal treatment of symptomatic paravalvular leak (PVL) remains controversial between transcatheter closure (TC) and surgery. This large-scale study aimed to retrospectively evaluate the long-term outcomes of the patients who underwent reoperation or TC of PVLs.Methods and resultsA total of 335 (men, 209 [62.4%]; mean age, 58.15±12.77 years) patients who underwent treatment of PVL at 3 tertiary centers between January 2002 and December 2021 were included. Echocardiographic features, procedure details, and in-hospital or long-term outcomes were assessed. The primary end point was defined as the all-cause death during follow-up. The regression models were adjusted by applying the inverse probability weighted approach to reduce treatment selection bias. The initial management strategy was TC in 171 (51%) patients and surgery in 164 (49%) cases. Three hundred cases (89.6%) had mitral PVL, and 35 (10.4%) had aortic PVL. The mean left ventricular ejection fraction was 52.03±10.79%. Technical (78.9 versus 76.2%; P=0.549) and procedural success (73.7 versus 65.2%; P=0.093) were similar between both groups. In both univariate and multivariable logistic regression analysis, the in-hospital mortality rate in the overall population was significantly higher (15.9 versus 4.7%) in the surgery group compared with the TC group (unadjusted odds ratio, 3.13 [95% CI, 1.75-5.88]; P=0.001; and adjusted odds ratio (inverse probability-weighted), 4.55 [95% CI, 2.27-10.0]; P<0.001). However, the long-term mortality rate in the overall population did not differ between the surgery group and the TC group (unadjusted hazard ratio [HR], 0.86 [95% CI, 0.59-1.25]; P=0.435; and adjusted HR (inverse probability-weighted), 1.11 [95% CI, 0.67-1.81]; P=0.679).ConclusionsThe current data suggest that percutaneous closure of PVL was associated with lower early and comparable long-term mortality rates compared with surgery.
| S-EPMC10863827 | biostudies-literature
Project description:Paravalvular regurgitation (PVR) remains one of the drawbacks of transcatheter aortic valve implantation (TAVI). Details of percutaneous closure (PCC) of PVR after TAVI remain obscure. We aimed to explore the patient characteristics, procedural details, closure devices used, and outcomes of PCC after TAVI. A systematic search of the MEDLINE/PubMed and Embase databases from January 2002 to September 2015 was conducted. Reports considered to include same patient were excluded and only the studies with largest cohorts were included. A total of 14 studies including 58 patients (61 cases) were included in the study. A balloon-expandable (BE) valve was used more frequently compared with a self-expandable (SE) valve (72.6% vs 27.4%, respectively). The mean success rate was 86.9% (100% and 77.8%, respectively; P = 0.097). The median number of closure devices used was 1 (range, 1-4) and did not differ between SE and BE valves (P = 0.71). Mean time from index procedure to PCC did not differ between SE and BE valves (295 ± 380 days vs 379 ± 353 days; P = 0.71). Seven patients had history of valve-in-valve and 6 patients had procedural success. Among the patients with available follow-up data (94.8%), there were 15 deaths (27.3%). Percutaneous closure of PVR after TAVI had a high success rate in selected patients in both BE and SE valves. The success rate, timing, and number of closure devices were similar between BE and SE valves. However, prognosis remains fairly poor.
| S-EPMC6490807 | biostudies-literature
Project description:Paravalvular leak (PVL) is an important complication of transcatheter aortic valve implantation (TAVI) and is associated with poor prognosis. We aimed to identify the risk factors for PVL after TAVI including patient (calcium amount or location), device (leakage-proof or not), and procedural (oversizing index (OI)) factors. The primary outcome was mild or greater PVL at 1-month follow-up echocardiography. Overall, 238 patients who underwent TAVI using eight types of valves (Edwards Sapien, Sapien XT, Sapien 3, CoreValve, Evolut R, Evolut PRO, Lotus, and Lotus Edge) were included. The incidence of significant PVL (≥mild PVL) was 24.4%. Although patient factors (calcification of valve) were not predictors of PVL, valve without leakage-proof function (Edwards Sapien, Sapien XT, and CoreValve) was a significant predictor of PVL (adjusted odds ratio, 3.194, 95% CI, 1.620-6.299). Furthermore, OI has a significant protective role against PVL (PVL increased by 45% when OI decreased by 5%). The best cutoff value of OI to predict the absence of PVL was ≥17.6% for the Evolut system and ≥10.2% for the Sapien system. The predictors of PVL after TAVI included factors from the device (valve without leakage-proof function) and procedure (under-sizing). In patients with a high risk of PVL, the procedure should be optimized using valves with leakage-proof function and adequate OI.
| S-EPMC7761987 | biostudies-literature
Project description:Transcatheter aortic valve replacement (TAVR) has emerged as an effective alternative to conventional surgical valve replacement in high-risk patients afflicted by severe aortic stenosis. Despite newer-generation devices enhancements, post-procedural complications such as paravalvular leakage (PVL) and related thromboembolic events have been hindering TAVR expansion into lower-risk patients. Computational methods can be used to build and simulate patient-specific deployment of transcatheter aortic valves (TAVs) and help predict the occurrence and degree of PVL. In this study finite element analysis and computational fluid dynamics were used to investigate the influence of procedural parameters on post-deployment hemodynamics on three retrospective clinical cases affected by PVL. Specifically, TAV implantation depth and balloon inflation volume effects on stent anchorage, degree of paravalvular regurgitation and thrombogenic potential were analyzed for cases in which Edwards SAPIEN and Medtronic CoreValve were employed. CFD results were in good agreement with corresponding echocardiography data measured in patients in terms of the PVL jets locations and overall PVL degree. Furthermore, parametric analyses demonstrated that positioning and balloon over-expansion may have a direct impact on the post-deployment TAVR performance, achieving as high as 47% in PVL volume reduction. While the model predicted very well clinical data, further validation on a larger cohort of patients is needed to verify the level of the model's predictions in various patient-specific conditions. This study demonstrated that rigorous and realistic patient-specific numerical models could potentially serve as a valuable tool to assist physicians in pre-operative TAVR planning and TAV selection to ultimately reduce the risk of clinical complications.
| S-EPMC6476328 | biostudies-literature