Background: Severe pulmonary regurgitation (PR) often occurs following a transannular patch repair of tetralogy of Fallot, resulting in an enlarged native right ventricular outflow tract (nRVOT) with varying shapes. Methods: We conducted a single-center study with eight patients having severe PR and enlarged nRVOT (diameters ≥ 29 mm). Transcatheter pulmonary valve replacement (TPVR) was performed using the self-expanding PT-Valve. Preoperative evaluation included echocardiography, computed tomography, and magnetic resonance imaging. A 3D-printed model of the nRVOT was used for preoperative assessment. Follow-up data were collected in 1-year follow-up. Results: PT-Valve was successfully implanted in all patients, resulting in immediate improvement of severe PR. Pulmonary artery diastolic pressure increased significantly (p < 0.001). No deaths or coronary compression occurred during the procedure. Over a 1-year follow-up, no stent displacement or fracture occurred. Only two patients had trace paravalvular leaks. Magnetic resonance imaging revealed a reversal of right ventricular remodeling, with a significant reduction in right ventricular end-diastolic volume index (p < 0.001) and improved right ventricular ejection fraction (p < 0.001). All patients achieved primary endpoints. Conclusion: 3D printing-guided PT-Valve implantation in enlarged nRVOT for severe PR is safe and effective, expanding TPVR indications and offering potential treatment for a broader patient population.

Background: Transcatheter treatments of tricuspid regurgitation (TR) have been emerging as alternatives for high-risk patients. In contrast to the immobilization of the common transcatheter tricuspid device, using a radial force-independent stent valve device at the native tricuspid annular site has several distinct advantages. Case summary: A 76-year-old patient with renal insufficiency who underwent mechanical mitral valve replacement in 2001 and transcatheter aortic valve replacement in 2021 due to severe aortic stenosis presented with chest pain and shortness of breath. Echocardiography suggested that the flow velocities of the mitral mechanical valve and aortic prosthetic valve were both within the normal range, with no significant paravalvular regurgitation; the tricuspid valve exhibited massive regurgitation (VMAX 258 cm/s, PGMAX 27 mmHg). Due to the high surgical risk, we simulated the procedure with a three-dimensional (3D)-printed model and performed transcatheter tricuspid valve replacement using a LuX-Valve (Ningbo Jenscare Biotechnology Co., Ningbo, China). Discussion: We describe transcatheter tricuspid valve replacement using the LuX-Valve and preprocedural guidance with 3D printing. Postprocedural TR was significantly reduced, indicating that 3D printing plays an important role in preprocedural guidance and that the LuX-Valve was safe and practicable for tricuspid valve replacement.

Background: The impact of aortic arch (AA) morphology on the management of the procedural details and the clinical outcomes of the transfemoral artery (TF)-transcatheter aortic valve replacement (TAVR) has not been evaluated. The goal of this study was to evaluate the AA morphology of patients who had TF-TAVR using an artificial intelligence algorithm and then to evaluate its predictive value for clinical outcomes. Materials and methods: A total of 1480 consecutive patients undergoing TF-TAVR using a new-generation transcatheter heart valve at 12 institutes were included in this retrospective study. The AA measurements were evaluated by deep learning, and then the approach index (I_A) was determined. The machine learning algorithm was used to construct the predictive model and was validated externally. Results: The area under the curve of the I_A model using random forest and logistic regression was 0.675 [95% confidence interval (CI): 0.586–0.764] and 0.757 (95% CI: 0.665–0.849), respectively. The I_A model was validated externally, and consistent distinctions were obtained. After we used a generalized propensity score matching method for continuous exposure, the I_A was the strongest correlation factor for major procedural events (odds ratio: 3.87; 95% CI: 2.13–7.59, P < 0.001). When leaflet morphology or transcatheter heart valve type was an interactive item with I_A, neither of them was statistically significant in terms of clinical outcomes. Conclusion: I_A may be used to identify the impact of AA morphology on procedural and clinical outcomes in patients having TF-TAVR and to help to predict the procedural complications.

Background: Transcatheter mitral valve-in-ring replacement (TMViR) is an emerging alternative for patients with recurrent mitral regurgitation (MR) after a prior failed annuloplasty ring. However, intraoperative common issues and complications remain to be addressed. Case summary: We describe the case of a 67-year-old male patient who underwent surgical mitral concomitant tricuspid annuloplasty repair 7 years ago who developed recurrent severe MR (New York Heart Association functional class IV). To avoid a high-risk surgical reoperation, we chose to perform a TMViR using an innovative dedicated device—the Mi-thos system—via a transapical approach. A patient-specific, 3-dimensional printed model was used to guide the procedure to avoid potential challenges. The procedure was performed successfully, and the patient exhibited symptomatic improvement. Conclusions: This case report highlights the first use of the innovative Mi-thos system in a TMViR procedure. The findings demonstrate the feasibility and safety of utilizing the Mi-thos system, guided by 3-dimensional printing technology, for patients who have experienced recurrent mitral regurgitation MR following a failed annuloplasty ring.

Background: Transcatheter aortic valve replacement (TAVR) using the J-Valve system provides a solution for patients with aortic regurgitation (AR). However, it remains unclear whether its coaxiality performance is related to procedural complications. Aim: Our goal was to improve the efficacy and accuracy of TAVR in patients with AR by adjusting J-Valve coaxiality using three-dimensional printing (3DP). Methods: This multicenter, prospective study included 612 patients with AR who underwent transapical TAVR. Of these, 228 patients were assigned to the 3DP group, in which the insertion angle and implantation depth were pre-determined. The coaxiality index was calculated using the distances from the bottom of the bioprosthesis to the base of the three cusps. Results: Compared to the non-3DP group, the 3DP group demonstrated better coaxiality performance (coaxiality index: 3.4 ± 1.7 vs. 4.0 ± 2.1; coaxiality angle: 10.5 ± 3.7° vs. 12 ± 4.2°; both p<0.001). Post-operative coaxiality index showed a strong correlation with the coaxiality angle (correlation coefficients: 0.85 in the 3DP group and 0.88 in the non-3DP group). The procedural success rate was higher in the 3DP group (100% vs. 96.4%; p=0.008). Paravalvular leakage (PVL) occurred less frequently in the 3DP group (mild PVL: 3.51% vs. 18.2%; p<0.001; moderate PVL: 0% vs. 1.04%; p<0.001). Multivariable analysis identified the coaxiality index, coaxiality angle, and horizocardia as independent predictors of PVL. Conclusion: PVL incidence after TAVR can be reduced through pre-operative simulations that adjust coaxiality using 3DP. Relevance for patients: The high incidence of PVL in transapical TAVR with the J-Valve is associated with coaxiality after bioprosthesis implantation. This study suggests that adjusting coaxiality using pre-procedural 3DP simulations may effectively reduce PVL incidence and other procedural complications during transapical TAVR. In the future, randomized clinical trials will be needed to evaluate the efficacy and accuracy of pre-procedural 3DP simulations and the coaxiality index in treating patients with pure AR undergoing transapical TAVR.