Early results of Pulsta® transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch

Ödemiş, Ender; Yenidoğan, İrem; Kizilkaya, Mete Han

doi:10.1017/s1047951122003511

Cited by 3 publications

(5 citation statements)

References 32 publications

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“…Similarly, the Harmony valve (Medtronic, Inc.) has also obtained FDA approval [10]. Other valves, such as the Pulsta valve (Tae Woong Medical Co, Gyeonggi-do, South Korea), are still undergoing clinical trials [25,26]. These new devices have the potential to expand the eligibility criteria for TPVR to include patients with an nRVOT width of up to 34 mm.…”

Section: Discussionmentioning

confidence: 99%

“…After the procedure, the right heart catheterization parameters showed no significant change in PA systolic pressure [from 35.5 (32, 36) mmHg to 37 (35, 38) mmHg, p = 0.762], but the PA diastolic pressure increased from 3.5 (3,6) mmHg to 10 (8, 11) mmHg (p < 0.001). The peak transpulmonary valve gradient was decreased from 28.5 (26,33) mmHg to 8.5 (7, 10) mmHg (p< 0.001) after the deployed device was viewed by TEE. Following the procedure, right heart catheterization parameters showed no significant change in PA systolic pressure [from 35.5 (32, 36) mmHg to 37 (35, 38) mmHg, p = 0.654].…”

Section: Perioperative and In-hospital Outcomesmentioning

confidence: 92%

“…Each patient received a single device. The mean procedure time was 61.8 min (range: 52-71), and the mean fluoroscopy time was 19 min (range: [14][15][16][17][18][19][20][21][22][23][24][25][26]. No instances of device malposition, coronary compression, or reduced flow to the PA branches were observed during the procedures.…”

Section: Perioperative and In-hospital Outcomesmentioning

confidence: 99%

“…MRI findings revealed a reversal of right ventricular remodeling, characterized by a significant reduction in the RVEDVI [from 164 (156, 176) mL/m 2 at baseline to 119 (107,148) mL/m 2 at the 1-year follow-up, respectively (p < 0.001)]. Consequently, there was an improvement in the right ventricular ejection fraction [from 22.5 (19,26)% at baseline to 33 (31, 39)% at the 1-year follow-up, respectively (p < 0.001)], indicative of enhanced right ventricular function. Furthermore, there were continuous improvements in NYHA class, peak O 2 levels, and 6-Minute Walk Test distances following the TPVR procedure, suggesting an enhancement in exercise capacity and overall quality of life (Figure 6).…”

Section: One-year Follow-up Datamentioning

confidence: 99%

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Treatment of Severe Pulmonary Regurgitation in Enlarged Native Right Ventricular Outflow Tracts: Transcatheter Pulmonary Valve Replacement with Three-Dimensional Printing Guidance

Wang,

Jin,

Meng

et al. 2023

Bioengineering

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Perioperative and In-hospital Outcomesmentioning

confidence: 92%

Section: Perioperative and In-hospital Outcomesmentioning

confidence: 99%

Section: One-year Follow-up Datamentioning

confidence: 99%

See 2 more Smart Citations

Treatment of Severe Pulmonary Regurgitation in Enlarged Native Right Ventricular Outflow Tracts: Transcatheter Pulmonary Valve Replacement with Three-Dimensional Printing Guidance

Wang,

Jin,

Meng

et al. 2023

Bioengineering

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“…On the other hand, RVOT is typically enlarged with various anatomies, and only a small number of patients with native RVOT are suitable for PPVI, especially when balloon expandible valves are to be used ( 10 ). The self-expandible new-generation pulmonary valve Pulsta THV® (Tae Woong Medical Co, South Korea) has been successfully used in patients with native RVOT and different anatomies ( 11 , 12 ).…”

Section: Introductionmentioning

confidence: 99%

Optimizing percutaneous pulmonary valve implantation with patient-specific 3D-printed pulmonary artery models and hemodynamic assessment

Odemis,

AKA,

Ali

et al. 2024

Front. Cardiovasc. Med.

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BackgroundPercutaneous pulmonary valve implantation (PPVI) has emerged as a less invasive alternative for treating severe pulmonary regurgitation after tetralogy of Fallot (TOF) repair in patients with a native right ventricular outflow tract (RVOT). However, the success of PPVI depends on precise patient-specific valve sizing, the avoidance of oversizing complications, and optimal valve performance. In recent years, innovative adaptations of commercially available cardiovascular mock loops have been used to test conduits in the pulmonary position. These models are instrumental in facilitating accurate pulmonic valve sizing, mitigating the risk of oversizing, and providing insight into the valve performance before implantation. This study explored the utilization of custom-modified mock loops to implant patient-specific 3D-printed pulmonary artery geometries, thereby advancing PPVI planning and execution.Material and MethodsPatient-specific 3D-printed pulmonary artery geometries of five patients who underwent PPVI using Pulsta transcatheter heart valve (THV) ® were tested in a modified ViVitro pulse duplicator system®. Various valve sizes were subjected to 10 cycles of testing at different cardiac output levels. The transpulmonary systolic and regurgitation fractions of the valves were also recorded and compared.ResultsA total of 39 experiments were conducted using five different patient geometries and several different valve sizes (26, 28, 30, and 32 mm) at 3, 4, and 5 L/min cardiac output at heart rates of 70 beats per minute (bpm) and 60/40 systolic/diastolic ratios. The pressure gradients and regurgitation fractions of the tested valve sizes in the models were found to be similar to the pressure gradients and regurgitation fractions of valves used in real procedures. However, in two patients, different valve sizes showed better hemodynamic values than the actual implanted valves.DiscussionThe use of 3D printing technology, electromagnetic flow meters, and the custom-modified ViVitro pulse duplicator system® in conjunction with patient-specific pulmonary artery models has enabled a comprehensive assessment of percutaneous pulmonic valve implantation performance. This approach allows for accurate valve sizing, minimization of oversizing risks, and valuable insights into hemodynamic behavior before implantation. The data obtained from this experimental setup will contribute to advancing PPVI procedures and offer potential benefits in improving patient outcomes and safety.

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