Transcatheter aortic valve implantation in a patient with isolated aortic regurgitation using JenaValve

Abstract

This case report details the successful use of JenaValve for transcatheter aortic valve implantation in a male patient in his early 50s with severe aortic regurgitation. The patient had multiple comorbidities, including chronic kidney disease and heart failure, increasing the risk of surgical intervention. JenaValve, a second-generation device with unique positioning and anchoring mechanisms, was deployed successfully, resulting in immediate improvements in cardiac function without significant regurgitation or paravalvular leakage. This case highlights the potential of transcatheter aortic valve implantation as a viable alternative to surgical aortic valve replacement in patients with severe aortic regurgitation, emphasizing the importance of technological advancements and a multidisciplinary approach in managing complex cardiovascular cases. Long-term follow-up is essential to assess the durability of the implanted valve and the patient’s overall prognosis.

Introduction

Transcatheter aortic valve implantation (TAVI) has emerged as a standard treatment for patients with severe symptomatic aortic stenosis who are at high or prohibitive surgical risk. ¹ Recent randomized controlled trials have demonstrated that the early outcomes of TAVI in intermediate-risk patients are not only noninferior but also potentially superior to those of surgical aortic valve replacement (SAVR). ² As technology and surgical techniques continue to improve, the indications for TAVI are expanding to include conditions such as predominant aortic regurgitation (AR), degenerated bioprosthetic valves, and bicuspid aortic valves. ³ However, data on the use of TAVI in treating predominant AR remain limited. A few previous studies have shown the feasibility and promising early outcomes of this technology using various devices, but midterm outcomes have not yet been reported. ⁴

For the majority of devices, addressing AR is marked by a lack of calcification, and relatively larger annuli present a technological hurdle due to uncertain anchoring, leading to frequent valve migration and paravalvular leakage (PVL). The experience with the use of first-generation transcatheter valves in treating AR has been generally unsatisfactory. In recent years, second-generation transcatheter valves, which feature specific positioning and anchoring mechanisms, have emerged as promising alternatives. TAVI—using devices such as JenaValve (J-Valve; JenaValve Technology, Munich, Germany) and Engager valve (Medtronic, Minneapolis, United States)—has shown encouraging results in treating pure AR. However, the clinical experience with these devices remains limited. ⁵

Case report

A male patient in his early 50s was admitted to the Chengdu Second People’s Hospital, Sichuan, China, due to positive urinary protein for 7 years, fatigue and shortness of breath for 1 month, and worsening symptoms over the past 7 h. Upon admission, the patient appeared chronically ill, was in a semi-reclining position, and exhibited slightly decreased breath sounds in both lungs, with a few moist rales heard in the right lower lung. The heart rhythm was regular, the abdomen was soft without tenderness, and there was edema in both lower limbs.

Diagnosis and treatment

Upon admission, the patient underwent extensive testing. Blood tests revealed the following results: hemoglobin level, 104 g/L; platelet count, 162 × 10⁹/L; white blood cell count, 6.55 × 10⁹/L; aspartate aminotransferase level, 7 U/L; total protein level, 58.8 g/L; albumin level, 32.4 g/L; magnesium level, 1.19 mmol/L; phosphate level, 1.90 mmol/L; bicarbonate level, 21.5 mmol/L; apolipoprotein B level, 0.41 g/L; A1/B ratio, 3.22; iron saturation, 8.16%; ferritin level, 55.40 ng/mL; parathyroid hormone level, 200.00 pg/mL; high-sensitivity C-reactive protein level, 6.5 mg/L; and and procalcitonin level, 0.123 ng/mL. Hepatitis B markers showed positive surface antibody and core antibody. Folate and vitamin B12 levels were 1097 pg/mL and >20.00 ng/mL, respectively. Coagulation tests indicated a prothrombin time of 12.9 s, prothrombin activity of 69%, and antithrombin III (AtIII) level of 65%. Brain natriuretic peptide (BNP) pro-BNP level was >35,000 pg/mL. Cardiac markers included a myoglobin level of 159 ng/mL and high-sensitivity troponin T (hsTNT) level of 54.700 ng/L. Hormone assessment showed an aldosterone (supine) level of 37.60 ng/dL and renin (supine) level of <0.50 µIU/mL. Antinuclear antibodies, vasculitis antibodies (including anti-glomerular basement membrane (GBM)), blood immunofixation electrophoresis, and fecal occult blood were negative. Ultrasound showed bilateral kidney shrinkage with altered echoes, a left renal cyst with calcification, poor renal artery blood flow, and bilateral pleural effusion. The Society of Thoracic Surgeons score was calculated, which indicated that the patient was at high risk.

Echocardiography (ECG) showed severe aortic valve insufficiency, enlarged left atrium and ventricle, thickened interventricular septum, dilated aorta and pulmonary artery, mild mitral regurgitation, small pericardial effusion, normal systolic function, and reduced diastolic function. Preoperative upper limb ultrasound showed no abnormalities in the arteriovenous fistula. Abdominal ultrasound revealed a gallbladder wall lesion, bilateral renal parenchymal echoes, a left renal cyst with calcification, and pleural effusion. ECG showed sinus rhythm and a prolonged QT interval. Chest computed tomography (CT) revealed lung nodules, pulmonary edema, pleural effusion, widened aorta and pulmonary artery, pericardial effusion, and an enlarged mediastinal nodule. Abdomen and pelvis CT showed adrenal nodules, reduced kidney volume, cysts, peritoneal effusion, enlarged prostate, cholecystitis, and rectal wall thickening. The patient experienced acute heart failure, had a poor response to diuresis, and was treated with nesiritide, Omacor, sacubitril/valsartan, nifedipine, terazosin, and metoprolol. Surgical consultation ruled out emergency surgery for adrenal hyperplasia and gallstones. The patient chose hemodialysis for renal replacement therapy.

On 24 March 2025, the patient underwent left forearm autogenous arteriovenous fistula formation. Given the patient’s severe aortic valve insufficiency and the presence of surgical indications, the patient requested surgical intervention and was subsequently transferred to the cardiothoracic department for further treatment. On 31 March 2025, the computed tomography angiography (CTA) report prior to TAVI surgery revealed the following findings.

Multifocal calcified and mixed plaques were detected in the coronary arteries, including the right coronary artery, left anterior descending artery, and first obtuse marginal branch. The distal right coronary artery had moderate stenosis, whereas other segments had mild stenosis. The coronary arteries had a normal origin and were right dominant. The first obtuse marginal branch was intramyocardial, superficial type, with a mural length of 2.3 cm, indicating a myocardial bridge. Similar plaques were also found in the left vertebral artery, innominate artery, aortic arch, descending aorta, abdominal aorta, left external iliac artery, bilateral internal iliac arteries, and origin of the inferior mesenteric artery. The left internal iliac artery had moderate stenosis, whereas other areas had mild stenosis. Chronic infection foci and small nodules (largest size: 0.6 cm) were present in both lungs, with calcified foci in the right upper lobe and right pulmonary artery dilation. Cardiac enlargement was noted, with the ascending aorta dilated to 4.4 cm and the pulmonary artery trunk to 4.0 cm (Figure 1). Bilateral pleural effusion was present. The left kidney had several cystic nodules (largest size: 2.3 cm). Perihepatic and right lower abdominal effusion, prostate enlargement, gallbladder stones, and rectal wall thickening were observed. A high-density patchy shadow in the left iliac bone required further evaluation.

Figure 1.

The average diameter of the left ventricular outflow tract (LVOT) is 23.0 mm; the average diameter of the ascending aorta is 47.7 mm.

Coronary angiography revealed mild stenosis in the middle segment of the anterior descending branch, with no calcification or stenosis observed in the circumflex and right coronary arteries. On 10 April 2025, a full hospital discussion was conducted, and the relevant discussion results were communicated to the patient’s family. The patient’s preoperative examinations were completed, with no obvious surgical contraindications identified. The patient’s family has requested surgery. On 11 April 2025, under general anesthesia, an “apical aortic valve replacement” was successfully performed.

During the surgery, under general anesthesia, a 3-cm incision was made along the left midclavicular line at the fifth intercostal space. The pericardium was gradually dissected, and an incision was made at the left ventricular apex to further expose the apex through suspension sutures. A vertical mattress suture was placed in the avascular area of the left ventricular surface, and a catheter was inserted into the left femoral artery. After heparin activation, the left ventricle was punctured, and the interventional device was introduced. The positioning component was released, and its angle was adjusted to smoothly enter the sinus. Following angiographic assessment, the J-Valve was deployed (Figure 2). Immediate angiography showed that the artificial valve had a stable shape and good position, with no significant regurgitation or PVL, and the bilateral coronary arteries were well-visualized (Figure 3). ECG was repeated, showing that the artificial valve at the aortic valve position was clearly visible, with normal position and opening amplitude, and no echo loss was noted between the valve frame and cardiac tissue. During the systole, the forward blood flow velocity and transvalvular pressure gradient of the artificial valve at the aortic valve position were normal, and no significant abnormal regurgitation signal was noted around the valve during diastole (Figure 4). The catheter was removed, and the incision was sutured, with a temporary pacemaker and drainage tube left in place. The surgery was completed smoothly, and the patient was safely returned to the intensive care unit (ICU) for continued treatment.

Figure 2.

During the surgery, the recommended use of angiography angles is as follows: left anterior oblique (LAO) at 1° and caudal (cranial) at 7°.

Figure 3.

(a) Preoperative aortic root angiography and (b) valve release.

Figure 4.

(a) Preoperative ultrasound and (b) postoperative ultrasound follow-up.

The patient received critical care and was subjected to electrocardiogram monitoring; blood oxygen saturation monitoring, with hourly urine output recorded; and continuous monitoring of central venous pressure (CVP) and arterial blood pressure (ABP). Dry and wet rales were heard in both lungs, and the patient was administered ipratropium bromide and budesonide (previous first-line drugs were ineffective) as anti-inflammatory treatment for nebulization to relieve spasm as well as esomeprazole for acid suppression and gastric protection. Infection prevention, expectoration, and other treatments were provided. Sacubitril/valsartan, nifedipine controlled-release tablets, and terazosin were used to control blood pressure, and warfarin was administered for anticoagulation and other symptomatic treatments. On 16 May 2025, high-resolution thin-layer CT of the chest revealed the following findings: (a) multiple small and tiny lung nodules showed little change since 24 April 2025; (b) the previous right lower lobe consolidation was resolved, and new linear shadows had appeared in the left lung; (c) bilateral pleural effusion decreased; (d) dilation and calcification of the aorta and pulmonary artery were observed, with a small amount of pericardial effusion; (e) enlargement of a low-density mass in front of the heart, which was considered a localized effusion/blood; and (f) the anterior mediastinal nodule slightly decreased in size, with follow-up recommended. Postoperative findings from apical aortic valve replacement include catheter shadows in the anterior pericardial space and left pleural cavity.

On 16 May 2025, left ventricular function measurement showed normal function of the artificial biological valve after apical aortic valve replacement. Enlargement of the left atrium and left ventricle, thickening of the interventricular septum at the base, slightly reduced contraction activity at the left ventricular apex, significant dilation of the aorta, dilation of the pulmonary artery, mild mitral regurgitation, trace pericardial effusion, normal left ventricular systolic function, and reduced left ventricular diastolic function were observed. The nature of the liquid dark area in front of the heart remained unknown (please refer to other imaging studies). The patient’s current condition is satisfactory, with the pericardial drainage tube having been removed. After examination by the Chief Physician, the patient was discharged. The 1-month follow-up assessment showed that the patient’s symptoms had resolved, echocardiogram findings were normal, and pro-BNP levels had returned to normal. The reporting of this study conforms to the Case Report (CARE) guidelines. ⁶

Discussion

Since its introduction into clinical practice in 2002, TAVI has emerged as a valuable alternative treatment for patients with symptomatic severe aortic stenosis who are deemed to be at high or prohibitive risk for SAVR. ⁷ This case highlights the evolving role of TAVI in treating severe AR, a condition traditionally managed with SAVR. The patient’s successful outcome underscores the potential of TAVI as a viable alternative, especially for those with comorbidities that increase surgical risk. Recent long-term studies have demonstrated that both balloon-expandable and self-expandable prostheses are superior to medical treatment for inoperable patients with aortic stenosis. ⁸ Additionally, evidence has shown that TAVI is not inferior to SAVR in terms of safety or efficacy in patients at high surgical risk. ⁹ The current American College of Cardiology/American Heart Association guidelines include a class I recommendation for TAVI in patients deemed at prohibitive or high risk for SAVR. ¹⁰ The indications for TAVI are expanding. Among these, the treatment of predominant AR remains controversial and challenging. ¹¹ The off-label use of TAVI for the treatment of AR without calcification has been reported with multiple devices. ¹²

Despite the limited experience with TAVI for AR, several previous studies have reported the off-label use of TAVI for noncalcified pure AR, utilizing a wide range of devices. ¹³ AR poses unique challenges due to the lack of calcification and larger annuli, which can complicate valve anchoring. The use of the J-Valve, with its specific positioning and anchoring mechanisms, addresses these challenges, demonstrating the importance of technological advancements in expanding TAVI indications.

The procedures and early outcomes in these studies exhibited significant variation. Given the anatomical distinctions between aortic stenosis and regurgitation, first-generation devices, which are designed specifically for severe calcified stenotic valves, encountered substantial challenges when treating noncalcified pure AR. The absence of calcified orifices, along with dilated root and annulus, led to a high incidence of valve migration, the need for second valve implantation, and PVL of more than moderate degree in early studies. The most crucial modification in second-generation devices is the introduction of a self-positioning clasper or feeler. ¹⁴ This innovative design enables precise positioning of the prosthesis and enhances anchoring power, thereby addressing the technical difficulties associated with treating AR. Consequently, the outcomes of second-generation devices have shown marked improvement. ¹⁵ The J-Valve is one such second-generation device, distinguished by its unique movable connection between the clasper and the frame (Figure 1).

The J-Valve system, developed by Jie Cheng Medical Technology Co., Ltd. in Suzhou, China, represents a significant advancement in transcatheter heart valve technology. As a second-generation self-expanding device, it features a unique two-piece structure comprising a three-prong clasper and a support frame, connected by three stitches (Figure 1). This innovative design facilitates a distinctive two-stage implantation process, which has been shown to be a feasible approach for treating AR. Previous studies have reported encouraging early outcomes, highlighting the potential benefits of this approach (Figure 2). ¹⁶

Although the feasibility of other commercially available TAVI devices, such as Edwards Sapien and Medtronic Core Valve, has been verified through evidence-based approaches, these classic devices still have some limitations. ¹⁷ For example, valve positioning is highly technical, and it cannot be repositioned during the deployment process. Specifically, valve positioning entirely depends on angiogram or echocardiogram images, and ensuring the optimal alignment between the prosthetic valve and the aortic annulus plane is crucial. Moreover, the fixation of the valve prosthesis to the native aortic annulus entirely relies on radial expansion force. Significant oversizing of the valve prosthesis or the use of a high-profile valve stent may subsequently lead to conduction block or even annular rupture. In addition, these devices are associated with a relatively high risk for postoperative PVL, which endangers the long-term outcome. Finally, they are not suitable for pure or dominant AR without obvious annular or leaflet calcification due to insufficient anchoring. These disadvantages highlight the urgent need for new TAVI devices. ¹⁸

The patient’s complex medical history, including chronic kidney disease, heart failure, and multiple comorbidities, illustrates the need for a multidisciplinary approach. The decision to proceed with TAVI was influenced by the patient’s overall condition and the presence of surgical indications. The successful management of his comorbidities, such as renal anemia and hypertension, was crucial for optimizing his preoperative status. The immediate postoperative ECG and CT findings indicated normal function of the implanted valve, with no significant regurgitation or PVL. This suggests that TAVI can effectively restore hemodynamic stability and improve cardiac function in patients with severe AR. The success of this case supports the ongoing expansion of TAVI indications to include predominant AR. As technology continues to improve, it is likely that TAVI will become an increasingly viable option for a broader range of patients with valvular heart disease. Although the immediate outcomes are promising, long-term follow-up is essential to assess the durability of the implanted valve and the patient’s overall prognosis. This case underscores the need for continued monitoring and research to fully understand the long-term benefits and potential complications of TAVI in treating AR.

Conclusion

This case report demonstrates the feasibility and potential benefits of TAVI using the J-Valve in a patient with severe AR. The successful outcome highlights the importance of technological advancements and a multidisciplinary approach in managing complex cardiovascular cases. Future research and clinical practice should focus on further refining TAVI techniques and expanding their indications to improve outcomes for patients with valvular heart disease.

Supplemental Material

sj-pdf-1-imr-10.1177_03000605251369848 - Supplemental material for Transcatheter aortic valve implantation in a patient with isolated aortic regurgitation using JenaValve

Supplemental material, sj-pdf-1-imr-10.1177_03000605251369848 for Transcatheter aortic valve implantation in a patient with isolated aortic regurgitation using JenaValve by Lina Xia, Wei Peng, Li Chen and Li Li in Journal of International Medical Research