ORIGINAL ARTICLE Year : 2022  |  Volume : 11  |  Issue : 1  |  Page : 13-19

First 10 transcatheter pulmonary valve-in-valve procedures in rajaie cardiovascular medical and research center

Seifollah Abdi1, Ata Firouzi1, Mohammad Javad Alemzadeh-Ansari1, Zahra Hosseini1, Azin Alizadehasl2, Zahra Khajali3, Sedigheh Saedi3, Nima Salehi4, Bahareh Mohajer Koohestani4, Ehsan Khalilipur1
1 Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
2 Cardio-Oncology Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
3 Department of Adult Congenital Heart Disease, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
4 Rajaie Cardiovascular Medical and Research Center, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

Date of Submission16-Dec-2021Date of Decision07-Jan-2022Date of Acceptance17-Jan-2022Date of Web Publication29-Mar-2022

Correspondence Address:
Dr. Ehsan Khalilipur
Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran
Iran

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/rcm.rcm_67_21

Background: Transcatheter pulmonary valves (TPVs) are feasible and much less invasive options for surgical right ventricular outflow tract (RVOT) repair or valve replacement in patients with degeneration of the pulmonary valve bioprosthesis or RVOT conduit failure. In 2005, the first Sapien valve was implanted in the pulmonic position, and proceeding In March 2016, the Food and Drug Administration approved the SAPIEN valve (Edwards Lifesciences) for use in malfunctioning RVOT conduits. Material and method: We describe the first ten cases of TPV-in-valve procedure conducted in our center, along with the patients' prior surgical history, procedural details, and their clinical and echocardiographic data. Result and conclusion: Our data provided safety and efficacy of transcatheter valve-in-valve procedure in degenerated pulmonary bioprotheses and our follow-up proved durability of this procedure.

Keywords: Bioprosthetic degeneration, Edwards Sapien XT/S3, transcatheter valve-in-valve

How to cite this article:
Abdi S, Firouzi A, Alemzadeh-Ansari MJ, Hosseini Z, Alizadehasl A, Khajali Z, Saedi S, Salehi N, Koohestani BM, Khalilipur E. First 10 transcatheter pulmonary valve-in-valve procedures in rajaie cardiovascular medical and research center. Res Cardiovasc Med 2022;11:13-9
How to cite this URL:
Abdi S, Firouzi A, Alemzadeh-Ansari MJ, Hosseini Z, Alizadehasl A, Khajali Z, Saedi S, Salehi N, Koohestani BM, Khalilipur E. First 10 transcatheter pulmonary valve-in-valve procedures in rajaie cardiovascular medical and research center. Res Cardiovasc Med [serial online] 2022 [cited 2022 Mar 29];11:13-9. Available from: https://www.rcvmonline.com/text.asp?2022/11/1/13/341268   Introduction 

Infants born with obstruction of the right ventricular tract have an estimated incidence of 1.6 per 1000 live births. Patients born with tetralogy of Fallot, pulmonary atresia, or truncus arteriosus typically require surgical placement of a conduit or bioprosthetic valve (BPV) in the right ventricular outflow tract. Over time, the reconstructed right ventricular outflow tract (RVOT) may become dysfunctional and develop stenosis or regurgitation, resulting in right ventricular dilatation, arrhythmias, and poor function. Thus, patients with RVOT conduits or BPVs frequently require multiple surgeries to replace the failing valve during their lifetime. Each surgical procedure necessitates another sternotomy and cardiopulmonary bypass. Transcatheter pulmonary valve replacement (TPVR) has emerged as a viable and significantly less invasive alternative to surgical RVOT repair or valve replacement (PVR). Transcatheter pulmonary valves (TPVs) are inserted through the femoral vein, and patients are frequently hospitalized for 1 day following the procedure. The use of TPVR enables a patient's future cardiac surgeries to be delayed or reduced.[1],[2]

Persistent pulmonary valve regurgitation results in right ventricular dilation and, ultimately, dysfunction. Tricuspid regurgitation occurs as the tricuspid valve annulus dilates. Arrhythmias of the atrium and ventricles can occur, resulting in right ventricular systolic dysfunction.[3]

Based on the success in valve replacements in an ovine model, Bonhoeffer et al. performed the first human TPV implantation in 2000 in a 12-year-old boy with a history of pulmonary atresia and ventricular septal defect who had undergone a repair with the closure of a ventricular septal defect and placement of an RVOT conduit at 4 years of age.[4]

The first implantation of a Sapien valve in the pulmonic position was performed in 2005 in a 16-year-old patient with a 24-mm homograft conduit with conduit insufficiency. The Food and Drug Administration (FDA) approved the SAPIEN XT (Edwards Lifesciences) in March 2016 for use in dysfunctional RVOT conduits. The SAPIEN XT is composed of a trileaflet bovine pericardial valve enclosed in a cobalt-chromium frame. It was originally intended for use in the aortic position. The SAPIEN XT valve has heights ranging from 14.3 mm for the 23-mm valve to 19.1 mm for the 29-mm valve. The S3 is a trileaflet bovine pericardial valve sewn into a cobalt-chromium stent, similar to the XT. The S3, on the other hand, features an additional polyethylene terephthalate skirt designed to reduce the incidence of paravalvular leaks in the aortic position. The Commander delivery system is used to deliver the valve, as it has a lower profile and is less rigid than the NovaFlex delivery system dedicated for the Sapien XT valve. The S3's valve height is slightly higher than that of the XT, ranging from 15.5 mm for the 20-mm valve to 22.5 mm for the 29-mm valve. The FDA approved the SAPIEN 3 (Edwards Lifesciences) to use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional RVOT conduit or surgical BPV in the pulmonic position with ≥ moderate regurgitation and/or a mean RVOT gradient of ≥35 mmHg.[5]

In this manuscript, we want to share our initial experience with pulmonary transcatheter valve replacement in the prior degenerated pulmonary BPV or failed RVOT conduit in Rajaie Cardiovascular Medical and Research Center.

  Methods 

Design of the study and patient selection

This is a retrospective study of single-center pulmonary valve implantation, and the purpose of this paper is to describe the procedural outcomes of patients who received the Sapien XT/S3 transcatheter valve in the pulmonic position in adults with congenital heart disease who had previously received a conduit or pulmonary BPV that had failed. Implantation of a Sapien XT/S3 valve was deemed possible if a balloon test revealed a waist large enough to firmly anchor the valve or if preprocedural echocardiography or computed tomography (CT) angiography demonstrated its feasibility. [Table 1] summarizes all indications and contraindications for transcatheter pulmonary valve replacement.[6]

Table 1: Indications and contraindications for transcatheter pulmonary valve in valve

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All patients provided written informed consent for the procedure, and the Local Ethics Committee approved the data collection.

Endpoints

Successful implantation of the Sapien XT or Sapien 3 was defined as proper positioning of the transcatheter valve in the appropriate anatomic location, the valve performing as intended with a peak-to-peak gradient between RV and PA of <20 mmHg, and the absence of significant valve regurgitation or paravalvular leakage as determined by angiography and intraprocedural transesophageal echocardiography. Additionally, we reviewed the patient's congenital heart disease, past surgery, and pre-, intra-, and postoperative transthoracic or transesophageal echocardiography. All patients were followed for at least 6 months to record echocardiographic data to detect clinical worsening or valve malfunction early.

Steps in the procedure

Transcatheter approaches are generally reserved for patients who have a bioprosthetic pulmonary valve with a diameter of at least 18 mm or a right ventricle (RV)-to-pulmonary artery conduit with a diameter larger than 16 mm. At the moment, however, patients with corrected tetralogy of Fallot and a patched/native right ventricular outflow tract are not candidates due to the RVOT and MPA diameters frequently exceeding the maximum diameter achievable safely with currently available devices. Following hemodynamic assessment and angiography of the RV and pulmonary arteries, a contrast agent was injected concurrently into the aortic root for coronary testing and through the RVOT's long sheath for RVOT testing. Coronary compression is a significant risk when considering any sort of TPV implantation, and if not diagnosed before valve implantation, it can have a potentially disastrous effect. It occurs at a rate of up to 5% during the inflating of test balloons.[7]

If the desired landing zone did not exist in patients who had previously received an RVOT conduit, the RVOT was stented with a CP stent to deploy the Sapien valve within the stent frame. We employed an inflated balloon to size certain patients with prior RVOT conduits, and the existence of a waist and a sealed RVOT generated by the inflated sizing balloon were the major requirements for implantation of a Sapien valve without a prestent. The Sapien valve was selected based on the size of the previous valve, the waist diameter measured during CT angiography, cardiac magnetic resonance imaging, or preprocedural echocardiography for the previous bioprosthesis or RVOT conduit. In general, the next larger Sapien valve available was chosen depending on the waist diameter measurement.

  Results 

We report on the first 10 patients at Shaheed Rajaie Cardiovascular Medical and Research Center who had a pulmonary valve in valve procedure. The average age of the patients was 28 ± 10.07 years, and the majority were female (6 patients). Nine individuals were diagnosed with tetralogy of Fallot throughout their childhood, while one patient was identified with pulmonary stenosis and an atrial septal defect in childhood and required surgical repair. All patients received surgical pulmonary valve replacement with a BPV after their primary corrective surgery failure, and all patients presented to our center due to BPV failure. The clinical and surgical histories of the patients are presented in [Table 2].

Half of the patients had normal LV size and preserved LVEF at presentation, whereas the other half had mild LV enlargement and mild systolic dysfunction. Three patients had a severe enlargement of the RV, four patients had a moderate-to-severe enlargement, and the other three patients had a moderate enlargement of the RV. Three patients had severe impairments of RV function, whereas five patients had at least moderate impairments. The mean peak PV bioprosthetic gradient was 46.9 ± 16.55 mmHg, and at least moderate pulmonary bioprosthetic regurgitation occurred in seven patients. Five patients had significant RA enlargement. [Table 3] summarizes further echocardiographic data obtained before the procedure.

The treatment was successful in all patients, and Edwards Sapien XT was implanted in six patients, while Edwards Sapien 3 was implanted in four patients. Three patients had a valve size of 23, while the remaining seven received a valve size of 26. In three patients, we required the placement of a non-Covered CP stent in the RVOT before valve implantation but did not require postdilation following valve implantation [Table 4]. The mean peak gradient of the postprocedural implanted valve was 14.3 ± 6.22 mmHg, and one patient had mild-to-moderate paravalvular regurgitation, while two patients had mild paravalvular regurgitation.

All patients were evaluated by transthoracic echocardiography on the day of the procedure, 1 month later, and then every 6 months thereafter to rule out any valvular malfunction. The mean duration of follow-up was 17.3 ± 11.45 months, and there was no significant decline in LV and RV size or function. The mean implanted valve peak gradient was 21.8 ± 11.07 mmHg, which was influenced mostly by one patient's peak gradient of 51 mmHg due to her 48-month follow-up. Additionally, one mild paravalvular regurgitation was observed, one mild-to-moderate transvalvular regurgitation was observed, and one moderate-to-severe transvalvular regurgitation was observed. [Table 5] summarizes additional follow-up (6–48-month follow-up duration) echocardiographic data.

  Discussion 

With outstanding early and late outcomes, TPVR has gained popularity as a nonsurgical alternative for the treatment of defective RV-to-pulmonary artery conduits or BPVs.[8] Available TPVR technologies continue to increase, with the US FDA currently approving two valves for this use. The Melody valve (Medtronic, Minneapolis, Minnesota) is a valved bovine jugular vein segment sutured to a platinum-iridium stent frame that is delivered by the company's unique Ensemble delivery method. The Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, California) was originally intended for aortic valve placement but was discovered to be adaptable to the pulmonary position.[9],[10]

This is a single-center case-series study on a failed prior pulmonary bioprosthesis that was successfully managed with the implantation of an Edwards Sapien valve-in-valve procedure. We collected clinical and echocardiographic data on the first 10 patients who received this procedure and followed them for at least 6 months. Nine patients had previously undergone tetralogy of Fallot surgical repair with implantation of a pulmonary BPV. Six patients received Sapient XT valves, while the remainder received Sapient S3 valves. The procedure was successful in all patients, and all patients were discharged with a final peak gradient in the pulmonary position of <20 mmHg and less than mild regurgitation. The most appropriate size for our patients was valve size 23 (seven patients), and we implanted a valve size 26 in the remaining three patients. The size of the valve was determined using data of previous BPV and preoperative echocardiographic and computed tomographic data. Three patients required the placement of a CP stent in the RVOT to facilitate valve implantation. The mean peak PV bioprosthetic gradient was 46.9 ± 16.55 mmHg at the time of the procedure and decreased to 14.3 ± 6.22 mmHg the following day. Rapid pacing was not required during valve implantation in any patient, and we observed no vascular complications, endocarditis, or deterioration in tricuspid valve regurgitation suggestive of valve injury during the procedure. We observed a peak gradient of more than 40 mmHg in only one patient due to degenerative changes and pannus formation during their follow-up and regurgitation that was more than mild during this patient's 48-month follow-up.

In the largest cohort study of patients with Sapien prosthesis implantation in pulmonary position by Shahanavaz et al.[11] with a follow-up median of 1 year, 23 centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT, 183 (24%) with a conduit, and 194 (25%) with a BPV. The S3 valve was utilized in 78% of patients, while the XT valve was used in 22%, with the majority of patients having a 29-mm (39%) or 26-mm (34%) valve. Technically, the implant was successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference in serious adverse events reported between RVOT anatomical groups. Fourteen individuals underwent emergency surgery. Nine individuals received a second valve. Among patients with accessible data, 11 (1.7%) suffered tricuspid valve damage, while 9 (1.3%) had new moderate or severe regurgitation two grades higher than preimplantation, totaling 20 (3.0%) patients with tricuspid valve problems. Although the majority of patients had satisfactory valve function at discharge, 58 (8.5%) had moderate or severe pulmonary regurgitation or maximum Doppler gradients > 40 mmHg. During the brief follow-up period (n: 349; median: 12 months), 9 patients were diagnosed with endocarditis, and another 17 received surgical valve replacement or valve-in-valve TPVR. They concluded that acute outcomes were generally satisfactory following TPVR with balloon-expandable valves in all forms of RVOT.

In another registry data from a French center,[12] between April 2011 and May 2017, 71 consecutive patients undergoing TPVR were enrolled. At TPVR, the median age was 26.8 years (range: 12.8–70.1 years). Forty patients (56.4) had pulmonary bioprostheses and they were previously diagnosed with conotruncal malformations (common arterial trunk, tetralogy of Fallot, and variations; n: 45), previous Ross procedure (n: 18), and other diagnoses (n: 8). 33.8% of patients had pure stenosis, 28.1% had pure regurgitation, and 38.1% had mixed lesions. In 68 patients, TPVR was successfully adopted (95.8%). In 70 cases, the right ventricular outflow tract was prestented (98.6%). Four participants (5.6%) experienced early significant problems, including one death, one coronary compression, and two pulmonary valve embolizations. Three of the four significant problems happened in the first 15 patients who underwent surgery. Following the operation, no major regurgitation was observed. The transpulmonary gradient was dramatically lowered (P = 0.0001) from 34.5 to 10.5 mmHg. During a 1-month follow-up period, no patient died. At 1 year, the death rate was 2.9%, and three patients required surgical reintervention (4.4%).

Coronary compression as a result of PPVI is a well-documented complication. Coronary compression occurs in around 5%–6% of all patients receiving PPVI during balloon compression testing but not during the procedure itself; the rate is significantly reduced with PPVI due to the compression testing performed before the procedure. Coronary compression is frequently related to aberrant coronary artery architecture (particularly in patients with TOF or great artery transposition).[7],[13] However, we experienced no coronary compression at the time of our procedure.

Endocarditis was previously observed at a low rate of 1% in the aortic SAPIEN TAVR group of the high-risk PARTNER (Placement of Aortic Transcatheter Valve) trial. The implantation technique may have an effect on the rate of early endocarditis following a transcatheter valve replacement, and more vigilance with procedural sterility may further reduce rates of early endocarditis. At 2 years, endocarditis rates of between 2.7% and 7.5% have been observed with the Medtronic Melody valve. While it has been demonstrated that bacteria have a stronger proclivity to cling to the bovine jugular vein material utilized in the Melody valve leaflets, the pathogenesis of endocarditis in TPVR remains unknown.[14],[15],[16] Our follow-up data revealed no finding suggestive of valve endocarditis.

A frequent procedural decision, especially in patients with a large native/patched RVOT, is whether to implant a prestent or directly insert the valve. While prestenting was customary in the past, the necessity of a prestent prior to valve delivery has been questioned.[11],[17]

  Conclusion 

Our study as the first report of case series of pulmonary valve-in-valve procedure in our country with the least complication rate and the most success rate proved the feasibility of Sapien valves in pulmonary bioprosthetic failure. With experienced operators on aortic valve implantation procedures, this could be achieved with the least complication rate and the most procedural success.

Ethical clearance

All patients were informed with a consent form.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

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  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]