Review Article

Transcatheter Heart Valves with Labelling for Aortic Regurgitation

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Abstract

Treatment of pure aortic regurgitation (AR) has historically been addressed via surgical aortic valve repair or replacement. A less invasive option for patients affected by AR has been attempted with the advent of transcatheter aortic valve replacement (TAVR). Here, we review the rationale, benefits and challenges of TAVR for the treatment of native pure AR. In particular, we explore upcoming dedicated technologies with labelling for transcatheter treatment of AR, detailing both device and procedural specifics. Finally, evidence from recent studies conducted in patients with pure AR is appraised in light of available evidence from TAVR with non-dedicated devices in this setting.

Keywords

Transcatheter aortic valve replacement, aortic regurgitation, paravalvular leak, valve migration, valve embolisation,

Received:

Accepted:

Published online:

DOI: https://doi.org/10.15420/icr.2024.53

Disclosure: AL serves on advisory boards for Abbott, Boston Scientific and Medtronic, and is on the Interventional Cardiology editorial board; this did not influence peer review. PPL has no conflicts of interest to declare.

Correspondence: Azeem Latib, Division of Cardiology, Montefiore Medical Center, 111 East 210th St, Bronx, NY 10467-2401, US. E: alatib@gmail.com

Copyright:

© The Author(s). This work is open access and is licensed under CC-BY-NC 4.0. Users may copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Native pure aortic regurgitation (AR) represents a frequently encountered disease, with a reported prevalence of more than or equal to trace severity in 13% of men and 8.5% of women.1 The prevalence of AR in the Framingham study was reported to be 5%, with regurgitation of moderate or greater severity occurring in 0.5%.2 Anatomically, AR can result from dilation of the aortic root with aortic annulus enlargement and malcoaptation of the aortic cusps, endocarditis, aortic valve leaflet degeneration yielding excessive or restricted motion or a combination of these. Degenerative aetiology is the most common, rheumatic heart disease and congenital causes – including bicuspid aortic valve – are rarer, while infective endocarditis and inflammatory diseases are the rarest.3,4

The natural history of the disease among patients with chronic severe AR is influenced by left ventricular compensation for volume and pressure overload. Despite being asymptomatic, patients with preserved left ventricular ejection fraction already exhibit a significantly reduced survival rate. Symptoms tend to appear late, usually when left ventricular compensatory mechanisms fail and dysfunction ensues; the mortality rate increases significantly in parallel with severity of symptoms. Nonetheless, given the often concurrent increase in surgical risk, often either candidacy for surgical intervention is not achieved or referral is not pursued.5 Although medical therapy for afterload reduction may alleviate symptom burden early in the disease course, definitive aortic valve management is warranted to alter the course of disease.

Surgical aortic valve repair or replacement remains the standard of care for patients with severe AR and it holds a class 1 recommendation in presence of symptoms. Clinical indication in asymptomatic patients is based on baseline surgical risk, left ventricular ejection fraction (≤50–55%), left ventricular end-systolic (>50 mm or 20–25 mm/m2) or end-diastolic (>65 mm) diameter.3,6,7 Nonetheless, extensive undertreatment because of advanced age and comorbid status has been witnessed.4 It is in the context of such unmet clinical need that less invasive definitive management may be of paramount importance.

Transcatheter aortic valve replacement (TAVR) has established itself as a valuable treatment strategy in the management of aortic stenosis during the past two decades. At present, TAVR can be performed in patients with symptomatic severe aortic stenosis irrespective of their predicted risk of mortality after surgical aortic valve replacement.3,6,8 Nonetheless, a large proportion of the safety and efficacy profile of this procedure depends on specifics related to the pathophysiology of aortic stenosis itself.9 We will highlight the peculiarities of native pure AR, their clinical relevance and consequent technical challenges for transcatheter therapies and the early experience with dedicated devices.

Limitations of Off-label Devices for TAVR in Pure Aortic Regurgitation

First, volume overload, left ventricular eccentric hypertrophy and progressive dysfunction need to be evaluated when performing TAVR in pure AR. In addition, numerous anatomical challenges need to be recognised:10–12

  • From a technical standpoint, a major issue is the absence of annular and leaflet calcification, which not only impacts stabilisation and anchoring during deployment of valves originally designed for stenotic valves, but also fluoroscopic visualisation.
  • Left ventricular hypercontractility (and related increased stroke volume) and aortic root dilation are additional factors predisposing to valve malpositioning, migration/embolisation or significant residual paravalvular leak (PVL).
  • Large annular dimensions need to be taken into account when proceeding with valve sizing, as sizes of currently available non-dedicated valves often do not allow for achieving the degree of oversizing needed for appropriate valve positioning.13,14
  • The asymmetric – often elliptical – annuli increase the risk of residual PVL, notwithstanding appropriate positioning.15

The risk of residual moderate or more PVL, need for a second valve and overall failure to meet the endpoint of device success have historically been the main complications observed in studies assessing outcomes after TAVR in pure AR, especially when first-generation devices were available.16,17 The properties of new-generation self-expanding and balloon-expandable devices, including repositionability and better outer sealing skirts, have contributed to improved outcomes in terms of not only device success (75–85%), residual AR more than moderate (3–10%), transcatheter heart valve (THV) migration/embolisation (5–15%) or second THV implantation (~10%), but also to major bleeding (3–14%) or vascular complications (1–8%), 30-day mortality (5–10%) and medium-term mortality.18–22 Nonetheless, results with non-dedicated devices remain subpar and less reproducible when compared with contemporary results in patients with aortic stenosis, in whom the incidence of residual AR more than moderate, THV migration/embolisation or second THV implantation is reported to be as low as <1%.23,24 Dedicated devices were then designed to also treat patients with pure AR safely and effectively, and are represented today by the J-Valve (JC Medical) and Trilogy (JenaValve Technology).

The J-Valve

Device and Procedure

The J-Valve is designed to treat patients with both AR and aortic stenosis. It comprises three bovine pericardial leaflets in a self-expanding, nitinol frame with three U-shaped anchor rings designed to engage the native valve leaflets and allow, first, valve deployment within the secured leaflets, second, sealing to the annulus and, third, commissural alignment (Figure 1 and Table 1). Of note, these anchoring rings are not directly attached to the prosthesis, but are flexibly connected to the valve stent by Dacron interconnecting sutures, and can be released and fully opened and positioned to locate annulus before valve deployment (Figure 2).7,25 Then, valve stent deployment follows, as guided by the anchoring rings. This two-stage releasing design concept allows the axial alignment between the valve stent and anchoring rings to be adjusted separately as needed to achieve optimal alignment and positioning of the valve stent. The valve is available in five sizes (22, 25, 28, 31 and 34 mm) to treat a wide range of anatomies, with an annular diameter of up to 33.1 mm (Table 2).7 The frame has a notably low profile, extending between 17 mm and 25 mm according to valve size, and has sinus cut-outs at the level of anchor ring engagement to native leaflets that facilitate coronary access. The woven polyester fabric encircling the THV optimises sealing at the annulus.

Figure 1: Device Characteristics of the J-Valve and Trilogy Transvascular Systems

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Table 1: Design Characteristics of the J-Valve and Trilogy Transvascular Systems

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Transapical System

The first J-Valve TAVR system was designed for transapical approach, with its inaugural use in humans in 2014 and China National Medical Products Administration approval in 2017.26 It showed improved procedural success rate to 93% or more and reduced residual AR to mild or better at 30 days in nearly all treated patients with pure AR.27,28 Short- and mid-term follow-up studies recently confirmed optimal haemodynamic and symptomatic improvements, with no cases of moderate or severe residual AR, only 15% of patients having mild or moderate residual AR, and nine of ten patients classified as New York Heart Association class I or II at 3-year follow-up.25,29 Similarly, promising results are available on few patients with up to 4-year follow-up.30 Nevertheless, this system did not reach mainstream adoption due to its transapical design and it is no longer available on the market.

Figure 2: J-Valve Anchor Rings

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Table 2: Sizing Charts for J-Valve and Trilogy

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Table 2: Cont.

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Transvascular System

Complete redesign for transvascular use followed and the first-in-human transfemoral implantation was performed in 2018.31 The valve is advanced using a steerable delivery system designed for transfemoral access, 18 Fr or 21 Fr in size according to valve size. Similarly, the delivery sheath size compatibility varies with valve size: 22 mm valves require ≥18 Fr, 25 mm valves require ≥20 Fr, while 28, 31 and 34 mm valves require ≥22 Fr.

Recently, a North American multicentre compassionate use cohort study conducted in 27 pure AR patients (41% female; median age 81 years; Society of Thoracic Surgery predicted risk of mortality [STS-PROM] 4.3%) showed no moderate or severe residual AR at 30 days and overall good haemodynamic performance, with an average mean gradient ≤10 mmHg and effective orifice area >2 cm2. Any access-site complication occurred in five patients. Of note, the majority of patients were treated via transfemoral access (78%); four patients had a subclavian access (15%) and carotid and transcaval access were adopted in one patient each. Clinical outcomes were satisfactory, with a single case (4%) reported for both 30-day mortality and stroke, as well as the need for permanent pacemaker implantation (PPI) in three patients (13%). Nevertheless, device success was only 81% in the whole series due to three patients requiring a second THV because of premature deployment in the sinuses above the annular plane and two patients with conversion to surgery. Among the latter, the nose cone of the first-generation J-Valve separated from the device during retrieval in one case. In the second case, the J-Valve embolised to the ventricle shortly after deployment due to inadequate anchoring of the THV on prolapsing aortic valve leaflets. Changes in valve design, including redesign of the attachment points and bonding methods and the exclusion of valves with prolapsing leaflets from subsequent enrolment led to improvement in later cases, with the last fifteen consecutive cases in this compassionate use experience being successful without surgical conversion or need for a second THV.32

Results from the J-Valve early feasibility study (NCT06034028) provided additional insights on safety and efficacy in fifteen patients with severe symptomatic AR, high surgical risk (mean age 80 years; STS-PROM 5.5%) and suitable anatomy for transfemoral access.33 In contrast with studies conducted on alternative devices dedicated to pure AR, the J-Valve system allowed treatment of a patient population with large aortic annuli, as evident from implanted valve sizes including 31 mm (40%), 34 mm (27%), 28 mm (27%) and 25 mm (6%). Procedural success was 93.5%, with no intraprocedural mortality, coronary obstruction, THV migration/embolisation or need for a second THV, and one single patient requiring conversion to surgery because of inability to release the anchor rings after successful valve deployment, secondary to extreme tortuosity of the aorta. At 30 days, there were no cases of cardiovascular death, stroke, device-related intervention or PPI. All patients had no or trace residual AR and the mean effective orifice area was 2.9 cm2 (Figure 3). Results from the upcoming JOURNEY pivotal trial (NCT06455787) will provide insights on the safety and efficacy in a larger patient cohort.

Figure 3: Characteristics and Outcomes of Transcatheter Aortic Valve Replacement Studies in Patients with Native Pure Aortic Regurgitation

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JenaValve

Early JenaValve Transapical System

The JenaValve comprises porcine root leaflets mounted on low-profile self-expanding flexible nitinol stent posts and relies on active clip fixation to the native aortic valve leaflets (Figure 1 and Table 1). A dedicated transapical system including a sheathless 32 Fr delivery catheter was adopted for a three-step deployment, including first, feelers release and positioning into the sinuses of the native aortic root; second, release of the lower part of the stent, thus clipping and attaching the native leaflets to the THV; and third, complete deployment with release of the upper part of the stent.34 Early studies, including patients at high risk for surgery, revealed the JenaValve as a reasonable option in patients with pure AR, with successful implantation in 97% of patients and no moderate or severe residual AR.35,36 Nonetheless, this system did not reach widespread adoption due to the intrinsic need for a thoracotomy and it has not been commercially available since June 2016.

The Next-generation Trilogy Transvascular System

Device

The Trilogy is the second and current iteration of the JenaValve. It comprises a self-expanding THV with a nitinol frame housing three porcine pericardial leaflets (Figure 1 and Table 1). Three radio-opaque locators clip onto the native leaflets in each aortic root sinus and have multiple functions, including enabling commissural alignment; minimising implant depth, thus decreasing the risk of THV left ventricular migration; and enhancing paravalvular seal. The delivery system, which includes a deflection knob to fine-tune valve position and a controller to rotate the valve, allows alignment of locators and each cusp. The 24 diamond-shaped cells in the inflow portion conform to the annulus, contributing to both paravalvular sealing and anchoring. In addition, coronary access is facilitated by the large, open cells in the top row of the THV frame. The THV is available in three sizes (23, 25 and 27 mm) and can be adapted to treat annuli between 21.0 and 28.6 mm in diameter.

Procedure

The device is advanced through an 18 Fr, 85 cm long pre-shaped introducer sheath extending through the aortic arch until the sinotubular junction (Figure 4). The Trilogy is advanced through the introducer sheath, positioned above the aortic valve and the introducer sheath is retracted into the descending aorta, exposing the locators. The valve is then deflected to align it coaxially, the locators are spread further, and rotation of the THV follows via the controller. Two orthogonal fluoroscopic views and selective angiography with a multipurpose catheter in each cusp follow to confirm correct alignment and engagement of the locators. Once appropriate position is confirmed, the valve is finally deployed, often under rapid ventricular pacing to a heart rate of 120–140 BPM.37

Figure 4: Trilogy Introducer Sheath

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Evidence

The first-in-human implantation was performed successfully in 2017 in a patient with pure AR. The device later received CE marking for the treatment of both pure AR and aortic stenosis in 2021, thus representing the first commercially available dedicated TAVR system for treatment of patients with pure AR.

The initial commercial experience was described in a German multicentre real-world cohort including 58 patients with a mean age of 76 years and a STS-PROM of 4.2% undergoing transfemoral Trilogy implantation for pure AR. Results were particularly promising, with 98% device success, no moderate or severe residual AR, no conversion to open surgery or valve embolisation, no major vascular complications or bleeding events and optimal forward-flow haemodynamics.38 Of note, one of five patients underwent PPI.

A recent multicentre, retrospective registry including 256 inoperable patients with severe tricuspid native pure AR assessed the performance of Trilogy (n=88) compared with the latest iteration of off-label devices (n=168).39 Trilogy had higher technical success rates (98% versus 81%; p<0.001) and device success rates (95% versus 73%; p<0.001). This was primarily driven by a significantly lower incidence of THV embolisation (1.1% versus 15%; p<0.001), need for a second valve (1.1% versus 11%; p=0.004) and moderate residual AR (1.1% versus 10%; p=0.007). The fact that the PPI rate was comparable and elevated for both groups (22% versus 24%; p=0.70) might suggest a class-effect, possibly due to ventricular and left ventricular outflow tract dilatation or a higher prevalence of underlying conduction disturbances.

Similar results were reported in the landmark ALIGN-AR prospective, multicentre, single-arm investigation device exemption study.40 The study enrolled symptomatic patients with moderate-to-severe or severe AR at high risk for mortality and complications after surgical aortic valve replacement at 20 sites in the US undergoing transfemoral Trilogy implantation. Among 180 patients (mean age 75 years; STS-PROM 4.1%), technical success was high and was achieved in 171 (95%) patients. Rates of 30-day mortality or major complications were promising: 2% mortality, 1% surgical conversion, 2% need for second THV and major bleeding and major vascular complications each in 4% of patients. Excellent valve haemodynamics with a large effective orifice area, low mean gradients and minimal PVL (moderate or greater AR in <1% of cases) were observed. Favourable haemodynamic valve performance was sustained at 1- and 2-year follow-up, with an average effective orifice area >2.5 cm2 and no cases of haemodynamic valve deterioration. Similarly, no cases of moderate or greater PVL were observed after 6-month follow-up, with more than 95% of patients experiencing none/trace PVL at 2-year follow-up.41 However, the incidence of PPI was high (24%), and whether this risk might be mitigated by less aggressive oversizing and reduction in implant depth, as seen in the final third of enrolled patients in the trial, needs to be validated in future studies.

Conclusion

While the feasibility of TAVR in pure AR has been proven with different valves, an unmet clinical need remains because of the undertreatment of pure AR and lack of a reproducible, predictable percutaneous alternative to surgery. Dedicated devices have shown promising results thus far. Although most evidence derives from retrospective studies conducted in heterogeneous populations with no standardised treatment strategies, recent results from prospective studies seem to confirm the safety and efficacy of transvascular TAVR with dedicated devices in patients with pure AR. Randomised controlled trials comparing these technologies with surgical aortic valve replacement are eagerly awaited.

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