Simultaneous Kissing Balloon Inflation Technique for Coronary Protection during Transcatheter Aortic Valve Replacement

Abstract

Transcatheter aortic valve replacement (TAVR) using the valve-in-valve (ViV) approach presents a substantial risk of coronary artery obstruction, which adversely impacts patient outcomes. In this report, we describe the utilization of the simultaneous kissing balloon inflation technique during ViV TAVR, which resulted in significant improvement in the patient’s condition.

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) using the valve-in-valve (ViV) approach presents a substantial risk of coronary artery obstruction (CAO), which adversely impacts patient outcomes.

CASE PRESENTATION

An 89-year-old male with a previous surgical aortic valve replacement with a 23 mm Trifecta (St. Jude Medical, Inc., USA) in 2012 presented with acute left ventricular failure.

Chest X-ray revealed pulmonary edema, and transthoracic echocardiography confirmed structural valve deterioration secondary to severe valvular aortic regurgitation (AR). Computed tomography (CT) measurements showed sinus of Valsalva’s height and diameter of 18.6 mm and 29.8 mm, respectively. The heights of the left coronary arteries (LCAs) and right coronary arteries (RCAs) were 11 mm and 10 mm, respectively. The virtual valve-to-coronary (VTC) distances were 3.7 mm for LCA and 4.8 mm for RCA. Notably, the right coronary cusp leaflet was higher than the RCA ostium [Figure 1].

Figure 1.

Computed tomography transcatheter aortic valve replacement pre, (a) trifecta prosthesis and its relation to the coronary ostia. (b) Left coronary artery (LCA) valve-to-coronary (VTC) (virtual transcatheter heart valve to coronary ostial distance) 3.7 mm. (c) Right coronary artery (RCA) VTC 4.8 mm. (d) The left coronary leaflet length is more than the LCA height. (e) The right coronary leaflet length is more than the RCA height. (f) Tip of coronary leaflets close to coronary ostia. Red arrow: RCC leaflet tip and black arrow: LCC leaflet tip

Once stable, the heart team recommended ViV TAVR. Given the combination of externally mounted leaflets of the trifecta valve and narrow VTCs, there was a high risk of periprocedural CAO. We used triple simultaneous kissing balloon (SKB) inflation during TAVR deployment to mitigate this risk.

The procedure was performed using the right femoral artery for transcatheter heart valve (THV) access (23 mm S3 Ultra Sapien Ultra, Edwards Lifesciences, USA). A guide extension (GuideLiner, Teleflex, USA) with a 4.5 × 20 noncompliant (NC) balloon was positioned at the ostium of the LCA, and a 4.0 × 20 NC balloon was positioned at the ostium of the RCA. The distal ends of both balloons were placed at the ostia while the remaining bodies were positioned in the aorta.

With the THV in position and rapid pacing over a Safari extra-small wire, the coronary balloons were first inflated with the aim to deflect the bioprosthetic valve leaflets away from the coronary ostia. Subsequently, the 23 mm S3 Sapien Ultra valve was deployed at nominal pressure [Figure 2]. The THV balloon was then deflated, followed by the deflation of the coronary balloons.

Figure 2.

Procedure and computed tomography transcatheter aortic valve replacement post. (a) Simultaneous kissing of the S3 balloon (1), Right coronary artery (RCA) balloon (2), and left coronary artery (LCA) balloon (3). (b) Cross-sectional view of the valve-in-valve. (c and d) The arrows show a clean channel of blood into the LCA. (e and f) The arrows show a clear channel of blood into the RCA. (c-f) No obvious leaflet material between the frame of the prosthesis and the coronary ostia

A final aortogram confirmed the absence of AR and patent coronaries. The hemodynamic transition was remarkable, with the end-diastolic left ventricular pressure dropping from 23 to 11 mmHg, diastolic blood pressure increased from 35 to 65 mmHg, and the mean aortic valve gradient dropping from 23 to 8 mmHg.

Considering the novelty of the technique, we opted to perform a postprocedural CT scan to assess the TAVR outcome. The CT scan revealed patent coronary ostia with unobstructed blood flow channels into both coronary arteries [Figure 2]. The leaflet material appeared to be trapped within the aortic sinuses. The patient experienced an uneventful recovery and was discharged on the third postprocedural day with a small dose of diuretics.

At the 2-year follow-up, the patient is doing exceptionally well and can walk the equivalent of three football fields without using a walking stick.

DISCUSSION

ViV TAVR is increasing. In the UK, 249 cases (4.4% of total TAVR procedures) were performed in 2021/2022, compared to 132 cases in 2016 (3.9%).[1] The 2021 European Society of Cardiology guidelines recognize the role of ViV TAVR for failed bioprostheses.[2]

Ribeiro et al. reported an odds ratio of 7.67 (3.14–18.7, P < 0.001) for coronary obstruction in stented bioprostheses with externally mounted leaflets or stentless bioprostheses.[3] The incidence of coronary obstruction ranged from 0.7% to 6.4%, depending on the type of bioprosthesis used. Stented bioprostheses with externally mounted leaflets carried the highest risk.[3]

The CORPROTAVR registry and Hsiung et al. reported incidences of 2.2% and 2.1% of coronary protection use in all cases, respectively.[4,5] Wire-only or unexpanded balloon strategies offer the advantage of simplicity, avoiding coronary stenting and the long-term commitment to dual antiplatelet therapy (DAPT). However, a reasonable risk of immediate coronary obstruction can be remedied with stenting and the prevention of delayed coronary obstruction, which may occur in up to 35% of cases.[3]

Ostial coronary stenting or chimney techniques increase procedural complexity and subject patients to DAPT. Long-term ischemic outcomes and coronary access must be carefully considered, especially when using the chimney technique. Palmerini et al. reported a 7.8% risk of myocardial infarction at 3 years.[4] Clinical outcomes were comparable when using coronary protection with or without stents. However, numerically, there were more myocardial infarction events in patients who underwent the “coronary protection with stents” strategy (9.8% vs. 2.8%, P = 0.30).[4]

The BASILICA trial reported a 94.7% of success rate.[6] However, the primary safety endpoint was met in only 70% of cases (21/30), with a 20% incidence of major vascular complications.[6] The BASILICA registry mirrored these findings but reported a 4.7% partial or complete coronary obstruction despite the BASILICA technique.[6] More recently, Dvir et al. reported on the first-in-human experience with a dedicated leaflet-splitting device, the ShortCut device (Pi-Cardia).[7]

In this case, we employed the planned SKB technique to protect the coronary arteries during TAVR. This technique involves inflating two coronary balloons simultaneously, each sized 1:1, to the THV, along with the THV deployment. The distal ends of the coronary balloons are positioned at the ostium of each coronary artery to avoid intimal injury during inflation. The objective is to deflect the coronary leaflets away from the coronary ostia, potentially anchoring them by the TAVR prosthesis below the coronaries, as demonstrated by the repeat CT scan in our case. Deflecting the leaflets away from the coronaries could provide a long-term solution.

Hsiung et al. reported coronary ballooning after TAVR in 3 out of 14 cases.[5] However, coronary ballooning after TAVR is unlikely to deflect the leaflets within the aortic sinuses, thus not achieving our proposed objective. The SKB technique offers several advantages: simplicity, availability, “less metal” in the aortic root, and avoiding DAPT. Furthermore, a guide extension and an extra support wire provide necessary backup if stenting is necessary.

The 4.7% rate of coronary obstruction despite the BASILICA technique reflects the various mechanisms of coronary obstruction during TAVR. Lederman et al. listed six potential mechanisms of CAO, for example, “deficient sinus” and “sequestered sinus.”[8] The balloon leaflet-deflection technique may not provide the required safety in the “deficient sinus” group. Therefore, careful CT analysis and planning for these procedures remain crucial.

CONCLUSION

The SKB inflation technique is a novel strategy with several advantages over the chimney and BASILICA techniques. Real-world experience will inform the cardiac community about its utility in future. Conducting randomized studies comparing these strategies would be highly challenging.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given his consent for his images and other clinical information to be reported in the journal. The patient understands that his name and initials will not be published and due efforts will be made to conceal his identity, but anonymity cannot be guaranteed.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.