First application of the distal radial approach for severe mechanical surgical aortic valve paravalvular leak transcatheter closure with a double vascular plug: a case report

Abstract Background Severe aortic paravalvular leaks (PVLs) after surgical mechanical aortic valve replacement (AVR) represent a high risk for congestive heart failure, haemolysis, and infective endocarditis. This is the first reported case of distal radial artery (DRA) access for severe mechanical aortic PVL closure with a sequential double vascular plug guided by computed tomography angiography (CTA), transoesophageal echocardiography (TOE), and 3D TOE in an acute setting. Case summary A 51-year-old male presented with significant mixed aortic valve disease. Aortic valve replacement was performed (Slimline Bicarbon A-25 mm) according to guidelines. Four and 16 days later, a re-exploration was carried out due to pericardial effusion. Four months after discharge from rehabilitation, the patient was readmitted due to worsening dyspnoea on exertion and then at rest. Transthoracic echocardiography, TOE, and consequently, CTA, revealed severe PVL, following which the procedure of transcatheter PVL closure was chosen, with a preference for DRA access. After a CTA scan analysis and angiographic, TOE, and 3D TOE visualization of the leak, a 14/5 mm and a 10/5 mm vascular plug (AVPIII) were deployed to achieve good results. A 9-month clinical, echocardiographic, and CTA follow-up revealed good long-term results. Discussion For transcatheter PVL closure, CTA is helpful for not only vascular access planning, but also a visualization of the magnitude of the leak, location, and device planning. This case report demonstrates that the distal radial approach is feasible in patients with severe mechanical aortic valve PVL retrograde transcatheter closure. DRA access could possibly represent less bleeding and vascular access site complications when compared with femoral access and has some potential advantages over regular radial access.

First application of the distal radial approach for severe mechanical surgical aortic valve paravalvular leak transcatheter closure with a double vascular plug: a case report

Background
Severe aortic paravalvular leaks (PVLs) after surgical mechanical aortic valve replacement (AVR) represent a high risk for congestive heart failure, haemolysis, and infective endocarditis.This is the first reported case of distal radial artery (DRA) access for severe mechanical aortic PVL closure with a sequential double vascular plug guided by computed tomography angiography (CTA), transoesophageal echocardiography (TOE), and 3D TOE in an acute setting.
Case summary A 51-year-old male presented with significant mixed aortic valve disease.Aortic valve replacement was performed (Slimline Bicarbon A-25 mm) according to guidelines.Four and 16 days later, a re-exploration was carried out due to pericardial effusion.Four months after discharge from rehabilitation, the patient was readmitted due to worsening dyspnoea on exertion and then at rest.Transthoracic echocardiography, TOE, and consequently, CTA, revealed severe PVL, following which the procedure of transcatheter PVL closure was chosen, with a preference for DRA access.After a CTA scan analysis and angiographic, TOE, and 3D TOE visualization of the leak, a 14/5 mm and a 10/5 mm vascular plug (AVPIII) were deployed to achieve good results.A 9-month clinical, echocardiographic, and CTA follow-up revealed good long-term results.

Discussion
For transcatheter PVL closure, CTA is helpful for not only vascular access planning, but also a visualization of the magnitude of the leak, location, and device planning.This case report demonstrates that the distal radial approach is feasible in patients with severe mechanical aortic valve PVL retrograde transcatheter closure.DRA access could possibly represent less bleeding and vascular access site complications when compared with femoral access and has some potential advantages over regular radial access.

Introduction
Paravalvular leak (PVL) is a defect between the outer skirt of the surgically sutured or transcatheter implanted bioprosthesis and the native valve annulus, resulting in regurgitation of varying severity.The rate of prevalence of aortic PVLs ranges from 6 to 18%, but it can even be as high as 47%, 1,2,3 as reported in some retrospective studies; however, only a small minority of the detected leaks requires further treatment.
Severe aortic PVLs after surgical mechanical aortic valve replacement (AVR) represent a high risk for congestive heart failure, haemolysis, and infective endocarditis and could indicate poor prognosis for the patient. 3This is the first reported case of a distal radial artery (DRA) approach used for severe mechanical aortic PVL closure with a sequential double vascular plug guided by computed tomography angiography (CTA), transoesophageal echocardiography (TOE), and 3D TOE in an acute setting.

Summary figure Case presentation
A 51-year-old male patient was admitted to the university hospital with chest discomfort, dyspnoea, and decreased exertion capacity.A physical examination on admission revealed an enlarged heart, a harsh systolic ejection murmur, and a decrescendo diastolic murmur in the aortic area.The electrocardiogram showed sinus rhythm with signs of left ventricular hypertrophy.The chest X-ray showed enlarged left heart chambers.Transthoracic echocardiography (TTE) revealed an ejection fraction (EF) of 43% (normal: >60%).No resting wall motion abnormality was detected, mixed aortic valve disease was confirmed, the stenosis gradient was 74/47 mmHg, the aortic valve area was 0.33 cm 2 , aortic insufficiency grade was found to be II-III, and the pressure half time value was 222 ms.Grade II tricuspid insufficiency with a pulmonary pressure of 70 mmHg was confirmed.The cardiac risk factors were hypertension, Type 2 diabetes mellitus, hyperlipidaemia, peripheral artery disease, and smoking.The right femoral common and right femoral superficial artery had been intervened prior to surgery.The left common iliac artery and left superficial femoral artery showed non-significant lesions at that time.Both common carotid arteries showed non-significant lesions.Coronary angiography revealed a non-significant proximal circumflex artery lesion.The Society of Thoracic Surgeons risk score (STS score) and EuroSCORE II before primary AVR were 0.842 and 2.8%, respectively.Aortic valve replacement was performed according to guidelines, and a LivaNova Bicarbon Slimline A-25 mm mechanical valve was implanted.Four days later, a reoperation had to be performed due to haematoma causing right heart compression, which was evacuated.Active bleeding was not revealed.Two weeks later, another reoperation had to be performed due to repeat haematoma formation in the pericardium.Discharge TTE showed good mechanical valve function with a peak gradient of 19 mmHg, and there was no sign of any PVL.Six months after discharge, the patient started to experience dyspnoea on exertion and also at rest.1A-D).Computed tomography angiography helped to pinpoint the largest ostium of the PVL located at the left coronary sinus and quantify the regurgitation jet (Figure 1E-H, Supplementary material online, Video S1).Computed tomography angiography discovered a chronic occlusion of the right subclavian artery, and distal filling was provided by collaterals from the right vertebral artery.The left subclavian artery was free of disease.Pleural effusion was present in both pleural cavities, which also supported the diagnosis of cardiac decompensation.Shortly after readmission, the patient became noradrenaline dependent.The calculated STS score for mortality was 5.85%, which was in line with EuroSCORE II (42.35%).Both preoperative scores represent an extremely high surgical risk for mortality.Percutaneous PVL closure represented the consensus of the heart team.Due to peripheral vascular disease in both lower extremities and right subclavian artery occlusion, a decision was made to use the left DRA as the initial approach to reduce the potential risk of vascular access site complications and bleeding risk.The left DRA was punctured with ultrasound guidance (Figure 2A and B), and a 6 French (F) Terumo radial sheath (Terumo, Japan) was introduced and later replaced with a Sheathless 8.5F MP1 catheter (Asahi, Japan; Figure 2C).Aortography confirmed a large-volume PVL (Figure 3A, Supplementary material online, Video S2).With fluoroscopy and TOE and 3D TOE guidance, a Gladius 0.018″ guidewire (Asahi, USA) could pass through the largest opening of the leak into the left ventricle.It was followed by a CXI 4.0 support catheter (Cook, USA).After exchanging it with Confida 0.035′ wire (Medtronic, USA), through the Sheathless guide catheter, a 14/5 mm Amplatzer Vascular plug III (AVPIII; Abbott, USA) was deployed after careful positioning to avoid mechanical valve leaflet interaction aided by TOE, 3D TOE, and fluoroscopy (Figure 3B and C).Control angiography and TOE still revealed a large-volume residual leak (Figure 3D and E, Supplementary material online, Video S3).With a Halberd 0.018″ wire (Asahi, Japan), it was possible to cross the left ventricle beside the priorimplanted AVPIII through the remaining leak in the ostium.A 10/5 mm AVPIII was deployed in the largest remaining leak without compromising mechanical valve function (Figure 3F and G).Final angiography revealed only a small volume of contrast entering the left ventricle through the leak (Figure 3H, Supplementary material online, Video S4).Transoesophageal echocardiography confirmed the angiography result (Figure 4A and B).By the end of the procedure, no medical haemodynamic support had to be provided (Figure 4C).The patient was discharged home five days later.Discharge TTE confirmed good mechanical aortic valve function, increased left ventricle EF, minimal regurgitation, and proper position of the deployed vascular plugs (Figure 4D-F).
At a 9-month follow-up, the patency of the prior-punctured left DRA was checked by ultrasound and a patent flow with no luminal narrowing was detected (Figure 5A and B).Transthoracic echocardiography, TOE, and 3D TOE confirmed excellent vascular plug positions with only a moderate-sized residual leak (Figure 5C and D).Control CTA confirmed proper plug positions and only a small-sized residual leak was revealed.No further intervention was performed (Figure 5E-H, Supplementary material online, Video S5).

Discussion
Previously, the gold standard for treating severe aortic mechanical valve PVL was cardiac surgery.In 1992, the first successful transcatheter aortic paravalvular closure was performed in patients. 4The ESC/EACTS 2021 guidelines state that reoperation due to severe PVL causing heart failure symptoms and haemolysis requiring blood transfusion is a Class I or Class IIa indication.It is also stated that transcatheter PVL closure represents a Class IIa indication and should be the treatment of choice if surgery is prohibited or represents a very high surgical risk. 5With the evolution of implantable devices, the number of transcatheter closures has risen, as opposed to reoperation, due to a significantly lower overall mortality risk. 5,6In the patient case presented here, the overall mortality risk after three prior operations was unacceptably high.By analysing TTE, 3D TOE, and CTA findings, a decision was made to perform a transcatheter closure, to place AVPIII device/s that are specifically designed for PVL closures to prevent mechanical valve leaflet interaction. 6,7For a procedure with large devices, at least 7F catheter size is required.If an anchor/safety wire is planned, +1F is needed. 7In most centres, the standard access site for aortic PVL closure is the common femoral artery. 6,8In the last decade, there has been a shift from femoral access toward radial access for coronary procedures even in acute settings due to decreased overall mortality, bleeding, and access site complications. 9,10Unlike in the case of coronary procedures, for aortic PVL closure, there are only two reports mentioning the adoption of the radial access approach. 11,12In the patient case presented here, the left DRA was chosen for access after careful ultrasound evaluation.Computed tomography angiography was performed, partially to evaluate arterial vascular access site options.The right subclavian artery was found to be occluded, and both the iliac and femoral arteries showed numerous lesions; thus, femoral access was avoided in an attempt to minimalize potential bleeding and access site complications.In a previous large-scale study, it has been demonstrated that DRA access is feasible for various coronary and peripheral interventions. 13Although ultrasound guidance is not mandatory, it is strongly recommended for DRA puncture. 14In their DR-BAV study, Achim et al. 15 have demonstrated that with all pre-puncture ultrasound measurements, the DRA can bear an 8F or even a 9F hydrophilic sheath introducer insertion for balloon aortic valvuloplasty.

Conclusion
Paravalvular leaks requiring further invasive treatment remain infrequent abnormalities after surgical AVR, but carry major risks for the patient.Transcatheter leak closure delivers significantly less overall risk compared with reoperation.Up to now, the radial artery access approach has not gained enough traction for performing closure procedures, even though less bleeding and less vascular complications have been documented.We have demonstrated in this report that DRA access is feasible for aortic PVL closure and carries potential advantages over even conventional radial access.However, for certain structural interventions, we should follow the evolution of access sites used in coronary interventions.

Figure 1
Figure 1 (A, B) Transoesophageal echocardiography images of a large-sized mechanical aortic valve.A white arrow points at the location in the left coronary sinus.(C, D) Three-dimensional TOE images of the location of the large-sized mechanical aortic valve paravalvular leak.The white arrows point at the large ostium of the leak.(E, F) Computed tomography angiography images of the mechanical aortic valve and the detected paravalvular leak.The white arrows point at the leak location.(G, H ) A three-dimensional reconstruction of the mechanical surgical valve, paravalvular leak, and regurgitation volume.The white arrows point at the leak location in the left coronary sinus.

Figure 2 Figure 3 Figure 4 Figure 5
Figure 2 (A) An image of the planned puncture site of the left distal radial artery (snuffbox).Peak velocity is 21.5 cm/s.(B) A colour ultrasound image of the planned puncture site of the left distal radial artery (snuffbox).A white arrow points at the left distal radial artery.(C ) An image of the left distal radial artery puncture site at the end of the procedure just before taking out the Sheathless guide catheter.