Intravascular lithotripsy (IVL) enabled the percutaneous closure of a severely calcified paravalvular leak regurgitation following implantation of a self-expandable transcatheter aortic valve: a case report.

Background: Closure of paravalvular leak (PVL) regurgitation after self-expandable (SE) transcatheter aortic valve implantation (TAVI) may be more challenging than after balloon-expandable (BE) valve implantation. Case summary: An 85-year-old woman suffering from long-standing atrial fibrillation and severe symptomatic aortic stenosis underwent SE TAVI (26 mm Evolut™ R®, Medtronic Inc., MN, USA). A total of eighteen months after TAVI she was admitted for congestive heart failure and two-dimensional (2D) transesophageal echocardiography (TEE) color Doppler showed moderate-severe PVL regurgitation due to a long and heavily calcified leak located below the left coronary sinus. The patient was deemed to be at prohibitive surgical risk and a catheter-based PVL closure procedure was planned. A first attempt to cross the PVL from the femoral artery was unsuccessful due to an inappropriate angle between the catheter and the entry site of this hard-to-approach calcified leak. A Terumo hydrophilic guidewire 0.35 inch-260 cm from the right radial artery was then successfully advanced across the leak to the left ventricle (LV); however, of most of the catheters used, only a Glidecath 4-Fr could cross the leak over the hydrophilic wire. The hydrophilic guidewire was replaced with a stiffer guidewire that, after creating a loop in the LV, was advanced across the self-expandable valve into the descending aorta where it was snared and externalized through the left femoral artery, thus creating an arterio-arterial (AA) loop. A 6-Fr Multipurpose guiding catheter was advanced over the exchange wire and the leak was crossed with an additional 0.0014 coronary guidewire (PILOT, Abbott Vascular), predilated with two non-compliant balloon dilatation catheters, and finally, the PVL was engaged with a 3.0 mm × 12 mm Shockwave balloon (Shockwave Medical Inc, Santa Clara, California, USA). Intravascular lithotripsy (IVL) application to this highly calcified leak and the increased support provided by the stiff guidewire finally allowed the progression of the 6-Fr dedicated delivery sheath (ODS III) into the LV. A 5 mm square twist (ST) device (PLD, Occlutech, Helsingborg, Sweden) was successfully deployed within the leak and the final echocardiographic and angiographic control confirmed the effective PVL closure. Discussion: In patients at high surgical risk with moderate to severe regurgitation after SE TAVI due to a hard-to-approach calcified long tract, an extra AA support loop is mandatory during percutaneous PVL closure. Furthermore, IVL application greatly facilitates the progression of the delivery sheath and occluder which is key to a successful procedure.

Is Moderate/Large Residual Shunt After PFO Closure Justifiable for a Patient with a Prior History of Cryptogenic Stroke and Transient Ischemic Attack?

A 36-year-old woman suffered from an embolic stroke of an undetermined source documented by magnetic resonance imaging with residual right arm weakness. She underwent percutaneous patent foramen ovale (PFO) closure with an 18/25 mm device in another center. One year later, the patient suffered from a transient ischemic attack with dysarthria. She asked for a second opinion at our institution and a contrast-transthoracic (cTTE) /transesophageal echocardiography showed a large residual right-to-left shunt (RLS) through a still patent tunnel after PFO closure. Written informed consent for a redo procedure was obtained from the patient. A catheter-based closure of the residual shunt was therefore planned under local anesthesia and rotational intracardiac echo monitoring. A second equally sized disc (18/18 mm) device was successfully implanted without complications. The patient was discharged home the following day in good clinical condition. Dual antiplatelet therapy was recommended for the first 2 months and then single antiplatelet therapy up to 6 months. At the 6-month follow-up, the cTTE color Doppler showed the stable position of the two nitinol double-disc devices and the c-transcranial Doppler confirmed the abolition of the residual RLS.

Clinical Outcomes and Quality of Life after Patent Foramen Ovale (PFO) Closure in Patients with Stroke/Transient Ischemic Attack of Undetermined Cause and Other PFO-Associated Clinical Conditions: A Single-Center Experience.

INTRODUCTION: The aim of this study was to assess clinical outcomes and quality of life after PFO closure in patients with previous stroke/TIA of undetermined cause and in patients with other complex PFO-associated clinical conditions. METHODS: Between July 2009 and December 2019 at our University Cardiology Department, 118 consecutive patients underwent a thorough diagnostic work-up including standardized history taking, clinical evaluation, full neurological examination, screening for thrombophilia, brain magnetic resonance imaging (MRI), ultrasound-Doppler sonography of supra-aortic vessels and 24 h ECG Holter monitoring. Anatomo-morphological evaluation using 2D transthoracic/transesophageal echocardiography (TTE/TEE) color Doppler and functional assessment using contrast TTE (cTTE) in the apical four-chamber view and contrast transcranial Doppler (cTCD) using power M-mode modality were performed to verify the presence, location and amount of right-to-left shunting via PFO or other extracardiac source. Completed questionnaires based on the Quality-of-Life Short Form-36 (QoL SF-36) and Migraine Disability Assessment (MIDAS) were obtained from the patients before PFO closure and after 12 months. Contrast TTE/TEE and cTCD were performed at dismission, 1, 6 and 12 months and yearly thereafter. Brain MRI was performed at 1-year follow-up in 54 patients. RESULTS: Transcatheter PFO closure was performed in 106 selected symptomatic patients (mean age 41.7 ± 10.7 years, range 16-63, 65% women) with the following conditions: ischemic stroke (n = 23), transient ischemic attack (n = 22), peripheral and coronary embolism (n = 2), MRI lesions without cerebrovascular clinical events (n = 53), platypnea-orthodeoxia (n = 1), decompression sickness (n = 1) and refractory migraine without ischemic cerebral lesions (n = 4). The implanted devices were Occlutech Figulla Flex I/II PFO (n = 99), Occlutech UNI (n = 3), Amplatzer PFO (n = 3) and CeraFlex PFO occluders (n = 1). Procedures were performed under local anesthesia and rotational intracardiac monitoring (Ultra ICE) alone. The devices were correctly implanted in all patients. The mean fluoroscopy time was 15 ± 5 min (range = 10-45 min) and the mean procedural time was 55 ± 20 min (range = 35-90 min). The total occlusion rate at follow-up (mean 50 months, range 3-100) was 98.1%. No recurrent neurological events were observed in the long-term follow-up. CONCLUSIONS: The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure, showing long-term prevention of recurrent cerebrovascular events, significant reduction in migraine symptoms and substantial improvement in quality of life.

Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry.

BACKGROUND: Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce. AIMS: This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure. METHODS: All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included. RESULTS: Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%). CONCLUSIONS: Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

Noblestitch® system for PFO closure: A novel but judicious alternative to traditional devices-A case report.

Background: Percutaneous suture-mediated patent foramen ovale (PFO) closure has recently been used with the aim of avoiding double-disc nitinol device implantation. This novel technique has been carried out successfully in several centers offering PFO closure with an effective closure rate comparable to conventional double-disc devices. Case summary: A 50-year-old man, a pentathlon athlete, suffering from a previous left-sided ischemic stroke, underwent percutaneous closure of a permanent right-to-left shunt via PFO with a large fenestrated septum primum aneurysm at another institution. The NobleStitch® system was successfully implanted using local anesthesia and under angiographic-fluoroscopic monitoring. He was discharged home on aspirin 100 mg daily with a moderate residual shunt on contrast transthoracic echocardiography (cTTE) that persisted unaltered at subsequent controls. After 7 months, unable to resume sporting activity because of physical discomfort and dyspnea on exertion, the patient asked for a second opinion at our Heart and Brain clinic. Two-dimensional (2D) TTE showed septum primum laceration next to a radiopaque polypropylene knot with a moderate bidirectional shunt located at the fenestrated septum primum far from the PFO site. A catheter-based closure of the septal defect was therefore planned under local anesthesia and rotational intracardiac echo monitoring. An equally sized discs 28.5 mm × 28.5 mm Flex II UNI occluder (Occlutech GmbH, Jena, Germany) was successfully implanted across the atrial septal defect without complications. The patient was discharged in good clinical conditions; dual antiplatelet therapy (aspirin 100 mg/daily and clopidogrel 75 mg/daily) was recommended for 2 months and then single antiplatelet therapy (aspirin100 mg/daily) up to 6 months. Abolition of the residual shunt was confirmed at 1- and 6-month follow-up by contrast transcranial Doppler and 2D color Doppler cTTE. Discussion: Closing a PFO with a suture-base system, without leaving a device implant behind, may be a cutting-edge technology and potential alternative to traditional devices. Nevertheless, meticulous selection of the PFO anatomies by 2D TEE is key to a successful closure procedure in order to avoid complications that must be managed again with a second percutaneous procedure or by surgery.

A Comparison of the Catheter-Based Transapical and Surgical Treatment Modalities for Mitral Paravalvular Leak.

BACKGROUND: There is a lack of studies where the outcomes of mitral paravalvular leak treatment were compared between surgery and catheter-based closure. The aim of this study was to compare the outcomes of re-do surgery with transapical catheter-based paravalvular leak closure. METHODS: This is a retrospective observational study at a single institution; 76 patients were included. According to the treatment, two groups were formed: the "Surgical" group (49 patients after re-do surgery) and the "Catheter" group (27 patients after transapical catheter-based treatment). RESULTS: In-hospital myocardial infarction occurred in 9 (18%) cases in the "Surgical" group and none in the "Catheter" group, p = 0.018. Procedure-related life-threatening bleeding occurred in 9 (18%) patients in the "Surgical" group and none in the "Catheter" group, p = 0.018. Nine (18%) patients died in 30 days in the "Surgical" group, and none died in the "Catheter" group, p = 0.039. A mean follow-up was 3.3 years. No difference was found between the groups by the degree of residual paravalvular regurgitation either at discharge or at follow-up. During the follow-up, 19 (39%) patients died in the "Surgical" group and 2 (7%) among the "Catheter" patients. CONCLUSIONS: Transapical catheter-based closure of mitral paravalvular leak seems to be a safer treatment procedure than conventional re-do surgery, and the effectiveness of these procedures does not differ.

Case Report: Challenging Treatment of an AorticParavalvular Leak: How We Avoided Interference With Mechanical Valve Function?

Background: Aortic paravalvular leak (APVL) after surgical valve replacement (AVR) is an ominous complication with a high risk of morbidity and mortality. Approximately 1-5% of PVLs can lead to serious clinical consequences, including congestive heart failure and/or hemolytic anemia. Case Summary: A 69-year-old man with multiple comorbidities underwent surgical replacement of the aortic valve with a mechanical tilting disc prosthetic valve (Medtronic Starlight 27 mm). Several years later, recurrent episodes of congestive heart failure and hemolytic anemia developed due to a large crescent-shaped aortic PVL located at non coronary cusp (NCC) 9-12 o'clock, with moderate-to-severe regurgitation. The patient was deemed at prohibitive surgical risk due to significant multiple comorbidities and a transcatheter PVL closure (TPVLc) was planned. The huge PVL was partially closed by a first specifically designed paravalvular leak device (PLD). The procedure was complicated by transient interference of the second PLD with mechanical prosthetic valve function. This issue has however been solved with correct manipulation, orientation and downsizing of the second device implanted. At 3-month and 13-month follow-up, the patient showed a relevant clinical improvement and good quality of life. 2D TTE color Doppler confirmed the stable position of the two PLDs with trace residual leak. Discussion: Surgical redo has been considered the treatment of choice for symptomatic patients with PVLs. Notwithstanding, TPVLc is a less invasive alternative, particularly in patients at high surgical risk in whom early diagnosis and prompt interventional treatment are crucial for improving expectancy and quality of life. Dedicated devices, appropriate procedural techniques, and the close interaction between imaging modalities, allowed to deal successfully with a challenging case of severe symptomatic aortic PVL.

Paravalvular Leakages after Surgical Aortic-Valve Replacement and after Transcatheter Aortic-Valve Implantation: Strategies to Increase the Success Rate of Percutaneous Closure.

Moderate to severe paravalvular-leak (PVL) regurgitation after surgical aortic-valve replacement or after transcatheter valve implantation represents a well-known complication associated with symptoms related to heart failure, hemolysis, or both in patients with multiple comorbidities and with poor prognostic outcomes. The transcatheter closure of aortic paravalvular leaks (APVLs) is currently considered a valid alternative to cardiac surgery. Nevertheless, careful patient selection, optimal cardiac imaging for intraprocedural guidance, and expert operators are key for success. Although technically demanding, particularly in APVLs after transcatheter valve implantation, catheter-based closure is an effective, less invasive, and often the only option for high-risk patients with symptomatic PVL regurgitation.

Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

Technical Recommendations for Real-Time Echocardiography and Fluoroscopy Imaging Fusion in Catheter-Based Mitral Valve Paravalvular Leak and Other Procedures.

Widespread catheter-based interventions for structural heart disease have overtaken the treatment of paravalvular leaks (PVL). Multimodality imaging techniques play a crucial role in accurate diagnosis, procedure planning and performance. However, PVL closure is often technically challenging due to the complex anatomy of the defects and their relation to surrounding anatomical structures. The application of echocardiography and fluoroscopy imaging fusion (EFF) may simplify challenging imaginative three-dimensional reconstruction of the intracardiac anatomy and facilitate the procedure. To master new technology, personnel must make cognitive changes, overcome a learning curve, and obtain adequate theoretical knowledge. Main aim of this manuscript is to present basic recommendations for EFF application in practice, alongside, each scenario is supported by technically challenging clinical examples. We may conclude that our manuscript may provide useful information for physicians on EEF application in clinical practice.

Procedural Tools and Technics for Transcatheter Paravalvular Leak Closure: Lessons from a Decade of Experience.

Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and hemolysis. Surgical PVL closure carries high risks. Transcatheter implantation of occluding devices in PVL is a lower risk but challenging procedure. Of the available devices, only two have been specifically approved in Europe for transcatheter PVL closure (tPVLc): the Occlutech® Paravalvular Leak Device (PLD) and Amplatzer™ ParaValvular Plug 3 (AVP 3). Here, we review the various tools and devices used for tPVLc, based on three observational registries including 748 tPVLc procedures performed in 2005-2021 at 33 centres in 11 countries. In this case, 12 registry investigators with over 20 tPVLc procedures each described their practical tips and tricks regarding imaging, approaches, delivery systems, and devices. They considered three-dimensional echocardiography to be the cornerstone of PVL assessment and procedure guidance. Anterograde trans-septal mitral valve and retrograde aortic approaches were used in most centres, although some investigators preferred the transapical approach. Hydrophilic-coated low-profile sheaths were used most often for device deployment. The AVP 3 and PLD devices were chosen for 89.0% of procedures. Further advances in design and materials are awaited. These complex procedures require considerable expertise, and experience accumulated over a decade has no doubt contributed to improve practices.

Can aura migraine be elicited by isolated pulmonary arteriovenous fistula?-A case report.

A pulmonary arteriovenous fistula (PAVM) is an abnormal blood vessel that creates a direct connection between a pulmonary artery and its tributary vein bypassing capillary filter, establishing as a consequence of a low-resistance right-to-left shunting (RLS). The vast majority of PAVMs are congenital appearing more often in females than in males. A great number of patients with PAVMs is suffering concurrently from hereditary hemorrhagic telangiectasia (HHT) whose incidence is around 1 in 5,000. Very few cases of acquired PAVMs have been described in the literature. Paradoxical embolism through PAVMs can cause systemic desaturation, cyanosis, and serious cerebrovascular ischemic events (transient ischemic attacks, strokes, and intracranial abscess), even when the abnormal blood vessel is small (diameter <3 mm). Notably, it has been reported a high prevalence of aura migraine (MHA) symptoms in patients with PAVMs and concomitant HHT. We described in this study the case of a young aura migraineur female patient without HHT in whom isolated PAVM below the detection limit of pulmonary angiography and chest computed tomography angiography (CTA) has been documented by contrast Transthoracic and Transesophageal Echocardiography (cTTE/TEE) showing a delayed (>17 s) RLS coming from left pulmonary veins to left atrium while a patent foramen ovale (PFO), small atrial septal defects or septum primum fenestration could not be detected despite several attempts. Contrast Transcranial Doppler (cTCD) confirmed a delayed (>16 s) RLS with two short "shower" patterns corroborating the diagnosis of an extra-cardiac RLS. During the right heart catheterization and pulmonary angiography, it was impossible to cross the interatrial septum with a multipurpose catheter. The patient was finally discharged with off-label thienopyridine agents (clopidogrel 75 mg die) in terms of primary prophylaxis for paradoxical right-to-left embolization of thrombotic material ultimately. Aura migraine symptoms were nearly abolished by P2Y12 platelet inhibition, suggesting a platelet-based mechanism. During 2 years of clinical follow-up on thienopyridine therapy, the resolution of aura migraine episodes was definitively accomplished with significant improvement in her quality of life.

Percutaneous Closure of Paravalvular Regurgitation After Third-Generation Transcatheter Aortic Valve Replacement.

Significant paravalvular leak regurgitation (PVLR) after transcatheter aortic valve replacement (TAVR) is a well-known complication associated with disabling symptoms related to heart failure and hemolysis or both, with poor prognostic implications. Although challenging and technically demanding, percutaneous closure is an effective treatment option for high-risk patients with symptomatic PVLR. Here, we present two cases of transcatheter PVLR closure after replacement of third-generation (one self-expandable and one balloon-expandable) transcatheter aortic valves, each with peculiar challenges, and the strategies adopted to increase the success rate of percutaneous closure.

Corrigendum: Catheter-based Closure of a Post-infective Aortic Paravalvular Pseudoaneurysm Fistula With Severe Regurgitation After Two Valve Replacement Surgeries: A Case Report.

[This corrects the article DOI: 10.3389/fcvm.2021.693732.].

Catheter-based Closure of a Post-infective Aortic Paravalvular Pseudoaneurysm Fistula With Severe Regurgitation After Two Valve Replacement Surgeries: A Case Report.

Backgsround: Infective endocarditis (IE) of prosthetic valves is a dire complication of cardiac valve replacement surgery and is associated with high rates of morbidity and mortality. Case Summary: A 72-year-old woman with multiple comorbidities underwent surgical replacement of the aortic valve with a mechanical prosthetic valve after recurrent IE. After 10 years, IE recurred and the mechanical valve was surgically replaced with a bioprosthetic valve. Ten years later, severe heart failure developed due to severe paravalvular leak (PVL) caused by an aortic annulus abscess complicated by a paravalvular pseudoaneurysm fistula (PPF). The patient was deemed at prohibitive surgical risk and a catheter-based PVL closure procedure was planned. However, the interventional procedure was delayed several months due to the Covid-19 pandemic with progressive heart failure worsening. Despite an acute satisfactory result of the PPF transcatheter closure and a significant clinical improvement, the patient died 10 months later due to multiorgan failure. It is likely that this was due, at least in part, to the long treatment delay caused by the unprecedented strain on the healthcare system. Discussion: In patients at high surgical risk, early diagnosis and prompt interventional treatment of severe PVL are crucial for improving expectancy and quality of life. However, the recent outbreak of COVID-19 caused deferral of elective and semi-elective structural heart disease procedures (SHD) as in our case. Thus, a proactive and vigilant stance on managing SHD should be a priority even in the context of the COVID-19 pandemic.

Large eustachian valve fostering paradoxical thromboembolism: passive bystander or serial partner in crime?

Catheter-based closure of patent foramen ovale (PFO) is more effective than medical therapy in the prevention of recurrent stroke[1]. It is likely that a proportion of patients evaluated for potential transcatheter PFO closure has actually different anatomical variants particularly common in the right atrium such as eustachian valve, Chiari network, Thebesian valve and Crista Terminalis. Notably, the eustachian valve may represent an increased risk factor for left circulation thromboembolism beyond that associated with PFO size and shunting. Such patients may benefit the most from percutaneous closure procedure.

EchoNavigator® technology facilitates transapical mitral paravalvular leak closure: a case report.

BACKGROUND: Catheter-based closure has emerged as a less invasive alternative to surgery in high-risk patients with paravalvular leak (PVL) and clinically significant regurgitation with feasibility and efficacy demonstrated in multiple studies. CASE SUMMARY: A 72-year-old female with a past history of long-standing rheumatic heart disease underwent mechanical mitral valve replacement in 2008. Ten years later, redo surgery was performed due to a worsening mitral PVL and the leakage was closed by direct pledget-supported sutures, preserving the mechanical valve. She was recently admitted again for haemolytic anaemia and congestive heart failure (New York Heart Association Classes III-IV) due to a recurrent mitral PVL. We report our initial clinical experience using a novel software solution (EchoNavigator®-system) for intuitive guidance during a catheter-based transapical mitral PVL closure. DISCUSSION: Transapical mitral PVL closure with a specifically designed device demonstrated in our case to be a better option than redo surgery. Recently introduced fusion imaging modalities enhanced visualization of soft tissue anatomy and device location improving enormously the results of this challenging intervention.