Periprosthetic Leak Research Articles

Transcatheter Aortic Valve Implantation for Severe Chronic Aortic Regurgitation.

Transcatheter aortic valve implantation (TAVI) has revolutionised the management of aortic valve disease, offering a less invasive alternative to traditional surgical valve replacement for severe aortic stenosis (AS). TAVI for pure aortic regurgitation (AR) is less well established, and, in fact, it was previously labelled as a relative contraindication. However, TAVI has been utilised for selected cases of pure or predominant AR. The primary limitations regarding the use of TAVI in AR are related to the absence of anatomical factors seen in patients with AS that have contributed to the safe and stable functioning of current-generation prostheses. These include aortic root dilatation, mobile valve leaflets and labile blood pressure within the aortic root, which may further increase the risk of valve migration and periprosthetic leak after deployment. Furthermore, patients with AR have more heterogeneous aortic root anatomies when compared to the population of patients with calcific or degenerative AS. This review article describes the current evidence for the off-label use of TAVI in pure AR and the various clinical syndromes associated with AR where there may be specific challenges in the application of TAVI.

A RARE CASE OF LOEYS–DIETZ SYNDROME: THE IMPORTANCE OF DIAGNOSIS IN PATIENTS UNDERGOING CARDIOVASCULAR SURGERY

Abstract Background Loeys–Dietz syndrome (LDS) is a rare autosomal dominant genetic disorder of connective tissue, characterised by a broad spectrum of craniofacial, vascular (arterial tortuosity and aneurysms) and skeletal clinical signs. Four subtypes have been described, related to mutations in genes encoding for components of the transforming growth factor beta signalling pathway (TGFBR1, TGFBR2, SMAD2, SMAD3, TGFB2 and TGFB3). Diagnosis is based on the evaluation of clinical manifestations and family history. Therefore, many radiologists remain unfamiliar with the imaging and clinical findings in LDS. The Case 75–year–old woman, history of surgery for ruptured gastric a. aneurysm and ectasia of visceral arterial vessels. One year onset of worsening dyspnoea and asthenia, at echocardiography (ECOCG) severe aortic insufficiency has been detected and patient underwent aortic valve replacement with bioprosthesis. Cardiac surgery was complicated by aortic dissection (Stanford A; DeBakey I type) treated with replacement of ascending aorta and anterior hemiarch with tubular prosthesis. On that occasion a family diagnosis of SMAD3 gene mutation was made (both sister and nephew typed), compatible with Loeys–Dietz syndrome type 3. At the control angioTC evidence of proximal and distal anastomosis in order, in the absence of signs of periprosthetic leak. At ECOCG (FE 55%), thickened septum with marked postcardiac dyskinesia. No abnormality detected on ECG. Due to persistence of dyspnoea on mild exertion (NYHA class III) and reduced tolerance to orthostatism, cardiac rehabilitation program was undertaken on an outpatient basis for three months, providing an improvement in exertion tolerance (NYHA II) and a benefit on functional autonomy. LDS is a multisystem connective tissue disorder that is associated with a high burden of complications, a correct diagnosis will allow clinicians to appropriately establish the best therapeutic strategy, especially in cardiac surgery, taking into account the intraoperative and perioperative potential risks.

Long-Term Management of Voice Rehabilitation Using Voice Prosthesis (Provox<sup>®</sup>) After Total Laryngectomy

Voice rehabilitation after total laryngectomy is of paramount importance for improving quality of life following surgery. Tracheoesophageal voice with a voice prosthesis has been considered the gold standard for voice rehabilitation. The success rate of voice rehabilitation using a voice prosthesis is known to be over 90%. However, voice prostheses require regular replacement. The average lifespan of the device is four to six months. Common reasons for replacement include leakage around or within the prosthesis (endo- or periprosthetic leakage). Adjustments to the prosthesis may be necessary to address these adverse events. Provox<sup>®</sup> (Atos medical, Sweden) has been one of the most widely used voice prostheses. It offers a range of devices to address various issues. Regular follow-up appointments are essential for monitoring voice quality, identifying and addressing any complications, and providing ongoing support and guidance.

Treatment of an Enlarged Periprosthetic Leakage Using Filler Injection in Patients With Provox Prosthesis: A Case Report

Recently, the most commonly used method for voice rehabilitation in total laryngectomy patients is to maintain tracheoesophageal shunt speech after inserting a voice prosthesis. One of the most common side effects, besides valve deterioration, is periprosthetic leakage due to dilatation of the tracheoesophageal shunt. Tissue implantation may be considered as one of the conservative treatments before attempting surgical treatment. When tissue implantation is attempted more than once, the treatment success rate is close to 90%. The authors experienced a case in which an 86-year-old patient developed aspiration pneumonia due to periprosthetic leakage. The patient refused surgical treatment. He was treated successfully for injecting hyaluronic acid filler 3 times and has been without a leakage for 9 months. This procedure can be considered as an alternative method to treat periprosthetic leakage.

Efficacy of 3D-multidetector computed tomography and fluoroscopy fusion for percutaneous left atrial appendage occlusion procedures.

We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.

The acceptance and voice quality of a new voice prosthesis ‘Vega High performance’ – a feasibility study

Background The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime. Objectives This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime. Methods Laryngectomized patients previously using a Provox Vega or ActiValve Light were included. Acceptance and voice outcomes were evaluated at two-time points with a 2-week interval. Baseline measurements were taken with the standard VP, followed by placement of the PVHP for the 2-week assessment. Results Fifteen participants completed the study, with thirteen being initial Vega-users. PVHP acceptance was 87% 2 weeks after placement. Median device lifetime for all VPs was 64 d (range 14–370). In the subgroup without periprosthetic leakage, the median device lifetime was 101 d (range 31–370). Acceptance dropped to 40% after device failure. Voice quality did not differ between PVHP and baseline VP. The most reported adverse event was PVHP valve stickiness (46%). Conclusion and significance Acceptance of the PVHP is largely dependent on device lifetime, decreasing from 87% to 40% after leakage or replacement. Voice quality remains consistent across different VPs. Developing a long-lasting VP remains a challenge.

Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients.

Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal® stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega® and Provox XtraSeal® prostheses used in these patients in a tertiary university hospital. A prospective crossover case study of laryngectomees with Provox Vega® who underwent Provox XtraSeal® placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan-Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation. A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega® and 68 Provox XtraSeal®. The mean duration of Provox Vega® was 119.75 ± 148.8 days and that of Provox XtraSeal® was 181.99 ± 166.07 days (p = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega® and 29 (48.33%) in that of XtraSeal® (p < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63. The Provox XtraSeal® is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega®.

P298 TRANS–AXILLARY ACCESS AS AN ALTERNATIVE ROUTE IN TRANSCATHETER AORTIC VALVE IMPLANTATION

Abstract Background Transcatheter aortic valve replacement (TAVR) is the main procedure for treating severe aortic stenosis in patients considered at high surgical risk. Generally, this procedure is performed through percutaneous femoral arterial access. The presence of anatomical variants or peripheral atherosclerotic pathology sometimes necessitates the use of alternative vascular accesses, including access through the axillary artery. Data from a meta–analysis involving 1793 patients who underwent TAVR through trans axillary or transapical access showed a statistically significant reduction in 30–day mortality in the former group. We wait for future randomized trials to confirm the consistency of these data. Clinical case 71–year–old man, smoker, hypertensive and dyslipidaemic. In 2018, he underwent bilateral aorta–iliac–femoral bypass surgery for severe lower limb arteriopathy. Due to the onset of angina and dyspnea at rest, he went to the ER where a diagnosis of NSTEMI was made. On echocardiogram, there was evidence of severe high–gradient aortic stenosis while coronary angiography showed 80% RCA stenosis in the middle tract. Because of the high surgical risk (EUROSCORE II: 12%) and the evidence of bilateral femoral artery occlusion on CT–angiography, the Heart Team concluded to perform TAVR through percutaneous left trans–axillary access with concomitant percutaneous coronary revascularization. Obtained the backup access on the left radial artery, PTCA+DES was performed on RCA through the right radial access with subsequent placement of a pigtail catheter in the non–coronary sinus of Valsalva. Once the temporary pacemaker had been placed through the right femoral vein, an angio–guided puncture of the left axillary artery was performed with placement of the 14 Fr introducer for implantation of the Medtronic Evolut R 26 mm aortic biological prosthesis. Post–procedure ultrasound examination showed a residual mean aortic valve gradient of 17 mmHg with evidence of a small periprosthetic leak. Seven days after the procedure, the patient was discharged, asymptomatic and in good hemodynamic compensation without vascular complications. Conclusions Trans–axillary arterial access should be considered a viable alternative to transfemoral access for the performance of TAVR.

Tissue augmentation treatment for periprosthetic leakage in patients who have undergone a total laryngectomy: A systematic review.

Tracheoesophageal puncture (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy. One of the main causes of treatment failure, and a potentially serious complication, is the TEP enlargement and/or leakage around the voice prosthesis. The injection of biocompatible material to increase the volume of the puncture surrounding tissue has been studied as a popular option for conservative treatment of enlarged tracheoesophageal fistula. The aim of this paper was to perform a systematic review of the efficacy and safety of such treatment. Search conducted in PubMed/MEDLINE, the Cochrane Library, Google Scholar, Scielo and Web of Science and through the meta-searcher Trip Database based on Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) statement. Human experiments published in peer-reviewed journals, where investigators assessed the use of peri-fistular tissue augmentation for periprosthetic leakage were evaluated. Laryngectomized patients with voice prosthesis, presenting periprosthetik leak due to enlarged fistula. mean-duration without new leak. A total of 196 peri-fistular tissue augmentation procedures in 97 patients were found in the 15 selected articles. The 58.8% of patients had a time without periprosthetic leak after treatment of >6months. The 88.7% of tissue augmentation treatments resulted in periprosthetic leakage cessation. The general level of evidence of the studies included in this review was low. Tissue augmentation treatment is a minimally invasive, biocompatible and safe solution that temporarily resolves periprosthetic leaks in many cases. There is no standard technique or material, and treatment needs to be individualised according to the experience of the practitioner and the characteristics of the patient. Future randomised studies are needed to confirm these results.

Handling Extensive Mitral Annular Calcification via a Minimally Invasive Right Mini-Thoracotomy Approach

Mitral annular calcification is a chronic and degenerative process of the fibrous base of the mitral valve. Surgical management of mitral valve dysfunction with severe annular calcification remains technically demanding and, to date, the preferred approach is still a standard full sternotomy. We aimed to analyze and report our experience with mitral valve surgery addressing annular calcification via the minimally invasive approach through a right mini-thoracotomy. Data of patients with mitral valve disease and underlying annular calcification undergoing minimally invasive surgery from 2018 to 2022 were prospectively collected and retrospectively analyzed. The severity of mitral annular calcification was categorized with an angio-computerized tomography scan analysis as mild, moderate or severe according to calcium thickness, calcium distribution, and trigone and leaflet involvement using the Mitral Annular Calcification Computerized Tomography-score. During the study period, 27 patients with mitral valve disease and associated mitral annular calcification were enrolled. The most common etiology was advanced Barlow’s disease, which was encountered in 18 cases (67%). Mitral valve replacement was performed in 21 patients (78%). No intraoperative death, atrioventricular disruption, or circumflex coronary artery injury occurred. Conversion to sternotomy was necessary in a single case. Residual moderate periprosthetic leak requiring early reoperation and permanent heart block mandating permanent pacemaker implantation were reported in one and in three patients, respectively. No cases of stroke were reported. Two patients died, accounting for a 7.4% perioperative mortality. At a median follow-up of 9 months, one patient had residual moderate mitral regurgitation, whereas two patients required short-term reoperation and prosthetic valve (re)replacement. Minimally invasive mitral valve surgery via right mini-thoracotomy should be considered an and effective approach to be indicated also in patients with mild-to-severe mitral annular calcification. Routine angio-computerized tomography scan during work-up is a mandatory step to stratify the anatomical extension and severity of the mitral annular calcification.

3D printing integrated with multimodality imaging for planning periprosthetic leak closures

Percutaneous closure of the paravalvular leak (PVLc) has emerged as a palliative alternative to surgical management in selected cases. A multimodal imaging analysis before and during the procedure is mandatory to choose the better device based on anatomical factors. However, it remains challenging in achieving complete leak occlusion, while respecting prosthesis function. 3D printed models have emerged as a useful tool to assist complex cardiac interventions. To explore the additional value of 3D printing integrated with multimodality imaging in predicting complications including mechanical valve leaflets blockade, device embolization, residual shunt. We selected 11 PVLc procedures from 3 centers in which 3D printed model were used prior to the procedure from the prospective FFPP registry between 2017 and 2019 (NCT05089136). Cardiac CT was used for segmentation for 3D printed (3D-heart modeling, Caissargues, France). Technology used a laser to fuse very fine powders [thermoplastic polyurethane (TPU)] into a final part – laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed before the procedure. Four PVLc mitral prostheses (3 mechanical). Six aortic: 2 biological, 2 suturesless, 2 mechanical. One PVLC post-tricuspid annuloplasty (Fig. 1). The device chosen on 3D model matched with in situ one in 8/11 cases without residual leakage. A risk of prosthesis blocage was detected in 5 cases. In one patient the plug was not implanted, in another the plug was removed, in another case the orientation of the plug was optimally adapted according to the simulation while in 2 patients, the plug-induced blockage detected during the 3D printing simulation occurred delayed after the procedure when the loading conditions changed. 3D printing can be integrated into the multimodal planning of PVLc procedures. It improves the detection of the risk of complications such as leaflet blockage or residual leakage through a direct study of the interaction between the devices and the prosthesis, taking into account the deformations of both the devices and the surrounding structures.

Minimally invasive treatment of postoperative fistulas, leakages, and perforations of the upper gastrointestinal tract: a single-center observational study.

Most anastomotic leaks in the upper gastrointestinal (GI) tract can be treated with minimally invasive techniques dominated by endoluminal vacuum therapy (EVT) or stent implantation. Chronic leaks often require additional solutions, such as tissue adhesives or cellular growth stimulants. To present a treatment strategy for postoperative leakage of upper GI anastomoses with noninvasive procedures. A group of 19 patients treated in the period 2015-2023 with postoperative upper GI tract leakage was enrolled for endoscopic treatment. The indication for the therapy was anastomotic dehiscence not exceeding half of the circumference and the absence of severe septic complications. All patients were managed using endoscopic vacuum therapy (EVT) or a self-expanding stent while persistent fistulas were additionally treated with alternative methods. The EVT was successfully implemented in 13 cases, but 7 patients required alternative methods to achieve definitive healing. Self-expanding stent placement was performed in 6 patients; however, in 3 cases a periprosthetic leakage occurred. In this group, 2 patients had the stent removed and the third one died due to septic complications. Post-treatment stenosis was identified in 5 patients after EVT that required balloon dilation with acceptable resolution in all cases. Early detected anastomotic dehiscence limited to half of the circumference most effectively responded to the noninvasive treatment. Nutritional support as well as complementary endoscopic solutions such as tissue adhesives, growth stimulants and hemostatic clips increase the percentage of complete healing.

870 COMBINING PERCUTANEOUS CORONARY INTERVENTION AND TRASCATHETER AORTIC VALVE REPLACEMENT PROCEDURES: THE IMPORTANCE OF INTRAVASCULAR LITHOTRIPSY

Abstract Background Calcified coronary artery disease and severe valvular aortic stenosis (AS) often coexist. For instance, severely calcified lesions may strongly influence the revascularization strategy in patients undergoing transcutaneous aortic valve replacement (TAVR). Shock wave intravascular lithotripsy (S-IVL) (Shockwave Medical Inc. Santa Clara, CA) is the only technology available that cracks both medial and intimal calcium while minimizing trauma to the vessel wall, thus allowing a safe plaque debulking. We report a case of percutaneous coronary intervention (PCI) and TAVR in the same procedure, where S-IVL has been used to treat a heavily calcified lesion and optimize stent under-expansion. Case Report A 79 years-old male patient with a history of diabetes mellitus type 2, hypertension, and peripheral artery disease, was admitted to our institution with symptomatic severe AS and severe calcified left anterior descending (LAD) artery lesion at CT scan. Deemed eligible for TAVR, Heart Team planned a percutaneous coronary intervention (PCI) of LAD and TAVR in the same procedure. Through the left radial artery, coronary angiography confirmed 90% stenosis of the LAD at the central segment. Accordingly, pre-dilatation of the stenosis was performed with a 2.5×12 mm non-compliant balloon (NCB) and, because of the severe calcification, S-IVL with a 3.0×12 mm balloon inflated at 4-6 Atmospheres (ATM), delivering 40 pulses. Following, a 3.5×18-mm drug-eluting stent was implanted at 18 ATM. After implantation, an inadequate expansion of the stents was observed, which persisted despite post-dilation with 3.75×8 mm NCB at high-pressure. Bail-out S-IVL was then performed with the 3.0×12 mm balloon inflated at 4-6 ATM, delivering 40 pulses in-stent, followed by a further stent post-dilated with a 3.75×8 mm NCB up to 20 ATM. The final angiogram showed a satisfactory stent expansion. Since the low contrast volume was used, we decided to go ahead with transfemoral TAVR. Therefore, through the left femoral artery access, a 34-mm self-expandable Evolut R valve was implanted. Transthoracic echocardiography showed optimal valve implantation with a trivial periprosthetic leak. No complications were observed after the procedures and the patient was discharged after 6 days with 6 months of mandated dual antiplatelet therapy (Aspirin and Clopidogrel). Discussion In this case, the bail-out use of S-IVL was essential for an optima stent implantation, allowing TAVR procedure and avoiding prolonged theoretical antithrombotic therapy underlying suboptimal stent implantation. Despite encouraging initial results, future large studies with long-term observation are required to evaluate the safety and efficacy of S-IVL in this scenario.

Surgical Management of Periprosthetic Leakage after Prosthetic Voice Restoration: Report of 2 Cases

Surgical Management of Periprosthetic Leakage after Prosthetic Voice Restoration: Report of 2 Cases

Troubleshooting recalcitrant tracheoesophageal prosthesis site leak with internal mammary artery perforator flap: a case report

BackgroundAn enlarged tracheoesophageal puncture (TEP) site is a grave complication of voice prosthesis rehabilitation.Case presentationWe report a case of periprosthetic leakage with an enlarged tracheoesophageal fistula causing aspiration, not responding to conservative management and primary closure. Internal mammary artery perforator (IMAP) flap was subsequently used in the management. The flap was successfully taken up at the recipient site with no leak post-operatively as confirmed by barium swallow, thereby preventing further aspiration.ConclusionThough minor degrees of TEP leak usually respond to conservative management, the recalcitrant ones require active intervention which one should be aware of.

Novel stapler-assisted technique for closure of persistent tracheoesophageal puncture fistula.

Tracheoesophageal puncture (TEP) is a reliable method to restore voice and is an important part of voice rehabilitation following laryngectomy. However, complications following this procedure, including peri-prosthetic leakage and resulting aspiration pneumonia, may necessitate surgical closure. In this study, we present an effective and reliable method for TEP closure using a stapler-assisted technique. Case series study for patients who underwent stapler-assisted TEP closure reviewed from 2017 to 2021. All five patients had successful closure of their TEP tract without further leakage. No postoperative bleeding, wound infection, or esophageal stenosis occurred. One patient had postoperative stomal stenosis. The stapler-assisted technique for TEP closure is easy, quick, and effective. The reliability and quick return to oral intake post-operatively make it a preferable option over previous techniques.

Sustitución valvular aórtica con bioprótesis convencionales o sin sutura: resultados clínicos y comportamiento hemodinámico a 3 años

Introduction1-year outcomes of the sutureless bioprosthesis Perceval S are similar to conventional bioprostheses. Nevertheless, the mid-term evidence is scarce. ObjectivesMid-term follow up analysis of major adverse cardiovascular events analysis and hemodynamic performance, after aortic valve replacement with conventional bioprostheses or the Perceval S bioprosthesis in an adjusted cohort. MethodsRetrospective analysis of a 1:1 propensity score matched cohort of patients who underwent aortic valve replacement, with or without concomitant coronary artery bypass grafting. Results52 patients were included in each group, with similar preoperative characteristics. At 3-year follow up, we observed no statistically significant differences in major adverse cardiovascular events nor hemodynamic performance between conventional or sutureless bioprostheses. Survival: 92,31% vs 92,1%; P=.957. Stroke: 100% vs 94,23%; P=.080. Valve reintervention: 100% vs 94,81%; P=.200. Mean gradient: 10,6mmHg vs 10,7mmHg; P=.875. Peak gradient: 20,7mmHg vs 21,0mmHg; P=.856. Moderate or severe periprosthetic leak: 0 vs 1,92%; P=.136. ConclusionsAt 3 years, the Perceval S bioprosthesis presented similar outcomes in major adverse cardiovascular events and hemodynamic performance as conventional bioprosthesis.

Experiencia de un centro en el reemplazo percutáneo de la válvula mitral mediante el dispositivo Tendyne™

Introduction and objectivesTranscatheter mitral valve replacement (TMVR) is an alternative treatment for high-risk surgical patients with severe symptomatic mitral valve disease who are not candidates for other percutaneous techniques. The TendyneTM prosthesis (Abbott Vascular, USA) is a self-expanding, repositionable, and recoverable porcine pericardium prosthesis, which is implanted transapically. The objective of our study is to present our initial experience in the implantation of the TendyneTM prosthesis. Material and methodsAll patients undergoing transcatheter mitral valve replacement with a TendyneTM prosthesis since december 2020 were retrospectively analyzed. Baseline, intraoperative, and postoperative characteristics were described. The preoperative, immediate postoperative and one-month postoperative echocardiogram were analyzed. ResultsTen transcatheter mitral valve replacements have been performed in our center with a TendyneTM prosthesis. 40% (n=4) of the patients were male with a median age of 79.1 (IQR 76.4-81). The median of the EuroScore II was 4.8 (IQR 2.8-6.9) %. The most frequent etiologies were rheumatic 33.3% (n=3) and degenerative 33.3% (n=3). No patient had to be reconverted. One patient died in the immediate postoperative period due to stroke. The echocardiogram performed one month after surgery did not detect periprosthetic leaks, prosthetic thrombosis, or LVOT obstruction in any patient. During follow-up, 100% of the patients presented an MR less than or equal to I/IV. The median transprosthetic mean gradient at discharge was 4.1 (IQR 3.7-5.2) mmHg and 4.1 (IQR 2.3-5.6) mmHg one month postoperatively. ConclusionsTranscatheter mitral valve replacement with the TendyneTM prosthesis is a safe and effective therapeutic alternative in patients with high or prohibitive surgical risk and symptomatic mitral valve disease.

Post-Laryngectomy Voice Prosthesis Changes by Speech-Language Pathologists: Preliminary Results.

Background: In the present study, we assess the feasibility and success outcomes of voice prosthesis (VP) changes when performed by a speech-language pathologist (SLP). Methods: Patients treated with total laryngectomy (TL) from January 2020 to December 2020 were prospectively recruited from our medical center. Patients benefited from tracheoesophageal puncture. The VP changes were performed by the senior SLP and the following data were collected for each VP change: date of placement; change or removal; VP type and size; reason for change or removal; and use of a washer for periprosthetic leakage. A patient-reported outcome questionnaire including six items was proposed to patients at each VP change. Items were assessed with a 10-point Likert-scale. Results: Fifty-two VP changes were performed by the senior SLP during the study period. The mean duration of the SLP consultation, including patient history, examination and VP change procedure, was 20 min (range: 15–30). The median prosthesis lifetime was 88 days. The main reasons for VP changes were transprosthetic (n = 34; 79%) and periprosthetic (n = 7; 21%) leakages. SLP successfully performed all VP changes. He did not change one VP, but used a periprosthetic silastic to stop the periprosthetic leakages. In two cases, SLP needed the surgeon’s examination to discuss the following indication: implant mucosa inclusion and autologous fat injection. The patient satisfaction was high according to the speed and the quality of care by the SLP. Conclusions: The delegation of VP change from the otolaryngologist–head and neck surgeon to the speech-language pathologist (SLP) may be achieved without significant complications. The delegation of VP change procedure to SLP may be interesting in some rural regions with otolaryngologist shortages.

P331 IMPLANT OF THE BALLOON EXPANDABLE BIOLOGICAL PROSTHESIS FOR TAVI (EDWARDS SAPIEN 3 ULTRA) PRE–ASSEMBLED ON EXPANSION BALLOON, IN “OPEN” SITUATION WITH PATIENT IN CEC

Abstract The biological valve prostheses malfunctioning often leads to severe forms of heart failure, whose treatment requires surgical or percutaneous re–intervention. We report the case of a 77–year–old man with a biological aortic prosthesis since 2009 (Elan stentless–21), hospitalized for acute cardiac decompensation related to severe aortic prosthetic insufficiency (likely infective endocarditis with periprosthesis abscess involving the perivalvular fibrous lamina) and coexistence of severe mitral insufficiency. After 25 days of therapy, in stable haemodynamic conditions, surgery was scheduled to replace the aortic prosthesis and the mitral valve, in CEC. The exposure of the aortic valve plane highlighted the rupture of the prosthetic coronary cusp in the absence of prosthetic detachment and perivalvular abscess. After removal of the degenerated cusps, the preparation and implantation of the new biological prosthesis (perimount–Magna–19) was hindered by the excessive presence of calcium–fibrosis in the suture site of the valve ring which did not allow adequate sealing, with multiple peri–prosthetics leaks; the possibility of sutureless prostheses implantation was made impossible by lack of adequate anatomical conditions. In these conditions, the possibility of implanting a biological prosthesis for TAVI, pre–mounted on the expansion balloon (Ewards–Sapien3–Ultra–23mm), in an “open” situation and in CEC, was considered. The implantation of the balloon–expandable prosthesis was performed with direct vision of the aortic annulus and coronary ostia; the insertion of the prosthesis was performed on a standard “J” guide wire positioned in the ventricle; the expansion of the prosthesis was performed in two balloon inflation steps. The intraoperative ecotransophageal echo demonstrated the correct positioning of the biological aortic prosthesis with minimal periprosthetic leak. The presence of severe residual mitral insufficiency suggested a replacement of the mitral valve with biological prosthesis. On day 4 the patient was clinically stable; the transesophageal echocardiogram showed normal functioning of the prostheses. The direct implantation of the expandable biological prosthesis in the cardiac surgery room, in “open” and CEC, after excluding active endocarditic processes and infectious complications, allowed the implantation of a larger prosthesis and to avoid significant perivalvular leaks.