Implantation Of Bioprosthesis Research Articles

Sutureless Bioprostheses for Aortic Valve Replacement: An Updated Systematic Review with Long-Term Results.

Background: In recent years, in case of aortic valve replacement (AVR), a significant increase in the use of bioprostheses has been observed. The Perceval sutureless bioprosthesis has proven to be safe and reliable in the short and mid-term, with limited but promising long-term results. An updated systematic review with the long-term results of patients who underwent a sutureless bioprosthesis implantation with a Perceval biological valve is herewith presented. Methods: Studies published between 2015 and 2024, including the long-term outcomes-with clinical as well as echocardiographic information for up to five years-of patients who underwent a Perceval implantation for AVR were selected from the published literature. The Cochrane GRADE system was used to assess the study quality, and the risk of bias in non-randomized studies (ROBINS-I) tool was used to evaluate studies. Results: Ten studies were selected with an overall number of 5221 patients. The long-term survival ranged from 64.8 to 87.9%, freedom from structural valve degeneration (SVD) from 96.1 to 100%, freedom from significant paravalvular leak from 98.5 to 100%, freedom from prosthetic endocarditis from 90.7 to 99%, and freedom from reintervention from 94 to 100%. The long-term mortality ranged from 6.5 to 27.4%. SVD was observed in 0-4.8% patients. Significant paravalvular leak was observed in 0-3.4% patients, and infective endocarditis was observed in 0-3.4%. A bioprosthesis-related reintervention at long-term follow-up was required for 0-4.3% of patients, and 1.7-7.1% of patients required a late new pacemaker implantation. The transprosthetic mean pressure gradient ranged from 9 to 14.7 mmHg, peak pressure gradient ranged from 17.8 to 26.5 mmHg, and EOA ranged from 1.5 to 1.7 cm2. Conclusions: This systematic review shows that there is still a paucity of data about sutureless bioprostheses. Nevertheless, the clinical results from prospective studies or retrospective series are encouraging. Medium- and long-term results seem to support the increasing use of this type of prosthesis.

Prevalence and prognostic value of thrombocytopenia in aortic valve replacement surgery: bioprosthesis versus mechanical prosthesis

Abstract Background Thrombocytopenia is a frequent complication of valve surgery, and is associated with different postoperative outcomes. Concern has recently arisen about thrombocytopenia following aortic valve replacement (AVR), as some authors have reported increased postoperative thrombocytopenia with certain biological aortic valves. In adittion, it is unclear whether thrombocytopenia predicts mortality in this type of surgery. Purpose The aim of this study was to determine the prevalence and prognostic value of thrombocytopenia in biological and mechanical aortic valve replacement. Methods The study was an observational analysis of patients undergoing AVR with or without associated coronary artery bypass grafting (CABG) at a single center between October 2014 and October 2023. Cardiac Surgery database was computerized and prospectively completed. Preoperative and first 4 days postoperative platelet counts were analyzed. Thrombocytopenia was defined as platelet count < 100 × 10³/mm³. To obtain comparable populations, a propensity score matching analysis was performed. Results A total of 1,197 patients underwent AVR with (n = 494) or without CABG (n = 703). Patients received either a mechanical prosthesis (n = 320), or a biological prosthesis (n = 877). The mean population age was 68 years (SD 6), with the majority being male (68%). Univariate analysis of the baseline characteristics of both groups of patients showed that they were not comparable. A risk-adjusted subanalysis was performed according to a propensity score (n=278). The nadir of bioprostheses was on the third postoperative day with an average of 93.8 × 10³/mm³, while in mechanical prostheses was also on the same day but with an average of 114.7 × 10³/mm³ (p: 0.001). (Figure 1) Bioprosthesis implantation was significantly associated with a higher prevalence of thrombocytopenia (72.7% vs. 45.3%, p<0.001). The presence of postoperative thrombocytopenia has been associated with higher in-hospital mortality (6.7% vs. 0.9%, p=0.019); but not with other postoperative complications. (Figure 2) Conclusions Patients undergoing AVR with bioprostheses had a significantly higher prevalence of thrombocytopenia, and also lower platelet counts than mechanical prothesis within the first 4 postoperative days. Thrombocytopenia was associated with higher in-hospital mortality in a risk score-adjusted population.Platelet counts after AVROutcomes according to platelet count

Sutureless Aortic Valve Replacement with Perceval Bioprosthesis Superior to Transcatheter Aortic Valve Implantation: A Promising Option for the Gray-Zone of Aortic Valve Replacement Procedures-A State-of-the-Art Systematic Review, Meta-Analysis, and Future Directions.

Background: The management of patients with aortic valve pathologies can sometimes fall into a "gray zone", where the optimal treatment approach is not straightforward. The comparative benefits of sutureless aortic valve replacement (SUAVR) using the Perceval bioprosthesis versus transcatheter aortic valve implantation (TAVI) for the "gray zone" of aortic valve replacement procedures remain a topic of debate. To further explore this issue, we conducted a study with pairwise, single-arm, and Kaplan-Meier-based meta-analyses to compare the outcomes of SUAVR with the Perceval bioprosthesis versus TAVI, as well as to evaluate the efficacy, safety, and durability of SUAVR with the Perceval bioprosthesis over mid-term and long-term follow-up periods. Methods: The PubMed, PubMed Central, OVID Medline, Cochrane Library, Embase, and Web of Science databases were systematically searched. All study types were included, except study protocols and animal studies, without time restrictions. The final search was carried out in May 2024. Results: No statistically significant differences were observed in permanent pacemaker implantation (PPI) rates between the two groups. SUAVR showed a lower incidence of new-onset myocardial infarction but was associated with higher rates of new-onset atrial fibrillation and major bleeding. TAVI had higher rates of left bundle branch block and major vascular complications. Conclusions: Our findings show that SUAVR has a lower incidence of complications and a favorable mid-term overall survival compared to TAVI. SUAVR has more advantages compared to TAVI and can be considered a valuable and promising option for the "grey zone" of aortic valve pathologies.

Transfemoral leadless pacemaker implantation after tricuspid valve surgery and intervention

Abstract Background and Purpose Pacemaker (PM) implantation after surgical or transcatheter tricuspid valve (TV) repair or replacement may be challenging. Transcatheter leadless pacemaker (LPM) implantation has become a routine procedure and is frequently adopted in patients without the need for an atrial lead, in cases with cardiac implantable device infection or in patients with marked comorbidities. The use of LPM in patients with previous TV repair or replacement has only been described in singular cases in literature. We present our single center experience of LPM implantation after TV repair. Methods Patients with a history of TV repair or replacement who underwent LPM in our institution between 01/2020 and 11/2023 were retrospectively analyzed. All patients underwent routine clinical follow-up investigations including LPM interrogation and transthoracic echocardiography to assess for TV status. For LPM implantation right anterior oblique (RAO) and left anterior oblique (LAO) caudal fluoroscopy projections were utilized to enable LPM device passage across the TV. Results The study population consisted of 10 patients (9 females, mean age 74.0±10.0 years). Two patients had a history of surgical TV annuloplasty repair and two patients a history of surgical valve replacement, four patients of transcatheter TV repair (one through the mitral clip), one patient of transcatheter valve-in-ring bio prosthesis implantation prosthesis after previous surgical ring deployment and one patient transcatheter TV replacement (Figure1). All patients suffered from permanent atrial fibrillation previous to implantation procedures. Three patients were on chronic hemodialysis therapy before LPM implantation. LPM systems were successfully implanted in all cases with a mean procedure time of 43.5±26.5 minutes and a mean fluoroscopy time of 5.9±5.5 minutes and a radiation dose of 1148,7±1424,9 cGy·cm2. For fluoroscopically guided TV crossing a mean LAO angle of 43.6±14.1° (range 22 to 53°) and caudal angle of 8.5±6.9° (range 0 to 20°) was utilized (Figure 2). The LPM device was positioned in the first positioning attempt in a right ventricular high septal localization in 8 cases. Mean pacing threshold was 0.36±0.07 V at 0.25 ms, with a mean sensing amplitude of 10.5±2.9 mV and a mean of 853±324 Ohms pacing impedance. No periprocedural complications occurred. Mean duration of follow-up was 8.1±9.2 months. There were no newly developed TV regurgitations noted. Pacing thresholds (0.37±0.1 V/0.25 ms), sensing amplitude (11.8±4.5 mV) as well as pacing impedances (865±365 Ohms) remained stable until the last follow-up investigation. Conclusion LPM implantation was feasible in patients with a history of TV repair or replacement. LPM implantation was safe and effective in various modalities of TV repair. LPM may be an alternative to conventional pacemaker implantations as well as surgical lead placement in selected patients.Figure 1.Figure 2.

NOSOCOMIAL ENDOCARDITIS ON AORTIC BIOPROSTHESIS, A CASE OF ACCELERATED ATHEROSCLEROSIS

Abstract Male, 79 years old, presented to the ED with chest pain and hemodynamically instability. Approximately one month prior, he underwent aortic bioprosthesis implantation for severe aortic stenosis. Pre–intervention coronary angiography revealed diffuse atheromatous plaques, none of which were stenotic. Additionally, the patient‘s medical history included paroxysmal atrial fibrillation on NOAC, hypertension and COPD. Upon admission: NIBP 80/50 mmHg, HR 150 bpm, and oxygen saturation was 85%. ECG showed atrial fibrillation with ST–segment elevation from V1 to V5. Arterial blood gas analysis revealed pH 7.25 and lactate 6 mmol/L. He received inotropic and vasopressor support, and prompt coronary angiography was performed, revealing 99% stenosis of the mid left anterior descending artery at the bifurcation with the diagonal branch, which was treated with angioplasty and coronary stent placement (Fig.1). Transthoracic echocardiography demonstrated the presence of the aortic bioprosthesis with diffusely thickened leaflets consistent with multiple vegetations. Transesophageal echocardiography confirmed a nosocomial infectious endocarditis, with mild–to–moderate stenosis, and evidence of peri–prosthetic echogenic material directed towards the left atrium, suggestive of abscess. The patient reported low–grade fever and asthenia in the weeks prior. The systemic and local inflammatory state of the endocarditis contributed to an accelerated atherosclerotic process, destabilizing the plaque and resulting in its rupture. Blood cultures identified multidrug–resistant Staphylococcus hemolyticus, for which specific antibiotic therapy was started. The patient and his family declined cardiac surgery due to high operative risk. Follow–up TEE, after approximately six weeks of intravenous antibiotic therapy, showed reduced vegetations on the bioprosthetic valve leaflets, with evolution of the previously noted large echolucent cavity, along with two similar peri–prosthetic lesions. These findings were confirmed on contrast–enhanced CT. The patient, achieving hemodynamic stability, was discharged home, continuing intravenous antibiotic therapy (OPAT protocol). At the one–month post–discharge follow–up, the patient was asymptomatic and hemodynamically stable. A repeat TEE showed normally mobile bioprosthetic valve leaflets without vegetations, and the previously noted large cavity with internal flow, consistent with cleansed abscess (Fig.2–3).

Pulmonary valve replacement-A 10-year single-center surgical experience in ACHD patients.

Large-scale analyses of surgical outcomes after surgical pulmonary valve replacement (sPVR) as part of re-do surgery in adults with congenital heart disease (ACHD) are rare. Therefore, we present our outcomes of sPVR in ACHD patients over the last decade and demonstrate our standardized surgical approach. All ACHD patients who underwent sPVR between January 2013 and August 2022 were included. Primary diagnoses, peri-operative data, post-operative echocardiography, pre- and post-operative RV MRI and in-hospital mortality were examined. Pre- and postoperative MRI parameters were compared using paired testing. Standardized surgery was documented. Normality of continuous variables was tested using Shapiro-Wilk test. 79 patients (male 59.5% (n = 47), 71 re-operations (89.9%)) at a median age of 41.7 (52.2-28.8) years were included. Main underlying disease was Tetralogy of Fallot (TOF; n = 47, 59.5%). After removal of degenerated valve/conduit parts, right ventricular outflow tract (RVOT) patch augmentation and implantation of a larger stented bioprosthesis (25mm in 78.5%) were conducted. In 57% of cases, concomitant surgery was performed (mainly tricuspid valve surgery: n = 28, 35.4%). 25 patients (31.6%) were operated with beating heart technique. Echocardiographic outcomes showed no moderate or severe insufficiency (median Vmax of 2 m/s (2.3-1.77 m/s)) upon discharge. Available MRI data showed significantly lower indexed RV-EDV (p = 0.0006) and RV-ESV (P = 0.0017) after surgery. In-hospital mortality was 5.1% (n = 4). SPVR is a safe therapeutic option with low surgical risk and satisfying post-operative results. It can serve as a solid therapeutic option for patients who need future valve-in-valve interventions.

Perceval sutureless bioprosthesis versus Trifecta sutured bioprosthesis for aortic valve replacement: immediate results of the Perfecta study.

The Perceval sutureless biological prosthesis for aortic valve replacement has been introduced with the rationale for shortening surgical, extracorporeal circulation and aortic cross-clamping times, in order to reduce postoperative complications. To evaluate early hemodynamic performance and immediate outcomes of implantation of the Perceval sutureless bioprosthesis in comparison with the St. Jude Trifecta sutured bioprosthesis for aortic valve replacement (Perfecta study). Between December 2014 and June 2023, 281 patients underwent St. Jude Trifecta implantation (n = 220, mean age: 75.2 ±6.5 years) and Perceval implantation, when indicated (n = 61, mean age: 77.9 ±5.1 years). Concomitant CABG was performed in 73 (33%) and in 27 (44%) patients, respectively. Extracorporeal circulation and cross-clamp times were significantly shorter in Perceval patients in all aortic valve replacements (61 ±23 and 49 ±18 minutes vs. 96 ±36 and 67 ±21 minutes), and in isolated procedures (54 ±10 and 43 ±8 minutes vs. 84 ±28 and 66 ±21 minutes) (p < 0.0001, for all comparisons). Operative mortality was absent and 2.7%, respectively (p = 0.2). Postoperatively, low output cardiac syndrome (0% vs. 4.5%) and total rate of major cardiac and non-cardiac related complications (6.6% vs. 18.6%) were significantly lower in Perceval patients (p = 0.01). Echocardiography at discharge in comparison with preoperatively showed a relevant and similar decrease of mean and peak trans-aortic valve gradients for the Trifecta prosthesis (11.6 ±4.3 vs. 50 ±15.2 mm Hg; 21.6 ±7.3 vs. 78.8 ±24 mm Hg) and for the Perceval prosthesis (12.6 ±4.8 vs. 52 ±12.5 mm Hg; 22.6 ±7.9 vs. 77.8 ±16 mm Hg) (p < 0.00001, for all comparisons). Better global cardiac function was observed in Perceval patients. Concomitant multi-vessel and left main coronary artery disease (p = 0.046; HR = 4.6) and chronic pulmonary disease (p = 0.006; HR = 5.6) were detected as independent predictors of death and postoperative major complications. Early hemodynamic performance appears to be satisfactory with the use of Trifecta sutured and Perceval sutureless bioprostheses. Perceval implantation allows reduction of surgical times, better preservation of myocardial contractile function and, consequently, reduction of the risk of postoperative complications.

Platelet Reduction after Aortic Bioprosthesis Implantation: Results from the PORTRAIT Study

Background: Platelet count reduction (PR) is a common but unclear phenomenon that occurs after aortic bioprosthesis valve implantation (bio-AVR). This study aimed to investigate the occurrence and clinical impact of PR in patients receiving stented, rapid deployment (RDV), or stentless bioprostheses. Methods: 1233 adult bio-AVR patients were enrolled. Platelet count variation, early post-operative adverse events, and in-hospital mortality were analysed. Results: 944 patients received a stented valve, an RDV was implanted in 218 patients, and 71 patients had a stentless bioprosthesis. In all groups, the platelet count at discharge was lower than the baseline values (p &lt; 0.001). The percentage of PR was 27% in the stented group, 56% in the RDV group, and 55% in the stentless group. A higher platelet reduction, reaching the minimum platelet value, was observed in the RDV (mean: −30.84, standard error (SE): 5.91, p &lt; 0.001) and stentless (mean: 22.54, SE: 9.10, p = 0.03) groups compared to the stented group. A greater PR occurred as the size of the bioprosthesis increased in RDV (p = 0.01), while platelet count variation was not directly proportional to the stented bioprosthesis size (p &lt; 0.001). PR was not affected by cardiopulmonary bypass (mean: −0.00, SE: 0.001, p = 0.635) or cross-clamp (mean: −0.00, SE: 0.002, p = 0.051) times in any of the groups. RDV subjects experienced more in-hospital adverse events. PR was found to be associated with ischemic strokes in the overall population. Conclusions: Bio-AVR is associated with significant but transient PR. RDV patients more likely experience significant PR and related adverse clinical events. PR is associated with ischemic strokes, regardless of the bioprosthesis type.

Endothelial Microparticles: Markers of Inflammatory Response After Sutureless Valve Implantation.

Systemic inflammatory response syndrome (SIRS) is related to increased circulating endothelial microparticles (EMP). The aim of this study was to compare the plasma concentration of EMP between patients undergoing aortic valve replacement with conventional bioprosthesis implantation and Perceval™ S (LivaNova) and to evaluate its impact on the inflammatory response in the short-term follow-up. This is a randomized clinical trial with 24 patients submitted to isolated aortic valve replacement divided into two groups: Perceval™ S (Group P) and conventional bioprostheses (Group C). Incidence of severe SIRS (three or more criteria) in the first 48 hours postoperatively, EMP release profile, interleukins (IL) 6 and 8, C-reactive protein, and procalcitonin were analyzed preand postoperatively at 24 hours and three months. There were 24 patients (12 in each group), mean age was 69.92±5.17 years, 83.33% were female, the incidence of severe SIRS was 66.7% and 50% in groups C and P, respectively (P=0.68), and EMP showed a significant increase in the 24-hour postoperative period (P≤0.001) and subsequent decrease in the three-month postoperative period (P≤0.001), returning to baseline levels. For IL-6 and IL-8, there was a greater increase in group C at 24 hours postoperatively (P=.0.02 and P<0.001). The incidence of severe SIRS was similar in both groups, with significantly higher levels of IL-6 and IL-8, at the 24-hour postoperative period, in group C, however with higher levels of EMP in group P, and subsequent return to baseline levels at the three-month postoperative period in both groups.

Transcatheter Aortic Valve Replacement in Degenerated Perceval Bioprosthesis: Clinical and Technical Aspects in 32 Cases.

Sutureless aortic bioprostheses are increasingly being used to provide shorter cross-clamp time and facilitate minimally invasive aortic valve replacement. As the use of sutureless valves has increased over the past decade, we begin to encounter their degeneration. We describe clinical outcomes and technical aspects in patients with degenerated sutureless Perceval (CorCym, Italy) aortic bioprosthesis treated with valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). Between March 2011 and March 2023, 1310 patients underwent aortic valve replacement (AVR) with Perceval bioprosthesis implantation. Severe bioprosthesis degeneration treated with VIV-TAVR occurred in 32 patients with a mean of 6.4 ± 1.9 years (range: 2-10 years) after first implantation. Mean EuroSCORE II was 9.5 ± 6.4% (range: 1.9-35.1%). Thirty of thirty-two (94%) VIV-TAVR were performed via transfemoral and two (6%) via transapical approach. Vascular complications occurred in two patients (6%), and mean hospital stay was 4.6 ± 2.4 days. At mean follow-up of 16.7 ± 15.2 months (range: 1-50 months), survival was 100%, and mean transvalvular pressure gradient was 18.7 ± 5.3 mmHg. VIV-TAVR is a useful option for degenerated Perceval and appears safe and effective. This procedure is associated with good clinical results and excellent hemodynamic performance in our largest single-center experience.

One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: a single-center experience.

The use of an aortic bioprosthesis is on the rise in younger patients with severe aortic stenosis despite the risk of accelerated structural valve degeneration (SVD). In the search for an optimal valve substitute that would not be prone to SVD, the INSPIRIS bioprosthesis represents a promising solution to lowering the risk of SVD. Here, we report the 1-year outcomes of the INSPIRIS RESILIA aortic bioprosthesis in a population of young patients who underwent aortic valve replacement. In this prospective single-center study, we included all consecutive patients receiving INSPIRIS RESILIA bioprosthesis between June 2017 and July 2021. Patients with isolated severe aortic regurgitation were excluded. Clinical assessment and transthoracic echocardiography were performed preoperatively and at 1 year post-operatively. The primary outcome was overall mortality at one year. A total of 487 patients were included. The mean age was 58.2 ± 11.5 years, 75.2% were men. Most of the interventions were elective, with a mean EuroSCORE II of 4.8 ± 7.9. The valve annulus size in most cases was either 23 mm or 25 mm. Overall mortality at 1-year was 4.1%. At 1-year, 7 patients (1.4%) had a stroke, 4 patients (0.8%) had a myocardial infarction, and 20 patients (4.1%) were hospitalized for congestive heart failure. The Kaplan-Meier estimated survival rates and survival without major adverse cardiac events at 1-year were 96.4% and 96.7%, respectively. At 1-year follow-up, 10 patients (2.1%) had endocarditis and 1 patient (0.2%) had partial prosthetic thrombosis. Pacemaker implantation at 1-year post-operative was necessary in 27 patients (5.5%). Severe patient prosthesis mismatch and severe intra valvular regurgitation were 1.2% and 0.6%, respectively. The Kaplan-Meier estimated survival rates at 1-year of no infective endocarditis preoperative and infective endocarditis preoperative were 97.9 ± 0.7% and 89.5 ± 3.3%, respectively (P < 0.001). Excluding endocarditis-related complication, no structural valve deterioration and no valve failure requiring redo surgery were reported. This is the largest single-center descriptive study of the 1-year outcomes after INSPIRIS RESILIA bioprosthesis implantation. The EDWARDS INSPIRIS RESILIA bioprosthesis provides encouraging clinical outcomes with an excellent 1- year survival rates and good hemodynamic performance. Long-term studies are mandatory to assess valve durability.

An Analysis of Early Results after Valve Replacement in Isolated Aortic Valve Stenosis by Using Sutureless vs. Stented Bioprostheses: A Single-Center Middle-Income Country Experience.

Background and Objectives: There is a lack of data about the survival of patients after the implantation of sutureless relative to stented bioprostheses in middle-income settings. The objective of this study was to compare the survival of people with isolated severe aortic stenosis after the implantation of sutureless and stented bioprostheses in a tertiary referral center in Serbia. Materials and Methods: This retrospective cohort study included all people treated for isolated severe aortic stenosis with sutureless and stented bioprostheses from 1 January 2018 to 1 July 2021 at the Institute for Cardiovascular Diseases "Dedinje". Demographic, clinical, perioperative and postoperative data were extracted from the medical records. The follow-up lasted for a median of 2 years. Results: The study sample comprised a total of 238 people with a stented (conventional) bioprosthesis and 101 people with a sutureless bioprosthesis (Perceval). Over the follow-up, 13.9% of people who received the conventional and 10.9% of people who received the Perceval valve died (p = 0.400). No difference in the overall survival was observed (p = 0.797). The multivariate Cox proportional hazard model suggested that being older, having a higher preoperative EuroScore II, having a stroke over the follow-up period and having valve-related complications were independently associated with all-cause mortality over a median of 2 years after the bioprosthesis implantation. Conclusions: This research conducted in a middle-income country supports previous findings in high-income countries regarding the survival of people with sutureless and stented valves. Survival after bioprosthesis implantation should be monitored long-term to ensure optimum postoperative outcomes.

Specificity of long-term management of a woman patient of reproductive age after surgical mitral valve repair against the background of infective endocarditis

As a clinical case, we present the "portrait" of a woman patient with acquired mitral valve (MV) defect against the background of infective endocarditis which was diagnosed during the third trimester of pregnancy. The patient underwent mitral valve replacement surgery with biological prosthesis "KemKor" followed by two successful deliveries. In 18 years after the correction of the mitral valve defect, she developed valve prosthesis dysfunction therefore, she underwent endovascular transcatheter implantation of bioprosthesis by method "prosthesis-into-prosthesis" in the mitral position.This clinical case is unique in terms of the reasoning the biological prosthesis choice to correct acquired MV defect in a patient of reproductive age, the long-term period of the bioprosthesis functioning and the correction of further developed valve dysfunction using the techniques of transcatheter implantation.

P230 A RARE CASE OF INFECTIVE MYOCARDIAL INFARCTION

Abstract Background Prosthetic valve endocarditis (PVE) occurs in 1–6% of patients with valve prostheses. The most common agent of late PVE are S. aureus and Streptococci. Spondylodiscitis may precede the onset of endocarditis or may be the first clinical manifestation. Coronary embolization is a rare but possible complication of endocarditis. Case report: A 61 years–old man was admitted to the Emergency Department for low back pain, fever and chest pain. Four years before he underwent mitral valve bioprosthesis implantation and hybrid myocardial revascularization (percutaneous on right coronary artery). During observation cardiac arrest from ventricular fibrillation occurred, treated with single shock and evidence of anterolateral myocardial infarction at ECG. An urgent coronarography revealed chronic occlusion of CABG on LAD and acute occlusion, of possible embolic origin, involving LAD mid tract, first diagonal branch and intermediate branch. Thromboaspiration and subsequent PTCA was performed. For hemodynamic instability inotropic and vasopressor supports were started. A transthoracic echocardiogram showed severe left ventricular dysfunction (EF 25%) and 3.5x1mm endocardial vegetation on the mitral bioprosthesis without significant bioprosthesis dysfunction (confirmed by transesophageal echocardiogram). Blood cultures resulted positive for Streptococcus gordonii and antibiotic therapy based on the antibiogram was begun. Cardiac surgery was ruled out due to prohibitive surgical risk despite high probability of embolization. Because of the history of back pain spinal MRI was performed with evidence of cervial and lumbosacral spondylodiscitis. Neurosurgical indications were ruled out. Levosimendan infusion allowed weaning of vasopressor and inotropic therapy, however without improvement of left ventricular ejection fraction. Daily echocardiographic follow–up showed disappearance of the vegetation. Antibiotic targeted therapy was continued for 5 months, given the persistence of spondylodiscitis, in anticipation of intracardiac defibrillator (ICD) implantation in primary prevention. Conclusion PVE is a severe clinical condition associated with high morbidity and mortality. Antibiotic therapy is recommended for at least 6 weeks in PVE, in this case prolonged up to 5 months given the need to implant an ICD. Regarding the treatment of embolic infarction thromboaspiration is recommended as the initial strategy and, if successful, may be the only interventional option.

P344 OCCURRENCE OF PERMANENT PACE–MAKER IMPLANTATION DURING HOSPITALIZATION AFTER INTUITY RAPID DEPLOYMENT AORTC BIOPROSTHESIS IMPLANTATION: A RETROSPECTIVE SINGLE CENTER STUDY

Abstract Between March 2017 and June 2020, 97 consecutive patients underwent aortic valve replacement (AVR) with the Edwards Intuity and its evolution Intuity Elite rapid deployment bioproshesis were enrolled at the Cardio Surgery Department at the “San Carlo” Hospital in Potenza. A total of nine patients were excluded: 3 patients for incomplete data, 3 patients because they already had a pacemaker at the time of admission, and other 3 patients because they underwent combined aortic and mitral valve surgery. The remaining 88 patients were evaluated. Among these, 62 (70%) underwent insolated AVR and the remaining 26 (30%) combined procedure with myocardial revascularization, performed through mini–sternotomy or full sternotomy respectively. Population was divided into two groups according to the date of surgery: before (N: 66, 75%), group A, and after (N: 22,25%), group B, September 2019, when we modified prosthesis implantation technique in order to reduce the incidence of permanent pacemaker implantation (PPI), with a particular attention in annular decalcification compared to standard technique near to the interventricular septum, in order to prevent hard calcium block compression on conduction system. Subjects underwent serial ECGs at baseline, after the intervention and every 24 hours until hospital discharge, moreover they had continuous monitoring till discharge. ECG Holter monitoring were prescribed during the first year after discharge if any alteration at basal ECG were observed. The policy for PPI followed the current guidelines. All the ECGs and the Holter monitoring were analyzed by two independent physicians blinded to each other’s. At the end of our study, we observed 4 PPI in the group A, 3 cases for complete AV block (third degree AV block) and one case for tachy–brady syndrome about four months after the AVR, no PPI were observed in the group B. In conclusion the new technique of aortic valve decalcification during INTUITY rapid deployment bioprosthesis implantation, introduced in our institution in September 2019, provided to be safe and effective in reducing the occurrence of cardiac conduction disorders and consequently of PPI compared to standard technique.

P228 MINOCA/TYPE 2 IMA: WHEN WE HAVE TO EXIT FROM STANDARD DIAGNOSTIC FLOW–CHART

Abstract MINOCA is an Acute Myocardial Infarction (AMI), defined on the basis of Fouth Universal Definition, in absence of epicardial coronaries stenosis &amp;gt;50%. This definition is very broad, including typical mechanisms of type 1 and type 2 AMI. Diagnostic flow–chart recommended by ESC and AHA includes imaging tests, coronary physiology and cardiac MRI. Here we present the case of 71–year–old man who underwent aortic bioprosthesis implantation (Trifecta n.25) and atrial septal defect (ASD) closure in 2019. In December 2022, the patient arrived in the Emergency Department (ED) with anterior STEMI, apical akinesia and angiographic evidence of distal left anterior descending (LAD) artery occlusion. Whereas angiographic feature was compatible with an embolic phenomenon, we performed in the 1st day transesophageal echocardiogram (TEE) that showed a voluminous, rounded mass (maximum diameter 1.2 cm) isoechoic, mobile, adherent to the aortic side of left coronary cusp. Despite the absence of clinical features of an acute infection (apyrexia and negative CRP/PCT) and the atypical mass localization for endocarditis, we took 3 sets of blood cultures and we required an immediate cardiac surgical consultation. In consideration of high estimated embolic risk, patient underwent urgent cardiac surgery with aortic bioprosthesis explantation, annular malacia (probable abscess) explantation and Carpentier n.23 biological prosthesis implant. Histological examination of the removed mass showed exudative material with intense acute inflammation. According to counseling of infectious disease specialist, we started an empiric antibiotic therapy with intravenous vancomycin and gentamicin. Given persistence of 3rd degree atrioventrocular block, patient underwent definitive pacemaker implantation. Cultures on blood and on explanted valve were negative and patient was discharged without further complications after 4 weeks of antibiotic therapy. In our opinion, this clinical case underlines the importance of an individualized diagnostic–therapeutic approach in patients with MINOCA, also considering rare etiologies and involving various medical specialist (clinical cardiologist, echocardiographer, surgeon).

C59 CLINICAL AND ECHOCARDIOGRAPHIC FOLLOW–UP IN PATIENTS WITH SUTURELESS AORTIC PERCEVAL BIOPROSTHESIS: SINGLE CENTER ANALYSIS IN ELEVEN–YEARS EXPERIENCE

Abstract Aims We describe long–term clinical and echocardiographic follow–up in the largest single center cohort of patients underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. Methods Between March 2011 and September 2022, 1237 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 78 ± 4 years and mean EuroSCORE II was 6.9 ± 2.8%. Concomitant procedures were performed in 272 patients (22%). Results Thirty–day mortality was 1.37% (17/1237). 890 of 951 (93.5%) isolated AVR underwent minimally invasive surgery with a ministernotomy (n = 221) or right minithoracotomy (n = 669) approach. Cardiopulmonary bypass and aortic cross–clamp times were 80.6 ± 21.5 and 50.1 ± 10.5 minutes for isolated AVR and 145.8 ± 33.6 and 95.8 ± 20.7 minutes for combined procedures. At mean follow–up of 55.09 ± 6.7 months (range: 1–138.5 months), survival was 95.4% and mean transvalvular pressure gradient was 13.3 ± 4.2 mmHg. LV mass decreased from 153.5 g/m2 to 114.6 g/m2 (p&amp;lt; 0.001) and moderate paravalvular leakage occurred in 3 patients without hemolysis not requiring any treatment. Freedom from reoperation was 97.4%. Nine patients required surgical reintervention and 21 patients transcatheter valve–in–valve procedure for structural prosthesis degeneration at mean of 6.3 years after first operation (range: 2–10 years). Conclusion AVR with Perceval bioprosthesis is associated with good clinical results and excellent hemodynamic performance in our eleven–years experience. Structural degeneration rate of Perceval is comparable with others bioprosthetic aortic valve. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Ten-year experience with sutureless Perceval bioprosthesis: single-centre analysis in 1157 implants.

We describe long-term clinical and echocardiographic outcomes in the largest single-centre cohort of patients who underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. Between March 2011 and March 2021, 1157 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 77 ± 6 years (range: 46-89 years) and mean EuroSCORE II was 6.7 ± 3.2% (range: 1.7-14.2%). Concomitant procedures were performed in 266 patients (23%). Thirty-day mortality was 1.38% (16/1157). Eight hundred and twenty of 891 (92%) isolated AVRs underwent minimally invasive surgery with a ministernotomy (n = 196) or right minithoracotomy (n = 624) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.1 ± 24.3 and 50.6 ± 11.7 min for isolated AVR and 144.5 ± 34.7 and 96.4 ± 21.6 min for combined procedures. At mean follow-up of 53.08 ± 6.7 months (range: 1-120.5 months), survival was 96.5% and mean transvalvular pressure gradient was 13.7 ± 5.8 mmHg. Left ventricular mass decreased from 152.8 to 116.1 g/m2 (P < 0.001) and moderate paravalvular leakage occurred in three patients without haemolysis not requiring any treatment. Freedom from reoperation was 97.6%. Eight patients required surgical reintervention and 19 patients transcatheter valve-in-valve procedure for structural prosthesis degeneration at a mean of 5.6 years after first operation (range: 2-9 years). AVR with a Perceval bioprosthesis is associated with good clinical results and excellent haemodynamic performance in our 10-year experience. Structural degeneration rate of Perceval is comparable with other bioprosthetic aortic valves. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Xenograft bone-patellar tendon-bone ACL reconstruction: a case series at 20-year follow-up as proof of principle

PurposeACL reconstruction has a significant failure rate. To address the need for inexpensive strong tissue, a treatment process to “humanize” porcine tissue was developed and tested in primates and humans. This report describes the long-term outcomes from the first human clinical trial using a porcine xenograft ACL reconstruction device.MethodsThe study was performed with Z-Lig™ xenograft ACL device in 2003 as a pilot clinical feasibility study. This device was processed to slow its immune-mediated destruction by enzymatic elimination of α-gal epitopes and by partial crosslinking to slow the infiltration of macrophages into the biotransplant.ResultsTen patients underwent reconstruction with the Z-Lig™ device. Five of 10 patients failed due to subsequent trauma (n = 3), arthrofibrosis (n = 1), and surgical technical error (n = 1). One patient was lost to follow-up after the 12-year evaluation. Each remaining patient reported a stable fully athletic knee. Physical exams are consistent with a score of less than one on the ACL stability tests. MRIs demonstrate mature remodeling of the device. There is no significant degradation in patient-reported outcome scores, physical exams, or MRI appearance from 12 to 20-year follow-ups.ConclusionsThe studies in a small group of patients have demonstrated that implantation of porcine ligament bioprosthesis into patients with torn ACLs can result in the reconstruction of the bioprosthesis into autologous ACL that remains successful over 20 years. The possibility of humanizing porcine tissue opens the door to unlimited clinical material for tissue reconstructions if supported by additional clinical trials.Level of evidenceIV, case series.

869 SUCCESSFUL TREATMENT OF COMBINED ANNULAR RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A CASE REPORT

Abstract Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of patients with severe, symptomatic aortic stenosis. Despite being less invasive than conventional open-chest surgery, TAVI remains associated with rare but serious complications such as vascular injury, stroke, coronary obstruction, cardiac perforation and annular rupture. We report a case of a combined annular rupture successful treated by emergent surgery. Case presentation: A low-risk (EuroSCORE:1.14%) 73-year-old male presenting with high-gradient, normal-flow severe aortic stenosis (AS) was referred to our centre. He had preserved left ventricular ejection fraction and heavily calcified aortic valve. The Heart Team recommended isolated surgical aortic valve replacement, but the patient refused this option. We decided to perform transfemoral-TAVI with a 26 mm Edwards valve which was deployed after predilatation with a 23 mm balloon. Immediately after valve deployment, the angiography revealed contrast leakage at the level of the Valsalva sinuses. The patient developed hypotension due to cardiac tamponade which was immediately managed with pericardial drainage. A bailout cardiac surgery was required to remove the TAVI prosthesis and the native aortic leaflets. A left ventricular outflow tract (LVOT) rupture was observed in addition to supra- annular and intra-annular injury. Repair of the left ventricle with a pericardial patch and implantation of a surgical bioprosthesis (Dafodil Meril 21 mm) were performed. No complications occurred post-operatively Annular rupture occurs in about 1% of all TAVI procedures and may involve the region of the aortic root and LVOT. According to the anatomical location of the injury, it can be classified into 4 types: intra-annular, sub-annular, supra-annular, and combined rupture. Annular rupture has been mainly observed after the use of balloon-expandable valves and only exceptionally after TAVI with self- expandable prosthesis. Nevertheless, the following anatomic characteristics are associated with an increased incidence of this catastrophic event: small aortic valve annulus (&amp;lt;20 mm), a narrow aortic root, heavy calcifications of aortic valve leaflets, annulus, LVOT and sinuses of Valsalva, bicuspid valve, short distance from a coronary artery to the annulus and LV hypertrophy. The voluminous amount of calcification located in the landing zone in addition to the force applied during the balloon expansion may be the main mechanism of this catastrophic complication. Clinical presentation is dramatic and emergent surgery can be the sole solution. Alternative bailout treatments, such as placing a second transcatheter valve to close the rupture have been occasionally reported. A precise preprocedural analysis of the device landing zone is mandatory. This includes determination of the size, morphology of all anatomical structures and a careful identification of possible factors for annular rupture. Moreover, in these cases, the availability of cardiac surgery onsite is pivotal to save patient's life. As more and younger patient will undergo TAVI in next years, our report highlightsthe need to optimize preprocedural planning and prosthesis selection. Improvements in devices, procedural techniques, and imaging tools may simplify TAVI and reduce possible complications.