Search

To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor — Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS. • Transcatheter aortic valve implantation (TAVI) has become an established intervention for treating severe aortic stenosis. • Cardiac complications can occur after TAVI due to improper size or fit of the valve. • The commonest complications are left bundle branch block and paravalvular leak. • The design of the new Myval Octacor transcatheter heart valve (THV) aims at minimizing these complications. • In this study, the rate of these complications after Myval Octacor THV implantation was low. [ABSTRACT FROM AUTHOR]

In silico simulations can be used to evaluate and optimize the safety, quality, efficacy and applicability of medical devices. Furthermore, in silico modeling is a powerful tool in therapy planning to optimally tailor treatment for each patient. For this purpose, a workflow to perform fast preoperative risk assessment of paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is presented in this paper. To this end, a novel, efficient method is introduced to calculate the regurgitant volume in a simplified, but sufficiently accurate manner. A proof of concept of the method is obtained by comparison of the calculated results with results obtained from in vitro experiments. Furthermore, computational fluid dynamics (CFD) simulations are used to validate more complex stenosis scenarios. Comparing the simplified leakage model to CFD simulations reveals its potential for procedure planning and qualitative preoperative risk assessment of PVL. Finally, a 3D device deployment model and the efficient leakage model are combined to showcase the application of the presented leakage model, by studying the effect of stent size and the degree of stenosis on the regurgitant volume. The presented leakage model is also used to visualize the leakage path. To generalize the leakage model to a wide range of clinical applications, further validation on a large cohort of patients is needed to validate the accuracy of the model's prediction under various patient-specific conditions. [ABSTRACT FROM AUTHOR]

Objective: Literature presents conflicting results on the pros and cons of pledget-reinforced sutures during surgical aortic valve replacement (SAVR). We aimed to investigate the effect of pledget-reinforced sutures versus sutures without pledgets during SAVR on different outcomes in a systematic review and meta-analysis. Methods: A literature search was performed in five different medical literature databases. Studies must include patients undergoing SAVR and must compare any pledget-reinforced with any suturing technique without pledgets. The primary outcome was paravalvular leakage (PVL), and secondary outcomes comprised thromboembolism, endocarditis, mortality, mean pressure gradient (MPG) and effective orifice area (EOA). Results were pooled using a random-effects model as risk ratios (RRs) or mean differences (MDs) for which the no pledgets group served as reference. Results: Nine observational studies met the inclusion criteria. The risk of bias was critical in seven studies, and high and moderate in two other. The pooled RR for moderate or greater PVL was 0.59 (95 % confidence interval [CI] 0.13, 2.73). The pooled RR for mortality at 30-days was 1.02 (95 % CI 0.48, 2.18) and during follow-up was 1.15 (95 % CI 0.67, 2.00). For MPG and EOA at 1-year follow-up, the pooled MDs were 0.60 mmHg (95 % CI −4.92, 6.11) and −0.03 cm2 (95 % CI −0.18, 0.12), respectively. Conclusions: Literature on the use of pledget-reinforced sutures during SAVR is at high risk of bias. Pooled results are inconclusive regarding superiority of either pledget-reinforced sutures or sutures without pledgets. Hence, there is no evidence to support or oppose the use of pledget-reinforced sutures.

The cusp overlap technique allows greater visual separation between the basal annular plane and the conduction system and decreases the permanent pacemaker implantation rate. We assessed the impact of the cusp overlap technique on conduction disturbance and paravalvular leakage after transcatheter aortic valve replacement. A total of 97 patients underwent transfemoral transcatheter aortic valve replacement with self-expandable valves at our institution from November 2018 to January 2023. The mean age of the patients was 85 years, and 23% were male. The patients were divided into two groups: the cusp overlap technique group and the non-cusp overlap technique group. We compared the clinical results between the two groups. The 30-day permanent pacemaker implantation rate was similar between the two groups (cusp overlap technique: 6.3% vs. non-cusp overlap technique: 10.2%, p = 0.48). The rate of new-onset conduction disturbance was slightly lower in the cusp overlap than non-cusp overlap technique group (18.8% vs. 34.7%, respectively; p = 0.08). The implanted valve function was similar between the two groups, but the rate of trivial or less paravalvular leakage (PVL) was significantly higher in the cusp overlap technique group on echocardiography (69% vs. 45%, p = 0.02). On multidetector computed tomography, the implantation depth at the membranous septum was significantly shorter in the cusp overlap technique group (2.0 ± 2.3 vs. 2.9 ± 1.5 mm, p = 0.02). The degree of canting was slightly smaller in the cusp overlap technique group (1.0 ± 2.2 vs. 1.7 ± 1.9 mm, p = 0.07). The relative risk of PVL equal to or greater than mild was 1.76 times higher for valve implantation without the cusp overlap technique (adjusted odds ratio, 3.74; 95% confidence interval, 1.45–9.69; p < 0.01). Transcatheter aortic valve replacement using the cusp overlap technique is associated with an optimized implantation depth, leading to fewer conduction disturbances. Optimal deployment may also maximize the radial force of self-expanding valves to reduce paravalvular leakage. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Relevant paravalvular leakage (PVL) due to prosthesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning manoeuvres. METHODS From 2017 to 2021, N  = 18 patients who underwent secondary tether retensioning were identified. Baseline, procedural and follow-up data were available from N  = 11 patients and analysed according to the Mitral Valve Research Consortium definitions. Continuous variables are shown as median with interquartile range. RESULTS All patients [age 75 years (73.5, 85.0), 64% male (N  = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N  = 7) with PVL ≥3+]. Of these, 54% (N  = 6) showed signs of haemolysis. The majority were severely symptomatic [New York Heart Association ≥III (91%, N  = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N  = 10) of patients with 1 case of remaining moderate PVL. At 30 days, Mitral Valve Research Consortium device success was achieved in 82% (N  = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N  = 8) of patients with successful retensioning procedure, New York Heart Association class was I/II. There was no 30-day mortality. CONCLUSIONS This multicentre study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk. [ABSTRACT FROM AUTHOR]

Background: Edwards Intuity is recognized as a relatively contraindicated bioprosthesis for bicuspid aortic valve disease. This study compared the early echocardiographic and clinical outcomes of rapid-deployment aortic valve replacement for bicuspid versus tricuspid aortic valves. Methods: Of 278 patients who underwent rapid-deployment aortic valve replacement using Intuity at Seoul National University Hospital, 252 patients were enrolled after excluding those with pure aortic regurgitation, prosthetic valve failure, endocarditis, and quadricuspid valves. The bicuspid and tricuspid groups included 147 and 105 patients, respectively. Early outcomes and the incidence of paravalvular leak were compared between the groups. A subgroup analysis compared the outcomes for type 0 versus type 1 or 2 bicuspid valves. Results: The bicuspid group had more male and younger patients. Comorbidities, including diabetes mellitus, hypertension, chronic kidney disease, and coronary artery disease, were less prevalent in the bicuspid group. Early echocardiographic evaluations demonstrated that the incidence of ≥mild paravalvular leak did not differ significantly between the groups (5.5% vs. 1.0% in the bicuspid vs. tricuspid groups, p=0.09), and the early clinical outcomes were also comparable between the groups. In the subgroup analysis between type 0 and type 1 or 2 bicuspid valves, the incidence of mild or greater paravalvular leak (2.4% vs. 6.7% in type 0 vs. type 1 or 2, p=0.34) and clinical outcomes were comparable. Conclusion: Rapid-deployment aortic valve replacement for bicuspid aortic valves demonstrated comparable early echocardiographic and clinical outcomes to those for tricuspid aortic valves, and the outcomes were also satisfactory for type 0 bicuspid aortic valves.

Background Behcet's disease is a multi-systemic inflammatory disorder. Paravalvular leakage and aortic pseudoaneurysm are rare in patients with Behcet's disease after aortic root replacement. Complicated post-operative infective endocarditis can make the treatment more difficult. We applied a flanged Bentall procedure to treat one such case. Case summary A 27-year-old man with aortic regurgitation and Behcet's disease underwent aortic root replacement. Post-operative electrocardiogram showed a complete atrioventricular block. One year after the operation, he underwent percutaneous temporary pacemaker implantation and endovascular stent graft exclusion because of pseudoaneurysm of the ascending aorta. Post-operative fever and blood culture confirmed infective endocarditis. Examination showed paravalvular leakage and pseudoaneurysm recurrence. Then, the patient underwent a third operation in our hospital. Aortic root replacement with a flanged composite valved conduit was performed. Immunosuppressants and antibiotic treatment were given after surgery. After 3 months, the cardiovascular examination was normal, and the patient was in good condition. Discussion Surgical treatment of aortic regurgitation caused by Behcet's disease was characterized by a high rate of paravalvular leakage, which led to reoperation and high mortality. Combined infective endocarditis would further increase the difficulty and risk of treatment. It is important to maintain effective immunosuppressive therapy while monitoring serum biomarkers and inflammation indicators. The potential hazards of immunosuppressants are increased risk of infection and poor tissue healing. In our case, targeted antibiotic treatment and appropriate immunosuppressive therapy were well balanced. The flanged Bentall procedure was also the key to success, which could increase aortic effective orifice area and reduce the risk of dehiscence. [ABSTRACT FROM AUTHOR]

Tomoki Sakata,1 Corazon De La Pena,2 Suguru Ohira2 1Cardiovascular Research Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY, USACorrespondence: Suguru Ohira, Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, 100 Woods Road, Macy Pavilion, Valhalla, NY, 10595, USA, Tel +1 404 234 5433, Email Suguru.Ohira@wmchealth.orgAbstract: Sutureless or rapid deployment valves in the setting of aortic valve replacement (AVR) is an emerging surgical technique using the transcatheter valve technology, which may lead to reduction in cross-clamp time and potentially better hemodynamics compared to a stented bioprosthetic valve. The absence of subannular pledgets results to excellent hemodynamic performance with reduced turbulent flow and larger effective orifice area. However, complications from both surgical and transcatheter AVR may still occur and impact survival. The incidence of paravalvular leakage and permanent pacemaker implantation are not low. Although technical modifications can improve these outcomes, there is a learning curve effect. Therefore, technical and anatomical considerations as well as better patient selection are paramount for better outcomes. In this review, we discuss the use of sutureless or rapid deployment valves in setting of (1) complex procedures, (2) minimally invasive AVR, and (3) small aortic annulus. The advantage of sutureless or rapid deployment valves in terms of mortality remains to be clarified; therefore, it is necessary to accumulate long-term outcomes in an appropriate patient cohort.Keywords: sutureless valve, rapid deployment valve, aortic valve replacement, minimally invasive cardiac surgery, paravalvular leakage, permanent pacemaker implantation

Sutureless aortic valve replacement is a widely used technique that facilitates short cross-clamping time and has excellent hemodynamic outcomes. However, it is associated with paravalvular leakage or migration risk. We report a surgical case using a sutureless aortic valve replacement in a 74-year-old male patient with a history of previous aortic valve replacement. He underwent redo aortic valve replacement with the Perceval valve (Corcym Canada Corp, Vancouver, Canada), which got dislocated with moderate-to-severe aortic paravalvular leakage at 3 months after implantation. Our observations suggested that redo aortic valve replacement using a sutureless aortic valve can cause valve dislocation as it might be difficult to clearly remove calcification and excess tissue and implant the valve to crimp on the annulus precisely. This report also highlights the challenges of performing repeat aortic valve replacement after explanting the Perceval valve, which includes the aortotomy height and annulus identification. Although the Perceval valve can help improve patient prognosis, careful implantation and thorough follow-up examinations are warranted. [ABSTRACT FROM AUTHOR]

Aims To study sex-specific differences in the amount and distribution of aortic valve calcification (AVC) and to correlate the AVC load with paravalvular leakage (PVL) post-transcatheter aortic valve intervention (TAVI). Methods and results This registry included 1801 patients undergoing TAVI with a Sapien3 or Evolut valve in two tertiary care institutions. Exclusion criteria encompassed prior aortic valve replacement, suboptimal multidetector computed tomography (MDCT) quality, and suboptimal transthoracic echocardiography images. Calcium content and distribution were derived from MDCT. In this study, the median age was 81.7 (25th–75th percentile 77.5–85.3) and 54% male. Men, compared to women, were significantly younger [81.2 (25th–75th percentile 76.5–84.5) vs. 82.4 (78.2–85.9), P ≤ 0.01] and had a larger annulus area [512 mm2 (25th–75th percentile 463–570) vs. 405 mm2 (365–454), P < 0.01] and higher Agatston score [2567 (25th–75th percentile 1657–3913) vs. 1615 (25th–75th percentile 905–2484), P < 0.01]. In total, 1104 patients (61%) had none-trace PVL, 648 (36%) mild PVL, and 49 (3%) moderate PVL post-TAVI. There was no difference in the occurrence of moderate PVL between men and women (3% vs. 3%, P = 0.63). Cut-off values for the Agatston score as predictor for moderate PVL based on the receiver-operating characteristic curve were 4070 (sensitivity 0.73, specificity 0.79) for men and 2341 (sensitivity 0.74, specificity 0.73) for women. Conclusion AVC is a strong predictor for moderate PVL post-TAVI. Although the AVC load in men is higher compared to women, there is no difference in the incidence of moderate PVL. Sex-specific Agatston score cut-offs to predict moderate PVL were almost double as high in men vs. women. [ABSTRACT FROM AUTHOR]

Purpose: Our goal was to report the transcatheter closure of a paravalvular leak after transcatheter aortic valve replacement (TAVR) using 3-dimensional (3D) printing. Case Report: A 66-year-old man who had undergone transapical and TAVR 2 years ago due to aortic regurgitation, presented with palpitations and shortness of breath owing to exacerbation of paravalvular regurgitation. Echocardiography suggested that the stented aortic valve was fixed securely in place and the valve leaflets moved normally after TAVR, but there was severe paravalvular regurgitation (3 bundles, volume 11.0 mL). Due to the high surgical risk, we closed the transcatheter paravalvular leak using preprocedural guidance with 3D printing and intraprocedural guidance with digital subtraction angiography. Postoperative echocardiography showed that the paravalvular leak was significantly reduced. 3D construction showed that the occluders and the stent valve were well placed. Conclusion: Transcatheter closure of a paravalvular leak of the aortic valve may be feasible with appropriate pre- and intraoperative 3D printing guidance. Clinical Impact: 3D printing technology may help surgeons to make accurate preoperative strategy before occlusion procedures. [ABSTRACT FROM AUTHOR]

Abstract Background Transcatheter aortic valve replacement (TAVR) is a growing less invasive surrogate for high-risk patients with aortic valve disease. Although the number of TAVR procedures is growing rapidly, TAVR prosthesis surgical explantation are rare procedures but increasing in frequency. Case presentation We herein presented a case of 68-year-old male who underwent quaternate TAVR bioprostheses implantation. Three months later, his symptoms deteriorated due to aggravated paravalvular leakage and severe mitral regurgitation. A challenging surgical explantation procedure was therefore performed. During the surgery, lethal penetrations of aortic wall due to migration of these devices were found and four bioprostheses were integrally explanted. The native calcified aortic leaflet was removed and replaced with a 23 mm. The impaired segment of ascending aorta was replaced with a Dacron graft afterwards. Conclusions In summary, we presented a surgical case of explantation of four TAVR Bioprostheses, which is so far the maximum number of surgical-explant devices ever reported. This extreme individual case aggregates our technical experiences with this unique category of patients and raise the concern of the best initial valve strategy for relatively younger patients with severe aortic valve stenosis.

Comparisons of hemodynamic results between ACURATE Neo and ACURATE Neo 2, which have updated outer sealing skirts, are limited. This retrospective study aimed to demonstrate the differences in hemodynamic outcomes between the two transcatheter heart valves (THVs). We included 449 patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with either ACURATE Neo2 (n = 100) or ACURATE Neo (n = 348) between January 2016 and November 2021. The primary endpoint was the incidence of moderate or severe paravalvular leakage (PVL). The mean aortic pressure gradient (APG), peak aortic velocity (AV), and early clinical outcomes were assessed as secondary outcomes. In the propensity-score matching comparison (94 pairs), there were no significant differences in the incidence of moderate or severe PVL (4.3 % in Neo2 group vs. 8.5 % in Neo group, p = 0.233), and peak AV and mean APG were significantly higher in Neo2 group (Peak AV: 2.1 ± 0.4 vs. 1.9 ± 0.5 m/s, p = 0.003; mean APG: 10.6 ± 4.8 vs. 9.0 ± 6.1 mmHg, p = 0.045). In the multivariate logistic regression analysis, the THV type (ACURATE Neo2) was not an independent predictor of moderate or severe PVL. The incidence of moderate or severe PVL did not significantly differ between TAVR with ACURATE Neo2 and ACURATE Neo; however, it was numerically lower in ACURATE Neo2. In contrast, the Neo2 group had a higher residual mean APG and peak AV. A larger study with long-term follow-up is warranted to assess the clinical relevance of these findings. • ACURATE Neo2 has an updated sealing skirt to improve paravalvular leakage (PVL). • However, ACURATE Neo2 did not reduce significant PVL compared to ACURATE Neo. • Residual pressure gradient (PG) was higher in patients treated with ACURATE Neo2. • Technical solutions to reduce PVL and PG with ACURATE Neo2 were needed. • Lager studies are warranted to assess clinical relevance of these findings. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve replacement (TAVR) is a growing less invasive surrogate for high-risk patients with aortic valve disease. Although the number of TAVR procedures is growing rapidly, TAVR prosthesis surgical explantation are rare procedures but increasing in frequency.Case Presentation: We herein presented a case of 68-year-old male who underwent quaternate TAVR bioprostheses implantation. Three months later, his symptoms deteriorated due to aggravated paravalvular leakage and severe mitral regurgitation. A challenging surgical explantation procedure was therefore performed. During the surgery, lethal penetrations of aortic wall due to migration of these devices were found and four bioprostheses were integrally explanted. The native calcified aortic leaflet was removed and replaced with a 23 mm. The impaired segment of ascending aorta was replaced with a Dacron graft afterwards.Conclusions: In summary, we presented a surgical case of explantation of four TAVR Bioprostheses, which is so far the maximum number of surgical-explant devices ever reported. This extreme individual case aggregates our technical experiences with this unique category of patients and raise the concern of the best initial valve strategy for relatively younger patients with severe aortic valve stenosis. [ABSTRACT FROM AUTHOR]

Background: Paravalvular leakage (PVL) and conduction disorders that require permanent pacemaker implantation (PPI) remain clinically relevant challenges after transcatheter aortic valve implantation (TAVI). Computed tomography-based simulations may predict the risk of significant PVL and PPI., Aims: To evaluate the feasibility and accuracy of preprocedural computer simulation with FEops HEARTguide™ to predict >trace PVL and PPI after TAVI with the self-expanding supra-annular ACURATE Neo2 transcatheter heart valve., Methods: Prospective multicenter observational study that included consecutive patients undergoing TAVI with an ACURATE Neo2 valve. Computer simulations were performed before the TAVI procedure as part of the preprocedural planning. Follow-up period for PPI and PVL was 30 days., Results: Sixty-five patients were included (median age 81 years (25th-75th percentile 77-84.5)). New left bundle branch block occurred in five patients (7.7%) and PPI in two patients (3%). Contact pressure index (CPI) was similar for patients with vs without new conduction disorders. Patients with PPI had numerically higher CPI than those without PPI (median CPI 20.0% (25th-75th percentile 15.0-25.0) vs. 13.0% (25th-75th percentile 5.5-18), p = 0.27). More than trace PVL occurred in 30%. Median PVL was significantly lower in patients with none-trace PVL (3.2 mL/s [25th-75th percentile 2.2-5.0]), compared to mild PVL (5.2 mL/s [25th-75th percentile 3.2-10.3]) and moderate PVL (12.6 mL/s [25th-75th percentile 3.9-21.3])(p = 0.036). A simulated PVL-cutoff of 9.65 mL/s identified patients with >trace PVL (AUC 0.70 (95% CI 0.55-0.85), sensitivity 42%, specificity 95%)., Conclusion: In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Competing Interests: The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

More than mild paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) is associated with a twofold increase in all-cause mortality, heart failure hospitalizations, and the need for reintervention. Successfully addressing PVL in TAVIs is more challenging than in surgical valves. The arterial-arterial (A-A) rail technique emerges as a valuable strategy for post-TAVI PVL closure, enhancing success rates by enabling the effective use of lower-profile vascular plug devices. When standard approach is ineffective, generating an A-A loop for post-TAVI PVL closure is probably the most recommended strategy to ensure procedural success., (© 2024 Wiley Periodicals LLC.)

Patients undergoing transcatheter aortic valve replacement (TAVR) may suffer severe clinical complications, caused by paravalvular leakage (PVL) which is defined as leakage between TAVR and aortic annulus. PVL is often facilitated by a severely calcified annulus. This limits the expansion of a self-expandable TAVR stent. To assess TAVR performance in terms of leakage, measurement of regurgitation fraction in a pathophysiological annulus is recommended according to ISO 5840. For this purpose, a configuration of a circular annulus with a calcification nodule has been proposed in the recently published ISO 5840. The impact of the proposed pathophysiological annulus model on the expansion of self-expandable TAVR stents and on the regurgitation fraction was investigated in this study. For this purpose, two commercially available selfexpandable TAVRs (Evolut R and Portico) were implanted in a calcified annulus model. Circular expansion of the TAVR stents was investigated based on μCT scans of the implanted TAVR. The calcification-induced area in which retrograde flow can occur during diastole was detected. These results were then compared with the experimentally determined regurgitation fraction obtained from pulse duplicator tests. The results of the μCT scans showed a continuous leakage area in the region of the annulus for the Evolut R compared to a locally larger leakage area of the Portico, which, however, reattaches to the annulus in the distal inflow region. The hydrodynamic measurements confirmed a smaller leakage in the pathological annulus for the Portico. In summary, it can be assumed that a continuous leakage area in the TAVR stent inflow region encourages the PVL of TAVR.

Paravalvular leakage (PVL) has a crucial impact on clinical outcomes of transcateheter aortic valve replacements (TAVR), especially the mortality increases dramatically with high-grade PVL. Furthermore, the calcification of the aortic annulus has a decisive influence on the PVL of TAVR. Therefore, we developed a technical model of a calcified aortic annulus and used it for the investigation of PVL in steady-state back-flow conditions. We investigated an Evolut PRO (Medtronic, Minneapolis, MN, USA), implanted the TAVR at different depths in the aortic annulus model ranging between 0 mm and -6 mm and characterized PVL in steady-state retrograde flow from 0 mmHg up to a maximum achievable pressure. The used test bench and detailed test method was described in previous studies. The aortic annulus model exhibits three elevations symmetrically distributed around the circumference. Depending on the degree of calcification the elevations reached 1 mm to 3 mm into the lumen. For the Evolut PRO bioprosthesis, a decreasing PVL was measured with increasing implantation depth. At an implantation depth of 0 mm (inflow of TAVR and annulus model at same height) maximum PVL was measured. Minimum PVL was measured at a height of -6 mm. Furthermore, even a small calcification of 1 mm led to a large increase in PVL. This trend continued with increasing height of the calcification. The maximum regurgitation of (2,025.21 ± 12.47) ml (n = 3 measurements) was measured at a pressure of 6 mmHg in the annulus model with 3 mm calcification. A test method to quantify PVL depending on annular calcification was successfully developed. Additionally, the influence of implantation depth on PVL was characterized. Due to the technical operating principle of the test bench, only a limited increase in pressure was possible when large PVL occurred. In this respect, the test bench must be optimized in the future.

Paravalvular leakage (PVL), defined as the leakage between the aortic annulus and a transcatheter aortic valve replacement (TAVR), is verifiably associated with short- and long-term clinical outcome, especially with increased mortality. Therefore, with the ambition to reduce or even prevent PVL of next generation TAVR, it is necessary to extend the hemodynamic understanding of PVL.

Aortic insufficiency caused by paravalvular leakage (PVL) is one of the most feared complications following transcatheter aortic valve replacement (TAVI) in patients. Domestic pigs (Sus scrofa domestica) are a popular large animal model to study such conditions and develop novel diagnostic and therapeutic techniques. However, the models based on prosthetic valve implantation are time intensive, costly, and often hamper further hemodynamic measurements such as PV loop and 4D MRI flow by causing implantation-related wall motion abnormalities and degradation of MR image quality. This study describes in detail, the establishment of a minimally invasive porcine model suitable to study the effects of mild-to-moderate “paravalvular“ aortic regurgitation on left ventricular (LV) performance and blood flow patterns, particularly under the influence of altered afterload, preload, inotropic state, and heart rate. Six domestic pigs (Swiss large white, female, 60–70 kg of body weight) were used to establish this model. The defects on the hinge point of aortic leaflets and annulus were created percutaneously by the pierce-and-dilate technique either in the right coronary cusp (RCC) or in the non-coronary cusp (NCC). The hemodynamic changes as well as LV performance were recorded by PV loop measurements, while blood flow patterns were assessed by 4D MRI. LV performance was additionally challenged by pharmaceutically altering cardiac inotropy, chronotropy, and afterload. The presented work aims to elaborate the dos and don'ts in porcine models of aortic insufficiency and intends to steepen the learning curve for researchers planning to use this or similar models by giving valuable insights ranging from animal selection to vascular access choices, placement of PV Loop catheter, improvement of PV loop data acquisition and post-processing and finally the induction of paravalvular regurgitation of the aortic valve by a standardized and reproducible balloon induced defect in a precisely targeted region of the aortic valve.

Open in new tab Download slide Open in new tab Download slide OBJECTIVES Complications like complete atrioventricular block (CAVB) and paravalvular leakage (PVL) following rapid deployment aortic valve (AV) replacement (RDAVR) remain unresolved. Selecting an optimal size of the valve might be important to minimize the incidence of these complications. We sought to determine the impact of prosthesis size relative to the anatomic profile of the AV on the occurrence of CAVB or PVL after RDAVR. METHODS Preoperative computed tomographic (CT) images were evaluated in patients receiving RDAVR (INTUITY ELITE) between February 2016 and December 2019. The occurrence of CAVB requiring permanent pacemaker implantation and PVL (≥ mild) was evaluated. The relative size of implants against the cross-sectional dimensions of recipients' AV annulus and left ventricular outflow tract (LVOT) were calculated. RESULTS Among 187 eligible patients, CAVB and PVL (≥ mild) occurred in 12 (6.4%) and 11 patients (5.9%), respectively. CAVB was associated with oversized RDAVR (RDAVR frame width minus average diameter of LVOT calculated from the cross-sectional area [ΔLVOTarea]: odds ratio, 2.05; 95% confidence interval, 1.28–3.30): this was with an area under the curve of 0.78 (P  = 0.005). The projected probability of CAVB was <3% when the ΔLVOTarea was <1.3. In contrast, PVL was associated with under-sized RDAVR (RDAVR size divided by the longest diameter of AV annulus [index Annlong]: odds ratio, 0.64; 95% confidence interval, 0.51–0.79): This was with an area under curve of 0.94 (P  < 0.001). CONCLUSIONS CT parameters of the AV annulus and LVOT are highly reliable in the prediction of CAVB or PVL after RDAVR. Our data might justify CT-based sizing of prosthesis for RDAVR. [ABSTRACT FROM AUTHOR]

Our study investigated the feasibility to measure pressure profiles inside the inflation balloon during direct implantation of Edwards Sapien 3 ultra-prostheses using an additional syringe with a digital pressure read-out. Pressure profiles of 15 patients for 26 mm valve size were analyzed. Uniform patterns were found for 5 patients similar to those of previously acquired in vitro curves. 10 patients showed strikingly different pressure profiles compared to the above-mentioned group, marked by an earlier pressure increase, single or multiple pressure drops or higher overall pressure. Measuring the percentage of under-expansion of the prostheses, using calibrated angiographic projections revealed a significant difference between both groups. Our data raises the hypothesis that the acquisition of pressure profiles might help to better understand not only the implantation procedure itself but also the highly individual patient-device interaction, offering new information and a new perspective on optimization of TAVR implantation in the future. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement is a valuable alternative technique to surgery and the spectrum of therapy continues to evolve. The JenaValve Pericaridal transcatheter aortic valve replacement System allows prosthesis fixation in a native, noncalcified aortic annulus with a unique paper clip-like anchorage mechanism. The low rate of paravalvular leakage and permanent pacemaker implantation emphasizes the further widespread use of the JenaValve - despite the limited data available. In May 2021, a CE mark for the transfemoral implantation in both aortic regurgitation and aortic stenosis was granted. However, no data have been published so far. The ongoing ALIGN trials are expected to provide the pending long-term data. [ABSTRACT FROM AUTHOR]

Background: For transcatheter aortic valve implantation (TAVI), accurate determination of valve size is crucial. Multidetector Computed Tomography (MDCT) is considered gold standard, however sometimes there are conflicting measurements or aortic annulus is ambiguous between 2 prosthesis sizes. In such cases balloon sizing can serve in selecting valve size. Methods: 110 patients were prospectively enrolled. Aortic annular diameter was measured by 2D TEE. Balloon sizing was done with balloons equal or 1 mm smaller than TEE measurements. Supra-aortic angiography was performed during balloon inflation. Contrast regurgitation and balloon movement indicated annulus size underestimation, balloon wasting indicated annulus size overestimation. Valve size selection was based on balloon sizing. Agreement between 2D TEE and balloon measurements was calculated. Inhospital outcomes related to valve sizing and routine predilation were determined. Results: TEE was correctly sizing the valve in 81% of patients, oversizing in 17% and undersizing in only 2% compared with balloon sizing. Agreement between 2D TEE and balloon sizing measurement yielded a K value of 0.71. Hemodynamic instability after balloon sizing was observed in 2 patients, valve embolization occurred in one patient, no case of aortic rupture or coronary occlusion was detected. Two patients needed a second valve. Stroke rate was 0.9%, inhospital mortality was 1.8%. At hospital discharge, rate of significant PVL (≥ grade II) was 3.4% and pacemaker implantation rate was 6.4%. Conclusions: Balloon sizing based on 2D TEE annular measurements represents an appropriate approach for selecting valve size with favorable outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background Aortic root abscess (ARA) is a major complication of infective endocarditis that is associated with increased morbidity and mortality. Limited data are present about patient characteristics and outcomes in this lethal disease. We aimed to study the clinical and echocardiographic characteristics of patients with ARA compared to patients with left-sided infective endocarditis without ARA. We included patients with a definite diagnosis of left-sided infective endocarditis according to modified Duke’s criteria. The patients were classified into two groups according to the presence of ARA (ARA and NO-ARA groups). All the patients were studied regarding their demographic data, clinical characteristics, laboratory and imaging data, and complications. Results We included 285 patients with left-sided infective endocarditis. The incidence of ARA was 21.4% (61 patients). Underlying heart disease, mechanical prosthesis, bicuspid aortic valve, and prior IE were significantly higher in ARA. The level of CRP was higher in ARA (p = 0.03). ARA group showed more aortic valve vegetations (73.8% vs. 37.1%, p < 0.001), more aortic paravalvular leakage (26.7% vs. 4.5%, p < 0.001), and less mitral valve vegetations (21.3% vs. 68.8%, p < 0.001). Logistic regression analysis showed that the odds of ARA increased in the following conditions: aortic paravalvular leak (OR 3.9, 95% CI 1.2–13, p = 0.03), mechanical prosthesis (OR 3.6, 95% CI 1.5–8.7, p = 0.005), aortic valve vegetations (OR 3.0, 95% CI 1.2–8.0, p = 0.02), and undetected organism (OR 2.3, 95% CI 1.1–4.6, p = 0.02), while the odds of ARA decreased with mitral valve vegetations (OR 0.2, 95% CI 0.08–0.5, p = 0.001). We did not find a difference between both groups regarding the incidence of major complications, including in-hospital mortality. Conclusion In our study, ARA occurred in one fifth of patients with left-sided IE. Patients with mechanical prosthesis, aortic paravalvular leakage, aortic vegetations, and undetected organisms had higher odds of ARA, while patients with mitral vegetations had lower odds of ARA.

Abstract Background Perpendicular transvalvular leakage (TVL) is occasionally observed after aortic valve replacement (AVR) in biological valves with a stent post, often originating from the base of the stent post. However, an observed perpendicular jet flow is not always a TVL. In rare cases, paravalvular leakages (PVLs) can be perpendicular and are present behind a TVL. In the present case, both PVL and TVL existed simultaneously as unusual perpendicular jet flows that originated from sites in close proximity to the stent post. Case presentation A 73-year-old man underwent AVR with a biological valve in the supra-annular position using the non-everting mattress suture technique with pledgets. After weaning from cardiopulmonary bypass (CPB), transesophageal echocardiography (TEE) revealed an unfamiliar perpendicular turbulent flow, similar to reported TVL, originating from the anterior stent post. Further TEE examination revealed a PVL had originated from the site between the sewing ring at the anterior stent post and native annulus attached to a pledget. The space between the sewing ring and annular retained native portion caused the perpendicular turbulent jet. Consequently, two types of perpendicular turbulent flows, TVL and PVL, existed adjacent to each other. After reinstitution of CPB, inspection of the prosthesis itself indicated it to be normal, but there was a region adjacent to the anterior stent post near the right coronary ostium where the tip of the curved Pean forceps entered between the sewing ring and the native annulus. The region was consistent with TEE findings. AVR was performed with the same prosthesis again. After weaning from CPB, immediate TEE revealed that the unusual perpendicular turbulent flows had disappeared and only a few small TVLs were observed. Regarding the disappearance of TVL, we considered that the fabric region of the prosthetic valve was covered with cellular elements to prevent the leak, as it was already used in AVR once and soaked in blood. Conclusions Perpendicular turbulent flow raises the possibility of both TVL and PVL in the case of AVR with stented bovine pericardial valves. For a differential diagnosis of TVL or PVL, it is important to know the surgical procedures and valve morphology.

Objective: Literature presents conflicting results on the pros and cons of pledget-reinforced sutures during surgical aortic valve replacement (SAVR). We aimed to investigate the effect of pledget-reinforced sutures versus sutures without pledgets during SAVR on different outcomes in a systematic review and meta -analysis., Methods: A literature search was performed in five different medical literature databases. Studies must include patients undergoing SAVR and must compare any pledget-reinforced with any suturing technique without pledgets. The primary outcome was paravalvular leakage (PVL), and secondary outcomes comprised thromboembolism, endocarditis, mortality, mean pressure gradient (MPG) and effective orifice area (EOA). Results were pooled using a random-effects model as risk ratios (RRs) or mean differences (MDs) for which the no pledgets group served as reference., Results: Nine observational studies met the inclusion criteria. The risk of bias was critical in seven studies, and high and moderate in two other. The pooled RR for moderate or greater PVL was 0.59 (95 % confidence interval [CI] 0.13, 2.73). The pooled RR for mortality at 30-days was 1.02 (95 % CI 0.48, 2.18) and during follow-up was 1.15 (95 % CI 0.67, 2.00). For MPG and EOA at 1-year follow-up, the pooled MDs were 0.60 mmHg (95 % CI -4.92, 6.11) and -0.03 cm 2  (95 % CI -0.18, 0.12), respectively., Conclusions: Literature on the use of pledget-reinforced sutures during SAVR is at high risk of bias. Pooled results are inconclusive regarding superiority of either pledget-reinforced sutures or sutures without pledgets. Hence, there is no evidence to support or oppose the use of pledget-reinforced sutures., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier B.V.)

Background: East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve implantation (TAVI) outcomes in Asian patients with a large annulus., Objectives: This study aimed to compare the short- and long-term outcomes of TAVI using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus., Methods: The study retrospectively analyzed the data from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry. A large annulus was defined by an annular area ≥500 mm 2 and an average diameter ≥25 mm as measured by computed tomography. The primary endpoint was 3-year all-cause mortality. Secondary endpoints were 3-year heart failure rehospitalization (HFR) after TAVI, short-term outcomes of TAVI, and changes in valve function 2 years after TAVI., Results: Among 773 patients, 671 underwent BEV TAVI. The SEV TAVI group showed a significantly higher incidence of greater than moderate paravalvular leakage (PVL) ( P  < 0.001), and an increased pacemaker implantation rate ( P  = 0.035). The incidence of prosthesis-patient mismatch did not differ between the 2 groups. The Kaplan-Meier curve showed no significant differences in 3-year all-cause mortality and HFR rates (log-rank P  = 0.900), and echocardiographic valve function at 2 years post-TAVI did not differ between the 2 groups., Conclusions: The lack of differences in postoperative valve performance and long-term prognosis between BEV TAVI and SEV TAVI highlights the importance of selecting valves that can reduce the pacemaker implantation rate and PVL grade in the acute phase in patients with a large annulus. (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation [OCEAN-TAVI]; UMIN000020423)., Competing Interests: The OCEAN-TAVI registry was supported by Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Medical, and Daiichi-Sankyo. Dr Mizutani has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Ohno has served as a clinical proctor for Medtronic. Dr Yashima has served as a clinical proctor for Medtronic. Dr Naganuma has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Tada has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Shirai has served as a clinical proctor for Edwards Lifesciences, Abbott Medical, and Medtronic. Dr Takagi has served as a clinical proctor for Edwards Lifesciences. Dr Asami has served as a clinical proctor for Medtronic. Dr H. Ueno has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Watanabe has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Yamamoto has served as a clinical proctor for Edwards Lifesciences, Abbott Medical, and Medtronic. Dr Hayashida has served as a clinical proctor for Edwards Lifesciences, Abbott Medical, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Angiopoietins (Angs) regulate endothelial permeability. Ang-1 and 2 (Ang-1 and Ang-2) are implied in endothelial stability through an antagonism effect. The objectives of the present study were to describe and compare changes in Ang levels after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). A prospective, single-center study. Adult patients with aortic stenosis scheduled for SAVR or TAVR. None. Ang-1 and Ang-2 were measured using an enzyme-linked immunosorbent assay right before surgery (T0), at the end of surgery (T1), and at day one (T2). Sixty consecutive patients (SAVR group [n = 30] and TAVR group [n = 30]) were included between January and June 2017. Ang-1 decreased significantly after both TAVR (T0: 3,663 [2,602-4,262]; T1: 1,611 [981-2,409]; T2: 1,082 [652-1,589] ng/mL; p < 0.0001) and SAVR (T0: 1,603 [975-2,849]; T1: 783 [547-1,024]; T2: 828 [460-1,227] ng/mL; p = 0.0001). Ang-2 increased significantly after SAVR (T0: 2,472 [1,502-3,622]; T1: 2,997 [1,759-3,839]; T2: 5,421 [3,557-7,087] ng/mL; p < 0.0001) but did not change markedly after TAVR (T0: 3,343 [2,661-6,272]; T1: 3,788 [2,574-5,016]; T2: 3,446 [3,029-6,313] ng/mL; p = 0.066). Among patients with paravalvular leakage, the changes in the plasma Ang-2 level and the Ang-2/Ang-1 ratio were greater. SAVR induces greater alterations of Ang homeostasis than TAVR, confirming a role for the use of cardiopulmonary bypass. Paravalvular leakage after TAVR is associated with Ang changes similar to those observed with SAVR. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) can provide unique insights in device-patient interaction.Aims: This study was to compare transcatheter aortic valve sealing behavior in patients with bicuspid aortic valves (BAV) and tricuspid aortic valves (TAV) through patient-specific computational modeling.Methods: Patient-specific computer simulation was retrospectively performed with FEops HEARTguide for TAVR patients. Simulation output was compared with postprocedural computed tomography and echocardiography to validate the accuracy. Skirt malapposition was defined by a distance larger than 1 mm based on the predicted device-patient interaction by quantifying the distance between the transcatheter heart valve (THV) skirt and the surrounding anatomical regions.Results: In total, 43 patients were included in the study. Predicted and observed THV frame deformation showed good correlation (R2 ≥ 0.90) for all analyzed measurements (maximum diameter, minimum diameter, area, and perimeter). The amount of predicted THV skirt malapposition was strongly linked with the echocardiographic grading of paravalvular leakage (PVL). More THV skirt malapposition was observed for BAV cases when compared to TAV cases (22.7 vs. 15.5%, p < 0.05). A detailed analysis of skirt malapposition showed a higher degree of malapposition in the interleaflet triangles section for BAV cases as compared to TAV patients (11.1 vs. 5.8%, p < 0.05).Conclusions: Patient-specific computer simulation of TAVR can accurately predict the behavior of the Venus A-valve. BAV patients are associated with more malapposition of the THV skirt as compared to TAV patients, and this is mainly driven by more malapposition in the interleaflet triangle region.

Background This study compared the clinical outcomes of transcatheter (TAVR) and surgical (SAVR) aortic valve replacements, focusing on postoperative valvular performance assessed by echocardiography. Method and Results A total of 425 patients who underwent TAVR (230 patients) or SAVR (195 patients) were included. Postoperative effective orifice area index (EOAI) was higher in the TAVR group (1.27 ± 0.35 cm2/m2) than in the SAVR group (1.06 ± 0.27 cm2/m2, p < 0.001), and patient–prosthesis mismatch (PPM) was more frequent in the SAVR group (22.6%) than in the TAVR group (8.7%, p < 0.001). Mild or greater paravalvular leakage (PVL) was more frequent in the TAVR group (21.3%) than in the SAVR group (0%, p < 0.001). Moreover, there was no difference in freedom from all-cause death, stroke, or rehospitalization between the groups. Patients with moderate or greater PPM (EOAI < 0.85 cm2/m2) had lower freedom from composite events than those without this PPM criterion (p = 0.008). Patients with mild or greater PVL also had lower freedom from composite events than those without this PVL criterion (p = 0.017). Conclusions Postoperative valvular performance of TAVR was superior to that of SAVR in terms of EOAI. This merit was counterbalanced by the significantly lower rates of PVL in patients who underwent SAVR. The overall clinical outcomes were similar between the study groups.

Objectives: Paravalvular leakage (PVL) and eccentric aortic regurgitation remain a major clinical concern in patients receiving transcatheter aortic valve replacement (TAVR), and regurgitant volume remains the main readout parameter in clinical assessment. In this work we investigate the effect of jet origin and trajectory of mild aortic regurgitation on left ventricular hemodynamics in a porcine model.Methods: A pig model of mild aortic regurgitation/PVL was established by transcatheter piercing and dilating the non-coronary (NCC) or right coronary cusp (RCC) of the aortic valve close to the valve annulus. The interaction between regurgitant blood and LV hemodynamics was assessed by 4D flow cardiovascular MRI.Results: Six RCC, six NCC, and two control animals were included in the study and with one dropout in the NCC group, the success rate of model creation was 93%. Regurgitant jets originating from NCC were directed along the ventricular side of the anterior mitral leaflet and integrated well into the diastolic vortex forming in the left ventricular outflow tract. However, jets from the RCC were orientated along the septum colliding with flow within the vortex, and progressing down to the apex. As a consequence, the presence as well as the area of the vortex was reduced at the site of impact compared to the NCC group. Impairment of vortex formation was localized to the area of impact and not the entire vortex ring. Blood from the NCC jet was largely ejected during the following systole, whereas ejection of large portion of RCC blood was protracted.Conclusions: Even for mild regurgitation, origin and trajectory of the regurgitant jet does cause a different effect on LV hemodynamics. Septaly oriented jets originating from RCC collide with the diastolic vortex, reduce its size, and reach the apical region of the left ventricle where blood resides extendedly. Hence, RCC jets display hemodynamic features which may have a potential negative impact on the long-term burden to the heart.

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 nine months, IE recurred and the mechanical valve was surgically replaced with a bioprosthetic valve. Three 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.

Abstract Background Behcet’s disease (BD)-related aortic regurgitation (AR) is known to be associated with paravalvular leakage (PVL) after successful aortic valve (AV) surgery. This study aimed to determine predictors of PVL after successful AV surgery in BD patients. We retrospectively collected data of 35 patients (42.1 ± 9.1 years, 27 men) who underwent surgery for severe BD-related AR at two tertiary centers. The diagnosis was established based on echocardiographic, surgical, and/or pathological findings in conjunction with the International Study Group criteria for BD. A total of 76 cases of AV surgery in 35 patients were analyzed. Results A median follow-up duration was 8.0 years (interquartile range, 5.4–14.3 years). PVL developed in 18 patients (51.4%) within 2 years after the first surgery. Six patients who met the diagnostic criteria for BD did not develop PVL, in whom 5 patients took immunosuppressive therapy (IST). However, 4 of 9 patients (44.4%) who did not meet the diagnostic criteria developed PVL, in whom four (44.4%) patients took IST. On multivariable analysis, postoperative IST and concomitant aortic root replacement (ARR) were two independent predictors for less PVL development (HR 0.38, 95% CI 0.17–0.89, p = 0.025 for postoperative IST; HR 0.17, 95% CI 0.08–0.36, p

Transcatheter aortic valve replacement (TAVR) strongly depends on the calcification patterns, which may lead to a malapposition of the stented valve and complication onsets in terms of structure kinematics and paravalvular leakage (PVL). From one anatomical-resembling model of the aortic root, six configurations with different calcific deposits were built. TAVR fluid-structure interaction simulations predicted different outcomes for the different calcifications patterns in terms of the final valve configuration in the implantation site and the PVL estimations. In particular models with deposits along the cups coaptation resulted in mild PVL, while those with deposits along the attachment line in moderate PVL. [ABSTRACT FROM AUTHOR]

• Bicuspid aortic valve cases have been long contraindicated for TAVI. • Patient-specific computational simulations of TAVI in bicuspid aortic valve anatomies are performed. • High radial force devices vs high conformability devices are investigated. • Four patient-specific clinical cases of bicuspid aortic valve are studied in details. • High radial force is a more desired characteristic in a device that will be deployed in bicuspid valve patients. Transcatheter Aortic Valve Implantation (TAVI) is a consolidated procedure showing a low operative risk and excellent long-term outcomes in patients with aortic stenosis. Patients presenting a bicuspid aortic valve (BAV) often require valve replacement due to the highly calcific nature of the aortic leaflets. However, BAV patients have usually been contraindicated for TAVI due to their complex valve anatomy. The aim of this work was to compare the performance of devices featuring high conformability (HC) against those with high radial force (HRF). Four BAV patients undergoing TAVI were retrospectively selected. The aortic roots including the native leaflets and calcifications were reconstructed from pre-operative Computed Tomography scans. In each patient, both HC and HRF devices were virtually implanted using Finite Element Analysis simulations. After implantation, paravalvular orifice area, von Mises stress distribution, root contact area, and device eccentricity were calculated. Simulations showed good agreement with intraoperative imaging. In 3 out of 4 patients, the HRF device resulted in a lower paravalvular area than the HC. Stress distribution was also more homogeneously distributed in the HRF group as compared with the HC group. Despite their lower adaptability, HRF devices showed consistently higher stent-root contact area. HRF devices showed improved results with respect to HC valves after being deployed in BAV anatomies. We hypothesize that the ability to reshape the annulus is the major determinant of success in this subgroup of patients featuring highly calcified leaflets. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Herz-, Thorax- und Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset.Methods: Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria.Results: Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm2 vs 0.70 cm2, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed.Conclusion: The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation. [ABSTRACT FROM AUTHOR]

Objectives: We retrospectively assessed the initial clinical impact of the locally administered bacteriostatic antibiotic, powder minocycline, during surgery for active infective endocarditis (AIE). Methods: Among 38 surgical AIE patients, 36 patients who underwent surgical intervention for AIE using local administration of powder minocycline between January 2008 and August 2017 in our institute were enrolled. During surgery, the local administration and dispersion of powder minocycline at not only the valvular annulus and perivalvular cavity, but also the prosthetic cuff and ring were performed following the complete resection and aggressive debridement of infectious tissues. Early clinical outcomes, including survival, postoperative co-morbidities, and freedom from re-intervention or significant paravalvular leakage (PVL), were assessed. Results: Early mortality within 30 days was 5.6% and hospital death was 13.9%. There was no reoperation within 30 days and only one patient (3.8%) developed recurrent infection, which improved with additional antibiotic treatments. More than moderate PVL within 30 days was detected in one patient only (3.8%). Over a median follow-up period of 38.3 ± 35.5 months, a Kaplan–Meier analysis revealed that 1- and 5-year survival rates were 75.7 and 66.8%, respectively, and freedom from reoperation was 100% at 5 years. Freedom from significant PVL at 5 years was 91.0%. Conclusions: The local administration of powder minocycline may be a simple and effective manipulation during surgical intervention for AIE without extensive reconstruction; however, the surgical management of AIE remains challenging. [ABSTRACT FROM AUTHOR]

Objectives: During transcatheter aortic valve implantation (TAVI), ideal positioning is crucial. The latest-generation balloon expandable Sapien3™ transcatheter heart valve (THV) comes with a marker, which is recommended to be exactly centered at the aortic annular level. We aimed to evaluate a higher "aortic" marker positioning. Material and methods: A total of 119 high-risk patients presenting with aortic stenosis were treated with the Sapien3™ THV. After having placed the THV more "aortic", clinical and hemodynamic data, especially postoperative pacemaker implantation and paravalvular leakages, were evaluated at 30-days according to VARC-2. Results: The Sapien3™ THV was implanted in 92 patients via the transapical, in 13 patients via the transaortic and in 14 patients via the tranfemoral access. Mean age was 80.6 ± 5.7 years. Aortic valve area increased significantly (0.9 ± 0.3 vs. 1.80 ± 0.35cm2, p <.0001) and mean pressure gradients decreased from 41.0 ± 15.0 to 10.4 ± 3.5 mmHg (p <.0001). The majority of patients showed no or mild paravalvular aortic regurgitation (99.1%, 112/113), confirmed by transthoracic echocardiography at 30-days: PVL was absent or trace in 91.2% (103/113), mild in 7.9% (9/113) and moderate in 0.9% (1/113), whereas no patient developed severe PVL. Thirty days mortality was 5.0% (6/119). All patients (n = 113) were in NYHA functional class I or II at 30 days and three patients (2.5%) needed pacemaker implantation. Conclusions: In conclusion, a modified higher "aortic" implantation of the Sapien3™ THV holds promise to further reduce paravalvular leakage as well as permanent pacemaker implantation in TAVI. This trial showed an extremely low postoperative pacemaker implantation rate of 2.5%. [ABSTRACT FROM AUTHOR]

Background: Perpendicular transvalvular leakage (TVL) is occasionally observed after aortic valve replacement (AVR) in biological valves with a stent post, often originating from the base of the stent post. However, an observed perpendicular jet flow is not always a TVL. In rare cases, paravalvular leakages (PVLs) can be perpendicular and are present behind a TVL. In the present case, both PVL and TVL existed simultaneously as unusual perpendicular jet flows that originated from sites in close proximity to the stent post.Case Presentation: A 73-year-old man underwent AVR with a biological valve in the supra-annular position using the non-everting mattress suture technique with pledgets. After weaning from cardiopulmonary bypass (CPB), transesophageal echocardiography (TEE) revealed an unfamiliar perpendicular turbulent flow, similar to reported TVL, originating from the anterior stent post. Further TEE examination revealed a PVL had originated from the site between the sewing ring at the anterior stent post and native annulus attached to a pledget. The space between the sewing ring and annular retained native portion caused the perpendicular turbulent jet. Consequently, two types of perpendicular turbulent flows, TVL and PVL, existed adjacent to each other. After reinstitution of CPB, inspection of the prosthesis itself indicated it to be normal, but there was a region adjacent to the anterior stent post near the right coronary ostium where the tip of the curved Pean forceps entered between the sewing ring and the native annulus. The region was consistent with TEE findings. AVR was performed with the same prosthesis again. After weaning from CPB, immediate TEE revealed that the unusual perpendicular turbulent flows had disappeared and only a few small TVLs were observed. Regarding the disappearance of TVL, we considered that the fabric region of the prosthetic valve was covered with cellular elements to prevent the leak, as it was already used in AVR once and soaked in blood.Conclusions: Perpendicular turbulent flow raises the possibility of both TVL and PVL in the case of AVR with stented bovine pericardial valves. For a differential diagnosis of TVL or PVL, it is important to know the surgical procedures and valve morphology. [ABSTRACT FROM AUTHOR]