40 results on '"Kappert, U."'
Search Results
2. Valve-in-valve transcatheter aortic valve implantation for degenerative stentless versus stented surgical bioprostheses
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Steul, J, primary, Abdel-Wahab, M, additional, Stankowski, T, additional, Haussig, S, additional, Woitek, F, additional, Gasior, T, additional, Crusius, L, additional, Knorr, L, additional, Mueller, F, additional, Kiefer, P, additional, Kappert, U, additional, Holzhey, D, additional, Linke, A, additional, and Mangner, N, additional
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- 2023
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3. Transaxillary Access for Minimally Invasive Surgery for Benign Primary Cardiac Tumors.
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Waghefi, Taghizadeh-, ŽIvković, I., Petrov, A., Alexiou, K., Kappert, U., Matschke, K., and Wilbring, M.
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MINIMALLY invasive procedures ,TUMORS ,HYPERHIDROSIS - Abstract
This article discusses the use of transaxillary access for minimally invasive surgery (MICS) in the treatment of benign primary cardiac tumors, specifically myxomas. The study compares the outcomes of patients who underwent MICS with those who underwent conventional surgery using full sternotomy (FS). The results show that transaxillary access is a safe and efficient alternative to FS, with similar EuroSCORE II scores and skin-to-skin times. Nondisabling strokes were observed in both groups, and wound healing complications were more frequent in the FS group. Overall, transaxillary access shows promise in reducing complications in cardiac tumor surgery. [Extracted from the article]
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- 2024
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4. Minimally Invasive Surgery for High-Risk Subpopulations: Transaxillary Access Enhances Survival in Adipose Patients.
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Wilbring, M., Arzt, S., Petrov, A., Alexiou, K., Matschke, K., and Kappert, U.
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MINIMALLY invasive procedures ,AORTIC valve transplantation ,PERIPHERAL vascular diseases ,CHRONIC kidney failure - Abstract
This article, published in the journal Thoracic & Cardiovascular Surgeon, examines the outcomes of minimally invasive cardiac surgery (MICS) in adipose patients compared to a sternotomy cohort. The study analyzed a cohort of 3,431 patients undergoing elective aortic valve replacement (AVR), with 200 patients with a body-mass-index (BMI) >30 g/m2 undergoing MICS-AVR using transaxillary access as the treatment group. A control group of isolated AVRs by full sternotomy was generated through propensity-matching. The results showed that MICS-AVR demonstrated better survival and less postoperative morbidity in adipose patients compared to the sternotomy-control group. [Extracted from the article]
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- 2024
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5. P46 TRANSAXILLARY MITRAL VALVE SURGERY IS ASSOCIATED WITH EARLY RECOVERY AND SHORTER ICU AND HOSPITAL STAY
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Malvindi, P, primary, Berretta, P, additional, Wilbring, M, additional, Bifulco, O, additional, De Angelis, V, additional, Cefarelli, M, additional, Zingaro, C, additional, Kappert, U, additional, and Di Eusanio, M, additional
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- 2023
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6. Concomitant Transventricular Mitral Valve Replacement in Posterior Postinfarction Ventricular Septal Defect
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Petrov, A., additional, Diab, A. H., additional, Taghizadeh-Waghefi, A., additional, Alexiou, K., additional, Wilbring, M., additional, Matschke, K., additional, and Kappert, U., additional
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- 2023
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7. Clinical Safety and Efficacy of the Transaxillary Access Route for Minimally Invasive Aortic Valve Replacement
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Wilbring, M., additional, Arzt, S., additional, Alexiou, K., additional, Charitos, E., additional, Matschke, K., additional, and Kappert, U., additional
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- 2023
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8. Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.
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Blankenberg, S., Seiffert, M., Vonthein, R., Baumgartner, H., Bleiziffer, S., Borger, M. A., Choi, Y.-H., Clemmensen, P., Cremer, J., Czerny, M., Diercks, N., Eitel, I., Ensminger, S., Frank, D., Frey, N., Hagendorff, A., Hagl, C., Hamm, C., Kappert, U., and Karck, M.
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DISEASE risk factors , *AORTIC stenosis , *STROKE , *HEART valve prosthesis implantation , *STENOSIS , *CONFIDENCE intervals - Abstract
BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; PcO.OOl for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. [ABSTRACT FROM AUTHOR]
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- 2024
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9. The transaxillary concept for minimally invasive isolated aortic valve replacement: results of 1,000 consecutive patients.
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Wilbring M, Arzt S, Taghizadeh-Waghefi A, Petrov A, Di Eusanio M, Matschke K, Alexiou K, and Kappert U
- Abstract
Objectives: The transaxillary concept for MICS-AVR is a new and versatile approach with nearly no visible scars. Due to its novelty, available data in literature is scarce. This study reports clinical outcomes of 1,000 consecutive patients., Methods: Between 2019 and 2023, 4,394 patients underwent elective isolated aortic valve procedures, with 2,958 (67.5%) TAVI's and 1,436 patients SAVR`s (32.5%). Within this period, first consecutive 1,000 transaxillary isolated MICS-AVR were enrolled. Endocarditis, redo's or combined procedures were excluded. Mean age was 67.9 ± 8.3 years, STS-PROM 1.39 ± 2.89% and EuroScore II 1.65 ± 1.12%., Results: Use of the transaxillary access increased from 18.7% (2019) to 97.8% (2023). Mean procedure-time was 127 ± 31 min, average cross-clamp 43 ± 14 min. Used prostheses were rapid deployment (81.1%), sutured biologic (14.5%) or sutured mechanical valves (4.1%). Conversion-rate was 1.9%. No patient died intraoperatively. Thirty-days MACCE was 1.9% including 0.9% mortality, 0.8% perioperative stroke and 0.6% myocardial infarction. Multivariate factors for MACCE are intraoperative conversion (OR 1.08 [1.00-1.16]; p = 0.04), intraoperative transfusions (OR 1.21 [1.07-1.38]; p < 0.01) and respiratory failure (OR 1.39 [1.30-1.49]; p < 0.01). Corresponding factors for mortality are diabetes on insulin (OR 1.02 [1.00-1.04]; p = 0.03), pure aortic regurgitation for primary indication (OR 1.03 [1.01-1.05]; p < 0.01), intraoperative conversion (OR 1.11 [1.07-1.16]; p < 0.01), renal failure (OR 1.08 [1.05-1.10]; p < 0.01) and respiratory failure (OR 1.22 [1.17-1.26]; p < 0.01)., Conclusions: Transaxillary MICS-AVR is a safe, effective and cosmetically convincing method for SAVR, having the potential for >95.0% MICS-rate in selected patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2024
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10. Minimally Invasive Aortic Valve Replacement for High-Risk Populations: Transaxillary Access Enhances Survival in Patients with Obesity.
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Taghizadeh-Waghefi A, Petrov A, Arzt S, Alexiou K, Matschke K, Kappert U, and Wilbring M
- Abstract
Background/Objectives : Minimally invasive cardiac surgery is often avoided in patients with obesity due to exposure and surgical access concerns. Nonetheless, these patients have elevated periprocedural risks. Minimally invasive transaxillary aortic valve surgery offers a sternum-sparing "nearly no visible scar" alternative to the traditional full sternotomy. This study evaluated the clinical outcomes of patients with obesity compared to a propensity score-matched full sternotomy cohort. Methods : This retrospective cohort study included 1086 patients with obesity (body mass index [BMI] of >30 kg/m
2 ) undergoing isolated aortic valve replacement from 2014 to 2023. Two hundred consecutive patients who received transaxillary minimally invasive cardiac lateral surgery (MICLAT-S) served as a treatment group, while a control group was generated via 1:1 propensity score matching from 886 patients who underwent full sternotomy. The final sample comprised 400 patients in both groups. Outcomes included major adverse cardio-cerebral events, mortality, and postoperative complications. Results : After matching, the clinical baselines were comparable. The mean BMI was 34.4 ± 4.0 kg/m2 (median: 33.9, range: 31.0-64.0). Despite the significantly longer skin-to-skin time (135.0 ± 37.7 vs. 119.0 ± 33.8 min; p ≤ 0.001), cardiopulmonary bypass time (69.1 ± 19.1 vs. 56.1 ± 21.4 min; p ≤ 0.001), and aortic cross-clamp time (44.0 ± 13.4 vs. 41.9 ± 13.3 min; p = 0.044), the MICLAT-S group showed a shorter hospital stay (9.71 ± 6.19 vs. 12.4 ± 7.13 days; p ≤ 0.001), lower transfusion requirements (0.54 ± 1.67 vs. 5.17 ± 9.38 units; p ≤ 0.001), reduced postoperative wound healing issues (5.0% vs. 12.0%; p = 0.012), and a lower 30-day mortality rate (1.5% vs. 6.0%; p = 0.031). Conclusions : MICLAT-S is safe and effective. Compared to traditional sternotomy in patients with obesity, MICLAT-S improves survival, reduces postoperative morbidity, and shortens hospital stays.- Published
- 2024
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11. Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.
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Micovic S, Nobre A, Choi JW, Solinas M, Shehada SE, Torella M, Baeza C, Parrino E, Pollari F, Troise G, Kappert U, Mellert F, Je HG, Argano V, Lam KY, Rinaldi M, Gutermann H, and Meuris B
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- Humans, Aged, Male, Female, Prospective Studies, Treatment Outcome, Prosthesis Design, Sutureless Surgical Procedures methods, Quality of Life, Hemodynamics physiology, Aged, 80 and over, Middle Aged, Heart Valve Prosthesis, Aortic Valve surgery, Heart Valve Prosthesis Implantation methods, Aortic Valve Stenosis surgery
- Abstract
Background: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve., Methods: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days., Results: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported., Conclusions: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS., Trial Registration: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021)., (© 2024. The Author(s).)
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- 2024
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12. Bioresorbable molybdenum temporary epicardial pacing wires.
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Prieto Jarabo ME, Redlich C, Schauer A, Alves PKN, Guder C, Poehle G, Weissgaerber T, Adams V, Kappert U, El-Armouche A, Linke A, and Wagner M
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- Humans, Animals, Rats, Molybdenum pharmacology, Absorbable Implants, Pericardium, Cardiac Pacing, Artificial, Pacemaker, Artificial
- Abstract
Cardiac pacing with temporary epicardial pacing wires (TEPW) is used to treat rhythm disturbances after cardiac surgery. Occasionally, TEPW cannot be mechanically extracted and remain in the thorax, where they may rarely cause serious complications like migration and infection. We aim to develop bioresorbable TEPW that will dissolve over time even if postoperative removal is unsuccessful. In the present study, we demonstrate a completely bioresorbable design using molybdenum (Mo) as electric conductor and the resorbable polymers poly(D, L-lactic-co-glycolic acid) (PLGA) and polycaprolactone (PCL) for electrically insulating double-coating. We compared the pacing properties of these Mo TEPW demonstrators to conventional steel TEPW in Langendorff-perfused rat hearts and observed similar functionality. In vitro, static immersion tests in simulated body fluid for up to 28 days elucidated the degradation behaviour of uncoated Mo strands and the influence of polymer coating thereon. Degradation was considerably reduced in double-coated Mo TEPW compared to the uncoated and the PLGA-coated condition. Furthermore, we confirmed good biocompatibility of Mo degradation products in the form of low cytotoxicity in cell cultures of human cardiomyocytes and cardiac fibroblasts. STATEMENT OF SIGNIFICANCE: Temporary pacing wires are routinely implanted on the heart surface to treat rhythm disturbances in the days following cardiac surgery. Subsequently, these wires are to be removed. When removal attempts are unsuccessful, wires are cut at skin level and the remainders are left inside the chest. Retained fragments may migrate within the body or become a centre of infection. These complications may be prevented using resorbable pacing wires. We manufactured completely resorbable temporary pacing wires using molybdenum as electrical conductor and assessed their function, degradation and biological compatibility. Our study represents an important step in the development of a safer approach to the treatment of rhythm disturbances after cardiac surgery., Competing Interests: Declaration of competing interest 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., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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13. BASILICA Left, CHIMNEY Right: Protecting Coronary Arteries According to Anatomical Requirements in Valve-in-Valve TAVR.
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Mangner N, Madej T, Tomko M, Fassl J, Kappert U, Haussig S, and Linke A
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- Humans, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Treatment Outcome, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Bioprosthesis
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, B. Braun, and Boston Scientific outside the submitted work. Dr Fassl has received speaker fees from CSL Behring and Edwards Lifesciences outside the submitted work. Dr Haussig has received speaker honoraria and consulting fees from Edwards Lifesciences, Abbott, and Boston Scientific outside the submitted work. Dr Linke has received grants from Novartis; personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer; and personal fees from Picardia, Transverse Medical, and Claret Medical outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2024
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14. Right Anterior versus Right Transaxillary Access for Minimally Invasive Aortic Valve Replacement: A Propensity Matched Competitive Analysis.
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Taghizadeh-Waghefi A, Arzt S, Wenzel L, Petrov A, Wilbring M, Matschke K, Kappert U, and Alexiou K
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(1) Background: Right anterior thoracotomy (RAT-AVR) has been the sole established sternum-sparing technique for minimally invasive aortic valve replacement (MICS-AVR) thus far. Nevertheless, transaxillary access, known as Minimally Invasive Cardiac LATeral Surgery (MICLATS-AVR), represents the latest and innovative advancement in sternum-sparing MICS-AVR access routes. In this study, procedural and clinical outcomes of a substantial transaxillary MICS-AVR cohort are compared to those of a RAT-AVR control group; (2) Patients and Methods: This retrospective study included 918 consecutive patients who underwent MICS-AVR at our facility between 2014 and 2022. This cohort was divided into two surgical access-related groups: RAT-AVR ( n = 492) and MICLATS-AVR ( n = 426). Procedural data, operative morbidity, and mortality were compared between groups. Further analysis was performed using propensity score matching; (3) Results: After matching, 359 pairs of patients were included and analyzed. There were no notable differences observed between the two groups regarding major adverse cardio-cerebral events. Despite longer cardiopulmonary bypass time in the MICLATS-AVR group (63.1 ± 20.4 min vs. 66.4 ± 18.2 min; p ≤ 0.001) the skin-to-skin time (129.4 ± 35.9 min. vs. 126.5 ± 29.8 min.; p = 0.790) and the aortic cross-clamp time was comparable between both groups (41.9 ± 13.3 min. vs. 43.5 ± 14.4 min.; p = 0.182). The overall hospital stay was significantly shorter in the MICLATS-AVR cohort (9.7 ± 5.2 days vs. 9.2 ± 4.5 days; p = 0.01). Both groups were comparable in terms of postoperative morbidities. However, significantly lower rates of postoperative impaired wound healing were noted in the MICLATS-AVR group (11.7% vs. 3.9%, p < 0.001); (4) Conclusions: In comparing MICLATS-AVR and RAT-AVR, our study found MICLATS-AVR to be at least as safe and time-efficient as RAT-AVR, with no significant differences in MACCE. MICLATS-AVR showed a shorter hospital stay and lower postoperative wound issues, indicating its feasibility and safety as an alternative. Notably, MICLATS-AVR is sternum- and bone-sparing, preserving the right mammary artery, and facilitates combined procedures like multiple valve surgeries.
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- 2024
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15. Clinical Outcomes after Multivalve Surgery in Octogenarians: Evaluating the Need for a Paradigm Shift.
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Taghizadeh-Waghefi A, Petrov A, Arzt S, Alexiou K, Tugtekin SM, Matschke K, Kappert U, and Wilbring M
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(1) Background: this study addresses the lack of comprehensive research on outcomes in octogenarians undergoing cardiac surgery for multivalvular disease, emphasizing the need for a critical examination of the intervention's overall worth in this aging population. (2) Methods: By analyzing short-term and mid-term data from 101 consecutive octogenarian patients undergoing multivalve surgery, the study identifies predictors for in-hospital and one-year mortality. (3) Results: In-hospital mortality increased fourfold with the occurrence of at least one postoperative complication. Octogenarians undergoing multivalve surgery experienced an in-hospital mortality rate of 13.9% and an overall one-year mortality rate of 43.8%. Postoperative delirium was identified as an independent risk factor, contributing to elevated risks of both in-hospital and one-year mortality. Prolonged surgical procedure time emerged as an independent risk factor associated with increased in-hospital mortality. Continuous veno-venous hemodialysis showed an independent impact on in-hospital mortality. Both re-intubation and the transfusion of packed red blood cells were identified as independent risk factors for one-year mortality. (4) Conclusions: This study urges a critical examination of the justification for multivalve surgeries in high-risk elderly patients, emphasizing a paradigm shift. It advocates for interdisciplinary collaboration and innovative strategies, such as staged hybrid procedures, to improve therapeutic approaches for this challenging patient group to achieve a better therapeutic outcome for these patients.
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- 2024
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16. VARC-3 defined outcome of valve-in-valve transcatheter aortic valve implantation in stentless compared with stented aortic bioprostheses.
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Steul JH, Abdel-Wahab M, Stankowski T, Haussig S, Woitek FJ, Gasior T, Crusius L, Knorr L, Müller FV, Fritzsche D, Kiefer P, Kappert U, Holzhey D, Linke A, and Mangner N
- Abstract
Background: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable alternative to redo surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in stented bioprosthetic valves (ST); stentless bioprostheses (SL) lack fluoroscopic markers and could be more challenging for ViV-TAVI. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce. We compared patient characteristics, procedural outcomes, and 5-year mortality of patients with SL versus ST aortic bioprosthetic valve failure undergoing ViV-TAVI., Methods: Patients undergoing ViV-TAVI between 2007 and 2022 (52.5% of cases after 2015) at 3 German centers were included in this analysis. The co-primary outcome measures were technical success, device success, and early safety defined by VARC-3. Mortality was assessed up to 5 years., Results: Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age, sex, clinically relevant baseline comorbidities, and surgical risk. Technical success (SL: 83.7% versus ST: 79.9%, p = 0.552), device success (SL: 67.4% versus ST: 54.3%, p = 0.105), and early safety (SL: 74.4% versus ST: 66.5%, p = 0.296) were comparable between groups. The 30-day mortality (SL: 7.0% versus ST: 2.6%, p = 0.136) and 5-year mortality rates (SL: 23.3% versus ST: 24.6%, p = 0.874) were not significantly different between groups., Conclusion: SL and ST ViV-TAVI led to comparable short-term outcomes according to VARC-3- defined endpoints and similar mortality rates up to 5 years of follow-up. VARC-3 defined technical success, device success, and early safety as well as 5-year all-cause mortality in patients undergoing valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) into stentless (SL) compared with stented (ST) failed aortic bioprostheses., (© 2023. The Author(s).)
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- 2023
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17. Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.
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Pollari F, Berretta P, Albertini A, Carrel T, Teoh K, Meuris B, Villa E, Kappert U, Andreas M, Solinas M, Misfeld M, Savini C, Fiore A, Shrestha M, Santarpino G, Martinelli GL, Mignosa C, Glauber M, Yan T, Fischlein T, and Di Eusanio M
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- Humans, Retrospective Studies, Research Report, Treatment Outcome, Prosthesis Design, Aortic Valve diagnostic imaging, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis, Pacemaker, Artificial, Sutureless Surgical Procedures adverse effects
- Abstract
Objectives: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR)., Methods: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019)., Results: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time., Conclusion: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods., Competing Interests: C.M. and E.V. are proctors for Perceval/LivaNova. A.A. receives consulting and lecture fees from LivaNova. M.A. is proctor/speaker/consultant (Edwards, Abbott, Medtronic) and received institutional grants (Edwards, Abbott, Medtronic, LSI). T.F. is consultant for LivaNova. Other authors declared no conflicts of interest., (Thieme. All rights reserved.)
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- 2023
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18. Minimally Invasive Isolated Aortic Valve Replacement in a Potential TAVI Cohort of Patients Aged ≥ 75 Years: A Propensity-Matched Analysis.
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Taghizadeh-Waghefi A, Petrov A, Jatzke P, Wilbring M, Kappert U, Matschke K, Alexiou K, and Arzt S
- Abstract
(1) Background and Objectives: Transcatheter aortic valve implantation is guideline-recommended from the age of 75. However, this European guideline recommendation is based on limited evidence, since no interaction between age and primary outcome has been found in guideline-stated references. This study aimed to compare the short-term outcomes of minimally invasive isolated aortic valve replacement in patients aged ≥ 75 with those of younger patients; (2) Patients and Methods: This retrospective cohort study included 1339 patients who underwent minimally invasive isolated aortic valve replacement at our facility between 2014 and 2022. This cohort was divided into two age-based groups: <75 and ≥75 years. Operative morbidity and mortality were compared between groups. Further analysis was performed using propensity score matching; (3) Results: After matching, 347 pairs of patients were included and analyzed. Despite the higher EuroSCORE II in the ≥75 group (2.2 ± 1.3% vs. 1.80 ± 1.34%, p ≤ 0.001), the 30-day mortality (1.4% vs. 1.2%; p = 0.90) and major adverse cardiac and cerebrovascular events, such as perioperative myocardial infarction (0.0% vs. 1.2%, p = 0.12) and stroke (1.4% vs. 2.6%, p = 0.06), were comparable between both treatment groups; (4) Conclusions: Minimally invasive aortic valve replacement is a safe treatment method for patients aged ≥ 75. Our results indicate that the unilateral cut-off of 75 years is not a limiting factor for performing minimally invasive aortic valve replacement.
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- 2023
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19. Transaxillary approach enhances postoperative recovery after mitral valve surgery.
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Malvindi PG, Wilbring M, De Angelis V, Bifulco O, Berretta P, Kappert U, and Di Eusanio M
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- Humans, Mitral Valve surgery, Postoperative Complications, Sternotomy methods, Thoracotomy methods, Minimally Invasive Surgical Procedures adverse effects, Minimally Invasive Surgical Procedures methods, Treatment Outcome, Retrospective Studies, Cardiac Surgical Procedures adverse effects, Cardiac Surgical Procedures methods, Heart Valve Prosthesis Implantation methods
- Abstract
Objectives: Several thoracic incisions have been described and different techniques used for cardiopulmonary bypass, myocardial protection, and valve exposure in minimally invasive mitral valve surgery. The aim of this study is to compare the early outcomes of patients operated using a simplified minimally invasive approach through a right transaxillary (TAxA) access with those achieved with conventional full sternotomy (FS) operations., Methods: Prospectively collected data of patients who underwent mitral valve surgery between 2017 and 2022 at 2 academic centres were reviewed. Among them, 454 patients were operated through minimally invasive mitral valve surgery TAxA access and 667 patients through FS; associated aortic and coronary arteries surgery (CABG) procedures, infective endocarditis, redo and urgent operations were excluded. A propensity-matched analysis was performed using 17 preoperative variables., Results: Two well-balanced cohorts including a total of 804 patients were analysed. The rate of mitral valve repair was similar in both groups. Operative times were shorter in the FS group; nevertheless, in patients operated with a minimally invasive approach, there was a trend towards decreasing cross-clamp time over the study period (P = 0.07). In the TAxA group, 30-day mortality was 0.25%, and postoperative cerebral stroke rate was 0.7%. TAxA mitral surgery was associated with shorter intubation time (P < 0.001) and intensive care unit stay (P < 0.001). After a median hospital stay of 8 days, 30% of patients who had TAxA surgery were discharged home versus 5% in the FS group (P < 0.001)., Conclusions: When compared with FS access, TAxA approach provides at least similar excellent early outcomes in terms of perioperative morbidity and mortality and allows shorter mechanical ventilation time, intensive care unit and postoperative hospital stay with a higher rate of patients able to be discharged home without any further period of cardiopulmonary rehabilitation., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2023
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20. Long-Term Outcomes after Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedures.
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Wilbring M, Petrov A, Arzt S, Eiselt JP, Taghizadeh-Waghefi A, Matschke K, Kappert U, and Alexiou K
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Background: Redo mitral valve surgery is the standard of care for failed mitral bioprostheses or recurrence of mitral regurgitation after repair. Nonetheless, catheter-based valve-in-valve (ViV) or valve-in-ring (ViR) procedures have increasingly become viable alternatives in high-risk subpopulations. Despite reported good initial results, little is known about longer-term outcomes. Here, we report the long-term outcomes of transcatheter mitral ViV and ViR procedures., Methods: All consecutive patients ( n = 54) undergoing transcatheter mitral ViV or ViR procedures for failed bioprostheses or recurring regurgitation after mitral repair in the time period between 2011 and 2021 were retrospectively enrolled. The mean age was 76.5 ± 6.5 years, and 30 (55.6%) of the patients were male. The procedures were done using a commercially available balloon-expandable transcatheter heart valve. Clinical and echocardiographic follow-up data were obtained from the hospital's database and analyzed. Follow-up reached up to 9.9 years with a total of 164.3 patient-years., Results: A total 25 patients received a ViV and 29 patients a ViR procedure. Both groups were at high surgical risk with an STS-PROM of 5.9 ± 3.7% in ViV and 8.7 ± 9.0% in ViR patients ( p < 0.01). The procedures themselves were mainly uneventful with no intraoperative deaths and a low conversion rate ( n = 2/54; 3.7%). VARC-2 procedural success was low (ViV 20.0% and ViR 10.3%; p = 0.45), which was either driven by high rates of transvalvular pressure gradients ">5 mmHg" (ViV 92.0% and ViR 27.6%; p < 0.01) or residual regurgitation ">trace" (ViV 28.0% and ViR 82.7%; p < 0.01). ICU-stay was prolonged in both groups (ViV 3.8 ± 6.8 days and ViR 4.3 ± 6.3 days; p = 0.96) with acceptable hospital stay (ViV 9.9 ± 5.9 days and ViR 13.5 ± 8.0 days; p = 0.13). Despite 30-day mortality being acceptable (ViV 4.0% and ViR 6.9%; p = 1.00), the mean posthospital survival time was disappointingly low (ViV 3.9 ± 2.6 years and ViR 2.3 ± 2.7 years; p < 0.01). Overall survival in the entire group was 33.3%. Cardiac reasons for death were frequent in both groups (ViV 38.5% and ViR 52.2%). Cox-regression analysis identified ViR procedures as a predictor of mortality (HR 2.36, CI 1.19-4.67, p = 0.01)., Conclusions: Despite acceptable immediate outcomes in this high-risk subpopulation, long-term results are discouraging. Transvalvular pressure gradients as well as residual regurgitations remained drawbacks in this real-world population. The indication for catheter-based mitral ViV or ViR procedures rather than conventional redo-surgery or conservative treatment must be thoughtfully considered.
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- 2023
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21. Cardiac Surgery for Treatment of COVID-19-Associated Infectious Endocarditis.
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Taghizadeh-Waghefi A, Petrov A, Wilbring M, Alexiou K, Kappert U, Matschke K, and Tugtekin SM
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- Humans, Male, Middle Aged, Female, SARS-CoV-2, COVID-19, Endocarditis diagnosis, Endocarditis surgery, Endocarditis, Bacterial diagnosis, Endocarditis, Bacterial surgery, Cardiac Surgical Procedures adverse effects
- Abstract
Background: Significant uncertainty exists about the optimal timing of surgery for infectious endocarditis (IE) surgery in patients with active SARS-CoV-2 infection. This case series and a systematic review of the literature were carried out to evaluate the timing of surgery and postsurgical outcomes for patients with COVID-19-associated IE., Methods: The PubMed database was searched for reports published from June 20, 2020, to June 24, 2021, that contained the terms infective endocarditis and COVID-19. A case series of 8 patients from the authors' facility was also added., Results: A total of 12 cases were included, including 4 case reports that met inclusion criteria in addition to a case series of 8 patients from the authors' facility. Mean (SD) patient age was 61.9 (17.1) years, and patients were predominantly male (91.7%). Being overweight was the main comorbidity among patients studied (7/8 [87.5%]). Among all patients evaluated in this study, dyspnea (n = 8 [66.7%]) was the leading symptom, followed by fever (n = 7 [58.3%]). Enterococcus faecalis and Staphylococcus aureus caused 75.0% of COVID-19-associated IE. The mean (SD) time to surgery was 14.5 (15.6) days (median, 13 days). In-hospital and 30-day mortality for all evaluated patients was 16.7% (n = 2)., Conclusion: Clinicians must carefully assess patients diagnosed with COVID-19 to prevent missing underlying diseases such as IE. If IE is suspected, clinicians should avoid postponement of crucial diagnostic and treatment steps., (© 2023 by the Texas Heart® Institute, Houston.)
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- 2023
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22. Impact of Enterococci vs. Staphylococci Induced Infective Endocarditis after Transcatheter Aortic Valve Implantation.
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Gasior T, Woitek FJ, Schroth A, Abdel-Wahab M, Crusius L, Haussig S, Kiefer P, Scislo P, Huczek Z, Dabrowski M, Witkowski A, Olasinska-Wisniewska A, Grygier M, Protasiewicz M, Hudziak D, Kappert U, Holzhey D, Wojakowski W, Linke A, and Mangner N
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Background: The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are enterococci (EC-IE) and staphylococci (SC-IE). We aimed to compare clinical characteristics and outcomes of patients with EC-IE and SC-IE., Methods: TAVI-IE patients from 2007 to 2021 were included in this analysis. The 1-year mortality was the primary outcome measure of this retrospective multi-center analysis., Results: Out of 163 patients, 53 (32.5%) EC-IE and 69 (42.3%) SC-IE patients were included. Subjects were comparable with regard to age, sex, and clinically relevant baseline comorbidities. Symptoms at admission were not significantly different between groups, except for a lower risk for presenting with septic shock in EC-IE than SC-IE. Treatment was performed in 78% by antibiotics alone and in 22% of patients by surgery and antibiotics, with no significant differences between groups. The rate of any complication, in particular heart failure, renal failure, and septic shock during treatment for IE, was lower in EC-IE compared with SC-IE ( p < 0.05). In-hospital (EC-IE: 36% vs. SC-IE: 56%, p = 0.035) and 1-year mortality (EC-IE: 51% vs. SC-IE: 70%, p = 0.009) were significantly lower in EC-IE compared with SC-IE., Conclusions: EC-IE, compared with SC-IE, was associated with a lower morbidity and mortality. However, absolute numbers are high, a finding that should trigger further research in appropriate perioperative antibiotic management and improvement of early IE diagnosis in the case of clinical suspicion.
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- 2023
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23. Safety and Efficacy of the Transaxillary Access for Minimally Invasive Aortic Valve Surgery.
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Wilbring M, Alexiou K, Schmidt T, Petrov A, Taghizadeh-Waghefi A, Charitos E, Matschke K, Arzt S, and Kappert U
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- Humans, Middle Aged, Aged, Aged, 80 and over, Stroke Volume, Treatment Outcome, Retrospective Studies, Ventricular Function, Left, Aortic Valve surgery, Heart Valve Prosthesis Implantation methods
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Background and Objectives: Transaxillary access is one of the latest innovations for minimally invasive aortic valve replacement (MICS-AVR). This study compares clinical performance in a large transaxillary MICS-AVR group to a propensity-matched sternotomy control group. Materials and Methods: This study enrolled 908 patients undergoing isolated AVR with a mean age of 69.4 ± 18.0 years, logistic EuroSCORE of 4.0 ± 3.9%, and body mass index (BMI) of 27.3 ± 6.1 kg/m2. The treatment group comprised 454 consecutive transaxillary MICS-AVR patients. The control group was 1:1 propensity-matched out of 3115 consecutive sternotomy aortic valve surgeries. Endocarditis, redo, and combined procedures were excluded. The multivariate matching model included age, left ventricular ejection fraction, logistic EuroSCORE, pulmonary hypertension, coronary artery disease, chronic lung disease, and BMI. Results: Propensity-matching was successful with subsequent comparable clinical baselines in both groups. MICS-AVR had longer skin-to-skin time (120.0 ± 31.5 min vs. 114.2 ± 28.7 min; p < 0.001) and more frequent bleeding requiring chest reopening (5.0% vs. 2.4%; p < 0.010), but significantly less packed red blood cell transfusions (0.57 ± 1.6 vs. 0.82 ± 1.6; p = 0.040). In addition, MICS-AVR patients had fewer access site wound abnormalities (1.5% vs. 3.7%; p = 0.038), shorter intensive care unit stays (p < 0.001), shorter ventilation times (p < 0.001), and shorter hospital stays (7.0 ± 5.1 days vs. 11.1 ± 6.5; p < 0.001). No significant differences were observed in stroke > Rankin 2 (0.9% vs. 1.1%; p = 0.791), renal replacement therapy (1.5% vs. 2.4%; p = 0.4762), and hospital mortality (0.9% vs. 1.5%; p = 0.546). Conclusions: Transaxillary MICS-AVR is at least as safe as AVR by sternotomy and can be performed in the same time frame. Its advantages are fewer transfusions and quicker postoperative recovery with a significantly shorter hospital stay. The cosmetic result and unrestricted physical abilities due to the untouched sternum and ribs are unique advantages of transaxillary access.
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- 2023
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24. Pyoderma Gangrenosum after Cardiac Surgery.
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Petrov A, Kappert U, Schmidt T, Matschke KE, and Wilbring M
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- Humans, Male, Middle Aged, Female, Surgical Wound Infection diagnosis, Surgical Wound Infection etiology, Surgical Wound Infection therapy, Treatment Outcome, Pyoderma Gangrenosum diagnosis, Pyoderma Gangrenosum etiology, Pyoderma Gangrenosum therapy, Cardiac Surgical Procedures adverse effects
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Background: Pyoderma gangrenosum after cardiac surgery is a rare, noninfectious ulcerating skin disease mimicking sternal wound infection., Methods: A systematic search of literature for pyoderma gangrenosum complicating cases of cardiac surgery was conducted between September 1985 and September 2020 on PubMed and Cochrane databases. A systematic review and detailed overview of clinical presentation, diagnostic, treatment, and outcome is provided., Results: A total of 15 studies enclosing 15 patients suffering from pyoderma gangrenosum following cardiac surgery were identified. Onset of symptoms was observed after a median of 5 days. Patients were predominantly male (81.3%) with a median age of 64 years. Typical clinical presentation mimicked sternal site infection, mainly by means of mediastinitis. Specific signs were rapid progression, erythematous to violaceous color of the wound border, accompanied by unspecific symptoms including fever, malaise, and severe pain. Additionally, pathergy (development of ulcers at the sites of minor cutaneous trauma) was reported frequently. Biopsy is mandatory with a cutaneous neutrophilic inflammation confirming the diagnosis. Initial treatment mostly (75.0% of reported cases) was misled, addressing suspicion of surgical site infection. After correct diagnosis, the treatment was switched to an immunosuppressive therapy. Full sternal wound closure took between 5 weeks and 5 months. Reported case mortality was 12.5% in actually low-risk surgeries., Conclusion: Despite pyoderma gangrenosum has typical signs, it remains an exclusion diagnosis. The treatment is completely opposite to the main differential diagnosis-the typical surgical site infection. Knowledge about diagnosis and treatment is essential in the context of avoiding fatal mistreatment., Competing Interests: None declared., (Thieme. All rights reserved.)
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- 2023
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25. Safety and Efficacy of the Transaxillary Access for Minimally Invasive Mitral Valve Surgery-A Propensity Matched Competitive Analysis.
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Taghizadeh-Waghefi A, Arzt S, De Angelis V, Schiffarth J, Petrov A, Tomko M, Alexiou K, Matschke K, Kappert U, and Wilbring M
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- Humans, Female, Middle Aged, Aged, Male, Minimally Invasive Surgical Procedures adverse effects, Minimally Invasive Surgical Procedures methods, Sternotomy methods, Blood Transfusion, Treatment Outcome, Retrospective Studies, Mitral Valve surgery, Cardiac Surgical Procedures adverse effects, Cardiac Surgical Procedures methods
- Abstract
Background and Objectives: Transaxillary access is a straightforward “single incision—direct vision” concept, based on a 5 cm skin incision in the right anterior axillary line. It is suitable for aortic, mitral and tricuspid surgery. The present study evaluates the hospital outcomes of the transaxillary access for isolated mitral valve surgery compared with full sternotomy. Patients and Methods: The final study group included 480 patients. A total of 160 consecutive transaxillary patients served as treatment group (MICS-MITRAL). Based on a multivariate logistic regression model including age, sex, body-mass-index, EuroScore II and LVEF, a 1:2 propensity matched control-group (n = 320) was generated out of 980 consecutive sternotomy patients. Redo surgeries, endocarditis or combined procedures were excluded. The mean age was 66.6 ± 10.6 years, 48.6% (n = 234) were female. EuroSCORE II averaged 1.98 ± 1.4%. Results: MICS-MITRAL had longer perfusion (88.7 ± 26.6 min vs. 68.7 ± 32.7 min; p < 0.01) and cross-clamp (64.4 ± 22.3 min vs. 49.7 ± 22.4 min; p < 0.01) times. This did not translate into longer procedure times (132 ± 31 min vs. 131 ± 46 min; p = 0.76). Both groups showed low rates of failed repair (MICS-MITRAL: n = 6/160; 3.75%; Sternotomy: n = 10/320; 3.1%; p = 0.31). MICS-MITRAL had lower transfusion rates (p ≤ 0.001), less re-exploration for bleeding (p = 0.04), shorter ventilation times (p = 0.02), shorter ICU-stay (p = 0.05), less postoperative hemofiltration (p < 0.01) compared to sternotomy patients. No difference was seen in the incidence of stroke (p = 0.47) and postoperative delirium (p = 0.89). Hospital mortality was significantly lower in MICS-MITRAL patients (0.0% vs. 3.4%; p = 0.02). Conclusions: The transaxillary access for MICS-MITRAL provides superior cosmetics and excellent clinical outcomes. It can be performed at least as safely and in the same time frame as conventional mitral surgery by sternotomy.
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- 2022
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26. Hemodynamic follow-up after valve-in-valve TAVR for failed aortic bioprosthesis.
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Wilbring M, Kappert U, Haussig S, Winata J, Matschke K, Mangner N, Arzt S, and Alexiou K
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- Humans, Aged, Aged, 80 and over, Aortic Valve surgery, Follow-Up Studies, Prosthesis Design, Hemodynamics, Treatment Outcome, Transcatheter Aortic Valve Replacement adverse effects, Bioprosthesis adverse effects, Aortic Valve Stenosis etiology, Heart Valve Prosthesis adverse effects
- Abstract
Background: "valve-in-valve" TAVR (VIV-TAVR) is established and provides good initial clinical and hemodynamic outcomes. Lacking long-term durability data baffle the expand to lower risk patients. For those purposes, the present study adds a hemodynamic 3-years follow-up., Methods: A total of 77 patients underwent VIV-TAVR for failing aortic bioprosthesis during a 7-years period. Predominant mode of failure was stenosis in 87.0%. Patients had a mean age of 79.4 ± 5.8 years and a logistic EuroSCORE of 30.8 ± 15.7%. The Society of Thoracic Surgeons-PROM averaged 5.79 ± 2.63%. Clinical results and hemodynamic outcomes are reported for 30-days, 1-, 2-, and 3-years. Completeness of follow-up was 100% with 44 patients at risk after 3-years. Follow-up ranged up to 7.1 years., Results: Majority of the surgical valves were stented (94.8%) with a mean labeled size of 23.1 ± 2.3 mm and true-ID of 20.4 ± 2.6 mm. A true-ID ≤21 mm had 58.4% of the patients. Self-expanding valves were implanted in 68.8% (mean labeled size 24.1 ± 1.8 mm) and balloon-expanded in 31.2% (mean size 24.1 ± 1.8 mm). No patient died intraoperatively. Hospital mortality was 1.3% and three-years survival 57.1%. All patients experienced an initial significant dPmean-reduction to 16.8 ± 7.1 mmHg. After 3-years mean dPmean raised to 26.0 ± 12.2 mmHg. This observation was independent from true-ID or type of transcatheter aortic valve replacement (TAVR)-prosthesis. Patients with a true-ID ≤21 mm had a higher initial (18.3 ± 5.3 vs. 14.9 ± 7.1 mmHg; p = .005) and dPmean after 1-year (29.2 ± 8.2 vs. 13.0 ± 6.7 mmHg; p = .004). There were no significant differences in survival., Conclusions: VIV-TAVR is safe and effective in the early period. In surgical valves with a true-ID ≤21 mm inferior hemodynamic and survival outcomes must be expected. Nonetheless, also patients with larger true-IDs showed steadily increasing transvalvular gradients. This raises concern about durability., (© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)
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- 2022
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27. Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up.
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Fischlein T, Caporali E, Folliguet T, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, García-Puente J, and Lorusso R
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- Aortic Valve surgery, Follow-Up Studies, Humans, Prosthesis Design, Retrospective Studies, Sternotomy methods, Treatment Outcome, Aortic Valve Stenosis surgery, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods
- Abstract
Background: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS)., Methods: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches., Results: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%)., Conclusions: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2022
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28. Combined Bentall and Modified Ravitch Procedures: A Case Report and Systematic Review of the Evidence.
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Taghizadeh Waghefi A, Petrov A, Wilbring M, Fajfrova Z, Fitze G, Matschke K, and Kappert U
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- Humans, Male, Young Adult, Adult, Adolescent, Female, Sternum surgery, Aorta, Treatment Outcome, Funnel Chest complications, Funnel Chest surgery, Marfan Syndrome complications, Marfan Syndrome surgery, Aortic Dissection surgery
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Background and Objectives : Marfan syndrome (MS) is a genetic disorder with autosomal dominant inheritance that affects the connective tissue and consequently many organ systems. The cardiovascular manifestations of MS are notorious and include aortic root dilatation or acute aortic dissection, which can cause morbidity and early mortality. However, surgical treatment of aortic pathology may be complicated by musculoskeletal deformity of the chest wall, as in pectus excavatum. In this regard, single-stage combined Bentall and Ravitch surgery is an extreme rarity that has also been scarcely reported in the literature. Patients and Methods : We present the medical history and single-stage Bentall and modified Ravitch surgical treatment of an 18-year-old male MS patient with symptomatic and severe pectus excavatum (PEX) in conjunction with a pear-shaped aortic root aneurysm. To discuss our case in the context of a synopsis of similar published cases, we present a systematic review of combined Bentall surgical aortic aneurysm repair and Ravitch correction of PEX. Results : A total of four studies (one case series and three case reports) and a case from our institution describing a single-stage combined Bentall and Ravitch operation were included. Patients were 22 ± 5.9 years of age (median = 22.5 years) and predominantly male (60%). All cases reported a midline vertical skin incision over the sternum. The most common surgical approach was midsternotomy (80%). In all cases metal struts were used to reinforce the corrected chest wall. Postoperative mortality was zero. Conclusions : Single-stage combined Bentall and Ravitch surgery is an underutilized surgical approach. Its use in MS patients with concomitant PEX and ascending aortic aneurysm that require surgical treatment warrants further investigation. Midsternotomy seems to be a viable access route that provides sufficient exposure in the single-stage surgical setting. Although operative time is long, the intraoperative and postoperative risks appear to be low and manageable.
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- 2022
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29. Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.
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Panagides V, Del Val D, Abdel-Wahab M, Mangner N, Durand E, Ihlemann N, Urena M, Pellegrini C, Giannini F, Gasior T, Wojakowski W, Landt M, Auffret V, Sinning JM, Cheema AN, Nombela-Franco L, Chamandi C, Campelo-Parada F, Munoz-Garcia E, Herrmann HC, Testa L, Kim WK, Castillo JC, Alperi A, Tchetche D, Bartorelli AL, Kapadia S, Stortecky S, Amat-Santos I, Wijeysundera HC, Lisko J, Gutiérrez-Ibanes E, Serra V, Salido L, Alkhodair A, Livi U, Chakravarty T, Lerakis S, Vilalta V, Regueiro A, Romaguera R, Kappert U, Barbanti M, Masson JB, Maes F, Fiorina C, Miceli A, Kodali S, Ribeiro HB, Mangione JA, Sandoli de Brito F, Actis Dato GM, Rosato F, Ferreira MC, Correia de Lima V, Colafranceschi AS, Abizaid A, Marino MA, Esteves V, Andrea J, Godinho RR, Alfonso F, Eltchaninoff H, Søndergaard L, Himbert D, Husser O, Latib A, Le Breton H, Servoz C, Pascual I, Siddiqui S, Olivares P, Hernandez-Antolin R, Webb JG, Sponga S, Makkar R, Kini AS, Boukhris M, Gervais P, Linke A, Crusius L, Holzhey D, and Rodés-Cabau J
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- Abscess, Coagulase, Humans, Risk Factors, Aneurysm, False complications, Aneurysm, False surgery, Endocarditis epidemiology, Endocarditis etiology, Endocarditis surgery, Endocarditis, Bacterial epidemiology, Endocarditis, Bacterial etiology, Endocarditis, Bacterial surgery, Renal Insufficiency, Chronic complications, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients., Methods: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula., Results: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all)., Conclusions: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes., Competing Interests: Potential conflicts of interest. J. R.-C. has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. V. P. has received institutional research grants from Medtronic, Boston Scientific, and Microport. D. T. has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. H. C. H. has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Edwards Lifesciences and Medtronic. J. G. W. has received consulting fees from Edwards Lifesciences and St. Jude Medical. R. M. has received research grants from Edwards Lifesciences, Medtronic, Abbott, Capricor, and St. Jude Medical; has served as a proctor for Edwards Lifesciences; and has received consulting fees from Medtronic. F. S. de B. has received honoraria from Medtronic and Edwards Lifesciences for symposium speeches and proctoring cases. S. L. has received consulting fees from Edwards Lifesciences. H. Le B. has received lecture fees from Edwards Lifesciences outside the submitted work. J. M. S. has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. K. W.-K. has received personal fees from Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, and Meril outside the submitted work. S. S. reports grants to their institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and has received personal fees from Boston Scientific, BTG, and Teleflex outside the submitted work. O. H. has received personal fees from Boston Scientific and payments from Abbott. N. M. has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, and Bayer outside the submitted work. All remaining authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2022
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30. Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial.
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Lorusso R, Ravaux JM, Pollari F, Folliguet TA, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, Garcia-Puente J, and Fischlein T
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- Aortic Valve surgery, Humans, Prospective Studies, Prosthesis Design, Risk Factors, Treatment Outcome, Aortic Valve Stenosis etiology, Aortic Valve Stenosis surgery, Bioprosthesis adverse effects, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods, Pacemaker, Artificial adverse effects
- Abstract
Objectives: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts., Methods: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size., Results: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes., Conclusions: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR., Clinical Trial Registration Number: NCT02673697., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2022
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31. Sutureless Versus Rapid Deployment Aortic Valve Replacement: Results From a Multicenter Registry.
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Berretta P, Meuris B, Kappert U, Andreas M, Fiore A, Solinas M, Misfeld M, Carrel TP, Villa E, Savini C, Santarpino G, Teoh K, Albertini A, Fischlein T, Martinelli G, Mignosa C, Glauber M, Shrestha M, Laufer G, Phan K, Yan T, and Di Eusanio M
- Subjects
- Aortic Valve surgery, Humans, Prosthesis Design, Registries, Retrospective Studies, Treatment Outcome, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods
- Abstract
Background: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR)., Methods: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created., Results: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation., Conclusions: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2022
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32. Sutureless and rapid deployment versus sutured aortic valve replacement: a propensity-matched comparison from the Sutureless and Rapid Deployment International Registry.
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Berretta P, Andreas M, Meuris B, Langenaeken T, Solinas M, Concistrè G, Kappert U, Arzt S, Santarpino G, Nicoletti A, Misfeld M, Borger MA, Savini C, Gliozzi G, Albertini A, Mikus E, Fischlein T, Kalisnik J, Martinelli GL, Cotroneo A, Mignosa C, Ricasoli A, Yan T, Laufer G, and Di Eusanio M
- Subjects
- Aortic Valve surgery, Humans, Prosthesis Design, Registries, Treatment Outcome, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods, Sutureless Surgical Procedures
- Abstract
Objectives: To compare procedural and in-hospital outcomes of patients undergoing sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (Intuity Elite, Edwards Lifesciences, Irvine, CA, USA) aortic valve replacement (group 1) versus sutured aortic valve replacement (group 2)., Methods: Patients receiving isolated aortic valve replacement between 2014 and 2020 were analysed using data from the Sutureless and Rapid Deployment International Registry. Patients in group 1 and group 2 were propensity-score matched in a 1:1 ratio., Results: A total of 7708 patients were included in the study. After matching, 2 groups of 2643 each were created. Patients in group 1 were more likely to undergo minimally invasive approaches and were associated with shorter operative times when compared with group 2. Overall in-hospital mortality was similar between groups. While an increased risk of stroke was observed in group 1 in the first study period (2014-2016; relative risk 3.76, P < 0.001), no difference was found in more recent year period (relative risk 1.66, P = 0.08; P for heterogeneity 0.003). Group 1 was associated with reduced rates of postoperative low cardiac output syndrome, atrial fibrillation and mild aortic regurgitation. New pacemaker implant was three-fold higher in group 1., Conclusions: Our findings showed significant differences in procedural and clinical outcomes between the study groups. These results suggest that sutureless and rapid deployment aortic valve replacement should be considered as part of a comprehensive valve programme. The knowledge of the respective post-aortic valve replacement benefits for different valve technologies may result in patient-tailored valve selection with improved clinical outcomes., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2022
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33. Aortic root reinforcement in aortic valve endocarditis with annular abscess: The Calamari procedure.
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Petrov A, Diab AH, Taghizadeh-Waghefi A, Wilbring M, Alexiou K, Matschke KE, Tugtekin SM, and Kappert U
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- Abscess etiology, Abscess surgery, Aortic Valve surgery, Humans, Endocarditis complications, Endocarditis surgery, Endocarditis, Bacterial complications, Endocarditis, Bacterial surgery, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Treatment of infective endocarditis can often prove challenging due to its wide range of anatomical presentations. When complicated by an aortic root abscess, patients may require extensive root surgery, which on its own leads to a worse outcome. We present our experience with a surgical technique for reinforcing the aortic annulus with a ring from a Dacron aortic prosthesis placed in the left ventricular outflow tract to avoid the need for root replacement procedures or patch closures of the defect. The technique described in this paper provides a viable alternative to the standard techniques used for the treatment of annular abscesses in aortic valve endocarditis. Due to the relative simplicity and ease of use, this approach may present a means of reducing operation time and possibly postoperative complications of this severe condition., (© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)
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- 2022
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34. Correction to: An unintentional complication during an intentional procedure-Sinus of Valsalva laceration during BASILICA.
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Mangner N, Abdel-Wahab M, Sveric K, Kappert U, Fischer J, Haussig S, and Linke A
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- 2022
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35. Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation.
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Panagides V, Del Val D, Abdel-Wahab M, Mangner N, Durand E, Ihlemann N, Urena M, Pellegrini C, Giannini F, Scislo P, Huczek Z, Landt M, Auffret V, Sinning JM, Cheema AN, Nombela-Franco L, Chamandi C, Campelo-Parada F, Munoz-Garcia E, Herrmann HC, Testa L, Kim WK, Castillo JC, Alperi A, Tchetche D, Bartorelli AL, Kapadia S, Stortecky S, Amat-Santos I, Wijeysundera HC, Lisko J, Gutiérrez-Ibanes E, Serra V, Salido L, Alkhodair A, Livi U, Chakravarty T, Lerakis S, Vilalta V, Regueiro A, Romaguera R, Kappert U, Barbanti M, Masson JB, Maes F, Fiorina C, Miceli A, Kodali S, Ribeiro HB, Mangione JA, Brito FS Jr, Dato GMA, Rosato F, Ferreira MC, de Lima VC, Colafranceschi AS, Abizaid A, Marino MA, Esteves V, Andrea J, Godinho RR, Alfonso F, Eltchaninoff H, Søndergaard L, Himbert D, Husser O, Latib A, Breton HL, Servoz C, Pascual I, Siddiqui S, Olivares P, Hernandez-Antolin R, Webb JG, Sponga S, Makkar R, Kini AS, Boukhris M, Gervais P, Linke A, Crusius L, Holzhey D, and Rodés-Cabau J
- Subjects
- Aortic Valve surgery, Catheters adverse effects, Humans, Mitral Valve surgery, Risk Factors, Treatment Outcome, Aortic Valve Insufficiency complications, Aortic Valve Insufficiency epidemiology, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis complications, Aortic Valve Stenosis surgery, Endocarditis epidemiology, Endocarditis etiology, Heart Valve Prosthesis adverse effects, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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36. Aortic Thrombosis following COVID-19: A Systematic Review.
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Petrov A, De Glee Romera JP, Wilbring M, Alexiou K, Kappert U, Matschke KE, and Tugtekin SM
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- Female, Humans, Male, SARS-CoV-2, Treatment Outcome, Aortic Diseases diagnostic imaging, Aortic Diseases etiology, COVID-19 complications, Thrombosis etiology
- Abstract
Background: Arterial and venous thromboses associated with the coronavirus disease 2019 (COVID-19) have been well described. These events are caused by a hypercoagulable state due to endotheliopathy and infection-driven coagulopathy. There has been an ever-increasing number of documented cases of aortic thrombosis (AoT) in COVID-19 patients. We conducted a systematic review of current scientific literature to identify and consolidate evidence of AoT in COVID-19 patients., Methods: A systematic review of literature was conducted between March 15, 2020, and May 1, 2021, on PubMed and Cochrane databases. Additionally, a case from our facility was included., Results: A total of 38 studies (12 case series and 26 case reports) and a case from our facility describing AoT in 56 COVID-19 patients were included. Patients were aged 64.8 ± 10.5 years, were predominantly male (75%), and had several comorbidities. AoT was symptomatic in 82,14% of patients; however, when D dimers were reported, they were significantly elevated even in otherwise asymptomatic patients. Most patients had no previous history of aortic disease. Thrombosis was described in all parts of the aorta, with several cases reporting multiple locations. The median reported time until development of AoT was 10 days. Peripheral thrombosis occurred in 73.21% of cases, most commonly causing lower limb ischemia. Mortality rate was 30.4%., Conclusions: AoT can occur with no clinical symptoms or as a primary symptom in otherwise asymptomatic COVID-19 patients. D dimers are a highly sensitive diagnostic tool. Diagnosis of this condition prior to development of complications could be instrumental in saving many lives., Competing Interests: None declared., (Thieme. All rights reserved.)
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- 2022
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37. Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.
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Mangner N, del Val D, Abdel-Wahab M, Crusius L, Durand E, Ihlemann N, Urena M, Pellegrini C, Giannini F, Gasior T, Wojakowski W, Landt M, Auffret V, Sinning JM, Cheema AN, Nombela-Franco L, Chamandi C, Campelo-Parada F, Munoz-Garcia E, Herrmann HC, Testa L, Kim WK, Castillo JC, Alperi A, Tchetche D, Bartorelli AL, Kapadia S, Stortecky S, Amat-Santos I, Wijeysundera HC, Lisko J, Gutiérrez-Ibanes E, Serra V, Salido L, Alkhodair A, Livi U, Chakravarty T, Lerakis S, Vilalta V, Regueiro A, Romaguera R, Kappert U, Barbanti M, Masson JB, Maes F, Fiorina C, Miceli A, Kodali S, Ribeiro HB, Mangione JA, Sandoli de Brito F Jr, Actis Dato GM, Rosato F, Ferreira MC, Correia de Lima V, Colafranceschi AS, Abizaid A, Marino MA, Esteves V, Andrea J, Godinho RR, Alfonso F, Eltchaninoff H, Søndergaard L, Himbert D, Husser O, Latib A, Le Breton H, Servoz C, Pascual I, Siddiqui S, Olivares P, Hernandez-Antolin R, Webb JG, Sponga S, Makkar R, Kini AS, Boukhris M, Gervais P, Côté M, Holzhey D, Linke A, and Rodés-Cabau J
- Subjects
- Aged, Aged, 80 and over, Anti-Bacterial Agents therapeutic use, Cardiac Surgical Procedures, Combined Modality Therapy, Endocarditis, Bacterial etiology, Female, Humans, Male, Prosthesis-Related Infections etiology, Staphylococcal Infections etiology, Endocarditis, Bacterial drug therapy, Endocarditis, Bacterial surgery, Prosthesis-Related Infections drug therapy, Prosthesis-Related Infections surgery, Staphylococcal Infections drug therapy, Staphylococcal Infections surgery, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain., Objectives: The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB)., Methods: Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry., Results: Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HR
unadj : 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj : 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj : 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj : 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock., Conclusions: In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications., Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific, outside the submitted work. Dr del Val was supported by a research grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). Dr Tchetche has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Herrmann has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr Webb has received consulting fees from Edwards Lifesciences and St. Jude Medical. Dr Makkar has received research grants from Edwards Lifesciences, Medtronic, Abbott, Capricor, and St. Jude Medical; has served as a proctor for Edwards Lifesciences; and has received consulting fees from Medtronic. Dr de Brito has received honoraria from Medtronic and Edwards Lifesciences for symposium speeches and proctoring cases. Dr Lerakis has received consulting fees from Edwards Lifesciences. Dr Le Breton has received lecture fees from Edwards Lifesciences, outside the submitted work. Dr Sinning has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic, outside the submitted work. Dr Kim has received proctor/speaker fees/served on the advisory board for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and Shockwave Medical, outside the submitted work. Dr Stortecky has received grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received personal fees from Boston Scientific, BTG, and Teleflex, outside the submitted work. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Dr Husser has received personal fees from Boston Scientific; and payments from Abbott. Dr Linke has received personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer outside the submitted work. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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38. Ring Fracture of a Degenerated Direct Flow Medical TAVR Prosthesis.
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Mangner N, Kappert U, and Linke A
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Prosthesis Design, Prosthesis Failure, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific, outside the submitted work. Dr Linke has received grants from Novartis; has received personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer; and has stock options from Picardia, Transverse Medical, and Claret Medical, outside the submitted work. Dr Kappert has reported that he has no relationships relevant to the contents of this paper to disclose.
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- 2022
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39. Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.
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Fischlein T, Caporali E, Asch FM, Vogt F, Pollari F, Folliguet T, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, García-Puente J, De Kerchove L, and Lorusso R
- Abstract
Objective: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab., Methods: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] ( n = 407) or a stented sutured [surgical AVR (SAVR)] ( n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance., Results: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm
2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% ( n = 42) of patients in Su-AVR and 82.3% in SAVR ( n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% ( n = 2) in Su-AVR and 12.9% ( n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups., Conclusion: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease., Competing Interests: UK was employed by Herzzentrum Dresden GmbH Universitätsklinik. This study received funding from Corcym S.r.l. The funder had the following involvement with the study: all trial-related activities and participated in site selection, data monitoring, trial management, and statistical analysis. TFi: consultant CORCYM and BioStable. TFo: consultant CORCYM (Steering Committee). BM and MS: consultant CORCYM Steering Committee and Proctor. ER: consultant CORCYM (Steering Committee and Proctor), speaker for Abbott, consultant, speaker and investigator for Edwards and Medtronic. NB: educational grants: Edwards Lifesciences and CORCYM, Speaker Honoraria: Edwards Lifesciences, CORCYM and Medtronic. OF, GT, SP, SK, JG-P: consultant CORCYM (Proctor). MA: consultant Abbott and Edwards (Proctor), advisor Medtronic. FR: consultant CORCYM and AtriCure (Proctor), Research Support Recipient Medtronic. RL: Consultant Medtronic, LivaNova, CORCYM and Getinge (honoraria paid to the Maastricht University) and Member of the Medical Advisory Board for Eurosets (honoraria paid to the Maastricht University). FA has no personal conflict of interest but directs an academic Core laboratory carrying institutional contracts (MedStar Health) for his work with Corcym/Livanova, Edwards, Medtronic, Boston Scientific, Abbott, Foldax, Biotronik. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Fischlein, Caporali, Asch, Vogt, Pollari, Folliguet, Kappert, Meuris, Shrestha, Roselli, Bonaros, Fabre, Corbi, Troise, Andreas, Pinaud, Pfeiffer, Kueri, Tan, Voisine, Girdauskas, Rega, García-Puente, De Kerchove, Lorusso and on behalf of the PERSIST-AVR Investigators.)- Published
- 2022
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40. Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.
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Del Val D, Abdel-Wahab M, Mangner N, Durand E, Ihlemann N, Urena M, Pellegrini C, Giannini F, Gasior T, Wojakowski W, Landt M, Auffret V, Sinning JM, Cheema AN, Nombela-Franco L, Chamandi C, Campelo-Parada F, Munoz-Garcia E, Herrmann HC, Testa L, Won-Keun K, Castillo JC, Alperi A, Tchetche D, Bartorelli AL, Kapadia S, Stortecky S, Amat-Santos I, Wijeysundera HC, Lisko J, Gutiérrez-Ibanes E, Serra V, Salido L, Alkhodair A, Vendramin I, Chakravarty T, Lerakis S, Vilalta V, Regueiro A, Romaguera R, Kappert U, Barbanti M, Masson JB, Maes F, Fiorina C, Miceli A, Kodali S, Ribeiro HB, Mangione JA, Sandoli de Brito F Jr, Actis Dato GM, Rosato F, Ferreira MC, Corriea de Lima V, Colafranceschi AS, Abizaid A, Marino MA, Esteves V, Andrea J, Godinho RR, Alfonso F, Eltchaninoff H, Søndergaard L, Himbert D, Husser O, Latib A, Le Breton H, Servoz C, Pascual I, Siddiqui S, Olivares P, Hernandez-Antolin R, Webb JG, Sponga S, Makkar R, Kini AS, Boukhris M, Gervais P, Linke A, Crusius L, Holzhey D, and Rodés-Cabau J
- Subjects
- Aged, Aged, 80 and over, Aortic Valve surgery, Aortic Valve Stenosis surgery, Endocarditis, Bacterial microbiology, Female, Follow-Up Studies, Global Health, Heart Valve Prosthesis microbiology, Hospital Mortality trends, Humans, Incidence, Male, Prosthesis-Related Infections diagnosis, Prosthesis-Related Infections microbiology, Retrospective Studies, Risk Factors, Staphylococcal Infections diagnosis, Staphylococcal Infections microbiology, Survival Rate trends, Transcatheter Aortic Valve Replacement adverse effects, Endocarditis, Bacterial epidemiology, Heart Valve Prosthesis adverse effects, Prosthesis-Related Infections epidemiology, Registries, Staphylococcal Infections epidemiology, Staphylococcus aureus isolation & purification
- Abstract
Background: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR)., Methods: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE., Results: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038)., Conclusions: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
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- 2022
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