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New-onset postoperative atrial fibrillation (POAF) after cardiac surgery is associated with increased rates of adverse events (including mortality and stroke). Its incidence after coronary artery bypass grafting (CABG) is considered to be approximately 30%, and it is believed to be a transient condition. However, studies investigating POAF after CABG fail to provide appropriate data on incidence and arrhythmia patterns due to the use of intermittent rhythm detection strategies. These methods have a low sensitivity as compared with continuous monitoring. Subsequently, studies using these techniques most likely do not identify all patients with arrhythmia and do not adequately demonstrate the long-term incidence of arrhythmia, which in turn may affect its association with adverse events. The Characterization of Post Coronary Artery Bypass Grafting Atrial Fibrillation Patterns (CABG-AF) study (German Clinical Trials Register Number: DRKS00018887) tests the hypothesis that the incidence of AF in the first 12 months after CABG is significantly underestimated. CABG-AF is an investigator-initiated multicenter, prospective, observational study in which 196 patients with no history of arrhythmia who underwent first-time CABG receive an insertable cardiac monitor for continuous postoperative rhythm monitoring. The primary end point of the study is any episode of AF within the first 12 months after surgery. Secondary end points include AF burden, AF density, and the ratio of silent to symptomatic AF episodes. End points will be investigated by automatic and patient-initiated data transfers from the implanted device, by telephone interview of patients, and by follow-up forms sent to patients by mail. The patients will be followed for a planned follow-up of 3 years. In conclusion, the CABG-AF study will provide information on the true incidence of AF after CABG and on the temporal patterns of the arrhythmia., Competing Interests: Declaration of competing interest Anders Jeppsson discloses personal payments for advisory boards and/or presentations from AstraZeneca, Bayer, Werfen, LFB Biotechnologies, Boehringer-Ingelheim (Ingelheim, Germany), and Novo Nordisk that are unrelated to the present work. Sebastian Sadoni discloses having received payments for work as a proctor for Boston Scientific that are unrelated to the present work. The remaining authors have no competing interests to declare. The graphical abstract and Figure 1 were created using Biorender.com., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: MRI (magnetic resonance imaging) represents the diagnostic image modality of choice in several conditions. With an increasing number of patients requiring MRI for diagnostic purposes, the issue of safety in patients with cardiac implantable electronic devices (CIED) undergoing this imaging modality will play an ever more important role. The purpose of this study was to assess the safety and device function following MRI in an unrestricted real-world cohort of patients with a wide array of cardiac devices., Methods: We conducted a retrospective single-center study including 1010 MRI studies conducted in adult patients (≥18 years) with an implanted CIED treated in the University Hospital of Munich (LMU) between July 2012 and March 2024. Patients with non-MR conditionally labeled leads, abandoned or epicardial leads, as well as lead fragments, were included for analysis., Results: Across a total of 1010 MRIs (920 total MR-conditional device generators) performed in patients with an implanted CIED, there were no deaths, reports of discomfort, palpitations, heating, or ventricular arrythmias in the 24 h following MRI. Only 2/1010 MRIs were followed by a reported atrial arrhythmia within 24 h, both in patients with an MR-conditional pacemaker (PM) device without an abandoned lead. No significant changes in device function following MRI from baseline were observed across all included CIEDs. Lastly, no instances of severe malfunction, such as generator failure, loss of capture, electrical reset, or inappropriate inhibition of pacing, were found in post-MRI interrogation reports across all MRI studies., Conclusions: Based on the analysis of 1010 MRIs undergone by patients with CIEDs, following standardized device interrogation, manufacturer-advised device programming, monitoring of vital function, and manufacturer-advised reprogramming, MRI can be performed safely and without adverse events or changes in device function.

Objectives: To analyze Heart Team decisions and outcomes following failure of surgical aortic valve replacement (SAVR) prostheses. Methods: Patients undergoing re-operations following index SAVR (Redo-SAVR) and those undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) following SAVR were included in this study. Patients who underwent index SAVR and/or Redo-SAVR for endocarditis were excluded. Data are presented as medians and 25th-75th percentiles, or absolute numbers and percentages. Outcomes were analyzed in accordance to the VARC-3 criteria. Results: Between 01/2015 and 03/2021, 53 patients underwent Redo-SAVR, 103 patients ViV-TAVR. Mean EuroSCORE II was 5.7% (3.5-8.5) in the Redo-SAVR group and 9.2% (5.4-13.6) in the ViV group. In the Redo-SAVR group, 12 patients received aortic root enlargement (22.6%). Length of hospital and ICU stay was longer in the Redo-SAVR group ( p < 0.001; p < 0.001), PGmax and PGmean were lower in the Redo-SAVR group as compared to the ViV-TAVR group (18 mmHg (10-30) vs. 26 mmHg (19-38), p < 0.001) (9 mmHg (6-15) vs. 15 mmHg (9-21), p < 0.001). A higher rate of paravalvular leakage was seen in the ViV-TAVR group ( p = 0.013). VARC-3 Early Safety were comparable between the two populations ( p = 0.343). Survival at 1 year and 5 years was 82% and 36% in the ViV-TAVR cohort and 84% and 77% in the Redo-SAVR cohort. The variables were patient age (OR 1.061; [95% CI 1.020-1.104], p = 0.004), coronary heart disease (OR 2.648; [95% CI 1.160-6.048], p = 0.021), and chronic renal insufficiency (OR 2.711; [95% CI 1.160-6.048], p = 0.021) showed a significant correlation to ViV-TAVR. Conclusions: Heart Team decisions are crucial in the treatment of patients with degenerated aortic bioprostheses and lead to a low mortality in both treatment paths thanks to patient-specific therapy planning. ViV-TAVR offers a treatment for elderly or intermediate-risk profile patients with comparable short-term mortality. However, this therapy is associated with increased pressure gradients and a high prevalence of paravalvular leakage. Redo-SAVR enables the surgical treatment of concomitant cardiac pathologies and allows anticipation for later VIV-TAVR by implanting the largest possible valve prostheses.

Background: Transcatheter aortic valve replacement (TAVR) is an effective and safe therapy for severe aortic stenosis. Rapid or fast pacing is required for implantation, which can be performed via a pre-existing cardiac implantable electric device (CIED). However, safety data on CIEDs for pacing in TAVR are missing., Objectives: The aim of this study was to elucidate procedural safety and feasibility of internal pacing with a CIED in TAVR., Methods: Patients undergoing TAVR with a CIED were included in this analysis. Baseline characteristics, procedural details, and complications according to Valve Academic Research Consortium 3 (VARC-3) criteria after TAVR were compared between both groups., Results: A total of 486 patients were included. Pacing was performed using a CIED in 150 patients and a transient pacemaker in 336 patients. No differences in technical success according to VARC-3 criteria or procedure duration occurred between the groups. The usage of transient pacers for pacing was associated with a significantly higher bleeding rate (bleeding type ≥2 according to VARC-3-criteria; 2.0% vs 13.1%; P < 0.01). Furthermore, impairment of the CIED appeared in 2.3% of patients after TAVR only in the group in which pacing was performed by a transient pacer, leading to surgical revision of the CIED in 1.3% of all patients when transient pacemakers were used., Conclusions: Internal pacing using a CIED is safe and feasible without differences of procedural time and technical success and might reduce bleeding rates. Furthermore, pacing using a CIED circumvents the risk of lead dislocation. Our data provide an urgent call for the use of a CIED for pacing during a TAVR procedure in general., Competing Interests: Funding Support and Author Disclosures Drs Steffen, Deseive, and Lackermair have received speaker honoraria from AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Residual and recurrent mitral regurgitation after transcatheter edge-to-edge repair are therapeutically challenging. In the present case report, we describe a simplified, transapical electrosurgical laceration and stabilization of clip procedure that represents an alternative and direct approach for electrosurgical laceration of mitral valve leaflets enabling transcatheter mitral valve replacement for recurrent mitral regurgitation after mitral valve transcatheter edge-to-edge repair., Competing Interests: Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Peterss has received speaker honoraria from Edwards Lifesciences, AstraZeneca, and CytoSorbents. Dr Hagl has received speaker honoraria from Edwards Lifesciences, Köhler Chemie, and CytoSorbents. Dr Näbauer has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: Concomitant moderate/severe mitral regurgitation (MR) is observed in 17-35% of patients undergoing transcatheter aortic valve implantation (TAVI) and contributes to a worse prognosis. Studies analysing outcomes in patients undergoing TAVI with different MR aetiologies, including atrial functional MR (aFMR), are lacking., Aims: We aimed to analyse outcomes and changes in MR severity in patients with aFMR, ventricular functional (vFMR) and primary mitral regurgitation (PMR) following TAVI., Methods: We analysed all consecutive patients with at least moderate MR undergoing TAVI between January 2013 and December 2020 at the Munich University Hospital. Characterisation of MR aetiology was performed by detailed individual echocardiographic assessment. Three-year mortality, changes in MR severity and New York Heart Association (NYHA) Functional Class at follow-up were assessed., Results: Out of 3,474 patients undergoing TAVI, 631 patients showed MR ≥2+ (172 with aFMR, 296 with vFMR, 163 with PMR). Procedural characteristics and endpoints were comparable between groups. The rate of MR improvement was 80.2% in aFMR patients, which was significantly higher compared to both other groups (vFMR: 69.4%; p=0.03; PMR: 40.8%; p<0.001). The estimated 3-year survival rates did not differ between aetiologies (p=0.57). However, MR persistence at follow-up was associated with increased mortality (hazard ratio 1.49, 95% confidence interval: 1.04-2.11; p=0.027), mainly driven by the PMR subgroup of patients. NYHA Class improved significantly in all groups. In patients with baseline MR ≥3+, the PMR aetiology was associated with the lowest MR improvement, the lowest survival rates and least symptomatic improvement., Conclusions: TAVI reduces MR severity and symptoms in patients with aFMR, vFMR and less-pronounced PMR. The presence of aFMR was associated with the greatest MR severity improvement.

Background: Implantable electronic cardiac devices (CIED) have emerged as an essential component in the treatment of cardiac arrhythmias and heart failure. Due to increased life expectancy, expanding indications and limited technical survival, an increasing number of revision procedures can be anticipated. Venous access site occlusion (VASO) is the main obstacle during revision surgery. In this retrospective study we evaluated the prevalence, predictive parameters and operative management of venous access site occlusion., Methods and Results: Between 01/2016 and 12/2020 304 patients underwent lead revision surgery of transvenous CIED in our department. Prevalence of VASO was 25.7% (n = 78), one patient was symptomatic. Independent predicting clinical parameters were male sex (2.86 (1.39-5.87), p < 0.01) and lead age (1.11 (1.05-1.18), p < 0.01)). Revision surgery despite VASO was successful in 97.4% (n = 76) without prolongation of the total surgery time or higher complication rates. Yet, lead extraction was possible in 92% of patients with VASO vs. 98.2% of patients without VASO (p 0.01)., Conclusion: VASO is a frequent condition in patients undergoing lead revision surgery, but successful revision is feasible in most cases without preceding lead extraction. However, the lower success rates of lead extractions may be prognostically relevant, especially for younger patients., Competing Interests: Declaration of Competing Interest This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no conflicts of interest to disclose. The data underlying this article will be shared anonymised on reasonable request to the corresponding author., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is a well-established, safe and effective therapy for severe symptomatic aortic stenosis (AS). The aim of this study was to objectively quantify improvement of physical activity after TAVR, with consideration of different low-gradient AS subtypes., Methods and Results: All patients undergoing TAVR for severe AS were screened. Participants received a wearable activity tracker (Fitbit®) at hospital discharge following TAVR and 6 months thereafter. The difference of median daily steps was defined as surrogate outcome for physical activity. For analysis, patients were grouped into high-gradient (HG) AS (dPmean ≥40 mmHg), classical low-flow low-gradient (LFLG) AS (dPmean <40 mmHg, EF <50%), paradoxical LFLG-AS (dPmean <40 mmHg, EF ≥50%, SVi ≤35 ml/m2) and normal-flow low-gradient (NFLG) AS (dPmean <40 mmHg, EF ≥50%, SVi >35 ml/m2) according to mean transvalvular pressure gradient (dPmean), stroke volume index (SVi) and left-ventricular ejection fraction (LVEF)., Results and Conclusions: The analysis is based on 230 patients. The median daily step count was 4409 [IQR 2581-7487] after hospital discharge and 5326 [IQR 3045-8668] 6 months thereafter. Median difference of daily steps was ∆529 [IQR -702-2152]). Patients with HG-AS and paradoxical LFLG-AS showed a significant improvement of daily steps (∆951 [IQR -378-2323], p <0.001 and (∆1392 [IQR -609-4444], p = 0.02, respectively). Patients with classical LFLG-AS showed no statistically relevant improvement of daily steps (∆192 [IQR -687-770], p = 0.79). Patients with NFLG-AS showed a numerical decline in daily steps without statistical significance (∆-300 [IQR -1334-1406], p = 0.67). This first prospective study of this sample size shows significant improvement of physical activity after TAVR with an objective and reproducible method. This was mainly driven by an improvement in patients with HG-AS and paradoxical LFLG-AS., Competing Interests: Declaration of Competing Interest JS received speaker honoraria from AstraZeneca. MO received speaker honoraria and travel compensations from Abbott Medical, AstraZeneca, Abiomed, Bayer vital, BIOTRONIK, Bristol-Myers Squibb, CytoSorbents, Daiichi Sankyo Germany, Edwards Lifesciences Services, and Sedana Medical. JH received research support Abbott Vascular and Edwards Lifesciences. DB received speaker honoraria from Abbott Vascular. SD received speaker honoraria from AstraZeneca. Other authors have no conflicts of interest to declare. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: The study objective was to characterize different groups of low-flow low-gradient (LFLG) aortic stenosis (AS) and determine short-term outcomes and long-term mortality according to Valve Academic Research Consortium-3 (VARC-3) endpoint definitions., Background: Characteristics and outcomes of patients with LFLG AS undergoing transcatheter aortic valve implantation (TAVI) are poorly understood., Methods: All patients undergoing TAVI at our center between 2013 and 2019 were screened. Patients were divided into three groups according to mean pressure gradient (dPmean), ejection fraction (LVEF), and stroke volume index (SVi): high gradient (HG) AS (dPmean ≥ 40 mmHg), classical LFLG (cLFLG) AS (dPmean < 40 mmHg, LVEF < 50%), and paradoxical LFLG (pLFLG) AS (dPmean < 40 mmHg, LVEF ≥ 50%, SVi ≤ 35 ml/m 2 )., Results: We included 1776 patients (956 HG, 447 cLFLG, and 373 pLFLG patients). Most baseline characteristics differed significantly. Median Society of Thoracic Surgeons (STS) score was highest in cLFLG, followed by pLFLG and HG patients (5.0, 3.9 and 3.0, respectively, p < 0.01). Compared to HG patients, odds ratios for the short-term VARC-3 composite endpoints, technical failure (cLFLG, 0.76 [95% confidence interval, 0.40-1.36], pLFLG, 1.37 [0.79-2.31]) and device failure (cLFLG, 1.06 [0.74-1.49], pLFLG, 0.97 [0.66-1.41]) were similar, without relevant differences within LFLG patients. NYHA classes improved equally in all groups. Compared to HG, LFLG patients had a higher 3-year all-cause mortality (STS score-adjusted hazard ratios, cLFLG 2.16 [1.77-2.64], pLFLG 1.53 [1.22-193]), as well as cardiovascular mortality (cLFLG, 2.88 [2.15-3.84], pLFLG, 2.08 [1.50-2.87])., Conclusions: While 3-year mortality remains high after TAVI in LFLG compared to HG patients, symptoms improve in all subsets after TAVI., (© 2022. The Author(s).)

Background: Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited., Aims: We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI., Methods: We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria., Results: Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08)., Conclusions: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Background: The subcutaneous cardioverter defibrillator (S-ICD) has been shown to be a viable alternative to transvenous ICDs (TV-ICD) in all patients at risk of sudden cardiac death (SCD) but without pacing indication., Aim: The aim of this study was to examine the impact of therapy with current S-ICD devices on quality of life (QoL) in comparison to patients with TV-ICD devices., Methods: In our single-centre study, 52 consecutive patients with S-ICD and 52 matched patients with TV-ICD were analysed. QoL has been assessed by a standardized questionnaire (EQ-5D-3L, modified). Additionally, clinical baseline and follow-up data were evaluated., Results: Two-thirds of the total study population reported restrictions in daily routine compared to their life before ICD implantation. A total of 27.7% of S-ICD patients stated to expect an improvement of QoL by deactivation or explantation of their defibrillator compared to only 6.4% of patients with TV-ICD ( p =0.006), which was mainly caused by discomfort and pain from the S-ICD pocket (relevant discomfort and pain in 32.6% vs 11.5%; p <0.01)., Limitations: Main limitation of the study is that quality of life was assessed for one single time point only and time since implantation differed significantly between S-ICD and TV-ICD. Furthermore our collective is younger, and, due to the high proportion of patients without cardiomyopathy, the mean EF is better than usual ICD collective. The absence of heart failure in about the half of our patients might have relevant impact on our QoL analysis., Conclusion: A relevant proportion of S-ICD patients expects an improvement of QoL by explantation of the device. Of note, this impression was not driven by the fear of receiving shocks but mainly by discomfort and pain caused by the pulse generator., Competing Interests: The authors report no conflicts of interest in this work., (© 2022 Thienel et al.)

Objectives : As surgical experience with infective endocarditis following transcatheter aortic valve replacement is scarce, this study compared the perioperative and short-term outcomes of patients suffering from endocarditis following surgical aortic valve replacement and transcatheter aortic valve replacement. Methods : Between January 2013 and December 2020, 468 consecutive patients were admitted to our center for surgery for IE. Among them, 98 were operated on for endocarditis following surgical aortic valve replacement and 22 for endocarditis following transcatheter aortic valve replacement. Results : The median EuroSCORE II (52.1 (40.6-62.0) v/s 45.4 (32.6-58.1), p = 0.207) and STS-PROM (1.8 (1.6-2.1) v/s 1.9 (1.4-2.2), p = 0.622) were comparable. Endocarditis following transcatheter aortic valve replacement accounted for 13.7% of the aortic prosthetic valve endocarditis between 2013 and 2015; this increased to 26.9% in the years 2019 and 2020.Concomitant procedures were performed in 35 patients (29.2%). The operative mortality was 26.5% in the endocarditis following surgical aortic valve replacement group and 9.1% in the endocarditis following transcatheter aortic valve replacement group ( p = 0.098). Upon follow-up, survival at 6 months was found to be 98% in the group with endocarditis following surgical aortic valve replacement and 89% in the group with endocarditis following transcatheter aortic valve replacement ( p = 0.081). Conclusions : Patients suffering from endocarditis following surgical aortic valve replacement and transcatheter aortic valve replacement present with comparable risk profiles and can be surgically treated with comparable results. Surgery as a curative option should not be rejected even in this intermediate-risk cohort.

Despite the rapid increase in experience and technological improvement, the incidence of conduction disturbances in patients undergoing transcatheter aortic valve replacement (TAVR) with the self-expandable CoreValve Evolut valve remains high. Recently, a cusp-overlap view (COP) implantation technique has been proposed for TAVR with self-expandable valves offering an improved visualization during valve expansion compared to the three-cusp view (TCV). This study aims to systematically analyze procedural outcomes of TAVR patients treated with the CoreValve Evolut valve using a COP compared to TCV in a high-volume center. The primary endpoint was technical success according the 2021 VARC-3 criteria. A total of 122 consecutive patients (61 pts. TCV: April 2019 to November 2020; 61 pts. COP: December 2020 to October 2021) that underwent TAVR with the CoreValve Evolut prosthesis were included in this analysis. Although there was no difference in the primary endpoint technical success between TCV and COP patients (93.4% vs. 90.2%, OR 0.65, 95% CI 0.16, 2.4, p = 0.51), we observed a significantly lower risk for permanent pacemaker implantation (PPI) among COP patients (TCV: 27.9% vs. COP: 13.1%, OR 0.39, 95% CI 0.15, 0.97, p = 0.047). Implantation of the CoreValve Evolut prosthesis using the COP might help to reduce the rate of PPI following TAVR.

Background and Objectives : Mitral stenosis with extensive mitral annular calcification (MAC) remains surgically challenging in respect to clinical outcome. Prolonged surgery time with imminent ventricular rupture and systolic anterior motion can be considered as a complex of causal factors. The aim of our alternative hybrid approach was to reduce the risk of annual rupture and paravalvular leaks and to avoid obstruction of the outflow tract. A review of the current literature was also carried out. Materials and Methods: Six female patients (mean age 76 ± 9 years) with severe mitral valve stenosis and severely calcified annulus underwent an open implantation of an Edwards Sapien 3 prosthesis on cardiopulmonary bypass. Our hybrid approach involved resection of the anterior mitral leaflet, placement of anchor sutures and the deployment of a balloon expanded prosthesis under visual control. Concomitant procedures were carried out in three patients. Results: The mean duration of cross-clamping was 95 ± 31 min and cardiopulmonary bypass was 137 ± 60 min. The perioperative TEE showed in three patients an inconspicuous, heart valve-typical gradient on all implanted prostheses and a clinically irrelevant paravalvular leakage occurred in the anterior annulus. In the left ventricular outflow tract, mild to moderately elevated gradients were recorded. No adverse cerebrovascular events and pacemaker implantations were observed. All but one patient survived to discharge. Survival at one year was 83.3%. Conclusion s : This "off label" implantation of the Edwards Sapien 3 prosthesis may be considered as a suitable bail-out approach for patients at high-risk for mitral valve surgery or deemed inoperable due to extensive MAC.

Conduction disorders with need for permanent pacemaker (PPM) implantation remain frequent complications after transcatheter aortic valve implantation (TAVI). Up to 22% of PPM after TAVI are implanted for new onset left bundle branch block (LBBB) and atrioventricular block (AVB) I. However, clinical benefit and predictors of ventricular pacing in TAVI patients receiving PPM for this indication remain unclear. We retrospectively evaluated pacemaker interrogation data of patients who received a PPM post TAVI for new LBBB and new AVB I. The primary endpoint of this study was relevant ventricular pacing (ventricular pacing rate: Vp ≥ 1%) at the first outpatient pacemaker interrogation. Secondary endpoints were predictors for relevant ventricular pacing. At the first pacemaker interrogation (median follow up at 6.23 [2.8-14.8] months), median ventricular pacing frequency was 1.0% [0.1-17.8]. Out of 61 patients, 36 (59%) had Vp rates ≥ 1%. Patients with frequent ventricular pacing showed longer QRS duration (155 ms ± 17 ms vs. 144 ms ± 18 ms, p = 0.018) at the time of PPM implantation and were less likely treated with a balloon-expandable Edwards Sapiens Valve (39% vs. 12%, p = 0.040). Our findings suggest that the majority of patients with new LBBB and new AVB I after TAVI show relevant ventricular pacing rates at follow up. Further prospective studies are necessary to identify patients at higher risk of pacemaker dependency., (© 2021. The Author(s).)

Objectives: The objective of this study was to retrospectively analyse surgical outcomes of patients undergoing secondary cardiac surgery after initial transcatheter aortic valve replacement (TAVR)., Methods: Between December 2012 and February 2020, a total of 41 consecutive patients underwent cardiac surgery after a TAVR procedure at our institution. Patients who underwent emergency operations due to periprocedural complications such as ventricular rupture and TAVR dislocation were excluded from this study (n = 12). Thus, 29 patients were included in the analysis. Data are presented as medians (25th-75th quartiles) or as absolute numbers (percentages)., Results: The median age was 76 years (68-80); 58.6% were men. The median time to a secondary conventional procedure was 23 months (8-40), with 8 patients requiring surgical intervention within the first year post TAVR. The indications for secondary conventional procedures were prosthesis endocarditis (n = 15), prosthesis degeneration or dysfunction (n = 7) and progression of valvular, aortic or coronary artery disease (n = 7). Surgical redo aortic valve replacement was performed in 24 patients (82.8%). No complications involving the aortic root or the aortomitral continuity were observed. The operative mortality was 10.3%. Extracorporeal life support was required in 3 patients (10.3%) for a median duration of 3 days (3-3 days). No adverse cerebrovascular events were observed postoperatively. Postoperatively, 4 patients (13.8%) required a pacemaker and 7 patients (24.1%) required renal replacement therapy. Overall survival at 1 year was 83.0%., Conclusions: Conventional cardiac surgical procedures following TAVR are feasible with reasonable results and a low complication rate., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: The heart rate score (HRS) serves as a device-based measure of impaired heart rate variability and is an independent predictor of death in patients with heart failure and a cardiac implantable electrical device. However, no data are available for predicting death from the HRS in patients with end stage heart failure and a left ventricular assist device., Methods: From November 2011 to July 2018, a total of 56 patients with a pre-existing cardiac implantable electrical device underwent left ventricular assist device implantation at our 2 study sites. The ventricular HRS was calculated retrospectively during the first cardiac implantable electrical device follow-up examination following the index hospitalization. Survival during follow-up was correlated with initial HRS., Results: During the follow-up period, 46.4% of the patients (n = 26) died. The median follow-up period was 33.2 months. The median HRS after the index hospitalization was 41.1 ± 21.8%. More patients with an HRS >65% died compared to patients with an HRS <30% (76.9% vs 14.4%; P = 0.007)., Conclusions: In our multicentre experience, survival of patients after an left ventricular assist device implant correlates with the HRS. After confirmation of our findings in a larger cohort, the effect of rate-responsive pacing will be within the scope of further investigation., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: In the aging western societies, an increasing prevalence of severe, symptomatic aortic stenosis is observed. The aim of this study was to examine the safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients aged 90 years and older., Methods: All patients with severe symptomatic aortic stenosis undergoing TAVR at LMU Munich-University-Hospital between 2013 and 2018 were included. Procedure-related mortality (<30 days) was defined as the primary endpoint and survival rates at two years, device failure, and procedural complications were defined as secondary endpoints according to the Valve Academic Research Consortium II criteria., Results and Conclusions: Out of 2336 patients, 2183 were younger than 90 years (<90y.-group) and 153 patients were aged 90 or older (≥90y.-group). Procedure-related mortality (3.6% <90y.-group vs. 3.3% ≥90y.-group, log-rank p=0.9) and device success (97.2% <90y.-group vs. 96.0% ≥90y.-group, p=0.44) were similar. Estimated survival rates at 2 years were 62.8% (95% CI 55.3 and 71.4) in the elder and 76.0% (95% CI 74.1 and 77.8) in the younger patients (p<0.01). The incidence of acute kidney injury, stroke, major bleeding, and permanent pacemaker implantations were comparable between both groups. TAVR procedure is equally safe and feasible in patients aged 90 years or older compared to younger patients. Differences in 2-year survival appear to be patient-related rather than procedure-related., (Copyright © 2021. Published by Elsevier Ltd.)

Introduction: Mitral valve surgery has developed into a strong subspecialty of cardiac surgery with operative techniques and outcomes constantly improving. The development of bradyarrhythmias after mitral valve surgery is not completely understood., Methods: We investigated a cohort of 797 patients requiring mitral valve surgery with and without concomitant procedures. Incidences and predictors of pacemaker requirement as well as survival were analyzed., Results: In the complete follow-up period (median follow-up time: 6.09 years [95% confidence interval [CI]: 5.94-6.22 years, maximum 8.77 years) 80 patients (10% of the complete cohort) required pacemaker implantation for bradyarrhythmia. The cumulative rate of pacemaker implantation was 6.4% at 50 days (48 patients) with most (54.2%) requiring pacing for atrioventricular block. Mitral valve replacement (odds ratio [OR]: 1.905; 95% CI: 1.206-3.536; p = .041) and tricuspid ring annuloplasty (OR: 2.348; 95% CI: 1.165-4.730, p = .017) were identified as operative risk factors of pacemaker requirement after mitral valve surgery. Insulin-dependent diabetes mellitus was also identified as a predictor of pacemaker requirement (OR: 4.665; 95% CI: 1.975-11.02; p = .001). There was no difference in survival in the paced and unpaced groups., Conclusions: After mitral valve surgery, a relevant subgroup of patients requires pacemaker implantation-most for atrioventricular block. We identified mitral valve replacement and tricuspid ring annuloplasty as significant operative risk factors and insulin-dependent diabetes mellitus as a demographic risk factor. While anatomic relationships help explain the operative risk factors the role of diabetes mellitus is not completely understood., (© 2021 Wiley Periodicals LLC.)

Tricuspid valve (TV) surgery is associated with a high risk of postoperative pacemaker requirement. We set out to identify the incidence of atrioventricular block (AVB) after TV surgery and determine whether atrioventricular conduction recovers within time.We investigated pre/intra- and postoperative predictors of AVB in patients who underwent tricuspid valve surgery (not only isolated TV surgery) at our institution between 2004 and 2017. Patients who had pacemakers prior to surgery were excluded.One year after surgery, 5.8% of the surviving cohort had received a pacemaker due to AVB. In the complete follow-up time, 33 out of 505 patients required pacemaker implantation because of AVB. Of the 37 patients who presented to the intensive care unit postoperatively with AVB III, 14 (38%) underwent pacemaker implantation for AVB, and 20 (54%) did not require a pacemaker. AVB III at ICU admission was identified as a predictor of pacemaker implantation (OR: 9.7, CI: 3.8-24.5, P < 0.001). TV endocarditis was also identified as a predictor (OR: 12.4, CI: 3.3-46.3, P < 0.001). Eleven out of 32 patients (34%) with tricuspid endocarditis required a pacemaker for AVB. The mean ventricular pacing burden within the first 5 years after pacemaker implantation was 79%.The issue of AVB after TV surgery is significant. Both the initial rhythm after surgery and etiology of the tricuspid disease can help predict pacemaker requirement. Within the first 5 years after surgery, the ventricular pacing burden remains high without relevant rhythm recovery.

Introduction: Cardiac implantable electronic device (CIED) infections are associated with a high mortality. Our aim was to identify key predictors of survival in patients with CIED infections as to be able to detect high-risk patients and possibly affect modifiable factors., Methods and Results: In this observational study, we collected data from 277 patients with CIED infections treated in our department between 2001 and 2017; predictors of survival were evaluated. The median time since the last CIED procedure was 0.83 years (interquartile range [IQR]: 0.25-3.01), median time since initial CIED implant was 4.79 years (IQR: 0.90-11.0 years). Survival at 30 days was 94.9% (95% confidence interval [CI]: 92.3-97.5) and survival at 1 year was 80.9% (CI: 76.4-85.7). Age (odds ratio [OR]: 1.05, CI: 1.01-1.09; P = .009), end stage renal disease (ESRD) with dialysis (OR: 5.14, CI: 1.87-14.11; P = .001), positive blood cultures (OR: 2.19, CI: 1.08-4.45; P = .030), and thrombocytopenia (OR: 2.3, CI, 1.03-5.15; P = .042) were identified as predictors of death within 1 year of treatment of CIED infection., Conclusion: Patients with CIED infection with prior ESRD with dialysis or preoperative thrombocytopenia are at an increased risk of 1-year mortality. We suggest that these patients be evaluated critically and resources be allocated to these patients more liberally. A greater understanding of the role of platelets in immunity may improve treatment of advanced infection in the future., (© 2019 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.)

Aims: The tricuspid valve is situated in close proximity to cardiac conduction tissue and damage to this tissue can affect postoperative rhythm. The aim of this study was to quantify the incidence of pacemaker requirement after tricuspid valve surgery and investigate predictors., Methods: Data were collected via our operative data collection system and patient files. All patients who underwent surgical procedures of the tricuspid valve from 2004 until 2017 and lacked a pacemaker preoperatively were included in the study., Results: In our cohort of 505 patients 54 required a pacemaker in the first 50 days after surgery. We calculated a 17.5% (95% confidence interval [CI], 13.5-21.3) risk of pacemaker implantation at 4 years postoperatively. Multivariate analysis identified preoperative active endocarditis (odds ratio 3.17; CI, 1.32-7.65; P = 0.010) and "inadequate pacemaker dependent rhythm" (defined as any intrinsic heart rate below 45 per minute requiring pacing) upon admission to the intensive care unit after surgery (odds ratio 5.924; CI, 2.82-12.44; P = 0.001) as predictors for pacemaker requirement in the first 50 days after surgery. Twenty-six pacemakers (48%) were implanted for atrioventricular block, 16 (30%) for sinus node dysfunction and 12 (22%) for atrial fibrillation. Kaplan-Meier analysis showed no difference in survival between the pacemaker and no pacemaker group., Conclusion: Surgery of the tricuspid valve has a high burden of postoperative pacemaker requirement. Preoperative active endocarditis and the initial postoperative rhythm are predictors. Understanding this allows for better decision-making regarding further medical/device therapy., (© 2019 Wiley Periodicals, Inc.)

Introduction: We investigated the development of sinus node dysfunction (SND) requiring pacemaker implantation after heart transplant (HTx) especially regarding pacing burden in these patients., Patients and Methods: Patients requiring a pacemaker for SND were compared to all other patients in an HTx cohort including transplant patients from 1981 to 2016., Results: Sinus node dysfunction requiring pacemaker implantation developed in 118 patients (10%). These patients had received a biatrial anastomosis more frequently than those in the No SND group 95.8% vs 90.0% (P = .042). The ratio of reperfusion time to aortic cross-clamp time was significantly smaller in the SND group compared to the No SND group 71.7% vs 80.3% (P = .033). This also holds for the ratio of reperfusion time to ischemia time, which was 23.2% and 28.6%, respectively (P = .032). Pacing burden decreased from 90.5% to 66.3% after 2 years and remained around this value in the remaining 4 years of follow-up., Conclusion: We identified the biatrial anastomosis and a low ratio of reperfusion time to aortic cross-clamp time as well as to ischemia time as risk factors for SND requiring pacing. After implantation pacemakers continue to pace for over 60% of the time after 6 years., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Clinical relevant cerebrovascular events (CVE) following transcatheter aortic valve implantation (TAVI) still remain a devastating complication associated with mortality and severe impairments. Therefore, identification of particularly modifiable predictors of this complication is clinically relevant and an important step for planning preventive strategies., Methods: A total of 985 patients who underwent trans-femoral TAVI for aortic valve stenosis in our institution from February 2008 to January 2015 were considered. The influence of demographics, clinical and procedural data on the occurrence of CVE was assessed with a competing risk model with death as competing event. Clinical events were defined according to VARC-2 criteria., Results: At a median follow-up of 838days, 95% CI 807-892, 59 patients experienced any CVE (5.9%) and the overall cumulative mortality rate was 46.1%. CVEs mainly occur later than 30days after TAVI (47.5%), 88.1% of them were of ischemic origin and 52.5% were disabling events. Independent predictors of CVEs were age (hazard ratio 1.05; 95% CI 1.01 to 1.09), history of CVE (hazard ratio 2.54; 95% CI 1.39 to 4.63) and use of balloon post-dilation (hazard ratio 1.85; 95% CI 1.08 to 3.18)., Conclusion: In patients undergoing TAVI incidence of clinically relevant CVEs is frequent with half of the events occurring after the first 30days post-TAVI. Identification of balloon post-dilation as the only modifiable predictor of CVE risk at mid-term, urges its cautious performance after prosthesis implantation. CLINICALTRIALS., Gov Identifier: NCT02289339., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is used for the treatment of aortic stenosis (AS). Besides major bleeding, conduction blocks, stroke or atrial fibrillation, complications include cardiac perforation with possible left-to-right-shunts. Herein is reported the sixth case of a left-to-right shunt in an 87-year-old man who underwent TAVR using a 29 mm Edwards SAPIEN S3 prosthesis to treat AS. Soon after the procedure, a small channel evolving from the right coronary cusp could be detected on echocardiography. The patient was managed medically.

Background: Thromboembolism is a major complication in patients with ventricular assist devices (VADs). Drug anticoagulation and the use of biocompatible surfaces, such as coating with heparin, aim to reduce thromboembolism in these patients. Administration of heparin can lead to heparin-induced thrombocytopenia (HIT) type II, mainly through heparin/platelet factor 4 (PF4) antibodies. We assessed the presence of PF4 antibodies in VAD thrombi of patients with heparin-coated VADs and HIT II., Methods: Thrombi (n = 6) were obtained from the replaced Excor ventricles of patients with HIT II after biventricular VAD implantation (Excor Adult; Berlin Heart, Germany). Excor ventricles were changed after clinical examination and suspicion of thrombi in the polyurethane valves. Expression of PF4- antibodies was assessed with the use of a polyclonal rabbit antibody (anti-PF4 antibody; Abcam, USA). Expression was assessed by 2 independent observers., Results: Biopsies of all thrombi showed an extreme positive immunoreaction for PF4. No differences between the different thrombi and localization (left/right Excor ventricle) were observed. The thrombi were organized, without lamination of fibrin and cellular layers., Conclusions: Platelet surface expression of PF4 in the thrombi reflects HIT antigen presentation. The physical relationship between the PF4-positive thrombi and the heparin-coated surface suggests that onset of HIT II could be influenced by the immobilized heparin coating., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Despite improvements in immunosuppressive therapy, the most advantageous combination for cardiac transplant recipients has not been established. This randomized controlled trial was performed to evaluate the efficacy and safety of 3 immunosuppressive protocols., Methods: Between 2003 and 2005, 78 de novo cardiac transplant recipients were randomized 2:2:1 to receive steroids and tacrolimus plus mycophenolate mofetil (TAC/MMF; n = 34), TAC and sirolimus (TAC/SRL; n = 29), or SRL and MMF (SRL/MMF) plus anti-thymocyte globulin (ATG; n = 15). Steroids were withdrawn after 6 months., Results: The 5-year survival was 85.3% for TAC/MMF, 93.1% for TAC/SRL, and 86.7% for SRL/MMF (p = 0.31 for TAC/MMF vs TAC/SIR; p = 0.47 for TAC/MMF vs SIR/MMF and p = 0.86 for TAC/SIR vs SIR/MMF). Despite the use of ATG, patients in the SRL/MMF group revealed numerically fewer freedom from acute rejection episodes: TAC/MMF, 82.4%; TAC/SRL, 85.2%; SRL/MMF, 73.3% (p = 0.33). Mean creatinine at 5 years revealed preservation of renal function in the SRL/MMF vs the TAC/MMF group (p = 0.045): TAC/MMF, 1.70±0.91 mg/dl; TAC/SRL, 1.44±0.65 mg/dl; and SRL/MMF, 1.25±0.46 mg/dl. Freedom from cardiac allograft vasculopathy was improved in the SRL/MMF group (93.3%) compared with TAC/MMF (73.5%) and TAC/SRL (80.8%) groups, reaching no statistical significance. Freedom from cytomegalovirus infection was TAC/MMF, 72.2%; TAC/SRL, 89.7%; and SRL/MMF, 86.7%. There was a trend toward improved freedom from cytomegalovirus infection with TAC/SRL vs TAC/MMF (p = 0.076). More frequent discontinuations of study medication occurred in SRL-based immunosuppression protocols (TAC/SRL vs TAC/MMF, p = 0.034; SRL/MMF vs TAC/MMF, p = 0.003)., Conclusions: The 3 strategies yield no survival advantage at 5 years, with higher numeric rates of rejection and adverse effects in the calcineurin inhibitor-free arm. A trend was observed in favor of freedom from cardiac allograft vasculopathy and preservation of renal function in the calcineurin inhibitor-free arm. However, the clinical relevance on outcomes is unclear because only few patients were receiving the assigned treatment protocols., (Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Left atrial intramural hematoma is a seldom cause of left atrial mass. It has been described to occur spontaneously, after interventional procedures, after blunt chest trauma, or after aortocoronary bypass surgery. We present a case of mitral valve replacement together with the removal of a large intraatrial space-occupying lesion. Intraoperative transesophageal echocardiography confirmed a successful resection of this mass. Surprisingly, upon admission to ICU, transesophageal and transthoracic echocardiography revealed a recurrence of an intramural lesion, closest matching a hematoma, which was confirmed by contrast-enhanced computed tomography. Surgical intervention was thoroughly discussed but a conservative management was favoured. 3 months after surgery, a reassessed transthoracic echocardiography and computed tomography demonstrated an almost complete resolution of the pre-existing hematoma.

Allosensitization represents a major obstacle to successful re-transplantation since circulating antibodies can elicit antibody-mediated rejection episodes with subsequent graft failure. Since sensitization is primarily considered a contraindication to transplantation the duration for patients waiting for a suitable donor organ to become available is considerably prolonged. Herein, we report on the successful application of a Luminex-based virtual crossmatch approach to facilitate combined third-time cardiac and de novo renal transplantation in a sensitized patient with sustained antibody-mediated cardiac allograft rejection., (© 2009 John Wiley & Sons A/S.)

Background: Increasing numbers of patients with advanced coronary artery disease have limited options for percutaneous and/or surgical revascularization. A prospective, randomized, phase I clinical multicenter trial was performed to assess the feasibility and safety of delivering a pro-angiogenic transcription factor termed "hypoxia inducible factor-1alpha", delivered to ischemic cardiac muscle via a type 2 adenoviral (Ad2HIF) vector., Methods and Results: The 13 patients were included under the following criteria: 1 hypoperfused area of viable ventricular muscle without options for revascularization and left ventricular ejection fraction > or =30%. After coronary artery bypass grafting was completed, 10 injections of the study drug (n=10), in 3 escalating doses up to 1 x 10(11) viral particles or saline (n=3) as a placebo control, were injected intramyocardially. After completion of the 1-year follow-up, all patients had uncomplicated postoperative courses, are alive and feeling well; 1 patient had a self-limited run of tachycardia postoperatively and at 6 months, 1 patient developed recurrent angina. Positron emission tomography perfusion analysis revealed improvement in the Ad2HIF injected areas in selected patients., Conclusions: These data support the feasibility and preliminary safety of adenoviral transfection with Ad2HIF in regions of viable myocardium. Additional studies will be required to determine the efficacy and safety of Ad2HIF.

Congenital anomalies of the pericardium are extremely rare and often difficult to diagnose. We describe a 66-year-old woman presenting with multivessel coronary artery disease and right heart insufficiency complicated by an extremely left-rotated heart due to a congenital absence of left pericardium. A multidetector row computerized tomographic study was performed to evaluate the torsion of the heart as well as the physical relationship between the left internal thoracic artery and the left coronary system. Off-pump coronary surgery was scheduled. Both the operative and postoperative courses were uneventful and the patient was discharged after 11 days.

The insertion of a central venous catheter (CVC) via the subclavian vein is often associated with complications. We report a case in which a patient suffered an esophageal lesion with severe bleeding and a pneumothorax with mediastinal shift induced by the insertion of the dilator of a CVC. The pneumothorax had to be treated immediately by pleural drainage, and the esophageal lesion was successfully corrected by means of an endoclip. The patient survived the complication. However, he died 1 week later from multiple organ failure not associated with the CVC insertion.

Acute massive or submassive pulmonary embolism is a life-threatening condition with a poor prognosis. It causes sudden hemodynamic deterioration and warrants immediate surgery. We report the case of a 41-year-old male heart transplant recipient who had not been treated prophylactically for thrombosis, who was referred to our center because of exertional dyspnea after immobilization owing to an injury in one of his legs. Transesophageal echocardiography revealed a large, mobile, right atrial mass originating from a pacemaker lead. Furthermore, contrast-enhanced computed tomography scanning of the chest revealed multiple pulmonary emboli resulting in subtotal occlusion of both pulmonary arteries. Although typically reserved for patients with chronic thromboembolic pulmonary hypertension, surgical thromboendarterectomy was successfully performed. Six months after discharge, the patient is well and has a New York Heart Association class 1 rating. This is the first report of a successful pulmonary thromboendarterectomy in a heart transplant recipient.

Chronic rejection is still the major limitation of long-term outcome of heart transplant recipients. Several recent studies demonstrated that a not negligible proportion of chronic allograft rejection episodes are not only mediated by T-cell response but also triggered by pre-transplant and de novo post-transplant donor-specific alloantibodies. This points at a fundamental role of humoral immune response mechanisms that contribute to early and late graft failure. This type of rejection is an unsolved problem solid organ transplantation because current immunosuppressive regimens are generally intended to interfere in T-cell signalling pathways. Various options for the removal of circulating alloantibodies and the prevention of alloantibody formation by B-cell depletion have been described. Nevertheless, effective standardized schemes for the treatment of antibody-mediated graft rejection have to be defined. We present a heart transplant recipient with sustained antibody-mediated graft rejection who was successfully managed with a combination treatment consisting of 3 cycles of immunoadsorption and a single-dose administration of the anti-CD20 monoclonal antibody rituximab.

Background: Statins reduce the risk for transplant vasculopathy and mortality among heart transplant recipients. Interactions between commonly used statins (ie, simvastatin, atorvastatin) and immunosuppressant drugs lead to side effects or withdrawal of statin therapy. Fluvastatin shows fewer interactions with the immunosuppressant agents because it is not metabolized via the cytochrome P-450 3A4 pathway like most immunosuppressants, steroids, or other statins. This study investigated the impact of a switch from other statins to fluvastatin in heart transplant recipients who revealed elevated creatine-kinase levels., Methods: A total of 23 heart transplant patients with elevated creatine-kinase levels were included in this study. Statins were replaced with an equal dosage of fluvastatin. We measured on the day of replacement as well as there after at 3, 6, 9, and 12 months creatine-kinase, lipid status, ALT, AST, and creatinine levels., Results: After 6 months creatine-kinase showed a significant reduction of 25% (P < .05) and after 9 months of 38% (P < .05). The HDL-cholesterol levels were significantly reduced at 6 months (8%; P < .05) and 9 months (23%; P < .05). At 3 months, triglyceride levels were significantly elevated (18%; P < .05). No differences were observed in ALT, AST, creatinine, total, and LDL-cholesterol at any time., Conclusion: A conversion from commonly used statins to fluvastatin in heart transplant patients with elevated creatine-kinase was safe, leading to a significant reduction in creatine-kinase levels. Except for an initial raise in triglycerides and a lowering of HDL-cholesterol, no changes in lipid status were seen. This conversion might help to maintain lipid-lowering therapy in transplant recipients who show side effects using conventional statins.

Background: The impact of long-term mycophenolate mofetil (MMF) treatment on the development of cardiac allograft vasculopathy (CAV) after heart transplantation is an area of much recent interest. This study analyzed the effects of various immunosuppressive combinations, including cyclosporine (CsA), azathioprine (Aza), tacrolimus (Tac) and MMF, on the time of onset, extent and progression of CAV., Methods: Two hundred seventy-three consecutive heart transplant recipients (mean age: 51.2 +/- 12.2 years; mean follow-up: 6.8 +/- 1.9 years) were examined by coronary angiography on a yearly basis between 1995 and 2003. The extent of CAV was evaluated using a scoring system based on the severity of vessel stenosis. The onset of CAV was analyzed using Kaplan-Meier estimates and the log rank test for four treatment combinations, CsA/Aza (n = 47, 17.2%), CsA/MMF (n = 26, 9.5%), Tac/Aza (n = 62, 22.7%) and Tac/MMF (n = 138, 50.5%), and for the primary and the secondary immunosuppressants alone., Results: The rate of freedom from CAV at 5 years was 47% with CsA/Aza, 66% with CsA/MMF, 60% with Tac/Aza and 70% with Tac/MMF. After 5 years, the Tac/MMF group showed a significantly lower incidence of CAV than the CsA/Aza group (log rank 7.58, p = 0.0059). CsA (n = 73) was compared with Tac (n = 200) and MMF (n = 164) with Aza (n = 109): the rate of freedom from CAV was 51.2% in CsA patients vs 66.1% in Tac patients (log rank 5.7, p = 0.017), and 54.6% in Aza patients vs 67% in MMF patients (log rank 4.36, p = 0.037). Multivariate Cox regression analysis revealed that MMF decreased the incidence of CAV significantly (p = 0.041). In this patient cohort, Tac or CsA medication was not an independent risk factor for incidence of CAV nor for decreased survival., Conclusions: The choice of immunosuppression has an impact on the incidence of CAV. In terms of prevention of CAV, MMF is superior to Aza in either combination. A trend toward improved survival in MMF patients was noted. The lower number of rejection episodes in the MMF groups may have contributed to these results.

Posttransplant lymphoproliferative disorders are severe complications that arise after solid organ transplantation, which are often related to Epstein- Barr virus. Reports are anecdotal, and a standardized therapy does not exist. We report a case of a 36-year-old man who developed posttransplant lymphoproliferative disorder of the oropharynx 1 year after receiving a heart transplant. A short review of the literature is presented, after which a new therapeutic approach that combines antiviral therapy, monoclonal antibodies, and a sirolimus-based maintenance immunosuppression regimen with reduced target trough levels of tacrolimus is introduced. The patient achieved complete remission and was free from recurrence 18 months after the therapy was initiated.

Advanced recipient age is considered a relative contraindication for heart transplantation because it might be associated with increased morbidity and mortality. We analyzed 349 consecutive heart transplantations performed at our institution from 1995 to 2002 (n = 349, mean follow-up 3.5 +/- 2.5 years). The survival rate was lower in older recipients. Less chronic rejection but increased risk for infectious complications, renal failure and neoplasms indicate the need for decreased immunosuppression and effective infection prophylaxis in older recipients.

Administration of perioperative antibiotic prophylaxis is a routine procedure in orthopedic surgery. Besides systemic prophylaxis, only few techniques are established for local application of antibiotics to reduce infection related to orthopedic implants. The aim of this study was to evaluate the efficacy of locally versus systemically applied gentamicin in a rat model (n = 60). For local application, the antibiotic was delivered from a biodegradable poly(D,L-lactide) (PDLLA) coating of titanium implants. The efficacy of local prophylaxis was compared to a systemic single shot application of gentamicin as well as a combination of both administrations. Half of the animals received a weight-adopted single shot application of gentamicin 30 min prior to surgery. At surgery, the medullary cavities of the tibiae were contaminated with Staphylococcus aureus (10(2) colony forming units /CFU) and titanium Kirschner wires were implanted into the medullary canals. The implants were either uncoated, PDLLA coated, or coated with PDLLA + 10% w/w gentamicin. The animals were followed up for 42 days. X-ray examinations were performed; body weight, temperature, and the clinical condition were determined. After sacrifice, infection was evaluated by histological and microbiological analysis. All animals treated with uncoated or PDLLA-coated Kirschner wires without systemic application of the antibiotic developed osteomyelitis and all cultures of implants were tested positive on S. aureus. Implant-related osteomyelitis could be prevented by prophylaxis of systemically applied gentamicin in 15% of animals. In contrast, local application of gentamicin delivered from a PDLLA coating was more effective. Onset of infection could be prevented in 90% of animals treated with gentamicin coated Kirschner wires, and in 80% of the animals that were treated with a combination of local and systemic application. The local application from PDLLA-coated implants might support systemic antibiotic prophylaxis in preventing implant-associated osteomyelitis.

Infection related to osteosynthesis often has dramatic consequences for the patient. Prolonged hospitalization with systemic antibiotic therapy, several revision procedures, possible amputation, and even death may occur. To investigate the pathology of infection in orthopedic surgery, a new rat model of implant related osteomyelitis was developed. Three different concentrations (10(6), 10(3), and 10(2) colony-forming units (CFU)/10 microl) of Staphylococcus aureus were inoculated into the tibial medullary cavity with simultaneous insertion of a titanium Kirschner wire. Controls received phosphate-buffered saline (PBS). Each group consisted of 10 animals. Animals were followed for 4 weeks until sacrifice. X-rays of the tibiae were taken weekly, blood counts were analyzed, and body temperature and weight were determined. After sacrifice, infection was evaluated by histological and microbiological investigations. All animals inoculated with Staph. aureus in either concentration developed microbiological, histological, and radiological signs of osteomyelitis in correlation to the amount of inoculated bacteria. X-rays clearly revealed osseous destruction after 14 days with progression of osteomyelitis during the following weeks. CFU/g bone and bone weight after sacrifice showed dependence on the amount of inoculated CFU. The histological results confirmed the radiological findings. No significant changes in blood counts, body weight, and body temperature between the groups could be observed. The results demonstrate that it is possible to develop a model of implant-related osteomyelitis in rats with dependence on the amount of inoculated bacteria. No other promoters of infection besides intramedullary insertion of titanium Kirschner wires were used in this model., (Copyright 2003 Wiley Periodicals, Inc.)

Antibiotic prophylaxis is a routine procedure in orthopedic surgery. Various local antibiotic delivery techniques are used to reduce bone- and soft tissue-related infection. The objective of this study was to evaluate the efficacy of a new biodegradable, gentamicin-loaded poly(D,L-lactide) (PDLLA) coating of orthopedic devices in preventing implant-related osteomyelitis. The medullary cavities of tibiae in 30 Sprague Dawley rats were contaminated with Staphylococcus aureus (10(3) colony forming units). Simultaneously titanium Kirschner wires, uncoated (group II), coated with PDLLA (group III), or coated with PDLLA + 10% gentamicin (group IV), were implanted. Ten animals that received phosphate-buffered saline and uncoated Kirschner wires served as controls (group I). Follow-up was 6 weeks. In weekly intervals X-rays of the tibiae were performed, blood counts were taken, and body temperature and weight were determined. After sacrifice infection was evaluated by histological and microbiological analysis. All animals of groups II and III developed microbiological, histological, and radiological signs of infection, including osseous destruction and soft tissue swelling. All animals of the control group remained sterile. Cultures of implants of group IV showed significantly reduced bacterial growth compared to cultures of groups II and III, and three implants of group IV remained sterile. Further radiological and histological signs of infection were significantly reduced in the gentamicin-coated group compared to groups II and III. No significant differences in body weight, body temperature, and blood parameters between all groups were observed. Local application of antibiotic-coated orthopedic devices containing PDLLA and 10% gentamicin significantly reduced implant-related infection in this animal model.