First-in-Man Study of a Novel, Balloon-Adjustable Mitral Annuloplasty Ring.

Objectives: Mitral valve repair is the current standard approach for mitral valve regurgitation. However, patients suffering from functional mitral regurgitation have a significant risk of recurrent regurgitation. Adjustable mitral rings may provide a solution for this adverse event. Methods: A single-center, first-in-man clinical study was performed on patients suffering from mitral valve regurgitation. Patients were implanted with the study ring and followed for six months. A balloon catheter can be inserted into the study ring frame at any time after implantation and inflated independently in the areas P1, P2, or P3, which reduces the anterior-posterior diameter. Results: Five patients (75.4 ± 6.1 years; EuroSCORE II 2.1 ± 0.9%; three female) were successfully implanted. Mechanisms of mitral regurgitation were prolapse of the P2-segment in three patients and annular dilation in two patients. Surgical implantation according to the protocol was feasible and is described herein. Median cardiopulmonary bypass time and cross clamp time were 105 (118; 195) and 94 (90; 151) min, respectively. The median intensive care unit stay was 2 (2; 3) days. No perioperative, 30-day, or 6-month mortality was observed, and the repair was stable without residual or recurrent regurgitation ≥ grade 2. All patients reached the primary endpoint without device-related morbidity. Conclusions: Successful implantation was completed in five patients without device-related adverse events. Ring implantation was safe and feasible for all patients. The opportunity of post-implant adjustment to improve leaflet coaptation is a promising new therapeutic strategy that is assessed in a phase II study.

Automated titanium fastener for surgical aortic valve replacement-preventive role for infective endocarditis?

OBJECTIVES: Evidence on long-term clinical outcomes considering suture-securing techniques used for surgical aortic valve replacement is still uncertain. METHODS: A total of 1405 patients who underwent surgical aortic valve replacement between January 2016 and December 2022 were included and grouped according to the suture-securing technique used (automated titanium fastener versus hand-tied knots). The occurrence of infective endocarditis during follow-up was set as the primary study end-point. As secondary study end-points, stroke, all-cause mortality and a composite outcome of either infective endocarditis, stroke, or all-cause mortality were assessed. RESULTS: The automated titanium fastener was used in 829 (59%) patients, whereas the hand-knot tying technique was used in 576 (41%) patients. The multivariable proportional competing risk regression analysis showed a significantly lower risk of infective endocarditis during follow-up in the automated titanium fastener group (adjusted sub-hazard ratio 0.44, 95% confidence interval 0.20-0.94, P = 0.035). The automated titanium fastener group was not associated with an increased risk of mortality or attaining the composite outcome, respectively (adjusted hazard ratio 0.81, 95% confidence interval 0.60-1.09, P = 0.169; adjusted hazard ratio 0.82, 95% confidence interval 0.63-1.07, P = 0.152). This group was not associated with an increased risk of stroke (adjusted sub-hazard ratio 0.82, 95% confidence interval 0.47-1.45, P = 0.504). Also, a significantly lower rate of early-onset infective endocarditis was observed in the automated titanium fastener group, (0.4% vs 1.4%, P = 0.032). CONCLUSIONS: Suture-securing with an automated titanium fastener device appears to be superior compared to the hand-knot tying technique in terms of lower risk of infective endocarditis.

Automated titanium fastener vs. hand-tied knots for prosthesis fixation in infective endocarditis.

Objectives: To date, there is no evidence regarding the safety of automated titanium fastener compared with hand-tied knots for prosthesis fixation in infective endocarditis. Methods: Between January 2016 and December 2022, a total of 220 patients requiring surgery for infective endocarditis were included in this retrospective analysis. The primary study endpoint was re-endocarditis during follow-up. The secondary study endpoints included stroke onset, all-cause mortality, and a composite outcome of either re-endocarditis, stroke, or all-cause mortality during follow-up. Results: Suture-securing with an automated titanium fastener was performed in 114 (51.8%) patients, whereas the conventional technique of hand knot-tying was used in 106 (48.2%) patients. The risk of re-endocarditis was significantly lower in the automated titanium fastener group, as shown in a multivariable proportional competing risk regression model (adjusted sub-hazard ratio 0.33, 95% confidence interval 0.11-0.99, p = 0.048). The multivariable Cox proportional hazards regression analysis showed that the automated titanium fastener group was not associated with an increased risk of stroke-onset or attaining the composite outcome, respectively, (adjusted hazard ratio 0.54, 95% confidence interval 0.27-1.08, p = 0.082), (adjusted hazard ratio 0.65, 95% confidence interval 0.42-1.02, p = 0.061). Also, this group was not associated with an increased risk of all-cause mortality, as demonstrated in the multivariable Poisson regression analysis (adjusted incidence-rate ratio 1.42, 95% confidence interval 0.83-2.42, p = 0.202). Conclusions: The use of automated titanium fastener device seems to be safe for infective endocarditis. Analyses of larger cohorts are required.

Myocardial Oedema as a Consequence of Viral Infection and Persistence-A Narrative Review with Focus on COVID-19 and Post COVID Sequelae.

Microvascular integrity is a critical factor in myocardial fluid homeostasis. The subtle equilibrium between capillary filtration and lymphatic fluid removal is disturbed during pathological processes leading to inflammation, but also in hypoxia or due to alterations in vascular perfusion and coagulability. The degradation of the glycocalyx as the main component of the endothelial filtration barrier as well as pericyte disintegration results in the accumulation of interstitial and intracellular water. Moreover, lymphatic dysfunction evokes an increase in metabolic waste products, cytokines and inflammatory cells in the interstitial space contributing to myocardial oedema formation. This leads to myocardial stiffness and impaired contractility, eventually resulting in cardiomyocyte apoptosis, myocardial remodelling and fibrosis. The following article reviews pathophysiological inflammatory processes leading to myocardial oedema including myocarditis, ischaemia-reperfusion injury and viral infections with a special focus on the pathomechanisms evoked by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In addition, clinical implications including potential long-term effects due to viral persistence (long COVID), as well as treatment options, are discussed.

Aortic Valve Replacement in Adult Patients with Decellularized Homografts: A Single-Center Experience.

BACKGROUND: decellularized aortic homografts (DAH) represent a promising alternative for aortic valve replacement in young adults due to their low immunogenicity and thrombogenicity. Herein, we report our midterm, single-center experience in adult patients with non-frozen DAH from corlife. METHODS: safety, durability, and hemodynamic performance were evaluated according to current guidelines in all consecutive patients who had received a DAH at our center since 03/2016. RESULTS: seventy-three (mean age 47 ± 11 years, 68.4% (n = 50) male) patients were enrolled. The mean diameter of the implanted DAH was 24 ± 2 mm. Mean follow-up was 36 ± 27 months, with a maximum follow-up of 85 months and cumulative follow-up of 215 years. No cases of stenosis were observed, in four (5.5%) cases moderate aortic regurgitation occurred, but no reintervention was required. No cases of early mortality, non-structural dysfunction, reoperation, valve endocarditis, or thrombosis were observed. Freedom from bleeding and thromboembolic events was 100%; freedom from re-intervention was 100%; survival was 98.6% (n = 72). CONCLUSIONS: early and mid-term results showed low mortality and 100% freedom from reoperation, thromboembolic events, and bleeding at our center. However, in order for this novel approach to be established as a valid alternative to aortic valve replacement in young patients, long-term data are required.

Ross procedure with personalized external aortic root support.

The Ross-Personalized External Aortic Root Support procedure is a surgical aortic valve replacement technique in which the autologous pulmonary valve is transposed in the aortic position to replace the malfunctioning aortic valve and a homograft is implanted in the pulmonary position. To prevent autograft dilatation, a Personalized External Aortic Root Support prosthesis is included in the proximal autograft anastomosis and wrapped around the ascending aorta. The aorta is transected transversely, the aortic valve is resected, and the coronary arteries are mobilized and cut out of the sinuses, leaving a rim. The pulmonary autograft is harvested by transecting the pulmonary artery and part of the right ventricular outflow tract. The autograft is approximated to the aortic root and inverted inside the ventricle. The proximal anastomosis is performed including the prosthesis between the aortic root and the autograft. The coronary buttons are threaded through appropriately positioned and sized holes in the prosthesis and reimplanted into the autograft. The ascending aorta is appropriately adapted and anastomosed with the distal autograft. When the patient is off cardiopulmonary bypass, the prosthesis can be closed longitudinally and is anchored to the distal aortic adventitia.

Novel Automated Suturing Technology for Minimally Invasive Mitral Chord Implantation: A Preclinical Evaluation Study.

OBJECTIVE: This study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators. METHODS: Five cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board. RESULTS: After a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% (n = 46) of leaflet aspect of the sutures and in 100% (N = 48) of papillary muscle sutures. CONCLUSIONS: Automated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.

The Ross procedure in adult patients: a single-centre analysis of long-term results up to 28 years.

OBJECTIVES: This study aimed to provide an in-depth insight into our single-centre experience with the Ross procedure. METHODS: All adults who underwent the Ross procedure between 1991 and 2014 were included. Based on the total number of Ross procedures performed by each surgeon at our centre during this 24-year period, surgeon volume was classified as low (<25 procedures), intermediate (25-44 procedures) and high (≥45 procedures). Survival, complications and reinterventions were evaluated. A single cardiologist assessed the pulmonary autograft's function and the neoaortic root diameter by echocardiography. RESULTS: The outcomes of 224 patients {176 men, 48 women; mean age 37.2 [standard deviation (SD) 10.0] years} were analysed. Patients operated on by a low-volume surgeon had 7.22 times higher odds (P < 0.001) for a serious adverse event during the intraoperative or early postoperative course than patients operated on by a high-volume surgeon. Early mortality was 1.8%. Overall survival was 87.3% at 20 years. Compared with the demographically matched general population, the patients' survival was significantly lower (P = 0.002). The cumulative incidence of autograft and right ventricular outflow tract conduit reintervention was 21.5% and 5.9% at 20 years, respectively. Patients with preoperative aortic regurgitation had 6.25 times the subdistribution hazard of autograft reintervention (Bonferroni-adjusted P = 0.042) and a higher neoaortic root z-score [1.37 (SD 2.04) vs 0.17 (SD 1.81), P = 0.004] than patients with aortic stenosis. In patients with preoperative aortic regurgitation, autograft wrapping (remnant aortic wall and/or Vicryl® mesh) was associated with a 74% reduction in the subdistribution hazard of autograft reintervention (Bonferroni-adjusted P = 0.002) and with a reduced incidence of neoaortic root dilatation (P = 0.037). CONCLUSIONS: The Ross procedure performed by a specialized surgeon provides very satisfying long-term results. The higher risk of autograft reintervention in preoperative aortic regurgitation may be counteracted by supporting the autograft.

Long Term Results of the Modified Bentall Procedure With Mechanical and Biological Composite Valve Grafts.

Objectives: Despite the evident shift toward biological prostheses, the optimal choice of valve remains controversial in composite valve graft (CVG) replacement. We investigated long-term morbidity and mortality after CVG implantation in an all-comer cohort with a subgroup analysis of patients aged 50-70 years stratified after valve type. Methods: A total of 507 patients underwent the Bentall procedure with either a mechanical (MCVG, n = 299) or a biological (BCVG n = 208) CVG replacement between 2000 and 2020. A single-center analysis comprising clinical and telephone follow-up was conducted to investigate late mortality and morbidity. Results: The 30-day mortality in all patients [age 56 ± 14 years, 78.1% male, EuroSCORE II 3.12 (1.7; 7.1)] was 5.9%. Patients who were electively operated on had a 30-day mortality of 1.5% (n = 5) while it remained higher in urgent/emergent procedures (n = 25, 15.4%). Survival at 10 and 15 years was 78.19 ± 2.26% and 72.6 ± 3.2%, respectively. In patients aged 50-70 years (n = 261; MCVG = 151, BCVG = 110), survival did not differ significantly between the valve groups (p = 0.419). Multivariable analysis showed no significant impact of valve type on survival (p = 0.069). A time-varying relation with survival was notable, showing a higher risk in the MCVG group in the early postoperative phase, which declined compared to the BCVG group in the course of follow-up. Conclusions: The Bentall technique presents with excellent mortality when performed electively. The type of valve prosthesis showed no statistically significant effect on mortality in patients aged 50-70 years. However, a time-varying relation showing an initially higher risk with MCVG which decreased compared to BCVG at long-term follow-up was notable. Further studies with even longer follow-up of BCVGs will clarify the ideal choice of prosthesis in this patient subset.

Deviations From the Ideal Plasma Volume and Isolated Tricuspid Valve Surgery-Paving the Way for New Risk Stratification Parameters.

Background: Congestion and plasma volume expansion are important features of heart failure, whose prognostic significance has been investigated in a range of surgical and non-surgical settings. The aim of this study was to evaluate the value of the estimated plasma volume status (ePVS) in patients undergoing isolated tricuspid valve surgery. Methods: This study included patients who underwent isolated tricuspid valve surgery at the Vienna General Hospital (Austria) between July 2008 and November 2018. The PVS cut-off was calculated using ROC analysis and Youden's Index. Results: Eighty eight patients (median age: 58 [IQR: 35-70] years; 44.3% male; 75.6% NYHA III/IV; median EuroSCORE II 2.65 [IQR: 1.70-5.10]; 33.0% endocarditis-related regurgitation; 60.2% isolated repair; 39.8% isolated replacement) were included in this study. Patients who died within 1 year following surgery had significantly higher baseline ePVS values than survivors (median ePVS 5.29 [IQR: -1.55-13.55] vs. -3.68 [IQR: -10.92-4.22]; p = 0.005). During a median actuarial follow-up of 3.02 (IQR: 0.36-6.80) years, patients with a preoperative ePVS ≥ -4.17 had a significantly increased mortality (log-rank p = 0.006). Conclusions: ePVS is an easily obtainable risk parameter for patients undergoing isolated tricuspid valve surgery capable of predicting mid- and long-term outcomes after isolated tricuspid valve surgery.

Observed versus predicted mortality after isolated tricuspid valve surgery.

BACKGROUND: Aim of this study is to analyse the performances of Clinical Risk Score (CRS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-II in isolated tricuspid surgery. METHODS: Three hundred and eighty-three patients (54 ± 16 year; 54% female) were enrolled. Receiver operating characteristic analysis was performed to evaluate the relationship between the true positive fraction of test results and the false-positive fraction for a procedure. RESULTS: Considering the 30-day mortality the area under the curve was 0.6 (95% confidence interval [CI] 0.50-0.72) for EuroSCORE II and 0.7 (95% CI 0.56-0.84) for CRS-score. The ratio of expected/observed mortality showed underestimation when considering EuroSCORE-II (min. 0.46-max. 0.6). At multivariate analysis, the CRS score (p = .005) was predictor of late cardiac death. CONCLUSION: We suggest using both scores to obtain a range of expected mortality. CRS to speculate on late survival.

Nose-shaped mass in the ascending aorta.

A 79-year-old man was referred for urgent coronary artery bypass grafting. Contrast-enhanced computed tomography revealed an atypically nose-shaped contrast defect, which intraoperatively turned out to be an atheromatous plaque. Its preoperative detection allowed us to prevent an adverse cerebral event. This case highlights that a thorough preoperative work-up should ideally include a CT angiography, in patients where atherosclerotic changes are to be expected.

Mechanical versus biological valve prostheses for left-sided infective endocarditis.

OBJECTIVES: Our aim was to analyse outcomes after implantation of mechanical versus biological valve prostheses in patients presenting with left-sided infective endocarditis. METHODS: We conducted a retrospective single-centre cohort study, analysing adults requiring valve surgery for left-sided infective endocarditis between January 2009 and December 2018 at the Department of Cardiac Surgery, Medical University of Vienna. The primary outcome variable was all-cause mortality. Secondary outcome variables included the occurrence of a combined event (death, stroke, intracerebral bleeding or reoperation) and the risk of re-endocarditis. RESULTS: Among 220 patients, 76 (34.5%) underwent mechanical valve replacement, while 144 (65.5%) underwent biological valve replacement. Recipients of mechanical valve prostheses were younger at the time of surgery and presented with lower European System for Cardiac Operative Risk Evaluation II values. In patients <55 years of age, implantation of a mechanical valve prosthesis was independently associated with significantly lower risk of all-cause mortality (adjusted hazard ratio 0.35, 95% confidence interval 0.15-0.80, P = 0.013). Moreover, this group was at significantly lower risk of a combined event (adjusted hazard ratio 0.38, 95% confidence interval 0.19-0.76, P = 0.006). Implantation of a mechanical valve prosthesis was not associated with increased risk of re-endocarditis. The presence of an annular abscess significantly increased the risk of re-endocarditis (adjusted hazard ratio 3.06, 95% confidence interval 1.40-6.71, P = 0.005). CONCLUSIONS: In patients presenting with left-sided infective endocarditis <55 years of age, implantation of a mechanical valve prosthesis is associated with superior outcomes. A prospective randomized controlled trial is warranted to confirm these results.

Rapid-deployment aortic valve replacement for patients with bicuspid aortic valve: a single-centre experience.

OBJECTIVES: The benefit of rapid-deployment aortic valve replacement (RD-AVR) in patients with a bicuspid aortic valve (BAV) is controversial due to aortic root asymmetry and potential increased risk for valve dislocation and paravalvular leak. This study aimed to analyse the outcomes of surgical aortic valve replacement with a rapid-deployment bioprosthesis in patients with a BAV. METHODS: Between May 2010 and December 2020, all consecutive patients who underwent RD-AVR at the Medical University of Vienna were included in our institutional database. Assessment of preoperative characteristics, operative outcomes, long-term survival and clinical events was performed. The outcomes of patients presenting with a native BAV were compared with a control group of patients with native tricuspid valve (TAV); reoperative aortic valve replacements were excluded. RESULTS: Out of 816 patients, who underwent RD-AVR at our institution, 107 patients with a BAV, mean age 68 (standard deviation: 8) years, were compared with a control group of 690 patients with a TAV, mean age 74 (standard deviation: 7) years; patients presenting with a BAV were significantly younger than patients with a TAV (P < 0.001). Concomitant procedures were performed in 44 (41.1%) patients in the BAV group and in 339 (49.1%) patients in the TAV group (P = 0.123); surgery of the ascending aorta was necessary in 24 (22.4%) in the BAV group, compared with 29 (4.2%) in the control group (P < 0.001). The 5-year cumulative incidence of moderate-to-severe paravalvular regurgitation in the BAV group was 10.7% [95% confidence interval (CI): 4.2-20.7%] and 3.9% (95% CI: 2.4-6.1%) in the TAV group (P = 0.057). Reoperation with valve explantation due to non-structural valve dysfunction at 5 years was 2.8% (95% CI: 0.5-8.8%) in the BAV group, compared to 1.9% (95% CI: 1.0-3.2%) in the TAV cohort (P = 0.89). The overall long-term survival rate in the BAV group was 92% (95% CI: 81-97%) at 5 years and 88% (95% CI: 73-95%), at 10 years, significantly better compared to the TAV group (log-rank test P = 0.002). CONCLUSIONS: RD-AVR can be performed in patients with a BAV with convincingly medical outcomes. However, a trend to increased frequency of moderate-severe paravalvular regurgitation was observed at long-term follow-up. Consequently, a different surgical approach, compared to tricuspid valves, with distinctly specific technical- and anatomical considerations and requirements, is recommended.

Beating Versus Arrested Heart Isolated Tricuspid Valve Surgery: Long-term Outcomes.

BACKGROUND: Isolated tricuspid valve (TV) surgery is a rare procedure generally considered at high risk for perioperative mortality and poor long-term outcomes. Surgical treatment can be performed with either an arrested heart (AH) or beating heart (BH) technique. The aim of this study was to compare the outcomes of isolated tricuspid surgery with 2 different approaches. METHODS: The Surgical-Tricuspid Study is a multicenter international retrospective study enrolling adult patients who underwent isolated TV procedures (n = 406; age 56 ± 16 years; 56% female) at 13 international sites. The AH and BH strategies were performed in 253 and 153 patients, respectively. Propensity score-matched analysis was used to compare groups. RESULTS: After matching, 129 pairs were obtained and analyzed. The 30-day mortality rate was 6.2% versus 5.0% in the AH and BH groups, respectively (P = .9). The rates of acute renal failure requiring replacement therapy (10% versus 3%; P = .02) and stroke (1.6% versus 0%; P = .08) were numerically higher in the AH group. The 6-year survival rate was 67% ± 6% versus 78% ± 5% in the AH and BH groups, respectively (P = .18), whereas freedom from cardiac death was 75% ± 5% versus 84% ± 4% (P = .21). The 6-year composite cardiac end point of cardiac death and reoperation rate was 60% ± 9% versus 86% ± 5% (P = .024) comparing AH-TV replacement and BH-TV repair groups. CONCLUSIONS: Isolated TV surgery performed with a BH strategy is a safe option and resulted in a trend of increased long-term survival and freedom from reoperation compared with the standard AH technique. Patients undergoing BH valve repair had the best long-term outcome.

Long-term durability after surgical aortic valve replacement with the Trifecta and the Intuity valve-a comparative analysis.

OBJECTIVES: Long-term durability of surgical bio-prostheses is a key factor, especially in the era of transcatheter aortic valve replacement. We compared the incidence of structural valve deterioration (SVD) between patients undergoing surgical aortic valve replacement (SAVR) with the Trifecta (Abbott Laboratories, Abbott Park, IL, USA) or the Intuity valve (Edwards Lifesciences, Irvine, CA, USA). METHODS: Between April 2010 and May 2020, 1118 patients underwent SAVR with the Trifecta (n = 346) and the Intuity (n = 772) valve at a single centre. A total of 1070 patients (Trifecta n = 298, Intuity n = 772) were analysed after the exclusion of patients with pure regurgitation and endocarditis. Retro- and prospective echocardiographic and clinical follow-up was performed. Cox proportional hazards regression models were performed to identify prognostic factors for SVD, aortic re-interventions and mortality. RESULTS: With 27 cases (Trifecta n = 23, Intuity n = 4) of SVD observed, cumulative incidence of SVD was significantly higher in the Trifecta cohort (P < 0.001). Implantation of a Trifecta valve [hazard ratio (HR) 11.20; 95% confidence interval 3.79-33.09], log-transformed preoperative creatinine (HR 2.47; 1.37-4.44) and sex (male HR 0.42; 0.19-0.92) emerged as prognostic factors of SVD. A significantly higher cumulative incidence of re-interventions was observed in the Trifecta cohort (P = 0.004) and valve type was an independent time-varying risk factor (HR at 12 months 2.78; 95% confidence interval 1.42-5.45). Overall, no significant differences in all-cause mortality were observed between the groups (log-rank test: P = 0.052). CONCLUSIONS: SVD was significantly more frequent in patients receiving a Trifecta valve and its implantation was an independent risk factor for the occurrence of SVD and aortic valve re-interventions. This comparative analysis of 2 low-gradient bioprosthesis put the long-term durability of the Trifecta valve in question and need to be taken into consideration when performing bioprosthetic SAVR.

The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease.

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

Lay abstract There is a wide variety of valve systems to treat aortic valve disease. This review summarizes the previously published data of the JenaValve system. Thanks to unique characteristics, this valve can be used either for aortic stenosis or regurgitation. Early data are promising with a low complication rate. Further studies are required to assess long-term results.

Conduction disturbances following surgical aortic valve replacement with a rapid-deployment bioprosthesis.

BACKGROUND: The implantation of rapid-deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a rapid-deployment balloon-expandable bioprosthesis in a single-center, real-world experience. METHODS: Between May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups. RESULTS: Preoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60). CONCLUSIONS: The PPI rate was in the range of previous reports for rapid-deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with rapid-deployment balloon-expandable bioprostheses.

Structural valve deterioration after aortic valve replacement with the Trifecta valve.

OBJECTIVES: Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS: Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS: Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan-Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS: We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.