Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves.

Importance: The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data. Objective: To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR. Design, Setting, and Participants: This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023. Interventions: ViV-TAVR vs redo SAVR. Main Outcomes and Measurements: The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis. Results: From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis. Conclusions and Relevance: Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.

Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation.

BACKGROUND/PURPOSE: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. METHODS: All consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. RESULTS: We included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03-1.91]). CONCLUSIONS: Routine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

Comparison of modified Del Nido and Custodiol® cardioplegia in minimally invasive mitral valve surgery.

OBJECTIVES: In this study, we evaluated if modified Del Nido cardioplegia delivers comparable cardiac protection in comparison to Custodiol® in patients undergoing isolated minimally invasive mitral valve repair. METHODS: From January 2018 to October 2021, all patients undergoing non-emergent isolated minimally invasive mitral valve repair were included in this study. The cardioplegia was chosen at the surgeons' discretion. The primary end points of this study were peak postoperative cardiac enzyme levels. Secondary end points were in-hospital mortality, hospital stay, occurrence of cardiac arrhythmias, pacemaker implantations, postoperative lactate and sodium levels and postoperative incidence of renal failure requiring dialysis. RESULTS: A total of 355 patients were included in this study. The mean age of patients was 57. After propensity score matching, a total of 156 pairs were identified. There was no difference in cross-clamp time between both groups. Postoperative creatine kinase levels were higher in patients receiving Custodiol on the 1st and 2nd postoperative days. Creatine kinase isoenzyme MB levels were higher in patients receiving Custodiol on the 2nd postoperative day (0.5 ± 0.2 vs 0.4 ± 0.1 µmol/l s; P < 0.001). Postoperative Troponin T concentrations were similar between both groups. Maximum lactate concentrations were higher in patients receiving Custodiol on the day of surgery (2.4 ± 1.9 vs 2.0 ± 1.1 mmol/l; P = 0.04). The overall hospital stay was longer in patients receiving Del Nido cardioplegia (10.6 ± 3.2 vs 8 ± 4.1 days; P < 0.01). CONCLUSIONS: Modified Del Nido cardioplegia based on Ionosteril® solution offers equivalent protection compared to Custodiol for isolated minimally invasive mitral valve repair.

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

Early and long-term outcomes following redo mitral valve surgery in patients with prior minimally invasive mitral valve surgery.

OBJECTIVES: The frequency of minimally invasive mitral valve surgery (MVS) has steadily increased over the last decades and therefore surgeons are now encountering an increasing number of patients requiring mitral valve (MV) reoperations post-minimally invasive MVS. The aim of this study was to analyse the early postoperative outcomes and the long-term survival in patients who undergo reoperative MVS following previous minimally invasive surgery. METHODS: Patients who underwent redo MVS following prior minimally invasive MVS between January 2002 and December 2021 were included in our analysis. Study data were prospectively collected and retrospectively analysed. The primary outcomes were 30-day mortality and long-term survival. RESULTS: Among the 187 included patients, 34 (18.2%) underwent repeat MV repair and 153 (81.8%) MV replacement. The median age was 66 years (interquartile range 56-74) and 80 (42.8%) patients were female. Redo MVS was performed through median sternotomy in 169 patients (90.4%). A total of 77 (41.2%) patients had additional concomitant procedures. The median intensive care unit stay was 1 day (1-5). The 30-day mortality was 6.4% (12/187). Estimated survival at 5 and 12 years was 61.8% and 38.3%, respectively. Preoperative stroke (hazard ratio 3.28, 95% confidence interval 1.37-7.85, P = 0.007) as well as infective endocarditis (hazard ratio 1.85; 95% confidence interval 1.09-3.11, P = 0.021) were independent predictors of long-term mortality. CONCLUSIONS: Redo MVS following prior minimally invasive MVS can be performed safely with low early perioperative mortality and acceptable long-term survival. Preoperative stroke, infective endocarditis and concomitant tricuspid valve surgery are independent predictors of long-term mortality.

Mortality in patients with normal left ventricular function requiring emergency VA-ECMO for postcardiotomy cardiogenic shock due to coronary malperfusion.

OBJECTIVES: To analyze outcomes in patients with normal preoperative left ventricular ejection fraction (LVEF) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO) therapy due to postcardiotomy cardiogenic shock (PCCS) related to coronary malperfusion. METHODS: Retrospective single-center analysis in patients with normal preoperative LVEF treated with VA-ECMO for coronary malperfusion-related PCCS between May 1998 and May 2018. The primary outcome was 30-day mortality, which was compared using the Kaplan-Meier method and the log-rank test. Multivariable logistic regression was performed to identify predictors of mortality. RESULTS: During the study period, a total of 62,125 patients underwent cardiac surgery at our institution. Amongst them, 59 patients (0.1%) with normal preoperative LVEF required VA-ECMO support due to coronary malperfusion-related PCCS. The mean duration of VA-ECMO support was 6 days (interquartile range 4-7 days). The 30-day mortality was 50.8%. Under VA-ECMO therapy, a complication composite outcome of bleeding, re-exploration for bleeding, acute renal failure, acute liver failure, and sepsis occurred in 51 (86.4%) patients. Independent predictors of 30-day mortality were lactate levels > 9.9 mmol/l before VA-ECMO implantation (odds ratio [OR]: 3.3; 95% confidence interval [CI] 1.5-7.0; p = 0.002), delay until revascularization > 278 minutes (OR: 2.9; 95% CI 1.3-6.4; p = 0.008) and peripheral arterial artery disease (OR: 3.3; 95% 1.6-7.5; p = 0.001). CONCLUSIONS: Mortality rates are high in patients with normal preoperative LVEF who develop PCCS due to coronary malperfusion. The early implantation of VA-ECMO before the development of profound tissue hypoxia and early coronary revascularization increases the likelihood of survival. Lactate levels are useful to define optimal timing for the VA-ECMO initiation.

[Summary: International consensus statement on nomenclature and classification of the congenital bicuspid aortic valve and its aortopathy, for clinical, surgical, interventional and research purposes]. / Resumen: Consenso internacional para la nomenclatura y clasificación de la válvula aórtica bicúspide congénita y su aortopatía, con fines clínicos, quirúrgicos, intervencionistas y de investigación.

This consensus of nomenclature and classification for congenital bicuspid aortic valve and its aortopathy is evidence-based and intended for universal use by physicians (both pediatricians and adults), echocardiographers, advanced cardiovascular imaging specialists, interventional cardiologists, cardiovascular surgeons, pathologists, geneticists, and researchers spanning these areas of clinical and basic research. In addition, as long as new key and reference research is available, this international consensus may be subject to change based on evidence-based data1.

Este consenso de nomenclatura y clasificación para la válvula aórtica bicúspide congénita y su aortopatía está basado en la evidencia y destinado a ser utilizado universalmente por médicos (tanto pediatras como de adultos), médicos ecocardiografistas, especialistas en imágenes avanzadas cardiovasculares, cardiólogos intervencionistas, cirujanos cardiovasculares, patólogos, genetistas e investigadores que abarcan estas áreas de investigación clínica y básica. Siempre y cuando se disponga de nueva investigación clave y de referencia, este consenso internacional puede estar sujeto a cambios de acuerdo con datos basados en la evidencia1.

Outcomes after surgical revascularization in diabetic patients.

OBJECTIVES: Patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) have been repeatedly demonstrated to have worse clinical outcomes compared to patients without DM. The objective of this study was to evaluate the impact of DM on 1-year clinical outcomes after isolated CABG. METHODS: The European DuraGraft registry included 1130 patients (44.6%) with and 1402 (55.4%) patients without DM undergoing isolated CABG. Intra-operatively, all free venous and arterial grafts were treated with an endothelial damage inhibitor. Primary end point in this analysis was the incidence of a major adverse cardiac event (MACE), a composite of all-cause death, repeat revascularization or myocardial infarction at 1 year post-CABG. To balance between differences in baseline characteristics (n = 1072 patients in each group), propensity score matching was used. Multivariable Cox proportional hazards regression was performed to identify independent predictors of MACE. RESULTS: Diabetic patients had a higher cardiovascular risk profile and EuroSCORE II with overall more comorbidities. Patients were comparable in regard to surgical techniques and completeness of revascularization. At 1 year, diabetics had a higher MACE rate {7.9% vs 5.5%, hazard ratio (HR) 1.43 [95% confidence interval (CI) 1.05-1.95], P = 0.02}, driven by increased rates of death [5.6% vs 3.5%, HR 1.61 (95% CI 1.10-2.36), P = 0.01] and myocardial infarction [2.8% vs 1.4%, HR 1.99 (95% CI 1.12-3.53) P = 0.02]. Following propensity matching, no statistically significant difference was found for MACE [7.1% vs 5.7%, HR 1.23 (95% CI 0.87-1.74) P = 0.23] or its components. Age, critical operative state, extracardiac arteriopathy, ejection fraction ≤50% and left main disease but not DM were identified as independent predictors for MACE. CONCLUSIONS: In this study, 1-year outcomes in diabetics undergoing isolated CABG were comparable to patients without DM.

Neochordal Goldilocks: Analyzing the biomechanics of neochord length on papillary muscle forces suggests higher tolerance to shorter neochordae.

OBJECTIVE: Estimating neochord lengths during mitral valve repair is challenging, because approximation must be performed largely based on intuition and surgical experience. Little data exist on quantifying the effects of neochord length misestimation. We aimed to evaluate the impact of neochord length on papillary muscle forces and mitral valve hemodynamics, which is especially pertinent because increased forces have been linked to aberrant mitral valve biomechanics. METHODS: Porcine mitral valves (n = 8) were mounted in an ex vivo heart simulator, and papillary muscles were fixed to high-resolution strain gauges while hemodynamic data were recorded. We used an adjustable system to modulate neochord lengths. Optimal length was qualitatively verified by a single experienced operator, and neochordae were randomly lengthened or shortened in 1-mm increments up to ±5 mm from the optimal length. RESULTS: Optimal length neochordae resulted in the lowest peak composite papillary muscle forces (6.94 ± 0.29 N), significantly different from all lengths greater than ±1 mm. Both longer and shorter neochordae increased forces linearly according to difference from optimal length. Both peak papillary muscle forces and mitral regurgitation scaled more aggressively for longer versus shorter neochordae by factors of 1.6 and 6.9, respectively. CONCLUSIONS: Leveraging precision ex vivo heart simulation, we found that millimeter-level neochord length differences can result in significant differences in papillary muscle forces and mitral regurgitation, thereby altering valvular biomechanics. Differences in lengthened versus shortened neochordae scaling of forces and mitral regurgitation may indicate different levels of biomechanical tolerance toward longer and shorter neochordae. Our findings highlight the need for more thorough biomechanical understanding of neochordal mitral valve repair.

Left ventricular fibrosis and CMR tissue characterization of papillary muscles in mitral valve prolapse patients.

PURPOSE: Mitral valve prolapse (MVP) is associated with left ventricle (LV) fibrosis, including the papillary muscles (PM), which is in turn linked to malignant arrhythmias. This study aims to evaluate comprehensive tissue characterization of the PM by cardiovascular magnetic resonance (CMR) imaging and its association with LV fibrosis observed by intraoperative biopsies. METHODS: MVP patients with indication for surgery due to severe mitral regurgitation (n = 19) underwent a preoperative CMR with characterization of the PM: dark-appearance on cine, T1 mapping, conventional bright blood (BB) and dark blood (DB) late gadolinium enhancement (LGE). CMR T1 mapping was performed on 21 healthy volunteers as controls. LV inferobasal myocardial biopsies were obtained in MVP patients and compared to CMR findings. RESULTS: MVP patients (54 ± 10 years old, 14 male) had a dark-appearance of the PM with higher native T1 and extracellular volume (ECV) values compared with healthy volunteers (1096 ± 78ms vs. 994 ± 54ms and 33.9 ± 5.6% vs. 25.9 ± 3.1%, respectively, p < 0.001). Seventeen MVP patients (89.5%) had fibrosis by biopsy. BB-LGE + in LV and PM was identified in 5 (26.3%) patients, while DB-LGE + was observed in LV in 9 (47.4%) and in PM in 15 (78.9%) patients. DB-LGE + in PM was the only technique that showed no difference with detection of LV fibrosis by biopsy. Posteromedial PM was more frequently affected than the anterolateral (73.7% vs. 36.8%, p = 0.039) and correlated with biopsy-proven LV fibrosis (Rho 0.529, p = 0.029). CONCLUSIONS: CMR imaging in MVP patients referred for surgery shows a dark-appearance of the PM with higher T1 and ECV values compared with healthy volunteers. The presence of a positive DB-LGE at the posteromedial PM by CMR may serve as a better predictor of biopsy-proven LV inferobasal fibrosis than conventional CMR techniques.

Degenerative mitral regurgitation.

Degenerative mitral regurgitation is a major threat to public health and affects at least 24 million people worldwide, with an estimated 0.88 million disability-adjusted life years and 34,000 deaths in 2019. Improving access to diagnostic testing and to timely curative therapies such as surgical mitral valve repair will improve the outcomes of many individuals. Imaging such as echocardiography and cardiac magnetic resonance allow accurate diagnosis and have provided new insights for a better definition of the most appropriate timing for intervention. Advances in surgical techniques allow minimally invasive treatment with durable results that last for ≥20 years. Transcatheter therapies can provide good results in select patients who are considered high risk for surgery and have a suitable anatomy; the durability of such repairs is up to 5 years. Translational science has provided new knowledge on the pathophysiology of degenerative mitral regurgitation and may pave the road to the development of medical therapies that could be used to halt the progression of the disease.

Aortic arch redo surgery: early and mid-term outcomes in 120 patients.

OBJECTIVES: The aim of this study was to analyse the indications, surgical extent and results of treatment, as well as determine the risk factors for adverse outcomes after redo arch surgery. METHODS: Between January 1996 and December 2022, 120 patients underwent aortic arch reoperations after primary proximal aortic surgery. We retrospectively analysed perioperative data, as well as early and mid-term outcomes in these patients. RESULTS: Indications for arch reintervention included new aortic aneurysm in 34 patients (28.3%), expanding post-dissection aneurysm in 36 (30.0%), aortic graft infection in 39 (32.5%) and new aortic dissection in 9 cases. Two patients underwent reoperation due to iatrogenic complications. Thirty-one patients (25.8%) had concomitant endocarditis. In-hospital and 30-day mortality rates were 11.7% and 15.0%, respectively. Stroke was observed in 11 (9.2%) and paraplegia in 1 patient. Prior surgery due to aneurysm [odds ratio 4.5; 95% confidence interval (CI) 1.4-17.3] and critical preoperative state (odds ratio 5.9; 95% CI 1.5-23.7) were independent predictors of 30-day mortality. Overall 1- and 5-year survival was 65.8 ± 8.8% and 51.2 ± 10.6%, respectively. Diabetes mellitus (hazard ratio 2.4; 95% CI 1.0-5.1) and peripheral arterial disease (hazard ratio 4.7; 95% CI 1.1-14.3) were independent predictors of late death. The cumulative incidence of reoperations was 12.6% (95% CI 6.7-20.4%) at 5 years. Accounting for mortality as a competing event, connective tissue disorders (subdistribution hazard ratio 4.5; 95% CI 1.6-15.7) and interval between primary and redo surgery (subdistribution hazard ratio 1.04; 95% CI 1.02-1.06) were independent predictors of reoperations after redo arch surgery. CONCLUSIONS: Despite being technically demanding, aortic arch reoperations are feasible and can be performed with acceptable results.

Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis.

BACKGROUND: This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. METHODS: Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. RESULTS: Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. CONCLUSIONS: Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.

Long-Term Results Following Combined Repair of Atrioventricular Septal Defect with Tetralogy of Fallot.

Atrioventricular septal defect (AVSD) in association with tetralogy of Fallot (TOF) is a rare and complex congenital cardiac malformation. We report our institutional experience and outcomes following surgical correction over a 20-year period. Patients who underwent combined surgical AVSD and TOF correction between October 2001 and February 2020 were included for analysis. All patients underwent primary repair. The study data were prospectively collected and retrospectively analyzed. Primary outcomes were in-hospital mortality and long-term freedom from reoperation. During the study period, a total of 10 consecutive patients underwent combined surgical AVSD and TOF correction. Median age at operation was 307 days (IQR 228-457) and median weight was 7.7 kg (IQR 6.7-9.5). Down Syndrome was present in six of the patients. In-hospital mortality was 0%. One patient required re-exploration due to bleeding. Median follow-up was 11 years (IQR 11 months -16 years). There was one case of reoperation due to significant residual ventricular septal defect after 2 months. None of the patients died during follow-up. Combined primary AVSD and TOF repair can be performed with low early mortality and morbidity, as well as a high long-term freedom from reoperation.

The Feasibility of Less-Invasive Bentall Surgery: A Real-World Analysis.

OBJECTIVE: Minimally invasive approaches are being used increasingly in cardiac surgery and applied in a wider range of operations, including complex aortic procedures. The aim of this study was to examine the safety and feasibility of a partial upper sternotomy approach for isolated elective aortic root replacement (a modified Bentall procedure). METHODS: We performed a retrospective analysis of 768 consecutive patients who had undergone isolated Bentall surgery between January 2000 and January 2021 at our institution, with the exclusion of re-operations, endocarditis, acute aortic dissections, and root replacement with major concomitant procedures such as multi-valve or coronary bypass surgery. A total of 98 patients were operated on via partial sternotomy (PS) and were matched 2:1 to 196 patients operated on via full sternotomy (FS). RESULTS: The procedure time was 12 min longer in the PS group (205 min vs. 192.5 min in the FS group, p = 0.002), however, cardiopulmonary bypass and aortic cross-clamp times were comparable between groups. Eight PS-procedures were converted to full sternotomy, predominantly for bleeding complications (n = 6). Re-exploration for acute bleeding was necessary in 11% of the PS group and 4.1% of the FS group (p = 0.02). Five FS patients and none in the PS group required emergency coronary bypass grafting for postoperative coronary obstruction (p = 0.2). PS patients were hospitalized for a significantly shorter period (9.5 days vs. 10.5 days in the FS group, respectively). There were no significant differences regarding in-hospital (p = 0.4) and mid-term mortality (p = 0.73), as well as for other perioperative complications. CONCLUSIONS: Performing Bentall operations via partial upper sternotomy is associated with similar perfusion and cross-clamp times, as well as overall mortality, when compared to a full sternotomy approach. A low threshold for conversion to full sternotomy should be accepted if limited access proves insufficient for the handling of intraoperative complications, particularly bleeding.

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.

OBJECTIVE: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. METHODS: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. RESULTS: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. CONCLUSIONS: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.

Body mass index-dependent immunological profile changes after left ventricular assist device implantation.

Purpose: Infection is a common complication following left ventricular assist device (LVAD) implantation. Patients with obesity are particularly at risk due to their high percentage of adipose tissue and the resulting chronic inflammatory state and resulting immunological changes. This study investigated changes of immunological parameters in relation to body mass index (BMI) during the first year after LVAD implantation. Methods: Blood samples were obtained prior to LVAD implantation and at 3 (1st FU), 6 (2nd FU) and 12 mo (3rd FU) after LVAD implantation. Patients were divided into three groups (normal weight: BMI of 18.5-24.9 kg/m2; n=12; pre-obesity: 25.0-29.9 kg/m2; n=15; obesity: ≥ 30.0 kg/m2; n=17) based on their BMI at the time of LVAD implantation. Flow cytometric analyses for CD4+ and CD8+ T cells, regulatory T cells (Tregs), B cells as well as dendritic cells (DCs) were performed. Results: After LVAD implantation, obese patients (0.51 ± 0.20%) showed a higher proportion of overall DCs than normal-weight (0.28 ± 0.10%) and pre-obese patients (0.32 ± 0.11%, p<0.01) at 3rd FU. The proportion of BDCA3+ myeloid DCs was lower in obese patients (64.3 ± 26.5%) compared to normal-weight patients (82.7 ± 10.0%, pnormal-weight vs. obesity=0.05) at 2nd FU after LVAD implantation. The analysis of BDCA4+ plasmacytoid DCs revealed a reduced proportion in pre-obese (21.1 ± 9.8%, pnormal-weight vs. pre-obesity=0.01) and obese patients (23.7 ± 10.6%, pnormal-weight vs. obesity=0.05) compared to normal-weight patients (33.1 ± 8.2%) in the 1st FU. T cell analysis showed that CD4+ T cells of obese patients (62.4 ± 9.0%) significantly increased in comparison to pre-obese patients (52.7 ± 10.0%, ppre-obesity vs. obesity=0.05) and CD8+ T cells were lower in obese patients (31.8 ± 8.5%) than in normal-weight patients (42.4 ± 14.2%; pnormal-weight vs. obesity=0.04) at the 3rd FU. Furthermore, we observed significantly reduced proportions of Tregs in pre-obese patients compared to normal-weight and obese patients at 2nd FU (p=0.02) and 3rd FU (p=0.01) after LVAD implantation. Conclusion: This study reported changes of the innate and adaptive immune system of pre-obese and obese compared to normal-weight patients one year after LVAD implantation. DCs and their subsets, CD8+ T cells and Tregs were affected immune cell populations that indicate immunological changes which might increase the incidence of postoperative infection.