Objectives
We present 1‐year outcomes of the post‐market registry of a next‐generation transcatheter heart valve used for aortic regurgitation (AR).
Background
Transcatheter aortic valve replacement ...(TAVR) is routine in high‐risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism.
Methods
The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012‐2015, 30 patients with AR were enrolled.
Results
Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One‐year Kaplan‐Meier survival was 79.9%, one‐year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow‐up.
Conclusions
The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One‐year results using the JenaValve for AR encourage its use for this indication.
The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in ...part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).
Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation.
Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality.
Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg).
Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.
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Background Chronic kidney disease is a significant risk factor for mortality as well as acute kidney injury in cardiac surgery. The impact of contrast agent application on outcome is not well ...described in patients undergoing transcatheter aortic valve implantation. Methods We analyzed data of 270 patients who underwent transcatheter aortic valve implantation (TAVI) between September 2008 and March 2012. Acute kidney injury was defined according to modified risk, injury, failure, loss and end-stage renal failure criteria. Patients on chronic hemodialysis were analyzed separately (n = 15). In 129 (47.8%) patients chronic kidney disease was apparent preoperatively. On average, 83.7 (± 32.4) mL of contrast agent were used per patient. Results Postoperatively, 41 patients (15.2%) developed acute kidney injury. In 19 patients (7.1%) transient renal replacement therapy was necessary; no chronic hemodialysis was required. Thirty-day-mortality did not differ between patients with or without chronic kidney disease (7.0% vs 7.1%, p = 0.97). Additionally, chronic kidney disease had no influence on the incidence of postoperative acute kidney injury (12.8% vs 20.2%, p = 0.07) or postoperative hemodialysis (5.0% vs 10.5%, p = 0.08). No correlation between the amount of contrast agent applied and the incidence of acute kidney injury could be verified ( p = 0.57). Conclusions Preoperative chronic kidney disease does not increase the risk of mortality and acute kidney injury after transcatheter aortic valve implantation. Acute kidney injury after TAVI is associated with an elevated risk of mortality. The amount of contrast agent applied intra-procedurally does not affect the risk of acute kidney injury.
Abstract
OBJECTIVES
This study sought to assess the incremental prognostic value of the psoas muscle area in patients scheduled for transcatheter aortic valve implantation (TAVI).
METHODS
A total of ...1076 consecutive patients undergoing TAVI at 2 centres between 2010 and 2017 were prospectively included in this study. Computed tomography-derived cross-sectional area of the psoas muscle was measured at the superior border of the third (L3) and fourth (L4) lumbar vertebra and indexed to body surface area (PMAi) as well as stratified into tertiles. Multivariable logistic regression and Cox regression analyses were performed to investigate the value of PMAi as a predictor of 30-day and cumulative mortality. The incremental prognostic value of PMAi over the Society of Thoracic Surgeons (STS) score was assessed using a net reclassification analysis.
RESULTS
The rate of 30-day mortality was 5.8% (n = 62). PMAi at the level of L3 odds ratio 0.082, 95% confidence interval (CI) 0.011–0.589; P = 0.013 and L4 (odds ratio 0.049, 95% CI 0.005–0.536; P = 0.013) was independently associated with 30-day mortality. During a median follow-up of 435 days (interquartile range 139–904), 292 patients (27.1%) died. PMAi of L3 (hazard ratio 0.200, 95% CI 0.083–0.482; P < 0.001) and L4 (hazard ratio 0.083, 95% CI 0.029–0.235; P < 0.001) was independently associated with mortality during follow-up. The addition of PMAi to the STS score led to a net reclassification improvement for 30-day and cumulative mortality.
CONCLUSIONS
PMAi emerged as a valuable outcome predictor in patients undergoing TAVI. The addition of PMAi to the established STS score led to an increase in its prognostic ability.
Background Minimally invasive extracorporeal circulation (MECC) is predominantly used in coronary operations. Data supporting the benefits of MECC in minimally invasive valve operations are still ...absent. Methods Patients undergoing either isolated minimally invasive mitral or aortic valve procedures were prospectively randomized to a minimally invasive group (MECC; n = 101) or a conventional extracorporeal circulation group (CECC; n = 99). The procedural and postoperative outcomes were compared, including the levels of inflammation factors (procalcitonin, interleukin IL-6, IL-8, and IL-10), tumor necrosis factor-α TNF-α, and interferon-gamma IFN-γ). Results The demographics were comparable between the groups regarding age (MECC versus CECC, 70.5 ± 10.2 years versus 73.1 ± 8.9 years; P = 0.086), left ventricular function (59.2% ± 13.4% versus 62.1% ± 14.0%; p = 0.302), EuroSCORE (7.4% ± 7.9% versus 6.8% ± 4.0%; p = 0.256), and other comorbidities. Hospital mortality (n = 1 versus n = 3; p = 0.339) and other complications were similar. However, hemoglobin level (111.9 ± 19.0 g/L versus 103.8 ± 14.6 g/L; p = 0.001), the number of packed red blood cells (PRBCs) (1.1 ± 1.9 versus 1.7 ± 1.8; p = 0.003), the levels of ILs (IL-6, 194.0 ± 131.8 pg/mL versus 289.2 ± 62.5 pg/mL; p = 0.020; IL-8, 38.1 ± 27.3 pg/mL versus 45.8 ± 43.4 pg/mL; p = 0.012; IL-10, 29.0 ± 123.9 pg/mL versus 49.9 ± 85.6 pg/mL; p = 0.012), TNF-α (3.8 ± 6.7 ng/mL versus 10.8 ± 47.7 ng/mL; p = 0.049), and IFN-γ (1.9 ± 1.9 pg/mL versus 4.5 ± 2.7 pg/mL; p = 0.027) were in favor of patients in the MECC group. Additionally, those patients had shorter postoperative ventilation time (7.7 ± 8.4 hours versus 9.3 ± 12.9 hours; p = 0.010) and intensive care unit (ICU) stay (1.2 ± 1.2 days versus 2.2 ± 3.8 days; p = 0.047). Conclusions The intraprocedural data were excellent and comparable in the groups, but postoperative outcomes were better in the MECC group. Thus MECC is preferable to CECC even for minimally invasive valve procedures. These findings strongly support a combined strategy of minimally invasive valve operations and minimally invasive extracorporeal circulation.
Coronary artery disease (CAD) is associated with poorer outcomes after aortic valve replacement (AVR). For high-risk patients with complex CAD, combined transcatheter aortic valve replacement (TAVR) ...plus off-pump/minimally-invasive coronary artery bypass (OPCAB/MIDCAB) has been proposed.
A prospective registry analysis was performed to compare the characteristics and outcomes of patients undergoing TAVR+OP/MIDCAB with those undergoing TAVR plus percutaneous coronary intervention (PCI) and surgical AVR plus coronary artery bypass grafting (CABG) between 2008 and 2015 at a single site in Germany.
464 patients underwent SAVR+CABG, 50 underwent TAVR+OP/MIDCAB, and 112 underwent TAVR+PCI. The mean ages (p < 0.001) and logistic EuroSCOREs (p < 0.001) were similarly higher in TAVR+OP/MIDCAB and TAVR+PCI patients compared to SAVR+CABG patients. Prior cardiac surgery was more common in TAVR+PCI than in TAVR+OP/MIDCAB and SAVR+CABG patients (p < 0.001). Procedural times were shortest (p < 0.001), creatine kinase (muscle brain) levels least elevated (p < 0.001), pericardial tamponade least common (p = 0.027), and length of hospital stay shortest (p = 0.011) in TAVR+PCI, followed by TAVR+OP/MIDCAB and SAVR+CABG patients. In-hospital mortality was highest for TAVR+OP/MIDCAB patients (18.0%) with comparable rates for TAVR+PCI and SAVR+CABG groups (9.0 and 6.9%; p = 0.009). Mortality by 12 months was more probable after TAVR+OP/MIDCAB (HR: 2.17, p = 0.002) and TAVR/PCI (HR: 1.63, p = 0.010) than after SAVR+CABG, with the same true of rehospitalisation (HR: 2.39, p = 0.003 and HR: 1.63, p = 0.033).
TAVR+OP/MIDCAB patients share many characteristics with TAVR+PCI patients, with only slightly poorer long-term outcomes. In patients ineligible for SAVR+CABG and TAVR+PCI, hybrid interventions are reasonable second-line options.
Abstract Objectives The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic ...(TAo) access for transcatheter aortic valve replacement (TAVR) procedures ( NCT01991431 ). Background TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. Methods ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. Results A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. Conclusions TAo access for TAVR seems to be a safe alternative to the transapical procedure.
Background and Objectives: The strategy of revascularization may be constrained in patients with insufficient bypass grafts and with increased risk of wound healing disorders. Among those with ...complex left-sided double-vessel disease in whom a percutaneous coronary intervention (PCI), as well as the surgical procedure of minimally invasive coronary artery bypass grafting via left minithoracotomy (MICS CABG), is not a treatment option, CABG using the left internal mammary artery as a T-graft with itself may be an effective treatment strategy. Materials and Methods: We reviewed the data from patients treated in Cologne and Tuebingen from 2019 to 2022. We included 40 patients who received left internal mammary artery (LIMA) grafting, and additional T-graft with the LIMA itself. The objective was focused on intraoperative and short-term outcomes. Results: A total of 40 patients were treated with the LIMA-LIMA T-graft procedure with a Fowler score calculated at 20.1 ± 3.0. A total of 37.5% of all patients had lacking venous graft material due to prior vein stripping, and 21 patients presented severe vein varicosis. An overall of 2.6 ± 0.5 distal anastomoses (target vessels were left anterior descending, diagonal, intermediate branch, and/or left marginal ramus) were performed, partly sequentially. Mean flow of LIMA-Left anterior descending (LAD) anastomosis was 59.31 ± 11.04 mL/min with a mean PI of 1.21 ± 0.18. Mean flow of subsequent T-Graft accounted for 51.31 ± 3.81 mL/min with a mean PI of 1.39 ± 0.47. Median hospital stay was 6.2 (5.0; 7.5) days. No incidence of postoperative wound healing disorders was observed, and all patients were discharged. There was one 30-day readmission with a diagnosis of pericardial effusion (2.5%). There was no 30-day mortality within the cohort. Conclusions: Patients requiring surgical myocardial revascularization due to complex two-vessel coronary artery disease (CAD) can be easily managed with LIMA alone, despite an elevated Fowler score and a promising outcome. A prospective study needs to be conducted, as well as longer term surveillance, to substantiate and benchmark the long-term results, as well as the patency rates.
Background Valve-sparing aortic root replacement has already proven its excellent long-term results, with low valve-related complications comparable with conventional aortic valve replacement. The ...aim of this study was to investigate whether additional expanded cusp repair is an alternative with comparable results. Methods Data of 192 elective patients undergoing valve-sparing aortic root replacement were prospectively recorded: 58 patients (30.2%) received an isolated aortic root replacement (group I, isolated David), and 134 patients (69.8%) received additional cusp repair (group II, complex David), such as plication of the free margin (n = 77), decalcification (n = 45), or pericardial patch (n = 39). Cumulative follow-up was 480 patient-years, with a mean of 2.5 ± 1.5 years. Results Mean age was 60 years, and 76.6% were men. In hospital mortality was 3.4% in group I and 0.0% in group II. Freedom from cardiac death at 5 years (by Kaplan-Meier estimation) was 83% vs 98% ( p = 0.058). Freedom from moderate or severe aortic insufficiency at 5 years was 100% in group I vs 93% (95% confidence interval, 86% to 97%) in group II ( p = 0.110). Seven patients required reoperation for aortic insufficiency or stenosis: repeat repair (n = 3), Ross procedure (n = 2), and biologicical aortic valve replacement (n = 2). Freedom from reoperation at 5 years was 96% (95% confidence interval, 76% to 99%) in group I vs 89% (95% confidence interval, 71% to 96%) in group II ( p = 0.305). Conclusions Overall survival and freedom from reoperation after valve-sparing aortic root replacement, even with additional complex cusp repair, provides excellent midterm results. Low risk of valve-related complications and absence of anticoagulation therapy are distinctive advantages of this complex procedure.
Objective: This study aimed to compare postoperative outcomes and 30-day mortality in patients with reduced ejection fraction (<40%) who underwent isolated coronary artery bypass grafting (CABG) with ...(ONCAB) and without (OPCAB) the use of cardiopulmonary bypass. Methods: data from four university hospitals in Germany, spanning from January 2017 to December 2021, were retrospectively analyzed. A total of 551 patients were included in the study, and various demographic, intraoperative, and postoperative data were compared. Results: demographic parameters did not exhibit any differences. However, the OPCAB group displayed notably higher rates of preoperative renal insufficiency, urgent surgeries, and elevated EuroScore II and STS score. During surgery, the ONCAB group showed a significantly higher rate of complete revascularization, whereas the OPCAB group required fewer intraoperative transfusions. No disparities were observed in 30-day/in-hospital mortality for the entire cohort and the matched population between the two groups. Subsequent to surgery, the OPCAB group demonstrated significantly shorter mechanical ventilation times, reduced stays in the intensive care unit, and lower occurrences of ECLS therapy, acute kidney injury, delirium, and sepsis. Conclusions: the study’s findings indicate that OPCAB surgery presents a safe and viable alternative, yielding improved postoperative outcomes in this specific patient population compared to ONCAB surgery. Despite comparable 30-day/in-hospital mortality rates, OPCAB patients enjoyed advantages such as decreased mechanical ventilation durations, shorter ICU stays, and reduced incidences of ECLS therapy, acute kidney injury, delirium, and sepsis. These results underscore the potential benefits of employing OPCAB as a treatment approach for patients with coronary heart disease and reduced ejection fraction.
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