Transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement in patients with failed aortic bioprostheses

OBJECTIVES: Transcatheter aortic valve-in-valve implantation (ViV) is a new treatment for failing bioprostheses (BP) in patients with high surgical risk. However, comparative data, using standard repeat surgical aortic valve replacement (redo-SAVR), are scarce. We compared outcomes after ViV with those after conventional redo-SAVR in two European centres with established interventional programmes. METHODS: In-hospital databases were retrospectively screened for patients ?60 years, treated for failing aortic BP. Cases of infective endocarditis or combined procedures were excluded. End-points were adjudicated according to the Valve Academic Research Consortium (VARC-2) criteria. RESULTS: From 2002 to 2015, 130 patients were treated (ViV: n = 71, redo-SAVR: n = 59). Age and logistic EuroSCORE I scores were higher with ViV (78.6 7.5 vs 72.9 6.6 years, P 0.01; 25.1 18.9 vs 16.8 9.3%, P 0.01). The 30-day mortality rate was not significantly different (4.2 and 5.1%, respectively) (P = 1.0). Device success was achieved in 52.1% (ViV) and 91.5% (P 0.01). No stroke was observed after ViV but in 3.4% after redo-SAVR (P = 0.2). Intensive care stay was longer after redo-SAVR (3.4 2.9 vs 2.0 1.8 days, P 0.01). Mean transvalvular gradients were higher post-ViV (19.7 7.7 vs12.2 5.7 mmHg, P 0.01), whereas the rate of permanent pacemaker implantation was lower (9.9 vs 25.4%, P 0.01). Survival rates at 90 and180 days were 94.2 and 92.3% vs 92.8 and 92.8% (P = 0.87), respectively. CONCLUSIONS: Despite a higher risk profile in the ViV group, early mortality rates were not different compared with those of surgery. Although ViV resulted in elevated transvalvular gradients and therefore a lower rate of device success, mortality rates were similar to those with redo-SAVR. At present, both techniques serve as complementary approaches, and allow individualized patient care with excellent outcomes.</p

Transcatheter Edge-to-Edge Mitral Valve Repair versus Minimally Invasive Mitral Valve Surgery: An Observational Study

Background: Minimally invasive mitral valve surgery (MIC-MVS) has been established as preferred treatment of mitral regurgitation (MR), but mitral transcatheter edge-to-edge valve repair (M-TEER) is routinely performed in patients at high surgical risk and is increasingly performed in intermediate risk patients. Methods: From 2010 to 2021, we performed 723 M-TEER and 123 isolated MIC-MVS procedures. We applied a sensitivity analysis by matching age, left ventricular ejection fraction (LVEF), EuroSCORE II and etiology of MR. Results: Baseline characteristics showed significant differences in the overall cohort (p p p = 0.04). A matching with 49 pairs (n = 98) showed comparable survival during follow-up, but a numerically higher mean mitral valve gradient of 4.1 mmHg (95% CI: 3.6–4.6) vs. 3.4 mmHg (95% CI: 3.0–3.8) in M-TEER (p = 0.04). Conclusions: Patients undergoing M-TEER had lower one-year survival than MIC-MVS, but differences disappeared after matching. Reduction in MR was less effective in M-TEER patients and postprocedural mitral valve gradients were higher

Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial

BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [Delta SOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for Delta SOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, Delta SOFA, did not differ between the hemoadsorption and the control group (1.79 +/- 3.75 and 1.93 +/- 3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1 beta and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR â\u89¥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR â\u89¥ moderate compared with those with post-procedural AR â\u89¤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR â\u89¥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality