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This study features the longest experimental follow-up for decellularized heart valves implanted in an animal model. Porcine aortic heart valves were decellularized according to a disclosed standardized method in which TRITON X-100 and sodium cholate (TRICOL) are used in succession, followed by a further treatment with the endonuclease Benzonase to completely remove the nucleic acid remnants. Experimental animals (n = 17), represented by Vietnamese pigs (VPs), received a decellularized aortic allograft as a substitute for the replacement of their right ventricular outflow tract. The surgical implantation of the TRICOL-treated aortic valve conduit was successful in 11 VPs, while perioperative or postoperative complications occurred in the remaining six animals. In the sham-operated group (n = 4), the native pulmonary root was excised and immediately reimplanted orthotopically in the same animal. Echocardiography demonstrated a satisfactory hemodynamic performance of the TRICOL-treated valves during follow-up as well as the absence of relevant leaflet alterations concerning thickness and motility or valve insufficiency. At explantation, macroscopic inspection of tissue-engineered heart valve conduits did not evidence calcifications and showed a decreased wall thickness, comparable to that of the reimplanted native pulmonary roots. Noteworthy, extended functional performance, recovery of DNA content, and active extracellular matrix precursor incorporation are apparently compatible with the properties of a living self-supporting substitute.

We sought to examine the efficacy in preventing surgical site infection (SSI) in cardiac surgery, using two different incise drapes (not iodine-impregnated and iodine-impregnated). A cost analysis was also considered. Between January 2008 and March 2015, 5100 consecutive cardiac surgery patients, who underwent surgery in our Institute, were prospectively collected. A total of 3320 patients received a standard not iodine-impregnated steri-drape (group A), and 1780 patients received Ioban(®) 2 drape (group B). We investigated, by a propensity matched analysis, whether the use of standard incise drape or iodine-impregnated drape would impact upon SSI rate. Totally, 808 patients for each group were matched for the available risk factors. Overall incidence of SSI was significantly higher in group A (6.5 versus 1.9 %) (p = 0.001). Superficial SSI incidence was significantly higher in group A (5.1 vs 1.6 %) (p = 0.002). Deep SSI resulted higher in group A (1.4 %) than in group B (0.4 %), although not significantly (p = 0.11). Consequently, the need for vacuum-assisted closure (VAC) therapy use resulted 4.3 % in group A versus 1.2 % in group B (p = 0.001). Overall costs for groups A and B were 12.494.912 € and 11.721.417 €, respectively. The Ioban(®) 2 offered totally 773.495 € cost savings compared to standard steri-drape. Ioban 2 drape assured a significantly lower incidence of SSI. Additionally, Ioban(®) 2 drape proved to be cost-effective in cardiac surgery.

Background: Although studies demonstrate its feasibility, there is ongoing debate on the short and longterm outcomes of MitraClip versus surgical repair or mitral valve replacement (MVR). The objective of this meta-analysis is to compare the safety, morbidity, mortality and long-term function following MitraClip compared to MVR. Methods: Articles were searched in PubMed and Cochrane databases for studies comparing outcomes of MitraClip and surgery on December 1, 2019. Eligible prospective, retrospective, randomized and nonrandomized studies were reviewed. Results: A total of nine studies (n=1,873, MitraClip =533, MVR =644) were eligible for review. At baseline, MitraClip patients had more comorbidities than MVR patients, including myocardial infarction (P<0.001), chronic obstructive pulmonary disease (P=0.022) and chronic kidney disease (P<0.001). MitraClip was associated with shorter length of stay (-3.86 days; 95% CI,-4.73 to-2.99; P<0.01) with a similar safety profile. Residual moderate-to-severe mitral regurgitation was more frequent in MitraClip at discharge (OR, 2.81; 95% CI, 1.39-5.69; P<0.01) and at five years (OR, 2.46; 95% CI, 1.54-3.94; P<0.01), and there was a higher need for reoperation on the MitraClip group at latest follow-up (OR, 5.28; 95% CI, 3.43-8.11; P<0.01). The overall mortality was comparable between the two groups (HR, 2.06; 95% CI, 0.98-4.29; P=0.06) for a mean follow-up of 4.8 years. Conclusions: Compared to surgery, MitraClip demonstrates a similar safety profile and shorter length of stay in high-risk patients, at the expense of increased residual mitral regurgitation and higher reoperation rate. Despite this, long term mortality appears comparable between the two techniques, suggesting that a patient-tailored approach will lead to optimal results.

BackgroundSeveral studies suggest beneficial effects of perioperative statin therapy on postoperative outcome after cardiac surgery. However, recent randomized controlled trials (RCTs) show potential detrimental effects. The objective of this systematic review is to examine the association between perioperative statin therapy and clinical outcomes in cardiac surgery patients.MethodsElectronic databases were searched up to 1 November 2016 for RCTs of preoperative statin therapy versus placebo or no treatment in adult cardiac surgery. Postoperative outcomes were acute kidney injury, atrial fibrillation, myocardial infarction, stroke, infections, and mortality. We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using fixed-effects meta-analyses. Primary analysis was restricted to trials with low risk of bias according to Cochrane methodology, and sensitivity analyses examined whether the risk of bias of included studies was associated with different results. We performed trial sequential analysis (TSA) to test the strength of the results.ResultsWe included data from 23 RCTs involving 5102 patients. Meta-analysis of trials with low risk of bias showed that statin therapy was associated with an increase in acute kidney injury (314 of 1318 (23.82%) with statins versus 262 of 1319 (19.86%) with placebo; OR 1.26 (95%CI 1.05 to 1.52); p = 0.01); these results were supported by TSA. No difference in postoperative atrial fibrillation, myocardial infarction, stroke, infections, or mortality was present. On sensitivity analysis, statin therapy was associated with a slight increase in hospital mortality. Meta-analysis including also trials with high or unclear risk of bias showed no beneficial effects of statin therapy on any postoperative outcomes.ConclusionsThere is no evidence that statin therapy in the days prior to cardiac surgery is beneficial for patients’ outcomes. Particularly, statins are not protective against postoperative atrial fibrillation, myocardial infarction, stroke, or infections. Statins are associated with a possible increased risk of acute kidney injury and a detrimental effect on hospital survival could not be excluded. Future RCTs should further evaluate the safety profile of this therapy in relation to patients’ outcomes and assess the more appropriate time point for discontinuation of statins before cardiac surgery.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-016-1560-6) contains supplementary material, which is available to authorized users.

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During the last ten years, transcatheter procedures in native valves have become a standard technique in several centers with excellent procedural and mid-term results. Similarly, implantation of transcatheter stent-valves within degenerated aortic and mitral bioprosthesis, the 'valve-in-valve' procedure (V-in-V), represents a valid alternative to redo surgery in patients with high-risk surgical profiles. New challenges for V-in-V are the transcatheter stent-valve deployment in hostile targets (stented bioprosthesis with externally mounted leaflets, stentless valves, small bioprostheses), and avoid complications as delayed atrial embolization of mitral implantation and V-in-V thrombosis. Moreover a continuous ameliorated design of the devices on the market and new transcatheter stent-valves are recently developed in order to improve the outcome and safety of V-in-V treatment. Expert commentary: We reviewed the clinical outcomes and the procedural details of published transcatheter aortic and mitral valve-in-valve series focusing, in particular, on data from the Valve-in-Valve International Data registry (VIVID), and we provide a practical guide for valve sizing and stent-valve positioning.

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