Several 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. Electronic 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. We 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. There 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.
20 June 2023 in Journal of the American Heart Association
Background: In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low‐flow, low‐gradient (C‐LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high‐gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low‐flow, low‐gradient (P‐LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real‐world patients with severe HG, C‐LFLG, and P‐LFLG aortic stenosis undergoing TAVI. Methods and Results: Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P‐LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16–1.56]; P <0.001) and C‐LFLG (19.8%; HR, 1.93 [95% CI, 1.64–2.26]; P <0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all‐cause death rate was 44.4% in HG, 52.1% in P‐LFLG (HR, 1.35 [95% CI, 1.23–1.48]; P <0.001), and 62.8% in C‐LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54–1.88]; P <0.001). Conclusions: Up to 5 years after TAVI, patients with P‐LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C‐LFLG aortic stenosis.
27 January 2019 in European Journal of Cardio-Thoracic Surgery
OBJECTIVES: The SwissTAVI Registry includes all consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and valve-in-valve (VinV) procedures for a failed bioprosthesis in Switzerland. We report the real world, all-comers, 30-day and 1-year outcomes of patients undergoing VinV and standard TAVI procedures. METHODS: Prospectively collected data from the 2 groups (VinV and standard TAVI patients) were retrospectively analysed. In an adjusted analysis, in-hospital and 1-year outcomes of VinV patients were compared with those of patients undergoing TAVI for native aortic valve disease in the same registry. A subanalysis of VinV procedures in stenotic or regurgitant bioprosthesis was also performed. RESULTS: Between February 2011 and December 2016, 4599 and 157 consecutive patients underwent TAVI in native aortic valves and VinV procedures in degenerate bioprosthesis, respectively. VinV patients were younger (78 ± 9.1 years vs 82.2 ± 6.3 years; P < 0.001) but at a higher risk for surgery (the logistic EuroSCORE: 28.48 ± 15.3% vs 18.2 ± 13.6%; P < 0.001; the Society of Thoracic Surgery (STS) score: 6.4 ± 5% vs 5.5 ± 4.3%; P = 0.008). Valve predilatation was less frequently performed during VinV procedures (22.9% vs 69.1%; P < 0.001), and the hospital stay was shorter after VinV procedure (8.46 ± 4.2 days vs 9.83 ± 6 days; P = 0.005). VinV patients showed higher predischarge transvalvular mean gradients (14.14 ± 7.9 mmHg vs 8.42 ± 5.0 mmHg; P < 0.001), smaller mean valve surface area (1.54 ± 0.7 cm2 vs 1.83 ± 0.5 cm2; P < 0.001) and a lower risk of moderate/severe paravalvular leak (1.3% vs 5%). Post-procedural kidney injury (1.3% vs 4.8%; P = 0.06) and new pacemakers for conduction abnormalities (3.3% vs 18.5%; P < 0.001) were higher after TAVI. All-cause mortality and cardiovascular mortality at 30 days were similar between the 2 groups (1.9% vs 3.8%; P = 0.242 and 1.9% vs 3.4%; P = 0.321), whereas after 1 year, all-cause mortality was lower for VinV patients (6.8% vs 13%; P = 0.035). The bioprosthetic valve size correlated inversely with postoperative gradients after VinV procedures. CONCLUSIONS: VinV aortic procedures showed favourable 30-day and 1-year clinical outcomes compared with TAVI procedures for the native aortic valve disease. Despite higher transvalvular mean gradients following VinV implants, this appears not to impact the early clinical outcomes.
1 August 2010 in European Journal of Cardio-Thoracic Surgery
We reviewed our surgery registry, to identify predictive risk factors for operative results, and to analyse the long-term survival outcome in octogenarians operated for primary isolated aortic valve replacement (AVR). A total of 124 consecutive octogenarians underwent open AVR from January 1990 to December 2005. Combined procedures and redo surgery were excluded. Selected variables were studied as risk factors for hospital mortality and early neurological events. A follow-up (FU; mean FU time: 77 months) was obtained (90% complete), and Kaplan-Meier plots were used to determine survival rates. The mean age was 82+/-2.2 (range: 80-90 years; 63% females). Of the group, four patients (3%) required urgent procedures, 10 (8%) had a previous myocardial infarction, six (5%) had a previous coronary angioplasty and stenting, 13 patients (10%) suffered from angina and 59 (48%) were in the New York Heart Association (NYHA) class III-IV. We identified 114 (92%) degenerative stenosis, six (5%) post-rheumatic stenosis and four (3%) active endocarditis. The predicted mortality calculated by logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 12.6+/-5.7%, and the observed hospital mortality was 5.6%. Causes of death included severe cardiac failure (four patients), multi-organ failure (two) and sepsis (one). Complications were transitory neurological events in three patients (2%), short-term haemodialysis in three (2%), atrial fibrillation in 60 (48%) and six patients were re-operated for bleeding. Atrio-ventricular block, myocardial infarction or permanent stroke was not detected. The age at surgery and the postoperative renal failure were predictors for hospital mortality (p value <0.05), whereas we did not find predictors for neurological events. The mean FU time was 77 months (6.5 years) and the mean age of surviving patients was 87+/-4 years (81-95 years). The actuarial survival estimates at 5 and 10 years were 88% and 50%, respectively. Our experience shows good short-term results after primary isolated standard AVR in patients more than 80 years of age. The FU suggests that aortic valve surgery in octogenarians guarantees satisfactory long-term survival rates and a good quality of life, free from cardiac re-operations. In the era of catheter-based aortic valve implantation, open-heart surgery for AVR remains the standard of care for healthy octogenarians.
1 July 2010 in Interactive CardioVascular and Thoracic Surgery
The transapical transcatheter aortic valve implantation (TA-TAVI) in degenerated aortic bioprosthesis is an emerging therapy for surgically non-amenable patients. However, the presence of different types of aortic bioprostheses (stented and stentless), available in different sizes (19–27 mm), can be at the origin of important mismatches between the malfunctioning, degenerated aortic valves and the inner stent-valves implanted through transapical accesses (23 and 26 mm Edwards Sapien™ transcatheter stent-valves). We report an emergency TA-TAVI treatment of a severely regurgitant degenerated 23 mm Mitroflow aortic bioprosthesis (Sorin Group, Milano, Italy) implanted seven years earlier in an 80-year-old lady, and we reviewed the current available literature about transapical ‘valve-in-valve’ procedures to analyze the hemodynamic results and the ideal ‘prosthesis-to-prosthesis’ match.
Redo surgery still is the treatment of choice for degenerated bioprosthesis. However, as far as elderly patients with concomitant comorbidities are concerned, the standard reoperation carries additional operative risks and, therefore, minimally invasive procedures must be prioritized. 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.