Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis
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Clinical endpoint
Valve replacement
EuroSCORE
Subgroup analysis
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Objectives: One of the most prominent scores for the evaluation of procedural risk in cardiac surgery is the EuroSCORE. The aim of our study was to analyze the predictive value of the EuroSCORE in „high risk“ patients undergoing isolated aortic valve replacement (AVR).
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Surgical aortic valve replacement (SAVR) is the current treatment of choice for good surgical candidates with moderate to severe symptomatic aortic stenosis (AS). As transcatheter aortic valvular replacement (TAVR) has shown an improved one and two-year all-cause mortality, it has been chosen for moderately symptomatic severe AS patients. The purpose of this review was to perform a clinical comparison of TAVR vs. SAVR and to analyze the Health Index Factor (HIF) that makes TAVR a treatment of choice in asymptomatic AS patients. An extensive literature search of PubMed, Cochrane, and Embase databases was performed using the keywords “Aortic stenosis”, “SAVR”, “TAVR”, and “Asymptomatic”. A total of 45 prospective randomized clinical trials in the English language that were published from the year 2000 onwards were included in the final analysis. It has been found that 59.3% of asymptomatic AS patients are likely to die in the next five years without proactive treatment. Multiple studies have proven that early intervention with aortic valve replacement is superior to conservative treatment in severe asymptomatic AS; however, the choice between SAVR and TAVR is not well established. The NOTION Trial, SURTAVI Trail, and PARTNER 3 study have shown the non-inferiority of TAVR over SAVR, during one-year follow-up for low surgical risk patients. Evolut Low-Risk study and Early TAVR are the only two prospective studies performed to date that have enrolled patients with asymptomatic severe AS. The Evolut Trial demonstrated no difference in all-cause mortality at 30 days (1.3% vs. 4.8%. p=0.23), and 12 days (1.3% vs. 6.5%, p=0.11). Additionally, TAVR also decreases the risk of post-procedural atrial fibrillation, acute kidney injury (AKI), and rehospitalization, and leads to significant improvement in the mean trans-aortic pressure gradient. TAVR also showed marked improvement in the 30-day Quality of Life (QOL) index, where SAVR did not report any significant change in the QOL index. However, the official recommendations of Early TAVR are still awaited. TAVR has consistently shown a statistically non-significant difference in case mortality, risk of stroke, and rehospitalization with moderate to high surgical risk patients whereby recent initial trials have shown significant improvement in the QOL index and hemodynamic index for patients with asymptomatic disease. More extensive studies are required to prove the risk stratifications, long-term outcomes, and clinical characteristics that would make TAVR a preferred intervention in asymptomatic patients.
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Background The hemodynamics of most prosthetic valves are often inferior to that of the normal native valve, and a significant proportion of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) have high residual transaortic pressure gradients due to prosthesis–patient mismatch (PPM). As the experience with TAVR has increased and long-term outcomes are reported, a close look at the PPM literature is required in light of new evidence. Methods For this review, we searched the Embase, Medline, and Cochrane databases from 2000 to 2022. Articles reporting PPM as an outcome following aortic valve replacements were identified and reviewed. Results The impact of PPM on clinical outcomes in aortic valve replacement has not been clear as multiple studies failed to report PPM incidence. However, the PPM outcomes after SAVR vary more widely than after TAVR, ranging from 8% to 80% in SAVR and from 24% to 35% in TAVR. Incidence of severe PPM following redo SAVR ranges from 2% to 9% and following valve-in-valve TAVR is from 14% to 33%, however, while PPM is higher in valve-in-valve TAVR, patients had better survival rates. Conclusions The gap between valve performance and clinical outcomes in SAVR and TAVR could be reduced by carefully selecting patients for either treatment option. Understanding predictors of PPM can add to the safety, effectiveness, and increased survival benefit of both SAVR and TAVR.
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EuroSCORE
Univariate analysis
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The aim of the study was to assess the predictive ability of risk calculators of the EuroSCORE II and the Society of Thoracic Surgeons (STS) score in patients undergoing aortic valve replacement (AVR) due to severe aortic valve stenosis (AS) during a 30-day and 1-year follow-up.A prospective study was conducted on a group of consecutive patients with hemodynamically significant aortic valve stenosis that underwent elective valve replacement surgery. The risk of surgery using EuroSCORE II and STS was calculated for each patient. The primary and secondary endpoints were 30-day and 1-year mortality.The study group included 428 consecutive patients who underwent replacement of the aortic valve. Thirteen patients died during the 30-day follow-up and 25 patients died during 1-year follow-up. Actual mortality in 30-day observation was 3.0% compared to the predicted 2.9% using EuroSCORE II and 2.1% for STS. The discriminations of ES II and STS score were above 0.8 for mortality prediction during the 30-day and 1-year observation period.The EuroSCORE II and STS score showed satisfactory discrimination and calibration for predicting 30-day and 1-year mortality in patients undergoing AVR.
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Cardiothoracic surgery
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Logistic EuroSCORE overestimates the risk profile of octogenarians undergoing aortic valve replacement by traditional surgery. EuroSCORE II, that was created in an attempt to improve this previous version, has been evaluated in the general population. However, to our knowledge, there are no studies evaluating the predictive performance of EuroSCORE II in the elderly population undergoing surgery for aortic valve replacement despite the fact that the majority of patients receiving transcatheter techniques are octogenarians and this new version is being used for the selection of high-risk surgical patients.
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Objectives:Evaluation of the risk for post-operative delirium (POD) after surgical or transfemoral aortic valve replacement (AVR) as an additional decision parameter for the choice of treatment in patients with an EuroScore (ES) between 10% and 20%.Background:POD is well known as a not infrequent side effect of cardiac surgery necessitating extracorporeal circulation. In Germany a tendency to treat patients with ES <20% with transfemoral AVR (TF) instead of surgical AVR (SAVR) was observed in 2013. The risk of POD may influence the decision of physician and patient as to which procedure would be appropriate in the individual case. Therefore we performed an analysis of the incidence of POD in patients with comparable risk treated either with surgical or transfemoral aortic valve replacement.Methods:Patients with elective or urgent need for AVR and EuroScore between 10% and 20% were extracted from the database of all isolated AVR procedures in Germany of 2013. As a result 3407 cases, 771 SAVR patients and 2636 TF patients with EuroScore 10–20%, were extracted from the complete data-base of the German quality insurance registry for heart surgery. Two homogeneous groups with regard to the risk predicted by ES were built by case–control matches and compared for available variables. In a second step two groups with identical risk/co-morbidity profile for 10 variables were identified and analyzed with respect to POD and in-hospital mortality.Results:A total of 763 pairs with EuroScore of 13.5% each could be determined. Mean age was 75.6 years (SAVR, 51.6% male) and 78.8 years (TF, 56.5% male). Incidence of POD with need for therapy (POD-T) was 12.8% after SAVR and 3.8% after TF, resulting in numbers needed to harm of 8 and 26 respectively. In-hospital death rate of patients with POD-T was 5.1% after SAVR and 3.3% after TF, and nearly identical compared with patients without POD-T. POD-T had a negative influence on the regular discharge procedure. Further matching resulted in two groups of 470 patients each with identical co-morbidities and an age difference of 1 year but POD-T rates of 14.5% (SAVR) and 4.9% (TF); in-hospital mortality was 6.2% (SAVR) and 2.3% (TF).Limitations:The dataset contains valid data only for the period of hospital stay until discharge. Therefore conclusions about the duration and reversibility of POD, which are important parameters of quality of life and resource consumption as well as midterm consequences, cannot be estimated. The documentation of the German Federal Council asks only for POD and POD-T, a predefined definition of POD is not given; this may have some influence on the data. We therefore confined the analysis to only POD-T. In addition only a limited number of co-morbidities are documented.Conclusion:In patients with intermediate risk according to EuroScore (10–20%) the risk of post-operative delirium and in-hospital mortality is significantly higher after surgical aortic valve replacement than after transfemoral procedure. This may be considered for patient guidance and the decision as to which procedure is able to achieve the best result including minimizing side effects.
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