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Whether monitored anesthesia care is the optimal anesthetic strategy for transcatheter aortic valve implantation surgery? a meta-analysis and systematic review

BMC Anesthesiology volume 24, Article number: 429 (2024) Cite this article

Abstract

Objectives

To explore whether monitored anesthesia care is more beneficial to the outcome of transcatheter aortic valve implantation.

Methods

The research methodology involved comprehensive searches across major databases, including the Cochrane Library, PubMed, Scopus, and Web of Science, covering the period from January 1, 2010, to March 1, 2024. The aim was to identify trials comparing different anesthetic methods for transcatheter aortic valve implantation. The primary outcomes assessed were mortality and length of hospital stay, while secondary outcomes included common complications such as bleeding, stroke, paravalvular leakage, renal failure, and others. Data synthesis was conducted using risk ratios or standardized mean differences, along with 95% confidence intervals. The study protocol was prospectively registered with PROSPERO (CRD42024507749).

Results

A total of 35 trials and 45,616 patients were included in this study. The results showed that monitored anesthesia care significantly reduced the patient's risk of death, shortened the patient's length of hospital stay, and also reduced the risk of common complications such as paravalvular leakage (RR, 0.80; 95% CI: 0.72 to 0.88; p < 0.00001; I2 = 0) and stroke (RR, 0.80; 95% CI: 0.65 to 0.99; p = 0.04; I2 = 0).

Conclusion

Monitored anesthesia care has an absolute advantage in patient survival and effectively shortens the length of hospitalization. In addition, it also reduces the risk of complications such as paravalvular leakage and stroke. Monitoring care under anesthesia plays a vital role during TAVI surgery, not only helping to ensure the smooth progress of the surgery and patient safety, but also promoting the patient's recovery and recovery.

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Introduction

Aortic valve disease, a common degenerative condition, is becoming increasingly prevalent among the elderly population. Traditionally, patients with aortic stenosis (AS) were limited to surgical aortic valve replacement (SAVR), a procedure known for its invasiveness and significant postoperative complications. However, in 2002, Professor Cribier achieved a groundbreaking milestone by performing the world’s first transcatheter aortic valve implantation (TAVI) surgery, marking the beginning of a new era in the treatment of AS [1]. Compared to SAVR, TAVI is a less invasive procedure with a shorter recovery time, making it particularly suitable for elderly patients and those with comorbidities. Numerous studies have demonstrated that TAVI patients experience longer survival, lower all-cause mortality, and a reduced incidence of related complications compared to those undergoing SAVR [2, 3].

The anesthesia methods for TAVI primarily include general anesthesia, monitored anesthesia care, and local anesthesia. The choice of anesthesia often depends on factors such as the patient's condition, the surgeon's experience, and the overall capabilities of the anesthesia team. Currently, most TAVI procedures worldwide are performed under general anesthesia (GA). The main advantage of GA is its ability to provide comprehensive sedation and analgesia, ensuring patient comfort and minimizing intraoperative movement and the risk of choking. Additionally, GA allows for effective airway management, reducing the risks of respiratory depression, aspiration, and other complications, while also assisting clinicians in handling intraoperative emergencies. However, it is important to note that GA may prolong the patient's stay in the intensive care unit (ICU) and increase the overall hospitalization duration, and may also require higher doses of inotropic and vasoconstrictive medications [4, 5]. Local anesthesia (LA) for TAVI involves the direct application of anesthetic agents to the surgical site without the use of additional sedatives or analgesics. However, this method was primarily used in the early stages of TAVI and has largely been abandoned due to difficulties in adequately controlling pain, which can lead to patient agitation [6, 7].

In recent years, with advancements in anesthesia concepts and technology, the concept of "minimalism" has been introduced, promoting simple and rapid anesthesia methods while ensuring safety and comfort [8]. Monitored anesthesia care (MAC) is one such technique, where anesthesiologists administer analgesic or sedative drugs to patients under local anesthesia (LA) or those undergoing diagnostic or therapeutic procedures, while closely monitoring their vital signs. The implementation of MAC varies across institutions and countries, with LA often combined with different sedatives and analgesics to achieve the desired effect [9]. Over the past decade, numerous retrospective studies have attempted to compare the benefits of MAC in TAVI procedures. However, a clear consensus has yet to be reached, and the available evidence-based data remains incomplete. Therefore, this study aims to explore whether MAC could become the predominant anesthesia method for TAVI in the future.

Methods

The research was carried out following the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) statement [10]. Additionally, the protocol has been registered in the International Prospective Systematic Reviews Registry database under the registration number CRD42024507749.

Sources of data and search strategy

PubMed, Web of Science, Scopus, and the Cochrane Library were systematically searched from January 2010 to March 2024. The search terms used were as follows: [(Monitored anesthesia care) OR (Conscious Sedation)] AND (Anesthesia, General) AND (Transcatheter Aortic Valve Replacement) in the title/abstract. Additionally, citations from articles were retrieved to identify relevant studies that may not have been initially captured in the literature search. The detailed search strategy is provided in a Word document included in the supplementary materials.

Inclusion and exclusion criteria

The inclusion criteria were pre-specified following the PICOS approach. The inclusion criteria comprise: (1) The article is an original clinical study contrasting GA with non-GA; (2) The study population consists of individuals aged > 18 years who underwent TAVI, with baseline data and comorbidities not significantly special or high-risk; (3) It encompasses pertinent clinical outcomes essential for this investigation. The exclusion criteria are as follows: (1) Not clinical trial literature types such as reviews, letters, and conference abstracts; (2) Studies that do not compare GA with non-GA in TAVI; (3) Lack of required data or inability to transform data into a usable format. Following predetermined inclusion and exclusion criteria, two authors independently reviewed and selected studies. Any discrepancies were resolved through discussion with a third party.

Data collection and quality assessment

Two reviewers independently conducted data extraction. Any discrepancies were resolved through consensus or by consulting a third party. The extracted data included details such as the first author, year of publication, sample size, participant demographics (age, BMI, gender), types of anesthetic drugs used, surgical approach, comorbidities, and primary and secondary outcomes.

According to the "Randomized Trial Bias Risk Assessment Tool" outlined in the Cochrane Handbook, the quality of the included randomized controlled trials (RCTs) is evaluated across several domains. These include allocation concealment, randomization method, blinding procedures for investigators and participants, blinding of outcome assessors, selective reporting, completeness of data, and identification of other potential biases. The overall risk of bias assessment can result in categorizations of low, unclear, or high risk of bias [11].

For retrospective studies, quality assessment was conducted using the Newcastle–Ottawa Scale (NOS) by two independent reviewers. The assessment involved evaluating three aspects: selection bias, comparability, and exposure. Each aspect included specific evaluation criteria, with stars assigned accordingly. The maximum score for comparability is two stars.

Outcomes and definitions

The primary outcomes focused on patient mortality and the total length of hospital stay. We conducted analyses for in-hospital mortality, thirty-day mortality, and one-year mortality. The secondary outcomes are mainly common complications after TAVI. We analyzed the incidence of postoperative stroke, vascular complications, paravalvular leakage, pneumonia, cardiac arrest, etc.

Statistical analysis

All data were analyzed using Review Manager (RevMan) version 5.4 (The Cohrane Collaboration, Copenhagen, Denmark) and Stata SE 16.0 (Stata Corporation, College Station, TX, USA). For dichotomous data, risk ratios (RR) with 95% confidence intervals (CI) were calculated, while for continuous data, standard mean differences (SMD) with 95% CI were estimated. Both fixed and random effects models were employed to account for methodological and clinical heterogeneity. Heterogeneity among studies was assessed using the Q-test and I2 statistic, with significant heterogeneity defined as p < 0.1 or I2 > 50%. Subgroup and meta-regression analyses were conducted to explore potential sources of heterogeneity. Publication bias was assessed using funnel plots, with Egger's test employed when at least 10 studies were included. A significance level of α = 0.05 was set for all analyses. Sensitivity analysis was performed to evaluate the robustness of the results and to identify potential sources of heterogeneity.

Results

Literature selection

A total of 1393 literatures were retrieved from various databases. After removing 251 duplicate studies, 1094 studies were excluded during the preliminary screening. Subsequently, the full texts of 48 articles were retrieved for further evaluation, resulting in the inclusion of 35 trials in the final analysis. Among these, two articles were excluded as they were not original clinical studies, five articles were excluded due to the absence of a comparison between GA and non-GA, and six articles were excluded because they lacked relevant results or the data could not be converted into a usable format. The specific screening process is illustrated in Fig. 1. The 35 studies comprised 31 retrospective cohort studies [8, 12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41], 3 RCTs [42,43,44], and 1 case–control study [45].

Fig. 1
figure 1

Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flowchart of selection

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Included study characteristics and quality evaluation results

The included studies varied in sample size, ranging from 62 to 16,543 participants, totaling 45,616 patients. The average age of the patients was 81.5 years, and among them, 22,996 were women. The majority of surgical approaches utilized in the patients were transfemoral, with a smaller number involving subclavian, transaortic, and transapical approaches. The demographics and comorbidities of the included population are shown in Table 1 and Table 2.

Table 1 Basic information included in the studies
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Table 2 Prevalence of comorbidities in the patient population included in the study
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After conducting a thorough quality evaluation of the three RCTs, it was determined that one had a low risk of bias, while the remaining two were deemed to have an unclear risk of bias (Fig. 2). After assessing the quality of the remaining retrospective studies, we discovered that all studies scored above average on the NOS. Each study received a score exceeding five stars, meeting the criteria for inclusion in the meta-analysis. The conclusive findings are detailed in Table 3.

Fig. 2
figure 2

(A) Risk of bias summary: review authors' judgements about each risk of bias item for each included study; (B) Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Table 3 Results of NOS quality assessment
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Results of meta-analysis

TAVI performed under MAC offers a substantial advantage in patient survival. MAC is associated with lower rates of in-hospital death (Fig. 3A; RR, 0.65; 95% CI: 0.45 to 0.94; p = 0.02; I2 = 66%), thirty-day mortality (Fig. 3B; RR, 0.76; 95% CI: 0.64 to 0.90; p = 0.001; I2 = 0), and one-year mortality (Fig. 4A; RR, 0.89; 95% CI: 0.77 to 1.03; p = 0.12; I2 = 76%). The length of hospital stay in MAC is also shorter compared to that under GA (Fig. 4B; SMD, −0.58; 95% CI: −0.88 to −0.29; p = 0.0001; I2 = 99%).

Fig. 3
figure 3

The pooled effect of (A) In-hospital death. (B) Thirty-day mortality

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Fig. 4
figure 4

The pooled effect of (A) One-year mortality. (B) Length of hospital stay

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In addition, MAC reduces the patient's risk of postoperative stroke (Fig. 4A; RR, 0.80; 95% CI: 0.65 to 0.99; p = 0.04; I2 = 0), vascular complications (Fig. 4B; RR, 0.74; 95% CI: 0.59 to 0.94; p = 0.02; I2 = 71%), paravalvular leakage (Fig. 5A; RR, 0.80; 95% CI: 0.72 to 0.88; p < 0.00001; I2 = 0), pneumonia (Fig. 5D; RR, 0.44; 95% CI: 0.28 to 0.69; p = 0.0004; I2 = 0), and cardiac arrest (Fig. 5E; RR, 0.49; 95% CI: 0.36 to 0.68; p < 0.0001; I2 = 0). Patients in the MAC group also had a lower risk of secondary valve implantation (Fig. 5B; RR, 0.63; 95% CI: 0.50 to 0.79; p < 0.0001; I2 = 10%) and blood transfusion (Fig. 5C; RR, 0.55; 95% CI: 0.41 to 0.74; p < 0.0001; I2 = 75%) (Fig. 6). MAC may reduce the risk of postoperative bleeding and renal failure, although this result was not statistically significant. The relevant results are shown in Table 4.

Fig. 5
figure 5

The pooled effect of (A) Postoperative stroke. (B) Postoperative vascular complications

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Fig. 6
figure 6

The pooled effect of (A) Postoperative paravalvular leak. (B) Secondary valve implantation. (C) Blood transfusion during the process. (D) Postoperative pneumonia. (E) Postoperative cardiac arrest

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Table 4 Other outcomes and statistical results
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Subgroup analysis

We performed subgroup analyses according to various study types to assess thirty-day mortality and length of hospital stay. The findings revealed no significant disparity in thirty-day mortality outcomes pre- and post-grouping, with no evident heterogeneity observed among the groups (refer to Figure S6). However, the subgroup analysis on length of hospital stay indicated that diverse study types may contribute to the observed heterogeneity (refer to Fig. 7).

Fig. 7
figure 7

Subgroup analysis of length of hospital stay based on different study types

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Meta-regression

In the random-effect multivariate meta-regression analysis of in-hospital death, variables such as age, female were considered. The results show that age and female are not the main sources of heterogeneity for in-hospital death. In the random-effects multivariable meta-regression analysis of postoperative vascular complications, variables such as age, female gender, percutaneous coronary intervention and coronary-artery-bypass-grafting history were considered, and the above factors were not found to be the main source of heterogeneity.

Publication bias and sensitivity analysis

The funnel plots of all results did not show significant publication bias. We also performed Egger's test and Begg's test, and the results also showed that there was no publication bias for all outcomes. Outcomes with fewer than 10 included studies were not investigated for publication bias. All funnel plots and test results can be viewed in the supplementary material. The results of the sensitivity analysis indicate that our results are robust (can be seen in the supplementary material).

Discussion

The fundamental anesthesia requirements for TAVI include ensuring that the patient remains immobile, avoids coughing, maintains a clear airway, and sustains stable circulation throughout the procedure. Achieving comprehensive analgesia and applying appropriate levels of sedation are crucial during the initial phase of surgical site access. During key steps such as guidewire insertion, balloon expansion, rapid pacing, and valve deployment, it is essential to maintain patient immobility and prevent coughing to reduce the risk of complications [46]. In recent years, transesophageal echocardiography (TEE) has become a rapid and essential imaging modality for evaluating the cardiovascular system during TAVI. TEE plays a critical role in guiding valve selection and positioning and is equally vital for postoperative assessment and complication monitoring. However, the insertion of a TEE probe is an invasive procedure that carries risks, including aspiration and circulatory fluctuations [47].

Our research findings demonstrate significant advantages of MAC compared to GA. Correlation analysis of patient survival revealed a lower risk associated with the MAC group across various metrics, including short-term in-hospital death, thirty-day mortality, and long-term one-year mortality. However, the limitation of follow-up time resulted in insufficient inclusion of one-year mortality studies, rendering the results statistically non-significant. Nonetheless, they still indicate relevant trends. Simultaneously, the length of hospital stay in the MAC group was notably shorter compared to the GA group, indicative of a swifter recovery period. Despite considerable heterogeneity in this outcome, we attribute it to clinical variations stemming from diverse care practices and medical standards across different regions. Importantly, we maintain that this variability does not undermine the reliability of our findings. In addition, subgroup analysis showed that different study types are also a potential source of heterogeneity. After excluding the in-hospital death outcomes from Ara et al. [13].'s study, the I2 statistic decreased to 17%.

sFurthermore, the MAC group exhibited reduced risks of stroke, vascular complications, paravalvular leakage, pneumonia, cardiac arrest, transfusion, and secondary valve implantation compared to the GA group. We attribute the heterogeneity in vascular complications primarily to variations in the definitions used across studies conducted in different regions. Additionally, differences in grading standards for vascular complications contribute to clinical heterogeneity. Following the exclusion of Herrmann et al. [23] 2021 study, the I2 for this outcome decreased to 48%. We suspect that the variability in transfusion outcomes stems from differences in the transfusion components utilized across studies. Some investigations involve the transfusion of whole blood, while others focus solely on platelets or red blood cells, resulting in discrepancies. Unfortunately, due to limitations in the available data, we were unable to perform subgroup analyses to delve deeper into this matter. Lastly, our study also indicated that the risk of bleeding and renal failure in the MAC group was lower compared to the GA group. While this finding didn't reach statistical significance, it still highlights a discernible difference. However, no significant disparities were observed between groups concerning renal insufficiency, myocardial infarction, and pacemaker implantation. Since TAVI surgery requires strict prevention of intraoperative body movements, MAC may have the problem of insufficient analgesia compared with GA. Therefore, before the study, we believed that the risk of paravalvular leakage and secondary valve implantation in the MAC group was higher. It could be higher, but it turns out our considerations were redundant.

The finding that patients who received MAC had shorter hospital stays may be directly related to the use of MAC. This could be because MAC reduces postoperative recovery time and eliminates the need for mechanical ventilation associated with general anesthesia. Additionally, the observed lower in-hospital mortality, 30-day mortality, and 1-year mortality rates may be linked to MAC, as it reduces the incidence of complications related to general anesthesia, such as pneumonia and cardiac arrest, which often contribute to higher mortality rates. While MAC is also associated with a reduced incidence of stroke, vascular complications, and paravalvular leak, these results may be coincidental rather than directly attributable to the anesthesia method. The occurrence of these complications is typically influenced by the surgical procedure, the patient's underlying medical conditions, and other factors, rather than being a direct consequence of the anesthesia approach. Therefore, it is recommended to interpret these results with caution, and further research is necessary to confirm these findings.

Currently, there's a growing trend towards standardized perioperative management. This involves optimizing every step of patient care, from preoperative to perioperative and postoperative phases. The emphasis is on minimizing the use of general anesthesia, streamlining procedure times, promoting early discharge, and ultimately cutting down medical expenses [48]. In this scenario, the advantages of MAC are increasingly emphasized and gaining popularity. However, with the rising number of TAVI procedures, the adoption of MAC necessitates certain fundamental prerequisites. Firstly, thorough consideration should be given to assessing patient characteristics and providing preoperative education. Additionally, an anesthesia team and skilled nursing staff capable of monitoring anesthesia effectively are essential, alongside an imaging team proficient in post-TAVI evaluation. Thus, the implementation of the new MAC protocol demands a dedicated multidisciplinary core team committed to enhancing procedural care and outcomes [49].

This study still presents several limitations. Firstly, the majority of the included studies are retrospective cohort studies, with a scarcity of RCTs in this field. Consequently, it is challenging for this study to attain the highest level of evidence. Secondly, despite our meticulous selection process, the potential for data duplication remains due to overlapping patient samples. Thirdly, the analysis of long-term survival outcomes is hindered by the inherent difficulty in conducting extended follow-up assessments. However, the above limitations do not mean that our results are unreliable, because we adopted strict inclusion and exclusion criteria and had a logical statistical method. However, multicenter large-scale RCTs are still needed to further explore the applicability of MAC in different populations and promote the application of MAC in TAVI.

Conclusion

MAC significantly reduces the risk of in-hospital death and thirty-day mortality after TAVI, and significantly shortens the patient's length of hospital stay. In addition, the risk of secondary valve implantation, blood transfusion, postoperative stroke, vascular complications, paravalvular leakage, pneumonia, and cardiac arrest in the MAC group was also lower than that in the GA group. The risk of one-year mortality, bleeding and renal failure may also be lower in MAC than in the GA group. MAC plays an indispensable role in TAVI surgery. Through comprehensive nursing measures, we ensure that patients obtain the best therapeutic effect during the operation and minimize the occurrence of complications.

Data availability

All data generated or analysed during this study are included in this published article [and its supplementary information files].

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  1. Lili Xie and Zekun Lang these authors contributed equally to this work.

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  1. Department of Anesthesia and Surgery, First Hospital of Lanzhou University, Lanzhou, 730000, Gansu, China

    Lili Xie, Ying Liu, Haihong Yue, Qiaoli Chen & Guiyan Tao

  2. The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, Gansu, China

    Zekun Lang

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Contributions

Lili Xie and Guiyan Tao designed the study, Zekun Lang was responsible for the main statistical analysis, Lili Xie and Ying Liu were responsible for most of the manuscript writing, Haihong Yue and Qiaoli Chen were respectively responsible for part of the manuscript writing, data extraction and literature screening.

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Xie, L., Lang, Z., Liu, Y. et al. Whether monitored anesthesia care is the optimal anesthetic strategy for transcatheter aortic valve implantation surgery? a meta-analysis and systematic review. BMC Anesthesiol 24, 429 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12871-024-02834-w

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BMC Anesthesiology

ISSN: 1471-2253

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