Introduction
Aortic stenosis is a health condition characterized by the narrowing of the aortic valve, affecting the flow of blood from the heart to the rest of the body. If left untreated, this disorder can be fatal and trigger other complications like pain in the thoracic cavity, shortness of breath, and fainting (Kapadia & Krishnaswamy, 2021). Aortic stenosis is treated with transcatheter aortic valve replacement (TAVR), a minimally invasive surgery that involves replacing the defective valve with a prosthetic one.
Study Rationale
Nevertheless, TAVR may result in the embolization of debris, a condition which is commonly associated with strokes. Thus, to remove this debris and lower the risk of stroke after TAVR, cerebral embolic protection (CEP) devices are required (Kapadia & Krishnaswamy, 2021).
In that regard, the primary rationale of a study titled “Cerebral embolic protection during transcatheter aortic valve replacement” was to assess the incidence of stroke within 72 hours after TAVR or before discharge. A summary of the aforementioned study whereby CEP devices were used in TAVR procedures forms the basis of this paper.
Study Design and Methodology
This study was a randomized controlled trial conducted across multiple centers in Europe, Australia, and North America. The participants were randomized to receive TAVR with CEP (CEP cohort) or without CEP (placebo group) in a ratio of 1 to 1. (Kapadia et al., 2022). The incidence of a stroke within 72 hours after TAVR or prior to discharge was examined (Kapadia et al., 2022). The trial also evaluated severe or moderate vascular disorders, acute renal impairment, delirium, incapacitating stroke, mortality rates, transient ischemic attack, and delirium among patients. An expert in neurology assessed all of the patients both before and after TAVR to guarantee the accuracy, generalizability, and reliability of the results.
The use of such specialists made it easier to detect any potential neurological issues or adverse events that may have happened during or after the treatment. According to the study, the prevalence of stroke and other neurological complications was much lower when CEP devices were used during TAVR procedures. After 30 days of the trial, there were 4.1% strokes and related fatalities in the CEP group as opposed to 8.7% in the placebo cohort (Kapadia et al., 2022). From these deductions, the study concluded that the use of CEP devices during TAVR procedures significantly lowers the risk of stroke and other neurological complications.
On the other hand, the randomized controlled trial design made it possible to compare the results between the CEP and control groups. These designs and methodology guaranteed that any differences between the two clusters were brought about by the intervention (CEP devices) rather than extraneous causes. Concomitantly, the study’s multi-centered design further facilitated the inclusion of a broad and representative sample of patients from different geographical topographies. The section below highlights some of the criteria used to select the study’s participants.
Patient Population
To guarantee that the findings applied to patients with severe aortic stenosis who were qualified for TAVR, the study enrolled participants from specific populations. All patients were rigorously screened for eligibility before other inclusion and exclusion criteria could be deployed. Firstly, all patients were required to have significant aortic stenosis, as shown by echocardiography.
Secondly, they had to be considered good candidates for TAVR by their health practitioners before being accepted into the trial. Patients who were deemed to be at high or moderate risk for SAVR or who met the Society of Thoracic Surgeons (STS) risk threshold of 4% or above were included (Kapadia et al., 2022). Nonetheless, those with a history of incapacitating stroke were not allowed to participate in the trial. The segment that follows summarizes the critical results obtained from the study.
Important Results
The study’s key objective was to investigate if the implementation of CEP during TAVR could decrease the occurrence of complications such as stroke. A total of 3000 patients were randomized in the study, with 1501 in the CEP group and 1499 in the control group (Kapadia et al., 2022). A CEP device was implanted in 94.4% of eligible patients (Kapadia et al., 2022). Results showed that stroke cases did not vary substantially between the control and CEP groups within 3 days of the TAVR program and after discharge.
The results were 2.3% vs. 2.9%; difference, −0.6 percentage points and 95% confidence interval, −1.7 to 0.5; P = 0.30 (Kapadia et al., 2022). Disabling stroke occurred in 0.5% of the patients in the CEP group and 1.3% of those in the control cohort (Kapadia et al., 2022). To obtain generalizable results, it was important to record the fatality associated with the intervention.
The proportion of patients who died was not substantially different between the CEP and placebo groups. The results showed (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%) (Kapadia et al., 2022). However, one patient (0.1%) had a vascular complication at the CEP access site (Kapadia et al., 2022). The section below presents some of the implications that were deduced based on the study results.
Implication for Clinical Practice
The outcomes of this research imply that the frequency of periprocedural stroke was negligibly influenced by the use of CEP during TAVR. The 95% confidence interval associated with this result, however, signifies that employing CEP during TAVR could continue to be effective. In light of this outcome, the patient’s use of CEP in TAVR should be determined individually depending on variables like procedural risk, related complications, and the practitioner’s competence.
Moreover, the CEP group demonstrated a notably lower occurrence of disabling stroke (0.5%) than the placebo cohort (1.3%) (Kapadia et al., 2022). However, there were no significant disparities between the two groups regarding patient mortality, stroke, transient ischemic attack, delirium, or acute kidney injury.
The results of the study do not undervalue the advantages of CEP application during TAVR, even though the latter did not have a significant impact on the prevalence of periprocedural stroke. Regarding its implications for clinical practice, this study suggests that the use of CEP during TAVR may not dramatically reduce the incidence of periprocedural stroke (Kapadia et al., 2022).
However, the study recorded some limitations, including a relatively short follow-up period of 72 hours and its focus solely on patients undergoing transfemoral TAVR (Kapadia et al., 2022). Therefore, future research should investigate the effects of CEP in other types of TAVR procedures and longer follow-up periods.
Conclusion
Whereas the trial did not identify a substantial change across the placebo and CEP cohorts in terms of the prevalence of stroke, the deployment of CEP was linked to a lower risk of a debilitating stroke. This data shows that if a stroke does occur, using CEP during TAVR may help to lessen its severity (Ciobanu et al., 2021). Additionally, the low frequency of CEP-related problems (only one patient experienced a vascular issue at the CEP access site) implies that using CEP during TAVR is safe and practical. The study’s key findings indicate that the choice to deploy CEP should be evaluated on a case-by-case basis. During such contexts, the practitioner’s competence and the patient’s specific medical history should be critically analyzed.
References
Ciobanu, A. O., Gherasim, L., & Vinereanu, D. (2021). Risk of stroke after transcatheter aortic valve implantation: epidemiology, mechanism, and management. American Journal of Therapeutics, 28(5), e560-e572.
Kapadia, S. R., & Krishnaswamy, A. (2021). Cerebral embolic protection in transcatheter aortic valve replacement: Connecting intuition and proof. Cardiovascular Interventions, 14(2), 169-171. Web.
Kapadia, S. R., Makkar, R., Leon, M., Abdel-Wahab, M., Waggoner, T., Massberg, S., & Linke, A. (2022). Cerebral embolic protection during transcatheter aortic valve replacement. New England Journal of Medicine, 387(14), 1253-1263. Web.