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Art and Science of Cerebrovascular Event Prevention After Transcatheter Aortic Valve Replacement

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Abstract

Abstract

Groundwork: The long-term incidence of stroke and the proportion of cardioembolic events afterward bioprosthetic surgical aortic valve replacement (SAVR) remain largely unknown.

Methods: The CAREAVR report sought to assess the rate of stroke and transient ischemic assault (TIA) in patients who underwent isolated surgical aortic valve replacement with a bioprosthesis at iv Finnish university hospitals between 2002 and 2014. Data was collected retrospectively and included 721 patients. Median follow-up time was 4.eight [3.0–7.0] years.

Results: At 5 years, freedom from stroke was 89.0%, from TIA 94.1%, and from stroke and TIA 83.7%. The median time between index process and stroke or TIA was one.7 years [29 days–iii.9 years]. Stroke was of cardioembolic origin in 44.4% of patients. In multivariable competing risk assay, increased age (Hour 1.03, 95%CI 1.00–1.06, p = 0.022), previous stroke or TIA (HR one.75, 95%CI 1.14–2.seventy, p = 0.010), New York Centre Association (NYHA) form III or more than (HR 1.51, 95%CI one.01–2.24, p = 0.044) and insulin treatment at belch (60 minutes 1.20, 95%CI 1.09–3.64, p = 0.024) were independent predictors of stroke or TIA. Cerebrovascular events occurred in 47.2% of patients with ongoing anticoagulation therapy.

Decision: In this report, the incidence of stroke in the early postoperative period after bioprosthetic SAVR was higher than previously documented. Most half of strokes were of cardioembolic etiology. These findings highlight the demand for the better prevention strategies for cardioembolic events after bioprosthetic SAVR.

Introduction

Stroke and transient ischemic attack (TIA) are frequent complications subsequently surgical aortic valve replacement (SAVR) with a bioprosthesis. 1 The adverse events increase bloodshed and disability, prolong hospitalization with incremental costs. In previous registry-based studies, the incidence of stroke varied between 1.4% and two.four% of patients during the in-infirmary stay and between 6.1% and 13.8% during long-term follow-upwardly. 1–7 Contempo randomized studies, however, have suggested that in intermediate-risk patients the occurrence of stroke and TIA can already be equally high equally 6.v% within 30 days after surgery and ix.7% at 12 months. 8 This discrepancy may derive from register-based analyses, which are prone to an underestimation of the complication rates. Moreover, no information exists on the classification of subtypes and etiology of acute ischemic strokes in patients undergoing bioprosthetic SAVR. Thus, at that place is an unmet clinical need for more authentic long-term assessment of cerebrovascular events as well as a demand to allocate these events co-ordinate to their etiology. This information might be useful when designing and testing approaches aimed at reducing the hazard of cerebrovascular events, for assessing risks and benefits of treatment options every bit well as for patient counseling in patients undergoing surgical or transcatheter aortic valve replacement.

In this observational, multicenter study nosotros sought to evaluate the short- and long-term occurrence, nature and predictors of stroke and TIA later isolated bioprosthetic SAVR.

Material and methods

Data drove

The CAREAVR (Consortium of Studies in the Field of Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Valve Replacement) is a Finnish multicenter retrospective written report (ClinicalTrials.gov Identifier: NCT02626871) assessing the rate of atrial fibrillation, thromboembolic complications, and bleeding events in patients undergoing isolated bioprosthetic SAVR. The data is collected every bit part of a broader ongoing protocol in Finland to evaluate the thromboembolic and haemorrhage complications of atrial fibrillation management in patients undergoing cardiac procedures. nine–11

Patient data was retrieved from cardiac surgery units of four Finnish university hospitals (Helsinki, Turku, Oulu, and Kuopio) over the period of 2002–2014 (in Helsinki 2006–2014). Infirmary records were reviewed for patients who underwent isolated bioprosthetic SAVR. Patients who underwent any other major concomitant cardiac surgery process were excluded from this written report. In order to obtain accurate follow-up data, only patients from the hospitals' catchment areas were included. All the major adverse events including cerebrovascular events, bleeding and myocardial infarctions were treated in the same alphabetize hospitals, and therefore, the patient follow-up for adverse events can exist considered reliable. Patient records were individually reviewed with a standardized structured information drove protocol for pre- and perioperative information, belch data, and long-term follow-up events, including postoperative atrial fibrillation, stroke, TIA, bleeding events, and mortality. The endpoints of this pre-specified substudy included the occurrence of TIA and stroke. The causes of expiry were derived from Statistics Republic of finland. This governmental function monitors the time and causes of death in the whole of Finland. Therefore, each example was carefully monitored even if the person moved.

During the period under study, the routine anticoagulation practice was enoxaparin 40 mg given subcutaneously once a day starting in the evening of the mean solar day of the surgery and continuing until vitamin One thousand antagonist treatment (started on the showtime postoperative day) reached the therapeutic level (international normalized ratio [INR] ≥ 2.0).

An ischemic stroke was defined as a permanent focal neurological deficit adjudicated by a neurologist and confirmed via computed tomography or magnetic resonance imaging. TIA was defined as a transient (< 24 hours) focal neurological arrears adjudicated by a neurologist. If a stroke or TIA was clinically diagnosed during index hospitalization by the treating physician and confirmed by computed tomography or magnetic resonance imaging, a split up adjudication by a neurologist was not required. Just ischemic strokes and TIAs considered definite past the treating neurologist or physician were included in the nowadays study. Subtypes of ischemic strokes were categorized past treating physicians using the Trial of Org 10172 in Acute Stroke Handling (TOAST) classification system. 12 Lacunar stroke was divers every bit an infarct < twenty mm in diameter. Diabetes, dyslipidemia and hypertension were defined as a disease requiring medical treatment and chronic lung illness as a pulmonary illness requiring long-term use of bronchodilators or steroids. Peripheral arterial disease was divers equally one or more of the following: claudication, carotid artery illness of >fifty% diameter and previous or planned intervention on the abdominal aorta, limb arteries or carotids. Heavy alcohol consumption was defined every bit >fourteen doses a calendar week for women and >21 doses a week for men. Poor mobility was defined equally astringent damage of mobility secondary to musculoskeletal or neurological dysfunction. Urgent functioning was defined every bit an performance performed during the same in-infirmary stay, emergency functioning equally an functioning earlier the side by side working 24-hour interval and salvage procedure as an functioning where patients require cardiopulmonary resuscitation en road to the operating theatre or prior to the consecration of anesthesia.

An independent, certified third-party data monitor controlled the integrity of the information at each study site.

The study protocol was approved by the Medical Ethics Commission of the Infirmary Commune of Southwest Republic of finland and the ethics committee of the National Institute for Health and Welfare (Republic of finland). Because of the retrospective, observational nature of the report, informed consent was non required. The study conforms to the Declaration of Helsinki.

Statistical analysis

Statistical analyses were conducted with Stata version fourteen.0 statistical software (StataCorp LLC, College Station, TX, USA) and SPSS version 23.0 statistical software (SPSS, IBM SPSS Inc., Chicago, IL, USA). Continuous variables were reported as mean ± standard departure if commonly distributed, and as median [25th–75th percentiles] if they were skewed. The data were tested for normal distribution using Kolmogorov-Smirnov and Shapiro-Wilk tests. Categorical variables were described as counts and percentages. Pearson χ2, Fisher'southward exact exam, unpaired t-test, Isle of man-Whitney test and Cox regression were used for univariable analysis. Multivariable competing risk analysis was performed by including variables of relevance with a p < 0.10 in the univariable analysis. This method was called because postoperative death is a competing risk, i.e. an adverse event that modifies the hazard that stroke and/or TIA occur during follow-up. A p value < 0.05 was considered statistically significant. Multiple testing correction was not applied due to the explorative nature of the report.

Results

Incidence of stroke and TIA

A total of 721 patients underwent isolated bioprosthetic SAVR at the four participating hospitals during the report period. The median follow-upwards time was 4.8 [3.0–seven.0] years. Kaplan-Meier estimates of freedom from stroke at 30 days and at i, five and 10 years were 96.9%, 95.v%, 89.0%, and 77.3%, and from TIA 99.3%, 98.1%, 94.1%, and 92.8%, respectively. The median time between the performance and stroke or TIA was 1.vii years [29 days–3.ix years]. Freedom from stroke and TIA is presented in Effigy 1. At 30 days and at ane, 5 and 10 years, liberty from stroke and TIA were 95.9%, 93.2%, 83.7%, and 72.7%, respectively. When lacunar strokes were excluded, liberty from stroke at 30 days and at 1, five and 10 years were 97.i%, 96.ii%, 90.9%, and 82.4%, respectively. TOAST classification of subtypes of stroke after surgery is detailed in Table ane and the cumulative stroke incidence according to the TOAST classification is detailed in Effigy 2. Liberty from stroke in patients undergoing isolated SAVR with bioprosthesis is shown in Effigy iii.

Table one. Subtypes of astute ischemic stroke after surgical aortic valve replacement with a bioprosthesis according to the TOAST classification.

Figure 1. Freedom from stroke and TIA later surgical aortic valve replacement with a bioprosthesis. TIA, transient ischemic attack.

Effigy 2. Cumulative stroke incidence co-ordinate to TOAST classification of subtypes of stroke. TOAST, Trial of Org 10172 in acute stroke treatment.

Figure iii. Freedom from stroke after surgical aortic valve replacement with a bioprosthesis.

The baseline characteristics of patients with and without stroke or TIA are shown in Table two. Patients with stroke or TIA were significantly older and more than often had peripheral arterial disease, a history of heart failure and a previous marked limitation of physical activity due to eye failure. Patients with a stroke or TIA too more often had a prior stroke or TIA. Patients who suffered a stroke had a significantly lower prevalence of prior percutaneous coronary intervention. No differences in the pre- and postoperative laboratory values were detected. Preoperative and discharge drugs in patients with and without a stroke or TIA are detailed in Tabular array iii. No differences in the medical therapies were detected except that patients with stroke or TIA were significantly more likely to be on insulin treatment at discharge. Notably, 47.2% of patients with stroke or TIA were on anticoagulation therapy at the time of the neurological result (TIA 48.vi% and stroke 43.4%). Moreover, twoscore.nine% of patients with cardioembolic stroke after xc days were on anticoagulation handling at the fourth dimension of the event.

Table 2. Baseline characteristics and pre- and postoperative laboratory values in patients with or without stroke or TIA during follow-up.

Table three. Medication before surgery and at discharge in patients with or without stroke or TIA during follow-up.

Predictors of stroke and TIA

A multivariable competing take chances analysis identified the following variables as independent predictors of stroke or TIA: increased age (HR 1.03, 95%CI 1.00–1.06, p = 0.022), previous stroke or TIA (HR 1.75, 95%CI 1.14–2.70, p = 0.010), New York Heart Association (NYHA) grade III or more (Hour 1.51, 95%CI one.01–2.24, p = 0.044) and insulin treatment at belch (HR 1.20, 95%CI 1.09–three.64, p = 0.024). In multivariable competing take a chance analysis, increased historic period (HR 1.05, 95%CI 1.01–1.08, p = 0.005), history of center failure (HR two.22, 95%CI 1.37–3.59, p = 0.001), and insulin treatment at discharge (HR 2.56, 95%CI 1.27–5.19, p = 0.009) were contained predictors of stroke.

Word

Principal findings

The main findings in this study are: (i) the early event rate of stroke afterwards bioprosthetic SAVR was higher than previously reported; 1–vii (two) almost half of the strokes (44.iv%) were of cardioembolic etiology; (three) preoperative atrial fibrillation was not associated with a higher risk of stroke or TIA; (4) approximately half of the patients with cerebrovascular events (47.2%) were on anticoagulation therapy at the time of the event.

Clinical implications

This study has several clinical implications. This patient population is at high take chances for ischemic cerebrovascular events and factors predisposing to postoperative stroke and TIA should be better understood in social club to provide effective preventive strategies. In item cardioembolic strokes were more frequent in this study population compared to earlier reports in the full general population (Figure two, Table 1, xiii ), when evaluating the subtypes of stroke. It is likely that this is related to the prothrombotic country caused by the biological valve and surgery during the immediate postoperative menses, and possibly, by the occurrence of atrial fibrillation and leaflet thrombosis later. Such a loftier incidence of cardioembolic stroke suggests that some patients with bioprosthetic SAVR may demand permanent anticoagulation therapy to prevent atrial fibrillation-related strokes as well as emboli arising from the leaflets of the bioprosthesis. 14 Strikingly, less than half of patients with new stroke were on warfarin therapy despite having AF previously. This implicates underuse of oral anticoagulation in this patient population.

Take a chance factors of cerebrovascular events

This study implicates that the risk of stroke is higher in patients who carry traditional gamble factors for cerebrovascular events, and the risk is notably high in patients with a previous marked limitation of concrete activity due to center failure. Therefore, preventive strategies should be targeted in patients with multiple run a risk factors of stroke, with a special focus on patients with more severe symptoms of heart failure. Preventive measures include surgical closure of the left atrial bagginess or a combination of anticoagulant and antiplatelet medications. The efficacy of left atrial appendage closure in these patients is currently under investigation in the LAA-CLOSURE trial (NCT02321137), which is testing whether safe surgical closure of the left atrial appendage decreases strokes and cardiovascular mortality in patients undergoing SAVR.

Although the risk of stroke was highest in patients with traditional risk factors of cerebrovascular events, some differences require more than detailed word. Preoperative eye failure was a major predictor for college postoperative stroke incidence. This finding was not unexpected, since heart failure is a common crusade of ischemic stroke. 15,16 Cardiac function may, however, improve later on SAVR procedure, only the increased risk of stroke is nigh likely related to the permanent structural changes leading to increased thrombus formation. 17,eighteen

Surprisingly, preoperative atrial fibrillation was non associated with a college take chances of stroke or TIA—probably because of long-term anticoagulation afterward surgery. Still, well-nigh of the remaining traditional adventure factors of cerebrovascular events, such equally female gender, diabetes, hypertension, and vascular disease, had a non-significant trend towards a college chance of stroke. When compared to previously known correlates of stroke in atrial fibrillation patients, the gamble factors presented in this study were fairly like. In fact, all chance factors included in the CHA2DS2-VASc score were either significant in the nowadays report as well or had a non-significant trend toward higher stroke incidence. Therefore, the CHA2DSii-VASc score could be a useful tool, when estimating the hazard of postoperative stroke.

In improver, our data shows that approximately half of the patients with ischemic cerebrovascular events were anticoagulated at the time of the event. This might be due to poor command of anticoagulation or non-adherence to the medication or both. However, in club to clarify this finding, we need to conduct a more detailed analysis of these events.

Incidence charge per unit of cerebrovascular events

There was a articulate-cut deviation in the early event rates when compared to previous studies. i–7 The discrepancy was most axiomatic when compared to registry-based studies, i–iv followed by other observational studies 6 also as interventional studies. vii In a previous large registry-based study, the reported liberty from stroke in similar patients population was two.one% at 1 year and 7.3% at v years. 1 When compared to the present results, the event rates were notably higher in the present written report in the early post-operative menstruum (Effigy 2). This difference also remained in subpopulations of men, women, ejection fraction <50%, ejection fraction ≥50% and dissimilar age groups. ane

When it comes to reliability of endpoints, registry-based studies take multiple challenges. Incomplete information capture, heterogeneity between different systems and coding errors, may affect data quality. nineteen Even so, it is unlikely that these would explicate the lower incidence in other observational studies and interventional studies. Some other challenge relating to both observational and interventional studies is that symptoms related to cerebrovascular events are often perceived as unavoidable surgery-related factors rather than complications. Equally a consequence, the events may remain unreported.

In the present written report the estimated incidence of stroke at 5 years was xi.0%, giving an average incidence of ii.2% per year. As a comparing, the long-term stroke risk of atrial fibrillation is 4.1% per year without anticoagulation and approximately 1.5% per twelvemonth with anticoagulation. xx Thus the incidence of stroke is markedly college after bioprosthetic SAVR when compared to patients with atrial fibrillation on anticoagulation therapy.

Strengths and limitations

Methodologically, this study has several strengths. A validated, structured case report course was used at all study sites. As a quality command, a professional person third political party monitored the data. This patient population is from regional catchment areas where cerebrovascular events are treated exclusively at the participating centers. Moreover, to the authors' noesis, this is the first study assessing the cumulative stroke incidence according to subtypes of stroke later cardiac surgery.

The main limitation of this report is its retrospective nature. However, data are from electronic patient records and data on baseline, operative and outcomes are reported in particular at each of the participating hospitals. Second, diagnoses were made by treating physicians, which might have affected the sensitivity of registering the end points. On the other hand as a issue of the retrospective nature and physicians' diagnoses, there is a problem with false negative cerebrovascular events rather than false positives. This strengthens further the conclusion of the problem of underdiagnosing early cerebrovascular events in previous studies. In addition, the subtypes of stroke were classified by the treating physicians. The determination regarding the use of imaging methods in the etiological cess of stroke or TIA was at the discretion of the treating neurologist. Withal, especially in the case of cardioembolic stroke, the categorization is e'er an educated guess fabricated by the treating physician instead of an absolute medical finding. In practice this means that the treating neurologists used the imaging methods needed (e.one thousand. computer tomography, carotid ultrasound imaging, echocardiogram) to exclude large artery atherosclerosis, small vessel occlusion and other adamant etiologies and to evaluate the probability of cardioembolic etiology. Based on these findings, the treating neurologists classified the events as of cardioembolic or other etiologies. Neurological events were defined as "Unknown TOAST" when not otherwise categorized by the treating neurologists. The minor size of this study is another limitation of this assay, and therefore, these findings should exist viewed as hypothesis generating.

Conclusion

The present results advise that the incidence of stroke in the early postoperative period later isolated bioprosthetic SAVR is higher than previously documented. More severe symptoms of center failure preoperatively were associated with a markedly increased risk of cerebrovascular events. About a half of the strokes were of cardioembolic origin. These findings highlight the need for amend prevention of cardioembolic events afterward SAVR.

Acknowledgments

The authors would like to thank study coordinator Tuija Vasankari (RN) for her input on data management and Tero Vahlberg (MSc) for statistical advice.

Disclosure statements

Joonas Lehto: enquiry grants from Orion Enquiry Foundation and the Finnish Foundation for Cardiovascular Research. Markus Malmberg: research grant from Clinical Research Fund (VTR) of Turku University Hospital, Turku, Finland. Juha Hartikainen: research grants from the Finnish Foundation for Cardiovascular Enquiry, Clinical Research Fund (VTR) of Kuopio Academy Infirmary, Kuopio, Finland; Lectures for; Cardiome AG, MSD and AstraZeneca. Member of the informational boards for Amgen, Pfizer, MSD, AstraZeneca, Bayer and BMS. Leo Ihlberg: Full-fourth dimension employee and stockholder for Boston Scientific (since September 2016), proctor for Edwards Lifesciences. Juhani Airaksinen: research grants from the Finnish Foundation for Cardiovascular Research, Clinical Research Fund (VTR) of Turku University Hospital, Turku, Finland; Lectures for Bayer, Cardiome AG and Boehringer Ingelheim, Member in the advisory boards for Bayer, Astra Zeneca, Bristol-Myers Squibb-Pfizer and Boston Scientific. Tuomo Nieminen: lectures for AstraZeneca, Boehringer Ingelheim, FCG Koulutus, GE Healthcare, Medtronic, Orion, Sanofi; enquiry grants from Abbvie, Medtronic, research fund of Helsinki and Uusimaa Infirmary District. Tuomas Kiviniemi: lectures for Bayer, Boehringer Ingelheim, Medicines Company, AstraZeneca and St. Jude Medical, Bristol-Myers Squibb-Pfizer, MSD; received inquiry grants from The Finnish Medical Foundation, Helsinki, Finland; the Finnish Foundation for Cardiovascular Research; Clinical Research Fund (VTR) of Turku University Hospital, Turku, Republic of finland, Finnish Cardiac Society, and an unrestricted grant from Bristol-Myers Squibb-Pfizer. Fellow member of advisory lath for Boehringer Ingelheim, MSD.

Additional data

Funding

This work was supported past the Land Clinical Enquiry Fund (VTR) of Turku University Hospital, Turku, Republic of finland; an unrestricted grant from Bristol-Myers Squibb-Pfizer; The Finnish Medical Foundation, Helsinki, Republic of finland; and the Finnish Foundation for Cardiovascular Research, Helsinki, Finland.

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Source: https://www.tandfonline.com/doi/full/10.1080/24748706.2017.1419327

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