Abstract
Aims
The present study aimed to evaluate the impact of prior cardiovascular events (CVE) on outcome in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
Patients with severe AS undergoing TAVR between May 2007 and March 2015 were included and categorized to patients with and without prior stroke, defined as embolic, hemorrhagic stroke and transit ischemic attack. Baseline, procedural characteristics, in-hospital outcomes, and 1-month and 1-year mortality were compared in accordance with the Valve Academic Research Consortium-2 consensus. A cohort of 662 consecutive patients with severe AS undergoing TAVR were included in the analysis. Of these, 120 patients had prior stroke, and 542 without. Transfemoral access was used in 78% (571), and pre-TAVR balloon aortic valvuloplasty was performed in 87% (574). Patients with prior stroke had a higher mean Society of Thoracic score compared to those without (10.1% versus 8.8%, respectively; p = 0.006) and higher rates of atherosclerotic disease involving the coronary, peripheral, and carotid arteries. Patients with prior stroke also had more occurrence of in-hospital minor stroke (3.3% versus 0.7%; p = 0.04). Nevertheless, similar mortality rates were recorded at 1, 6, and 12 months, and there were no significant differences in major stroke, bleeding, or post-procedure hospital stay between both groups.
Conclusion
Prior history of stroke infers a higher risk for in-hospital minor stroke, yet no impact on other outcomes post TAVR. Therefore, history of prior stroke should not be considered an exclusion criterion for TAVR in patients with severe AS.
1
Introduction
Patients undergoing stroke are prone to a subsequent cerebrovascular event and considered at high risk for any further intervention. Usually patients who experienced stroke are suffering from other co-morbidities and are at higher risk for a subsequent event. Stroke is a major complication of both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). In most TAVR trials, patients with a history of stroke were excluded . In the PARTNER trial , although a recent neurologic event was an exclusion criterion, the rates of cerebrovascular events (CVE) were almost double in the TAVR group in comparison to patients who underwent SAVR (3.8 versus 2.1, respectively). However, subsequent trials and registries indicate that the actual incidence of stroke has declined in the TAVR population due to the evolution and improvement of the TAVR technique and devices and patient selection. Patients with prior stroke may be at higher risk due to hemodynamic instability coagulation issues and impaired neurological reserve. A history of a prior stroke in patients undergoing SAVR has been identified as an independent risk factor for post-procedural stroke . However, there are scarce data regarding incidence of post-procedural stroke and mortality in patients with prior stroke undergoing TAVR. The present study aimed to evaluate the impact of prior CVE in patients undergoing TAVR in regard to in-hospital and early and late mortality outcomes.
2
Methods
The present study is an observational, prospective single-center study. The study populations included patients with severe aortic stenosis undergoing TAVR with and without a prior history of stroke, defined as previous stroke embolic or hemorrhagic or transient ischemic attack. All patients were evaluated by our multidisciplinary heart team to be at a high or prohibitive risk for SAVR. All consecutive patients with severe symptomatic aortic stenosis confirmed by transthoracic echocardiography and invasive hemodynamic evaluation who were treated with TAVR between May 2007 and March 2015 were included and categorized according to their history of prior stroke. All data were prospectively collected and stored in the internal Aortic Valve System database of the MedSatar Cardiovascular Research Network.
All patients had conscious sedation or general anesthesia administered by our cardiac anesthesiologists in our hybrid catheterization laboratory. Transapical access was performed by a thoracic surgeon, and transfemoral access was achieved via a percutaneous route. All patients received either a self-expandable device (valve sizes: 23, 26, 29, 31 mm) or a balloon-expandable device (valve sizes: 23, 26, 29 mm). Intraprocedural, prevalve balloon aortic valvuloplasty (BAV) was preformed for the majority of our balloon-expandable valve cases for the aim of testing the expansion capacity of the native annulus and preparing the annulus for implantation of the transcatheter heart valve. As opposed to the self-expanding valves, pre-BAV was usually performed only if the baseline cardiac computed tomography demonstrated a significant burden of native annular or leaflet calcification and/or fibrosis of the native aortic leaflets. The TAVR was implanted under the instruction for use for each valve.
Prespecified clinical, procedural, and laboratory data were prospectively collected for all patients during screening, on admission, immediately post-procedure, and during follow-up. This included demographic information, medical history, clinical data (baseline treatment, baseline electrocardiogram, echocardiographic indices), and laboratory indices. The Society of Thoracic Surgeons (STS) score was calculated for every patient. Procedural data collected in the database included type of anesthesia, device access, pre and post TAVR balloon, number of valves deployed, pacing and hypotension during the procedure, and type and size of valve. Immediate post-procedural complications and post-procedural data, including major and minor stroke, occurring during the index procedure were collected and assessed in accordance with the Valve Academic Research Consortium (VARC)-2 guidelines . The prior history of stroke was collected from the notes of the patient’s cardiologist and the information provided by the patient. All patients presenting a stroke after the procedure had a clinical evaluation by an experimented neurologist and a neuroimaging documentation (brain computer tomography or brain magnetic resonance imaging) was performed. Long-term follow-up was based upon the clinical trial requirements. Clinical events were adjudicated by an independent cardiologist who determined the nature of the event. The local institutional review board approved the data collection.
The primary end-point was all-cause mortality at 1 year of follow-up. In addition, secondary outcomes included a comparison of complications during the index hospitalization, such as acute kidney injury, major vascular complication, bleeding, stroke, atrial fibrillation, new pacemaker implantation, and mortality.
Continuous variables were expressed as mean ± standard deviation for normally distributed variables and compared using student’s t-test. Median and interquartile range for non-parametric variables were compared using the Mann–Whitney test. Categorical variables were expressed as numbers and percentages and compared using chi-square or Fisher’s exact test as appropriate. Uni- and multivariate Cox proportional hazard regression models were conducted to assess the independent effect of prior CVE on mortality at 1 year and were adjusted for hypertension, STS score, valve type, renal insufficiency, arrhythmia, and transapical access. The result was presented as hazard ratios with its 95% confidence intervals and respective p-value.
Statistical analysis was performed by using SAS version 9.2 (SAS Institute Inc., Cary, NC), and p < 0.05 was considered statistically significant.
2
Methods
The present study is an observational, prospective single-center study. The study populations included patients with severe aortic stenosis undergoing TAVR with and without a prior history of stroke, defined as previous stroke embolic or hemorrhagic or transient ischemic attack. All patients were evaluated by our multidisciplinary heart team to be at a high or prohibitive risk for SAVR. All consecutive patients with severe symptomatic aortic stenosis confirmed by transthoracic echocardiography and invasive hemodynamic evaluation who were treated with TAVR between May 2007 and March 2015 were included and categorized according to their history of prior stroke. All data were prospectively collected and stored in the internal Aortic Valve System database of the MedSatar Cardiovascular Research Network.
All patients had conscious sedation or general anesthesia administered by our cardiac anesthesiologists in our hybrid catheterization laboratory. Transapical access was performed by a thoracic surgeon, and transfemoral access was achieved via a percutaneous route. All patients received either a self-expandable device (valve sizes: 23, 26, 29, 31 mm) or a balloon-expandable device (valve sizes: 23, 26, 29 mm). Intraprocedural, prevalve balloon aortic valvuloplasty (BAV) was preformed for the majority of our balloon-expandable valve cases for the aim of testing the expansion capacity of the native annulus and preparing the annulus for implantation of the transcatheter heart valve. As opposed to the self-expanding valves, pre-BAV was usually performed only if the baseline cardiac computed tomography demonstrated a significant burden of native annular or leaflet calcification and/or fibrosis of the native aortic leaflets. The TAVR was implanted under the instruction for use for each valve.
Prespecified clinical, procedural, and laboratory data were prospectively collected for all patients during screening, on admission, immediately post-procedure, and during follow-up. This included demographic information, medical history, clinical data (baseline treatment, baseline electrocardiogram, echocardiographic indices), and laboratory indices. The Society of Thoracic Surgeons (STS) score was calculated for every patient. Procedural data collected in the database included type of anesthesia, device access, pre and post TAVR balloon, number of valves deployed, pacing and hypotension during the procedure, and type and size of valve. Immediate post-procedural complications and post-procedural data, including major and minor stroke, occurring during the index procedure were collected and assessed in accordance with the Valve Academic Research Consortium (VARC)-2 guidelines . The prior history of stroke was collected from the notes of the patient’s cardiologist and the information provided by the patient. All patients presenting a stroke after the procedure had a clinical evaluation by an experimented neurologist and a neuroimaging documentation (brain computer tomography or brain magnetic resonance imaging) was performed. Long-term follow-up was based upon the clinical trial requirements. Clinical events were adjudicated by an independent cardiologist who determined the nature of the event. The local institutional review board approved the data collection.
The primary end-point was all-cause mortality at 1 year of follow-up. In addition, secondary outcomes included a comparison of complications during the index hospitalization, such as acute kidney injury, major vascular complication, bleeding, stroke, atrial fibrillation, new pacemaker implantation, and mortality.
Continuous variables were expressed as mean ± standard deviation for normally distributed variables and compared using student’s t-test. Median and interquartile range for non-parametric variables were compared using the Mann–Whitney test. Categorical variables were expressed as numbers and percentages and compared using chi-square or Fisher’s exact test as appropriate. Uni- and multivariate Cox proportional hazard regression models were conducted to assess the independent effect of prior CVE on mortality at 1 year and were adjusted for hypertension, STS score, valve type, renal insufficiency, arrhythmia, and transapical access. The result was presented as hazard ratios with its 95% confidence intervals and respective p-value.
Statistical analysis was performed by using SAS version 9.2 (SAS Institute Inc., Cary, NC), and p < 0.05 was considered statistically significant.
3
Results
From May 2007 to March 2015, there were 662 consecutive patients undergoing TAVR that were included in the present study. The mean age was 83 ± 7.75 years, and 317 were males (48%). In this population, 120 patients had a prior history of stroke, defined as ischemic, and 543 patients did not. As detailed in Table 1 , patients with prior stroke had a higher surgical risk compared to the patient without prior stroke according to the STS score (10.1 ± 4.9 versus 8.8 ± 4.5, p = 0.006, respectively). In addition, patients with prior stroke had higher rates of renal insufficiency; history of coronary artery bypass grafting; and vascular disease of carotid, peripheral, or coronary arteries. Interestingly, prior BAV was more common in the group with prior stroke. However, cardiovascular risk factors, baseline atrial fibrillation, anticoagulation treatment, and antiplatelet treatment (baseline and discharge) were similar in both groups, with the exception of aspirin, which was more frequently used before the TAVR procedure in the group with prior stroke.
| No prior stroke (N = 542) | Prior stroke (N = 120) | p | |
|---|---|---|---|
| Age, years, SD | 83 ± 7.9 | 83.2 ± 7 | 0.82 |
| BMI, SD | 27.89 ± 7.5 | 26.2 ± 5 | 0.005 |
| LVEF, SD | 49.3 ± 18.3 | 43 ± 19.8 | 0.24 |
| NYHA class III or IV | 90% (475) | 85.7% (102) | 0.18 |
| Cardiovascular risk factor | |||
| Hypertension | 93.2% (506) | 95% (114) | 0.46 |
| Diabetes | 33.1% (179) | 34.2% (41) | 0.98 |
| Insulin dependent diabetes | 10.9% (59) | 10.8% (13) | 0.98 |
| Hyperlipidemia | 79.1% (427) | 84.9% (101) | 0.15 |
| Current or prior smoking | 33.6% (159) | 31.4% (33) | 0.66 |
| Past medical history | |||
| COPD | 36.4% (197) | 27.5% (33) | 0.06 |
| Renal insufficiency (GFR < 60/dialysis) | 43.8% (235) | 59% (69) | 0.003 |
| History of cancer | 26.2% (121) | 21.7% (20) | 0.36 |
| Carotid artery disease | 12.3% (56) | 67.8% (61) | < 0.001 |
| Peripheral vascular disease | 32.5% (171) | 42.9% (51) | 0.03 |
| History of CAD | 72.4% (323) | 83.8% (83) | 0.02 |
| Prior CABG | 31.7% (171) | 45% (54) | 0.005 |
| Prior PCI | 31.5% (169) | 26.9% (32) | 0.32 |
| Prior MI | 18.4% (97) | 20.2% (24) | 0.65 |
| Prior valve surgery | 4.9% (23) | 3.3% (3) | 0.78 |
| Prior BAV | 27.5% (135) | 37.8% (37) | 0.04 |
| Multiple prior BAV | 2.9% (13) | 12.8% (11) | < 0.001 |
| Baseline rhythm | |||
| History of atrial fibrillation/flutter | 43.2% (234) | 35.8% (43) | 0.14 |
| Pacemaker | 25.1% (94) | 22% (20) | 0.54 |
| Baseline ECG sinus rhythm | 61.7% (255) | 66.3% (55) | 0.44 |
| Baseline ECG atrial fibrillation | 19.7% (81) | 13.6% (11) | 0.2 |
| Baseline antiplatelet and anticoagulation treatment | |||
| Aspirin | 83.3% (229) | 94.5% (69) | 0.02 |
| Clopidogrel | 46.9% (84) | 58.2 (32) | 0.14 |
| Warfarin | 37.6% (65) | 32% (16) | 0.47 |
| Discharge antiplatelet and anticoagulation treatment | |||
| Aspirin | 95.1% (270) | 95.8% (69) | 1 |
| Clopidogrel | 91% (262) | 85.7% (60) | 0.19 |
| Warfarin | 34.2% (51) | 43.5% (20) | 0.25 |
| Porcelain aorta | 7.2% (39) | 8.3% (10) | 0.66 |
| Frailty | 43% (101) | 47.2% (25) | 0.57 |
| STS Score | |||
| STS Score > 8 | 52.2% (283) | 64.7% (77) | 0.013 |
| STS Score, SD | 8.8 ± 4.5 | 10.1 ± 4.9 | 0.006 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
