Transcatheter Versus Surgical Aortic-Valve Replacement Increases Risk of Subsequent Stroke

Be careful out there. Ask your doctor for interventions that reduce that 20% increase to nothing.
http://dgnews.docguide.com/transcatheter-versus-surgical-aortic-valve-replacement-increases-risk-subsequent-stroke?

By Brian Hoyle
SAN DIEGO, California -- October 18, 2017 -- In the year following transcatheter aortic valve replacement (TAVR), patients experience an approximate 20% increased risk of ischaemic stroke and an over 6-fold increased risk of haemorrhagic stroke compared with patients who underwent surgical aortic-valve replacement (SAVR), according to results of a large, nationwide study presented at the 142nd Annual Meeting of the American Neurological Association (ANA).
The risk of 1-year events was similar for patients undergoing a coronary-artery bypass graft (CABG) procedure versus percutaneous coronary intervention (PCI).
“Patient selection may impact this risk,” explained author Laura Stein, MD, Icahn School of Medicine at Mount Sinai, New York, New York, at a poster presentation here on October 15.
The risk of stroke following cardiac procedures is reported to be about 9%; however, this figure is based on a small number of patients, local rather than national scope, limited types of cardiac procedures, and a focus on the perioperative period and long-term periods following surgery.
Dr. Stein and colleagues sought to get a clearer picture of patients’ intermediate risk using data from the 2013 Nationwide Readmission Database (NRD). The NRD contains readmissions data for over 14 million insured and uninsured Americans. The team scrutinised the data standard codes for cardiac procedures, and then analysed relevant data to determine the risk of stroke for up to 1 year following TAVR vs SAVR, and CABG vs PCI.
The NRD data included 2,819,649 patients nationwide who had undergone medical procedure; of these, 653,216 underwent a cardiac procedure, 1,198,209 a non-cardiac procedure, and 968,224 some other medical procedure. The groups were similar in age, prevalence of obesity, and length of hospital stay following surgery.
Dr. Stein and colleagues observed that, compared with their non-cardiac counterparts, patients receiving a cardiac procedure were more likely to present with atrial fibrillation or flutter, to have carotid-artery disease, coagulation disorder, congestive heart failure, coronary-artery disease, and peripheral-artery disease. Those receiving a cardiac procedure also had a higher prevalence of diabetes, hypertension, hyperlipidaemia, and renal failure.
The cumulative risk of ischaemic and haemorrhagic stroke was greater after TAVR compared with SAVR in the unadjusted data as well as following adjustment for baseline vascular risk factors, hospital bed size, teaching-hospital status, income, risk of mortality / severity of illness, and the residence of each subject (urban or rural nationwide).
The fully adjusted data revealed a hazard ratio (HR) for ischaemic stroke after TAVR, compared with SAVR, of 1.86 (95% confidence interval [CI]: 1.12 to 3.08) (P = .016). The HR for haemorrhagic stroke comparing the same procedures was 6.17 (95% CI: 1.97 to 19.33) (P = .0018). There was no statistically significant difference in the risk of stroke when CABG was compared with PCI, with a similar 1-year risk of ischaemic stroke. The risk of haemorrhagic stroke was similar for CABG and PCI throughout the 1-year follow-up.
The reasons for the increased risk associated with TAVR remain unknown, the authors concluded, but need to be understood if interventions are to be developed.
Dr. Stein and colleagues suggested that patients might benefit from the development of a risk index calculator that would better define the risk of stroke following cardiac and non-cardiac surgeries.
[Presentation title: Intermediate Risk of Stroke Following Cardiac Procedures in a Nationally Representative Dataset. Abstract S162]

More Bad News for Embolic Protection Devices Randomized trial shows little benefit for filtration or suction

If you need this, you will have lots of questions for your doctor to answer.
https://www.medpagetoday.com/Cardiology/Strokes/67168?

• by Nicole Lou, Contributing Writer, MedPage Today August 09, 2017
• This article is a collaboration between MedPage Today® and:
  

Cerebral embolic protection devices do nothing to cut down on ischemic strokes after surgical aortic valve replacement (SAVR), a randomized trial suggested.
Freedom from clinical or radiographic central nervous system (CNS) infarction stood at 32.0% at the 7-day mark after surgery with suction-based extraction using CardioGard, versus 33.3% for protection-less control (P=0.84), reported Annetine C. Gelijns, PhD, of New York's Icahn School of Medicine at Mount Sinai, and collaborators of the Cardiothoracic Surgical Trials Network, online in the Journal of the American Medical Association.
The Embol-X system for intra-aortic filtration also failed to deliver significant protection, with infarct freedom rate of 25.6% versus 32.4% for control (P=0.22).
Patients also gained no clinical advantage with respect to combined mortality, clinical ischemic stroke, and acute kidney injury within 30 days of surgery, no matter if they got a suction device (21.4% versus 24.2% for control) or a filter protector (33.3% versus 23.7%),
Preliminary results from the study were previously reported at this year's American College of Cardiology meeting.
No differences in the individual endpoints of mortality or clinical stroke were observed between device groups and control. Nor was there a benefit relative to control for quality of life at 90 days.
"Despite the fact that debris was captured in most patients who received a cerebral embolic protection device, rates of clinical and radiographic infarction were not reduced," Gelijns' group concluded.
"However, the infarct volume pattern suggested a possible differential effect of devices compared with the control intervention, with larger volume infarcts more numerous in patients in the control group. This observation may be important because the risk of clinically evident stroke increases with infarct volume," they suggested, even as study groups shared similar numbers of MRI lesions and total lesion volume.
One benefit for embolic protection was identified, though: a reduction in delirium risk at day 7 when suction was employed during surgery (6.3% versus 15.3% for control, P=0.03).
"This difference may be related to the fact that, in addition to particulate matter, the suction-based device also extracts gaseous microemboli, which have been shown to affect neuropsychological functioning early during the postoperative phase among patients undergoing cardiac surgery," they suggested.
Embol-X, on the other hand, not only failed to reduce delirium but was also associated with more 90-day acute kidney injury (3.8% versus 1.1% for control, P=0.02) and cardiac arrhythmias (15.3% versus 8.1%, P=0.004).
For this study, patients were randomized to a suction-based extractor (n=118), an intra-aortic filtration device (n=133), or standard aortic cannula/control (n=132) at the time of surgery, which was more likely than not to be isolated SAVR (58%) or concomitant SAVR and coronary artery bypass grafting (41%). North American centers performed all surgeries from 2015 to 2016.
Radiographic lesions -- identified using diffusion-weighted 1.5- or 3.0-T MRI scanners -- made up the bulk of CNS infarcts found. "The significance of the many small and clinically silent lesions identified by diffusion-weighted MRI cannot be established," Gelijns and colleagues admitted.
Another caveat: performing scans at 7 days could overestimate infarct burden by capturing lesions unrelated to intraoperative factors -- but also could underestimate it, if smaller lesions disappeared by then. Furthermore, the authors said, they stopped randomization prematurely due to low conditional power for the primary endpoint.

Gelijns disclosed no conflicts of interest.
Co-authors reported relationships with Edwards LifeSciences, Abbott Vascular, Medtronic, and Claret Medical.

• Primary Source

  Journal of the Amerian Medical Association

  Source Reference: Mack MJ, et al "Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement: a randomized clinical trial" JAMA 2017; DOI: 10.1001/jama.2017.9479.