Stroke risk after TAVR still much higher for female patients

You still need to have YOUR DOCTOR GUARANTEE NO COMPLICATIONS FROM THE PROCEDURE!

Stroke risk after TAVR still much higher for female patients

Women are still associated with a significantly higher stroke risk after transcatheter aortic valve replacement (TAVR) than men, according to a new study published in the Journal of the American Heart Association.[1] Disabling strokes are the primary driver of this trend. 

“Sex differences have been documented for certain post‐TAVR outcomes, such as vascular complications and survival, but other outcomes remain less thoroughly explored,” wrote first author Vijay A. Joshi, BS, a researcher with the University of Colorado School of Medicine, and colleagues. “Stroke remains a feared complication of TAVR, though contemporary data on sex differences in post‐TAVR stroke are sparse.”

Joshi et al. explored in-hospital data from the National Inpatient Sample, focusing on nearly 380,000 TAVR patients treated from 2016 to 2021. Approximately 44% of patients were women, and their mean age was 79.3 years old. The mean age for men undergoing TAVR, meanwhile, was 78.2 years old.

Male patients were more likely to present with a history of smoking, coronary artery disease, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, implantable cardioverter-defibrillator placement or chronic kidney disease. Female patients, on the other hand, were more likely to present with a history of obesity. 

The overall stroke rates were 2.31% for women and 1.69% for men. Disabling strokes—defined as any stroke that results in death or discharge to a facility other than home—were the primary cause for this difference between the two sexes. They occurred in 1.61% of women and 1.02% of men. 

“Our findings regarding differences in stroke and disabling stroke by sex have potentially important clinical implications,” the authors wrote. “Specifically, as clinicians counsel patients regarding treatment options for aortic stenosis, they should be aware that women may face a heightened risk of disabling stroke, which carries significant prognostic and quality‐of‐life implications. This underscores the potential value of investigating tailored procedural strategies, such as the use of embolic protection devices in women given their potential association with a reduction in disabling stroke in particular.”

The group also called for more research in the future examining what, exactly, causes this increased stroke risk when female patients undergo TAVR. Identifying the “anatomical, physiological and procedural factors” associated with this trend could lead to new prevention strategies and improved patient outcomes.

Click here for the full analysis.

Stroke risk after TAVR still much higher for female patients

 Your competent? doctor should be able to guarantee no complications from this procedure.

Stroke risk after TAVR still much higher for female patients

Women are still associated with a significantly higher stroke risk after transcatheter aortic valve replacement (TAVR) than men, according to a new study published in the Journal of the American Heart Association.[1] Disabling strokes are the primary driver of this trend. 

“Sex differences have been documented for certain post‐TAVR outcomes, such as vascular complications and survival, but other outcomes remain less thoroughly explored,” wrote first author Vijay A. Joshi, BS, a researcher with the University of Colorado School of Medicine, and colleagues. “Stroke remains a feared complication of TAVR, though contemporary data on sex differences in post‐TAVR stroke are sparse.”

Joshi et al. explored in-hospital data from the National Inpatient Sample, focusing on nearly 380,000 TAVR patients treated from 2016 to 2021. Approximately 44% of patients were women, and their mean age was 79.3 years old. The mean age for men undergoing TAVR, meanwhile, was 78.2 years old.

Male patients were more likely to present with a history of smoking, coronary artery disease, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, implantable cardioverter-defibrillator placement or chronic kidney disease. Female patients, on the other hand, were more likely to present with a history of obesity. 

The overall stroke rates were 2.31% for women and 1.69% for men. Disabling strokes—defined as any stroke that results in death or discharge to a facility other than home—were the primary cause for this difference between the two sexes. They occurred in 1.61% of women and 1.02% of men. 

“Our findings regarding differences in stroke and disabling stroke by sex have potentially important clinical implications,” the authors wrote. “Specifically, as clinicians counsel patients regarding treatment options for aortic stenosis, they should be aware that women may face a heightened risk of disabling stroke, which carries significant prognostic and quality‐of‐life implications. This underscores the potential value of investigating tailored procedural strategies, such as the use of embolic protection devices in women given their potential association with a reduction in disabling stroke in particular.”

The group also called for more research in the future examining what, exactly, causes this increased stroke risk when female patients undergo TAVR. Identifying the “anatomical, physiological and procedural factors” associated with this trend could lead to new prevention strategies and improved patient outcomes.

Click here for the full analysis.

Brain-Protected TAVR Results in Fewer Real-World Disabling Strokes

 If you need this demand your doctor guarantee no stroke at all.

Brain-Protected TAVR Results in Fewer Real-World Disabling Strokes

Also, patients with prior stroke ID'd as likely responders in TVT registry analysis

by Nicole Lou, Senior Staff Writer, MedPage Today June 5, 2024

NEW YORK CITY -- Researchers eked out evidence of a small clinical benefit with the Sentinel cerebral embolic protection (CEP) device in transcatheter aortic valve replacement (TAVR) -- and pointed to the patients more likely to benefit -- on the basis of disabling strokes.

The incidence rate of in-hospital disabling stroke, defined as stroke associated with either in-hospital death or discharge to a non-home location, was 0.79% with the CEP device versus 0.91% without the device (RR 0.87, 95% CI 0.73-1.00) in nationwide STS/ACC TVT registry data from 2018 to 2023, the largest dataset to date in this field.

This reduction in disabling stroke in the real world was supported by a secondary analysis using propensity score weighting (OR 0.79, 95% CI 0.70-0.90), reported Neel Butala, MD, of Rocky Mountain Regional VA Medical Center and the University of Colorado School of Medicine, both in Aurora.

"Our prespecified primary analysis using an instrumental variable approach demonstrated a small, borderline significant reduction in in-hospital disabling stroke that is likely to be causal in nature," Butala said here at the New York Valvesopens in a new tab or window meeting, the successor to the annual TVT conferenceopens in a new tab or window previously hosted by the Cardiovascular Research Foundation. The study was simultaneously published in Circulation: Cardiovascular Interventionsopens in a new tab or window.

Panelist Samir Kapadia, MD, of the Cleveland Clinic, called the study an "important contribution" that signals that the CEP field is still "active," with newer, better devices on the horizon.

Despite FDA approval of the Sentinel deviceopens in a new tab or window, CEP remains controversial following multiple trial setbacks. The technology never entered mainstream practice because of what many consider to be an unproven benefit of capturing debris dislodged during TAVR.

For example, the Sentinel CEP device failed to reduce periprocedural strokes in the randomized PROTECTED-TAVR trialopens in a new tab or window, even though it prevented embolic material from reaching the brain. In that study, the researchers tried and failed to find subgroup responders who would likely have strokes prevented by the CEP device.

Based on the TVT registry, however, Butala and colleagues did identify TAVR patients with prior stroke as a subgroup that disproportionately benefited from fewer disabling strokes with CEP.

"We've been trying to find this, a cohort of patients that would benefit more from EPD [embolic protection devices] and I think you kind of nailed it," said session discussant Alexandra Lansky, MD, of Yale School of Medicine in New Haven, Connecticut. "The sample size is large enough that patients with prior stroke are probably the ones we want to target."

There was no reduction in nondisabling strokes in the cohort overall or in any subgroup. This may be explained by the Sentinel device allowing smaller particles to get to the head and causing smaller strokes, Butala told the audience.

"These findings are congruent with those from the PROTECTED-TAVR trial and suggest that the reduction in disabling stroke from EPD use is real, but the effect size may be relatively small in all-comer patients," he concluded.

The investigators had conducted a retrospective study of first-time TAVR recipients in the STS/ACC TVT registry. They excluded emergent procedures, alternative access, and people who received a non-Sentinel CEP device.

In the end, there were 414,649 TAVR recipients included in the study (mean age 78-79, 39-44% women), of whom nearly 13% received a Sentinel device.

The Sentinel group had more bicuspid valves (8.9% vs 5.5%) and more prior aortic valve procedures (11.6% vs 8.1%) compared with controls. Otherwise, baseline characteristics were relatively well-matched, according to Butala's group.

Use of CEP devices had plateaued at 15% until the 3,000-patient PROTECTED-TAVR results were released in 2022 -- dropping down to 12% by mid-2023, Butala said. He highlighted the variation in CEP use across the study period, with 40% of sites reporting no CEP use and 6% using the devices for over half their cases.

The investigators acknowledged that their analysis was not randomized, but maintained that causal inference was supported by their quasi-experimental approach of an instrumental variable analysis with site-level preference for CEP use as the instrument.

Lansky added that the potential underestimating of event rates and lack of long-term mortality data were limitations to the study.

In addition, Butala and colleagues had relied on discharge location as a proxy for stroke severity, a variable that is not explicitly identified in the TVT registry. The disabling stroke endpoint was separately validated in a population pooling data from PARTNER 2A, PARTNER 3, the Sapien S3i Registry, SURTAVI, Evolut Low Risk, and PROTECTED TAVR -- with sensitivity of 80%, specificity of 66.7%, and a positive predictive value (PPV) of 58.2%.

"While we can be fairly certain that a patient discharged home after TAVR did not have a disabling stroke, the lower sensitivity and PPV temper our ability to verify if discharge to non-home location or death was truly due to a disabling stroke post-TAVR or due to another postprocedure complication(s) or for other reasons such as frailty," cautioned Dharam Kumbhani, MD, SM, of the University of Texas Southwestern Medical Center in Dallas, and Frederick Welt, MD, of the University of Utah Health Sciences Center in Salt Lake City, in an accompanying editorialopens in a new tab or window. "In addition, baseline residential status is not factored into this definition."

"The current endeavor by Butala and colleagues is a creative and interesting approach to try and shed light on a question that has yet to be definitively answered by randomized data," they added. "It potentially sets the stage for future studies and action items on this topic."

The duo pointed to the BHF PROTECT TAVIopens in a new tab or window study as an ongoing randomized trial in the CEP space, but said it is unlikely to be powered for a disabling stroke endpoint.

For now, "we don't find evidence of harm. It's not like we're harming people using this device," Butala said, adding that the only downsides with the CEP device are longer procedure time and higher cost.

• 

  Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

The study was funded by a grant from Boston Scientific.

Butala disclosed receiving consulting fees/honoraria from Shockwave Medical and Boston Scientific.

Kapadia had no disclosures.

Lansky reported personal ties to Boston Scientific, Cordis/MedAlliance, and Abiomed; and grant support from Abbott, Sinomed, and Abiomed.

Kumbhani and Welt had no disclosures.

Primary Source

Circulation: Cardiovascular Interventions

Source Reference: opens in a new tab or windowButala NM, et al "Impact of cerebral embolic protection devices on disabling stroke after transcatheter aortic valve replacement: updated results from the STS/ACC TVT registry" Circ Cardiovasc Interv 2024; DOI: 10.1161/CIRCINTERVENTIONS.123.013697.

Secondary Source

Circulation: Cardiovascular Interventions

Source Reference: opens in a new tab or windowKumbhani DJ, Welt FG "Supplementing randomized trial data to answer a real world question: discharge to home status as a heuristic for stroke severity after transcatheter aortic valve replacement" Circ Cardiovasc Interv 2024; DOI: 10.1161/CIRCINTERVENTIONS.124.014374.

Cerebral embolic protection during TAVR did not reduce overall stroke

 So your doctor still has some work to do to prevent strokes after TAVR(transcatheter aortic valve replacement). YOUR DOCTOR'S RESPONSIBILITY to prevent those strokes.

 

Cerebral embolic protection during TAVR did not reduce overall stroke

BOSTON — In PROTECTED TAVR, the largest-ever randomized trial of transcatheter aortic valve replacement, cerebral embolic protection did not decrease incidence of periprocedural stroke.

However, cerebral embolic protection was associated with reduced incidence of disabling stroke, so the results do not necessarily rule out the benefit of cerebral embolic protection in patients undergoing TAVR, Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said during a press conference at TCT 2022.

Source: Adobe Stock

Samir R. Kapadia

“As a scientific trial, you would say that the primary endpoint was negative,” Kapadia said at the press conference. “However, the disabling strokes are reduced, so it would be the wrong message to say there was no benefit. [We had to state] the conclusion without overstating it or misguiding the readership.”

The researchers randomly assigned 3,000 patients with aortic stenosis to undergo transfemoral TAVR with or without a cerebral embolic protection device (Sentinel, Boston Scientific).

The primary endpoint was stroke within 72 hours of TAVR or before discharge, whichever came first, in the intention-to-treat population. Secondary endpoints included disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the cerebral embolic protection access site and acute kidney injury. All patients were assessed by a neurologist before and after the procedure.

The results were simultaneously published in The New England Journal of Medicine.

Among the patients from the cerebral embolic protection arm in whom an attempt was made, 94.4% had the device successfully deployed, according to the researchers.

The primary endpoint occurred in 2.3% of the cerebral embolic protection group and 2.9% in the control group (difference, –0.6 percentage points; 95% CI, –1.7 to 0.5; P = .3), Kapadia and colleagues found.

Disabling stroke occurred in 0.5% of the cerebral embolic protection group and 1.3% of the control group (difference, –0.8 percentage points; 95% CI, –1.5 to –0.1; P = .02), according to the researchers. The number needed to treat with cerebral embolic protection to prevent one disabling stroke was 125, Kapadia said at the press conference.

The difference in disabling stroke was driven by disabling ischemic stroke, with six occurring in the cerebral embolic protection group and 17 occurring in the control group, Kapadia said.

There were no differences between the groups in death (cerebral embolic protection, 0.5%; controls, 0.3%), stroke/TIA/delirium (cerebral embolic protection, 3.1%; controls, 3.7%) or acute kidney injury (0.5% in both groups), Kapadia and colleagues found.

One patient in the cerebral embolic protection group had a vascular complication at the device access site, according to the researchers.

A cerebral embolic protection device could not be deployed in 5.5% of patients assigned to that group, but a per-protocol analysis of patients who received the assigned treatment did not differ from the intention-to-treat analysis, the researchers reported.

There were no differences in the primary outcome by subgroup except that it significantly favored the cerebral embolic protection group in patients from the U.S. but not in patients from outside the U.S., and the researchers do not have an explanation for why that happened, Kapadia said.

“Stroke remains unpredictable,” Kapadia said at the press conference. “Despite a big effort, we did not identify who is likely to have them.”

Reference:

• Kapadia SR, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2204961.

Presumed Clinical Benefits of TAVR Cerebral Protection Remain Unproven

 So your doctor still has some work to do to prevent strokes after TAVR(transcatheter aortic valve replacement). YOUR DOCTOR'S RESPONSIBILITY to prevent those strokes.

Presumed Clinical Benefits of TAVR Cerebral Protection Remain Unproven

Large trial comes up short in proving a definitive benefit to debris filters

by Nicole Lou, Senior Staff Writer, MedPage Today September 17, 2022

BOSTON -- Cerebral embolic protection (CEP) again came up empty in preventing strokes after transcatheter aortic valve replacement (TAVR) despite safely capturing embolic material dislodged during the procedure, a large randomized trial found.

In the 3,000-person PROTECTED TAVR trial, the sentinel dual-filter system produced no significant reduction in periprocedural strokes compared with control cases without the device (2.3% vs 2.9%, P=0.30), according to Samir Kapadia, MD, of Cleveland Clinic.

Kapadia added that no subgroup seemed to get less strokes from protected TAVR. "Stroke remains unpredictable," he said in a presentation at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation. The results were simultaneously published in the New England Journal of Medicine (NEJM).

This might be disappointing for clinicians who had hoped to narrow down CEP candidates based on this trial. It had been thought that by valve anatomy or procedural characteristics, certain patients would at least benefit more than others, commented Robert Cubeddu, MD, of Naples Heart Institute in Florida, at a TCT press conference.

There was some redemption in Sentinel's association with fewer disabling strokes after TAVR (0.5% vs 1.3%, P=0.02), with the number needed to treat to prevent one disabling stroke being 125 patients.

But this is not a definitive finding and will need to be replicated, cautioned John Carroll, MD, of University of Colorado School of Medicine/Anschutz Medical Campus in Aurora, and Jeffrey Saver, MD, of David Geffen School of Medicine at the University of California Los Angeles, in a NEJM editorial.

Otherwise, the trial produced no substantial differences in mortality rates or the combined endpoint of stroke, transient ischemic attack, or delirium. Incidence of acute kidney injury was the same 0.5% between groups.

PROTECTED TAVR comes years after the much smaller SENTINEL trial, in which CEP successfully filtered out histopathologic debris in 99% of patients but failed to significantly reduce new lesion volume in protected brain territories or reduce major adverse cardiac and cerebrovascular events.

Nevertheless, FDA approved the Sentinel in 2017 on the presumption that catching debris before it reaches the brain should theoretically benefit patients undergoing intracardiac procedures. Since approval, however, real-world data continues to show no stroke benefit with the device.

The adoption of CEP has been variable and slow to proliferate. When asked how the new data would affect clinical practice at the press conference, the panelists broke into a few chuckles.

Michael Young, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, said the study "muddies the waters for programs that are more medium-volume. A number needed to treat of 125 is going to be a tough sell for some of those programs to ubiquitously use that for all their patients."

"A lot of it rolls down to cost and we need to be realistic about that," Cubeddu said. "In many [TAVR] programs across the country, the margins of sustainability and cost and revenue are just marginal."

He suggested it would be interesting to see how the Centers for Medicare & Medicaid Services (CMS) interprets the results of PROTECTED TAVR.

The postmarket trial was conducted at 51 centers in North America, Europe, and Australia. Investigators randomized transfemoral TAVR candidates to the procedure with or without CEP.

Neurologic examinations were performed on all the patients at baseline and after TAVR. Routine neuroimaging was not performed to identify covert brain infarction.

Participants averaged age 78.9. There was a greater proportion of women in the protected group (42.0% vs 37.8% of controls), whereas Society of Thoracic Surgeons surgical risk was similar between groups (3.4% vs 3.3%).

The Sentinel was successfully deployed in 94.4% of attempts.

The trial's primary endpoint was stroke within 72 hours after TAVR or before discharge. Carroll and Saver warned that the counting of these events may have been flawed in the study.

"An underdetection of stroke events may have occurred because neurologic assessments were not always performed by experienced neurologists and because a formal structured interview to determine the presence of stroke symptoms was not used. A small amount of overcounting of end-point events may also have occurred owing to the use of a nonstandard approach of classifying asymptomatic covert infarctions as strokes," they wrote.

As for safety, only one patient had a vascular complication at the access site, according to Kapadia.

"The safety of the device and its possible effect on disabling strokes provide a ray of hope, but the concern persists that CEP, approved and marketed on the basis of surrogate outcomes, may not actually provide a clear and incontestable clinical benefit," according to Carroll and Saver.

In any case, PROTECTED TAVR may be a testament to how much TAVR has matured since it was first developed in 2002.

"The fact that the negative results of the study are in part due to the low incidence of stroke events in the control group conveys good news -- stroke frequency without CEP is low in contemporary practice as compared with the early experience with TAVR and is likely due to operator experience, technical refinements to procedural equipment, and the use of TAVR in healthier patients," the editorialists said.

• 

  Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

PROTECTED TAVR was funded by Boston Scientific.

Kapadia disclosed relationships with Navigate and Admedus.

Carroll disclosed relationships with Edwards LifeSciences and Medtronic. Saver disclosed relationships with, and/or support from, Filterlex, Abbott, Medtronic, Bayer, Roche, Johnson & Johnson, Amgen, MIVI, Rapid Medical, Novo Nordisk, and Edwards.

Cubeddu disclosed no relationships with industry.

Young disclosed a relationship with Medtronic.

Primary Source

New England Journal of Medicine

Source Reference: Kapadia SR, et al "Cerebral embolic protection during transcatheter aortic-valve replacement" New Engl J Med 2022; DOI: 10.1056/NEJMoa2204961.

Secondary Source

New England Journal of Medicine

Source Reference: Carroll JD and Saver JL "Does capturing debris during TAVR prevent strokes?" New Engl J Med 2022; DOI: 10.1056/NEJMe2210185.

Cerebral embolic protection during TAVR reduces disabling stroke but not overall stroke

 So how are your doctors guaranteeing your 100% recovery from that stroke if they can't prevent it? Don't let them weasel out of truthfully answering.

Cerebral embolic protection during TAVR reduces disabling stroke but not overall stroke

BOSTON — In PROTECTED TAVR, the largest-ever randomized trial of transcatheter aortic valve replacement, cerebral embolic protection did not decrease incidence of periprocedural stroke.

However, cerebral embolic protection was associated with reduced incidence of disabling stroke, so the results do not necessarily rule out the benefit of cerebral embolic protection in patients undergoing TAVR, Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said during a press conference at TCT 2022.

Source: Adobe Stock

Samir R. Kapadia

“As a scientific trial, you would say that the primary endpoint was negative,” Kapadia said at the press conference. “However, the disabling strokes are reduced, so it would be the wrong message to say there was no benefit. [We had to state] the conclusion without overstating it or misguiding the readership.”

The researchers randomly assigned 3,000 patients with aortic stenosis to undergo transfemoral TAVR with or without a cerebral embolic protection device (Sentinel, Boston Scientific).

The primary endpoint was stroke within 72 hours of TAVR or before discharge, whichever came first, in the intention-to-treat population. Secondary endpoints included disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the cerebral embolic protection access site and acute kidney injury. All patients were assessed by a neurologist before and after the procedure.

The results were simultaneously published in The New England Journal of Medicine.

Among the patients from the cerebral embolic protection arm in whom an attempt was made, 94.4% had the device successfully deployed, according to the researchers.

The primary endpoint occurred in 2.3% of the cerebral embolic protection group and 2.9% in the control group (difference, –0.6 percentage points; 95% CI, –1.7 to 0.5; P = .3), Kapadia and colleagues found.

Disabling stroke occurred in 0.5% of the cerebral embolic protection group and 1.3% of the control group (difference, –0.8 percentage points; 95% CI, –1.5 to –0.1; P = .02), according to the researchers. The number needed to treat with cerebral embolic protection to prevent one disabling stroke was 125, Kapadia said at the press conference.

The difference in disabling stroke was driven by disabling ischemic stroke, with six occurring in the cerebral embolic protection group and 17 occurring in the control group, Kapadia said.

There were no differences between the groups in death (cerebral embolic protection, 0.5%; controls, 0.3%), stroke/TIA/delirium (cerebral embolic protection, 3.1%; controls, 3.7%) or acute kidney injury (0.5% in both groups), Kapadia and colleagues found.

One patient in the cerebral embolic protection group had a vascular complication at the device access site, according to the researchers.

A cerebral embolic protection device could not be deployed in 5.5% of patients assigned to that group, but a per-protocol analysis of patients who received the assigned treatment did not differ from the intention-to-treat analysis, the researchers reported.

There were no differences in the primary outcome by subgroup except that it significantly favored the cerebral embolic protection group in patients from the U.S. but not in patients from outside the U.S., and the researchers do not have an explanation for why that happened, Kapadia said.

“Stroke remains unpredictable,” Kapadia said at the press conference. “Despite a big effort, we did not identify who is likely to have them.”

Reference:

• Kapadia SR, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2204961.

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]

PinnacleHealth’s new technology helps protect patients from risk of stroke during TAVR

63% reduction and 99% capture rate is still not good enough, better than nothing but send them back to the drawing board. We let the known failure rate of tPA being 88% last for decades without being challenged. Demand better, your doctors probably won't, it is not their problem if you get a stroke. OR ARE WE WAITING FOR SOMEONE ELSE TO SOLVE THE PROBLEM?     

PinnacleHealth’s new technology helps protect patients from risk of stroke during TAVR

• Download PDF Copy

August 24, 2017

PinnacleHealth is the first hospital in Pennsylvania and one of the first 10 in the country to introduce new technology shown to help protect patients from the risk of stroke during transcatheter aortic valve replacement (TAVR).
Minimally invasive TAVR is proven effective in treating aortic stenosis without open heart surgery for patients at too high of a risk for surgery. However, during TAVR, calcium deposits from the heart valve or tissue can be dislodged and may travel to the brain, which can create a stroke risk. Based on clinical trial results and major TAVR registry data, the reported risk of stroke for TAVR patients varies between 1-5 percent.

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PinnacleHealth is implementing the Sentinel Cerebral Protection System, the first FDA-cleared device available in the U.S., to capture and remove this debris before it reaches the brain. The device has been shown to reduce strokes by 63 percent during the procedure and in the first 72 hours post-procedure, when most strokes occur.
In the U.S. clinical trial of the technology, the device captured debris in 99 percent of TAVR cases,⁶ with no added risk for the overall procedure. The Sentinel device is inserted through the catheter before the TAVR device and comes out after the valve is deployed. It is shaped like a butterfly net, collapsing around the debris and allows the debris to be removed from the body after the procedure.
"Any stroke is one stroke too many," says Hemal Gada, MD, MBA, medical director of structural heart at PinnacleHealth CardioVascular Institute.
"We are proud to be on the vanguard of offering the most advanced medical technology to keep our patients safe and value the added layer of protection this device brings to our patients," says Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of structural heart at PinnacleHealth CardioVascular Institute.
More than 3,500 patients worldwide have been protected with the innovative technology to-date.

Source:

http://www.pinnaclehealth.org/our-health-system/news-and-announcements/article/new-technology-helps-protect-pinnaclehealth-patients-from-risk-of-stroke-during-heart-valve-replacement

CardioBrief: New Stroke Prevention Device Might Not Prevent Strokes

A great stroke association president would have a team validating all research to do with stroke rather than working on the fucking lazy items of press releases, prevention, awareness and F.A.S.T.. But no, we have fucking failures of stroke associations instead, doing nothing useful for survivors.
https://www.medpagetoday.com/Cardiology/CardioBrief/65872?

There's no hard evidence the Sentinel filter reduces stroke in TAVR

• by Larry Husten, CardioBrief June 08, 2017

Here's how to get a second-generation medical product or add-on product approved: Show that the original device isn't nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up.
Until now, proponents of transcatheter aortic valve replacement (TAVR) have sought to emphasize the benefits of TAVR and have downplayed its negative aspects, including stroke. Now, with the clearance of an add-on device for TAVR that may help prevent some strokes, these same TAVR supporters are emphasizing the stroke risk.
Martin Leon (Columbia University), a top TAVR advocate, said in a press release for the new device that "anything we can do as clinicians to reduce the risk of brain injury is extremely meaningful."
On Monday, the FDA cleared the Sentinel Cerebral Protection System, which is designed to reduce the incidence of stroke in the aftermath of a TAVR procedure. In a press release the manufacturer of the device, Claret Medical, said it is "the first and only embolic protection device shown to reduce TAVR procedural strokes by 63%."
But there are a few big problems the company did not exactly highlight in its press release. The device has not been proven effective and, although stroke is certainly a serious complication of TAVR, until now the actual rate of stroke associated with TAVR has been reported to be much lower than the company stated in its press release.
Sentinel therefore joins the growing list of cardiac devices that have been cleared but for which there is no or extremely limited evidence showing that they work. These include the Watchman left atrial appendage closure device, the Absorb bioresorbable stent, the Impella heart pump, patent foramen ovale (PFO) closure devices, and catheters to open chronic totally obstructed arteries.
TAVR and Stroke
The Claret Medical press release exaggerated the significance of stroke in TAVR patients: "Recent studies have found that almost one in 10 patients experience a clinically-apparent stroke due to the procedure." But the source for this statistic is their own clinical trial, in which they went looking for evidence of stroke.
Like a baseball field of dreams, in the field of medical devices if you build it they will come. But outside their own field of dreams, in the real world, the numbers are quite different. As Sanjay Kaul (Cedars-Sinai) observes, the stroke rate is much lower in real life: "The 30-day stroke rate of 9.1% in the control arm appears to be much higher than what is observed with contemporary newer-generation TAVR devices such as SAPIEN 3 (2.7%)." Of course, no one would want to discount stroke as an adverse event, but a rate of one in 10 is a lot worse than a rate of one in 37.
Robert Yeh (Beth Israel Deaconess) said he thinks the high rate is reasonable, although it includes minor strokes that might not be caught in normal clinical practice. He said that the high stroke rate in the control arm was a result of the trial's design, which included detailed stroke assessments. "This is a very sensitive (albeit probably accurate) definition of stroke."
Questions About Effectiveness
More importantly, there's no solid evidence that the device actually reduces the risk of stroke.
In the press release, Leon broadly endorsed the benefits of the device: "The 63 percent reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking. The device was delivered safely, added minimal time to the procedure, and performed as intended with capture of embolic material and reduction in ischemic brain injury."
But Leon neglected to mention the single most important fact about the trial: It failed to meet its primary effectiveness endpoint. There was no significant difference in the size of new lesions in the brain. Instead, Leon focused exclusively on the secondary or post-hoc endpoints.
A major problem is that the small number of strokes in the trial make it is impossible to draw any firm conclusions about the effectiveness of Sentinel. There were only 23 strokes in the trial, just 3 of which were disabling.
Here are the details: The overall stroke rate was 9.1% in the control group versus 5.6% in the Sentinel group. But this was based on 10 events in 110 patients in the control group versus 13 events in 231 treated patients. These numbers are very small and did not come close to statistical significance (P=0.25). Even worse, the numbers are driven almost entirely by nondisabling strokes. There were 9 nondisabling strokes in 110 control patients versus 11 nondisabling strokes in 231 treated patients. For disabling strokes -- the most important thing you want to prevent -- there were only 3 events, 1 (out of 109) in the control group versus 2 (out of 231) in the treatment group. No difference whatsoever.
'Reasonable People Will Argue'
Given the clinical importance of stroke, the absence of any other available treatment, and the lack of any safety concerns, FDA clearance was not indefensible but not a given either, said two cardiologists who were asked to comment.
Kaul said that "reasonable people will argue" whether the results provide "the 'reasonable assurance' statute for device approvals, even for a Class II device."
Yeh said that clearance of the device "looks fair to me based on biological plausibility, direction of effect of the major endpoints (namely stroke), the fact this is not a long-term therapy or a permanent implant, but just a device that supports another procedure, and the low risk of harm."
Yeh concluded that "1) there probably are a fair amount of minor strokes after TAVR. This is probably true for SAVR [surgical aortic valve replacement] as well. 2) Using a sensitive definition of stroke helps the company. 3) It's probably fair to use the sensitive definition of stroke here since it is considered the gold standard, and also, going full circle, if it were me, I would want to avoid those very minor strokes in addition to the larger clinically obvious ones."
The good news, in my opinion, is that the device appears to be safe. It's unlikely that patients will be directly harmed by the device (except for the added cost, of course), and it is for this reason that the FDA went ahead and cleared the device. But there's a very dangerous and very steep and slippery slope here. Now that the device is on the market it may well be impossible to prove whether or not it is effective. Next-generation devices will only need to prove that they are equivalent to Sentinel. An entire industry could develop based on a safe but ineffective device.
Related stories:

• Interventional Cardiologists Face Major Obstruction In Treatment Of Total Blockages
• Interventional Cardiology And The Rejection Of Science
• Impella No Better Than IABP in Cardiogenic Shock
• The Impact Of ABSORB II: Down The Slippery Slope
• Reality Check On The 'Noninferior' Abbott Bioresorbable Stent
• Study Shows Why Sham Controls Are Necessary For Device Trials

Strokes and TAVR: More Reporting Needed?

Current reporting of brain damage is fucking idiotic. At least until they start reporting 3d representations of MRI and PET scans along with damage to white matter connections.
http://www.medpagetoday.com/Cardiology/Strokes/62947?

Group claims 'covert' brain damage is under-reported

• by Kristina Fiore
  Associate Editor, MedPage Today February 06, 2017

Citing under-reporting of certain neurologic events, a group of U.S. and European researchers has published a consensus statement on new standardized neurological endpoints for cardiovascular clinical trials. The paper calls for classification of three types of brain damage to enable better reporting: overt CNS damage such as stroke symptoms; "covert" CNS damage that lacks symptoms but is recognized on brain imaging; and neurologic dysfunction without detectable injury, such as slurred speech or temporary weakness.
The paper arises from concerns over a growing body of literature about these "covert" brain injuries following transcatheter aortic valve replacement (TAVR) and other cardiac procedures, researchers said. Co-author Michael Mack, MD, of Baylor Scott & White Health in Dallas, Tex., noted in a statement that until now, "many studies evaluating the safety of TAVR and other cardiovascular procedures only recorded the most devastating strokes, which meant that doctors – and their patients – were unaware of the full risk potential. We hope this paper will cause researchers to report their findings in a more comprehensive and consistent way so that clinicians can properly interpret the results to provide the best care to patients." Mack was a principal investigator in the pivotal PARTNER trials of the Sapien valve.
The consensus paper, developed by the Neurologic Academic Research Consortium (NeuroARC), was published in the Journal of the American College of Cardiology and European Heart Journal.