ACC 2021 Late Breaking Cardiology Study Results | DAIC

Combining TAVR, LAA Closure In Same Procedure Safe, Trial Says

SAN FRANCISCO -- Left atrial appendage occlusion (LAAO) at the time of transcatheter aortic valve replacement (TAVR) appeared as safe as TAVR alone, the WATCH-TAVR trial showed.

For patients with severe aortic stenosis and atrial fibrillation (AF or Afib), the combined approach met non-inferiority to TAVR plus medical therapy for the primary composite endpoint of all-cause mortality, stroke, and major bleeding at 2 years (22.7 vs 27.3 events per 100 patient-years, P<0.001 for non-inferiority).

While the hazard ratio for that combined endpoint favored TAVR plus LAAO (HR 0.86, 95% CI 0.60-1.22), it was not significantly superior (P=0.40), reported Samir Kapadia, MD, of the Cleveland Clinic, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting and online in Circulation.

Some 20% of TAVR patients subsequently get a Watchman device for LAA closure, Kapadia estimated at a TCT press conference. "Actually making the procedure at the same time ... Is better for the patient rather than doing sequential procedures," Kapadia said, referencing convenience for the patient and potentially reduced cost and risk from repeated interventions.

Indeed, surgical LAA closure is routine for Afib patients undergoing cardiac surgery, noted TCT press conference panelist Kendra Grubb, MD, of the Emory Structural Heart and Valve Center in Atlanta. Such an approach in the LAAOS III trial reduced risk of stroke or systemic embolism by 2.2 percentage points over 3 years, with a relative 33% ischemic stroke reduction.

"WATCH-TAVR not only replicates this surgical learning but is the first study to investigate concomitant percutaneous procedures treating two separate conditions in structural heart disease patients," Kapadia's group wrote.

TCT session study discussant Megan Coylewright, MD, MPH, of the Erlanger Health System in Chattanooga, Tennessee, said she questioned 20 of her TAVR patients with Afib and high bleeding risk about whether they would want the procedures combined or staged. "They looked at me like I lost my mind. 'What do you mean? Why would I want it staged?'" she said. "I asked my colleagues if they want to take more beds for staged procedures. It seems like a no-brainer."

She questioned whether, with so much data on both procedures, there was a need for such a trial at all and future combinations of structural heart procedures could just rely on registry data.

"I hope after today, people will say 'Gosh, that makes a lot of sense,'" Coylewright told MedPage Today.

However, the researchers cautioned: "The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR."

The combined procedure group had a higher rate of thromboembolism, mainly from more frequent venous thrombosis. Arterial or venous thrombosis or embolism occurred in 9.0% of the combined procedure group compared with 1.7% of the TAVR-alone group, a more than five-fold higher risk (95% CI 1.47-17.26).

Pericardial effusion occurred in 2.4% of combined procedures compared to 0.5% in TAVR alone.

Need for pericardiocentesis is a known complication of the Watchman 2.5 LAA closure device used in the study, although the newer-generation Watchman FLX device "demonstrated a marked reduction in the risk of pericardial effusion in the NCDR [National Cardiovascular Data Registry] LAAO Registry database," Kapadia's group noted.

Another aspect of adding LAAO is that it is often performed under general anesthesia and transesophageal echocardiography, whereas TAVR usually just takes conscious sedation. However, the same delayed-phase acquisition CT could be used to plan both procedures "and make preoperative evaluation of the combined procedure seamless and efficient," Kapadia's group suggested.

Trial Details

Their trial included 349 patients getting TAVR with any commercially available device for symptomatic, severe aortic stenosis at 34 U.S. Centers from December 2017 to November 2020.

Participants were randomized to TAVR with concomitant LAAO with the Watchman 2.5 device or TAVR with anticoagulation according to treating physician preference. The combined procedure group got anticoagulation for 45 days followed by dual antiplatelet therapy (DAPT) until 6 months.

Participants' mean age was 81, with an average CHA2DS2-VASc score of 4.9 and HAS-BLED score of 3.0. Antithrombotic therapy use at baseline included anticoagulation and antiplatelet therapy for most patients (85.4% and 71.3%, respectively, for the two classes individually and 59.3% on both).

LAAO added 38 minutes to the TAVR procedure on average, with an additional 49 mL of contrast volume, which Kapadia's group called "acceptable."

In-hospital mortality was low (0.6%) in both groups, with similar hospital length of stay and acute kidney injury rates.

At 24 months follow-up, the combined procedure group was more likely to be on any antiplatelet therapy (82.5% vs 50.8%) but less likely to be on any anticoagulant (13.9% vs 66.7%). Patients with severe mitral stenosis or other indications for anticoagulation were excluded.

The combined procedure group had numerically more major and life-threatening bleeding during the initial 6-month period of oral anticoagulation and DAPT (HR 1.35, 95% CI 0.76-2.39) then numerically lower rates than the TAVR-alone group between 6 months and 2 years (HR 0.63, 95% CI 0.25-1.57).

"The prescribed adjunctive pharmacotherapy was based on the approved WATCHMAN 2.5 device label at that time which has since been updated to allow for DOACs [direct oral anticoagulants] or DAPT with the WATCHMAN FLX device," the researchers noted. They pointed to the higher bleeding risk seen with DAPT than with anticoagulation alone in data from the NCDR LAAO registry.

"It is likely that with insights from CHAMPION-AF and other studies investigating less intense anticoagulation/antiplatelet regimens post WATCHMAN implant, bleeding will be reduced during the initial 6 months after device implantation," Kapadia's group suggested.

Money Matters

The recently reported ADALA trial, the first randomized trial of antithrombotic therapy after LAAO, showed that low-dose apixaban (Eliquis) had substantially lower risk of thromboembolic events and device-related thrombosis at 3 months than DAPT with aspirin and clopidogrel, and also numerically less VARC-3 major bleeding and significantly fewer bleeds when combining major and minor events.

Perhaps a bigger issue for many centers is financial, noted TCT press conference panelist Pinak B. Shah, MD, of the Brigham and Women's Hospital Cardiac Catheterization Lab in Boston.

"I take away from this [trial] that this is a safe approach, if you decide to have that conversation with the patients," he said. However, he added: "We get DRG [diagnosis-related group], at least in the United States, for one procedure. I think a lot of programs in the country have a hard time just keeping TAVR programs afloat. And now we're thinking about adding a Watchman on top of that, what are the financial implications for individual institutions?"

Kapadia said that talks have started with CMS about getting a combined code for reimbursement. "There is some hope."

Disclosures

The trial was funded by Boston Scientific.

Kapadia disclosed stock options for Navigate and stocks for Anteris (no longer held but within the last 12 months).

Grubb disclosed relationships with Boston Scientific, Edwards Lifesciences, Medtronic, and Ancora Heart.

Coylewright disclosed relationships with Edwards Lifesciences, Boston Scientific, Medtronic, Occlutech, and Abbott.

Shah disclosed relationships with Edwards Lifesciences.

Primary Source

Circulation

Source Reference: Kapadia SR, et al "Valve replacement among patients with atrial fibrillation" Circ 2023; DOI: 10.1161/CIRCULATIONAHA.123.067312.

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TAVR And Watchman Procedures Together Yield Similar Outcomes To Blood Thinners After TAVR For Atrial Fibrillation

Findings from a trial led by Cleveland Clinic show that patients with atrial fibrillation undergoing a transcatheter aortic valve replacement (TAVR) at the same time as a left atrial appendage occlusion (LAAO) procedure using the Watchman device had similar outcomes as patients getting TAVR in addition to medical therapy or blood thinners.

Results from the "Safety and Efficacy of Left Atrial Appendage Occlusion at the Time of Transcatheter Aortic Valve Replacement—The WATCH TAVR Trial" were presented today during a late-breaking clinical trial session at the 2023 annual Transcatheter Cardiovascular Therapeutics conference and simultaneously published in the journal Circulation.

"WATCH TAVR is a novel study where two devices were used in order to combine the TAVR procedure for patient convenience and safety," said lead author Samir Kapadia, M.D., chairman of Cardiovascular Medicine at Cleveland Clinic. "If patients can get both procedures done at the same time, that eliminates the need to be on blood thinners, which can have significant side effects. In addition, many patients can't take the medications due to high risk of bleeding."

TAVR is most commonly the first-line treatment for patients over 65 years old with symptomatic severe aortic stenosis or narrowing of the aortic valve. Up to 40% of these patients experience atrial fibrillation, a type of abnormal heart rhythm. Atrial fibrillation also can increase the risk of stroke, and patients with atrial fibrillation undergoing TAVR have an increased risk of death, stroke and rehospitalization compared to those without atrial fibrillation.

The multicenter, randomized WATCH-TAVR trial set out to investigate the safety of implantation of the WATCHMAN 2.5 device at the time of TAVR and to compare the efficacy of WATCHMAN LAAO with contemporary medical therapy in this population of patients with an increased risk of bleeding and stroke.

The trial enrolled 349 patients with severe aortic stenosis and atrial fibrillation. Of these, 177 patients received TAVR plus the LAAO procedure and 172 patients received the TAVR plus medical therapy. The trial took place between December 2017 and November 2020 at 34 centers in the United States. The mean age was 81 years old.

Patients in the TAVR plus medical therapy control group were managed by their treating physician, which allowed for the use of a direct oral anticoagulant, warfarin or no blood thinners, based on the physician's discretion. Approximately one third of patients who were in the medical therapy control group were not on blood thinners at two years.

The primary endpoint, a collection of all-cause death, stroke and major bleeding at two years, showed that there were no differences in outcomes for patients when getting TAVR plus LAAO compared to getting TAVR plus medical therapy. However, there was a higher rate of blood clots, mainly more frequent blood clots in the veins, in patients undergoing TAVR plus LAAO compared to TAVR plus medical therapy.

In the trial, the WATCHMAN patients received blood thinners for 45 days followed by dual antiplatelet therapy until six months. Anticoagulation was based on the treating physician's preference for patients randomized to TAVR plus medical therapy.

At baseline, 85.4% of patients were taking blood thinners and 71.3% of patients were on antiplatelet therapy. After 24 months, 82.5% compared to 50.8% of patients were on any antiplatelet therapy, and 13.9% compared to 66.7% of patients were on any blood thinner therapy in the TAVR plus LAAO group compared to TAVR plus medical therapy group, respectively.

"Although the findings showed similar outcomes, the increased complexity and risks of the combined procedure should be considered when LAAO is viewed as an alternative to medical therapy for patients with atrial fibrillation undergoing TAVR," said Dr. Kapadia.

More information: Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients with Atrial Fibrillation, Circulation (2023). DOI: 10.1161/CIRCULATIONAHA.123.067312

Citation: TAVR and Watchman procedures together yield similar outcomes to blood thinners after TAVR for atrial fibrillation (2023, October 24) retrieved 31 October 2023 from https://medicalxpress.Com/news/2023-10-tavr-watchman-procedures-yield-similar.Html

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WATCH-TAVR: Adding LAAO To TAVI No Worse Than TAVI Alone

SAN FRANCISCO, CA—Performing left atrial appendage occlusion (LAAO) at the same time as TAVI provides noninferior results compared with the valve procedure alone in patients with severe aortic stenosis and atrial fibrillation (AF), according to the results of the WATCH-TAVR trial.

Through 2 years, the rate of all-cause mortality, stroke, or major/life-threatening bleeding (primary endpoint) was 33.9% in patients treated with the combined procedure and 37.2% in those treated with TAVI alone, a difference that met criteria for noninferiority (P < 0.001) but not superiority, Samir Kapadia, MD (Cleveland Clinic, OH), reported here at TCT 2023.

There were no differences between groups for any of the individual components of that endpoint, or for most other secondary endpoints, although the rate of thromboembolism—mostly driven by venous events—was higher with the combined procedure (5.5 vs 1.1 events per 100 patient-years; HR 5.03; 95% CI 1.47-17.26). There was one in-hospital death in each arm.

The combined procedure "can be performed with low hospital mortality," Kapadia said during a press conference, estimating that about 20% of patients treated with TAVI will later undergo LAAO. Doing both interventions at the same time "can be viewed as an alternative considering the complexity of the procedure and [the] few complications we listed."

AF is common in the setting of aortic stenosis, and the presence of the arrhythmia is an important factor to consider in weighing the potential benefits of surgical versus transcatheter aortic valve replacement. That's because when surgeons replace the valve, they will commonly exclude the LAA at the same time, an approach supported by LAAOS III trial. WATCH-TAVR explores that type of combined approach using only percutaneous techniques, with the idea that it would reduce the cost and inconvenience of bringing patients back for a second procedure.

Commenting on the results for TCTMD, Megan Coylewright, MD (Erlanger Health System, Chattanooga, TN), said, "It's really important for interventional cardiology to think about doing multiple procedures at once for patients. When I talked to my patients about the concept behind this trial, they were really excited about the possibility of being able to have multiple disease conditions treated at one time, as is currently offered in surgery. So I think for that reason it's important."

Performing multiple procedures at one time would not only be more convenient for patients, who wouldn't have to make additional trips to the hospital, but also would lower costs for payers and free up beds for health systems, she said.

Asked whether the trial provides sufficient evidence of safety and effectiveness to present the option for a combined TAVI and LAAO procedure to patients, Coylewright said, "Based on the results of the WATCH-TAVR trial, I feel we have the evidence needed to move the conversation forward to provide combined therapies to our patients with severe aortic stenosis and high risk for bleeding with atrial fibrillation in a way that will really benefit patients, families, clinicians, and hospital systems."

The WATCH-TAVR Trial

AF affects about 40% of high-risk patients and 16% of low-risk patients undergoing TAVI, and it's associated with poorer clinical outcomes after the procedure. One potential strategy for addressing the risk of stroke associated with AF after TAVI is to additionally perform LAAO, which is being increasingly used as a treatment alternative in patients who are not good candidates for chronic oral anticoagulation. However, patients with severe aortic stenosis were excluded from the pivotal LAAO trials, so there is limited evidence about use of LAAO in the setting of TAVI.

WATCH-TAVR, conducted at 34 North American centers, helps fill that gap. The trial randomized 349 patients (mean age 81 years; 38.7% women) with severe aortic stenosis and AF to undergo TAVI and LAAO during a single procedure or TAVI alone. For LAAO, operators used the Watchman 2.5 device (Boston Scientific), treating patients with anticoagulation plus aspirin for 45 days after the procedure, followed by dual antiplatelet therapy (DAPT) through 6 months. In the TAVI-only arm, anticoagulation use was left to the discretion of the treating physician.

At baseline, the mean CHA2DS2-VASc score was 4.9 and the mean HAS-BLED score was 3.0. Most patients (85.4%) were taking oral anticoagulation and antiplatelet therapy (71.3%), with 59.3% on both and 2.6% on neither.

LAAO added a median of 38 minutes to the overall procedure time, and also required a greater median contrast volume (119 vs 70 mL) compared with TAVI alone. General anesthesia and transesophageal echocardiography (TEE) were more frequently used during combined procedures. Median length of stay was 2 days in both groups.

There were four moderate or large pericardial effusions during combined procedures—three of which required pericardiocentesis—and one during TAVI alone. The rate of acute kidney injury was no different between the combined and TAVI-only groups (2.8% vs 3.4%).

Through 2 years of follow-up, there were no substantial differences in clinical outcomes between the two groups, although major/life-threatening bleeding was numerically more common after the combined procedure during the first 6 months of follow-up and less frequent from 6 months to 2 years; these findings were not statistically significant.

In terms of medical therapy, patients treated with the combined procedure were more likely to be on antiplatelet therapy (82.5% vs 50.8%) and less likely to be on anticoagulation (13.9% vs 66.7%) at 2 years.

Eyeing the Impact of Recent Advances

Addressing the greater use of general anesthesia during combined procedures in WATCH-TAVR, the investigators note that in recent years, it has become more common for LAAO to be performed under conscious sedation. "Therefore, the procedural limitation for the greater use of general anesthesia may be minimized with recent advances in both procedures," they say.

There was an apparent front-loaded of risk of bleeding in the combined group attributed to the required antithrombotic regimen with the Watchman 2.5 device, but Kapadia said that might be different with newer device generations. The "next-generation Watchman FLX device does not require this anticoagulation so hopefully we will mitigate the initial bleeding complications that we saw," he said.

There are reasons patients would opt for a combined procedure rather than receiving the interventions sequentially, the investigators indicate. "From a patient convenience perspective, as well as the standpoints of safety of repeated interventions and cost, concomitant procedures could be of great value," they write, noting, for instance, that a single CT scan could be used to plan both TAVI and LAAO. "This should obviate the need for additional investigations like TEE to assess the size and shape of LAA for procedural planning of LAAO and make preoperative evaluation of the combined procedure seamless and efficient."

Initial costs are higher with the combined procedure, Kapadia et al acknowledge, but "LAAO delivers more quality-adjusted life-years and lower total costs within 10 years. WATCH-TAVR supports the reimbursement of concomitant procedures."

Kapadia said he has talked with the Centers for Medicare & Medicaid Services (CMS) about reimbursement for the combined procedure, but there still isn't such a code.

Indeed, the current lack of a reimbursement pathway for combining TAVI and LAAO is a barrier to adoption of this approach, Coylewright said. The trial "won't impact my practice until we have a system that will support clinicians in providing these therapies at the same time, and right now there's not reimbursement to do both procedures at once. So until we have buy-in from our payers, it won't be something that will be possible."

But combining procedures is likely to become more common in the future, Coylewright predicted. "I think that we will continue to evolve as a specialty where we will be able to offer patients more of the therapies for their cardiac needs in one setting."

Kapadia agreed in a discussion following his presentation: "This is I think a new era where things are moving in the right direction."

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