Registry Data Support TAVI in AS Patients With Cardiogenic Shock

PARIS, France—For patients with both aortic stenosis and cardiogenic shock, TAVI with balloon-expandable valves is a “safe and effective treatment,” according to snapshot of data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry spanning a recent 7-year period.

Abhijeet Dhoble, MD (University of Texas Health Science Center, Houston), who presented the results this afternoon at EuroPCR 2023, pointed out to TCTMD that since patients with cardiogenic shock were excluded from the pivotal trials testing TAVI, the procedure’s outcomes in today’s practice—as indications continue to expand—are unknown. “Yet we’re doing it,” he noted, so it’s important to see from real-world data how these patients fare with TAVI.

Unlike in acute MI, where the causes of cardiogenic shock are multifactorial, shock in aortic stenosis “is mostly obstructive in nature . . . at the level of the aortic valve,” Dhoble explained. “So if you relieve that obstruction by doing either a TAVR or surgical valve, or sometimes even balloon aortic valvuloplasty, you can [treat] their shock.”

Balloon aortic valvuloplasty, however, “is only modestly effective, with often suboptimal hemodynamic results and risk of aortic regurgitation,” he told EuroPCR attendees.

Outcomes are, as would be expected, worse for these sicker patients than for those without concomitant shock. But in the TVT Registry, the difference post-TAVI wasn’t all that large over the long term, Dhoble stressed: by 1 year, all-cause mortality was around 30% for those who’d had shock and around 23% for those who hadn’t.

The report follows an earlier look at the registry data for 2012-2017.

TVT Registry Data

For their analysis, Dhoble and colleagues turned to the STS/ACC TVT Registry to identify 309,505 patients who underwent TAVI using Sapien 3 and Sapien 3 Ultra balloon-expandable valves (Edwards Lifesciences) between June 17, 2015, and September 30, 2022. Among them, 5,006 (1.6%) had cardiogenic shock, which was defined by coding for shock itself, preprocedural use of inotropes or mechanical circulatory support (MCS), or cardiac arrest within 24 hours pre-TAVI.

There were numerous baseline differences between the shock group and no-shock controls. Patients with cardiogenic shock were younger; were more likely to be male, to have comorbidities (eg, diabetes, atrial fibrillation/flutter, PAD, and chronic lung disease), to have histories of stroke or CABG, and to be in NYHA Class III/IV; and on average had higher STS PROM scores and lower LVEF.

To adjust for these imbalances, the researchers performed a propensity-matched analysis of 4,952 pairs. Most procedural complication rates were similar in the two groups, although coronary occlusion (0.4% vs 0.2%; P= 0.04) and conversion to open surgery (0.7% vs 0.4%; P = 0.02) occurred more frequently in the shock group.

In-hospital outcomes, as would be expected, were worse for the shock patients versus controls. The only exception was permanent pacemaker (PPM) placement.

Propensity-Matched Analysis: In-Hospital Outcomes

Compared with controls, the cardiogenic shock patients had longer stays in the hospital (median 5 vs 2 days) and ICU (mean 90 vs 40 hours). They also were less likely to be discharged to home (59.5% vs 79.3%; P< 0.0001 for all comparisons).

Both all-cause mortality and stroke were elevated in the cardiogenic shock group at 30 days and 1 year, though hospital readmission rates were similar in the two groups.

Propensity-Matched Analysis: Longer-term Outcomes

 

For the shock group, independent predictors of higher 30-day mortality included currently being on dialysis, PPM placement, having an MCS in place at the start of TAVI, comorbid PAD, and higher age.

Landmark analysis showed that the greatest disparity in deaths occurred within 4 weeks of TAVI. For the patients who survived this window, the long-term outlook was similar irrespective of whether they’d had cardiogenic shock. And with or without shock, patients saw improvements in quality of life and function after their TAVI procedure.

Dhoble cautioned that their study is observational and that its findings can’t be generalized to self-expanding valves.

Still, their results show it’s important to address the aortic stenosis sooner rather than later, he noted.

A concern that’s sometimes aired in heart team discussions is that these particular high-risk patients have never been studied in an RCT. “One of the arguments is that this a Cohort C patient population and instead of doing TAVR, we should let them cool down or provide a more-temporary [solution] by doing balloon aortic valvuloplasty and think about TAVR at a later date,” he said. “That’s the general approach to these kinds of patients nowadays at some centers,” especially newer ones.

More-experienced centers, Dhoble added, have been performing TAVI in cardiogenic shock for some time, and these data lend support to that approach.

You should not minimize the role of balloon aortic valvuloplasty in these patients. Alain Cribier

In his presentation, he highlighted that the first-ever TAVI case, performed by Alain Cribier, MD (Hôpital Charles Nicolle, Rouen, France), was done in a patient with cardiogenic shock.

Not only did that patient have cardiogenic shock, said Cribier, a discussant for the late-breaking session—so too did half of the first few dozen people who underwent the procedure during its earliest days.

“It’s a near-miraculous improvement that you can expect, if you succeed with the procedure and the patient doesn’t die of the consequence of the cardiogenic shock,” he noted. “I just wanted to comment: you should not minimize the role of balloon aortic valvuloplasty in these patients.”

Even if it’s just done while setting up for the TAVI case, it “can change totally the game, because it’s a small orifice, a small puncture site. Even though the result is not great like after TAVR, you can have a change in ejection fraction from 20% to 30% . . . within 1 day,” and that might serve as a bridge to future treatment, Cribier explained.

Jonathan Schwartz, MD (Sanger Heart & Vascular Institute, Charlotte, NC), also a discussant, asked if there are any shock patients who clearly would not be expected to do well with TAVI.

Based on their multivariable analysis, “patients who are already in stage D or E shock and have a mechanical circulatory support device . . . typically don’t do well, as opposed to the other patients,” Dhoble said. The same can said for those on dialysis, he added. “However, I don’t think we can exclude patients based on just that fact, because sometimes these devices are extremely helpful to get them through the TAVR and the devices can be removed later.”

Anatomy is a consideration, as well, said Dhoble. For instance, TAVI shouldn’t be done on a patient in shock who has a bicuspid aortic valve with severe calcification. And the most-unstable patients who are already requiring cardiopulmonary bypass to sustain them might benefit from balloon aortic valvuloplasty as a bridge, he suggested, though there are no data yet to back this up.

Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who volleyed virtual questions from the audience during the session, strongly advocated for a randomized clinical trial to compare shock patients who do and don’t get TAVI.

“Conduct a trial already,” she commented.