Despite a higher risk of coronary obstruction with degenerated internally stented bioprosthetic valves, performing valve-in-valve (ViV) procedures in patients with these valves shows a similar rate of 3-year survival to ViV procedures in other degenerated bioprosthetic valves, a single-center retrospective study suggests.

Ahmed AlBadri, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues reported these findings in a manuscript published Monday online and in the March 13 issue of JACC: Cardiovascular Interventions.

ViV transcatheter aortic valve replacement (TAVR) is indicated in patients at high or prohibitive surgical risk whose previously implanted aortic valve bioprostheses have degenerated. Internally stented valves, namely Mitroflow (Sorin Group) and Trifecta (St. Jude Medical) present specific challenges because their pericardial leaflets are mounted outside the valve stent, AlBadri and colleagues wrote.

Both of these valves have been associated with adverse events in patients undergoing ViV procedures.

The externally mounted pericardial leaflets could be displaced away from the valve stent during deployment, which could interfere with coronary blood flow. Also, these valves have been used for small native aortic annuli, and ViV TAVR in small bioprostheses has an elevated risk for significant residual stenosis, the authors wrote.

Study setup

The investigators retrospectively collected baseline, procedural and clinical data for 296 patients who underwent ViV TAVR at Cedars-Sinai between January 2012 and December 2020. Of these patients, 46 who underwent TAVR-in-TAVR were excluded from the analysis. The analysis included 71 patients who underwent TAVR within degenerated internally stented valves (ViV-IS) and 179 within other degenerated surgical valves (ViV-OS).

Clinical outcomes were analyzed based on Valve Academic Research Consortium 3 criteria.

At baseline, the 250 analyzed patients’ mean age was 74 ± 13 years, 65% were men, their mean Society of Thoracic Surgeons (STS) Predicted Risk of Mortality score was 4.4% (interquartile range [IQR]: 2.2% to 8.4%), 94% presented with New York Heart Association (NYHA) functional class III or IV heart failure, and 30% required urgent or emergent intervention because of refractory acute heart failure or cardiogenic shock.

The ViV-IS group had a higher mean age (77 ± 9 years vs. 73 ± 14 years; p=0.018), lower percentage of male patients (55% vs. 68%, p=0.04) and similar median STS score (4.6 [IQR: 3.1% to 8.9%] vs. 4.4% [IQR: 2.0% to 8.3%]; p=0.15) compared to the ViV-OS group.

Results

While both groups had similar preprocedural mean gradients (median 32 mmHg [IQR: 19-43] vs. 29 mmHg [IQR: 20-45]; p=0.086), the ViV-IS group had a significantly higher postprocedural mean gradient (median 12 mmHg [IQR: 6-16] vs. 6 mmHg [IQR: 2-13 mmHg]; p<0.001). Also, 48% of the ViV-IS group had a postprocedural mean gradient >20 mmHg, which was significantly higher than ViV-OS group (22%; p<0.001).

After propensity-score matching on the basis of age, sex and valve internal diameter size, the there was no longer a significant difference between the groups in postprocedural mean gradient (median 18 mmHg [IQR: 13-25] vs. 18 mmHg [IQR: 11-24]; p=0.36) or in percentage of patients with postprocedural mean gradient >20 mmHg (49% vs. 35%; p=0.26).

Fluoroscopy time was longer in the ViV-IS group (median 23.1 minutes [IQR: 18.3-31.7] vs. 17 minutes [IQR: 13-23.2]; p<0.001), and more contrast was used in ViV-IS patients (110 mL [IQR: 70-150] vs. 70 mL [IQR: 50-100]; p<0.001). After propensity-score matching, fluoroscopy time was numerically longer in the ViV-IS group (21 minutes [IQR: 18-27.4] vs. 18.1 minutes [IQR: 14.2-25]; p=0.066), but the significance remained in contrast use (ViV-IS 100 mL [IQR: 65-130] vs. 70 mL [IQR: 45-100]; p=0.007).

Also, a significantly higher percentage of the ViV-IS patients were at risk for coronary artery occlusion both before (54% vs. 3.3%; p<0.001) and after propensity-score matching (19% vs. 2%; p<0.001). Coronary protection for potential occlusion was performed more often in the ViV-IS group (79% vs. 6%; p<0.001).

Coronary protection was performed before valve deployment in patients with high-risk features for coronary artery occlusion. This protection consisted of engaging the coronary ostium with a guide catheter and advancing a guidewire with an appropriately sized stent, which was positioned undeployed distal to the coronary ostium, the authors explained.

There was no significant difference between the groups in the 3-year all-cause mortality rate (unmatched: 15.5% vs. 15.6%, p=0.98; propensity-score matched: 14% vs. 12%, p-0.75).

At 30-day follow-up, mean gradient was still significantly higher in the ViV-IS group (median 20 mmHg [IQR: 15.5-30] vs. 15 mmHg [IQR: 11-21]; p<0.001). With propensity-score matching, which showed no significant difference in mean gradient postprocedurally, at 30 days, the ViV-IS group was significantly higher (median 21.5 mmHg [IQR: 15-31] vs. 17 mmHg [IQR: 12-21.8], p=0.027.

By 1-year follow-up, however, there was no significant difference in mean gradient in either the unmatched (median 18.5 mmHg [IQR: 13.2-20.8] vs. 15 mmHg [IQR: 11.5-22.5]; p=0.35) or matched cohorts (median 18.5 mmHg [IQR: 11.8-21.8] VS. 21 mmHg [13.3-26.8]; p=0.33).

Also, 83% of the ViV-IS patients and 89% of the ViV-OS patients were at NYHA class I or II at 30 days; at  year, 91% of the ViV-IS group and 88% of the ViV-OS group were at NYHA class I or II.

Median Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved from 43 (IQR: 26.2-55.6) at baseline to 71.9 (IQR: 52.6-88.5) at 30 days and 78.1 (IQR: 57.6-94.3) at 1 year in the ViV-IS group and from 47.9 (IQR: 31.3-71.9) at baseline to 83.3 (IQR: 60.4-97.9) at 30 days and 81.5 (IQR: 66-97.9) at 1 year. The KCCQ score was significantly lower in the ViV-IS group at 30 days (p=0.01), but the significance disappeared by 1 year (p-0.27).

‘Internally stented heart valves should not be used any more’

In an accompanying editorial, Stefan Toggweiler, MD, Federico Moccetti, MD, and Peter Matt, MD, all of the Heart Center Lucerne, Switzerland, congratulated AlBadri and colleagues for their analysis.

The editorialists wrote that based on this paper and other studies providing “a solid body of evidence … that internally stented heart valves degenerate earlier … this must lead to the conclusion that internally stented heart valves should not be used any more.”

“Indeed,” they wrote, “many cardiac surgeons nowadays rarely implant such valves.”

The expert commentators also wrote that in patients with small annuli, cardiac surgeons can implant a bioprosthesis in the supra-annular position instead of the intra-annular position, as the supra-annular position allows for larger valve sizes to be used.

“Finally,” the editorialists concluded,” many studies have demonstrated that TAVR is associated with lower gradients than surgical aortic valve replacement, and this benefit appears to be greatest in patients with small annuli.”

Sources:

AlBadri A, Joseph J, Patel V, et al. Hemodynamic and Mid-Term Outcomes for Transcatheter Aortic Valve Replacement in Degenerated Internally Stented Valves. JACC Cardiovasc Interv 2023;16:542–554.

Toggweiler S, Moccetti F, Matt P. Internally Stented Bioprosthetic Heart Valves Should Not Be Used Any More. JACC Cardiovasc Interv 2023;16:555–557.

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