Early Trifecta valve failure: Report of a cluster of cases from a tertiary care referral center

Kalra, Ankur; Rehman, Hasan; Ramchandani, Mahesh; Barker, Colin M.; Lawrie, Gerald M.; Reul, Ross M.; Reardon, Michael J.; Kleiman, Neal S.

doi:10.1016/j.jtcvs.2017.05.044

Cited by 55 publications

(43 citation statements)

References 10 publications

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“…Trifecta valve failures have been reported in the literature based on a case report and a case series. [2][3][4][5][6][7][8][9][10][11][12][13] We reviewed 21 cases with early Trifecta valve failure from these reports. The mean age of patients was 69 AE 9 years and 43% were men.…”

Section: Commentmentioning

confidence: 99%

“…14 Although an ethanol-based anticalcification agent was applied to the Trifecta valve, early prosthetic valve stenosis due to leaflet calcification was still observed. 10 Renal insufficiency is associated with early calcification of bioprosthetic heart valves. 14 In the present study, the rate of end-stage renal disease was substantially higher in patients with early Trifecta valve failure.…”

Section: Commentmentioning

confidence: 99%

“…Subannular pannus formation was found in the explanted Trifecta valves in our reports and the previous literature. 10,11 Pannus forms as a result of surgical injury that leads to thrombus formation. 14 Patients who undergo Trifecta valve implantation can benefit from administration of postoperative warfarin for at least 3 months to prevent early leaflet thrombosis.…”

Section: Commentmentioning

confidence: 99%

“…In one study that reported the midterm 6-year outcomes of 710 Trifecta valves that were implanted in patients between 2007 and 2009 during the premarket approval phase, the rate of freedom from reoperation from structural valve degeneration was 97.3%. 1 Although some researchers have recently reported early Trifecta valve failure, [2][3][4][5][6][7][8][9][10][11][12][13] the number of reports that establish the mechanism of Trifecta valve failure and longterm durability and efficacy are still limited. We have experienced seven instances of early Trifecta valve failure at our single center among the 107 patients who underwent Trifecta valve implantation between 2012 and 2014 (6.5%).…”

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confidence: 99%

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Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

Kaneyuki

Nakajima

Asakura

et al. 2020

The Annals of Thoracic Surgery

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Background. The Trifecta valve (Abbott, St Paul, MN) has excellent hemodynamic performance with acceptable rates of freedom from structural valve degeneration. However, some recent studies have reported early Trifecta valve failure. Here, we report a case series of seven Trifecta valve failures with a review of the literature. Methods. Of 107 implantations of Trifecta bioprostheses between 2012 and 2014, we encountered seven Trifecta valve failures (6.5%). Failure of a 19-mm Trifecta valve occurred in 1 patient, failure of a 21-mm Trifecta valve occurred in 5 patients, and failure of a 23-mm Trifecta valve occurred in 1 patient. The mean duration of valve durability was 51 ± 16 months. The mean effective orifice area index on the first echocardiogram after Trifecta valve implantation was 0.96 ± 0.26. The mode of presentation was prosthetic valve stenosis in 3 patients and severe aortic regurgitation in 4 patients.

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Section: Commentmentioning

confidence: 99%

Section: Commentmentioning

confidence: 99%

Section: Commentmentioning

confidence: 99%

mentioning

confidence: 99%

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Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

Kaneyuki

Nakajima

Asakura

et al. 2020

The Annals of Thoracic Surgery

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“…1 Kalra and colleagues report 8 early Trifecta valve failures during a 5-year period, encountered in a tertiary referral center with extensive experience with Trifecta. 2 Why this series is considered a ''cluster'' is not clear. Furthermore, 2 of the patients were not operated initially at their center, which nullifies any possibility of determining a valid denominator when attempting to calculate a valve failure rate.…”

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confidence: 99%

Early trifecta valve failure: Warning shot or unfair scrutiny?

Cohen

2017

The Journal of Thoracic and Cardiovascular Surgery

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Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk

et al. 2023

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ImportanceThe frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood.ObjectiveTo evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery.Design, Setting, and ParticipantsThis post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022.InterventionsPatients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies.Main Outcomes and MeasuresThe primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.ResultsOf 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P &lt; .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis.Conclusions and RelevanceThis study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes.Trial RegistrationClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374

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Early Trifecta valve failure: Report of a cluster of cases from a tertiary care referral center

Cited by 55 publications

References 10 publications

Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

Early trifecta valve failure: Warning shot or unfair scrutiny?

Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk

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