What is the clinical evidence from this study?

Study design: Cohort. Population: Implanted Björk-Shiley 70 degrees convexo-concave prosthetic heart valves (n=831). Intervention: Large (29-33 mm) Björk-Shiley 70 degrees convexo-concave prosthetic heart valves vs. Small (21-27 mm) valves. Primary outcome: 10-year actuarial strut fracture rate (p=<0.001).

What does this research mean for the field?

Large (29-33 mm) Björk-Shiley 70-degree convexo-concave prosthetic heart valves have a significantly higher 10-year strut fracture rate than smaller (21-27 mm) valves. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

Determine the incidence, long-term hazard, and clinical risk factors associated with outlet strut fractures in Björk-Shiley 70-degree convexo-concave prosthetic heart valves.

January 1, 1992European Journal of Cardio-Thoracic Surgery

Strut fracture with Björk-Shiley 70U convexo-concave valve An international multi-institutional follow-up study

Q: What are the key findings of this study?

Large (29-33 mm) Björk-Shiley 70 degrees convexo-concave valves had a significantly higher 10-year actuarial strut fracture rate compared to small (21-27 mm) valves (10.5% vs 3.3%, P<0.001).

Q: What does this research mean for the field?

Large (29-33 mm) Björk-Shiley 70-degree convexo-concave prosthetic heart valves have a significantly higher 10-year strut fracture rate than smaller (21-27 mm) valves. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

Determine the incidence, long-term hazard, and clinical risk factors associated with outlet strut fractures in Björk-Shiley 70-degree convexo-concave prosthetic heart valves.

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Key result

Large Björk-Shiley convexo-concave valves linked to ~218% higher 10-year strut fracture risk versus small valves.

P<0.001
n=831

Why the study?

The risk and outcomes of outlet strut fractures in Björk-Shiley 70 degrees convexo-concave prosthetic heart valves implanted internationally were not fully characterized.

Does valve size affect the risk of strut fracture in patients with Björk-Shiley 70 degrees convexo-concave prosthetic heart valves?

Population

831 patients implanted with Björk-Shiley 70 degrees convexo-concave valves at five institutions in Sweden, Germany, The Netherlands, and Canada

Comparison

Large (29-33 mm) valves vs small (21-27 mm) valves

Design

International multi-institutional cohort study

Follow-up

Up to 10.1 years (median 4.6 years)

Authors

AEAnders EricssonLund University DLDan LindblomKarolinska University Hospital GSGudmund SembOslo University Hospital

Discussion

Member takes

Implication

Large valves were associated with higher strut fracture risk; extends prior data but leaves optimal surveillance or reoperation thresholds open.

Key Points

Determine the incidence, long-term hazard, and clinical risk factors associated with outlet strut fractures in Björk-Shiley 70-degree convexo-concave prosthetic heart valves.
Followed an international cohort of 831 patients who underwent implantation of Björk-Shiley 70° convexo-concave valves between 1980 and 1983 across five centers in Sweden, Germany, the Netherlands, and Canada through January 1991.
Calculated actuarial fracture rates and evaluated associations with valve size, position, and manufacturer subgroups using Cox proportional hazards regression analysis.
Identified 34 outlet strut fractures occurring between 0.2 and 10.1 years after surgery (median 4.6 years), with an associated mortality of 84% overall and 50% following emergency valve replacement.
Demonstrated a 10-year actuarial fracture rate of 10.5% (SE 2.4%) for large (29–33 mm) valves compared to 3.3% (SE 1.2%) for small (21–27 mm) valves (P < 0.001), with early large models (group I) reaching a 12.3% 10-year fracture risk (constant hazard of 1.4% per year).
Identified valve size as the sole significant predictor of strut fracture via Cox regression, while reporting models from the manufacturer underestimated actual fracture rates by 27% to 37%.

Study Design

Type

Cohort (n=831)

Multicenter

Yes

Structured PICO

Does valve size affect the risk of strut fracture in patients with Björk-Shiley 70 degrees convexo-concave prosthetic heart valves?

Population

831 patients implanted with Björk-Shiley 70 degrees convexo-concave prosthetic heart valves between 1980 and 1983, followed for up to 10 years.

Exposure

Björk-Shiley 70 degrees convexo-concave prosthetic heart valves (large 29-33 mm valves)

Comparator

Small (21-27 mm) Björk-Shiley 70 degrees convexo-concave prosthetic heart valves

Outcome

Outlet strut fracturesafety

Main Result

Absolute Event Rate: 10.5% vs 3.3%

p-value: p=<0.001

Large Björk-Shiley 70 degrees convexo-concave valves have a significantly higher risk of strut fracture compared to smaller valves, prompting recommendations for elective reoperation in high-risk patients.

Cite This Study

Ericsson et al. (1992) conducted a cohort in Implanted Björk-Shiley 70 degrees convexo-concave prosthetic heart valves (n=831). Large (29-33 mm) Björk-Shiley 70 degrees convexo-concave prosthetic heart valves vs. Small (21-27 mm) valves was evaluated on 10-year actuarial strut fracture rate (p=<0.001). Large (29-33 mm) Björk-Shiley 70 degrees convexo-concave valves had a significantly higher 10-year actuarial strut fracture rate compared to small (21-27 mm) valves (10.5% vs 3.3%, P<0.001).

synapsesocial.com/papers/6aaa40c0aa5a357c100837e6 https://doi.org/10.1016/1010-7940(92)90169-x

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Implication

Large valves were associated with higher strut fracture risk; extends prior data but leaves optimal surveillance or reoperation thresholds open.

Strut fracture with Björk-Shiley 70U convexo-concave valve An international multi-institutional follow-up study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Strut fracture with Björk-Shiley 70U convexo-concave valve An international multi-institutional follow-up study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Also Consider