What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis (n=443). Intervention: Diabetes mellitus vs. Non-diabetic patients. Primary outcome: All-cause mortality at 2 years (HR 0.83, 95% CI 0.49-1.40, p=0.48).

What question did this study set out to answer?

To evaluate the impact of diabetes mellitus and insulin dependency on procedural complications and two-year survival among patients undergoing transcatheter aortic valve replacement.

October 1, 2015Cardiovascular DiabetologyOpen Access

Clinical impact of diabetes mellitus in patients undergoing transcatheter aortic valve replacement

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Key result

Diabetes mellitus was not associated with an increased risk of 2-year all-cause mortality in patients undergoing transcatheter aortic valve replacement (HR 0.83).

Why the study?

Does diabetes mellitus impact all-cause mortality and peri-procedural complications in patients with severe aortic stenosis undergoing TAVR?

Population

443 consecutive patients with severe aortic stenosis undergoing TAVR at a single center in Israel. Mean age…

Comparison

Diabetes mellitus (IDDM and NIDDM) vs Non-diabetic patients

Design

Cohort

Follow-up

median 599 days

Authors

ABAnat BerkovitchInterventional Cardiology ASAmit SegevInterventional Cardiology IBIsrael M. BarbashInterventional Cardiology

Discussion

Member takes

Implication

Supports equivalent TAVR mortality risk regardless of diabetes; leaves open effects on complications and longer-term outcomes.

Key Points

To evaluate the impact of diabetes mellitus and insulin dependency on procedural complications and two-year survival among patients undergoing transcatheter aortic valve replacement.
Analyzed 443 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), categorized into insulin-dependent diabetes mellitus (IDDM, N = 44), non-insulin-dependent diabetes mellitus (NIDDM, N = 114), and non-diabetic controls (N = 285).
Trans-femoral TAVR was utilized in 74% of IDDM, 79% of NIDDM, and 76% of non-diabetic patients, with complications recorded according to Valve Academic Research Consortium-2 criteria over two years of follow-up.
Periprocedural complication rates were comparable across groups, except for grade 3 acute kidney injury (AKI3), which occurred in 2% of IDDM and 3% of NIDDM versus 0.4% in non-diabetic patients (p = 0.032).
Kaplan-Meier survival analysis demonstrated that diabetes mellitus was not associated with increased two-year mortality regardless of treatment modality (log-rank p = 0.44).
Multivariable Cox regression adjusting for comorbidities showed AKI3 independently increased two-year mortality risk (HR = 7.35, 95% CI 2.16–25.07, p = 0.001), female gender was protective (HR = 0.47, 95% CI 0.28–0.80, p = 0.005), and diabetes was not an independent predictor.

Study Design

Type

Cohort (n=443)

Multicenter

Structured PICO

Does diabetes mellitus impact all-cause mortality and peri-procedural complications in patients with severe aortic stenosis undergoing TAVR?

Population

443 consecutive patients with severe aortic stenosis undergoing TAVR, including 158 with diabetes mellitus, followed for a median of 599 days.

Exposure

Diabetes mellitus (IDDM and NIDDM)

Comparator

Non-diabetic patients

Outcome

All-cause mortality during a follow-up period of 2 yearshard clinical

Main Result

Hazard Ratio: 0.83 (95% CI 0.49–1.4)

p-value: p=0.48

Limitations

Moderately sized cohort from a single center
Limited number of enrolled patients prevents assessment of specific outcome measures and sub-group analysis
High risk for type II errors in post hoc comparisons between the three groups
Limited number of enrolled patients avoids propensity-matched evaluation or post hoc comparisons due to high risk for type II errors

Cite This Study

Berkovitch et al. (2015) conducted a cohort in Severe aortic stenosis (n=443). Diabetes mellitus vs. Non-diabetic patients was evaluated on All-cause mortality at 2 years (HR 0.83, 95% CI 0.49-1.40, p=0.48). Diabetes mellitus was not associated with an increased risk of 2-year all-cause mortality in patients undergoing transcatheter aortic valve replacement (HR 0.83).

synapsesocial.com/papers/6a9330ce602aa564b2f8e7df https://doi.org/10.1186/s12933-015-0291-3

Topics

Transcatheter aortic valve replacement TAVR in low-risk patients

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Clinical impact of diabetes mellitus in patients undergoing transcatheter aortic valve replacement

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Clinical impact of diabetes mellitus in patients undergoing transcatheter aortic valve replacement

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider