Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Implantation

doi:10.1016/j.amjcard.2016.02.040

The American Journal of Cardiology

Volume 117, Issue 10, 15 May 2016, Pages 1636-1642

https://doi.org/10.1016/j.amjcard.2016.02.040 Get rights and content

Several clinical variables have been identified as predictors of clinical outcome after transcatheter aortic valve implantation (TAVI). Nonetheless, there is limited and contradictive data on the impact of diabetes mellitus (DM) on the prognosis of patients who undergo TAVI. We aimed to investigate the clinical characteristics and the early and midterm outcomes after TAVI according to DM status. From 802 consecutive patients who underwent TAVI, we compared 548 patients with no DM to 254 patients with diabetes (177 orally treated and 77 insulin treated). Patients with DM were younger had higher body mass index and incidence of coronary artery disease and lower incidence of frailty. Device success, 30-day mortality and major complications rates were similar between groups. One-year mortality was 12.1% for patient with DM and 12.2% for patients without DM (p = 0.91). In a multivariable regression analysis including age, body mass index, coronary artery disease and frailty, DM was associated with decreased overall survival. This was driven by increased overall mortality of the insulin-treated DM subgroup (hazard ratio 2.40, 95% CI 1.32 to 4.37; p <0.01). In conclusion, DM does not affect short-term mortality or rates of complications after TAVI. Insulin-treated DM, but not orally treated DM, is independently associated with death at midterm follow-up and therefore aggressive cardiovascular risk factor modification as well as intense glycemic control should be considered for patients with insulin-treated DM with severe aortic stenosis who undergo TAVI.

Section snippets

Methods

We examined consecutive patients at high risk with severe symptomatic AS who underwent TAVI during a 3-year period at our institute. All patients had congestive heart failure with New York Heart Association class II to IV symptoms. Aortic valve disease was assessed initially with transthoracic echocardiography followed by an electrocardiogram-gated, multislice computed tomography (CT) angiography study. Decision for TAVI sizing was made by the heart team using data from all available imaging

Results

From January 2012 to January 2015, 802 consecutive patients underwent TAVI at our institute. From this cohort, 548 patients had no DM (68.3%), 177 had orally treated DM (22.1%), and 77 had insulin-treated DM (9.6%). The mean age of the patients was 82.0 ± 8.5. The baseline clinical, echocardiographic, and CT characteristics of the study population are presented in Table 1. Several baseline characteristics were not similar between groups. Patients with DM were younger and had higher BMI compared

Discussion

The results of the present study indicate that performing TAVI in patients with DM is not associated with increased short-term complications or mortality. Patients with DM had similar device success, 30-day mortality, and major complications after the procedure. Similar findings were found when we examined separately patients with insulin-treated diabetes. We also found that DM is associated with decreased overall survival during a midterm follow-up period. This is driven mainly by increased

Disclosures

Dr. Makkar has received grant support from Edwards Lifesciences Corporation and St. Jude Medical and is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr. Jilaihawi is a consultant for Edwards Lifesciences Corporation, St. Jude Medical, and Venus MedTech. All other authors have no conflicts of interest to disclose.

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Cited by (31)

Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial
2019, International Journal of Cardiology
Citation Excerpt :
While it has been shown that DM patients with severe AS benefit more from TAVR procedures vs. surgical aortic valve replacement (SAVR) [9,15], the evidence regarding the impact of DM on clinical outcomes following TAVR has been inconclusive. In the current study comprising of patients with severe AS undergoing trans-femoral TAVR, we analyzed a high proportion of DM patients, comparable with reported rates of DM in other studies [11,16–22]. As expected, DM patients had higher rates of baseline DM-associated comorbidities such as PAD and CAD.
The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population.
BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE – death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days.
Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p = 0.48) and acute kidney injury (19.7% vs. 15.1%, p = 0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p = 0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p = 0.03) and life-threatening bleeding both in-hospital (OR 1.50, p = 0.046) and at 30-days (OR 1.50, p = 0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients.
Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.
Relationships Between Intraoperative Hemodynamic Parameters and Delayed Hemodynamic Recovery After Valve Deployment in Transcatheter Aortic Valve Replacement
2019, Journal of Cardiothoracic and Vascular Anesthesia
Citation Excerpt :
In addition, DM might cause several cardiac complications indirectly during the procedure. The rates of mortality and complications were shown to be higher in patients with insulin-treated DM and high hemoglobin A1c levels than in patients with orally treated DM or individuals without DM.21,25,26 Thus, close attention should be paid to intraoperative management of circulation in these patients.
To determine the relationships between intraoperative hemodynamic parameters and delayed hemodynamic recovery after valve deployment and identify the predictive factors of delayed hemodynamic recovery by focusing on intraoperative hemodynamics in patients with transcatheter aortic valve replacement (TAVR).
A retrospective study.
A single university hospital.
Sixty-four patients who underwent elective TAVR between 2015 and 2017.
No intervention.
The 64 patients were divided into the following 2 groups according to the time for recovery: systolic arterial pressure exceeded 90 mmHg and central venous oxygen saturation (ScvO₂) exceeded 65%—delayed recovery (DR) (n = 36) group, and early recovery (ER) (n = 28) group. ScvO₂ in the DR group was not lower than that in the ER group after induction of anesthesia. However, ScvO₂ in the DR group gradually decreased and was lower than that in the ER group before valve deployment, despite improvement in blood pressure through the administration of vasopressor agents.
ScvO₂ monitoring during TAVR is useful to predict delayed recovery greater than 60 seconds after valve deployment in TAVR.
Effect of Serum C-Reactive Protein Level on Admission to Predict Mortality After Transcatheter Aortic Valve Implantation
2018, American Journal of Cardiology
Citation Excerpt :
In our cohort, indeed, the patients with high CRP on admission had higher CFS, higher NYHA class, and higher incidence of diabetes, atrial fibrillation, stroke, and peripheral artery disease than those with low CRP on admission. Moreover, these factors have been reported as independent predictors of all-cause death after TAVI.18–21 These are the reasons why patients with high CRP level on admission had significantly higher incidence of all-cause death after TAVI compared with those with low CRP level in our analysis.
The relation between C-reactive protein (CRP) level on admission and mortality after transcatheter aortic valve implantation (TAVI) remains unclear. To evaluate the impact of serum CRP level on mortality after TAVI, we assessed 1,016 patients with CRP who underwent TAVI and 538 patients with high-sensitive CRP (hs-CRP) level who underwent TAVI on admission in the OCEAN (Optimized Transcatheter Valvular Intervention)-TAVI registry. Study population was stratified into 2 groups (high/low), according to the median of CRP and hs-CRP on admission. We assessed the impact of high CRP and hs-CRP level on all-cause death after TAVI. During 2-year follow-up, all-cause death after TAVI was 9.4% in patients with CRP and 11.9% in patients with hs-CRP. Median value of serum CRP was 0.10 mg/dl in both CRP and hs-CRP. Patients with high CRP (>0.10 mg/dl) had significantly higher incidence of all-cause death compared with those with low CRP (11.5% vs 7.6%, log-rank p = 0.015). Multivariate Cox regression analysis with a time-varying covariate demonstrated that high CRP was an independent predictor of all-cause death within the first 3 months (hazard ratio 2.78, 95% CI 1.30 to 5.95) compared with from 3 months to 2 years (hazard ratio 0.80, 95% CI 0.47 to 1.36) (P for interaction = 0.008). Inversely, these results were not observed in the stratification using hs-CRP on admission. In conclusion, high CRP on admission was significantly associated with an increased risk of all-cause death after TAVI, particularly within the first 3 months after TAVI. Risk stratification using CRP may be a simple and useful strategy to identify high-risk patients who undergo TAVI.
Does diabetes mellitus impact prognosis after transcatheter aortic valve implantation? Insights from a meta-analysis
2017, Journal of Cardiology
Diabetes mellitus (DM) is well known to increase mortality in several cardiovascular diseases. However, the prognostic impact of DM following transcatheter aortic valve implantation (TAVI) remains controversial. We sought to assess the impact of DM on perioperative (in-hospital or 30-day) complications and mid-term (≥1 year) all-cause mortality after TAVI through meta-analysis.
A comprehensive literature search of PUBMED and EMBASE was conducted through January 1st 2002 to May 15th 2016. Articles that reported adjusted hazards ratio (HRs) or unadjusted HR for mid-term all-cause mortality with 95% confidence intervals (CIs) of DM or insulin dependent DM (IDDM) on mid-term all-cause mortality post TAVI were included in the analysis. A meta-analysis was performed with combination of both adjusted HR and un-adjusted HR. Sensitivity analysis was performed with only the adjusted HR. Random-effects model was used to calculate the pooled effect size.
A total of 22 observational cohort studies were identified with 28,440 (8998 DM and 19,442 non-DM) patients. The risk of perioperative complications (myocardial infarction, bleeding, major vascular complications, stroke, and new-onset atrial fibrillation) was similar between DM and non-DM cohorts. A meta-analysis of all-cause mortality of DM (19 studies after excluding 3 studies that only reported HR of IDDM on mid-term all-cause mortality, 8808 DM and 17,829 non-DM patients) resulted in significantly worse outcome (HR 1.21, 95%CI 1.10–1.34, p = 0.0002, I² = 53%) in DM patients compared to non-DM patients post-TAVI. Sensitivity analysis showed consistent results. Subgroup analysis (4 studies with 267 IDDM versus 2161 non-IDDM) demonstrated that IDDM was associated with higher all-cause mortality (HR 2.05, 95%CI 1.54–2.73, p < 0.00001, I² = 0%) following TAVI.
DM was associated with similar perioperative complications but was associated with increased mid-term all-cause mortality after TAVI. Further study of the causes of increased mortality during the follow-up may lead to improved outcome.
Impact of interaction of diabetes mellitus and impaired renal function on prognosis and the incidence of acute kidney injury in patients undergoing transcatheter aortic valve replacement (TAVR)
2017, International Journal of Cardiology
In high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) diabetes mellitus (DM) is a common comorbidity. It is known to increase the risk of arteriosclerosis and adversely affect morbidity, mortality for all types of cardiovascular disease, and post-procedural outcome after percutaneous and surgical procedures. Moreover, DM is known to facilitate the genesis of renal failure (RF). Pre-existing RF seems to increase the rate of acute kidney injury (AKI), which is a powerful short- and midterm predictor of mortality in patients undergoing TAVR. Therefore, the aim of the present study was to investigate the impact of DM on AKI, short- and midterm prognosis after TAVR, especially in patients with pre-existing RF.
In 337(30%) of 1109 patients DM was documented. The incidence of RF at baseline (GFR < 60 mL/min) was statistically similar in both patient groups (no DM vs. DM: 54% vs. 61%; p = 0.057). Also, the incidence of AKI stage 3 was similar in all patients (no DM vs. DM: 1.6% vs. 1.8%; p = 0.799). There were no significant differences regarding the procedure-related complications according to VARC-2 and mortality between patients neither with nor without DM. Even after differentiating patients according to baseline renal function, similar incidence of AKI and midterm mortality were documented.
In patients undergoing TAVR, neither in case of preserved nor impaired renal function, we couldn't find any evidence for influence of DM on overall acute and midterm prognosis nor the incidence of AKI.
Meta-Analysis of Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Implantation
2017, American Journal of Cardiology
Citation Excerpt :
And DM was also recognized by Alassar et al25 as a predictor of acute kidney injury after TAVI. Still, some other studies came to the same conclusion as ours that DM was not associated with increased short-term complications after TAVI.26 Given the possible effect of smaller sample size of other studies compared with our meta-analysis, the detrimental impact of DM on complications mentioned previously may not be cogent enough and requires further investigation.
To date, the impact of diabetes mellitus (DM) on prognosis after transcatheter aortic valve implantation (TAVI) is still contradictory and thus merits further investigation. The purpose of this meta-analysis was to evaluate the impact of DM on outcomes after TAVI. A systematic search of the PubMed database was performed. Primary end points were 30-day and 1-year all-cause mortality after TAVI. Risk ratios (RRs) and 95% CIs were calculated using the random-effect or fixed-effect model, depending on heterogeneity between studies, and p values <0.05 was considered significant. A total of 16 studies involving 13,253 patients were included in our meta-analysis. There was no significant difference between the groups with DM and without DM regarding 30-day (RR 1.07, 95% CI 0.90 to 1.27, p = 0.45) or 1-year (RR 1.04, 95% CI 0.94 to 1.15, p = 0.42) all-cause mortality. The risks of 30-day complications, including myocardial infarction, stroke, major vascular complications, major bleeding, and acute kidney injury, were similar between patients with and without DM. In conclusion, DM neither affected short- or mid-term all-cause mortality nor short-term complications after TAVI.

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Valvular Heart DiseaseImpact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Implantation

Section snippets

Methods

Results

Discussion

Disclosures

Ann Thorac Surg

Am J Cardiol

Am J Cardiol

Int J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Lancet

Ann Thorac Surg

Ann Thorac Surg

J Am Coll Cardiol

J Am Coll Cardiol

Diabetes and mortality following acute coronary syndromes

JAMA

Valvular Heart Disease
Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Implantation