Transcatheter aortic valve implantation in obese patients: Overcoming technical challenges and maintaining adequate hemodynamic performance using new generation prostheses

doi:10.1016/j.ijcard.2016.06.155

International Journal of Cardiology

Volume 220, 1 October 2016, Pages 909-913

https://doi.org/10.1016/j.ijcard.2016.06.155 Get rights and content

Abstract

Background

Second-generation TAVI prostheses may enhance the procedure reducing operative time and complications rate, maintaining adequate valve hemodynamic performance. We present our results with 2 new generation trans-catheter aortic valve (TAVI) prostheses in obese patients.

Methods

A series of 172 patients underwent trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, and LOTUS®). Two groups were identified according to body mass index (BMI): group NO (125) BMI < 30 kg/m² and group O (47) BMI ≥ 30 kg/m².

Results

Trans-femoral approach was possible in all patients without conversion to conventional surgery/cardiopulmonary bypass. Operative/fluoroscopy time and contrast use were comparable. Vascular and bleeding complications were also equally represented in the 2 groups. Thirty-day mortality was 7.2% in group NO and 6.4% in group O (p = 0.9). At discharge, aortic regurgitation was absent/mild in 96% of group NO and in all patients in group O (p = 0.3). Mild prosthetic stenosis was reported in 3.8% of the patients in group NO and 2.2% in group O. No moderate/severe prosthetic stenosis was reported. Estimated 1-year survival was 93.1% in group NO and 83.2% in group O (p = 0.6). Estimated 1-year freedom from MACCE was 74.7% in group NO and 62.8% in group O (p = 0.4). At follow-up echocardiography no significant differences were noticed in the 2 groups.

Conclusions

Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient's body habitus, agile prosthesis placement will lead to optimized hemodynamics. Valve and clinical performance are confirmed at follow-up.

Introduction

Transcatheter aortic valve implantation (TAVI) has been proposed as a safe and effective therapy to treat patients with aortic valve stenosis (AVS) at increased risk for conventional surgical aortic valve replacement. Although obese patients may present challenges in terms of vascular access and fluoroscopic visualization, the feasibility of TAVI in this peculiar group of patients has been previously investigated and proven [1], [2], [3]. The recent introduction of second-generation TAVI prostheses with added features of valve full repositionability, retrievability, optimized trackability and aortic annulus sealing may enhance TAVI performance reducing operative time and complications rate, maintaining adequate valve hemodynamics.

In the present manuscript we present our results with 2 new generation TAVI prostheses focusing on the perioperative clinical and hemodynamic outcomes in obese patients.

Section snippets

Data collection

A series of 172 consecutive patients undergoing trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, Santa Rosa, California, USA and LOTUS®, Boston Scientific Corporation, Marlborough, Massachusetts, USA) were included. Two groups were identified according to their body mass index (BMI): group NO with BMI < 30 kg/m² and group O with BMI ≥ 30 kg/m².

All patients were treated by our TAVI team during the period March 2013–October 2015.

Perioperative data were prospectively

Results

Table 1 summarizes the preoperative findings. A total of 125 patients were included in group NO and 47 in group O. Obese patients had a higher risk profile (euro-SCORE II, systemic hypertension, and diabetes mellitus).

Anatomical features of the aortic unit and the iliac-femoral access were comparable in the 2 groups (Table 1).

Table 2 reports intraoperative data. A trans-femoral approach was possible in all patients, independently by their body habitus, and no conversion to conventional

Discussion

Although obesity is a recognized risk factor for cardiovascular disease, overweight and obese patients who undergo cardiac surgery, including aortic valve replacement, have a survival advantage over underweight, normal weight, and morbidly obese patients (obesity paradox) [7].

At times of stress, such as that experienced during surgical interventions, improved survival of obese patients could be attributed to high metabolic reserves and body fat.

In reality, the presence of obesity in patients

Limitations

In consideration of the limited sample size, we cannot draw definitive conclusions concerning the impact of obesity on follow-up outcomes. Moreover, our echocardiographic follow-up was limited to a part of the overall cohort.

Conclusions

Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient ´s body habitus, agile prosthesis placement will lead to optimized hemodynamics. Finally our clinical follow-up confirms the benefits of TAVI in both groups. Although no statistically significant differences were noted, obese patients seemed to have a trend for increased follow-up mortality and especially MACCEs. These findings may derive from the additional comorbidities that are

Authors contribution

SK, HA: Data Collection, designing, revising; GD: Data collection and analysis, Designing, writing, revising; GEA-MD-JO-AO-UK-AB-BL-HI: data collection, reading, revising.

Authorship declaration

All authors listed meet the authorship criteria according to the latest guidelines of the International Committee of Medical Journal Editors, and all authors are in agreement with the manuscript.

Disclosures

Drs. D'Ancona, Stephan Kische, and Hüseyin Ince have received proctors' fees from Direct Flow Inc.

Conflict of interest

The authors report no relationships that could be construed as a conflict of interest.

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Effect of BMI on patients undergoing transcatheter aortic valve implantation: A systematic review and meta-analysis
2023, Progress in Cardiovascular Diseases
The relationship of body mass index (BMI) and an “obesity paradox” with cardiovascular risk prediction is controversial. This systematic review and meta-analysis aims to compare the associations of different BMI ranges on transcatheter aortic valve implantation (TAVI) outcomes.
International databases, including PubMed, the Web of Science, and the Cochrane Library, were systematically searched for observational and randomized controlled trial studies investigating TAVI outcomes in any of the four BMI categories: underweight, normal weight, overweight, and obese with one of the predefined outcomes. Primary outcomes were in-hospital, 30-day, and long-term all-cause mortality. Random-effects meta-analysis was performed to calculate the odds ratio (OR) or standardized mean differences (SMD) with 95% confidence interval (CI) for each paired comparison between two of the BMI categories.
A total of 38 studies were included in our analysis, investigating 99,829 patients undergoing TAVI. There was a trend toward higher comorbidities such as hypertension, diabetes, and dyslipidemia in overweight patients and individuals with obesity. Compared with normal-weight, patients with obesity had a lower rate of 30-day mortality (OR 0.42, 95% CI 0.25–0.72, p < 0.01), paravalvular aortic regurgitation (OR 0.63, 95% CI 0.44–0.91, p = 0.01), 1-year mortality (OR 0.48, 95% CI 0.24–0.96, p = 0.04), and long-term mortality (OR 0.69, 95% CI 0.51–0.94, p = 0.02). However, acute kidney injury (OR 1.16, 95% CI 1.04–1.30, p = 0.01) and permanent pacemaker implantation (OR 1.25, 95% CI 1.05–1.50, p = 0.01) odds were higher in patients with obesity. Noteworthy, major vascular complications were significantly higher in underweight patients in comparison with normal weight cases (OR 1.62, 95% CI 1.07–2.46, p = 0.02). In terms of left ventricular ejection fraction (LVEF), patients with obesity had higher post-operative LVEF compared to normal-weight individuals (SMD 0.12, 95% CI 0.02–0.22, p = 0.02).
Our results suggest the presence of the “obesity paradox” in TAVI outcomes with higher BMI ranges being associated with lower short- and long-term mortality. BMI can be utilized for risk prediction of patients undergoing TAVI.
Comparison of In-Hospital Outcomes of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Obese (Body Mass Index ≥ 30 Kg/M2) Patients
2017, American Journal of Cardiology
Citation Excerpt :
Several studies have explored the perioperative complications in obese versus nonobese in TAVI patients. Previous reports varied in the results but suggested that major and minor vascular complications, stage 1 acute kidney injury, major/life-threatening bleeding, and minor stroke were more observed in obese TAVI,7–9 but other studies reported similar perioperative complications.10 Smith et al., in their large series of 1,066 SAVR patients from a single institution, reported that there was no association of perioperative complications (analyzed as a continuous variable, an increase of 1 kg/m2).11
The comparative outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in obese (body mass index ≥ 30 kg/m²) patients are underexplored. Nationwide Inpatient Sample database was queried from 2011 to 2014, and those who underwent TAVI or SAVR with obesity were identified. A complete case analysis with multivariate analysis was performed to adjust for the difference in underlying co-morbidities. We identified a total of 12,525 patients (989 TAVI and 11,536 SAVR). TAVI patients were elderly, more women, and had higher co-morbidity burden represented by a higher Deyo's modification of Charlson's score. Inpatient mortality was similar between the 2 groups (2.6% vs 3.2%, p = 0.21). TAVI patients had less hemorrhage requiring transfusion (8.5% vs 18%, p < 0.01), cardiac complication (7.3% vs 14%, p < 0.01), respiratory complication (1.3% vs 3.9%, p < 0.01), postop sepsis (1.0% vs 3.2%, p < 0.01), acute myocardial infarction (2.5% vs 5.5%, p < 0.01), acute kidney injury (18% vs 22%, p < 0.001), and nonroutine discharge (62% vs 67%, p < 0.001). Conversely, vascular complication (5.6% vs 4.5%, p = 0.04), new pacemaker (13% vs 5.4%, p < 0.001), and use of extracorporeal oxygen membrane (1.1% vs 0.3%, p = 0.002) were observed more frequently in TAVI patients. The median hospital cost was higher in TAVI ($50,957 vs $44,977, p = 0.004), whereas TAVI patients had a significantly shorter hospital stay (median 7.4 vs 10 days, p < 0.001). TAVI portended similar in-hospital mortality and less certain perioperative complications. In TAVI, the medical cost was higher, but the length of stay was shorter and nonroutine discharge was less frequent.
Assessment of transabdominal fat volumes as a predictor of prognosis in patients undergoing transcatheter aortic valve replacement
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A Meta-Analysis on the Impact of High BMI in Patients Undergoing Transcatheter Aortic Valve Replacement
2022, Journal of Cardiovascular Development and Disease
The obesity paradox: association of obesity with improved survival in medically managed severe aortic stenosis
2022, Singapore Medical Journal
Transcatheter vs. surgical aortic valve replacement and medical treatment: Systematic review and meta-analysis of randomized and non-randomized trials
2018, Herz

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¹: Authors have equally contributed to the manuscript.

²: This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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Transcatheter aortic valve implantation in obese patients: Overcoming technical challenges and maintaining adequate hemodynamic performance using new generation prostheses

Abstract

Background

Methods

Results

Conclusions

Introduction

Section snippets

Data collection

Results

Discussion

Limitations

Conclusions

Authors contribution

Authorship declaration

Disclosures

Conflict of interest

Am. J. Cardiol.

Am. J. Cardiol.

J. Thorac. Cardiovasc. Surg.

J. Am. Coll. Cardiol.

JACC Cardiovasc. Interv.