Transcatheter aortic valve implantation in nonagenarians: Effective and safe

doi:10.1016/j.ejim.2013.07.007

European Journal of Internal Medicine

Volume 24, Issue 8, December 2013, Pages 750-755

https://doi.org/10.1016/j.ejim.2013.07.007 Get rights and content

Highlights

•
TAVI is safe and effective even in a selected population of nonagenarians.
•
Age itself should not preclude the possibility of undergoing TAVI.
•
Patient’s motivation and general conditions are more important than age alone.
•
A multi–disciplinary approach is crucial to select appropriate candidates..

Abstract

Background

The number of nonagenarians is rising dramatically. These patients often develop severe aortic stenosis for which transcatheter aortic valve implantation (TAVI) is an attractive option. The aim of this study was to analyze the outcome of TAVI performed in a cohort of nonagenarian patients.

Methods

Between August 2008 and November 2012, 23 consecutive patients in their 90th year of age or older underwent TAVI in our institution after having been assessed by the local heart team. Data concerning baseline characteristics, procedural details and outcome were prospectively entered into a dedicated database. Transthoracic echocardiography and clinical follow-up were performed pre-procedure, at discharge, at 6 and 12 months and then annually post TAVI.

Results

Patients were male in 52% with a mean age of 90.3 ± 2.3 years. Mean logistic EuroSCORE and STS score were 26.6 ± 14.5% and 8.7 ± 2.9%, respectively. Transcatheter heart valve (THV) could be implanted in all but one patient. Mortality at 30 days was 8.7% overall and 4.8% for transfemoral approach. At 30 days the rate of stroke was 4.3%, paravalvular leak grade ≥ 2 was 8.7%, life-threatening bleeding was 13.0% and pacemaker implantation was 13%. Device success was 73.9%. The rate of all-cause mortality increased to 27.3% at one-year follow-up and 42.8% at a median follow-up of 417 days.

Conclusions

TAVI is safe and effective even in a selected population of nonagenarians. Consequently, these patients should not be refused such a procedure based only on their age. Multi-disciplinary assessment is essential in order to properly select candidates.

Introduction

An increase in life expectancy is responsible for the dramatic rise in the number of nonagenarians in developed countries. Since the prevalence of severe symptomatic aortic stenosis (AS) increases with age, the management of nonagenarians with this disease will be more and more frequent. Although nonagenarians are often frail and suffer from comorbidities, some have no relevant concomitant diseases and still enjoy a good quality of life with a low level of disability. Indeed, according to Fries' theory [1], [2] the age at which disease and functional impairment appears is progressively postponed, resulting in the phenomenon of “compression of morbidity” which in parallel influences the important concept of “healthy life expectancy”.

Considering the significant negative impact of severe AS on quality of life in the elderly [3], [4] it is essential to explore alternatives to surgery. Indeed, for the vast majority of nonagenarians, surgical aortic valve replacement (SAVR) is not an option due to the associated risks of mortality and morbidity. For those physically capable of undergoing SAVR, the procedure is often refused by the patient because of the surgical risk and the long rehabilitation process [5], [6]. Transcatheter aortic valve replacement (TAVI) now offers a therapeutic alternative to selected, very elderly patients with symptomatic severe AS [7], [8]. The aim of this article is to report the results of our TAVI experience in patients in their 90th year of life or older.

Section snippets

Patient population

Between August 2008 and November 2012, 23 consecutive patients in their 90th year of age or older (26.7% of our total number of TAVI performed during the study period) underwent TAVI in our institution after having been assessed by the heart team. During the study period, only one patient in this age group underwent a SAVR. All patients had severe symptomatic AS with a valve area < 1 cm² according to transthoracic echocardiography (TTE). If the echocardiographic assessment of stenosis severity

Results

The baseline patient characteristics and echocardiographic parameters are listed in Table 1, Table 2. Patients were male in 52% with a mean age of 90.3 ± 2.3 years. The oldest was 99 years old. Mean logistic EuroSCORE and STS scores were 26.6 ± 14.5% and 8.7 ± 2.9%, respectively. All but two patients were living at home at the time of the procedure and one of these two patients was in a nursing home only because of her 100 year-old husband's needs.

Procedural and post-procedural characteristics are

Discussion

Our results show that TAVI in selected nonagenarians is safe and effective. This is extremely important since patients in their nineties represented 26% of the patients undergoing TAVI in our institution, during the study period. Before the TAVI era, nonagenarians with severe symptomatic AS were mainly treated conservatively. However, this approach frequently failed to adequately improve symptoms and quality of life [12].

To the best of our knowledge this is only the second report of TAVI

Study limitations

We report a single center prospective observational registry with a small sample size and no comparative groups of severe AS patients treated by surgery or medical therapy alone.

Our echo parameters were not monitored by an external core-laboratory, but all patients had follow-up TTE between 6 months and one year in our center.

Conclusions

TAVI is safe and effective even in a selected population of nonagenarians. A multi-disciplinary approach to assess these patients is essential in order to correctly select appropriate candidates. General conditions such as comorbidities, functional level and quality of life may be more important variables to be taken into account than age alone.

Learning points

•
TAVI is safe and effective even in a selected population of nonagenarians.
•
Age itself should not preclude the possibility of undergoing TAVI.
•
Patient's motivation and general conditions are more important than age alone.
•
A multi-disciplinary approach is crucial to select appropriate candidates.

Conflict of interest

S. Noble is consultant for Medtronic. No disclosure to be reported for the other authors. Medtronic had no role in the design, subject recruitment or preparation of this manuscript. There was no industry funding for this manuscript.

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Cited by (32)

Long-Term Survival and Quality of Life Following Transcatheter Aortic Valve Replacement in Nonagenarians
2024, American Journal of Cardiology
Transcatheter aortic valve replacement (TAVR) has emerged as a successful treatment option for severe aortic stenosis. However, the long-term outcomes of TAVR in nonagenarians is lacking. We aimed to examine the long-term mortality and quality of life in nonagenarians after TAVR. This is a multicenter, retrospective analysis on patients with severe aortic stenosis who underwent TAVR. Patients were divided into 2 groups: nonagenarians (age ≥90 years) and age <90 years. The Kansas City cardiomyopathy questionnaire (KCCQ) and New York Heart Association (NYHA) scores were compared before and after TAVR. All-cause mortality was compared between both groups at 30 days, 1 year, and 5 years after TAVR using the Cox proportional hazard model. A total of 6,896 patients were included, of whom 591 were nonagenarians. Nonagenarians had a higher Society of Thoracic Surgeons perioperative risk of mortality (8.1 ± 4.6% vs 5.4 ± 4.2%, p <0.001) before TAVR. Both groups were similar in KCCQ and NYHA scores at baseline. At 1 year after TAVR, there was no significant difference in improvement in the KCCQ overall score between those aged <90 years and nonagenarians (−4.76, 95% confidence interval [CI] −11.4 to 1.9, p = 0.161). Similarly, there was no statistically significant difference in improvement in NYHA class between the 2 groups at 1 year (odds ratio 1.07, 95% CI 0.85 to 1.25), p = 0.526). The unadjusted 30-day (3.2% vs 2.7%, hazard ratio 1.11, 95% CI 0.70 to 1.80, p = 0.667) and 5-year (28.0% vs 26.6%, hazard ratio 1.05, 95% CI 0.89 to 1.24, p = 0.60) all-cause mortality were similar between the 2 groups. In conclusion, this study demonstrates an excellent long-term mortality rate at 5 years after TAVR in nonagenarians, comparable to patients younger than 90 years. There is a significant and enduring improvement in functional status in nonagenarians, observed up to 1 year after TAVR.
TAVR in nonagenarians: An analysis investigating safety, efficacy, symptomatic improvement, and long-term survival
2021, Journal of Cardiology
In the aging western societies, an increasing prevalence of severe, symptomatic aortic stenosis is observed. The aim of this study was to examine the safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients aged 90 years and older.
All patients with severe symptomatic aortic stenosis undergoing TAVR at LMU Munich-University-Hospital between 2013 and 2018 were included. Procedure-related mortality (<30 days) was defined as the primary endpoint and survival rates at two years, device failure, and procedural complications were defined as secondary endpoints according to the Valve Academic Research Consortium II criteria.
Out of 2336 patients, 2183 were younger than 90 years (<90y.-group) and 153 patients were aged 90 or older (≥90y.-group). Procedure-related mortality (3.6% <90y.-group vs. 3.3% ≥90y.-group, log-rank p=0.9) and device success (97.2% <90y.-group vs. 96.0% ≥90y.-group, p=0.44) were similar. Estimated survival rates at 2 years were 62.8% (95% CI 55.3 and 71.4) in the elder and 76.0% (95% CI 74.1 and 77.8) in the younger patients (p<0.01). The incidence of acute kidney injury, stroke, major bleeding, and permanent pacemaker implantations were comparable between both groups.
TAVR procedure is equally safe and feasible in patients aged 90 years or older compared to younger patients. Differences in 2-year survival appear to be patient-related rather than procedure-related.
Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation
2020, European Journal of Internal Medicine
Citation Excerpt :
Transcatheter aortic valve implantation (TAVI) has been proven to be the preferred procedure for patients with symptomatic aortic stenosis (AS) who do not qualify for surgery [1-2]. TAVI has been recently showed to present similar or even inferior all-cause mortality rates compared to surgery [3], thus representing a valid alternative also in the elderly [4]. Acute kidney injury (AKI) is one of the strongest predictors of mortality after TAVI and has been associated with worsened short- and long-term cardiovascular (CV) outcomes.
Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. However, the impact on outcome of AKI in TAVI-patients is not well established.
Inoperable patients with severe aortic stenosis (AS) undergoing TAVI in 2010-2018 were enrolled in this study. AKI and chronic kidney disease (CKD) were defined according to KDIGO guidelines. Patients were divided in two groups according to post-procedural AKI development. The primary endpoint was 30-day all-cause mortality across the two groups.
A total of 373 patients (mean age 82.3 ± 6) were analyzed. Compared to non-AKI patients, those who developed AKI, were treated more frequently with trans-apical TAVI (66% vs 35%, p<0.01), with greater amount of contrast medium (200.6 vs 170.4 ml, p=0.02) and in presence of clinically significant peripheral artery disease (PAD, 33% vs 21%, p=0.04). Trans-apical access (OR 3.24, 95% CI 1.76-5.60, p<0.01) was associated with a 3-fold risk of AKI. After adjustment for age, Society of Thoracic Surgery risk score (STS), PAD, access type, EF and contrast medium amount, patients with AKI presented an increased risk of 30-day all-cause mortality (HR=1.25, 95%CI 1.09-1.69, p=0.008). Patients with CKD IV and V, who developed AKI, presented a 9-fold 30-day mortality risk (HR=9.71, 95% CI 2.40-39.2, p=0.001).
In our analysis, AKI was a strong predictor of 30-day all-cause mortality. Particularly, patients with severe CKD with AKI showed the highest 30-day mortality risk. Thus, this group of patients might benefit from closer monitoring and specific kidney protection therapies.
Comparison of Outcomes of Transfemoral Aortic Valve Implantation in Patients <90 With Those >90 Years of Age
2018, American Journal of Cardiology
Citation Excerpt :
Our study shows that nonagenarian patients have very acceptable procedural and mid-term results compared with younger controls, when treated with TF-TAVI. Several earlier studies have shown that TAVI is feasible and safe in nonagenarians,6,8,16–19 a finding that we have confirmed in our study. In the current literature, 30-day mortality varies from 3.2% to 12.0%, depending on the access route used.
In patients who underwent transcatheter aortic valve implantation (TAVI), postoperative mortality risk is commonly assessed with risk scores such as the Society of Thoracic Surgeons—Postoperative Risk of Mortality (STS-PROM) and EuroSCORE II, in which age plays a dominant role. However, we reason that in the naturally selected oldest-old patients (nonagenarians), this may not be completely justified and that therefore age should play a minor role in decision-making. The objective of this study was to compare procedural outcome and mid-term mortality of transfemoral (TF)-TAVI patients aged ≥90 years with patients aged <90 years. In this single-center analysis of 599 prospectively acquired consecutive TF-TAVI patients between 2009 and 2017, we compared patients aged ≥90 (i.e., nonagenarians, n = 47) with patients aged <90 years (n = 552), using Kaplan-Meyer analysis and multivariate logistic regression. In the nonagenarians, we found more aortic regurgitation, moderate to severe paravalvular leakage, strokes and vascular complications, and less device success and bleeding complications compared with patients <90 years. Both groups showed similar symptomatic improvement. The predicted (STS-PROM) and actual procedural mortality were 8.033% and 2.1% (3.8×) and 4.868% and 1.8% (2.7×) for the nonagenarians and controls, respectively. Survival was not statistically different at the 1-, 2-, 3-, 4-, and 5-year mark. In conclusion, nonagenarians had similar symptomatic improvement and acceptable procedural outcome and mid-term survival to TF-TAVI patients aged <90 years. Thus, age is not a risk factor in predicting postoperative outcome and mortality and therefore should not be a reason to deny the oldest-old patient transfemoral TAVI.
Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians? Insights from the STS/ACC TVT Registry
2016, Journal of the American College of Cardiology
Citation Excerpt :
Although these patients are at increased risk for morbidity and mortality after TAVR simply on the basis of their age, our findings show that many nonagenarians have good outcomes after TAVR, with prolonged survival and improved QOL, making TAVR reasonable to consider in select nonagenarians with severe AS. Most of the existing studies report on single-center experiences with small patient cohorts and thus may only provide limited decision-making information on the outcomes of nonagenarians undergoing TAVR (6–9,17). In the largest previous study on TAVR in nonagenarians (346 nonagenarians of 2,254 enrolled patients; reported from the FRANCE-2 [French National Transcatheter Aortic Valve Implantation Registry]), Yamamoto et al. (18) demonstrated a 30-day mortality of 11.2% in nonagenarians without any significant difference compared with patients age 80 to 84 years or 85 to 89 years (18).
Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations.
The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice.
We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire.
Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs. <90 years: 30-day: 8.8% vs. 5.9%; p < 0.001; 1 year: 24.8% vs. 22.0%; p < 0.001, absolute risk: 2.8%, relative risk: 12.7%). However, nonagenarians had a higher mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score (10.9% vs. 8.1%; p < 0.001) and, therefore, had similar ratios of observed to expected rates of 30-day death (age ≥90 years vs. <90 years: 0.81, 95% confidence interval: 0.70 to 0.92 vs. 0.72, 95% confidence interval: 0.67 to 0.78). There were no differences in the rates of stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year. Nonagenarians had lower (worse) median Kansas City Cardiomyopathy Questionnaire scores at 30 days; however, there was no significant difference at 1 year.
In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.
TAVR in Nonagenarians: Pushing the Boundaries
2016, Journal of the American College of Cardiology

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Original articleTranscatheter aortic valve implantation in nonagenarians: Effective and safe

Highlights

Abstract

Background

Methods

Results

Conclusions

Introduction

Section snippets

Patient population

Results

Discussion

Study limitations

Conclusions

Learning points

Conflict of interest

J Am Coll Cardiol

J Am Coll Cardiol

J Psychiatr Res

Am J Cardiol

J Am Coll Surg

Ann Thorac Surg

Am J Cardiol

HPB (Oxford)

JACC Cardiovasc Interv

Ann Thorac Surg

Ann Thorac Surg

Aging, cumulative disability, and the compression of morbidity

Compr Ther

The theory and practice of active aging

Curr Gerontol Geriatr Res

Original article
Transcatheter aortic valve implantation in nonagenarians: Effective and safe