Outcomes in Nonagenarians Undergoing Transcatheter Aortic Valve Replacement in the PARTNER-I Trial

Thourani, Vinod H.; Jensen, Hanna; Babaliaros, Vasilis; Kodali, Susheel; Rajeswaran, Jeevanantham; Ehrlinger, John; Blackstone, Eugene H.; Suri, Rakesh M.; Don, Creighton W.; Aldea, Gabriel S.; Williams, Mathew; Makkar, Raj; Svensson, Lars; McCabe, James M.; Dean, Larry S.; Kapadia, Samir; Cohen, David J.; Pichard, Augusto D.; Szeto, Wilson Y.; Herrmann, Howard C.; Devireddy, Chandan; Leshnower, Bradley G.; Ailawadi, Gorav; Maniar, Hersh S.; Hahn, Rebecca T.; Leon, Martin B.; Mack, Michael J.

doi:10.1016/j.athoracsur.2015.05.021

Cited by 41 publications

(38 citation statements)

References 29 publications

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“…(25) Our data confirm these findings. We found that there was a significant increase in KCCQ scores by 30-days, but scores were significantly lower in nonagenarians compared to younger patients.…”

Section: Discussionsupporting

confidence: 90%

Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians?

Arsalan

Szerlip

Vemulapalli

et al. 2016

Journal of the American College of Cardiology

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Background Despite clinical trial evidence and clinical experience supporting the efficacy of transcatheter aortic valve replacement (TAVR), data demonstrating the benefit of TAVR specifically in the very elderly patients are limited, as they often represent only a small proportion of the clinical trial populations. Objectives To compare the outcomes of nonagenarians to younger patients undergoing TAVR in current clinical practice. Methods National U.S. data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry were analyzed. Outcomes at 30-days and 1-year were compared between patients ≥90 vs <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Results Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90. The 30-day and 1-year mortality was significantly higher among nonagenarians (≥90 vs. <90: 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 STS PROM score(10.9% vs. 8.1%; p<0.001) and therefore had similar ratios of observed to expected rates of 30-day death (≥90 vs. <90: 0.81, 95% CI 0.70–0.92 vs. 0.72, 95% CI 0.67–0.78). 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 KCCQ-12 scores at 30-days; however, there was no significant difference at 1-year. Conclusions In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality was 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.

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Section: Discussionsupporting

confidence: 90%

Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians?

Arsalan

Szerlip

Vemulapalli

et al. 2016

Journal of the American College of Cardiology

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“…The authors concluded that age alone should not preclude referral for TAVI, as TAVI can be performed in nonagenarians with acceptable short-and mid-term outcomes; transapical TAVI appears to carry a higher risk of early death without a difference in intermediateterm mortality. Nevertheless, the poorer outcome of the transapical approach has been confirmed by many other studies, as well (15,17,21,22). Indeed, routes other that the transfemoral approach seem to be of much higher risk and probably futile (15).…”

Section: Transfemoral Versus Other Routementioning

confidence: 54%

“…As deduced from studies reporting results of TAVI in nonagenarians summarized in Table 1, TAVI, as long as it is performed via the transfemoral route, is feasible and relatively safe and effective in this patient subpopulation, albeit at higher risk compared to younger patients, with satisfactory short-and mid-term outcomes, however, long-term data are meagre (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22). Procedural and 30-day mortality ranges from 0% to 27%, hovering around 10%, stroke risk ranges from 2% to 18% (average 3-4%), bleeding and vascular complications range from 9% to 34% (average ~16%), renal insufficiency ranges from 1% to 10%, while the emerging need for a pacemaker has a wide range depending on the type of valve employed (5-30%) (41).…”

Section: Clinical Outcomesmentioning

confidence: 99%

“…The authors propose that these findings suggest that nonagenarians may recover more slowly after TAVI and thus need more time until the beneficial effect of the procedure is appreciable. In another QoL data analysis in 531 nonagenarians from the PARTNER I trial, the authors reported that by 6 months, most QoL measures had stabilized at a level considerably better than baseline (17).…”

Section: Qolmentioning

confidence: 99%

“…According to a study reporting short-and mid-term outcomes of 531 nonagenarian patients undergoing transfemoral (n=329) or transapical (n=202) TAVI in the PARTNER-I trial (17), the post-procedure 30-day stroke risk was 3.6% vs. 2% for the two groups; major adverse events occurred in 35% vs. 32% of patients; 30-day paravalvular leak was greater than moderate in 1.4% vs. 0.61%; median post-procedure length of stay was 5 vs. 8 days. Thirty-day mortality was 4% vs. 12% and 3-year mortality 48% vs. 54% (44% vs. 42% for the matched population).…”

Section: Transfemoral Versus Other Routementioning

confidence: 99%

See 2 more Smart Citations

Transcatheter aortic valve implantation in nonagenarians: selectively feasible or extravagantly futile?

Manolis¹,

Manolis²

2017

Ann. Cardiothorac. Surg.

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A growing number of nonagenarians is recorded as life expectancy increases. Unfortunately, this extreme-aged group is plagued by increased prevalence of aortic stenosis amidst a higher occurrence of comorbidities that pose dilemmas to cardiologists and cardiac surgeons when having to choose a conservative or interventional treatment modality, and a surgical or transcatheter aortic valve implantation (TAVI) approach. TAVI is an expensive procedure, which also confers a higher mortality and morbidity risk in nonagenarians, compared to younger patients. Considering the physiologic rather the chronologic age alone, and adopting a shared-decision making approach (participatory medicine), it may be more realistic to determine a patient's candidacy for this non-surgical therapeutic modality. Thus, it comes down to the patient selection process by having the heart team review each nonagenarian case individually and getting the patient and the family involved, always aiming to prolong and improve patient's quality of life (QoL), but also taking into consideration patient preferences and values, sharing and respecting goals, realistic expectations, and end-of-life views and ideas. One should keep in mind that there is always the possibility that TAVI may be clinically futile for patients who have a multitude of comorbidities and extreme frailty, for whom a transition to palliative care might be prudent. Selecting nonagenarian patients with low comorbidity index and with no extreme frailty, adopting a minimalistic approach and paying attention to vascular access hemostasis may provide the elements that may lead to a successful, desirable and hopefully cost-effective outcome.

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