One in 5 cases of severe symptomatic aortic stenosis (AS) in the European EORP VHD II survey received no intervention in 2017 despite meeting the European Class I recommendation to intervene.
The figures show a marked drop in decisions not to intervene compared to 2001, when 1 in 3 patients in the Euro Heart Survey received no intervention, said the authors, led by Marc Eugène, MD, from the Assistance Publique–Hôpitaux de Paris and Université de Paris.
“Older age and combined comorbidities were linked with the decision not to intervene, whereas there was no longer any relationship with left ventricular ejection fraction [as there was in 2001], suggesting more appropriate risk-benefit analysis for decision making in the 2017 VHD II survey than in the 2001 Euro Heart Survey,” the researchers said.
The findings from the survey of clinical decision-making in valvular heart disease (EURObservational Research Programme Valvular Heart Disease II) were reported Monday online ahead of the Nov. 30 issue of the Journal of the American College of Cardiology.
Calcific AS is the most prevalent valvular heart disease (VHD) for which high-income country patients are referred to hospital, affecting around 3% to 5% after the age of 75 years, the researchers noted.
There are “strong recommendations” in place for aortic valve replacement, given poor severe symptomatic AS prognosis and positive results with surgical and transcatheter intervention, they added. This includes the European Society of Cardiology’s (ESC) recommendations, which have been updated regularly since the 2000s, and which “may have changed clinical decision making.”
Nevertheless, there have remained some gaps between guideline and practice when surgery is the only treatment for AS, the researchers said. The current study therefore set out to analyze therapeutic decision-making data from 2,152 severe AS patients in the EORP II survey – recruited between January and August 2017 – to determine the factors in decisions not to intervene as compared with the 2001 Euro Heart Survey, and assess the relationship between decision and 6-month survival.
The patients were over 18 years of age and were included in the survey if they had severe native VHD as defined by echocardiography using an integrative approach, or if they had undergone any previous surgical or transcatheter valvular intervention, and were followed up at 6 months.
Of these patients, 1,271 with high-gradient symptomatic AS fulfilled a Class I recommendation for intervention according to the 2012 ESC guidelines, and in turn, a decision not to intervene was taken in 262 (20.6%) of these patients.
A decision not to intervene was associated with a 6-month survival rate of an 87.4% (95% confidence interval [CI]: 82% to 91.3%) – significantly lower than intervention (94.6%; 95% CI: 92.8% to 95.9%; P < 0.001).
Older patients were more frequently the subject of decisions not to intervene (odds ratio [OR]: 1.34 per 10-year increase; 95% CI: 1.11 to 1.61; P = 0.002), as were those with higher age-adjusted Charlson comorbidity index (OR: 0.81 per 10-mmHg decrease; 95% CI: 1.10 to 1.17; P = 0.03).
Decisions not to intervene were also associated with New York Heart Association (NYHA) functional classes I and II versus III (OR: 1.63; 95% CI: 1.16 to 2.30; P = 0.03) and a lower transaortic mean gradient (OR: 0.81 per 10-mmHg decrease; 95% CI: 0.71 to 0.92; P < 0.001).
Jointly, the decision not to intervene in patients aged ≥75 years and in NYHA functional classes III and IV fell from 33.3% in 2001 to 21.8% in the current study, the researchers stressed.
“This marked improvement in adherence to guidelines may relate to publication of ESC guidelines on VHD in 2007 and 2012 and their consistency with AHA/ACC guidelines. In addition, the availability of TAVR led to intervention in more patients with AS during the last decade,” they said.
The researchers also highlighted “important geographical discrepancies,” with the decision not to intervene proportionally much higher in Southern Europe (51.5%) than any other region, followed by Eastern Europe (27.1%). Otherwise, decision-not-to-intervene rates were 17.2% in Western Europe, 3.4% in Northern Europe and 0.8% in the 12 patients in North Africa.
Of those who did receive an intervention during the study period, 346 (40.2%, median age 84 years, median EuroSCORE II 3.1%) underwent transcatheter intervention (333 transcatheter aortic valve replacement and 13 balloon aortic valvuloplasty), while 515 (58.8%, median age 69 years, median EuroSCORE II 1.5%) underwent surgical aortic valve replacement. Transcatheter intervention was extensively used in octogenarians, the researchers said.
Need for increased awareness
“The present findings support guideline-based educational initiatives aimed at practitioners and patients to improve early referral and health care policies that homogenize access to TAVR across different regions,” the researchers concluded.
They stressed that repeated surveys assessing guideline implementation are necessary to improve patient outcomes because the evolution of transcatheter techniques will continue to change management.
For instance, the advent of TAVR enabled the consideration of intervention in a wider range of patients with AS, they said.
“Another novel finding is that patients are still referred at an advanced stage of disease because a decision to intervene was less frequently taken in patients with mild symptoms,” they said, stressing the need for increased awareness toward patients with severe AS “as soon as they develop mild symptoms (NYHA functional class II dyspnea) because they derive the greatest benefit from valvular intervention”.
“The timing of surgery should also be improved because only one-half of the patients who had intervention scheduled actually underwent intervention within 6 months. When intervention is scheduled, it should be performed rapidly because of the risk of death during prolonged waiting times.”
In an accompanying editorial, Patrick T. O’Gara, MD, Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues agreed that “efforts to identify patients with AS at an earlier time point in the natural history of their disease” is important, “to facilitate their evaluation by a multidisciplinary heart team in a center offering both surgical and transcatheter intervention are critical to improving outcomes.”
The editorialists also called for improved patient awareness, community screening, access to care, resource allocation and clinician education because the findings “imply that practice gaps are closing, though there is clear room for further improvement.”
Eugène M, Duchnowski P, Prendergast B, et al. Contemporary Management of Severe Symptomatic Aortic Stenosis. J Am Coll Cardiol 2021;78:2131-2143.
O’Gara PT, Sun Y-P, Patel SM. Referral for Intervention in Severe Symptomatic Aortic Stenosis: Some Progress But Further Room for Improvement. J Am Coll Cardiol 2021;78:2144-2146.
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