“Urgent” action needed to improve outcomes in women undergoing coronary artery bypass surgery

Women have been found to have significantly higher risk of operative mortality and postoperative complications after isolated coronary artery bypass (CABG) when compared with men. Results from a retrospective cohort study of over a million US patients were released today, revealing the “essentially unchanged” excess operative risk for women between 2011 and 2020.

PUBLISHED ONLINE IN JAMA

Surgery, the investigators assert theirs is the first to provide “contemporary nationwide analysis” in operative mortality and morbidity trends for women undergoing CABG in the US. Women, the authors preface, are more commonly older and have a higher prevalence of cardiovascular risk factors when presenting for CABG. However, despite a national upward trend in CABG outcomes over the past decades, it is “unclear” why this improvement has remained static for women, the researchers state.

Led by Mario Gaudino (Weill Medical College, New York, USA) the authors reviewed data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STSACSD), comparing outcomes between men (979,488 [75.5%]) and women (317,716 [24.5%]). Spanning 110 participating centres, the STS-ACSD represents over 95% of the US cardiac surgical volume, and was evaluated by the authors using the primary analytic method to estimate the association

At one year follow-up, Akowuah et al recorded that all secondary outcomes were not significantly different between the two groups. Despite one mini-thoracotomy patient requiring a secondary operation due to bleeding, the researchers found mini-thoracotomy patients typically spent a median of five days in hospital—compared to six days for sternotomy patients—and were more likely to be discharged early.

Reflecting on the significance of their findings, Akowuah highlighted that speed of recovery to ultimately regain physical function and return to normal activities is important for patients. “Our results show that at three months, physical recovery is equivalent in both groups of patients,” he said. “In addition, we show that when both surgical procedures are performed by expert surgeons, minimally invasive mitral valve surgery is as safe and effective as conventional surgery.”

Answering focal questions about the effectiveness of approaches, the authors state their study confirms the valve repair rate and the quality and durability of valve repair when using mini-thoracotomy. Akowuah asserted: “Valve repair rates were excellent [at 96%] and similar to those obtained with sternotomy. Moreover, at one year after surgery more than 92% of patients in both groups had no or mild valve leakage.” of female sex with CABG operative outcomes over time.

Asserting their primary and secondary endpoints as operative mortality and combined mortality and morbidity respectively, Gaudino et al found their primary endpoint revealed significantly higher unadjusted mortality when compared with men (2.8% vs 1.7%; p<0.001). Their secondary endpoint also yielded significant results, showing the overall incidence of the composite of operative mortality and morbidity to be 22.9% for women (95% CI, 22.7–23.0) and 16.7% for men (95% CI, 16.6–16.8) (p<0.001).

Regarding trends over time, Gaudino and colleagues report that unadjusted mortality in women increased from 2.9% in 2011 to 3.3% in 2020, while adding the operative risk attributable to female sex varied from 1.28% in 2011 to 1.41% in 2020, showing no improvement over time.

“The reason for the lack of improvement in outcomes for women in the last decade is unclear,” the authors write. However, they recognise there are clear differences in baseline anatomical and clinical characteristics between men and women—such as the pattern of ischaemic heart disease— alluding to revascularisation being less beneficial in some cases.

The authors point out, however, that current diagnostic and therapeutic protocols for coronary revascularisation, including studies comparing coronary artery bypass with percutaneous coronary intervention (PCI) are “all informed by data derived from studies performed prevalently in men”, and so provide “inadequate” generalisability to women.

Addressing the larger significance of their results, the authors believe a “multifactorial” approach is required to reduce mortality in women after CABG. They affirm that it is important that sex disparities are evaluated in basic science research and women enrolled in clinical trials, and Gaudino et al conclude that “further investigation in the determinants of operative outcomes in women is urgently needed”.

News, reflecting that there are now various trials supporting the use of intravascular imaging, coupled with the consensus statement from ACC. “Overall, intravascular imaging offers the ability to perform more optimal and precise PCI, reduce short and long-term outcomes and preserve a safety profile that places the patient at little risk.

Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea).

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The researchers also reported that intracoronary imaging was associated with lower rates of one-year mortality, myocardial infarction (MI), repeat PCI procedures, and major adverse cardiac events (MACE).

Research from outside of the USA paints a picture of similar trends elsewhere. A paper from the UK, authored by Mohamed O Mohamed (Keele University, Keele, UK), published in the Journal of the American Heart Association (JAHA) in late 2022, points to a more than doubling of intracoronary imaging usage in England and Wales between April 2014 and March 2020, with better rates of in-hospital survival for intracoronary imaging-guided PCI than angiographyguided PCI for specific indications. Despite this trend, the authors of the study noted that intracoronary imaging remains underused with fewer than one in five cases using these modalities nationally in 2020.

“I do think we are at a turning point,” Secemsky told Cardiovascular

“We all need to overcome our own personal barriers to use—whether its perceived added procedural time or discomfort with imaging interpretation—to provide the best care for our patients. I think that we are approaching a moment where greater adoption will follow, similar to what we saw with radial artery access, and continued investment in this technology and improving procedural workflow will position the PCI field for improved outcomes guided by intravascular imaging.”

Truesdell also drew the parallel with the uptake of radial access amongst the interventional cardiology community, adding that the change may have been driven by a younger generation.

“Radial uptake lagged years behind the safety and outcomes data for many of the same reasons—habit, training, ability and willingness to train and evolve mid-career—but ultimately arrived at an inflection point as more and more younger interventionalists exited the training pipeline into practice with familiarity and comfort with radial access and helped raise up their peers,” Truesdell commented. “I think the same will occur over the next few years with intravascular imaging.”

Among the latest studies in the field is RENOVATE-COMPLEX-PCI, results from which were presented at the ACC meeting by Joo-Yong Hahn (Samsung

Results of the randomised TRILUMINATE pivotal trial indicate that transcatheter repair in symptomatic tricuspid regurgitation (TR) patients using the Triclip (Abbott) system was effective in reducing TR and led to improvements in quality of life at one year.

HOWEVER, THE RESULTS DID NOT SHOW any significant difference in survival or heart failure hospitalisation between patients treated with the interventional approach or with medical therapy, the study’s control arm, with the superiority of the device in meeting its composite primary endpoint primarily driven by improvements in quality of life for patients. Presented during the opening late-breaking trial session of the American College of Cardiology (ACC) annual scientific session (4–6 March, New Orleans, USA), by Paul Sorajja (Minneapolis Heart Institute Foundation, Minneapolis, USA) and published

Eric Secemsky

The prospective, multicentre, openlabel trial, was conducted in 20 sites throughout South Korea, where use of intravascular imaging modalities is more routine. Findings were simultaneously published in the New England Journal of Medicine (NEJM)

The study was set up with the intention to investigate whether intravascular imaging-guided PCI would improve outcomes as compared with

(n=1,092) or angiography-guided PCI (n=547), assessing the outcome of each approach against the composite primary endpoint of cardiovascular death, targetvessel MI, or clinically driven targetvessel revascularisation, as well as the safety of the procedures.

Hahn reported that at a median follow-up of 2.1 years, a primary endpoint event occurred in 76 patients (cumulative incidence 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence 12.3%) in the angiography group (hazard ratio [HR] 0.64; 95 confidence interval [CI] 0.45 to 0.89; p=0.008).

Death from cardiac causes occurred in 16 patients (cumulative incidence 1.7%) angiography-guided PCI in patients with complex coronary artery lesions. Complex lesions were defined as true bifurcation lesions, with a side branch diameter of at least 2.5mm, a chronic total occlusion, unprotected left main coronary artery disease, long coronary artery lesions, multivessel PCI, a lesion involving in-stent restenosis, a severely calcified lesion, or ostial lesions of a major epicardial coronary artery.

A total of 1,639 patients were randomised in a 2:1 ratio to undergo either intravascular imaging-guided PCI simultaneously in the New England Journal of Medicine (NEJM), the results from 350 patients are “very meaningful for a highly symptomatic population whose quality of life is impacted by TR”, investigators have suggested.

TRILUMINATE Pivotal saw patients considered to be at intermediate or greater risk for tricuspid valve surgery randomised 1:1 to receive either transcatheter repair using the Triclip device or medical therapy at centres throughout North America and Europe. Patients in Sorajja’s one-year report had a median age of 78 years and the population consisted of 55% women.

All patients enrolled in the trial had severe tricuspid regurgitation and heart failure symptoms despite receiving medical therapy, and 51% had torrential tricuspid regurgitation. Most patients had either atrial fibrillation (AF), high blood pressure, or both. Patients who had severe left ventricular heart failure, untreated other valvular disease or severe pulmonary hypertension were not eligible to enrol.

Headline findings at 12 months presented by Sorajja indicate that the trial met the primary endpoint, a composite of mortality or tricuspid valve surgery, heart failure hospitalisation, and quality of life improvement ≥15 points assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), evaluated in a hierarchical fashion using the Finkelstein Schoenfeld methodology favour transcatheter therapy (win ratio 1.48; 95% confidence interval 1.06 to 2.13; p=0.02).

Sorajja reported that the trial saw a significant reduction to moderate or less TR (grade <2) achieved in 87% of patients in the device arm at 30 in the intravascular imaging group and in 17 patients (cumulative incidence 3.8%) in the angiography group; target vessel-related myocardial infarction occurred in 38 (cumulative incidence 3.7%) and 30 (cumulative incidence 5.6%), respectively; and clinically driven target vessel revascularisation in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events. days, compared to 4.8% in the control group. TR reduction was sustained at one year, according to the investigators.

Added to this, patients receiving the device saw a significant improvement in quality of life, with 50% of the investigational group reporting at least a 15-point improvement in KCCQ score at one year, next to 26% in the control group. The rate of hospitalisation for heart failure did not appear to differ between the groups.

“Patients with TR transcatheter edge-to-edge repair (TEER) with the TriClip device, experienced significant improvements in quality of life,” said Sorajja, the lead author of the study. “In a patient population with a high symptom burden, this is a meaningful benefit.”

Allied to the efficacy findings, investigators also reported that three patients (1.7%) had a major adverse event at 30 days (one death due to a cardiovascular cause and two cases of new kidney failure). Nine patients treated with TEER (5.2%) experienced a major bleeding event within one year. Five patients in the TEER group (2.9%) and five in the control group (2.9%) needed surgery to implant a permanent pacemaker or defibrillator within one year.

One limitation of the study is that it was unblinded, according to Sorajja—who relayed that patients and their clinicians knew who had received TEER and who had not. However, independent experts who were blinded to patient treatment assessed the hospitalisations, deaths and other adverse events that occurred in the study.