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Featured topics and Editors' Picks from all of ACC's JACC Journals.
Research Finds TMVR With Tendyne Yields Favorable LV Remodeling
Transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis resulted in favorable left-sided chamber remodeling in the majority of patients treated, as detected on computed tomographic angiography (CTA) at one month after implantation, according to a study presented as a poster during ESC Congress 2020 and simultaneously published in JACC: Cardiovascular Interventions.
The study also showed that CTA identifies favorable post-TMVR changes, which could be related to specific characteristics of the device implantation.
Miho Fukui, MD, PhD, et al., used CTA to assess the anatomic and functional changes in left-sided chambers from baseline to one month after TMVR with the Tendyne prosthesis in a substudy of 36 patients who had participated in a feasibility study of the Tendyne mitral valve system or received it under compassionate use between 2015 and 2018. The median age of the patients in the substudy was 74 years, most (78%) were men, and 86% had secondary mitral regurgitation.
Results showed there were significant decreases in left ventricular (LV) end-diastolic volume (281 ml vs. 239 ml; p<0.001), LV ejection fraction (37% vs. 30%; p<0.001), LV mass (126 g vs. 116 g; p<0.001), left atrial volume (171 ml vs. 159 ml; p=0.027), and global longitudinal strain (–11% vs. –9%; p<0.001) from baseline to one-month follow-up.
In addition, the researchers found that favorable LV end-diastolic volume reverse remodeling occurred in 30 of 36 patients, and that closer proximity of the Tendyne apical pad to the true apex (24 mm vs. 35 mm) was predictive of favorable remodeling (p=0.037).
"These findings could have potential implications for expanding the role of CTA to optimize patient outcomes, selection, and implantation characteristics for the Tendyne system and the field of TMVR," the researchers conclude.
In an accompanying editorial comment, Michael Nabauer, MD, and Mathias Orban, MD, note that "the findings of Fukui et al. are a snapshot only one month after the procedure and need to be validated at longer follow-up times and by clinical outcome parameters."
They add, "Whether there is a favorable pad location in terms of LVRR [left ventricular reverse remodeling] that affects symptomatic improvement and long-term mortality, remains to be seen."
Fukui M, Sorajja P, Gössl M, et al. JACC Cardiovasc Interv 2020;Aug 28:[Epub ahead of print].
PCSK9 With Statin Provides Safe Approach in AMI Patients Undergoing Primary PCI
Early administration of a PCSK9 inhibitor in addition to a statin may provide a feasible and safe therapeutic approach for patients with acute myocardial infarction (AMI) undergoing primary PCI, according to a study simultaneously published in JACC: Cardiovascular Interventions and presented as a poster during ESC Congress 2020.
Tomoaki Okada, MD, et al., assessed the four-week efficacy of PCSK9 inhibitor therapy combined with a statin in patients who underwent primary PCI for AMI in a single center, prospective open-label randomized trial.
A total of 102 Japanese patients (88% male, 26% previously treated with a statin) participated in the trial and they all received pitavastatin (2 mg/day). Of the 102 patients, 52 received evolocumab (140 mg) subcutaneously within 24 hours after the indexed PCI and two weeks later, and 50 patients did not (control group).
Baseline LDL-C levels were 120.8 mg/dL and 124.7 mg/dl in the treatment and control groups, respectively.
Results showed the change in LDL-C levels from baseline to four weeks was –76.1% and –33.1% in the evolocumab and control groups, respectively (mean difference, –43.9%; 95% confidence interval, –52.1 to –35.6 mg/dL; p<0.001). LDL-C levels of <70 mg/dL at four weeks were achieved in 100% and 27% of the patients in the evolocumab and control groups, respectively. In the evolocumab group, researchers also found that LDL levels of <55 mg/dL were achieved in 92% of patients at two weeks and 96% of patients at four weeks.
In the evolocumab and control groups, the change in non–HDL-C was –66.2% and –26%, respectively; the change in HDL-C was 2.8% and –0.7%, respectively; and the change in small dense LDL was –67.3% and –13.8%, respectively. Lipoprotein(a) levels decreased by –2.7% in the evolocumab group and increased by 82% in the control group. The number of adverse events and serious adverse events in the evolocumab and control groups did not differ significantly.
"Notably, this study demonstrated that evolocumab with pitavastatin substantially reduced small dense LDL levels and mitigated lipoprotein(a) increase in patients after AMI compared to statin alone," write the authors of the study.
"Statin therapy significantly increased lipoprotein(a) levels by 10-20%. Here, lipoprotein(a) levels increased in the control but not in the evolocumab group, suggesting the benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels after AMI."
Okada T, Doi M, Miyoshi T, et al. JACC Cardiovasc Interv 2020;Aug 28:[Epub ahead of print].
Do Current Risk Models Accurately Predict Lifetime, 10-Year Cancer Risk in CV Disease Patients?
The lifetime and 10-year risk of total cancer, colorectal cancer and lung cancer can be estimated "reasonably well" with available clinical predictors in patients with cardiovascular disease, according to a study during ESC Congress 2020 and simultaneously published in JACC: CardioOncology.
Cilie C. van 't Klooster, MD, et al., sought to develop and validate prediction models for estimated lifetime and 10-year risk of total, colorectal and lung cancers in patients with established cardiovascular disease.
The researchers developed the model using data from 7,280 patients from the Dutch UCC-SMART trial, which looked at manifestation of arterial disease. The model was then validated using a cohort of 9,322 patients from the CANTOS trial, which evaluated the efficacy of canakinumab in preventing adverse cardiovascular events.
Predictors to assess cancer risk included age, sex, smoking status, weight, height, alcohol use, use of antiplatelet medication, presence of diabetes and C-reactive protein levels. Total cancer was defined as the first diagnoses of any invasive neoplasm, excluding nonmelanoma skin cancer. For colorectal and lung cancers, the researchers counted the first diagnosis of that particular cancer.
For internal validation, there was "good agreement" between the predicted and observed 10-year risk for total cancer (0.61; 95% confidence interval [CI], 0.59-0.63); colorectal cancer (0.61; 95% CI, 0.57-0.66); and lung cancer (0.74; 95% CI, 0.70-0.77). External validation showed "reasonable agreement" for total cancers (0.63; 95% CI, 0.61-0.66); colorectal cancer (0.64; 95% CI, 0.58-0.70); and lung cancer (0.74; 95% CI, 0.70-0.78).
Overall, the model showed a median predicted absolute lifetime risk of 26% for total cancer (range, 1%-52%); 4% for colorectal cancer (range, 0%-13%); and 5% (range, 0%-37%) for lung cancer. The median predicted absolute 10-year risk was 13% for total cancer (range, 1%-31%); 2% for colorectal cancer (range, 0%-6%), and 2% for lung cancer (range, 0%-24%).
According to the researchers, the findings demonstrate that lifetime and 10-year risk of total, colorectal and lung cancer "can be estimated reasonably well" in patients with established cardiovascular disease. With further research, they note that the models could be used to motivate patients to make healthy lifestyle changes and could inform clinical practice in better targeting diagnostics and cancer screenings.
ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, notes that while there is some predictability with the model used in the present study, the predictive accuracy is not at a sufficiently high level, and cautions that a need for better models remains.
van 't Klooster CC, Ridker PM, Cook NR, et al. JACC CadioOncology 2020;[Epub ahead of print].
Thromboembolism Risk in AFib Patients With EHRA Type 2 VHD May Be Greater Than Benefit of Oral Anticoagulation
The risk of thromboembolism may be higher than the clinical benefit of oral anticoagulation in patients with atrial fibrillation (AFib) with evaluated heart valves, rheumatic or artificial (EHRA) type 2 valvular heart disease (VHD) who are not receiving oral anticoagulation currently, according to a study presented as a poster during ESC Congress 2020 and simultaneously published in JACC: Clinical Electrophysiology.
Line Melgaard, MSc, PhD, et al., evaluated the thromboembolism risk in AFib patients with and without EHRA type 2 VHD who were not on oral anticoagulant therapy. The researchers also looked at the risk of thromboembolism in patients with a risk profile in whom guidelines recommend that oral anticoagulant therapy should be considered. The primary study outcome was a thromboembolic event, defined as ischemic stroke or systemic embolism.
The study cohort consisted of 55,613 Danish patients ≥18 years with an AFib diagnosis. Patients were divided into four subgroups based on CHA2DS2-VASc score-related comorbidities (congestive heart failure, hypertension, diabetes and vascular disease) and the presence of EHRA type 2 VHD: those without EHRA type 2 VHD and no comorbidities (41,120); those with EHRA type 2 VHD and no comorbidities (1,253); those without EHRA type 2 and one comorbidity (12,586); and those with EHRA type 2 and one comorbidity (654). The risk of thromboembolism was calculated one year and five years following AFib diagnosis.
After one year, in the two subgroups of patients with no comorbidities, the thromboembolism risk was 0.8% in those without EHRA type 2 VHD (95% confidence interval [CI], 0.4%-0.6%; 301 events) and 1.4% in those with EHRA type 2 VHD (95% CI, 0.5%-2.4%; 14 events). In patients with one comorbidity, the risk was 1.2% in patients without EHRA type 2 VHD (95% CI, 1%-1.4%; 135 events) and 1.1% in those with EHRA type 2 VHD (95% CI, 0.4%-2.2%; six events).
In all patients <65 years with EHRA type 2 VHD, the risk was 1.5% regardless of whether comorbidities were present.
At five years, among patients with no comorbidities, the risk was 2.6% in patients without EHRA type 2 VHD (95% CI, 2.4%-2.8%; 824 events) and 3.5% in those with EHRA type 2 VHD (95% CI, 2.3%-5.0%; 28 events).
Meanwhile, among patients with one comorbidity, the risk was 3.5% for individuals without EHRA type 2 VHD (95% CI, 3.1%-3.9%; 322 events) and 3.7% in those with EHRA type 2 VHD (95% CI, 2.1%-6%; 16 events).
According to the researchers, the findings suggest the thromboembolism risk "may exceed the level above which oral anticoagulation is considered beneficial" in AFib patients with EHRA Type 2 VHD who are not currently recommended oral anticoagulant therapy."
Further research looking at the benefit of anticoagulation in patients with EHRA type 2 VHD "would provide more definite evidence regarding whether these patients should be recommended lifelong oral anticoagulation," they conclude.
Melgaard L, Overvad TF, Jensen M, et al. JACC Clinic Electrophysiol 2020;Aug 28:[Epub ahead of print].
Higher Rate of Adverse Outcomes, Death For Black Patients Post PCI
Patients who are Black, compared with Hispanic or white, are at an increased risk for major adverse outcomes, including death, after undergoing PCI, according to a study published in JACC: Cardiovascular Interventions.
Mordechai Golomb, MD, et al., used pooled patient-level data from 10 prospective, randomized controlled trials of PCI, classified by race, to assess the presence of racial disparities in clinical characteristics and outcomes.
The authors note the source of current raced-based PCI outcomes was registries and single-center studies, which lack central monitoring and event adjudication.
A combined total of 22,638 patients who underwent PCI were included: 20,585 (90.9%) were white (reference group), 918 (4.1%) were Black, 473 (2.1%) were Hispanic and 404 (1.8%) were Asian. Other races were excluded from the analysis due to small sample sizes. Baseline characteristics and outcomes at 30 days, one year, and five years were assessed.
The principal outcomes of interest were all-cause death, myocardial infarction (MI), and major adverse cardiac events (MACE), defined as the composite of cardiac death, MI or ischemia-driven target lesion revascularization.
The researchers found that Black and Hispanic patients had more clinical comorbidities. Furthermore, Black and Hispanic patients had worse angiographic outcomes, although they did not have higher risk angiographic features. Black and Hispanic patients, but not Asian patients, had higher unadjusted rates of adverse clinical events. After multivariate analysis, Black patients had a higher adjusted risk for adverse events, but Hispanic and Asian patients did not.
At five years, the rate of MACE was 23.9% in Black patients, 21.5% in Hispanic patients, 18.8% in white patients and 11.2% in Asian patients. An independent association was found between Black race and five-year risk for MACE on multivariate analysis.
At one year, multivariate analysis revealed that Black race was associated with an increased adjusted risk for death (hazard ratio [HR], 2.06; 95% confidence interval [CI], 1.26-3.36; p=0.004) and MI (HR, 1.45; 95% CI, 1.01-2.10; p=0.045). At five years, Black race was associated with an increased adjusted risk for MI (HR, 1.55; 95% CI, 1.15-2.09; p=0.004) and MACE (HR, 1.28; 95% CI, 1.05-1.57; p=0.01).
The authors write that "[f]urther research examining race-based outcomes after PCI is warranted to understand and mitigate these differences."
In an accompanying editorial comment, Michael G. Nanna, MD, and Eric D. Peterson, MD, MPH, FACC, write that racial health disparities require, "... widespread commitment at the community, institution, and broader legislative levels," and, "...rather than merely observe these differences over and over again for the next 30 years, there is an urgent need for action to address these, both locally and nationally."
Golomb M, Redfors B, Crowley A, et al. JACC Cardiovasc Interv 2020;13:1586-95.
VIV TAVR or Repeat Aortic Valve Surgery? Research Shows More Randomized Trials Needed
Valve-in-valve (VIV) TAVR may be associated with better short-term outcomes than redo SAVR for failed surgically implanted bioprosthetic aortic valve, according to a study published in the Journal of the American College of Cardiology. However, major cardiovascular outcomes may not be different between the two treatments during long-term follow-up.
Pierre Deharo, PHD, et al., analyzed the outcomes of VIV TAVR vs. redo SAVR at a nationwide level in France. Based on the French administrative hospital-discharge database, the study collected information from 4,327 patients treated for aortic bioprosthesis failure with isolated VIV TAVR or redo SAVR between 2010 and 2019. After propensity-score matching, there were 717 patients in each group.
Results showed that at 30 days, VIV TAVR was associated with lower rates of the composite of all-cause mortality, all-cause stroke, myocardial infarction, and major or life-threatening bleeding (odds ratio, 0.62; 95% confidence interval [CI], 0.44 to 0.88; p=0.03).
However, during a median follow-up of 516 days, the combined endpoint of cardiovascular death, all-cause stroke, myocardial infarction or rehospitalization for heart failure was not different between the two groups (odds ratio, 1.18; 95% CI, 0.99 to 1.41; p=0.26).
Furthermore, the researchers found that rehospitalization for heart failure and pacemaker implantation were more frequently reported in the VIV TAVR group. The researchers also reported a time-dependent interaction between all-cause and cardiovascular mortality following VIV TAVR.
"Randomized trials are needed to determine the optimum approach to degenerated surgically implanted aortic valve bioprostheses, but the continued evolution of TAVR technology is likely to influence the comparative outcomes," the researchers conclude.
In a related editorial comment, Michael A. Borger, MD, PHD, et al., note that "when two therapy options exist with markedly different hazard functions, properly designed prospective randomized trials are mandatory in order to guide clinical decision making."
They add, "Whether there is enough clinical equipoise within the cardiovascular community to perform a randomized trial comparing redo SAVR with VIV with adequate follow-up is arguable. However, the available data suggest that we would serve our patients best with such a randomized trial, particularly in younger, lower-risk patients presenting with failed aortic bioprostheses."
Deharo P, Bisson A, Herbert J, et al. J Am Coll Cardiol 2020;76:489-99.
Anticoagulants Associated With Better Survival, Lower Risk of Intubation in COVID-19 Patients
A retrospective observational study of in-hospital anticoagulation at prophylactic and therapeutic doses, vs. no anticoagulation, was associated with decreased morality and intubation in patients positive for COVID-19. The findings were published in the Journal of the American College of Cardiology.
The study led by Girish N. Nadkarni, MD, MPH, CPH; Anuradha Lala, MD, FACC, and colleagues at Mount Sinai in New York, extends previous research from the institution that showed improved outcomes with anticoagulation in patients hospitalized with COVID-19. Thromboembolic disease is commonly seen in the setting of COVID-19.
The researchers examined the electronic health records of 4,389 adult patients confirmed COVID-19 positive and admitted between March 1 and April 30 to five New York City hospitals in the Mount Sinai system. The median age of the patients was 65 years and 44% were female; 26% self-identified as African American and 27% as Hispanic/Latino.
For the primary outcome of in-hospital mortality, compared with no anticoagulation (n=1,530, 34.9%), therapeutic (n=900, 20.5%) and prophylactic anticoagulation (n=1,959, 44.6%) were associated with lower risk (adjusted hazard ratio [aHR], 0.53; 95% confidence interval [CI], 0.45-0.62) and aHR, 0.50; 95% CI, 0.45-0.57, respectively). The risk was also lower for the secondary endpoint of intubation (aHR 0.69; 95% CI: 0.51-0.94, and aHR 0.72; 95% CI, 0.58-0.89, respectively).
A subanalysis of patients in whom anticoagulation was initiated within 48 hours of admission showed no statistically significant difference between therapeutic (n=766) and prophylactic doses (n=1,860) (aHR 0.86, 95% CI, 0.73-1.02; p=0.08).
The secondary endpoint of major bleeding occurred in 89 (2%) patients, adjudicated by clinician review, with 27/900 (3.0%) on therapeutic, 33/1,959 (1.7%) on prophylactic, and 29/1,530 (1.9%) on no anticoagulation. Major bleeding was defined using ICD-10 codes or receiving two or more packed red blood cell transfusions with 48 hours.
The researchers also reviewed data from the first consecutive autopsies of COVID-19 patients performed at their institution and found that 11 of 26 patients (42%) had thromboembolic disease that was not suspected clinically. Of these, 3 patients (27%) were on therapeutic anticoagulation.
"This work from the Mount Sinai COVID Informatics Center provides additional insight on the role of anticoagulation in the management of patients admitted to the hospital with COVID-19," says senior corresponding author Valentin Fuster, MD, PhD, MACC.
"Although this is an observational study, it helped in the design of a large-scale international clinical trial that we are coordinating."
The randomized trial is focusing on three antithrombotic regimens, therapeutic and prophylactic subcutaneous low-molecular weight heparin and therapeutic oral apixaban, to determine the type, duration and doses for improved treatment and outcomes for patients with COVID-19.
Nadkarni GN, Lala A, Bagiella E, et al. J Am Coll Cardiol 2020;Aug 26:[Epub ahead of print].
JACC Review Provides Update on Contemporary Knowledge of SCAD
While increasing recognition of spontaneous coronary artery dissection (SCAD) has improved understanding of the disease process and highlighted shortfalls in evidence, prospective and collaborative research across centers and geography are still needed to advance the science, concludes a state-of-the-art review published in the Journal of the American College of Cardiology.
Sharonne N. Hayes, MD, FACC, et al., provide a clinical update on the diagnosis and management of patients with SCAD and highlight high-priority knowledge gaps that must be addressed. The authors note that over the past decade, SCAD has emerged as an important cause of myocardial infarction, particularly among younger women.
According to the review, many SCAD patients experience substantial post-SCAD symptoms, recurrent SCAD and psychosocial distress. However, considerable uncertainty remains about optimal management of associated conditions, risk stratification, recommendations for physical activity, reproductive planning and the role of genetic evaluations.
Some of the specific high-impact areas for further study include effects of sex, gender, race, and ethnicity on susceptibility to SCAD and the contributing roles of endogenous and exogenous hormones; identification of appropriate indications and optimal techniques for revascularization; identification and individualization of risk factors for recurrent SCAD and other major adverse cardiovascular events, including temporal risk trends; and more.
"There must be continued education to enhance awareness of the signs, symptoms, and importance of taking action to expeditiously evaluate symptoms of heart disease and accurately diagnose the etiology of [acute coronary syndrome], especially among women," the authors write.
Hayes SN, Tweet MS, Adlam D, et al. J Am Coll Cardiol 2020;76:961-84.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Dyslipidemia, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Lipid Metabolism, Nonstatins, Novel Agents, Statins
Keywords: ACC Publications, Cardiology Magazine, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Atrial Fibrillation, Anticoagulants, PCSK9 protein, human, Proprotein Convertase 9, Propensity Score, Aortic Valve, Retrospective Studies, Cardiovascular Diseases, Bioprosthesis, Patient Discharge, New York
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