Trends in Women Undergoing TAVR

Although women with significant aortic valve disease who undergo transcatheter aortic valve replacement (TAVR) are considered higher risk than men in some respects, their survival rate after one year is higher, according to research published Dec. 19 in JACC.

Using data from The Society of Thoracic Surgeons/ACC TVT Registry, the study examined more than 23,000 patients (49.9 percent women) receiving TAVR with older generation devices between 2011 and 2014. In general, women were older and had higher predicted 30-day risk scores and were more likely to have other health issues at baseline, such as worsened kidney function, significant problems related to a leaking mitral heart valve and porcelain aorta. Men were more likely to be treated with percutaneous TAVR, while women were more likely to have a surgical incision for TAVR. Additionally, although very rare, there was a greater chance of the operating cardiologist or surgeon needing to abort TAVR and switch over to open heart surgery in women as a result of complications.

Despite experiencing more procedural problems, however, lower mortality was observed in women at one year compared with men (21.3 percent vs. 24.5 percent). The authors also found that with smaller and improved TAVR devices, women are increasingly able to undergo procedures percutaneously via the smaller artery in the groin, which could further reduce the risk of procedural complications.

“These findings are significant because it may mean heart teams are overestimating the risks of TAVR in some women and that also may mean that valve replacement is underutilized,” said Roxana Mehran, MD, FACC, the study’s senior researcher and chair of ACC’s Interventional Section. “In other words, some women who could benefit from TAVR may not be getting it. These study results also highlight that we need a robust scoring assessment that is specific to TAVR and catered to women so we can make the best decisions. Additionally, further study is needed on the medium- to long-term causes of death in men and women who have had TAVR, particularly studies that are focused on learning more about vascular biology and why the aorta becomes more calcified in women.”

In a related editorial comment, Molly Szerlip, MD, FACC, cautions that “the findings of this study are only applicable to the population that was studied and should not necessarily be extrapolated to lower risk populations or to patients who receive newer generation valves.”

Chandrasekhar J, Dangas G, Yu J, et al. J Am Coll Cardiol 2016;68:2733-44.

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NCDR Study Shows High Survival Rate For Elderly Patients With ICDs

Almost 80 percent of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac arrest or a near-fatal arrhythmia survived two years, according to a study published Jan. 16 in JACC.

Frederick A. Masoudi, MD, MSPH, FACC, and colleagues used data from ACC’s ICD Registry to examine 12,420 Medicare beneficiaries undergoing an ICD implantation after surviving sudden cardiac arrest or a near-fatal ventricular arrhythmia, between 2006 and 2009 in almost 1,000 U.S. hospitals.

The researchers found 65.4 percent of patients were hospitalized during the two years after receiving an ICD, ranging from 60.5 percent in those less than age 70, to 71 .5 percent in those 80 and older. In addition, 13.1 percent among those less than 70 years old and 21.9 percent of those 80 and older were admitted to a skilled nursing facility. The authors note that the risk of admission to a skilled nursing facility was greatest in the first 30 days after the procedure. The risks of hospitalization and admission to skilled nursing facility were all greater with increasing patient age. The high hospitalization and skilled nursing facility admission rates, particularly among the oldest patients, indicate there are substantial care needs after an ICD is implanted, the authors conclude.

In an accompanying editorial, Sumeet S. Chugh, MD, FACC, writes that the findings from the study would suggest that although patients over age 75 implanted with ICDs after a sudden cardiac arrest or near-fatal ventricular arrhythmia “may have reasonable overall survival, they also have significantly high rates of admission to hospitals and skilled nursing facilities, with no clear evidence of mortality benefit from the device.”

He adds that until more research is done about the devices in elderly patients, doctors should consider non–heart-related co-occurring medical conditions and frailty along with age in their decision-making process about ICDs. They should provide the patient with a clear understanding of the rationale and limitations of the ICD, encourage advance directives and raise the possibility of deactivating the ICD if the patient is nearing end of life.

Betz JK, Katz DF, Peterson PN, et al. J Am Coll Cardiol 2017;69:265-74.

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DAPT vs. Aspirin Monotherapy in Diabetics Undergoing CABG

Routine use of dual antiplatelet therapy (DAPT) may not be clinically warranted compared with aspirin monotherapy based on results from a recent study published in JACC that shows no associated differences in cardiovascular or bleeding outcomes.

In a post-hoc, nonrandomized analysis from the FREEDOM trial, researchers compared 544 patients receiving DAPT (aspirin plus thienopyridine) and 251 patients receiving aspirin monotherapy at 30 days postoperatively. The primary outcome was the risk-adjusted five-year FREEDOM composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Safety outcomes included major bleeding, blood transfusion and hospitalization for bleeding.

Results showed no significant difference in the five-year primary composite outcome between DAPT and aspirin-treated patients (12.6 percent vs. 16.0 percent, adjusted hazard ratio [HR], 0.83; 95 percent confidence interval [CI], 0.54-1.27; p = 0.39). The five-year primary composite outcomes were similar for patients receiving DAPT versus aspirin monotherapy, respectively, in subgroups with pre-CABG acute coronary syndrome (15.2 percent vs. 16.5 percent) and those with stable angina (11.6 percent vs. 15.8 percent). The composite outcomes of both treatment groups were also similar by SYNTAX score, duration of DAPT therapy, completeness of revascularization, and in off-pump CABG. No treatment-related differences were observed between the aspirin and DAPT-treated groups, respectively, in terms of major bleeding (5.6 percent vs. 5.7 percent), blood transfusions (4.8 percent vs. 4.5 percent), or hospitalization for bleeding (2.6 percent vs. 3.3 percent).

“The routine use of DAPT in post-CABG diabetic patients should be reassessed in an adequately powered, prospective, randomized clinical outcome trial,” writes Debabrata Mukherjee, MD, FACC, in an ACC.org Journal Scan.

van Diepen S, Fuster V, Verma S, et al. J Am Coll Cardiol 2017;69:119-27.

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Apixaban in AFib Patients Following Transfemoral AVR?

What is the impact of atrial fibrillation (AFib) on outcomes associated with transfemoral aortic valve replacement, and what are the safety and efficacy outcomes associated with apixaban versus vitamin K antagonists in these patients? A recently published study in JACC: Cardiovascular Interventions sheds new light on these questions.

The study enrolled 617 patients, 345 of whom were in sinus rhythm and 272 who were in AFib. Clinical follow-up was performed at 30 days and 12 months. The composite safety endpoints included all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary obstruction, major vascular complications and valve dysfunction requiring re-intervention.

Results showed that early composite safety endpoints at 30 days were significantly higher in AFib (23.2 percent) vs. sinus rhythm (11.0 percent) patients (p < 0.01). At 12 months, the composite of all-cause mortality and stroke were also higher in AFib (20.6 percent) vs. sinus rhythm (9.7 percent) patients (p = 0.02).

In terms of treatment, researchers noted that 51.8 percent of AFib patients were treated with apixaban, compared with 48.2 percent of AFib patients who were treated with vitamin K antagonists. Data showed that early safety endpoints at 30 days were lower among apixaban-treated patients (13.5 percent) vs. vitamin K antagonist-treated patients (30.5 percent). Groups were compared using Kaplan-Meier estimates.

“This single-center registry of TAVR patients demonstrated that comorbid AFib is associated with higher mortality rates at 30 days and one year, as compared with patients in sinus rhythm,” writes Geoffrey D. Barnes, MD, FACC, in an ACC.org Journal Scan. “While this is not a new finding, the association between use of apixaban and lower rates of 30-day safety endpoints is novel and important. …This study provides reassuring data on the safety and efficacy of apixaban among patients receiving bioprosthetic TAVR, and should be a consideration for patients with comorbid AFib undergoing TAVR procedures.”

Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. JACC Cardiovasc Interv 2017;10:66-74.

Keywords: Cardiology Interventions, ACC Publications, Acute Coronary Syndrome, Acute Kidney Injury, Advance Directives, Angina, Stable, Aorta, Aortic Valve, Atrial Fibrillation, Blood Transfusion, Death, Sudden, Cardiac, Defibrillators, Implantable, Diabetes Mellitus, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Medicare, Myocardial Infarction, Poecilia, Pyrazoles, Pyridones, Registries, Stroke, Surgeons, Transcatheter Aortic Valve Replacement

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