Cardiology

Natale, A., Calkins, H., Osorio, J., Pollak, S.J., Melby, D., Marchlinski, F.E., Athill, C.A., Delaughter, C., Patel, A.M., Gentlesk, P.J., DeVille, B., Macle, L., Ellenbogen, K.A., Dukkipati, S.R., Reddy, V.Y. and Mansour, M. (2020). “Positive Clinical Benefit on Patient Care, Quality of Life and Symptoms After Contact-Force Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses from PRECEPT Prospective Multicenter Study.” Circ Arrhythm Electrophysiol Dec 8. [Epub ahead of print].

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Background – There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation (PsAF). Methods – PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated Investigational Device Exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs (AADs), rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF) score. Results – A total of 333 enrolled PsAF patients underwent ablation. The cardioversion rate decreased by 83% at the 9-15 months follow-up. AAD utilization decreased by 69% at 12-15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% [95% confidence interval: 80.2%, 88.2%] at 15 months. Consistent improvements in mean AFEQT composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in AFEQT scores were significantly better among participants without documented atrial arrhythmia recurrences. By CCS-SAF symptom classification, over 80% of patients were asymptomatic (Class 0) at 15 months post-ablation compared to only 0.7% at baseline. Conclusions – Contact force-guided radiofrequency ablation of PsAF was associated with a significant decrease in AAD use, cardioversion rate and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. Majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced healthcare utilization may help with shared decision making in PsAF treatment.

McCullough, P.A. and Oskoui, R. (2020). “Early multidrug regimens in new potentially fatal medical problems.” Rev Cardiovasc Med 21(4): 507-508.

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The SARS-CoV-2 (COVID-19) pandemic has been the greatest challenge to medical practice in decades. We have witnessed fear, panic, confusion, division, and a wide array of regulatory and public health responses to the crisis (National Institutes of Health, 2020). We believe it is important for all physicians to keep in mind this pandemic is an emergency crisis and is not a usual context for drug development, guidelines, and recommendations for patient practice. In cardiovascular medicine we have had many disruptive forces as the field has evolved and we have witnessed reasonable responses with respect to pharmacotherapy when there was an absence of randomized trials to first guide the approach. [No abstract; excerpt from article].

Holmes, D.R., Jr., Farb, A.A., Chip Hance, R., Leon, M.B., Goldberg, P., Zuckerman, B.D., Kaplan, A.V., Rincon-Gonzalez, L., Hunt, J., Walkowiak, J. and Mack, M.J. (2020). “Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.” J Am Coll Cardiol 76(23): 2786-2794.

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The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success.

Filardo, G., Pollock, B.D., da Graca, B., Sass, D.M., Phan, T.K., Montenegro, D.E., Ailawadi, G., Thourani, V.H. and Damiano, R.J., Jr. (2020). “Lower Survival After Coronary Artery Bypass in Patients Who Had Atrial Fibrillation Missed by Widely Used Definitions.” Mayo Clin Proc Innov Qual Outcomes 4(6): 630-637.

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OBJECTIVE: To investigate the impact of limiting the definition of post-coronary artery bypass graft (CABG) atrial fibrillation (AF) to AF/flutter requiring treatment-as in the Society of Thoracic Surgeons’ (STS) database- on the association with survival. PATIENTS AND METHODS: We assessed in-hospital incidence of post-CABG AF in 7110 consecutive isolated patients with CABG without preoperative AF at 4 hospitals (January 1, 2004 to December 31, 2010). Patients with ≥1 episode of post-CABG AF detected via continuous in-hospital electrocardiogram (ECG)/telemetry monitoring documented by physicians were assigned to the following: Group 1, identified as having post-CABG AF in STS data and Group 2, not identified as having post-CABG AF in STS data. Patients without documented post-CABG AF constituted Group 3. Survival was compared via a Cox model, adjusted for STS risk of mortality and accounting for site differences. RESULTS: Over 7 years’ follow-up, 16.0% (295 of 1841) of Group 1, 18.7% (79 of 422) of Group 2, and 7.9% (382 of 4847) of Group 3 died. Group 2 had a significantly greater adjusted risk of death than both Group 1 (hazard ratio [HR]: 1.16; 95% confidence interval [CI], 1.02 to 1.33) and Group 3 (HR: 1.94; 95% CI, 1.69 to 2.22). CONCLUSIONS: The statistically significant 16% higher risk of death for patients with AF post-CABG missed vs captured in STS data suggests treatment and postdischarge management should be investigated for differences. The historical misclassification of “missed” patients as experiencing no AF in the STS data weakens the ability to observe differences in risk between patients with and without post-CABG AF. Therefore, STS data should not be used for research examining post-CABG AF.

Elbadawi, A., Ugwu, J., Elgendy, I.Y., Megaly, M., Ogunbayo, G.O., Omer, M.A., Elzeneini, M., Chatila, K., Al-Azizi, K., Goel, S.S. and Gafoor, S. (2021). “Outcomes of transcatheter versus surgical aortic valve replacement among solid organ transplant recipients.” Catheter Cardiovasc Interv Jan 5. [Epub ahead of print].

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BACKGROUND: There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid-organ transplant recipients. METHODS: Temporal trends in hospitalizations for aortic valve replacement among solid-organ transplant recipients were determined using the National Inpatient Sample database years 2012-2017. Propensity matching was conducted to compare admissions who underwent TAVR versus SAVR. The primary outcome was in-hospital mortality. RESULTS: The analysis included 1,730 hospitalizations for isolated AVR; 920 (53.2%) underwent TAVR and 810 (46.7%) underwent SAVR. TAVR was increasingly utilized for solid-organ transplant recipients (P(trend) = 0.01), while there was no change in the number of SAVR procedures (P(trend) = 0.20). The predictors of undergoing TAVR for solid-organ transplant recipients included older age, diabetes, and prior coronary artery bypass surgery, while TAVR was less likely utilized in small-sized hospitals. TAVR was associated with lower in-hospital mortality after matching (0.9 vs. 4.7%, odds ratio [OR] 0.19; 95% confidence interval [CI] 0.11-0.35, p < .001) and after multivariable adjustment (OR 0.07; 95% CI 0.03-0.21, p < .001). TAVR was associated with lower rate of acute kidney injury, acute stroke, postoperative bleeding, blood transfusion, vascular complications, discharge to nursing facilities, and shorter median length of hospital stay. There was no difference between both groups in the use of mechanical circulatory support, hemodialysis, arrhythmias, or pacemaker insertion. CONCLUSION: This contemporary observational nationwide analysis showed that TAVR is increasingly performed among solid-organ transplant recipients. Compared with SAVR, TAVR was associated with lower in-hospital mortality, complications, and shorter length of stay.