Cardiology

Hamandi, M., A. T. Lanfear, J. Fan, M. L. Bolin, J. M. DiMaio, R. L. Smith and C. Dib (2020). “Incidental finding of giant coronary artery aneurysm.” J Card Surg 35(1): 200-201.

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A 58‐year‐old asymptomatic man presented to our institution after a routine cardiac computed tomography (CT) for calcium scoring. He did not have any history of connective tissue disorders or Kawasaki disease. CT angiogram confirmed the presence of a coronary artery aneurysm (CAA) measuring 10.3 × 6.8 cm arising from the right coronary artery (RCA) with true lumen enhancement. The rest of the aneurysm was thrombosed, and distal calcification of the RCA was also noted. Management for patients with CAA is not standardized, as CAAs appear in only 0.3% to 5.3% of patients undergoing coronary angiographies, while “giant” CAAs (>5 cm) appear in less than 0.02%. Surgical or percutaneous intervention and antiplatelet/anticoagulation therapy are commonly reported. Due to the rarity of giant coronary aneurysms, there is no standardized management strategy supported by controlled trials. Data assessing the risk of mortality associated with these management options is sparse. The patient was referred for aneurysm ligation with distal bypass grafting due to the size and potential high risk of rupture and the risk of distal embolization which can result in myocardial ischemia or infarction. His perioperative risk of mortality and morbidity was deemed to be extremely low. Following the median sternotomy, the aneurysm was opened and the large orifice of the main right coronary artery was noted. The right coronary ostium was ligated and the old mural thrombus within the aneurysm was removed. The patient underwent coronary artery bypass grafting. The clinical course was uneventful and he was discharged on postoperative day 4. In conclusion, the management of a giant coronary artery aneurysm should be guided by the patient’s clinical presentation and perioperative risk, the size of the aneurysm, and the final decision should be made by an experienced Heart Team approach. (Excerpt from text of this image study, p. 200-201; no abstract available.)

Docherty, K. F., L. Shen, D. Castagno, M. C. Petrie, W. T. Abraham, M. Bohm, A. S. Desai, K. Dickstein, L. V. Kober, M. Packer, J. L. Rouleau, S. D. Solomon, K. Swedberg, A. Vazir, M. R. Zile, P. S. Jhund and J. J. V. McMurray (2019). “Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction.” Eur J Heart Fail Dec 17. [Epub ahead of print].

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AIMS: To investigate the relationship between heart rate and outcomes in heart failure and reduced ejection fraction (HFrEF) patients in sinus rhythm (SR) and atrial fibrillation (AF) adjusting for natriuretic peptide concentration, a powerful prognosticator. METHODS AND RESULTS: Of 13 562 patients from two large HFrEF trials, 10 113 (74.6%) were in SR and 3449 (25.4%) in AF. The primary endpoint was the composite of cardiovascular death or heart failure hospitalization. Heart rate was analysed as a categorical (tertiles, T1-3) and continuous variable (per 10 bpm), separately in patients in SR and AF. Outcomes were adjusted for prognostic variables, including N-terminal prohormone of B-type natriuretic peptide (NT-proBNP), and also examined using change from baseline heart rate to 1 year (/= +10 bpm, < +/-10 bpm). SR patients with a higher heart rate had worse symptoms and quality of life, more often had diabetes and higher NT-proBNP concentrations. They had higher risk of the primary endpoint [T3 vs. T1 adjusted hazard ratio (HR) 1.50, 95% confidence interval (CI) 1.35-1.66; P < 0.001; per 10 bpm: 1.12, 95% CI 1.09-1.16; P < 0.001]. In SR, heart rate was associated with a relatively higher risk of pump failure than sudden death (adjusted HR per 10 bpm 1.17, 95% CI 1.09-1.26; P < 0.001 vs. 1.07, 95% CI 1.02-1.13; P = 0.011). Heart rate was not predictive of any outcome in AF. CONCLUSIONS: In HFrEF, an elevated heart rate was an independent predictor of adverse cardiovascular outcomes in patients in SR, even after adjustment for NT-proBNP. There was no relationship between heart rate and outcomes in AF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers NCT01035255 and NCT00853658.

Chhatriwalla, A. K., S. Vemulapalli, M. Szerlip, S. Kodali, R. T. Hahn, J. T. Saxon, M. J. Mack, G. Ailawadi, J. Rymer, P. Manandhar, A. S. Kosinski and P. Sorajja (2019). “Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States.” J Am Coll Cardiol 74(24): 2955-2965.

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BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVES: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr. METHODS: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (less-than-or-equal-to 1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (less-than-or-equal-to 2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases. CONCLUSIONS: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Butler, J., M. Packer, S. J. Greene, M. Fiuzat, S. D. Anker, K. J. Anstrom, P. E. Carson, L. B. Cooper, G. C. Fonarow, A. F. Hernandez, J. L. Januzzi, Jr., M. Jessup, R. R. Kalyani, S. Kaul, M. Kosiborod, J. Lindenfeld, D. K. McGuire, M. S. Sabatine, S. D. Solomon, J. R. Teerlink, M. Vaduganathan, C. W. Yancy, N. Stockbridge and C. M. O’Connor (2019). “Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.” Circulation 140(25): 2108-2118.

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Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Asch, F. M., P. A. Grayburn, R. J. Siegel, S. Kar, D. S. Lim, J. G. Zaroff, J. M. Mishell, B. Whisenant, M. J. Mack, J. Lindenfeld, W. T. Abraham, G. W. Stone and N. J. Weissman (2019). “Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial.” J Am Coll Cardiol 74(24): 2969-2979.

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BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation, patients treated with transcatheter mitral valve repair (TMVr) through leaflet approximation had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: The purpose of this study was to describe the echocardiographic patient qualification process for the COAPT trial, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes. METHODS: A novel echocardiographic algorithm was implemented for grading mitral regurgitation severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and were analyzed by a core laboratory. RESULTS: A total of 614 patients were randomized to TMVr plus maximally tolerated GDMT or GDMT alone. Mean baseline left ventricular (LV) ejection fraction was 31.3 +/- 9.3%, LV end-diastolic volume was 192.7 +/- 71 ml, and effective regurgitant orifice area was 0.41 +/- 0.15 cm(2). The beneficial effect of TMVr compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual mitral regurgitation characteristics. The LV ejection fraction decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVr (p < 0.05). CONCLUSIONS: HF patients in the COAPT trial with 3+ or 4+ secondary mitral regurgitation, selected using strict echocardiographic criteria, benefitted from TMVr with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).