Cardiology

Cubeddu, R.J., Asher, C.R., Lowry, A.M., Blackstone, E.H., Kapadia, S.R., Alu, M.C., Thourani, V.H., Mack, M.J., Kodali, S.K., Herrmann, H.C., Forcillo, J., Babaliaros, V.C., Devireddy, C.M., Malaisrie, S.C., Davidson, C.J., Jaber, W.A., Leon, M.B. and Svensson, L.G. (2020). “Impact of Transcatheter Aortic Valve Replacement on Severity of Chronic Kidney Disease.” J Am Coll Cardiol 76(12): 1410-1421.

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BACKGROUND: The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in improved kidney function by alleviating cardiorenal syndrome. OBJECTIVES: The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality. METHODS: Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed. RESULTS: At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival. CONCLUSIONS: In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR.

Hahn, R.T., Asch, F., Weissman, N.J., Grayburn, P., Kar, S., Lim, S., Ben-Yehuda, O., Shahim, B., Chen, S., Liu, M., Redfors, B., Medvedofsky, D., Puri, R., Kapadia, S., Sannino, A., Lindenfeld, J., Abraham, W.T., Mack, M.J. and Stone, G.W. (2020). “Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.” J Am Coll Cardiol 76(11): 1305-1314.

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BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). OBJECTIVES: This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed. RESULTS: Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p(interaction) = 0.16, 0.29, and 0.21 respectively). CONCLUSIONS: Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).

Wilkoff, B.L., Boriani, G., Mittal, S., Poole, J.E., Kennergren, C., Corey, G.R., Krahn, A.D., Schloss, E.J., Gallastegui, J.L., Pickett, R.A., Evonich, R.F., Roark, S.F., Sorrentino, D.M., Sholevar, D.P., Cronin, E.M., Berman, B.J., Riggio, D.W., Khan, H.K., Silver, M.T., Collier, J., Eldadah, Z., Holbrook, R., Lande, J.D., Lexcen, D.R., Seshadri, S. and Tarakji, K.G. (2020). “Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.” Circ Arrhythm Electrophysiol 13(10): e008503. /p>

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BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Hassan, M.F., Mixon, T., Gray, W.T. and Reddy, R. (2020). “Occlusion following the deployment of MANTA VCD after TAVR.” J Card Surg Sep 16. [Epub ahead of print.].

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BACKGROUND: We present a complication following the deployment of the MANTA vascular closure device (VCD) following a transcatheter aortic valve replacement procedure which resulted in occlusion of the common femoral artery. AIMS: To address possible complications associated with MANTA VCD. RESULTS: This was addressed by ballooning the site from the contralateral side which re-established flow. CONCLUSION: We believe this is the first report to address this kind of complication and may prove useful as more of the MANTA devices are being used in multiple procedures.

Hamadeh, A., Aldujeli, A., Briedis, K., Tecson, K.M., Sanz-Sánchez, J., Al Dujeili, M., Al-Obeidi, A., Diez, J.L., Žaliūnas, R., Stoler, R.C. and McCullough, P.A. (2020). “Characteristics and Outcomes in Patients Presenting With COVID-19 and ST-Segment Elevation Myocardial Infarction.” Am J Cardiol 131: 1-6.

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There is limited information regarding clinical characteristics and outcomes of patients with SARS-CoV-2 (COVID-19) disease presenting with ST-segment elevation myocardial infarction (STEMI). In this multicenter retrospective study, we reviewed charts of patients admitted with symptomatic COVID-19 infection and STEMI to a total of 4 hospitals spanning Italy, Lithuania, Spain and Iraq from February 1, 2020 to April 15, 2020. A total of 78 patients were included in this study, 49 (63%) of whom were men, with a median age of 65 [58, 71] years, and high comorbidity burden. During hospitalization, 8 (10%) developed acute respiratory distress syndrome, and 14 (18%) required mechanical ventilation. 19 (24%) patients were treated with primary Percutaneous Coronary Intervention (PCI) and 59 (76%) were treated with fibrinolytic therapy. 13 (17%) patients required cardiac resuscitation, and 9 (11%) died. For the 19 patients treated with primary PCI, 8 (42%) required intubation and 8 (42%) required cardiac resuscitation; stent thrombosis occurred in 4 patients (21%). A total of 5 patients (26%) died during hospitalization. 50 (85%) of the 59 patients initially treated with fibrinolytic therapy had successful fibrinolysis. The median time to reperfusion was 27 minutes [20, 34]. Hemorrhagic stroke occurred in 5 patients (9%). Six patients (10%) required invasive mechanical ventilation; 5 (9%) required cardiac resuscitation, and 4 (7%) died. In conclusion, this is the largest case series to-date of COVID-19 positive patients presenting with STEMI and spans 4 countries. We found a high rate of stent thrombosis, indicating a possible need to adapt STEMI management for COVID-19 patients.