Michael J. Mack M.D.

Russo, M.J., Thourani, V.H., Cohen, D.J., Malaisrie, S.C., Szeto, W.Y., George, I., Kodali, S.K., Makkar, R., Lu, M., Williams, M., Nguyen, T., Aldea, G., Genereux, P., Fang, H.K., Alu, M.C., Rogers, E., Okoh, A., Herrmann, H.C., Kapadia, S., Webb, J.G., Smith, C.R., Leon, M.B. and Mack, M.J. (2021). “Minimally Invasive versus Full Sternotomy for Isolated Aortic Valve Replacement in Low-risk Patients.” Ann Thorac Surg Dec 24;S0003-4975(21)02134-2. [Epub ahead of print].

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BACKGROUND: Surgical aortic valve replacement can be performed either through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI versus FS for isolated surgery among patients enrolled in the PARTNER 3 low-risk trial. METHODS: Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite endpoint of death, stroke, or rehospitalization (valve-, procedure-, or heart-failure-related) at 1 year. Secondary outcomes included the individual components of the primary endpoint as well as patient-reported health status at 30 days and 1 year. RESULTS: In the PARTNER 3 study, 358 patients underwent isolated surgery at 68 centers through an MI (n=107) or FS (n=251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI versus FS groups (16.9% versus 14.9%; hazard ratio [95% CI]: 1.15 [0.66 – 2.03]; P=0.618). There were no significant differences in the 1-year rates of all-cause death (2.8% versus 2.8%), all stroke (1.9% versus 3.6%), or rehospitalization (13.3% versus 10.6%, P > 0.05 for all). Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year was comparable in both groups. CONCLUSIONS: For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes.

Lala, A., Chang, H.L., Liu, X., Charles, E.J., Yerokun, B.A., Bowdish, M.E., Thourani, V.H., Mack, M.J., Miller, M.A., O’Gara, P.T., Blackstone, E.H., Moskowitz, A.J., Gelijns, A.C., Mullen, J.C. and Stevenson, L.W. (2021). “Risk for non-home discharge following surgery for ischemic mitral valve disease.” J Thorac Cardiovasc Surg 162(6): 1769-1778.e1767.

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OBJECTIVES: To determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR). METHODS: Discharge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed. RESULTS: NHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P < .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P < .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups. CONCLUSIONS: NHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.

Grapsa, J., Blauth, C., Chandrashekhar, Y.S., Prendergast, B., Erb, B., Jr., Mack, M. and Fuster, V. (2021). “Staphylococcus Aureus Infective Endocarditis: JACC Patient Pathways.” J Am Coll Cardiol Nov 13;S0735-1097(21)07811-6. [Epub ahead of print].

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A 19-year-old female patient presented with Staphylococcus aureus infective endocarditis, with suspected subdural brain hemorrhage, disseminated intravascular coagulopathy, and septic renal as well as spleen infarcts. The patient had extensive vegetations on the mitral and tricuspid valves and underwent urgent mitral and tricuspid repair. This paper discusses the clinical case and current evidence regarding the management and treatment of Staphylococcus aureus endocarditis.

Gammie, J.S., Chu, M.W.A., Falk, V., Overbey, J.R., Moskowitz, A.J., Gillinov, M., Mack, M.J., Voisine, P., Krane, M., Yerokun, B., Bowdish, M.E., Conradi, L., Bolling, S.F., Miller, M.A., Taddei-Peters, W.C., Jeffries, N.O., Parides, M.K., Weisel, R., Jessup, M., Rose, E.A., Mullen, J.C., Raymond, S., Moquete, E.G., O’Sullivan, K., Marks, M.E., Iribarne, A., Beyersdorf, F., Borger, M.A., Geirsson, A., Bagiella, E., Hung, J., Gelijns, A.C., O’Gara, P.T. and Ailawadi, G. (2021). “Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.” N Engl J Med Nov 13. [Epub ahead of print].

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BACKGROUND: Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation. METHODS: We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death. RESULTS: Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60). CONCLUSIONS: Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

Piccini, J. P., A. Ahlsson, P. Dorian, M. A. Gillinov, P. R. Kowey, M. J. Mack, C. A. Milano, L. P. Perrault, J. S. Steinberg, N. H. Waldron, L. M. Adams, D. B. Bharucha, M. F. Brin, W. G. Ferguson and S. Benussi (2021). “Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation – The NOVA Study.” Am Heart J Oct 20;S0002-8703(21)00366-5. [Epub ahead of print].

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BACKGROUND: Post-operative AF (POAF) is the most common complication following cardiac surgery, occurring in 30% to 60% of patients undergoing bypass and/or valve surgery. POAF is associated with longer intensive care unit/hospital stays, increased healthcare utilization, and increased morbidity and mortality. Injection of botulinum toxin type A into the epicardial fat pads resulted in reduction of AF in animal models, and in 2 clinical studies of cardiac surgery patients, without new safety observations. METHODS: The objective of NOVA is to assess the use of AGN-151607 (botulinum toxin type A) for prevention of POAF in cardiac surgery patients. This randomized, multi-site, placebo-controlled trial will study one-time injections of AGN-151607 125 U (25 U / fat pad) and 250 U (50 U / fat pad) or placebo during cardiac surgery in ∼330 participants. Primary endpoint: % of patients with continuous AF ≥ 30 s. Secondary endpoints include several measures of AF frequency, duration, and burden. Additional endpoints include clinically important tachycardia during AF, time to AF termination, and healthcare utilization. Primary and secondary efficacy endpoints will be assessed using continuous ECG monitoring for 30 days following surgery. All patients will be followed for up to 1 year for safety. CONCLUSION: The NOVA Study will test the hypothesis that injections of AGN-151607 will reduce the incidence of POAF and associated resource utilization. If demonstrated to be safe and effective, the availability of a one-time therapy for the prevention of POAF would represent an important treatment option for patients undergoing cardiac surgery.